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Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A330-841 and -941 airplanes. This AD was prompted by a report of erroneous electronic centralized airplane monitoring (ECAM) warnings for low engine oil pressure, which can lead to a commanded shutdown of an engine. This AD requires installing serviceable engine electronic control (EEC) software or EEC units having the serviceable software, limiting certain parts installation configurations, and prior or concurrent modification of EEC software, 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 October 20, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 20, 2022.
For EASA material incorporated by reference (IBR) in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
You may examine the AD docket at
Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3229; email
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0198, dated August 27, 2021 (EASA AD 2021-0198) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A330-841 and -941 airplanes.
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus SAS Model A330-841 and -941 airplanes. The NPRM published in the
The FAA is issuing this AD to address erroneous ECAM engine oil pressure warnings, which could lead to dual engine in-flight shutdown and result in reduced control of the airplane. See the MCAI for additional background information.
The FAA received comments from three commenters, including Delta Air Lines and two individuals. The following presents the comments received on the NPRM and the FAA's response to each comment.
Delta Air Lines (Delta) requested adding paragraph (k), “Material Incorporated by Reference,” to the proposed AD that states the incorporation by reference of EASA AD 2021-0198. Delta supported the improved efficiency of FAA ADs that reference EASA ADs as a primary source of information for accomplishing the requirements of FAA ADs.
The FAA agrees to add paragraph (k) to this AD to identify the material that is incorporated by reference. In ADs, whenever there is material to be incorporated by reference, the paragraph that states which material has been approved by the Director of the Federal Register for incorporation by reference is typically added to final rules, not NPRMs.
Two individuals generally disagreed with the proposed AD without any further justification.
The FAA infers that these individuals are requesting that the FAA withdraw the proposed AD. The FAA disagrees with withdrawing the proposed AD. The FAA has determined that the issuance of an airworthiness directive is the appropriate method to correct the unsafe condition described in this AD. The FAA has not changed the AD in this regard.
The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires
EASA AD 2021-0198 specifies procedures for installing serviceable EEC software or EEC units having the serviceable software, limiting certain parts installation configurations, and prior or concurrent modification of EEC software. 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 11 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
The FAA has received no definitive data on which to base the cost estimates for the software update specified in this AD.
According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in the cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
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 October 20, 2022.
None.
This AD applies to all Airbus SAS Model A330-841 and -941 airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 73, Engine Fuel & Control.
This AD was prompted by a report of erroneous electronic centralized airplane monitoring (ECAM) warnings for low engine oil pressure, which can lead to a commanded shutdown of an engine. The FAA is issuing this AD to address erroneous ECAM engine oil pressure warnings, which could lead to dual engine in-flight shutdown and result in reduced control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2021-0198, dated August 27, 2021 (EASA AD 2021-0198).
(1) Where EASA AD 2021-0198 refers to its effective date or “10 September 2021,” this AD requires using the effective date of this AD.
(2) Where paragraphs (5) and (6) of EASA AD 2021-0198 refers to “From 10 September 2021 . . . until 09 September 2023,” this AD requires using “from the effective date of this AD up to 24 months after the effective date of this AD.”
(3) Where paragraph (7) of EASA AD 2021-0198 refers to “10 September 2023,” this AD requires using 24 months after the effective date of this AD.
(4) This AD does not mandate compliance with the “Remarks” section of EASA AD 2021-0198.
The following provisions also apply to this AD:
(1)
(2)
(3)
For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3229; 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) European Union Aviation Safety Agency (EASA) AD 2021-0198, dated August 27, 2021.
(ii) [Reserved]
(3) For EASA AD 2021-0198, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; 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), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for certain The Boeing Company Model 737-8 airplanes. This AD was prompted by a report that, during production, a small number of fasteners in certain locations of the center fuel tank were cap sealed on top of a black stripe of ink with a clear overcoat. This clear overcoat is not an approved surface for sealing and can potentially compromise sealant adhesion. Compromised sealant adhesion can, over time, affect the lightning-protection properties of the airplane. This AD requires preparation of the affected surface areas to ensure that there is adequate sealant adhesion, and complete encapsulation of the discrepant fastener locations with the approved production sealant. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective October 20, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 20, 2022.
For service information identified in this final rule, 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
Chris Baker, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3552; 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 The Boeing Company Model 737-8 airplanes. The NPRM published in the
Compromised sealant adhesion can, over time, affect the lightning protection properties of the airplane. In the NPRM, the FAA proposed to require preparation of the affected surface areas to ensure that there is adequate sealant adhesion, and complete encapsulation of the discrepant fastener locations with
The FAA received comments from Air Line Pilots Association, International (ALPA) and an anonymous commenter, who supported the NPRM without change.
The FAA received additional comments from two commenters, Boeing and Southwest Airlines (SWA). The following presents the additional comments received on the NPRM and the FAA's response to each comment.
SWA requested that the FAA provide an option to operators that would allow removal of the current application of BMS5-45 sealant in the affected areas and removal of the black stripe of ink in accordance with certain operator procedures (or other acceptable procedures), then allowing for refinishing and sealing of the affected area in accordance with certain other operator instructions. SWA reasoned that these additional methods would address the unsafe condition and would allow airworthiness limitation (AWL) inspections and standard maintenance to be accomplished as intended in the structural repair manual (SRM) and maintenance planning document (MPD).
SWA explained that it is concerned that extending BMS5-45 sealant 0.6 inches beyond the current production application area could prevent inspections performed in accordance with 737-7/8/8200/9/10 Airworthiness Limitations (AWL) D626A011-9-04 and MPD principal structural element (PSE) 57-020-00. SWA went on to explain that extending the BMS5-45 sealant up to 0.6 inches beyond the current production application area to encapsulate the discrepant area contradicts the sealant restoration procedures outlined in 737-8MAX SRM 51-80-01 which states, “SEALANT MUST NOT EXTEND MORE THAN 0.125 INCH (3.18mm) ON TO THE SURFACE OF THE PART FOR DAMAGE TOLERANCE INSPECTION REASONS.” SWA expressed concern that if an airplane requires repairs or maintenance actions in the affected area, or requires AWL/MPD required inspection 57-020-00, the BMS5-45 sealant will be stripped and, if the affected area is restored in accordance with 737-8MAX SRM 51-80-01, could lead to an operator inadvertently undoing the actions specified in Boeing Special Attention Requirements Bulletin 737-57-1352 RB, dated February 1, 2021.
The FAA agrees that the service bulletin instructions could conflict with future actions required by the 737-7/8/8200/9/10 Airworthiness Limitations (AWL) D626A011-9-04, in that the added sealant might impede the operator's ability to inspect the structure. The FAA also agrees that operators could use the existing sealant restoration procedures to remove the current application of BMS5-45 sealant in the discrepant areas, remove the black stripe of ink in accordance with acceptable surface preparation procedures, and reseal the fasteners in accordance with standard sealing procedures of fasteners penetrating the fuel tank. The FAA has added an optional method of removing the existing sealant and black stripe of ink prior to reapplying a fastener seal in paragraph (h) of this AD and redesignated subsequent paragraphs.
Boeing requested that the unsafe condition statement found in the Background section of the preamble and paragraph (e) of the proposed AD include more detail of the conditions and failures required for a fuel tank ignition to occur. Boeing stated that in the proposed AD, the unsafe condition statement lists only compromised sealant adhesion as the condition needed for an ignition of fuel tank vapors in the event of a lightning strike. Boeing pointed out that ignition of fuel tank vapor requires an independent failure of the primary ignition prevention feature, a failed cap seal, a lightning attachment to the particular fastener, and that the fuel tank is flammable.
Boeing requested that the FAA change the fifth sentence in the Background section of the proposed AD to state, “This condition, if not addressed and combined with a flammable center tank ullage and an independent failure of the primary lightning protection feature, could result in ignition of the fuel vapors and subsequent explosion in the event of a lightning strike to that fastener.” Boeing requested similar changes to the second sentence of paragraph (e) of the proposed AD.
The FAA agrees with the request for the reasons provided. Boeing provided a more detailed description of the potential failure sequence. The FAA has revised the Background section of this final rule and the second sentence of paragraph (e) of this AD accordingly.
The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.
The FAA reviewed Boeing Special Attention Requirements Bulletin 737-57-1352 RB, dated February 1, 2021. This service information specifies procedures for preparing the surface and completely encapsulating the black stripe of ink, the clear overcoat, and the existing sealant with the approved production (BMS5-45) sealant at upper stringer U-S1, U-S10, U-S12, U-S20, and U-S21, and lower stringer L-S14. The affected areas are all located on the portion of the stringers just outboard of the center wing box. 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 FAA estimates that this AD affects 11 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this 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 October 20, 2022.
None.
This AD applies to The Boeing Company Model 737-8 airplanes, certificated in any category, as identified in Boeing Special Attention Requirements Bulletin 737-57-1352 RB, dated February 1, 2021.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by a report that, during production, a small number of fasteners in certain locations of the center fuel tank were cap sealed on top of a black stripe of ink with a clear overcoat. This clear overcoat is not an approved surface for sealing and can potentially compromise sealant adhesion. Compromised sealant adhesion can, over time, affect the lightning protection properties of the airplane. The FAA is issuing this AD to address compromised sealant adhesion within the center fuel tank, which, if combined with a flammable center tank ullage and an independent failure of the primary lightning protection feature, could result in ignition of fuel vapors and subsequent explosion of the fuel tank in the event of a lightning strike to that fastener.
Comply with this AD within the compliance times specified, unless already done.
Within 10 years after the date of issuance of the original airworthiness certificate or the original export certificate of airworthiness, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Special Attention Requirements Bulletin 737-57-1352 RB, dated February 1, 2021, except as specified by paragraph (h) of this AD.
As an option to the sealant application required by paragraph (g) of this AD, it is acceptable to remove the existing sealant and the black stripe of ink prior to reapplying a fastener seal. Remove existing sealant and black stripe of ink as follows:
(1) Remove existing sealant to expose the black stripe of ink.
(2) Remove existing black stripe of ink using aluminum oxide cloth or paper, 150 to 220 grit.
(3) Touch up exposed aluminum with Alodine 600 (Type I, II, or III) or Bonderite M-CR 600 Aero (Type I, II, or III).
(4) Apply fastener seal (cap seal) with BMS5-45.
(5) Apply BMS10-20 Type II fuel tank coating to any exposed alodine/bonderite surfaces not covered by the fastener seal; it is acceptable to extend BMS10-20 Type II coating over fastener seal.
(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 Chris Baker, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3552; email:
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (k)(3) and (4) of this AD.
(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 the AD specifies otherwise.
(i) Boeing Special Attention Requirements Bulletin 737-57-1352 RB, dated February 1, 2021.
(ii) [Reserved]
(3) 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
(4) 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.
(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,
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is superseding Airworthiness Directive (AD) 2017-19-13, AD 2018-24-04, and AD 2019-23-02, which applied to certain Airbus SAS Model A330-200 series, A330-200 Freighter series, and A330-300 series airplanes. ADs 2017-19-13, 2018-24-04, and 2019-23-02 required revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. This AD was prompted by the FAA's determination that new or more restrictive airworthiness limitations are necessary. This AD continues to require the actions in AD 2019-23-02, adds airplanes to the applicability, and requires 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 incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective October 20, 2022.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of October 20, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of December 30, 2019 (84 FR 64725, November 25, 2019).
For material incorporated by reference (IBR) in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
You may examine the AD docket at
Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206 231 3229; email
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0261, dated November 22, 2021 (EASA AD 2021-0261) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A330-201, -202, -203, -223, -243, -223F, -243F, -301, -302, -303, -321, -322, -323, -341, -342, -343, -841, and -941 airplanes.
Airplanes with an original airworthiness certificate or original export certificate of airworthiness issued after November 2, 2021, must comply with the airworthiness limitations specified as part of the approved type design and referenced on the type certificate data sheet; this AD therefore does not include those airplanes in the applicability.
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2017-19-13, Amendment 39-19043 (82 FR 43837, September 20, 2017) (AD 2017-19-13); AD 2018-24-04, Amendment 39-19508 (83 FR 60756, November 27, 2018) (AD 2018-24-04); and AD 2019-23-02, Amendment 39-19795 (84 FR 64725, November 25, 2019) (AD 2019-23-02), which applied to certain Airbus SAS Model A330-200 series, A330-200 Freighter series, and A330-300 series airplanes. The NPRM published in the
The FAA is issuing this AD to address fatigue cracking, accidental damage, and corrosion in principal structural elements; such fatigue cracking, accidental damage, and corrosion could result in reduced structural integrity of the airplane. See the MCAI for additional background information.
The FAA received comments from the Air Line Pilots Association, which supported the NPRM without change.
The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting this AD as proposed. 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. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products.
EASA AD 2021-0261 describes new or more restrictive airworthiness limitations for airplane structures, including a limit of validity (LOV) for Model A330-841 and A330-941 airplanes.
This AD also requires Airbus A330 Airworthiness Limitations Section (ALS) Part 2, Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 03, dated October 15, 2018; and Airbus A330 Airworthiness Limitations Section (ALS) Part 2, Damage Tolerant Airworthiness Limitation Items (DT-ALI), Variation 3.1, dated January 18, 2019, which the Director of the Federal Register approved for incorporation by reference as of December 30, 2019 (84 FR 64725, November 25, 2019).
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 138 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
The FAA estimates the total cost per operator for the retained actions from AD 2019-23-02 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 AD 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.
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 October 20, 2022.
This AD replaces the ADs specified in paragraphs (b)(1) through (3) of this AD.
(1) AD 2017-19-13, Amendment 39-19043 (82 FR 43837, September 20, 2017) (AD 2017-19-13).
(2) AD 2018-24-04, Amendment 39-19508 (83 FR 60756, November 27, 2018) (AD 2018-24-04).
(3) AD 2019-23-02, Amendment 39-19795 (84 FR 64725, November 25, 2019) (AD 2019-23-02).
This AD applies to the Airbus SAS airplanes specified in paragraphs (c)(1) through (5) of this AD, certificated in any category, with an original airworthiness certificate or original export certificate of airworthiness issued on or before November 2, 2021.
(1) Model A330-201, -202, -203, -223, and -243 airplanes.
(2) Model A330-223F and -243F airplanes.
(3) Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(4) Model A330-841 airplanes.
(5) Model A330-941 airplanes.
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 fatigue cracking, accidental damage, and corrosion in principal structural elements; such fatigue cracking, accidental damage, and corrosion 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 (g) of AD 2019-23-02, with no changes. For Model A330-201, -202, -203, -223, and -243; A330-223F and -243F; and A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes with an original airworthiness certificate or original export certificate of airworthiness issued on or before January 18, 2019: Within 90 days after December 30, 2019 (the effective date AD 2019-23-02), revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in Airbus A330 Airworthiness Limitations Section (ALS) Part 2, Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 03, dated October 15, 2018 (Airbus A330 ALS Part 2, DT-ALI, Revision 03), as supplemented by Airbus A330 ALS Part 2, DT-ALI, Variation 3.1, dated January 18, 2019. The initial compliance time for doing the tasks is at the time specified in Airbus A330 ALS Part 2, DT-ALI, Revision 03, including Airbus A330 ALS Part 2, DT-ALI, Variation 3.1, dated January 18, 2019; or within 90 days after December 30, 2019; whichever occurs later. This AD does not require Section 4, “Damage Tolerant-Airworthiness Limitations Items-Tasks Beyond MPPT,” of Airbus A330 ALS Part 2, DT-ALI, Revision 03. Accomplishing the revision of the existing maintenance or inspection program required by paragraph (i) of this AD terminates the requirements of this paragraph.
This paragraph restates the requirements of paragraph (h) of AD 2019-23-02, with a new exception. Except as required by paragraph (i) of this AD, after the existing maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (
(1) Where EASA AD 2021-0261 refers to its effective date, this AD requires using the effective date of this AD.
(2) The requirements specified in paragraphs (1) and (2) of EASA AD 2021-0261 do not apply to this AD.
(3) Paragraph (3) of EASA AD 2021-0261 specifies revising “the 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.
(4) The initial compliance time for doing the tasks specified in paragraph (3) of EASA 2021-0261 is at the applicable “associated thresholds” as incorporated by the requirements of paragraph (3) of EASA AD 2021-0261, or within 90 days after the effective date of this AD, whichever occurs later.
(5) This AD does not require incorporating Section 4, “Damage Tolerant-Airworthiness Limitations Items-Tasks Beyond MPPT,” of “the ALS” specified in EASA AD 2021-0261.
(6) The provisions specified in paragraphs (4) and (5) of EASA AD 2021-0261 do not apply to this AD.
(7) The “Remarks” section of EASA AD 2021-0261 does not apply to this AD.
After the existing maintenance or inspection program has been revised as required by paragraph (i) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(i) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
(ii) The AMOC specified in letter AIR-676-19-120, dated March 5, 2019, approved previously for AD 2018-24-04, is approved as an AMOC for the corresponding provisions of EASA AD 2021-0261 that are required by paragraph (i) of this AD for Model A330-200 and A330-300 series airplanes modified from a passenger to freighter configuration under the provisions of FAA Supplemental Type Certificate ST04038NY.
(iii) The AMOC specified in letter AIR-731A-20-179, dated May 11, 2020, approved previously for AD 2019-23-02 is approved as an AMOC for the corresponding provisions of EASA AD 2021-0261 that are required by paragraph (i) of this AD for Model A330-200 and A330-300 series airplanes modified from a passenger to freighter configuration under the provisions of FAA Supplemental Type Certificate ST04038NY.
(2)
For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206 231 3229; 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.
(3) The following service information was approved for IBR on October 20, 2022.
(i) European Union Aviation Safety Agency (EASA) AD 2021-0261, dated November 22, 2021.
(ii) [Reserved]
(4) The following service information was approved for IBR on December 30, 2019 (84 FR 64725, November 25, 2019).
(i) Airbus A330 Airworthiness Limitations Section (ALS) Part 2, Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 03, dated October 15, 2018.
(ii) Airbus A330 Airworthiness Limitations Section (ALS) Part 2, Damage Tolerant Airworthiness Limitation Items (DT-ALI), Variation 3.1, dated January 18, 2019.
(5) For EASA AD 2021-0261, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(6) For Airbus service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
(7) 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
(8) 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.
The FAA is adopting a new airworthiness directive (AD) for certain CFM International, S.A. (CFM) LEAP-1B model turbofan engines. This AD was prompted by multiple commanded in-flight shutdowns (IFSDs) due to inner radial drive shaft (RDS) failure. This AD requires initial and repetitive inspections of the transfer gearbox (TGB) scavenge screens and, depending on the results of the inspections, replacement or rework of the affected inner RDS. As a mandatory terminating action to the initial and repetitive inspections of the TGB scavenge screens, this AD requires replacement or rework of the affected inner RDS. This AD also prohibits the installation of an engine with an affected inner RDS onto an airplane that already has one engine with an affected inner RDS installed. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective October 20, 2022.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of October 20, 2022.
For service information identified in this final rule, contact CFM International, S.A., Aviation Operations Center, 1 Neumann Way, M/D Room 285, Cincinnati, OH 45125; phone: (877) 432-3272; email:
You may examine the AD docket at
Mehdi Lamnyi, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238-7743; 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 CFM LEAP-1B21, LEAP-1B23, LEAP-1B25, LEAP-1B27, LEAP-1B28, LEAP-1B28B1, LEAP-1B28B2, LEAP-1B28B2C, LEAP-1B28B3, LEAP-1B28BBJ1, and LEAP-1B28BBJ2 (LEAP-1B) model turbofan engines. The NPRM published in the
After the FAA issued AD 2019-12-01, further investigation by the manufacturer identified an additional contributing factor to the RDS bearing failures. The manufacturer revised the service information to include a repetitive TGB screen inspection until the RDS accumulates 1,500 flight hours (FHs) since new and borescope inspections of the RDS bearing at 1,500 FHs since new and 6,000 FHs since new. The FAA superseded AD 2019-12-01 by issuing AD 2020-06-01, Amendment 39-21103 (85 FR 14413, March 12, 2020), which requires revision to the airworthiness limitations section (ALS) of the applicable engine shop manual to incorporate the new inspections.
Since the FAA issued AD 2020-06-01, the FAA received further reports of commanded IFSDs due to inner RDS failure. The manufacturer initiated an investigation and identified a subpopulation of inner RDS susceptible to rivet fatigue failure occurring after the inspection thresholds required by the ALS revision in AD 2020-06-01. In the NPRM, the FAA proposed to require initial and repetitive inspections of the TGB1 and TGB2 scavenge screens and, depending on the results of the inspections, replacement or rework of the affected inner RDS. As a mandatory terminating action to the initial and repetitive inspections of the TGB1 and TGB2 scavenge screens, the FAA proposed to require replacement or rework of the affected inner RDS. The FAA also proposed prohibiting the installation of an engine with an affected inner RDS onto an airplane that already has one engine with an affected inner RDS installed. The FAA is issuing this AD to address the unsafe condition on these products.
The FAA received comments from three commenters. Commenters included The Boeing Company, Air Line Pilots Association, International, and United Airlines. All commenters supported the NPRM without change.
The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting the AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM.
The FAA reviewed CFM Service Bulletin (SB) LEAP-1B-72-00-0258-01A-930A-C, Issue 002, dated September 15, 2020. This service
The FAA estimates that this AD affects 34 engines installed on airplanes of U.S. registry.
The FAA estimates the following costs to comply with this AD:
For either replacement or rework of the inner RDS, depending on the option selected by the operator to comply with this AD, the FAA estimates the following costs:
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 October 20, 2022.
None.
This AD applies to CFM International, S.A. (CFM) LEAP-1B21, LEAP-1B23, LEAP-1B25, LEAP-1B27, LEAP-1B28, LEAP-1B28B1, LEAP-1B28B2, LEAP-1B28B2C, LEAP-1B28B3, LEAP-1B28BBJ1, and LEAP-1B28BBJ2 model turbofan engines with an installed inner radial drive shaft (RDS) with a serial number listed in Additional Information, paragraph 6.A., Table 1, of CFM Service Bulletin (SB) LEAP-1B-72-00-0365-01A-930A-D, Issue 003-00, dated April 26, 2022 (CFM SB LEAP-1B-72-00-0365-01A-930A-D).
Joint Aircraft System Component (JASC) Code 7260, Turbine Engine Accessory Drive.
This AD was prompted by multiple commanded in-flight shutdowns (IFSDs) due to inner RDS failure. The FAA is issuing this AD to prevent failure of the inner RDS and subsequent IFSDs. The unsafe condition, if not addressed, could result in failure of one or more engines, loss of thrust control, and loss of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Before exceeding 50 flight hours (FHs) after the effective date of this AD, and thereafter at intervals not to exceed 50 FHs from the previous inspection, inspect the transfer gearbox (TGB) TGB1 and TGB2 scavenge screens in accordance with the Accomplishment Instructions, paragraph 5.A.(1), of CFM SB LEAP-1B-72-00-0365-01A-930A-D.
(2) If, during any inspection required by paragraph (g)(1) of this AD, any metallic particles are found, before further flight, perform the actions in the Accomplishment Instructions, paragraphs 5.A.(2) and (3), of CFM SB LEAP-1B-72-00-0365-01A-930A-D. Where paragraph 5.A.(3)(b) of CFM SB LEAP-1B-72-00-0365-01A-930A-D specifies to remove the engine, this AD instead requires replacement or rework of the inner RDS in accordance with the Accomplishment Instructions, paragraph 5.A., of CFM SB LEAP-1B-72-00-0258-01A-930A-C Issue 002, dated September 15, 2020 (CFM SB LEAP-1B-72-00-0258-01A-930A-C).
As a mandatory terminating action to the initial and repetitive inspections of the TGB1 and TGB2 scavenge screens required by paragraph (g)(1) of this AD, at the next piece-part exposure after the effective date of this AD, replace or rework the inner RDS in accordance with the Accomplishment Instructions, paragraph 5.A., of CFM SB LEAP-1B-72-00-0258-01A-930A-C.
After the effective date of this AD, do not install an engine with an affected inner RDS onto an airplane that already has one engine with an affected inner RDS installed.
For the purpose of this AD, “piece-part exposure” is when the fan frame shroud is separated from the fan hub.
(1) The Manager, ECO 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 (l) of this AD 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.
For more information about this AD, contact Mehdi Lamnyi, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238-7743; 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 the AD specifies otherwise.
(i) CFM International, S.A. Service Bulletin LEAP-1B-72-00-0258-01A-930A-C, Issue 002, dated September 15, 2020.
(ii) CFM International, S.A. Service Bulletin LEAP-1B-72-00-0365-01A-930A-D, Issue 003-00, dated April 26, 2022.
(3) For service information identified in this AD, contact CFM International, S.A., Aviation Operations Center, 1 Neumann Way, M/D Room 285, Cincinnati, OH 45125; phone: (877) 432-3272; email:
(4) You may view this service information at 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.
Final rule.
The FAA is superseding Airworthiness Directive (AD) 2021-19-08, which applied to certain Robinson Helicopter Company (Robinson) Model R44 and R44 II helicopters. AD 2021-19-08 required checking each tail rotor blade (blade) for any crack and removing any cracked blade from service. AD 2021-19-08 also required removing all affected blades from service and prohibited installing any affected blade on any helicopter. Since the FAA issued AD 2021-19-08, it was determined that an additional model helicopter and additional blades are affected by the unsafe condition. This AD requires the same actions as AD 2021-19-08 and adds certain Robinson Model R66 helicopters to the applicability and adds additional part-numbered and serial-numbered blades to the applicability. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective October 20, 2022.
James Guo, Aerospace Engineer, Airframe Section, Los Angeles ACO Branch, Compliance & Airworthiness Division, FAA, 3960 Paramount Blvd., Lakewood, CA 90712; telephone (562) 627-5357; email
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2021-19-08, Amendment 39-21726 (86 FR 49915, September 7, 2021) (AD 2021-19-08). AD 2021-19-08 applied to Robinson Model R44 and R44 II helicopters with a blade part number (P/N) C029-3 with serial number (S/N) 9410 through 9909 inclusive, installed. The NPRM published in the
The FAA received no comments on the NPRM or on the determination of the costs.
The FAA reviewed the relevant data and determined that air safety requires adoption of the AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM.
The FAA reviewed Robinson R44 Service Bulletin SB-108, dated June 30, 2021. This service bulletin specifies removing P/N C029-3 blades with S/N 9410 through 9909 from service. For continued operation until the affected blades are replaced, the service bulletin specifies a preflight inspection to be performed by the pilot.
The FAA also reviewed Robinson R44 Service Bulletin SB-110, which specifies removing P/N C029-3 blades with S/N 9910 through 10659 from service and Robinson R66 Service Bulletin SB-40, which specifies removing P/N F029-1 blades with S/N 2410 through 2589 from service. Both of these service bulletins are dated January 6, 2022, and specify that a preflight inspection is to be performed by the pilot for continued operation until the affected blades are replaced.
The FAA estimates that this AD affects 432 helicopters of U.S. registry. The FAA estimates the following costs to comply with this AD. Labor costs are estimated at $85 per work-hour.
Checking a blade for any crack takes about 0.25 work-hour for an estimated cost of up to $44 per helicopter (up to two affected blades per helicopter) and up to $19,008 for the U.S. fleet per check. Replacing a blade takes about 3.5 work-hours and parts cost about $3,320 for an estimated cost of $3,618 per blade and up to $3,125,952 for the U.S. fleet.
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some 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.
The FAA has determined that 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 October 20, 2022.
This AD replaces AD 2021-19-08, Amendment 39-21726 (86 FR 49915, September 7, 2021) (AD 2021-19-08).
This AD applies to the following Robinson Helicopter Company (Robinson) helicopters, certificated in any category:
(1) Robinson Model R44 and R44 II helicopters with a tail rotor blade (blade) part number (P/N) C029-3 with serial number (S/N) 9410 through 9909 inclusive, installed;
(2) Robinson Model R44 and R44 II helicopters with a blade P/N C029-3 with S/N 9910 through 10659 inclusive, installed; and
(3) Robinson Model R66 helicopters with a blade P/N F029-1 with S/N 2410 through 2589 inclusive, installed.
Joint Aircraft System Component (JASC) Code: 6410, Tail Rotor Blades.
This AD was prompted by reports of cracked blades. The FAA is issuing this AD to detect and prevent cracks in the affected blades. The unsafe condition, if not addressed, could result in reduced controllability and subsequent loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) Before further flight after the effective date of this AD and thereafter before each flight, check each blade at the leading edge for a crack. This action may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.
(2) If there is any crack, before further flight, remove the blade from service.
(3) For helicopters identified in paragraph (c)(1) of this AD, within 3 months after September 22, 2021 (the effective date of AD 2021-19-08) remove from service any blade identified in paragraph (c)(1) of this AD.
(4) For helicopters identified in paragraphs (c)(2) and (3) of this AD, within 6 months after the effective date of this AD, remove from service any blade identified in paragraph (c)(2) or (3) of this AD, as applicable to your model helicopter.
(5) For helicopters identified in paragraph (c)(1) of this AD, as of September 22, 2021 (the effective date of AD 2021-19-08), do not install a blade identified in paragraph (c)(1) of this AD on any helicopter.
(6) For helicopters identified in paragraphs (c)(2) and (3) of this AD, as of the effective date of this AD, do not install a blade identified in paragraph (c)(2) or (3) of this AD, as applicable to your model helicopter, on any helicopter.
Special flight permits are prohibited.
(1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) AMOCs approved previously for AD 2021-19-08 are approved as AMOCs for the corresponding requirements in paragraph (g) of this AD.
For more information about this AD, contact James Guo, Aerospace Engineer, Airframe Section, Los Angeles ACO Branch, Compliance & Airworthiness Division, FAA, 3960 Paramount Blvd., Lakewood, CA 90712; telephone (562) 627-5357; email
None.
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP series airplanes. This AD was prompted by significant changes, including new or more restrictive requirements, made to the airworthiness limitations (AWLs) related to fuel tank ignition prevention. This AD requires revising the existing maintenance or inspection program, as applicable, to incorporate the latest revision of the AWLs. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective October 20, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 20, 2022.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; phone: 562-797-1717; internet:
You may examine the AD docket at
Samuel Dorsey, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3415; email:
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP series airplanes. The NPRM published in the
The FAA received comments from the Air Line Pilots Association, International (ALPA) and Boeing who supported the NPRM without change.
The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting this AD as proposed. 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.
The FAA reviewed Boeing 747-100/200/300/SP/SR Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D6-13747-CMR, dated September 2020. This service information describes AWLs that include airworthiness limitation instructions (ALIs) and critical design configuration control limitations (CDCCLs) tasks related to fuel tank ignition prevention. 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 FAA estimates that this AD affects 39 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
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. Therefore, the FAA estimates the average total cost per operator 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.
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 October 20, 2022.
This AD affects the ADs specified in paragraphs (b)(1) through (7) of this AD.
(1) AD 2008-10-07 R1, Amendment 39-16070 (74 FR 56098, October 30, 2009) (AD 2008-10-07 R1).
(2) AD 2008-18-09, Amendment 39-15666 (73 FR 52911, September 12, 2008) (AD 2008-18-09).
(3) AD 2010-13-12, Amendment 39-16343 (75 FR 37997, July 1, 2010) (AD 2010-13-12).
(4) AD 2010-24-13, Amendment 39-16532 (75 FR 78591, December 16, 2010; corrected May 25, 2011 (76 FR 30253)) (AD 2010-24-13).
(5) AD 2011-06-03, Amendment 39-16627 (76 FR 15814, March 22, 2011) (AD 2011-06-03).
(6) AD 2014-15-14, Amendment 39-17916 (79 FR 45324, August 5, 2014) (AD 2014-15-14).
(7) AD 2016-19-03, Amendment 39-18652 (81 FR 65872, September 26, 2016) (AD 2016-19-03).
This AD applies to all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by significant changes, including new or more restrictive requirements, made to the airworthiness limitations (AWLs) related to fuel tank ignition prevention. The FAA is issuing this AD to address the potential for ignition sources inside fuel tanks caused by latent failures, alterations, repairs, or maintenance actions, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 60 days after the effective date of this AD, revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in Boeing 747-100/200/300/SP/SR Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D6-13747-CMR, dated September 2020, except as specified in paragraphs (h) and (i) of this AD. The initial compliance times for the airworthiness limitation instruction (ALI) tasks are within the applicable compliance times for each AWL number specified in paragraphs (g)(1) through (8) of this AD:
(1) For AWL No. 28-AWL-01, “External Wires Over Center Fuel Tank”: At the applicable time specified in paragraph (g)(1)(i) or (ii) of this AD.
(i) For airplanes that did not have any version of AWL No. 28-AWL-01 in the existing maintenance or inspection program before the effective date of this AD: Within 144 months since issuance of the original airworthiness certificate or original export certificate, or within 12 months after the effective date of this AD, whichever occurs later.
(ii) For airplanes not identified in paragraph (g)(1)(i) of this AD: Within 144 months since AWL No. 28-AWL-01 was incorporated into the existing maintenance or inspection program, or within 144 months after the most recent inspection was performed as specified in AWL No. 28-AWL-01, whichever occurs later.
(2) For 28-AWL-03, “Fuel Quantity Indicating System (FQIS)—Out Tank Wiring Lightning Shield to Ground Termination”: At the applicable time specified in paragraph (g)(2)(i) or (ii) of this AD.
(i) For airplanes that did not have any version of AWL No. 28-AWL-03 in the existing maintenance or inspection program before the effective date of this AD: Within 144 months since issuance of the original airworthiness certificate or original export certificate of airworthiness, or within 12 months after the effective date of this AD, whichever occurs later.
(ii) For airplanes not identified in paragraph (g)(2)(i) of this AD: Within 144 months since AWL No. 28-AWL-03 was incorporated into the existing maintenance or inspection program, or within 144 months after the most recent inspection was performed as specified in AWL No. 28-AWL-03, whichever occurs later.
(3) For 28-AWL-09, “Over-Current and Arcing Protection Electrical Design Features Operation—Fault Current Detector for Center Tank Override/Jettison (O/J) Pumps”: At the applicable time specified in paragraph (g)(3)(i) or (ii) of this AD.
(i) For airplanes that did not have any version of AWL No. 28-AWL-09 in the existing maintenance or inspection program before the effective date of this AD: Within 18 months since issuance of the original airworthiness certificate or original export certificate of airworthiness, or within 90 days after the effective date of this AD, whichever occurs later.
(ii) For airplanes not identified in paragraph (g)(3)(i) of this AD: Within 18 months since AWL No. 28-AWL-09 was incorporated into the existing maintenance or inspection program, or within 18 months after the most recent inspection was performed as specified in AWL No. 28-AWL-09, whichever occurs later.
(4) For AWL No. 28-AWL-13, “Main Tank, Center Wing Tank, Body Tank (if installed), and Auxiliary Tank (if installed) Refuel Valve Installation—Fault Current Bond”: At the applicable time specified in paragraph (g)(4)(i) or (ii) of this AD.
(i) For airplanes that did not have any version of AWL No. 28-AWL-13 in the existing maintenance or inspection program before the effective date of this AD: Within 144 months since issuance of the original airworthiness certificate or original export certificate of airworthiness, or within 12 months after the effective date of this AD, whichever occurs later.
(ii) For airplanes not identified in paragraph (g)(4)(i) of this AD: Within 144 months since AWL No. 28-AWL-13 was incorporated into the existing maintenance or inspection program, or within 144 months after the most recent inspection was performed as specified in AWL No. 28-AWL-13, whichever occurs later.
(5) For AWL No. 28-AWL-22, “Center Tank Override/Jettison Fuel Pump Inlet Protection and Power Failed On Protection System”: At the applicable time specified in paragraph (g)(5)(i) or (ii) of this AD.
(i) For airplanes that did not have any version of AWL No. 28-AWL-22 in the existing maintenance or inspection program before the effective date of this AD: Within 12 months since issuance of the original airworthiness certificate or original export certificate of airworthiness, or within 90 days after the effective date of this AD, whichever occurs later.
(ii) For airplanes not identified in paragraph (g)(5)(i) of this AD: Within 12 months since AWL No. 28-AWL-22 was incorporated into the existing maintenance or inspection program, or within 12 months after the most recent inspection was performed as specified in AWL No. 28-AWL-22, whichever occurs later.
(6) For AWL No. 28-AWL-23, “Over-Current and Arcing Protection Electrical Design Features Operation—Main Tank AC Fuel Pump and Center Tank Scavenge AC Fuel Pump Ground Fault Interrupter (GFI)”: At the applicable time specified in paragraph (g)(6)(i) or (ii) of this AD.
(i) For airplanes that did not have any version of AWL No. 28-AWL-23 in the existing maintenance or inspection program before the effective date of this AD: Within 12 months since issuance of the original airworthiness certificate or original export certificate of airworthiness, within 12 months since Boeing Service Bulletin 747-28A2261 was incorporated, or within 90 days after the effective date of this AD, whichever occurs latest.
(ii) For airplanes not identified in paragraph (g)(6)(i) of this AD: Within 12 months since AWL No. 28-AWL-23 was incorporated into the existing maintenance or inspection program, or within 12 months after the most recent inspection was performed as specified in AWL No. 28-AWL-23, whichever occurs later.
(7) For AWL No. 28-AWL-25, “Cushion Clamps and Teflon Sleeving Installed on Out-of-Tank Wire Bundles Installed on Brackets that are Mounted Directly on the Fuel Tanks”: At the applicable time specified in paragraph (g)(7)(i) or (ii) of this AD.
(i) For airplanes that did not have any version of AWL No. 28-AWL-25 in the existing maintenance or inspection program before the effective date of this AD: Within 144 months since issuance of the original airworthiness certificate or original export certificate of airworthiness, or within 12 months after the effective date of this AD, whichever occurs later.
(ii) For airplanes not identified in paragraph (g)(7)(i) of this AD: Within 144 months since AWL No. 28-AWL-25 was incorporated into the existing maintenance or inspection program, within 144 months since Boeing Special Attention Service Bulletin 747-57-2327 was incorporated, or within 144 months after the most recent inspection was performed as specified in AWL No. 28-AWL-25, whichever occurs latest.
(8) For AWL No. 28-AWL-31, “Reserve Tank Refuel Valve Installation—Lightning Protection Electrical Bond”: At the applicable time specified in paragraph (g)(8)(i) or (ii) of this AD.
(i) For airplanes that did not have any version of AWL No. 28-AWL-31 in the existing maintenance or inspection program before the effective date of this AD: Within 72 months since issuance of the original airworthiness certificate or original export certificate of airworthiness, or within 6 months after the effective date of this AD, whichever occurs later.
(ii) For airplanes not identified in paragraph (g)(8)(i) of this AD: Within 72 months since AWL No. 28-AWL-31 was incorporated into the existing maintenance or inspection program, or within 72 months after the most recent inspection was performed as specified in AWL No. 28-AWL-31, whichever occurs later.
(1) Where the “Applicability” column of AWL Nos. 28-AWL-25 and 28-AWL-27 specifies “ALL” and “NOTE,” replace that text with “Airplanes L/N 645 and on.”
(2) In the “Description” column of AWL Nos. 28-AWL-25 and 28-AWL-27, remove the Applicability Note.
(1) Where AWL No. 28-AWL-11 identifies wire types BMS 13-48, BMS 13-58, and BMS 13-60, the following wire types are acceptable: MIL-W-22759/16, SAE AS22759/16 (M22759/16), MIL-W-22759/32, SAE AS22759/32 (M22759/32), MIL-W-22759/34, SAE AS22759/34 (M22759/34), MIL-W-22759/41, SAE AS22759/41 (M22759/41), MIL-W-22759/86, SAE AS22759/86 (M22759/86), MIL-W-22759/87, SAE AS22759/87 (M22759/87), MIL-W-22759/92, and SAE AS22759/92 (M22759/92); and MIL-C-27500 and NEMA WC 27500 cables constructed from these military or SAE specification wire types, as applicable.
(2) Where AWL No. 28-AWL-11 identifies TFE-2X Standard wall for wire sleeving, the following sleeving materials are acceptable: Roundit 2000NX and Varglas Type HO, HP, or HM.
After the existing maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (
Accomplishment of the revision required by paragraph (g) of this AD terminates the
(1) The revision required by paragraphs (g) and (h) of AD 2008-10-07 R1.
(2) The revision required by paragraph (g)(1) of AD 2008-18-09.
(3) The revision required by paragraph (h)(2) of AD 2010-13-12.
(4) The revision required by paragraph (h) of AD 2010-24-13.
(5) The revision required by paragraph (k) of AD 2011-06-03.
(6) The revision required by paragraph (h)(2) of AD 2014-15-14.
(7) The revision required by paragraph (h) of AD 2016-19-03.
(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 (m) 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.
For more information about this AD, contact Samuel Dorsey, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3415; 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 the AD specifies otherwise.
(i) Boeing 747-100/200/300/SP/SR Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D6-13747-CMR, dated September 2020.
(ii) [Reserved]
(3) 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; phone: 562-797-1717; internet:
(4) 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.
(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,
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is superseding Airworthiness Directive (AD) 2019-26-11, which applied to certain Airbus SAS Model A319-112, -115, and -132; A320-214, -216, -232, -233, -251N, and -271N; and A321-211, -231, -232, -251N, and -253N airplanes; and AD 2021-23-15, which applied to certain Airbus SAS Model A319-111, -112, -113, -114, -115, -131, -132, and -133; A320-211, -212, -214, -216, -231, -232, and -233; and A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. AD 2019-26-11 required replacing the affected bumpers with serviceable bumpers. AD 2021-23-15 required modifying the waste compartment door of each affected galley. This AD was prompted by reports that the waste compartment door opened prematurely during a test, that container/galley end stop bumpers were damaged in service, and that additional airplanes are subject to the unsafe conditions described in those ADs. This AD continues to require the actions in AD 2019-26-11 and AD 2021-23-15, and adds airplanes to the applicability; 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 October 20, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 20, 2022.
For material incorporated by reference (IBR) in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
You may examine the AD docket at
Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3223; email
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0026, dated February 16, 2022 (EASA AD 2022-0026) (also referred to as the MCAI), to correct an unsafe condition for certain Airbus SAS Model A319-111, A319-112, A319-113, A319-114, A319-115, A319-131, A319-132, A319-133, A320-211, A320-212, A320-214, A320-215, A320-216, A320-231, A320-
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2019-26-11, Amendment 39-21022 (85 FR 6755, February 6, 2020) (AD 2019-26-11), which applied to certain Airbus SAS Model A319-112, A319-115, A319-132, A320-214, A320-216, A320-232, A320-233, A320-251N, A320-271N, A321-211, A321-231, A321-232, A321-251N, and A321-253N airplanes; and AD 2021-23-15, Amendment 39-21813 (86 FR 68894, December 6, 2021) (AD 2021-23-15), which applied to certain Airbus SAS Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The NPRM published in the
The FAA is issuing this AD to address potential failure of the galley door and release of waste bins during a rejected take-off or an emergency landing, and potential container detachment from the galley under certain forward loading conditions, possibly resulting in damage to the airplane and injury to occupants. See the MCAI for additional background information.
The FAA received a comment from the Air Line Pilots Association, International (ALPA), who supported the NPRM without change.
The FAA reviewed the relevant data, considered the comment received, and determined that air safety requires adopting this AD as proposed. 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. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products.
EASA AD 2022-0026 specifies procedures for modifying the affected galleys by replacing the affected bumpers with serviceable bumpers; for modifying the waste compartment door of each affected galley by installing a door catch bracket and a new striker, and for re-identifying the affected galleys. 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 1,507 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in the cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
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 October 20, 2022.
This AD replaces AD 2019-26-11, Amendment 39-21022 (85 FR 6755, February 6, 2020) (AD 2019-26-11); and AD 2021-23-15, Amendment 39-21813 (86 FR 68894, December 6, 2021) (AD 2021-23-15).
This AD applies to the Airbus SAS airplanes specified in paragraphs (c)(1) through (3) of this AD, certificated in any category, as identified in European Union Aviation Safety Agency (EASA) AD 2022-0026, dated February 16, 2022 (EASA AD 2022-0026).
(1) Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.
(2) Model A320-211, -212, -214, -216, -231, -232, -233, -251N, and -271N airplanes.
(3) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -251N, and -253N airplanes.
Air Transport Association (ATA) of America Code 25, Equipment/Furnishings.
This AD was prompted by a report that during re-engineering of galley G5, a 9G forward full scale qualification test was performed, and the door of the waste compartment opened before the required load was reached, and by reports of finding container/galley end stop bumpers damaged in service. This AD was also prompted by the determination that additional airplanes are subject to the unsafe condition. The FAA is issuing this AD to address potential failure of the galley door and release of waste bins during a rejected take-off or an emergency landing, and potential container detachment from the galley under certain forward loading conditions, possibly resulting in damage to the airplane and injury to occupants.
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, EASA AD 2022-0026.
(1) Where EASA AD 2022-0026 refers to December 11, 2018 (the effective date of EASA AD 2018-0255), this AD requires using January 10, 2022 (the effective date of AD 2021-23-15).
(2) Where EASA AD 2022-0026 refers to May 29, 2019 (the effective date of EASA AD 2019-0106), this AD requires using March 12, 2020 (the effective date of AD 2019-26-11).
(3) Where EASA AD 2022-0026 refers to its effective date, this AD requires using the effective date of this AD.
(4) The “Remarks” section of EASA AD 2022-0026 does not apply to this AD.
The following provisions also apply to this AD:
(1)
(2)
(3)
For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3223; 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.
(i) European Union Aviation Safety Agency (EASA) AD 2022-0026, dated February 16, 2022.
(ii) [Reserved]
(3) For EASA AD 2022-0026, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; 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 adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-700-2A12 airplanes. This AD was prompted by a determination that the baggage bay line fire extinguishing tube assembly might not have been installed with the correct torque. This AD requires re-torqueing the baggage bay line fire extinguishing tube assembly to the correct torque values, and applying corrosion inhibiting compound on the discharge tubes. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective October 20, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 20, 2022.
• For service information identified in this final rule, contact Bombardier Business Aircraft Customer Response Center, 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-2999; email
• 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. It is also available at
Elizabeth Dowling, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model BD-700-2A12 airplanes. The NPRM published in the
In the NPRM, the FAA proposed to require re-torqueing the baggage bay line fire extinguishing tube assembly to the correct torque values, and applying corrosion inhibiting compound on the discharge tubes. 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.
Bombardier Inc. has issued Service Bulletin 700-26-7503, dated April 22, 2021. This service information describes procedures for re-torqueing the baggage bay line fire extinguishing tube assembly to the correct torque values, and applying corrosion inhibiting compound on the discharge tubes. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA estimates that this AD affects 42 airplanes of U.S. registry. The FAA estimates the following costs to comply with this 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.
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 October 20, 2022.
None.
This AD applies to Bombardier, Inc., Model BD-700-2A12 airplanes, certificated in any category, serial numbers (S/Ns) 70006 through 70044 inclusive, S/Ns 70046 through 70052 inclusive, and S/Ns 70055, 70056, and 70062.
Air Transport Association (ATA) of America Code 26, Fire protection.
This AD was prompted by a determination that the baggage bay line fire extinguishing tube assembly might not have been installed with the correct torque. The FAA is issuing this AD to address improper torqueing, which may lead to loss of the fire extinguishing system, which could prevent extinguishing a fire and possibly result in damage to the airplane and injury to occupants.
Comply with this AD within the compliance times specified, unless already done.
Within 28 months after the effective date of this AD: Re-torque the baggage bay line fire extinguishing tube assembly to the correct torque values, and apply corrosion inhibiting compound on the discharge tubes, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 700-26-7503, dated April 22, 2021.
Although Bombardier Service Bulletin 700-26-7503, dated April 22, 2021, 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)
(1) Refer to TCCA AD CF-2021-48, dated December 15, 2021, for related information. This TCCA AD may be found in the AD docket at
(2) For more information about this AD, contact Elizabeth Dowling, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email
(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) Bombardier Service Bulletin 700-26-7503, dated April 22, 2021.
(ii) [Reserved]
(3) For service information identified in this AD, contact Bombardier Business Aircraft Customer Response Center, 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-2999; email
(4) 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.
(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; request for comments.
The FAA is adopting a new airworthiness directive (AD) for certain Costruzioni Aeronautiche Tecnam S.P.A. (Tecnam) Model P2006T airplanes. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. This AD
This AD is effective September 30, 2022.
The FAA must receive comments on this AD by October 31, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
Jim Rutherford, Aviation Safety Engineer, General Aviation & Rotorcraft Section, International Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106; phone: (816) 329-4165; email:
The FAA invites you to send any written data, views, or arguments about this final rule. 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 AD 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 AD, 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 AD. Submissions containing CBI should be sent to Jim Rutherford, Aviation Safety Engineer, General Aviation & Rotorcraft Section, International Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106. 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 2022-0167, dated August 11, 2022 (referred to after this as “the MCAI”), to correct an unsafe condition on certain Tecnam Model P2006T airplanes. The MCAI states that screws attaching the ceiling panel covering the aileron control assembly could be of excessive length and cause the aileron control rod to become blocked, cracked, or damaged. This condition, if not detected and corrected, could result in unintended jamming of the aileron control rod assembly, the inability to use the aileron control surfaces, and loss of control of the airplane.
You may examine the MCAI in the AD docket at
The FAA reviewed Tecnam Service Bulletin 574-CS-Edition 1, Revision 3, dated August 1, 2022. The service information specifies performing a DVI of the aileron control assembly, measuring the length of the screws installed on the ceiling cover panel, and replacing the screws if found to be of excessive length. The service information also specifies contacting Tecnam for repair instructions if any crack or damage is found on the aileron control rod.
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 and service information described above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This AD requires accomplishing the actions specified in the service information already described, except as discussed under “Differences Between this AD, the MCAI, and the Service Information.”
The MCAI specifies that the DVI of the aileron control assembly and measurement of screws installed on the ceiling cover panel be performed within 10 flight hours after the effective date of EASA AD 2022-0132, dated July 4, 2022, or the effective date of the MCAI, depending on the airplane's serial number. This AD requires the inspection and measurement be performed before further flight after the effective date of this AD.
The service bulletin specifies contacting Tecnam for approved corrective action instructions, and this AD requires using a repair method approved by the FAA, EASA, or Tecnam's Design Organization Approval.
Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551
An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies foregoing notice and comment prior to adoption of this rule because the pilot could lose control of the airplane due to the jamming of the aileron control rod caused by screws of excessive length installed on the ceiling cover panel. Since this condition happens rapidly and without warning, the inspections and any necessary repair or replacement must be accomplished before further flight. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).
In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forego notice and comment.
The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.
The FAA estimates that this AD affects 71 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 actions that would be required based on the results of the inspection and measurement. The agency has no way of determining the number of airplanes that might need this repair or 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.
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, and
(2) Will not affect intrastate aviation in Alaska.
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 September 30, 2022.
None.
This AD applies to Costruzioni Aeronautiche Tecnam S.P.A. Model P2006T airplanes, all serial numbers (S/N) up to 345 inclusive, and S/N 348, 352, 353, 355, and 357, certificated in any category.
Joint Aircraft System Component (JASC) Code 2710, Aileron Control System.
This AD was prompted by mandatory continuing airworthiness information
Comply with this AD within the compliance times specified, unless already done.
Before further flight after the effective date of this AD, perform a detailed visual inspection of the aileron control assembly, part number 26-9-1502-000, for cracks and damage (including missing paint, nicks, or scrapes) and measure the length of the screws installed on the ceiling cover panel.
(1) If, during the inspection required by paragraph (g) of this AD, any crack or damage (including missing paint, nicks, or scrapes) is found on the aileron control rod assembly, before further flight, repair using a method approved by the FAA; the European Union Aviation Safety Agency (EASA); or Tecnam's Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
(2) If, during the inspection required by paragraph (g) of this AD, any screws installed on the ceiling cover panel do not match the limits specified in paragraph (g)(2)(i) or (ii) of this AD, before further flight, replace that screw with the correct screw identified in paragraph (g)(2)(i) or (ii) of this AD, as applicable.
(i) If blind rivet nuts are installed on the ceiling panel covering the aileron control assembly, then the correct panel screw would be 12mm in length with part number UNI7689-3-12.
(ii) If blind rivet nuts are not installed on the ceiling panel covering the aileron control assembly, then the correct panel screw would be equal to or less than 10mm in length with part number UNI6594-2.9-9.5.
Special flight permits are prohibited.
The Manager, International Validation 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 International Validation Branch, mail it to the address identified in paragraph (j)(2) of this AD or email to:
(1) Refer to EASA AD 2022-0167, dated August 11, 2022, for related information. This EASA AD may be found in the AD docket at
(2) For more information about this AD, contact Jim Rutherford, Aviation Safety Engineer, General Aviation & Rotorcraft Section, International Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106; phone: (816) 329-4165; email:
(3) Service information identified in this AD that is not incorporated by reference is available at Costruzioni Aeronautiche Tecnam S.P.A., Airworthiness Office Via S. D'acquisto 62, 80042 Boscotrecase, Italy; phone: +39 0823 997538; email:
None.
Food and Drug Administration, Department of Health and Human Services (HHS).
Direct final rule.
The Food and Drug Administration (FDA, the Agency, or we) is revising the “small number of animals” definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or for minor uses in major animal species. Congress provided a statutory definition of “minor use” that relies on the phrase “small number of animals” to characterize such use. We are revising the definition of “small number of animals” based on our most recent reassessment of the small numbers, which we conducted from 2018 to 2019.
This rule is effective December 14, 2022. Either electronic or written comments on this direct final rule or its companion proposed rule must be submitted by November 14, 2022. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in 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
Margaret Oeller, Center for Veterinary Medicine (HVF-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0566, email:
This direct final rule amends the definition of “small number of animals” as it relates to dogs and cats in our regulation implementing the MUMS Act. The term “minor use” is the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals, or occurs in limited geographical areas and in only a small number of animals annually. The “small number of animals” definition is used for purposes of determining whether a particular intended use of a drug in one of the seven major species of animals (horses, dogs, cats, cattle, pigs, turkeys, and chickens) qualifies as a minor use. In March 2008, FDA issued a proposed rule to establish the meaning of “small number of animals” as that term is used in the definition of minor use included in the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA finalized the rule in August 2009. The definition for the phrase “small number of animals” includes a specific upper limit number (
In response to comments submitted to FDA regarding the 2008 proposed rule, we stated in the final rule that we would periodically reevaluate the small numbers and update the definition if necessary. This direct final rule is the result of our 2018-2019 reassessment of the “small numbers of animals.”
Based on our 2018-2019 reassessment, we are revising the small number for dogs included in the “small number of animals” definition from 70,000 to 80,000 and the small number for cats from 120,000 to 150,000.
The legal authority for this direct final rule is the MUMS Act, which amended the FD&C Act. Additional authority comes from the “Regulations and Hearings” section of the FD&C Act, which authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act.
Sponsors that apply for and receive conditional approval for a new animal drug intended for a “minor use” in dogs or cats as a result of the changes to the small numbers made by the direct final rule will be able to market their drug earlier, which in turn could benefit pet owners by improving the health of dogs and cats with uncommon diseases or conditions. Both FDA and those sponsors receiving conditional approval could receive cost savings from deferring costs associated with providing FDA with substantial evidence that a new animal drug is effective until later in the drug development process. “Substantial evidence” is the effectiveness standard that must be met before a sponsor can receive full approval for its new animal drug under the FD&C Act. Conditional approval does not require the drug sponsor to demonstrate effectiveness by “substantial evidence.” Instead, the sponsor has to show that there is a “reasonable expectation” of effectiveness. Sponsors could incur
The MUMS Act (Pub. L. 108-282) amended the FD&C Act to provide incentives for the development of new animal drugs for use in minor animal species and for minor uses in major animal species. The MUMS Act defines “minor use” as the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually (see section 201(pp) of the FD&C Act (21 U.S.C. 321(pp)). Congress charged FDA to further define the term “small number of animals” for minor use purposes (see Senate Report 108-226 at 8, February 18, 2004). In the
The “small numbers of animals” definition was formally established by the final rule that was published on August 26, 2009 (74 FR 43043). In that final rule, we addressed comments from the public regarding the 2008 proposed rule, including comments suggesting that the Agency reevaluate the small numbers on a periodic basis. We agreed that periodic reassessment of the small numbers is appropriate and that such reassessments should occur approximately every 5 years.
We conducted our initial reassessment of the small numbers in 2013 and published the results of that reassessment on May 19, 2014 (79 FR 28736) (the 2013 reassessment). At that time, we did not change the small numbers for any of the major species.
From 2018 to 2019, we conducted our second reassessment (current reassessment) of the small numbers (Ref. 1). Based on the current reassessment, we are revising (
The term “small number of animals” is defined in § 516.3(b) (21 CFR 516.3(b)) of our regulation on new animal drugs for minor use and minor species. For each of the seven major species of animals, the definition specifies the greatest number of animals of that species that could be treated annually with a new animal drug for a particular indication and still qualify as a minor use. For dogs and cats, a “small number of animals” is defined as equal to or less than 70,000 dogs, or equal to or less than 120,000 cats.
The process FDA used to establish the small numbers for the companion animal major species (dogs, cats and horses) is outlined in detail in the 2008 proposed rule. That process involved estimating the development cost for an animal drug intended for each of the three major companion animal species, estimating the amount that companion animal owners were willing to pay for a drug to treat each of those species, estimating the average percentage of companion animals that would likely be treated, and estimating the uncertainty associated with estimates of the rate of occurrence of various uncommon conditions in companion animals. Assessment of these various factors resulted in the formula, published in the proposed rule (73 FR 14411 at 14414), that we use to determine the small numbers for companion animals.
In the preamble to the 2009 final rule in which we first established the definition of “small number of animals,” we agreed in response to comments that we should periodically reevaluate the small numbers and update the definition as necessary. We also agreed that such a reevaluation should take into account the potential for changes in the development cost of new animal drugs, changes in the amount that animal owners are willing to pay to treat affected animals, and changes in other factors involved in establishing a “small number,” such as the total population of major animal species (74 FR 43043 at 43044).
In a memorandum containing the results of our current reassessment, we describe the processes that we used to reevaluate the small number of animals (Ref. 1). Based on the current reassessment, we are increasing the small numbers for dogs and cats only.
We are issuing this direct final rule under the same legal authorities described in the proposed and final rules we issued to establish the “small number of animals” definition in 21 CFR part 516 (see 73 FR 14411 at 14415 and 74 FR 43043 at 43049). These authorities include sections 571, 573, and 701 of the FD&C Act (21 U.S.C. 360ccc, 360ccc-2, and 371). Sections 571 and 573 of the FD&C Act were established by the MUMS Act. Section 701(a) authorizes the Agency to issue regulations for the efficient enforcement of the FD&C Act.
As discussed in section III. C, when we published the final rule defining “small number of animals” for minor use designation in 2009, we agreed we should periodically reevaluate the small number of animals to account for changes in drug development costs, changes in the amount that animal owners are willing to pay to treat affected animals, and other relevant factors (74 FR 43043 at 43044). Based on our current reassessment (Ref. 1), we are revising the definition of “small number of animals” in § 516.3(b) to increase the small number for dogs from 70,000 to 80,000, and to increase the small number for cats from 120,000 to 150,000.
For our current reassessment of the small numbers, our primary source of information regarding costs related to dogs and cats is a 2018 report prepared by Brakke Consulting Inc., (BCI) containing population estimates, disease incidence rates, and information about drug development costs and treatment costs for companion animals (Ref. 2). The 2018 report is the latest update of the BCI report. We used previous versions of the BCI report for the 2008 proposed rule and the 2013 reassessment. Our primary source of information regarding healthcare costs for dogs and cats is the 2017-2018 edition of the American Veterinary Medical Association (AVMA) U.S. Pet Ownership and Demographics Sourcebook, which contains surveys of pet ownership (Ref. 3). This is an updated version of the same source we used for our 2008 proposed rule and the 2013 reassessment.
After evaluating the relevant data from these sources and using that information to reassess the small numbers for dogs and cats, we determined that the small numbers for dogs and cats should be increased. Therefore, we are revising the definition of “small numbers of animals” for these two species. For a full discussion of our current reassessment of the small numbers, see our current reassessment memorandum (Ref. 1).
In the document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,” announced in the
We have determined that the subject of this rulemaking is suitable for a direct final rule. We are revising the “small number of animals” definition for dogs and cats in § 516.3(b) to increase the small numbers for these two species. This rule is intended to make noncontroversial changes to an existing regulation. We do not anticipate that there will be any significant adverse comments.
Consistent with our procedures on direct final rulemaking, we are publishing elsewhere in this issue of the
We are providing a comment period for the direct final rule of 60 days after the date of publication in the
Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in the direct final rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to a part of this rule and that part can be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of the significant adverse comment.
If any significant adverse comment is received during the comment period, we will publish, before the effective date of this direct final rule, a notification of significant adverse comment and withdraw the direct final rule. If we withdraw the direct final rule, any comments received will be applied to the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedure. If we do not receive any significant adverse comment in response to this direct final rule during the comment period, we will publish a document in the
We have examined the impacts of the direct final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this direct final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because net costs of the direct final rule are less than 0.32 percent of average annual revenues for the smallest firms
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $165 million, using the most current (2021) Implicit Price Deflator for the Gross Domestic Product. This direct final rule would not result in an expenditure in any year that meets or exceeds this amount.
By expanding incentives for new animal drug development under the MUMS Act as a result of increasing the small numbers for dogs and cats, the direct final rule could benefit pet owners by improving the health of dogs and cats with uncommon diseases or conditions. These health improvements could result from the earlier marketing of new animal drugs by sponsors that apply for and receive conditional approval as a result of the direct final rule. The direct final rule also could result in cost savings to new animal drug sponsors and FDA. Sponsors that receive conditional approval have the ability to market their new animal drug for up to 5 years, subject to annual renewals, before providing substantial evidence that it is effective, as required for full approval. This would defer costs to sponsors and FDA associated with a demonstration of substantial evidence of effectiveness until later in the development process.
Because the direct final rule could increase the number of uncommon diseases or conditions in dogs and cats that qualify for minor use drug development incentives, including user fee waivers, exclusive marketing rights, grants, and eligibility for conditional approval, sponsors could incur costs to prepare and submit additional minor use determination requests and, for those sponsors that pursue designation for their new animal drug, annual designation reports to FDA. FDA will bear costs to review any additional minor use determination requests and annual designation reports. Potential sponsors of new animal drugs for minor uses in dogs or cats will also incur a one-time cost to read and understand the direct final rule.
We additionally estimate potential within-industry transfers from sponsors receiving user fee waivers as a result of the direct final rule to fee-paying sponsors, and transfers from government to industry in the form of grants to support safety and effectiveness testing.
We summarize the annualized benefits and costs of the rule in table 1. We estimate that the annualized benefits over 20 years will range from $0 to $6.06 million at a 7 percent discount rate, with a primary estimate of $3.03 million, and from $0 to $7.43 million at a 3 percent discount rate, with a primary estimate of $3.72 million. Annualized costs will range from $3,033 to $31,741 at a 7 percent discount rate, with a primary estimate of $17,387, and from $2,244 to $30,285 at a 3 percent discount rate, with a primary estimate of $16,264.
We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the direct final rule. The full analysis of economic impacts is available in the docket for this direct final rule (Ref. 4) and at
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This direct final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A description of these provisions is given in the
We estimate the burden of this information collection as follows:
Using the number of active sponsors of new animal drug applications and active sponsors of abbreviated new animal drug applications, we estimate there are 237 sponsors affected by this rule. We estimate two recordkeepers per sponsor.
We expect that new animal drug sponsors will incur a one-time burden associated with reading and understanding the rule and a nominal increase in the overall annual burden associated with reporting requirements resulting from a potential increase in submissions of minor use determination requests and annual designation reports to FDA.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection provisions of this direct final rule to OMB for review. Before the effective date of this direct final rule, FDA will publish a notice in the
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.
We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the direct final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13175. We have determined that the direct final rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the direct final rule does not contain policies that have tribal implications as defined in the Executive order and, consequently, a tribal summary impact statement is not required.
The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see
Administrative practice and procedure, Animal drugs, Confidential
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 516 is amended as follows:
21 U.S.C. 360ccc-1, 360ccc-2, 371.
(b) * * *
Pension Benefit Guaranty Corporation.
Final rule.
This final rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the asset allocation regulation for plans with valuation dates in the fourth quarter of 2022. These interest assumptions are used for valuing benefits under terminating single-employer plans and for other purposes.
Effective October 1, 2022.
Gregory Katz (
PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) prescribes actuarial assumptions—including interest assumptions—for valuing benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974 (ERISA). The interest assumptions in the regulation are also published on PBGC's website (
PBGC uses the interest assumptions in appendix B to part 4044 (“Interest Rates Used to Value Benefits”) to determine the present value of annuities in an involuntary or distress termination of a single-employer plan under the asset allocation regulation. The assumptions are also used to determine the value of multiemployer plan benefits and certain assets when a plan terminates by mass withdrawal in accordance with PBGC's regulation on Duties of Plan Sponsor Following Mass Withdrawal (29 CFR part 4281).
The fourth quarter 2022 interest assumptions will be 3.90 percent for the first 20 years following the valuation date and 3.65 percent thereafter. In comparison with the interest assumptions in effect for the third quarter of 2022, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), an increase of 1.09 percent in the select rate, and an increase of 0.71 percent in the ultimate rate (the final rate).
PBGC has determined that notice of, and public comment on, this rule are impracticable, unnecessary, and contrary to the public interest. PBGC routinely updates the interest assumptions in appendix B of the asset allocation regulation each quarter so that they are available to value benefits. Accordingly, PBGC finds that the public interest is best served by issuing this rule expeditiously, without an opportunity for notice and comment, and that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication to allow the use of the proper assumptions to estimate the value of plan benefits for plans with valuation dates early in the fourth quarter of 2022.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).
Employee benefit plans, Pension insurance, Pensions.
In consideration of the foregoing, 29 CFR part 4044 is amended as follows:
29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.
Issued in Washington, DC, by.
Office of Foreign Assets Control, Treasury.
Publication of a determination.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing a products determination issued pursuant to a March 11, 2022 Executive order. The determination was previously issued on OFAC's website.
The determination pursuant to section 1(a)(i) of Executive Order 14068 was issued on June 24, 2022. See
OFAC: Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; or Assistant Director for Sanctions Compliance & Evaluation, 202-622-2490.
This document and additional information concerning OFAC are available on OFAC's website:
On March 11, 2022, the President, invoking the authority of,
On June 24, 2022, pursuant to delegated authority, the Director of OFAC, in consultation with the Department of State and the Department of Commerce, determined that the prohibitions in section 1(a)(i) of E.O. 14068 shall apply to gold of Russian Federation origin. The determination took effect upon publication on OFAC's website (
Pursuant to sections 1(a)(i), 1(b), and 5 of Executive Order (E.O.) 14068 of March 11, 2022 (“Prohibiting Certain Imports, Exports, and New Investment With Respect to Continued Russian Federation Aggression”) and 31 CFR 587.802, the Director of the Office of Foreign Assets Control, in consultation with the Department of State and the Department of Commerce, hereby determines that the prohibitions in section 1(a)(i) of E.O. 14068 shall apply to gold of Russian Federation origin. As a result, the importation into the United States of gold of Russian Federation origin is prohibited, except to the extent provided by law, or unless licensed or otherwise authorized by the Office of Foreign Assets Control.
This determination excludes gold of Russian Federation origin that was located outside of the Russian Federation prior to the effective date of this determination.
This determination shall take effect upon publication by the Director of the Office of Foreign Assets Control on the Department of the Treasury's website.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing three temporary, 500-yard radius, moving security zones for certain vessels carrying Certain Dangerous Cargoes (CDC) within the Corpus Christi Ship Channel and La Quinta Channel. The temporary security zones are needed to protect the vessels, the CDC cargo, and the surrounding waterway from terrorist acts, sabotage, or other subversive acts, accidents, or other events of a similar nature. Entry of vessels or persons into these zones is prohibited unless specifically authorized by the Captain of the Port Sector Corpus Christi or a designated representative.
This rule is effective without actual notice from September 15, 2022 until September 22, 2022. For the purposes of enforcement, actual notice will be used from September 12, 2022, until September 15, 2022.
If you have questions on this rule, call or email Lieutenant Commander Anthony Garofalo, Sector Corpus Christi Waterways Management Division, U.S. Coast Guard; telephone 361-939-5130, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish these security zones by September 12, 2022 to ensure security of these vessels and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with the transit of the Motor Vessel (M/V) MATTERHORN EXPLORER and M/V CELSIUS CAROLINA when loaded will be a security concern within a 500-yard radius of each vessel. This rule is needed to provide for the safety and security the vessels, their cargo, and surrounding waterway from terrorist acts, sabotage or other subversive acts, accidents, or other events of a similar nature while they are transiting within Corpus Christi, TX, from September 12, 2022 until September 22, 2022.
The Coast Guard is establishing four 500-yard radius temporary moving security zones around M/V MATTERHORN EXPLORER and M/V CELSIUS CAROLINA. The zones for the vessels will be enforced from September 12, 2022, until September 22, 2022. The duration of the zones are intended to protect the vessels and cargo and surrounding waterway from terrorist acts, sabotage or other subversive acts, accidents, or other events of a similar nature. No vessel or person will be permitted to enter the security zones without obtaining permission from the COTP or a designated representative.
Entry into these security zones is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard (USCG) assigned to units under the operational control of USCG Sector Corpus Christi. Persons or vessels desiring to enter or pass through each zone must request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 361-939-0450. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate for the enforcement times and dates for each security zone.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the size, duration, and location of the security zones. This rule will impact a small designated area of 500-yards around the moving vessels in the Corpus Christi Ship Channel and La Quinta Channel as the vessels transit the channel over a two-week period. Moreover, the rule allows vessels to seek permission to enter the zones.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the temporary security zones may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves moving security zones lasting for the duration of time that the M/V MATTERHORN EXPLORER and M/V CELSIUS CAROLINA are within the Corpus Christi Ship Channel and La Quinta Channel while loaded with cargo. It will prohibit entry within a 500 yard radius of M/V MATTERHORN EXPLORER and M/V CELSIUS CAROLINA while the vessels are transiting loaded within Corpus Christi Ship Channel and La Quinta Channel. It is categorically excluded from further review under L60 in Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.2.
(a)
(b)
(c)
(2) Persons or vessels desiring to enter or pass through the zones must request permission from the COTP Sector Corpus Christi on VHF-FM channel 16 or by telephone at 361-939-0450.
(3) If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.
(d)
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2007-10-04, which applies to all McDonnell Douglas Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88 airplanes. AD 2007-10-04 requires repetitive inspections to detect cracks in the horizontal stabilizer, and related investigative and corrective actions if necessary. Since the FAA issued AD 2007-10-04, it has been determined that certain compliance times and repetitive intervals must be reduced to address the unsafe condition. This proposed AD continues to require the actions specified in AD 2007-10-04 with revised compliance times for certain 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 October 31, 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 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
Sean Newell, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5266; 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 Sean Newell, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5266; email:
The FAA issued AD 2007-10-04, Amendment 39-15045 (72 FR 25960, May 8, 2007) (AD 2007-10-04), for all McDonnell Douglas Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88 airplanes. AD 2007-10-04 was prompted by reports of cracks found in the horizontal stabilizer in the upper and lower aft skin panels at the aft inboard corner at station XH = 8.2 and in the rear spar upper caps adjacent to the aft skin panel at station XH = 10.0. AD 2007-10-04 requires repetitive inspections to detect cracks in the horizontal stabilizer, and related investigative and corrective actions if necessary. The FAA issued AD 2007-10-04 to detect and correct cracks in the
Since the FAA issued AD 2007-10-04, it has been determined that certain compliance times and repetitive intervals must be reduced for the high frequency eddy current (HFEC) surface and open hole inspections of the rear spar upper caps. The FAA received a report from Boeing of a crack found along fasteners in the upper rear spar that was longer than two inches during an inspection of the horizontal rear spar upper cap on a Model DC-9-82 (MD-82) airplane with 69,799 flight hours and 38,520 flight cycles. The crack was discovered prior to the compliance time intervals for the repetitive inspections required by AD 2007-10-04; it was determined that certain compliance times do not provide at least two opportunities to reliably detect dual origin cracks before they reach critical length.
In addition, since the FAA issued AD 2007-10-04, the legal name of the manufacturer has been changed from McDonnell Douglas Corporation to The Boeing Company on the most recent type certificate data sheet for the affected airplane models.
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 Alert Service Bulletin MD80-55A065, Revision 2, dated October 11, 2021. This service information specifies procedures for repetitive eddy current inspections (HFEC or low frequency eddy current inspections, as applicable) of the horizontal stabilizer; and applicable corrective actions. Corrective actions include stop drilling the end of the crack, trimming out the crack and installing filler, installing a horizontal stabilizer upper and lower aft skin panel splice, replacing the horizontal stabilizer upper and lower aft skin panel, installing bushings and cold working holes, removing the crack and performing a repair, replacing the horizontal stabilizer rear spar upper cap splice, and replacing the splice repair with a new horizontal stabilizer rear spar upper cap.
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
Although this proposed AD does not explicitly restate the requirements of AD 2007-10-04, this proposed AD would retain all requirements of AD 2007-10-04. Those requirements are referenced in the service information identified previously, which, in turn, is referenced in paragraph (g) of this proposed AD. This proposed AD would also reduce certain compliance times. This proposed AD would also require accomplishing the actions specified in the service information described previously. Alternative methods of compliance (AMOCs) previously approved for AD 2007-10-04 are approved for the corresponding provisions of Boeing Alert Service Bulletin MD80-55A065, dated April 25, 2007, that are required by paragraph (g) of this proposed AD. However, the following AMOCs are canceled as they reference specific inspection intervals that now fall outside of the new inspections requirements:
• FAA Letter Number 120L-14-226a, dated January 29, 2015.
• FAA Letter Number 120L-15-384b, dated November 2, 2015.
• FAA Letter Number 120L-10-345, dated August 3, 2010.
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 22 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 corrective actions (
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA has 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 that the 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) action by October 31, 2022.
This AD replaces AD 2007-10-04, Amendment 39-15045 (72 FR 25960, May 8, 2007) (AD 2007-10-04).
This AD applies to all The Boeing Company Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88 airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 55, Stabilizers.
This AD was prompted by reports of cracks found in the horizontal stabilizer in the upper and lower aft skin panels at the aft inboard corner at station XH = 8.2 and in the rear spar upper caps adjacent to the aft skin panel at station XH = 10.0; and by a determination that certain compliance times and inspection intervals must be reduced. The FAA is issuing this AD to detect and correct cracks in the upper and lower aft skin panels and rear spar upper caps, which, if not corrected, could lead to the loss of overall structural integrity of the horizontal stabilizer.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: At the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin MD80-55A065, Revision 2, dated October 11, 2021, do an eddy current inspection to detect any cracking in the horizontal stabilizer and do all applicable repetitive inspections and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin MD80-55A065, Revision 2, dated October 11, 2021. Do all applicable repetitive inspections and corrective actions at the times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin MD80-55A065, Revision 2, dated October 11, 2021.
(1) Where the Compliance Time columns of the tables in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin MD80-55A065, Revision 2, dated October 11, 2021, use the phrase “the original issue date of this service bulletin,” this AD requires using May 23, 2007 (the effective date of AD 2007-10-04).
(2) Where the Compliance Time columns of the tables in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin MD80-55A065, Revision 2, dated October 11, 2021, use the phrase “the Revision 2 date of this service bulletin,” this AD requires using “the effective date of this AD.”
(1) This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin MD80-55A065, dated April 25, 2007. This service information was incorporated by reference in AD 2007-10-04, Amendment 39-15045 (72 FR 25960, May 8, 2007).
(2) This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin MD80-55A065, Revision 1, dated September 23, 2008. This service information is not incorporated by reference in this AD.
(1) The Manager, Los Angeles 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 (k)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the 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, Los Angeles 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.
(4) AMOCs approved for AD 2007-10-04 are approved as AMOCs for the corresponding provisions of Boeing Alert Service Bulletin MD80-55A065, dated April 25, 2007, that are required by paragraph (g) of this AD, except the AMOCs specified in paragraphs (j)(4)(i) through (iii) of this AD are not approved as AMOCs for this AD.
(i) FAA Letter Number 120L-14-226a, dated January 29, 2015.
(ii) FAA Letter Number 120L-15-384b, dated November 2, 2015.
(iii) FAA Letter Number 120L-10-345, dated August 3, 2010.
(1) For more information about this AD, contact Sean Newell, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5266; 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).
The FAA proposes to adopt a new airworthiness directive (AD) for all The Boeing Company Model 707 and Model 727 airplanes. This proposed AD was prompted by a report indicating cracking in fastener holes at the center wing box and at certain positions of the rear spar and lower skin on a Model 737-300 airplane. A cross model review determined that similar cracking of the fastener holes in the center wing box lower skin could occur on Model 707 and Model 727 airplanes. For Model 707 airplanes this proposed AD would require repetitive detailed inspections of the center wing box lower skin for cracking and repetitive high frequency eddy current (HFEC) and ultrasonic (UT) inspections of the rear spar lower chord at a certain position for cracking, repetitive sealant application, and repair if necessary. For Model 727 airplanes this proposed AD would require repetitive detailed inspections of the center wing box, lower skin, and rear spar lower chord at a certain location for cracking, repetitive sealant application, and repair if necessary. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by October 31, 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 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
Sean Newell, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5266; 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 Sean Newell, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5266; email:
The FAA received a report from an operator of a Model 737-300 airplane indicating cracking in fastener holes at the center wing box, station 663.75 rear spar, lower skin located at left body buttock line (LBBL) 6.50. The lower skin cracks were hidden between the center wing box lower chord on the upper surface and the keel beam upper chord on the lower surface. The Model 737-300 airplane had a total of 72,702 flight
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.
Model 727-100 airplanes having line numbers 1 through 47 have a limit of validity (LOV) of 50,000 total flight cycles, and the actions proposed in this NPRM, as specified in Boeing Alert Requirements Bulletin 727-57A0190 RB, dated September 13, 2021, would be required at a compliance time occurring after that LOV. Although operation of an airplane beyond its LOV is prohibited by 14 CFR 121.1115 and 129.115, this NPRM would include those airplanes in the applicability so that these airplanes are tracked in the event the LOV is extended in the future.
The FAA reviewed Boeing 707 Alert Requirements Bulletin A3544 RB, dated November 1, 2021. This service information specifies procedures for repetitive internal detailed inspections of the center wing box lower skin for cracking and repetitive internal surface HFEC and UT inspections of the rear spar lower chord between LBBL 40 and right body buttock line (RBBL) 40 for cracking, repetitive sealant application, and repair.
The FAA reviewed Boeing Alert Requirements Bulletin 727-57A0190 RB, dated September 13, 2021. This service information specifies procedures for repetitive internal detailed inspections for cracking of the center wing box, lower skin, and rear spar lower chord between LBBL 34.7 and RBBL 34.7, repetitive sealant application, and repair.
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 48 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 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 October 31, 2022.
None.
This AD applies to The Boeing Company airplanes specified in paragraphs (c)(1) through (3) of this AD, certificated in any category.
(1) Model 707-100 Long Body, -200, -100B Long Body, and -100B Short Body series airplanes.
(2) Model 707-300, -300B, -300C, and -400 series airplanes.
(3) Model 727, 727C, 727-100, 727-100C, 727-200, and 727-200F series airplanes.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by a report indicating cracking in fastener holes at the center wing box and at certain positions of the rear spar and lower skin on a Model 737-300 airplane. A cross model review determined that similar cracking of the fastener holes in the center wing box lower skin could occur on Model 707 and Model 727 airplanes. The FAA is issuing this AD to address cracking in the center wing box lower skin or rear spar lower chord, which could result in the inability of the structure to sustain limit load and adversely affect the structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For airplanes identified as Group 1 in Boeing Alert Requirements Bulletin 727-57A0190 RB, dated September 13, 2021: Within 120 days after the effective date of this AD, inspect the airplane and do all applicable on-condition actions using a method approved in accordance with the procedures specified in paragraph (j) of this AD.
Except as specified by paragraph (i) of this AD: At the applicable times specified in the “Compliance” paragraph of Boeing 707 Alert Requirements Bulletin A3544 RB, dated November 1, 2021; or Boeing Alert Requirements Bulletin 727-57A0190 RB, dated September 13, 2021; as applicable, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing 707 Alert Requirements Bulletin A3544 RB, dated November 1, 2021; or Boeing Alert Requirements Bulletin 727-57A0190 RB, dated September 13, 2021, as applicable.
(1) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing 707 Alert Requirements Bulletin A3544 RB, dated November 1, 2021, uses the phrase “the original issue date of Requirements Bulletin 707A3544 RB” this AD requires using “the effective date of this AD.”
(2) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 727-57A0190 RB, dated September 13, 2021, uses the phrase “the original issue date of Requirements Bulletin 727-57A0190 RB” this AD requires using “the effective date of this AD.”
(3) Where Boeing 707 Alert Requirements Bulletin A3544 RB, dated November 1, 2021, specifies contacting Boeing for repair instructions: This AD requires doing the repair using a method approved in accordance with the procedures specified in paragraph (j) of this AD.
(4) Where Boeing Alert Requirements Bulletin 727-57A0190 RB, dated September 13, 2021, specifies contacting Boeing for repair instructions: This AD requires doing the repair using a method approved in accordance with the procedures specified in paragraph (j) of this AD.
(1) The Manager, Los Angeles 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 (k)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the 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, Los Angeles 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 Sean Newell, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5266; 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).
The FAA proposes to adopt a new airworthiness directive (AD) for certain Embraer S.A. Model ERJ 170 airplanes. This proposed AD was prompted by reports indicating that certain flight control electrical harnesses were routed incorrectly, providing inadequate separation from other electrical harness installations. This proposed AD would require an inspection of certain flight control electrical harnesses for incorrect routing, and modifying any incorrect electrical harness installations, as specified in an Agência Nacional de Aviação Civil (ANAC) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by October 31, 2022.
You may send comments, using the procedures found in 14 CFR
•
•
•
•
For material that will be incorporated by reference (IBR) in this AD, contact National Civil Aviation Agency (ANAC), Aeronautical Products Certification Branch (GGCP), Rua Dr. Orlando Feirabend Filho, 230—Centro Empresarial Aquarius—Torre B—Andares 14 a 18, Parque Residencial Aquarius, CEP 12.246-190—São José dos Campos—SP, Brazil; telephone 55 (12) 3203-6600; email
You may examine the AD docket at
Hassan M. Ibrahim, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3221; 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 Hassan M. Ibrahim, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3221; email
ANAC, which is the aviation authority for Brazil, has issued ANAC AD 2022-04-01, effective April 29, 2022 (ANAC AD 2022-04-01) (also referred to as the MCAI), to correct an unsafe condition for certain Embraer S.A. Model ERJ 170-100 LR, ERJ 170-100 SE, ERJ 170-100 STD, ERJ 170-100 SU, ERJ 170-200 LR, ERJ 170-200 STD, ERJ 170-200 SU, and ERJ 170-200 LL airplanes.
This proposed AD was prompted by reports indicating that flight control electrical harnesses were routed incorrectly on certain airplanes, providing inadequate separation from other electrical harness installations. These other electrical harness installations are considered critical according to the airplanes' critical design configuration control limits (CDCCLs), which identifies items that can be the source of a fuel tank ignition. The FAA is proposing this AD to address the incorrect routing of flight control electrical harnesses near critical fuel quantity indication harnesses, which could possibly result in fuel tank ignition and subsequent loss of the airplane.
ANAC AD 2022-04-01 specifies procedures for inspecting the installation of flight control electrical harnesses W126 and W127 for incorrect routing and modifying any incorrect electrical harness installations.
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 referenced 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 require accomplishing the actions specified in ANAC AD 2022-04-01 described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.
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 ANAC AD 2022-04-01 by reference in the FAA final rule. This
The FAA estimates that this proposed AD would affect 668 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 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 actions:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed 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 October 31, 2022.
None.
This AD applies to Embraer S.A. (Type Certificate previously held by Yaborã Indústria Aeronáutica S.A.; Embraer S.A.) Model ERJ 170-100 LR, -100 STD, -100 SE, and -100 SU airplanes; and Model ERJ 170-200 LR, -200 SU, -200 STD, and -200 LL airplanes, certificated in any category, as identified in Agência Nacional de Aviação Civil (ANAC) AD 2022-04-01, effective April 29, 2022 (ANAC AD 2022-04-01).
Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by reports indicating that certain flight control electrical harnesses were routed incorrectly, providing inadequate separation from other electrical harness installations. The FAA is issuing this AD to address the incorrect routing of flight control electrical harnesses near critical fuel quantity indication harnesses, which could possibly result in fuel tank ignition and subsequent loss of the airplane.
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, ANAC AD 2022-04-01.
(1) Where ANAC AD 2022-04-01 refers to its effective date, this AD requires using the effective date of this AD.
(2) The “Alternative methods of compliance (AMOC)” section of ANAC AD 2022-04-01 does not apply to this AD.
The following provisions also apply to this AD:
(1)
(2)
(1) For ANAC AD 2022-04-01, contact National Civil Aviation Agency (ANAC), Aeronautical Products Certification Branch (GGCP), Rua Dr. Orlando Feirabend Filho, 230—Centro Empresarial Aquarius—Torre B—Andares 14 a 18, Parque Residencial Aquarius, CEP 12.246-190—São José dos Campos—SP, Brazil; telephone 55 (12) 3203-6600; email
(2) For more information about this AD, contact Hassan M. Ibrahim, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3221; email
Federal Aviation Administration (FAA), DOT.
Proposed policy; request for comments.
This notice is directed to airport sponsors, consultants, and other stakeholders regarding a proposed update of the FAA policy and practice regarding processing land use changes on federally acquired or federally conveyed airport land. The updated policy confirms and clarifies the appropriate methods to document FAA's review and approval or consent for such changes, in light of amendments made by Section 163 of the FAA Reauthorization Act of 2018. This policy clarifies: When reviewing proposed land use changes on federally acquired or federally conveyed airport land, the FAA will review the proposal in its entirety without individually examining components of the proposal as aeronautical or non-aeronautical; a letter of approval or consent is required for a non-aeronautical use or mixed use and the approval or consent will remain in effect for the duration of the lease term; the determination of whether the non-aeronautical use is significant will be based on the primary use of the project; FAA will only release Federal obligations when the airport sponsor proposes the sale or conveyance of federally acquired or federally conveyed airport land that meets FAA release requirements; and, FAA letters of approval or consent and releases will be documented on an airport's Exhibit A in accordance with the ARP SOP 3.00—
The FAA will accept public comments on the proposed policy statement for 30 days. Comments must be submitted on or before October 17, 2022. The FAA will consider comments on the proposed policy statement. Any necessary or appropriate revisions resulting from the comments received will be adopted as of the date of a subsequent publication in the
You may send comments [identified by Docket Number, FAA 2022-1203] using any of the following methods:
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•
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Lorraine Herson-Jones, Manager, Office of Airport Compliance and Management Analysis, ACO-100, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, telephone (202) 267-3085.
Congress authorized the conveyance of federal surplus property and financial assistance for the acquisition of land where the land is needed for “airport purposes.” See 49 U.S.C. 47107(c)(1). Under the Airport Improvement Act, “airport purpose” means land that “may be needed for an aeronautical purpose (including runway protection zone) or serves as noise buffer land.” Id. Federally conveyed or federally acquired land must be used for airport purposes until the FAA approves or consents to a non-aeronautical use and thereby discharges the sponsor of that obligation. 49 U.S.C. 47153(a), 49 U.S.C. 47125(a), and 49 U.S.C. 47107(c)(2)(B). In addition, Congress requires the FAA to submit an annual report listing airports not in compliance with airport
Airport sponsors that have accepted federally conveyed or federally acquired airport land have agreed to comply with certain obligations and policies included in the federal grant agreement or the federal conveyance documents regarding the use of the land. Those obligations derive from multiple statutes, deed covenants and the grant assurances.
Airport sponsors must request FAA written approval or consent to allow federally conveyed or federally acquired land to be used for non-aeronautical purposes. 49 U.S.C. 47153(a), 49 U.S.C. 47125(a), 49 U.S.C. 47107(c)(2)(B). The FAA's authority to approve or consent to a non-aeronautical land use or to release obligations depends upon the obligating documents, the current and future aeronautical need of the property, and the proposed use. For example, residential use on airport property is incompatible with the needs of civil aviation, is prohibited by FAA policy, and is also contrary to federal obligations.
Limiting the use of aeronautical facilities to aeronautical purposes ensures that airport facilities are available to meet aviation demand at the airport. Aviation tenants and aircraft owners should not be displaced by non-aviation commercial uses that could be conducted off airport property.
In addition, the “
1. Any regulation ensuring the safe and efficient operation of aircraft or safety of people and property on the ground related to aircraft operations;
2. Any regulation imposed with respect to land or a facility acquired or modified using Federal funding;
3. Any authority contained in a Surplus Property Act instrument of transfer,
In cases covered by 163(b), FAA retains land use approval authority over the project. The FAA will follow this policy guidance and FAA Order 5190.6,
When FAA lacks approval authority over a particular change in land use or sale of land, all of the airport sponsor's federal statutory and grant assurance obligations remain in full force and effect, including over its remaining airport property. Airport sponsors remain obligated under the Grant Assurances, FAA's
The sale or lease of the land must be accomplished per the FAA's
The FAA may verify compliance with these requirements through a financial compliance review, review of supporting documentation, land use inspection, the enforcement of grant assurances, or other enforcement mechanisms. The sponsor also has the responsibility to comply with all federal, state, and local environmental laws and regulations.
Examples of aeronautical use include:
1. operational uses such as aerial approaches, navaids, runways, taxiways, aprons, or other aircraft movement areas;
2. future developmental uses to reserve property interests for foreseeable aeronautical development (
3. essential services that directly support flight operations (
1. A terminal complex: All components of a terminal complex (including the building, terminal concessions, terminal parking, and roads) serve an airport purpose.
2. A fixed base operator (FBO) facility that includes parking and classrooms. All components serve an airport purpose.
An aeronautical facility serving an airport purpose does not include certain uses such as aircraft manufacturing plants and warehouse distribution facilities, which are considered as mixed-use as defined below.
Examples of these include:
1. Car rental facility (stand-alone). All components will be considered a non-aeronautical use.
2. Hotel and associated parking lot.
3. Warehouse and distribution center.
1. Mail distribution centers that are connected to an air cargo operation.
2. Cargo operations containing non-aeronautical elements such as office building complexes, sorting facilities, long-term storage (warehousing), freight forwarders and third-party logistics providers, certain access infrastructure, or certain truck parking/trailer facilities (stalls). Most of these are related to other transportation modes or aspects of the cargo business, but not directly and substantially to its “aeronautical activity”.
3. Aircraft manufacturing facility that includes final assembly, but also significant non-aeronautical uses such as engineering facilities, research and development facilities, parts manufacturing and storage, employee parking, or office buildings.
1. Surplus Property Act, codified in 49 U.S.C. 47151-47153, including former military airports conveyed to local public entities under 10 U.S.C. 2687 of the Defense Base Closure and Realignment Act (BRAC) program or any other Federal laws; and,
2. Section 16 of the Federal Airport Act of 1946, 119 Public Law 79-377, Section 23 of the Airport and Airway Development Act of 1970, Public Law 91-258, and Section 516 of the Airport and Airway Development Act of 1982, codified in 49 U.S.C. 47125. These are sometimes referred to as non-surplus property transfers.
In accordance with the above, the FAA proposes to adopt the following policy statement on processing land use changes on federally acquired and federally conveyed land. The agency requests public comments on the proposed policy statement. Comments can be submitted as described in the
The FAA confirms and clarifies its prior policy and practice regarding the implementation of its statutory responsibility to review and approve or consent to, or deny, requests for land use changes on federally acquired or federally conveyed land:
Uses of airport land will fall into one of four categories: (1) Aeronautical use, (2) Airport Purpose, (3) Non-Aeronautical Use, or (4) Mixed-Use.
FAA must approve or consent to all non-aeronautical and mixed uses of federally acquired and federally conveyed land. If the FAA determines that the proposed use serves an aeronautical use or airport purpose as defined above, then FAA approval or consent is not required. The following explains the process when an airport sponsor requests a change in land use on federally conveyed or federally acquired land:
The sponsor's request needs to include the following:
a. documentation on how the land was acquired (
b. current and future aeronautical demand of the airport and the land; and
c. proposed non-aeronautical use, including the length of the lease.
FAA's determination of whether the non-aeronautical use is significant, consistent with the term “mixed uses” in “Explanation of Terms” in this document, will be made based on
a. reasonableness and practicality of the sponsor's request,
b. effect of the request on needed aeronautical facilities, and
c. compatibility of the proposal with the needs of civil aviation. (
The distinctions may vary slightly depending on the circumstances of the situation, such as intermodal functionality, proponent's business model, project integrity, available airport land, project size and location, airport planning priorities, and funding requirements and restrictions. The proposal must benefit the airport and its functions in support of aeronautical uses and not adversely affect the value of the Federal investment in the airport and its facilities. 49 U.S.C. 47107(a)(16)(B), 49 U.S.C. 47125(a), and 49 U.S.C. 47152(1).
The use should be compatible with the airport's current or future aeronautical use or demand. FAA approval shall not be granted if the FAA determines that an aeronautical demand for the land is likely to exist within the period of the proposed use, or it compromises the safety and operation of the airport. FAA consent to or approval of a non-aeronautical use should only extend for duration of the lease term and must provide that the land will be returned to aeronautical use at the end of the term.
Upon completion of the review, the FAA will either issue a letter of approval or letter of consent for the non-aeronautical use or mixed-use, or deny the request.
The letter of approval or letter of consent must document the FAA's approval of a non-aeronautical land use on federally acquired or federally conveyed airport land. This letter will outline the conditions of the approval or consent and include a requirement that the land must be available for aeronautical use at the end of the approval or consent period. Generally, the approval or consent will remain for the duration of the lease agreement. The letter of approval or letter of consent does not affect or negate the sponsor's federal obligations.
The requirement for NEPA should be coordinated with FAA Environmental Protection Specialists.
All land use changes should be shown on the Exhibit A in accordance with ARP SOP 3.00—
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA, the Agency, or we) is proposing to revise the “small number of animals” definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or for minor uses in major animal species. Congress provided a statutory definition of “minor use” that relies on the phrase “small number of animals” to characterize such use. We are proposing certain revisions to the definition of “small number of animals” based on our most recent reassessment of the small numbers, which we conducted from 2018 to 2019.
Either electronic or written comments on this proposed rule or its companion direct final rule must be submitted by November 14, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 14, 2022. If FDA receives any timely significant adverse comments on the direct final rule with which this proposed rule is associated, the Agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. FDA will apply any significant adverse comments received on the direct final rule to the proposed rule in developing the final rule. FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.
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
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) at
Margaret Oeller, Center for Veterinary Medicine (HVF-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0566, email:
The proposed rule would amend the definition of “small number of animals” as it relates to dogs and cats in our regulation implementing the MUMS Act. The term “minor use” is the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals, or occurs in limited geographical areas and in only a small number of animals annually. The “small number of animals” definition is used for purposes of determining whether a particular intended use of a drug in one of the seven major species of animals (horses, dogs, cats, cattle, pigs, turkeys, and chickens) qualifies as a minor use. In March 2008, FDA issued a proposed rule to establish the meaning of “small number of animals” as that term is used in the definition of minor use included in the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA finalized the rule in August 2009. The definition for the phrase “small number of animals” includes a specific upper limit number (
In response to comments submitted to FDA regarding the 2008 proposed rule, we stated in the final rule that we would periodically reevaluate the small numbers and update the definition if necessary. This proposed rule is the result of our 2018-2019 reassessment of the “small numbers of animals.”
Based on our 2018-2019 reassessment, we are proposing to revise the small number for dogs included in the “small number of animals” definition from 70,000 to 80,000 and the small number for cats from 120,000 to 150,000.
The legal authority for this proposed rule is the MUMS Act, which amended the FD&C Act. Additional authority comes from the “Regulations and Hearings” section of the FD&C Act, which authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act.
Sponsors that apply for and receive conditional approval for a new animal drug intended for a “minor use” in dogs or cats as a result of the changes to the small numbers that would be made by the proposed rule, if finalized, would be able to market their drug earlier, which in turn could benefit pet owners by improving the health of dogs and cats with uncommon diseases or conditions. Both FDA and those sponsors receiving conditional approval could receive cost savings from deferring costs associated with providing FDA with substantial evidence that a new animal drug is effective until later in the drug development process. “Substantial evidence” is the effectiveness standard that must be met before a sponsor can receive full approval for its new animal drug under the FD&C Act. Conditional approval does not require the drug sponsor to demonstrate effectiveness by “substantial evidence.” Instead, the sponsor has to show that there is a “reasonable expectation” of effectiveness. Sponsors could incur costs to prepare and submit additional minor use determination requests and annual designation reports to FDA. In addition, FDA would bear costs to review any additional minor use determination requests and annual designation reports it receives from sponsors. FDA estimates that the annualized benefits over 20 years would range from $0 to $6.06 million at a 7 percent discount rate, with a primary estimate of $3.03 million, and from $0 to $7.43 million at a 3 percent discount rate, with a primary estimate of $3.72 million. Annualized costs would range from $3,033 to $31,741 at a 7 percent discount rate, with a primary estimate of $17,387, and from $2,244 to $30,285 at a 3 percent discount rate, with a primary estimate of $16,264.
The MUMS Act (Pub. L. 108-282) amended the FD&C Act to provide incentives for the development of new animal drugs for use in minor animal species and for minor uses in major animal species. The MUMS Act defines “minor use” as the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually (see section 201(pp) of the FD&C Act (21 U.S.C. 321(pp)). Congress charged FDA to further define the term “small number of animals” for minor use purposes (see Senate Report 108-226 at 8, February 18, 2004). In the
The “small numbers of animals” definition was formally established by the final rule that was published on August 26, 2009 (74 FR 43043). In that final rule, we addressed comments from the public regarding the 2008 proposed rule, including comments suggesting that the Agency reevaluate the small numbers on a periodic basis. We agreed that periodic reassessment of the small numbers is appropriate, and that such reassessments should occur approximately every 5 years.
We conducted our initial reassessment of the small numbers in 2013 and published the results of that reassessment on May 19, 2014 (79 FR 28736) (the 2013 reassessment). At that time, we did not change the small numbers for any of the major species.
From 2018 to 2019, we conducted our second reassessment (current reassessment) of the small numbers (Ref. 1). Based on the current reassessment, we are proposing to revise (
The term “small number of animals” is defined in § 516.3(b) (21 CFR 516.3(b)) of our regulation on new animal drugs for minor use and minor species. For each of the seven major species of animals, the definition specifies the greatest number of animals of that species that could be treated annually with a new animal drug for a particular indication and still qualify as a minor use. For dogs and cats, a “small number of animals” is defined as equal
The process FDA used to establish the small numbers for the companion animal major species (dogs, cats and horses) is outlined in detail in the 2008 proposed rule. That process involved estimating the development cost for an animal drug intended for each of the three major companion animal species, estimating the amount that companion animal owners were willing to pay for a drug to treat each of those species, estimating the average percentage of companion animals that would likely be treated, and estimating the uncertainty associated with estimates of the rate of occurrence of various uncommon conditions in companion animals. Assessment of these various factors resulted in the formula, published in the proposed rule (73 FR 14411 at 14414), that we use to determine the small numbers for companion animals.
In the preamble to the 2009 final rule in which we first established the definition of “small number of animals,” we agreed in response to comments that we should periodically reevaluate the small numbers and update the definition as necessary. We also agreed that such a reevaluation should take into account the potential for changes in the development cost of new animal drugs, changes in the amount that animal owners are willing to pay to treat affected animals, and changes in other factors involved in establishing a “small number,” such as the total population of major animal species (74 FR 43043 at 43044).
In a memorandum containing the results of our current reassessment, we describe the processes that we used to reevaluate the small number of animals (Ref. 1). Based on the current reassessment, we are proposing to increase the small numbers for dogs and cats only.
We are issuing this proposed rule under the same legal authorities described in the proposed and final rules we issued to establish the “small number of animals” definition in 21 CFR part 516 (see 73 FR 14411 at 14415 and 74 FR 43043 at 43049). These authorities include sections 571, 573, and 701 of the FD&C Act (21 U.S.C. 360ccc, 360ccc-2, and 371). Sections 571 and 573 of the FD&C Act were established by the MUMS Act. Section 701(a) authorizes the Agency to issue regulations for the efficient enforcement of the FD&C Act.
As discussed in section III.C, when we published the final rule defining “small number of animals” for minor use designation in 2009, we agreed we should periodically reevaluate the small number of animals to account for changes in drug development costs, changes in the amount that animal owners are willing to pay to treat affected animals, and other relevant factors (74 FR 43043 at 43044). Based on our current reassessment (Ref. 1), we are proposing to revise the definition of “small number of animals” in § 516.3(b) to increase the small number for dogs from 70,000 to 80,000, and to increase the small number for cats from 120,000 to 150,000.
For our current reassessment of the small numbers, our primary source of information regarding costs related to dogs and cats is a 2018 report prepared by Brakke Consulting Inc., (BCI) containing population estimates, disease incidence rates, and information about drug development costs and treatment costs for companion animals (Ref. 2). The 2018 report is the latest update of the BCI report. We used previous versions of the BCI report for the 2008 proposed rule and the 2013 reassessment. Our primary source of information regarding healthcare costs for dogs and cats is the 2017-2018 edition of the American Veterinary Medical Association (AVMA) U.S. Pet Ownership and Demographics Sourcebook, which contains surveys of pet ownership (Ref. 3). This is an updated version of the same source we used for our 2008 proposed rule and the 2013 reassessment.
After evaluating the relevant data from these sources and using that information to reassess the small numbers for dogs and cats, we determined that the small numbers for dogs and cats should be increased. Therefore, we are proposing revisions to the definition of “small numbers of animals” for these two species. For a full discussion of our current reassessment of the small numbers, see our current reassessment memorandum (Ref. 1).
In the document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,” announced in the
This proposed rule is a companion to the direct final rule published elsewhere in this issue of the
Consistent with our procedures on direct final rulemaking, we are publishing elsewhere in this issue of the
We are providing a comment period for the proposed rule of 60 days after the date of publication in the
Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in this proposed rule would not be considered a significant adverse comment unless the comment states why the proposed
If any significant adverse comment is received during the comment period, we will publish, before the effective date of the direct final rule, a notice of significant adverse comment and withdraw the direct final rule. If we withdraw the direct final rule, any comments received will be applied to this proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedure. If we do not receive any significant adverse comment in response to the direct final rule during the comment period, no further action will be taken related to this proposed rule. Instead, we will publish a document in the
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because net costs of the proposed rule are less than 0.32 percent of average annual revenues for the smallest firms in the industry, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $165 million, using the most current (2021) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
By expanding incentives for new animal drug development under the MUMS Act as a result of increasing the small numbers for dogs and cats, the proposed rule, if finalized, could benefit pet owners by improving the health of dogs and cats with uncommon diseases or conditions. These health improvements could result from the earlier marketing of new animal drugs by sponsors that apply for and receive conditional approval as a result of the proposed rule, if finalized. The proposed rule, if finalized, also could result in cost savings to new animal drug sponsors and FDA. Sponsors that receive conditional approval have the ability to market their new animal drug for up to 5 years, subject to annual renewals, before providing substantial evidence that it is effective, as required for full approval. This would defer costs to sponsors and FDA associated with a demonstration of substantial evidence of effectiveness until later in the development process.
Because the proposed rule, if finalized, could increase the number of uncommon diseases or conditions in dogs and cats that qualify for minor use drug development incentives, including user fee waivers, exclusive marketing rights, grants, and eligibility for conditional approval, sponsors could incur costs to prepare and submit additional minor use determination requests and, for those sponsors that pursue designation for their new animal drug, annual designation reports to FDA. FDA would bear costs to review any additional minor use determination requests and annual designation reports. Potential sponsors of new animal drugs for minor uses in dogs or cats would also incur a one-time cost to read and understand the rule.
We additionally estimate potential within-industry transfers from sponsors receiving user fee waivers as a result of the proposed rule, if finalized, to fee-paying sponsors, and transfers from government to industry in the form of grants to support safety and effectiveness testing.
We summarize the annualized benefits and costs of the proposed rule in table 1. We estimate that the annualized benefits over 20 years would range from $0 to $6.06 million at a 7 percent discount rate, with a primary estimate of $3.03 million, and from $0 to $7.43 million at a 3 percent discount rate, with a primary estimate of $3.72 million. Annualized costs would range from $3,033 to $31,741 at a 7 percent discount rate, with a primary estimate of $17,387, and from $2,244 to $30,285 at a 3 percent discount rate, with a primary estimate of $16,264.
We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 4) and at
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A description of these provisions is given in the
FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
We estimate the burden of this information collection as follows:
Using the number of active sponsors of new animal drug applications and active sponsors of abbreviated new animal drug applications, we estimate there are 237 sponsors that would be affected by this rule. We estimate two recordkeepers per sponsor.
We expect that new animal drug sponsors would incur a one-time burden associated with reading and understanding the rule and a nominal increase in the overall annual burden associated with reporting requirements resulting from a potential increase in submissions of minor use determination
To ensure that comments on the information collections are received, OMB recommends that written comments be submitted through
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection provisions of this proposed rule to OMB for review. These information collection requirements will not be effective until FDA publishes a final rule, OMB approves the information collection requirements, and the rule goes into effect. FDA will announce OMB approval of these requirements in the
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the proposed rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.
The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see
Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 516 be amended as follows:
21 U.S.C. 360ccc-1, 360ccc-2, 371.
(b) * * *
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to amend the significant new use rules (SNURs) for certain chemical substances identified herein, which were the subject of one or more premanufacture notices (PMNs) and in some cases significant new use notices (SNUNs). This action would amend the SNURs to allow certain new uses reported in the SNUNs or PMNs without additional notification requirements and modify the significant new use notification requirements based on the actions and determinations for the SNUN or PMN submissions or based on the examination of new test data or other information. EPA is proposing these amendments based on our review of new and existing data for the chemical substances.
Comments must be received on or before October 17, 2022.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0302, through the
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Manufacturers or processors of the chemical substance (NAICS codes 325 and 324110),
This proposed rule may affect certain entities through pre-existing import certification and export notification rules under the Toxic Substances Control Act (TSCA). Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28 and must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a SNUR must certify their compliance with the SNUR requirements. Any person who exports or intends to export the chemical substance that is the subject of a final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and 40 CFR 721.20, and must comply with the export notification requirements in 40 CFR part 707, subpart D.
1.
2.
EPA is proposing amendments to the SNURs for certain chemical substances in 40 CFR part 721, subpart E. A SNUR for a chemical substance designates certain activities as a significant new use. Persons who intend to manufacture or process the chemical substance for the significant new use must notify EPA at least 90 days before commencing that activity. The required notification (
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors and may issue or modify a TSCA section 5(e) order and/or amend the SNUR promulgated under TSCA section 5(a)(2). Procedures and criteria for modifying or revoking SNUR requirements appear at 40 CFR 721.185.
TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In determining whether and how to modify the significant new uses for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, and the four TSCA section 5(a)(2) factors listed in this unit.
In this unit, EPA provides the following information for each chemical substance subject to the proposed amendments presented in this document:
• CFR citation for the existing SNUR that EPA is proposing to amend.
• PMN and SNUN number(s), as applicable.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities).
• Final rule citation (
• Basis for the proposed amendment.
•
On September 20, 2019, EPA received SNUN S-19-6 for the generic (non-confidential) significant new use as a component for 3D printing formulations. Based on available data on the chemical substance and data on analogous chemicals, EPA identified the following human health hazards: acute toxicity, skin and eye irritation, skin sensitization, genotoxicity, carcinogenicity, and specific target organ toxicity. Based on the activities described in the SNUN, EPA determined in accordance with TSCA section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk of injury to health or the environment under the conditions of use.
Pursuant to 40 CFR 721.185(a)(3), EPA determined that there is no need to require additional notice from persons who propose to engage in activities identical to those described in SNUN S-19-6. Accordingly, the proposed amendment to the SNUR would remove use as a component for 3D printing formulations from the scope of the significant new use, except where that use does not include the protective measures described in the SNUR.
On March 24, 2006, EPA received SNUN S-06-05 for the generic (non-confidential) significant new use as an adhesive additive. Based on the activities described in the SNUN, EPA took no action and allowed the significant new use. On December 9, 2015, EPA received SNUN S-16-6 for the generic (non-confidential) significant new use as a resin and to exceed the confidential aggregate production volume limit. Based on the SNUN submitter's amendment to S-16-6 confirming its intention to abide by the workplace protection, hazard communication, no domestic manufacture, disposal by incineration or landfill, and release to water restrictions in the SNUR, EPA did not determine the manufacturing, processing, use, or disposal of this substance in the manner described in S-16-6 may present an unreasonable risk to human health or the environment. The decision not to regulate the SNUN substance was based on limiting human exposure through the use of appropriate personal protective equipment by exposed workers, hazard communication warnings, import of the SNUN substance (
Pursuant to 40 CFR 721.185(a)(3), EPA determined that there is no need to require additional notice from persons who propose to engage in activities identical to those described in S-06-05 and S-16-6. Accordingly, the proposed amendment to the SNUR would remove the uses described in both SNUNs from the scope of the significant new uses and remove the aggregate production volume limit. It would also exempt SNUR requirements when the substance has been completely reacted or cured. The chemical substance which is the subject of this SNUR is now on the public TSCA Inventory. Because of that EPA is proposing to amend the SNUR to include the specific chemical name and CAS number.
EPA received a request from the PMN submitter to amend the Order when the substance is completely bound in the polymer matrix. EPA agreed that when
On June 30, 2003, EPA received SNUN S-03-15 for the chemical substance describing uses different than those in the PMN including uses that generate a vapor, mist, or aerosol. After review of this SNUN was completed on August 30, 2017, EPA determined according to TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I) that the new uses may present an unreasonable risk to human health and that an Order was required to protect against those risks. The Order requires that the substance is used only for anti-graffiti systems and surface treatment of mineral porous systems, requires use of a NIOSH-approved respirator with an APF of 100 for workers who are exposed by inhalation, allows as an alternative to the respirators maintaining a New Chemicals Exposure Limit (NCEL) of 0.03 mg/m
On December 18, 2017, before a Notice of Commencement was submitted that would add the substance to the TSCA Inventory, EPA received
On January 31, 2019, before a Notice of Commencement was submitted that would add the substance to the TSCA Inventory, EPA received PMN P-19-46 for the new chemical substance describing its intended use as a lubricating agent. Based on submitted data on the new chemical substance and data on analogous chemicals, EPA identified concerns for blood, liver, maternal, and developmental toxicity. Based on the activities described in the PMN, EPA determined in accordance with TSCA section 5(a)(3)(C) that the PMN substance is not likely to present an unreasonable risk of injury to health or the environment under the conditions of use.
The proposed amendment to the SNUR would revise and replace certain significant new uses to better tailor the SNUR to current risk concerns following EPA's review and determination for P-19-46. The proposed amendment would remove the significant new uses of annual production volume greater than 150,000 kilograms and use other than as a lubricant in chain oils for conveyor belts. EPA is proposing to remove these new uses from the SNUR as these uses are no longer expected to result in changes to human exposures or environmental releases that could result in risk. In lieu of the removed uses, the proposed amendments would add the significant new uses of release to water above 20,000 ppb and any manufacture, processing, or use resulting in inhalation exposure. EPA is proposing to designate these uses as significant new uses because these uses could result in significant changes to human exposures or environmental releases that could result in health risk.
On September 28, 2018, the PMN submitter sent to EPA seven ecotoxicity studies pursuant to the requirements of the Order. EPA evaluated the studies and determined that toxicity to aquatic organisms may occur at concentrations that exceed 13 ppb (
On June 9, 2020, before a Notice of Commencement was submitted that would add the substance to the TSCA Inventory, EPA received PMN P-20-111 describing the generic (non-confidential) intended use as a component in flexible automotive interior parts. Based on available data on the new chemical substance and data on analogous chemicals, EPA identified concerns for systemic and developmental effects. Based on the activities described in PMN P-20-111, EPA determined in accordance with TSCA section 5(a)(3)(C) that the PMN substance is not likely to present an unreasonable risk of injury to health or the environment under the conditions of use.
Based on EPA's review and determination for PMN P-20-111, the proposed amendment would remove use as a component in flexible automotive interior parts from the scope of the significant new use. Based on the PMN submitter for P-20-111 identifying use of a NIOSH certified respirator with an assigned protection factor of 10 and hazard communication that includes hazards for eye irritation and specific target organ toxicity, the proposed amendment would add significant new uses for use without worker personal protective equipment of a NIOSH certified respirator with an assigned protection factor of 10 and hazard communication that does not include eye irritation and specific target organ toxicity. The proposed significant new use for specific target organ toxicity hazard communication would replace the existing significant new use for internal organ effects hazard communication to better harmonize the hazard communication language with the Globally Harmonized System and OSHA Hazard Communication Standard. EPA also proposes to remove the significant new use requirement specified in 40 CFR 721.63(a)(2) as that was a typographical error in the original SNUR.
In those instances where EPA expanded the scope of the significant new use, the Agency identified concerns, as discussed in Unit IV., associated with certain potential new uses. In addition to considering the factors discussed in Unit IV., EPA determined that those uses could result in changes in the type or form of exposure to the chemical substance, increased exposures to the chemical substance, and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substance.
In those instances where EPA narrowed the scope of a significant new use, EPA has (1) received significant new use or premanufacture notices for some of the activities designated as significant new uses of the substance and, after reviewing such notices, concluded that there is no need to require additional notice from persons who propose to engage in identical or similar activities; or (2) received test data or other information that led the Agency to conclude that certain activities designated as significant new uses are not likely to present an unreasonable risk of injury to health or the environment. For the SNUR for P-89-632 EPA is proposing changes to be consistent with the Order (as modified) for that chemical substance.
To establish a significant new use, EPA must determine that the use is not ongoing. EPA solicits comments on whether any of the uses that are not currently a significant new use under the SNURs addressed in this proposed rule, but which would be regulated as a “significant new use” if this proposed rule is finalized, are ongoing. These specific new uses are the additional requirements if a vapor, mist, or aerosol is generated for the SNUR at 40 CFR 721.9502, use without worker personal protective equipment of a NIOSH certified respirator with an assigned protection factor of 10 and hazard communication that does not include eye irritation and specific target organ toxicity for the SNUR at 40 CFR 721.11227, and any manufacture, processing, or use that results in inhalation exposure or water release
EPA designates September 15, 2022, as the cutoff date for determining whether the use is ongoing. EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of public release of the proposed SNUR rather than as of the effective date of the final rule. If uses begun after public release were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became effective, and then argue that the use was ongoing as of the effective date of the final rule.
Thus, any persons who begin commercial manufacture or processing activities with the chemical substance that are not currently a significant new use under the current rule but which would be regulated as a “significant new use” if this proposed rule is finalized, must cease any such activity as of the effective date of the rule if and when finalized. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.
TSCA section 5 generally does not require developing any particular new information (
In the absence of a rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known or reasonably ascertainable (40 CFR 720.50). Unit IV. of this document lists potentially useful information for all SNURs addressed in this proposed rule. Descriptions of this information are provided for informational purposes. The potentially useful information identified in Unit IV. will be useful to EPA's evaluation of a chemical substance in the event that someone submits a SNUN for a significant new use pursuant to the SNURs address in this proposed rule. Companies who are considering submitting a SNUN are encouraged, but are not required, to develop the potentially useful information on the substance, which may assist with EPA's analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing on vertebrate animals, EPA encourages dialogue with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h).
The potentially useful information listed in Unit IV. may not be the only means of providing information to evaluate the chemical substance. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following: human exposure and environmental release that may result from the significant new use of the chemical substances; and information on risks posed by the chemical substances compared to risks posed by potential substitutes.
According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN under 40 CFR part 720, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available electronically at
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket for this rulemaking.
Additional information about these statutes and Executive Orders can be found at
This action proposes to modify SNURs for chemical substances that were the subject of PMNs and SNUNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).
This action does not impose any new information collection burden under the PRA (44 U.S.C. 3501
According to the PRA, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601
EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $19,020 to $3,330. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $11,164 for qualifying small firms. Therefore, the potential economic impacts of complying with this proposed SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the
This action does not contain any unfunded mandate as described in UMRA (2 U.S.C. 1531-1538) and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments. Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this rulemaking.
This action does not have federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This action is not expected to have substantial direct effects on Indian Tribes, significantly nor uniquely affect the communities of Indian Tribal governments and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 do not apply to this proposed rule.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action has not otherwise been designated as a significant energy action by the Administrator of the Office of Information and Regulatory Affairs.
This action does not involve technical standards. As such, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.
EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) and Executive Order 14008 (86 FR 7619, January 27, 2021) because it does not establish an environmental health or safety standard.
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, for the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 721 as follows:
15 U.S.C. 2604, 2607, and 2625(c).
(a) * * * (1) The chemical substance identified as 2-propen-1-one, 1-(4-morpholinyl)- (PMN P-95-169; SNUN S-08-7; SNUN S-14-1; SNUN S-17-10; and SNUN S-19-6; CAS No. 5117-12-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the chemical substance after it has been completely reacted (cured) because 2-propen-1-one, 1-(4-morpholinyl)- will no longer exist.
(2) * * *
(i) * * *
(A) * * *
(B) Additional requirements for use as a monomer for stereolithography and 3D printing: Requirements as specified in § 721.63(a)(4) and (5), (a)(6)(v), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (
(iii)
(a) * * * (1) The chemical substance identified as oxirane, 2,2′-[1,6-naphthalenediylbis(oxymethylene)]bis- (PMN P-87-1036, SNUN S-06-5, and SNUN S-16-6; CAS No. 27610-48-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the chemical substance after it has been completely reacted (cured).
(2) * * *
(iii)
(a) * * * (1) The chemical substance identified as 1,3-propanediamine, N,N′-1,2-ethanediylbis-, polymer with 2,4,6-trichloro-1,3,5-triazine, reaction products with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine (PMN P-89-632; CAS No. 136504-96-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely incorporated into a polymer matrix.
(2) * * *
(i)
(ii)
(a) * * * (1) The chemical substance identified generically as siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy-terminated salt (PMN P-00-1132, SNUN S-03-15, and SNUN S-11-5) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(2) * * *
(i)
(ii)
(B)
(C)
(b) * * *
(1)
(a) * * * (1) The chemical substance identified as fatty acids, C14-18 and C16-18-unsatd., polymers with adipic acid and triethanolamine, di-Me sulfate-quaternized (PMNs P-10-458 and P-18-67; CAS No. 1211825-32-9) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(2) * * *
(i)
(a) * * * (1) The chemical substance identified as 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (PMNs P-15-310 and P-19-46; CAS No. 90218-76-1) is subject to reporting under this section for the significant
(2) * * *
(ii)
(iv)
(b) * * *
(1)
(a) * * * (1) The chemical substances identified as 12-Hydroxystearic acid, reaction products with alkylene diamine and alkanoic acid (generic) (PMNs P-16-309 and P-16-310) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) * * *
(i)
(ii)
(a)
(2) * * *
(i)
(ii)
(iii)
Office of the Secretary, U.S. Department of Agriculture.
Notice.
The Office of the Secretary of the Department of Agriculture announces the establishment of the Fiscal Year (FY) 2023 (October 1, 2022—September 30, 2023) in-quota aggregate quantity of certain sugars, syrups, and molasses (also referred to as refined sugar) at 222,000 metric tons raw value (MTRV).
This notice is applicable on September 15, 2022.
Souleymane Diaby, Multilateral Affairs Division, Trade Policy and Geographic Affairs, Foreign Agricultural Service, U.S. Department of Agriculture, Stop 1070, 1400 Independence Avenue SW, Washington, DC 20250-1070; by telephone (202) 720-2916; or by email
The provisions of paragraph (a)(i) of Additional U.S. Note 5, chapter 17 in the Harmonized Tariff Schedule of the United States (HTS) authorize the Secretary to establish the in-quota tariff-rate quota (TRQ) amounts (expressed in terms of raw value) for imports of raw cane sugar and certain sugars, syrups, and molasses that may be entered under the subheadings of the HTS subject to the lower tier of duties during each fiscal year. The Office of the U.S. Trade Representative (USTR) is responsible for the allocation of these quantities among supplying countries and areas.
Section 359(k) of the Agricultural Adjustment Act of 1938, as amended, requires that at the beginning of the quota year the Secretary of Agriculture establish the TRQs for raw cane sugar and refined sugars at the minimum levels necessary to comply with obligations under international trade agreements, with the exception of specialty sugar.
The Secretary's authority under paragraph (a)(i) of Additional U.S. Note 5, chapter 17 in the HTS and section 359(k) of the Agricultural Adjustment Act of 1938, as amended, has been delegated to the Under Secretary for Trade and Foreign Agricultural Affairs (TFAA) (7 CFR 2.15). That authority, in turn, has been delegated to the Deputy Under Secretary for TFAA under certain circumstances (7 CFR 2.600).
Notice is hereby given that I have determined, in accordance with paragraph (a)(i) of Additional U.S. Note 5, chapter 17 in the HTS and section 359(k) of the 1938 Act, that an aggregate quantity of 222,000 MTRV of sugars, syrups, and molasses (refined sugar) may be entered or withdrawn from warehouse for consumption during FY 2023. This quantity includes the minimum amount to which the United States is committed under the WTO Uruguay Round Agreements, 22,000 MTRV, of which 20,344 MTRV is established for any sugars, syrups and molasses, and 1,656 MTRV is reserved for specialty sugar. An additional amount of 200,000 MTRV is added to the specialty sugar TRQ for a total of 201,656 MTRV. The conversion factor is 1 metric ton raw value equals 1.10231125 short tons raw value.
Because the specialty sugar TRQ is first-come, first-served, tranches are needed to allow for orderly marketing throughout the year. The FY 2023 specialty sugar TRQ will be opened in five tranches. The first tranche, totaling 1,656 MTRV, will open October 3, 2022. All specialty sugars are eligible for entry under this tranche. The second tranche of 60,000 MTRV will open on October 10, 2022. The third tranche of 60,000 MTRV will open on January 20, 2023. The fourth tranche of 40,000 MTRV will open on April 14, 2023. The fifth tranche of 40,000 MTRV will open on July 14, 2023. The second, third, fourth, and fifth tranches will be reserved for organic sugar and other specialty sugars not currently produced commercially in the United States or reasonably available from domestic sources.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding; whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by October 17, 2022 will be considered. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA).
Notice and response to comments.
FSIS is announcing that Lithuania is eligible to export egg products to the United States. FSIS has reviewed Lithuania's laws, regulations, and inspection system, as implemented, and has determined that Lithuania's egg products inspection system is equivalent to the food safety inspection system for egg products that the United States has established under the Egg Products Inspection Act (EPIA) and its implementing regulations. Therefore, egg products produced in certified Lithuanian establishments are eligible for export to the United States. All such products will be subject to reinspection at U.S. points-of-entry by FSIS inspectors.
Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development, telephone (202) 205-0495.
On December 28, 2021, FSIS published a notice in the
Section 590.910(a) requires a foreign country's inspection system to be authorized by a legal authority that imposes requirements equivalent to those of the United States, specifically with respect to labeling, packaging, sanitation, processing, facility requirements, and Government inspection. The foreign country's inspection system must ensure that establishments preparing egg products for export to the United States comply with requirements equivalent to those of the EPIA and the regulations promulgated by FSIS under the authority of that statute. The foreign country is required to certify establishments as having met the required standards and to notify FSIS of those establishments that are either certified as eligible to export to the United States or removed from eligibility.
As part of the FSIS initial equivalence review process, FSIS evaluated the country's food safety inspection system for egg products to determine whether it is equivalent to FSIS', and therefore, eligible to export egg products to the United States. This evaluation consisted of two processes: A document review and an onsite review. The document review is an evaluation of the laws, regulations, and other written materials used by the country to affect its inspection program (9 CFR 327.2(a)(2)(iii), 381.196(a)(2)(iii), and 590.910(a)). The onsite review is an FSIS audit to verify the implementation of the country's food safety inspection system. These comprehensive processes are described more fully on the FSIS website at
FSIS regulations (9 CFR 590.910(b)) provide that a list of countries eligible to export egg products to the United States be maintained at
FSIS explained in the December 28, 2021,
After considering the comments received on the notice, discussed below, FSIS has concluded that Lithuania's egg products inspection system is equivalent to the United States' inspection system for egg products. FSIS has added Lithuania to its list of eligible countries to export egg products to the United States on its website at:
Lithuania is eligible to export to the United States egg products produced in certified Lithuanian establishments produced on or after September 15, 2022. FSIS maintains a country specific web page
FSIS received three comments in response to the notice, one from a trade association representing U.S. egg farmers, one from a trade association representing U.S. egg products producers, and one from an individual. The two trade associations opposed the declaration of equivalence for Lithuania for the reasons discussed below. The individual asked about the importation of shell eggs from Lithuania. Because this notice does not deal with the importation of shell eggs from Lithuania, the comment is outside the scope of this notice and is not addressed. The following is a brief summary of the relevant issues raised in the comments and FSIS' responses.
As explained above, FSIS is listing Lithuania as a country eligible to export egg products to the United States. Given the limited market in the United States for Lithuania's egg products and Lithuania's projected low export volume, there is likely to be little, if any, impact on the United States economy.
In comparison to the United States, Lithuania is a small egg and egg products producer with limited capacity to export egg products. Between 2015 and 2019, Lithuania had an annual average of 3.2 million egg laying hens that produced 55,300 tons of eggs and imported 14,300 tons of eggs. During this same period, Lithuania consumed approximately 50,800 tons of eggs annually. The remaining eggs were exported as eggs or egg products, mainly to the European Union, of which Lithuania is a member. Of these exports, approximately 17.2 percent were in the form of egg products.
From 2017 to 2021, the U.S. had an annual average of 387 million egg laying hens
With only one establishment intending to export egg products to the U.S., Lithuanian egg products exports to the U.S. are likely to be small in comparison to the total U.S. egg products market, and are expected to have little or no effect on U.S. egg products supplies or their prices. U.S. consumers, however, are expected to enjoy more choices when purchasing egg products.
The FSIS Administrator has made a determination that this notice will not have a significant economic impact on a substantial number of small entities in the United States, as defined by the Regulatory Flexibility Act (5 U.S.C. 601
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
Pursuant to the Congressional Review Act at 5 U.S.C. 801
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
USDA is an equal opportunity provider, employer, and lender.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that the Arizona Advisory Committee (Committee) to the Commission will hold a virtual business meeting via Zoom platform on Friday, October 7, 2022, from 11 a.m. to 12:30 p.m. Arizona time, for the purpose of discussing revisions to the project proposal draft.
The meeting will take place on:
• Friday, October 7, 2022, from 11 a.m.-12:30 p.m. Arizona time.
Link to Join (Audio/Visual)
Telephone (Audio Only) Dial +1-551-285-1373; Meeting ID: 160 809 7593#.
Kayla Fajota, DFO, at
Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012 or email Kayla Fajota (DFO) at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meetings at
Please click on the “Committee Meetings” tab. Records generated from these meetings may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meetings. Persons interested in the work of this Committee are directed to the Commission's website,
U.S. Commission on Civil Rights.
Notice of virtual business meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the New York Advisory Committee (Committee) will hold a virtual business meeting via Zoom at 1 p.m. ET on Friday, October 21, 2022, for the purpose of discussing their project on the child welfare system in New York.
The meeting will take place from 1 p.m.-2:30 p.m. ET on Friday, October 21, 2022.
Mallory Trachtenberg, DFO, at
Committee meetings are available to the public through the conference link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Individuals who are deaf, deafblind, and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at (800) 877-8339 and providing the Service with the conference details found through registering at the web link above. To request additional accommodations, please email Liliana Schiller
Members of the public are also entitled to submit written comments; the comments must be received within 30 days following the meeting. Written comments may be emailed to
Records generated from this meeting may be inspected and reproduced at the
Commission on Civil Rights.
Announcement of meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that the Delaware Advisory Committee to the Commission will hold virtual meetings on the first Wednesdays of each month beginning at 1:00 p.m. and ending at approximately 2 p.m. ET (may end sooner than 2 p.m. if business concludes) as follows: October 5, November 2, and December 7, 2022. The purpose of the meetings is to continue discussing report progression on the topic of COVID 19 and health disparities.
10/5/22, 11/2/22, and 12/7/22; 1 p.m. ET.
The access information for all meetings is as follows:
•
• To join by phone only, dial 1-551-285-1373; Access code: 160 832 3278#.
Ivy L. Davis, at
These meetings are available to the public through the Zoom link or phone number above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges.
Individuals who are deaf, deafblind and hard of hearing. may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the call-in number found through registering at the web link provided for each meeting.
Members of the public are entitled to make comments during the open period at the end of each meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the respective meeting. Written comments may be emailed to Ivy David at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that the Connecticut Advisory Committee to the U.S. Commission on Civil Rights will hold a second briefing on the impact of algorithms on civil rights in Connecticut on Thursday, September 29, 2022, at 12:00 p.m. The briefing will convene virtually. The purpose of the briefing is to hear from experts on the topic of algorithms and civil rights in Connecticut.
Thursday, September 29, 2022; 12:00 p.m. ET.
Barbara Delaviez at
If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at
Time will be set aside at the end of the meeting so that members of the public may address the Committee after the briefing during the open comment session. This meeting is available to the public by attendance in person.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Barbara de La Viez at
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the California Advisory Committee (Committee) will hold a meeting via a Webex platform on Wednesday, October 12, 2022, from 1:30 p.m. to 3 p.m., for the purpose of discussing their current project on the civil rights implications of AB5.
The meeting will take place on:
• Wednesday, October 12, 2022, from 1:30 p.m.-3 p.m. Pacific time.
Brooke Peery, Designated Federal Officer (DFO), at
Members of the public may listen to the discussion. This meeting is available to the public through the public WebEx registration link listed above. An open comment period will be provided to allow members of the public to make a statement as time allows. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339.
Members of the public are also entitled to submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Brooke Peery at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available at:
Please click on the “Meeting Details” and “Documents” links. Persons interested in the work of this Committee are also directed to the Commission's website,
The City of San Diego, grantee of FTZ 153, submitted a notification of proposed production activity to the FTZ Board (the Board) on behalf of Ajinomoto Bio-Pharma Services, located in San Diego, California under FTZ 153. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on September 7, 2022.
Pursuant to 15 CFR 400.14(b), FTZ production activity would be limited to the specific foreign-status material(s)/component(s) and specific finished product(s) described in the submitted notification (summarized below) and subsequently authorized by the Board. The benefits that may stem from conducting production activity under FTZ procedures are explained in the background section of the Board's website—accessible via
The proposed finished product is yusimry—(active pharmaceutical ingredient (API) substance and packaging into measured doses in vials and/or syringes) (duty-free).
The proposed foreign-status material and component is yusimry API substance (duty-free).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to:
A copy of the notification will be available for public inspection in the “Online FTZ Information System” section of the Board's website.
For further information, contact Christopher Wedderburn at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that certain stainless steel sheet and strip (SSSS) of Chinese-origin that has undergone further processing in the Socialist Republic of Vietnam (Vietnam) is merchandise covered by the scope of the antidumping duty (AD) and countervailing duty (CVD) orders on SSSS from the People's Republic of China (China). Additionally, Commerce preliminarily determines that SSSS that is completed in Vietnam using certain non-subject stainless steel flat-rolled inputs sourced from China, is circumventing the AD/CVD orders on SSSS from China. As a result, SSSS of Chinese-origin that has undergone further processing or completion in Vietnam will be subject to suspension of liquidation effective May 15, 2020. We invite interested parties to comment on these preliminary determinations.
Applicable September 15, 2022.
Blaine Wiltse, Office of the Deputy Assistant Secretary for AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6345.
On May 15, 2020, Commerce published in the
For a complete description of the events that followed the initiation of these inquiries,
The product covered by the
This circumvention inquiry covers SSSS completed in Vietnam using certain non-subject stainless steel flat-rolled inputs of Chinese-origin that is subsequently exported from Vietnam to the United States.
This scope inquiry covers SSSS of Chinese-origin that has undergone further processing in Vietnam (including but not limited to cold-rolling, annealing, tempering, polishing, aluminizing, coating, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the
Commerce is conducting these scope and circumvention inquiries in accordance with section 781(b) of the Act. Because Vietnam and China
As detailed in the Preliminary Decision Memorandum, we preliminarily determine, pursuant to 19 CFR 351.225(k)(1), that SSSS of Chinese-origin that has undergone further processing in Vietnam is covered by the scope of the
Further, because Hoangvu Co., Ltd. and SK Networks Co., Ltd. did not cooperate to the best of their ability in responding to Commerce's requests for information, we have based parts of our preliminary determinations on the facts available, with adverse inferences, pursuant to sections 776(a) and (b) of the Act. For a full description of the methodology underlying our conclusions,
As stated above, Commerce has made preliminary affirmative findings that SSSS of Chinese-origin that has undergone further processing in Vietnam is merchandise covered by the scope of the
Where a Vietnamese company subject to these inquiries reports that the finished SSSS products that it has exported to the United States were produced by a specific Chinese supplier that has its own company-specific rate under the
SSSS that is further processed or completed in Vietnam from stainless steel flat-rolled inputs that are not of Chinese-origin is not subject to these inquiries. Therefore, cash deposits are not required for such merchandise subject to the following certification requirements.
If an importer of SSSS from Vietnam claims that the SSSS was not produced using any stainless steel flat-rolled inputs of Chinese-origin, in order not to be subject to cash deposit requirements, the importer and exporter must meet the certification and documentation requirements described in Appendix II. An exporter of SSSS produced in Vietnam claiming that its SSSS was not produced using any stainless steel flat-rolled inputs of Chinese-origin must prepare and maintain an Exporter Certification and documentation supporting the Exporter Certification (
As provided in 19 CFR 351.307, Commerce intends to verify information relied upon in making its final determination.
Interested parties may submit case briefs to the Assistant Secretary for Enforcement and Compliance. Commerce will notify interested parties of the timeline for the submission of case briefs and written comments at a later date. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than seven days after the deadline for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically and received successfully in its entirety via ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice.
Consistent with section 781(e) of the Act, Commerce is notifying the U.S. International Trade Commission (ITC) of this affirmative preliminary determination to include the merchandise subject to this circumvention inquiry within the
This notice is published in accordance with section 781(b) of the Act and 19 CFR 351.225(h).
If a company imports stainless steel sheet and strip (SSSS) from Vietnam and claims that the entry was not produced from Chinese-sourced stainless steel flat-rolled inputs and, thus, is not subject to the antidumping duty (AD) and countervailing duty (CVD)
All importers of SSSS from Vietnam are eligible for the certification process detailed below, with the exception that entries of SSSS produced and/or exported by Hoangvu Co., Ltd. and SK Networks Co., Ltd. are ineligible for certification.
The exporter is required to complete and maintain the Exporter Certification, attached as Appendix IV, and is further required to provide the importer a copy of that certification and all supporting documentation (
The importer will not be required to submit the certifications or supporting documentation to U.S. Customs and Border Protection (CBP) as part of the entry process. However, the importer and exporter will be required to present the certifications, and supporting documentation, to the U.S. Department of Commerce (Commerce) and/or CBP, as applicable, upon request by the respective agency. Additionally, the claims made in the certifications and any supporting documentation are subject to verification by Commerce and/or CBP. The importer and exporter are required to maintain the certifications and supporting documentation for the later of: (1) a period of five years from the date of entry; or (2) a period of three years after the conclusion of any litigation in United States courts regarding such entries.
For SSSS exported from Vietnam that was produced using Chinese-sourced stainless steel flat-rolled inputs subject to this inquiry that has been found to be circumventing the AD/CVD
If it is determined that the certification and/or documentation requirements in a certification have not been met, Commerce intends to instruct CBP to suspend, under the appropriate case numbers, either those established for the AD/CVD
For shipments and/or entries suspended pursuant to the preliminary determinations of these scope and circumvention inquiries that were shipped and/or entered, or withdrawn from warehouse, for consumption during the period on or after May 15, 2020 (the date of initiation of these scope and circumvention inquiries) through the date of publication of the preliminary determination in the
For shipments and/or entries suspended pursuant to the preliminary determinations of these scope and circumvention inquiries that were shipped and/or entered, or withdrawn from warehouse, for consumption within 30 days of the date of publication of the preliminary determination in the
For shipments and/or entries after 30 days from the date of publication of the preliminary determination in the
For unliquidated entries (and entries for which liquidation has not become final) of merchandise entered as non-AD/CVD type entries (
I hereby certify that:
A. My name is {IMPORTING COMPANY OFFICIAL'S NAME} and I am an official of {IMPORTING COMPANY}, located at {ADDRESS OF IMPORTING COMPANY};
B. I have direct personal knowledge of the facts regarding the importation into the Customs territory of the United States of the stainless steel sheet and strip (SSSS) produced in Vietnam that entered under entry summary number(s), identified below, and are covered by this certification. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, the importer should have “direct personal knowledge” of the importation of the product (
C. I have personal knowledge of the facts regarding the production of the imported products covered by this certification. “Personal knowledge” includes facts obtained from another party, (
D. This certification applies to the following entries (repeat this block as many times as necessary):
Entry Summary #:
Entry Summary Line Item #:
Foreign Seller:
Foreign Seller's Address:
Foreign Seller's Invoice #:
Foreign Seller's Invoice Line Item #:
Country of Origin of Stainless Steel Flat-Rolled Inputs:
E. The SSSS covered by this certification was imported by {IMPORTING COMPANY} on behalf of {U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER};
F. The SSSS covered by this certification does not contain stainless steel flat-rolled inputs produced in the People's Republic of China (China);
G. I understand that {IMPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
H. I understand that {IMPORTING COMPANY}is required to provide this certification and supporting records, upon request, to U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce);
I. I understand that {IMPORTING COMPANY} is required to maintain a copy of the exporter's certification (attesting to the production and/or export of the imported merchandise identified above), and any supporting documentation provided by the exporter to the importer, for the later of (1) a period of five years from the date of entry or (2) a period of three years after the conclusion of any litigation in United States courts regarding such entries;
J. I understand that {IMPORTING COMPANY}is required to maintain and provide a copy of the exporter's certification and supporting documentation provided by the exporter to the importer, upon request, to CBP and/or Commerce;
K. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
L. I understand that failure to maintain the required certification and supporting documentation and/or failure to substantiate the claims made herein and/or failure to allow CBP and/or Commerce to verify the claims made herein, may result in a
○ suspension of liquidation of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
○ the requirement that the importer post applicable AD and/or CVD cash deposits (as appropriate) equal to the rates determined by Commerce; and
○ the revocation of {IMPORTING COMPANY}'s privilege to certify that future imports of SSSS were not produced using stainless steel flat-rolled inputs sourced from China subject to these certifications.
M. I understand that agents of the importer, such as brokers, are not permitted to make this certification;
N. This certification was completed by the time of filing the entry summary or within 45 days of the date on which Commerce published notice of its preliminary scope and circumvention findings in the
O. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
I hereby certify that:
A. My name is {COMPANY OFFICIAL'S NAME} and I am an official of {NAME OF EXPORTING COMPANY}, located at {ADDRESS OF EXPORTING COMPANY};
B. I have direct personal knowledge of the facts regarding the production and exportation in the Customs territory of the United States of the stainless steel sheet and strip (SSSS) identified below. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own books and records. For example, an exporter should have “direct personal knowledge” of the producer's identity and location;
C. The SSSS covered by this certification does not contain stainless steel flat-rolled inputs produced in the People's Republic of China (China);
D. This certification applies to the following sales to {NAME OF U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER} (repeat this block as many times as necessary):
Foreign Seller's Invoice # to U.S. Customer:
Foreign Seller's Invoice to U.S. Customer Line item #:
Producer's Invoice # to Foreign Seller: (
Producer's Invoice # Foreign Seller: (
Producer of Stainless Steel Flat-Rolled Inputs' Name:
Location (Country) of Producer of Stainless Steel Flat-Rolled Inputs:
E. The SSSS products covered by this certification were shipped to {NAME OF U.S. PARTY TO WHOM MERCHANDISE WAS SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
F. I understand that {EXPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
G. The shipments/products referenced herein shipped before mm/dd/yyyy, the date on which Commerce published notice of its preliminary scope and circumvention findings in the
The shipments/products referenced herein shipped on mm/dd/yyyy. This certification was completed on mm/dd/yyyy, within 45 days of the date on which Commerce published its preliminary scope and circumvention findings in the
I understand that {EXPORTING COMPANY} must provide this Exporter Certification to the U.S. importer by the time of shipment;
H. I understand that failure to maintain the required certification and supporting documentation, failure to substantiate the claims made herein, and/or failure to allow U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) to verify the claims made herein, may result in a
○ suspension of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
○ the requirement that the importer post applicable AD and/or CVD cash deposits (as appropriate) equal to the rates as determined by Commerce; and
○ the revocation of {EXPORTING COMPANY}'s privilege to certify that future imports of SSSS were not produced using stainless steel flat-rolled inputs sourced from China subject to these certifications.
I. This certification was completed at time of shipment or within 45 days of the date on which Commerce published notice of its preliminary scope and anti-circumvention findings in the
J. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) is postponing the deadline for issuing the final determination in the less-than-fair-value (LTFV) investigation of certain lemon juice (lemon juice) from the Republic of South Africa (South Africa) until December 19, 2022, and is extending the provisional measures from a four-month period to a period of not more than six months.
Applicable September 15, 2022.
Elizabeth Bremer or Zachary Shaykin, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4987 or (202) 482-2638, respectively.
Commerce initiated this investigation on January 19, 2022.
Section 735(a)(2) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.210(b)(2) provide that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters or producers who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioner. Further, 19 CFR 351.210(e)(2) requires that a request by exporters for postponement of the final determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months, in accordance with section 733(d) of the Act.
On September 1, 2022, pursuant to 19 CFR 351.210(e), mandatory respondents Cape Fruit Processors (Pty) Ltd. (Cape Fruit) and Granor Passi (Pty). Ltd. (Granor Passi) requested that Commerce postpone the deadline for the final determination until no later than 135 days from the publication of the
This notice is issued and published in accordance with section 735(a)(2) of the Act and 19 CFR 351.210(g).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of incidental harassment authorization.
NMFS has received a request from the California Department of Fish and Wildlife (CDFW) for the re-issuance of a previously issued incidental harassment authorization (IHA) with the only change being effective dates. The initial IHA authorized take of Pacific harbor seals (
This authorization is effective from September 16, 2022, through September 15, 2023.
An electronic copy of the final 2021 IHA previously issued to CDFW, CDFW's application, and the
Amy Fowler, Office of Protected Resources, NMFS, (301) 427-8401.
Sections 101(a)(5)(A) and (D) of the Marine Mammal Protection Act (MMPA; 16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
On September 22, 2021, NMFS published final notice of our issuance of an IHA authorizing take of marine mammals incidental to the Elkhorn Slough Tidal Marsh Restoration Project, Phase III (86 FR 52644). The effective dates of that IHA were September 16, 2021, through September 15, 2022. On July 12, 2022, CDFW informed NMFS that the project was delayed. None of the work identified in the initial IHA (
The planned activities (including mitigation, monitoring, and reporting), authorized incidental take, and anticipated impacts on the affected stocks are the same as those analyzed and authorized through the previously issued IHA.
Phase III of the Elkhorn Slough Tidal Marsh Restoration Project will restore 28.6 acres (11.57 hectares) at the Seal Bend Restoration Area by relocating soil from an upland area called “the borrow” through use of heavy earth moving equipment, within a 12 month period. A detailed description of the planned restoration activities is found in the
Construction activities are expected to produce airborne noise and visual disturbance that have the potential to result in behavioral harassment of Pacific harbor seals. A description of the methods and inputs used to estimate take anticipated to occur and, ultimately, the take that was authorized is found in the previous documents referenced above. The data inputs and methods of estimating take are identical to those used in the initial IHA. NMFS has reviewed recent Stock Assessment Reports, information on relevant Unusual Mortality Events, and recent scientific literature, and determined that no new information affects our original analysis of impacts or take estimate under the initial IHA.
We refer to the documents related to the previously issued IHA, which include the
CDFW will conduct activities as analyzed in the initial 2021 IHA. As described above, the number of authorized takes of the same species and stocks of marine mammals are identical to the numbers that were found to meet the negligible impact and small numbers standards and authorized under the initial IHA and no new information has emerged that would change those findings. The reissued 2022 IHA includes identical required mitigation, monitoring, and reporting measures as the initial IHA, and there is no new information suggesting that our analysis or findings should change.
Based on the information contained here and in the referenced documents, NMFS has determined the following: (1) the required mitigation measures will effect the least practicable impact on marine mammal species or stocks and their habitat; (2) the authorized takes will have a negligible impact on the affected marine mammal species or stocks; (3) the authorized takes represent small numbers of marine mammals relative to the affected stock abundances; and (4) CDFW's activities will not have an unmitigable adverse impact on taking for subsistence purposes as no relevant subsistence uses of marine mammals are implicated by this action.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review. This action is consistent with categories of activities identified in CE B4 of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531
However, no incidental take of ESA-listed species is authorized or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
NMFS has issued an IHA to CDFW for restoration activities at the Seal Bend Restoration Area in Elkhorn Slough (Monterey County, CA) from September 16, 2022, through September 15, 2023. All previously described mitigation, monitoring, and reporting requirements from the initial 2021 IHA are incorporated.
National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of request for comments.
NOAA's Marine Debris Program and Environmental Protection Agency's (EPA) Trash Free Waters Program, on behalf of the Interagency Marine Debris Coordinating Committee (IMDCC), is soliciting public comments regarding the draft
Comments must be received on or before October 17, 2022, 11:59 p.m. Eastern Time (ET).
Comments may be submitted by the following method:
Ya'el Seid-Green, Executive Secretariat, IMDCC, Marine Debris Program; Phone 240-533-0399; Email
The IMDCC is a multi-agency body responsible for coordinating a comprehensive program of marine debris research and activities among Federal agencies, in cooperation and coordination with non-governmental organizations, industry, academia, States, Tribes, and other nations, as appropriate. Representatives meet to share information, assess and promote best management practices, and coordinate the Federal Government's efforts to address marine debris. The IMDCC was established in 2006 by the Marine Debris Act (33 U.S.C. 1954). The NOAA representative serves as the Chairperson of the Committee.
Section 132 of the Save Our Seas 2.0 Act of 2020 (Pub. L. 116-224) requires the IMDCC to complete a report on microfiber pollution that includes: (1) a definition of microfiber; (2) an assessment of the sources, prevalence, and causes of microfiber pollution; (3) a recommendation for a standardized methodology to measure and estimate the prevalence of microfiber pollution; (4) recommendations for reducing microfiber pollution; and (5) a plan for how Federal agencies, in partnership with other stakeholders, can lead on opportunities to reduce microfiber pollution during the 5-year period beginning on the date of the Act's enactment. This Report will provide Congress with an overview of the microfiber pollution issue, while also outlining a path forward for Federal agencies, in partnership with other stakeholders, to address this problem.
Microfibers have been found almost everywhere that scientists look, including in surface waters and throughout the water column, sea ice, deep-sea and coastal sediments, terrestrial soils, and indoor and outdoor air and dust. These fibers are released from clothing, carpets, cigarette butts, and other fiber-based products and are one of the most pervasive types of microplastics found in many environmental compartments. However, additional research is needed to improve our understanding of microfiber sources, pathways, fates, and impacts so that effective mitigation strategies and prevention measures can be developed. Microfibers are a highly complex and diverse type of contaminant and research on the subject is particularly challenging due to a lack of standard definitions and research methods, which make comparisons across studies difficult. In the course of addressing the five requirements specified in Section 132 of the Save Our Seas 2.0 Act, this report also provides an in-depth review of these topics, recommendations for addressing research data gaps, and solutions to mitigate this source of pollution.
NOAA's Marine Debris Program and the EPA's Trash Free Waters Program co-led the development of this report on behalf of the IMDCC, with support from the consulting firm, Materevolve. The draft report is approximately 90 pages in length. Section 1 of the report provides an introduction to the report and microfiber pollution issue. Section 2 focuses on establishing a proposed definition of `microfiber'. This section summarizes existing definitions from the environmental science, textile industry, and government sectors, and explains the issues that complicate efforts to define the term `microfiber'. It proposes an initial definition of microfiber that can serve as a starting point for building consensus around a standard definition that could be adopted by the United States Government. Section 3 of the report
NOAA's Marine Debris Program and EPA's Trash Free Waters Program, on behalf of the IMDCC, invite comments, feedback, and recommendations on the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for Letter of Authorization; request for comments and information.
NMFS has received a request from the Virginia Electric and Power Company, also known as Dominion Energy Virginia (Dominion Energy), for authorization to take small numbers of marine mammals incidental to the development of the Coastal Virginia Offshore Wind Commercial Project (CVOW-C) in Lease Area Outer Continental Shelf (OCS)-A-0483 off of Virginia over the course of 5 years beginning on March 4, 2024. Pursuant to regulations implementing the Marine Mammal Protection Act (MMPA), NMFS is announcing receipt of Dominion Energy's request for the development and implementation of regulations governing the incidental taking of marine mammals. NMFS invites the public to provide information, suggestions, and comments on Dominion Energy's application and request.
Comments and information must be received no later than October 17, 2022.
Comments on the applications should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Kelsey Potlock, Office of Protected Resources, NMFS, (301) 427-8401. An electronic copy of Dominion Energy's application may be obtained online at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An incidental take authorization shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance, which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
On February 16, 2022, NMFS received application from Dominion Energy, requesting authorization to take marine mammals incidental to the development of CVOW-C in the BOEM Lease Area (OCS)-A-0483 Commercial Lease of Submerged Lands for Renewable Energy Development off of Virginia. In response to our comments, and following
Dominion Energy plans to conduct the following activities associated with the wind farm construction: vibratory and impact installation of wind turbine generators (WTG) monopiles foundations and offshore substation (OSS) jacket foundations; temporary use of goal posts to guide installation activities during the trenchless installation by impact pile driving; vibratory installation and removal of temporary cofferdams using sheet piles at the sea-to-shore transitions; site characterization surveys using a range of frequencies; placement of scour protection; and export cable trenching, laying, and burial. Vessels will be used to transport crew, supplies, and materials to the project area and to support pile installation. A subset of these activities (
In Executive Order 14008, President Biden stated that it is the policy of the United States to organize and deploy the full capacity of its agencies to combat the climate crisis to implement a Government-wide approach that reduces climate pollution in every sector of its economy; increases resilience to the impacts of climate change; protects public health; conserves our lands, water, and biodiversity; delivers environmental justice; and spurs well-paying union jobs and economic growth, especially through innovation, commercialization, and deployment of clean energy technologies and infrastructure. Furthermore, this project would directly support the goals of the Virginia Clean Economy Act passed by the Virginia General Assembly in 2020, which supports the development of clean and reliable offshore wind energy to be developed by 2028 and consist of approximately 2,500 to 3,000 MW of energy.
Through a competitive leasing process under 30 CFR 585.211, Dominion Energy was awarded Commercial Lease OCS-A 0483 offshore of Virginia and the exclusive right to submit a construction and operations plan (COP) for activities within the lease area. Dominion Energy submitted a COP to BOEM proposing the construction, operation, maintenance, and conceptual decommissioning of the CVOW-C project, a 2,500 to 3,000 megawatt (MW) commercial-scale offshore wind energy facility with a Lease Area covering approximately 112,799 acres (456.48 km
Dominion Energy anticipates that activities potentially resulting in the take of marine mammals could occur for the life of the requested 5-year Incidental Take Regulation (ITR) and associated Letter of Authorization (LOA). This includes:
• Several construction-related high-resolution site assessment geophysical surveys using acoustic sources <180 kilohertz (kHz) for up to 1,108 days during all 5 years (with varying effort based on survey year);
• The installation of up to 205 WTGs monopile foundations; each foundation would be a tapered (
• The installation of up to three OSSs jacket foundations using four pin piles (2.8-m) each by vibratory and impact pile driving;
• The installation and removal of up to nine temporary cofferdams using steel sheet piles by vibratory pile driving at the offshore nearshore trenchless installation punch-out for the burial of the direct pipe west of the firing range at the State Military Reservation in Virginia Beach; and,
• The installation of temporary goal posts (
We note that Dominion Energy is not requesting take incidental to the detonation of munitions and explosives of concern or unexploded ordnances (MEC/UXOs) during the effective period of the regulation.
Interested persons may submit information, suggestions, and comments concerning the Dominion Energy's request (see
National Oceanic & Atmospheric Administration (NOAA), Commerce.
Notice of information collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before November 14, 2022.
Interested persons are invited to submit written comments to Adrienne Thomas, NOAA PRA Officer, at
Requests for additional information or specific questions related to collection activities should be directed to David Kaiser, Senior Policy Analyst, Office for Coastal Management, National Ocean Service, 246 Gregg Hall, 35 Colovos Road, Durham, NH 03824-3534, 603-862-2719 or
This notice and request for public comment is for a request to extend a
The Coastal Zone Management Act (CZMA) creates a State-federal partnership to improve the management of the nation's coastal zone through the development of federally approved State CMPs. The CZMA provides two incentives for States to develop federally approved CMPs: (1) the National Oceanic and Atmospheric Administration (NOAA) has appropriated monies to grant to States to develop and implement State CMPs that meet statutory and regulatory criteria; and (2) the CZMA requires federal agencies, non-federal licensees, and State and local government recipients of federal assistance to conduct their activities in a manner “consistent” with the enforceable policies of NOAA-approved CMPs. The latter incentive, referred to as the “federal consistency” provision, is found at 16 U.S.C. 1456. NOAA's regulations at 15 CFR part 930 implement NOAA's responsibilities to provide procedures for the consistency provision, the procedures available for an appeal of a State's objection to a consistency certification as provided for in 16 U.S.C. 1456(c)(3)(A) and (B) and 1456(d), and changes in the appeal process created by Congressional amendments in 1990, 1996 and 2005, and found at 16 U.S.C. 1465.
Paperwork and information collection routinely occurs by State CMPs pursuant to the CZMA federal consistency review requirements. Federal agencies proposing an action that may have reasonably foreseeable effects to coastal uses or resources must provide a consistency determination to affected states. The information requirements for consistency determinations are specified at 15 CFR 930.39. Non-federal applicants for federal licenses, permits and other forms of authorization that are listed by state CMPs as subject to review, must submit a statement certifying the consistency of the proposed activity to state CMPs pursuant to 15 CFR 930.57 accompanied by the necessary data and information specified at 15 CFR 930.58. Necessary data and information includes a copy of the application for the Federal license or permit; all material relevant to the State CMP provided to the Federal agency in support of the license or permit request; a detailed description of the proposed activity, its associated facilities and coastal effects; information specifically identified in the State CMP; and an evaluation that includes findings relating to the coastal effects of the proposal and its associated facilities to the relevant enforceable policies of the State CMP. For State and local agency applicants for federal financial assistance, the application shall be forwarded to the State CMP through the intergovernmental review process established pursuant to E.O. 12372, or submitted directly to the State CMP if the federal financial assistance is listed in the State CMP as subject to review. See 15 CFR 930.94.
Information is provided to NOAA only when there is a State objection to a proposed federal license or permit, or federal financial assistance; when informal mediation is sought by a Federal agency or State; or when an applicant for a federal license or permit, or federal financial assistance appeals to the Secretary of Commerce for an override to a State CMP objection to the issuance of the authorization, or award of assistance. Last, in 1990, Congress required State CMPs to provide for public participation in their permitting processes, consistency determinations and similar decisions. See 16 U.S.C. 1455(d)(14). How the public participation requirement is met is determined by each state with NOAA approval of the participation process.
These submissions are intended to provide a reasonable, efficient, and predictable means of complying with CZMA requirements. The information will be used by coastal states with federally-approved Coastal Zone Management Programs to determine if Federal agency activities, Federal license or permit activities, and Federal assistance activities that affect a state's coastal zone are consistent with the state's coastal management program.
Information developed for and during state reviews will also be collected and considered by NOAA for appeals filed by non-federal applicants seeking an override of state CZMA objections to federal license or permit activities or Federal assistance activities.
There have been no changes to the information collection requirements, their applicability or the methods of collection since the previous Paperwork Reduction Act extension.
Information is submitted pursuant to the procedural requirements of the CZMA and its implementing federal consistency regulations. Required information is case-specific and not submitted by form. Methods of submittal include email and mail.
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number,
Under Secretary of Defense for Research and Engineering, Department of Defense (DoD).
Notice of Federal Advisory Committee meeting.
The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Science Board (DSB) will take place.
Closed to the public Wednesday, September 14, 2022 from 8 a.m. to 5 p.m. Closed to the public Thursday, September 15, 2022 from 8 a.m. to 4 p.m. Closed to the public Friday, September 16, 2022 from 10 a.m. to 4:15 p.m.
The address of the closed meeting is the Executive Conference Center, 4075 Wilson Blvd., Floor 3, Arlington, VA 22203 on September 14-15, 2022 and 3140 Defense Pentagon, Room 2A528 on September 16, 2022.
Mr. Kevin Doxey, (703) 571-0081 (Voice), (703) 697-1860 (Facsimile),
This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) (title 5 United States Code (U.S.C.), appendix), the Government in the Sunshine Act (title 5 U.S.C., section 552b), and title 41 Code of Federal Regulations (CFR), sections 102-3.140 and 102-3.150.
Due to circumstances beyond the control of the Designated Federal Officer, the Defense Science Board was unable to provide public notification required by 41 CFR 102-3.150(a) concerning its September 14-16, 2022 meeting. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.
This is a supplemental notice in the above-referenced proceeding of VESI 24 LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 28, 2022.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
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The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a final environmental impact statement (EIS) for the Commonwealth LNG Project, proposed by Commonwealth LNG, LLC (Commonwealth) in the above-referenced docket. Commonwealth requests authorization to site, construct, and operate a natural gas liquefaction and export terminal and an integrated Natural Gas Act Section 3 natural gas pipeline, in Cameron Parish, Louisiana.
The final EIS assesses the potential environmental effects of the construction and operation of the Commonwealth LNG Project in accordance with the requirements of the National Environmental Policy Act (NEPA). FERC 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 on the environment would be reduced to less than significant levels; however, FERC staff conclude there would be significant impacts on visual resources and impacts on environmental justice communities would be disproportionately high and adverse. Regarding climate change impacts, this EIS is not characterizing the proposed project's greenhouse gas emissions as significant or insignificant because the Commission is conducting a generic proceeding to determine whether and how the Commission will conduct significance determinations going forward.
The U.S. Army Corps of Engineers, U.S. Coast Guard, U.S. Department of Energy, U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration, U.S. Environmental Protection Agency, U.S. Fish and Wildlife Service, and National Oceanic and Atmospheric Administration's National Marine Fisheries Service participated as cooperating agencies in the preparation of the final EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the NEPA analysis. Although the cooperating agencies provided input to the conclusions and recommendations presented in the final EIS, the agencies will present their own conclusions and recommendations in their respective Records of Decision for the project.
The final EIS addresses the potential environmental effects of the construction and operation of the following project facilities:
• six liquefaction trains;
• six gas pre-treatment trains;
• two flare systems (containing a total of four flares);
• six liquefied natural gas (LNG) storage tanks;
• one marine facility consisting of an LNG carrier berth and barge dock;
• utilities (
• operation and safety systems (
• appurtenant facilities (
• 3.0 miles of 42-inch-diameter pipeline;
• two interconnection facilities with existing pipelines; and
• one metering station.
The Commission mailed a copy of the
The final 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.
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 following hydroelectric application has been filed with the Commission and is available for public inspection.
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k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
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The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. This application is not ready for environmental analysis at this time.
n. The Rockton Project consists of the following existing facilities: (1) a 40.67-acre reservoir; (2) a 1000-foot-long the concrete overflow dam; (3) a 1600-foot-long earthen dike; (4) power canal headworks; (5) transmission equipment consisting of the generators connected through two oil filled, three phase, 400 Ampere-rated, 7.5-kilovolt (kV) circuit breakers to the 4.1-kV bus and three 4.1-kV/12.4-kV, 500-kilovolt amperes single phase transformers connected to the non-project 12.4-kV distribution system; (6) a tailrace; and (7) a powerhouse containing two generating units with a total installed capacity of 1.1 megawatts.
The Rockton Project is currently operated in a run-of-river mode and generates an annual average of approximately 5,076 megawatt hours. Midwest Hydro proposes to continue operating the project as a run-of-river facility and does not propose any new construction to the project.
o. A copy of the application can be viewed on the Commission's website at
You may also register online at
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Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
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The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. The application is not ready for environmental analysis at this time.
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o. A copy of the application may be viewed on the Commission's website, using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field, to access the document (P-2490). For assistance, contact FERC Online Support at
You may also register online at
p. Procedural schedule and final amendments: The application will be processed according to the following preliminary schedule. Revisions to the schedule will be made as appropriate.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
This is a supplemental notice in the above-referenced proceeding of VESI 25 LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 28, 2022.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
This is a supplemental notice in the above-referenced proceeding of PGR 2021 Lessee 17, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 29, 2022.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
As announced in the Notice of Technical Conference issued in this proceeding on April 21, 2022, the Federal Energy Regulatory Commission (Commission) will convene a Commissioner-led technical conference regarding transmission planning and cost management for transmission facilities developed through local or regional transmission planning processes in the above-captioned proceeding on October 6, 2022, from approximately 9:00 a.m. to 5:00 p.m. Eastern Time.
The purpose of this conference is to explore measures to ensure sufficient
Attached to this Supplemental Notice is an agenda for the technical conference, which includes the conference program and expected panelists.
Panelists are asked to submit advance materials to provide any information related to their respective panel (
An additional supplemental notice will be issued following the technical conference with the opportunity for interested parties to submit post-technical conference comments.
The technical conference will be open to the public and there is no fee for attendance. Information will also be posted on the Calendar of Events on the Commission's website,
The workshop will be held at the Commission on 888 First Street NE, Washington, DC 20002. It will be transcribed and webcast. Transcripts will be available for a fee from Ace Reporting (202-347-3700). A link to the webcast of this event will be available in the Commission Calendar of Events at
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 John Riehl at
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:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following settlement agreement has been filed with the Commission and is available for public inspection.
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The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. The City of Watervliet filed the Settlement Agreement on behalf of itself, the U.S. Fish and Wildlife Service, the New York State Department of Environmental Conservation, and the Town of Guilderland. The purpose of the Settlement Agreement is to resolve, among the signatories, issues related to operational, fisheries, wildlife, water quality, and recreation resources associated with issuance of a subsequent license and water quality certification for the project. Specifically, the Settlement Agreement includes proposed protection, mitigation, and enhancements measures to address eel passage, streamflow and water level monitoring, water quality management, bat and eagle protection, invasive species management, and recreation. The City of Watervliet states that the terms of the Settlement Agreement are an integrated and individual set of measures intended to address and balance non-power and power values relating to the project and requests that the Commission approve the Settlement Agreement and incorporate the proposed measures set forth in section 3 into any subsequent license issued.
l. A copy of the settlement agreement may be viewed on the Commission's website at
You may also register online at
This is a supplemental notice in the above-referenced proceeding of Eastover Solar LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 29, 2022.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
This is a supplemental notice in the above-referenced proceeding of VESI 21 LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 28, 2022.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
On November 20, 2019, the California Department of Water Resources (California DWR) filed an application for a new major license for the existing 279.7-megawatt Devil Canyon Project (FERC No. 14797).
In accordance with the Commission's regulations, on June 15, 2021, Commission staff issued a notice that the project was ready for environmental analysis (REA Notice). Based on the information in the record, including comments filed on the REA Notice, staff does not anticipate that licensing the project would constitute a major federal action significantly affecting the quality of the human environment. Therefore, staff intends to prepare a draft and final Environmental Assessment (EA) on the application to license the Devil Canyon Project.
The EA will be issued and circulated for review by all interested parties. All comments filed on the EA will be analyzed by staff and considered in the Commission's final licensing decision.
The application will be processed according to the following schedule. Revisions to the schedule may be made as appropriate.
Any questions regarding this notice may be directed to Quinn Emmering, the Commission's project coordinator for licensing the Devil Canyon Project, at (202) 502-6382 or at
Take notice that the Commission received the following exempt wholesale generator 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:
On June 17, 2021, the Commission established a Joint Federal-State Task Force on Electric Transmission (Task Force) to formally explore transmission-related topics outlined in the Commission's order.
The meeting will be open to the public for listening and observing and on the record. There is no fee for attendance and registration is not required. The public may attend in person or via Webcast.
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
As explained in the Establishing Order, the Commission will issue agendas for each meeting of the Task Force, after consulting with all Task Force members and considering suggestions from state commissions.
Comments may be filed electronically via the internet.
More information about the Task Force, including frequently asked questions, is available here:
On July 22, 2022, the staff of the Federal Energy Regulatory Commission (FERC or Commission) issued a
The July 22, 2022 notice
To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5:00 p.m. Eastern Time on October 20, 2022. Comments may be submitted in written or oral form. In lieu of or in addition to sending written comments, the Commission invites you to attend public scoping sessions to provide verbal and/or written comments on the Project. Appendix 1 describes the session format. Further details on how to submit comments, including attending the public scoping sessions, are provided in the
Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the environmental document. Commission staff will consider all written or oral comments during the preparation of the environmental document.
If you submitted comments on this Project to the Commission before the opening of this docket on May 20, 2022, you will need to file those comments in Docket No. PF22-7-000 to ensure they are considered.
This notice was sent to the Commission's current environmental mailing list for this Project. State and local government representatives should notify their constituents of this planned Project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the planned facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the Project, the Natural Gas Act conveys the right of eminent domain to the company. Therefore, if you and the company do not reach an easement agreement, the pipeline company could initiate condemnation proceedings in court. In such instances, compensation would be determined by a judge in accordance with state law. The Commission does not subsequently grant, exercise, or oversee the exercise of that eminent domain authority. The courts have exclusive authority to handle eminent domain cases; the Commission has no jurisdiction over these matters.
A fact sheet prepared by FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” addresses typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. This fact sheet along with other landowner topics of interest are available for viewing on the FERC website (
There are four methods you can use to submit your comments to the Commission. Please carefully follow these instructions so that your comments are properly recorded. 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
(2) You can file your comments electronically by using the eFiling feature, which is located 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 (PF22-7-000) 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, Maryland 20852.
(4) In lieu of sending written comments, the Commission invites you to attend one of the public scoping sessions its staff will conduct in the project area, scheduled as follows:
The primary goal of these scoping sessions is to have you identify the specific environmental issues and concerns that should be considered in the environmental document. Individual oral comments will be taken on a one-on-one basis with a court reporter. This format is designed to receive the maximum amount of oral comments in a convenient way during the timeframe allotted.
You may arrive at any time after the start times listed above. There will not be a formal presentation by Commission staff when the session opens. If you wish to speak, the Commission staff will hand out numbers in the order of your arrival. Comments will be taken until the end times listed above. However, if no additional numbers have been handed out and all individuals who wish to provide comments have had an opportunity to do so, staff may conclude the session up to an hour before the end times listed above. Please see appendix 1 for additional information on the session format and conduct.
Your scoping comments will be recorded by a 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 the last page of this notice for instructions on using eLibrary). If a significant number of people are interested in providing oral comments in the one-on-one settings, a time limit of 5 minutes may be implemented for each commentor.
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 scoping session. Although there will not be a formal presentation, Commission staff will be available throughout the scoping session to answer your questions about the environmental review process. Representatives from East Tennessee will also be present to answer project-specific questions.
Additionally, the Commission offers a free service called eSubscription, which makes it easy to stay informed of all issuances and submittals regarding the dockets/projects to which you subscribe. These instant email notifications are the fastest way to receive notification and provide a link to the document files which can reduce the amount of time you spend researching proceedings. Go to
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the Project and includes a mailing address with their comments. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that Commission notices related to this environmental review are sent to all individuals, organizations, and government entities interested in and/or potentially affected by the planned Project.
(1) Send an email to
(2) Return the attached “Mailing List Update Form” (appendix 3).
Once East Tennessee files its application with the Commission, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Only intervenors have the right to seek rehearing of the Commission's decision and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214). Motions to intervene are more fully described at
Additional information about the Project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
Public sessions or site visits will be posted on the Commission's calendar located at
Take notice that on August 24, 2022, Transcontinental Gas Pipe Line Company, LLC (Transco), P. O. Box 1396, Houston, Texas 77251, filed in Docket No. CP22-502-000, an application pursuant to section 7(c) of the Natural Gas Act (NGA) and Part 157 of the Commission's regulations, for authorization to construct, operate, and maintain its Commonwealth Energy Connector Project (CEC Project) located in various counties in Virginia. The CEC Project is designed to provide an additional 105,000 Dekatherms per day (Dth/d) of firm transportation service for Virginia Natural Gas, Inc. (VNG), from Transco's existing Station 165 Zone 5 Pooling Point in Pittsylvania County, Virginia to the existing interconnection between Transco and Columbia Gas Transmission, LLC (Columbia) in Greensville County, Virginia (EmporiaI/C), where VNG has contracted with Columbia for further firm transportation service.
In addition, on August 24, 2022, Columbia, 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, filed in Docket No. CP22-503-000, an application under sections 7(b) and 7(c) of the NGA and Part 157 of the Commission's regulations, for authorization to construct and operate its Virginia Reliability Project (VR Project) located in various counties in Virginia. The VR Project is designed to provide an additional 100,000 Dth/d of firm transportation service for VNG, from Emporia I/C to VNG's existing delivery point in Chesapeake County, Virginia.
Specifically, Transco proposes to: (1) install an additional 33,000 horsepower (HP) at existing Compressor Station (CS) 168 in Mecklenburg County, Virginia; (2) install a 6.35-mile-long, 24-inch-diameter extension of South Virginia Lateral B-Line in Brunswick and Greensville Counties, Virginia; and (3) modify the existing Emporia M&R Station at Emporia I/C. Transco estimates the cost of the CEC Project to be $117,709,858. Transco proposes a new incremental recourse rate designed to recover the cost of the proposed service, all as more fully set forth in the request which is on file with the Commission and open to public inspection with the Commission and open for public inspection.
Additionally, Columbia proposes to: (1) replace 49 miles of 12-inch-diameter pipeline with 24-inch-diameter pipeline in Virginia; (2) add a 5,500 HP hybrid compressor unit at the existing Emporia CS in Greensville County, Virginia; (3) modify the existing compressor units and increase power by 2,700 HP at the Petersburg CS in Prince George County, Virginia; and (4) modify other appurtenant facilities. Columbia will receive 105,000 Dth/d from Transco as proposed in Docket No. CP22-502-000 for re-delivery to VNG for VNG's markets. Columbia estimates the cost of the VR Project to be $917,925,527. Columbia proposes a new incremental reservation rate, FTS-VRP, to apply to the VR Project capacity, all as more fully set forth in the request which is on file with the Commission and open to public inspection with the Commission and open for public inspection.
In addition to publishing the full text of this document in the
Any questions regarding Transco's application should be directed to Nick Baumann, Regulatory Analyst, Transcontinental Gas Pipe Line Company, LLC, P.O. Box 1396, Houston, Texas 77251, by telephone at (713) 215-3383, or by email at
Any questions regarding Columbia's application should be directed to David A. Alonzo, Manager of Project Authorizations, Columbia Gas Transmission, LLC, 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, by telephone at (832) 320-5477, or by email at
On December 20, 2021, the Commission granted Columbia's request to utilize the National Environmental Policy Act Pre-Filing Process and assigned Docket No. PF22-3-000 to staff activities involved in the VR Project. Now, as of the filing of the August 24, 2022 application, the Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP22-503-000 as noted in the caption of this Notice.
Additionally, on December 20, 2021, the Commission granted Transco's request to utilize the National Environmental Policy Act Pre-Filing Process and assigned Docket No. PF22-4-000 to staff activities involved in the CEC Project. Now, as of the filing of the August 24, 2022 application, the Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP22-502-000 as noted in the caption of this Notice.
Pursuant to Section 157.9 of the Commission's Rules of Practice and Procedure,
There are two ways to become involved in the Commission's review of this project: you can file comments on the project, and you can file a motion to intervene in the proceeding. There is no fee or cost for filing comments or intervening. The deadline for filing a motion to intervene is 5:00 p.m. Eastern Time on September 29, 2022.
Any person wishing to comment on the project may do so. Comments may include statements of support or objections to the project as a whole or specific aspects of the project. The more specific your comments, the more useful they will be. To ensure that your comments are timely and properly recorded, please submit your comments on or before September 29, 2022.
There are three methods you can use to submit your comments to the Commission. In all instances, please reference the Project docket number CP22-502-000 and/or CP22-503-000 in your submission.
(1) You may file your comments electronically by using the eComment feature, which is located on the Commission's website at
(2) You may file your comments electronically by using the eFiling feature, which is located on the Commission's website (
(3) You may file a paper copy of your comments by mailing them to the following address below.
The Commission encourages electronic filing of comments (options 1 and 2 above) and has eFiling staff available to assist you at (202) 502-8258 or
Persons who comment on the environmental review of this project will be placed on the Commission's environmental mailing list and will receive notification when the environmental documents (EA or EIS) are issued for this project and will be notified of meetings associated with the Commission's environmental review process.
The Commission considers all comments received about the project in determining the appropriate action to be taken. However, the filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding. For instructions on how to intervene, see below.
Any person, which includes individuals, organizations, businesses, municipalities, and other entities,
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
There are two ways to submit your motion to intervene. In both instances, please reference the Project docket number CP22-502-000 and/or CP22-503-000 in your submission.
(1) You may file your motion to intervene by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your motion to intervene, along with three copies, by mailing the documents to the address below.
The Commission encourages electronic filing of motions to intervene (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Motions to intervene must be served on Transco either by mail or email at: Nick Baumann, Regulatory Analyst, Transcontinental Gas Pipe Line Company, LLC, P.O. Box 1396, Houston, Texas 77251 or
Motions to intervene must be served on Columbia either by mail or email at: David A. Alonzo, Manager of Project Authorizations, Columbia Gas
All timely, unopposed
Throughout the proceeding, additional information about the projects will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
Take notice that on August 30, 2022, Transcontinental Gas Pipe Line Company, LLC (Transco), P.O. Box 1396, Houston, Texas 77251-1396, filed in the above referenced docket a prior notice pursuant to sections 157.205 and 157.216 of the Federal Energy Regulatory Commission's regulations under the Natural Gas Act (NGA) and Transco's blanket certificate issued in Docket No. CP82-426-000, requesting authorization to abandon its Compressor Station 61 (CS 61) and appurtenant facilities located in East Feliciana Parish, Louisiana. Specifically, Transco proposes to abandon by removal: (1) one 2,000 horsepower (hp) compressor unit; (2) one 1,050 hp compressor unit; (3) appurtenant facilities including compressor buildings and one meter and regulator station; and (4) the piping connecting CS 61 to Transco's mainlines at milepost 591.80. Transco states that CS 61 has not provided service to any customers during the previous 12 months. The estimated cost for the project is approximately $2.98 million, all as more fully set forth in the request which is on file with the Commission and open to public inspection.
In addition to publishing the full text of this document in the
Any questions concerning this application should be directed to Antauis Byrd, Regulatory Analyst, Transcontinental Gas Pipe Line Company, LLC, P.O. Box 1396, Houston, Texas 77251-1396, phone: 713-215-3741, email:
There are three ways to become involved in the Commission's review of this project: you can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on November 7, 2022. How to file protests, motions to intervene, and comments is explained below.
Pursuant to section 157.205 of the Commission's regulations under the NGA,
Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.
Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before November 7, 2022. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.
There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP22-505-000 in your submission.
(1) You may file your protest, motion to intervene, and comments by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your submission by mailing it to the address below.
The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail or email (with a link to the document) at: P.O. Box 1396, Houston, Texas 77251-1396 or
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and
l.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. This application is not ready for environmental analysis at this time.
n.
The Janesville Project is currently operated in a run-of-river mode and generates an annual average of approximately 2.285 megawatt hours. Midwest Hydro proposes to continue operating the project as a run-of-river facility and does not propose any new construction to the project.
o. A copy of the application can be viewed on the Commission's website at
You may also register online at
p.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. This application is not ready for environmental analysis at this time.
n. The Dixon Project consists of the following existing facilities: (1) a 305.92-acre reservoir; (2) a 610-foot-long the concrete overflow dam; (3) a forebay; (4) transmission equipment is composed of generators connected to a 2.3-kilovolt bus; (5) a tailrace; and (6) a powerhouse containing five generating units with a total installed capacity of 3 megawatts.
The Dixon Project is currently operated in a run-of-river mode and generates an annual average of approximately 14,995 megawatt hours. STS Hydropower proposes to continue operating the project as a run-of-river facility and does not propose any new construction to the project.
o. A copy of the application can be viewed on the Commission's website at
You may also register online at
p.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. This application is not ready for environmental analysis at this time.
n. The Beloit Project consists of the following existing facilities: (1) a 686-acre reservoir; (2) a 315.9-foot-long concrete dam; (3) transmission equipment composed of a generator connected through one oil-filled, three phase, 400 Ampere-rated,7.5-kilovolt (kV) circuit breaker to the 4.1-kV bus and a 4.1-kV/12.4-kV, 500-kilovolt amperes three phase transformer connected to the non-project 12.4-kV distribution system; (4) a tailrace; and (5) a powerhouse containing one generating unit with a total installed capacity of 0.48 megawatts.
The Beloit Project is currently operated in a run-of-river mode and generates an annual average of approximately 3,035 megawatt hours. Midwest Hydro proposes to continue operating the project as a run-of-river facility and does not propose any new construction to the project.
o. A copy of the application can be viewed on the Commission's website at
You may also register online at
p.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
On September 6, 2022, the City of Watervliet submitted to the Federal Energy Regulatory Commission (Commission) a copy of its application for a Clean Water Act section 401(a)(1) water quality certification filed with New York State Department of Environmental Conservation (New York DEC), in conjunction with the above captioned project. Pursuant to 40 CFR 121.6 and section 4.34(b)(5) of the Commission's regulations,
If New York DEC fails or refuses to act on the water quality certification request on or before the above date, then the agency certifying authority is deemed waived pursuant to section 401(a)(1) of the Clean Water Act, 33 U.S.C. 1341(a)(1).
Environmental Protection Agency (EPA).
Notification of workshop.
The Environmental Protection Agency (EPA) is announcing a virtual public workshop on the new biointermediates provisions of the Renewable Fuel Standard program. Additional information regarding the workshop appears below under
The virtual workshop will be held on September 29th, 2022 from 1 p.m. to 4 p.m. eastern daylight time. Please monitor
All attendees must preregister for the workshop by emailing
Mark Goldman, Office of Transportation and Air Quality, Compliance Division; telephone number: (202) 564-0604; email address:
EPA is hosting a virtual public workshop to discuss the implementation of the new biointermediate provisions promulgated as a part of Renewable Fuel Standard (RFS) final rule for years 2020, 2021, and 2022 (see 87 FR 39600, July 1, 2022).
These new provisions allow for the use of certain biointermediates to produce qualifying renewable fuels and specify requirements that apply when renewable fuel is produced through sequential operations at more than one facility. Additionally, the new provisions cover the production, transfer, and use of biointermediates and new regulatory requirements related to registration, recordkeeping, and reporting for facilities producing or using a biointermediate for renewable fuel production.
The virtual public workshop will provide the opportunity for EPA to update stakeholders on how to register and comply with requirements for producing, transferring and using biointermediates. There will also be a question and answer period for stakeholders to ask additional questions related to biointermediates.
An agenda will be posted approximately one week before the workshop at:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Underground Storage Tank Finder Application” (EPA ICR No. 2696.01-NEW, OMB Control No. 2050-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a request for approval of a new collection. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Comments must be submitted on or before November 14, 2022.
Submit your comments, referencing Docket ID No. EPA-HQ-ORD-2021-0601, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Alexander Hall Office of Research and Development, Center for Environmental Solutions and Emergency Response, Environmental Protection Agency, 26 West Martin Luther King Drive., Cincinnati, OH 45268; 513-569-7374,
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
This information collection relates to information that state and territorial agencies already collect from UST and LUST owners and operators as part of their customary business practice to manage their compliance and enforcement programs. To successfully implement, maintain, and improve the data quality and usability of UST Finder, the Agency seeks to gather, on a voluntary basis, information from state and territorial agencies that oversee UST/LUST programs. Specifically, EPA will request that these agencies provide location and other relevant data about USTs and LUSTs that is already being collected and managed by states and territories. The UST Finder application may be used for many purposes, such as helping regulators, owners, and operators in decision-making; prioritizing site cleanups or inspections; triaging risk; and identifying sites that may be more likely to have a release based on UST age and substance stored. The application may also be used by emergency response personnel to protect UST facilities from extreme weather events. After disasters, the UST Finder can be used to rapidly identify LUST site cleanups impacted by natural disasters and assist in restarting cleanups after these events.
In order to have a dynamic database that provides more detailed and current data, the EPA intends to request UST/LUST data from state and territorial agencies that oversee UST/LUST programs. This information collection is voluntary and does not require the agencies to collect additional data on USTs/LUSTs beyond the data elements that are already being collected through their previously implemented programs. States and territories will decide the extent of information to be provided. The EPA intends to implement four options for collecting the UST/LUST data from states and territories: (1) by developing an Exchange server or other automated service through which states can “push” their data to the EPA, (2) by developing a link to the agencies' pre-existing electronic service used to maintain public websites such that the EPA can “pull” the data, (3) by allowing states and territories to submit existing databases or spreadsheets through an approved file sharing method, or (4) by EPA obtaining publicly available data from state and territory public agency websites (an option that will be exercised if states and territories do not voluntarily submit their data). For all data transfer options, the EPA will standardize, curate, and enter records into the UST Finder application. The EPA does not intend to collect any data that would be considered confidential business information.
Board of Governors of the Federal Reserve System.
Proposed policy statement with request for comment.
The Board of Governors of the Federal Reserve System (Board) is inviting comment on a proposed policy statement for prudent commercial real estate loan accommodations and workouts (proposed statement), which would be relevant to all financial institutions supervised by the Board. The proposed statement was developed jointly by the Board, the Office of the Comptroller of the Currency (OCC), the Federal Deposit Insurance Corporation (FDIC), and the National Credit Union Administration (NCUA) in consultation with state bank and credit union regulators and is identical in content to the proposal issued by the OCC, FDIC, and NCUA on August 2, 2022. The proposed statement would build on existing guidance on the need for financial institutions to work prudently and constructively with creditworthy borrowers during times of financial stress, update existing interagency guidance on commercial real estate loan workouts, and add a new section on short-term loan accommodations. The proposed statement would also address recent accounting changes on estimating loan losses and provide updated examples of how to classify and account for loans subject to loan accommodations or loan workout activity. The proposed statement is timely in the post-pandemic era, as trends such as increased remote working may shift historic patterns of demand for commercial real estate in ways that adversely affect the financial condition and repayment capacity of CRE borrowers.
Comments must be received by November 14, 2022.
Interested parties are encouraged to submit written comments.
Comments should be directed to:
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Juan Climent, Assistant Director, (202) 872-7526; Kathryn Ballintine, Manager, (202) 452-2555; Carmen Holly, Lead Financial Institution Policy Analyst, (202) 973-6122; Ryan Engler, Senior Financial Institution Policy Analyst I, (202) 452-2050; Kevin Chiu, Senior Accounting Policy Analyst, (202) 912-4608, the Division of Supervision and Regulation; Jay Schwarz, Assistant General Counsel, (202) 452-2970; Gillian Burgess, Senior Counsel, (202) 736-5564, Legal Division, Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551. For users of TTY-TRS, please call 711 from any telephone, anywhere in the United States.
On October 30, 2009, the Board, along with the OCC, FDIC, NCUA, Federal Financial Institutions Examination Council (FFIEC) State Liaison Committee, and the former Office of Thrift Supervision, adopted the Policy Statement on Prudent Commercial Real Estate Loan Workouts, which was issued by the FFIEC (2009 statement).
The Board is proposing to update and expand the 2009 statement by incorporating recent policy guidance on loan accommodations and accounting developments for estimating loan losses. The Board developed the proposed statement with the OCC, FDIC, and NCUA and consulted with state bank and credit union regulators. If finalized, the proposed statement would supersede the 2009 statement for all supervised financial institutions.
The proposed statement discusses the importance of working constructively with CRE borrowers who are experiencing financial difficulty and would be appropriate for all supervised financial institutions engaged in CRE lending that apply U.S. generally accepted accounting principles (GAAP). The proposed statement addresses supervisory expectations with respect to a financial institution's handling of loan accommodations and loan workouts on matters including (1) risk management elements, (2) classification of loans, (3) regulatory reporting, and (4) accounting considerations. While focused on CRE loans, the proposed statement includes general principles that are relevant to a financial institution's commercial loans that are collateralized by either real property or other business assets (
Prudent CRE loan accommodations and workouts are often in the best interest of both the financial institution and the borrower. As such, and consistent with safety and soundness standards, the proposed statement reaffirms two key principles from the 2009 statement: (1) financial institutions that implement prudent CRE loan accommodation and workout arrangements after performing a comprehensive review of a borrower's financial condition will not be subject to criticism for engaging in these efforts, even if these arrangements result in modified loans that have weaknesses that result in adverse credit classification; and (2) modified loans to borrowers who have the ability to repay their debts according to reasonable terms will not be subject to adverse classification solely because the value of the underlying collateral has declined to an amount that is less than the loan balance.
The proposed statement includes the following changes: (1) a new section on short-term loan accommodations; (2) information about recent changes in accounting principles; and (3) revisions and additions to examples of CRE loan workouts.
The Board recognizes that financial institutions may benefit from the proposed statement's inclusion of a discussion on the use of short-term and less complex CRE loan accommodations before a loan requires a longer term or more complex workout scenario. The proposed statement would identify short-term loan accommodations as a tool that can be used to mitigate adverse effects on borrowers and would encourage financial institutions to work prudently with borrowers who are or may be unable to meet their contractual payment obligations during periods of financial stress. This section of the proposed statement would incorporate principles consistent with existing interagency guidance on accommodations.
The proposed statement also would reflect changes in GAAP since 2009, including those in relation to current expected credit losses (CECL).
The Board also notes that the Financial Accounting Standards Board (FASB) has issued ASU 2022-02, “Financial Instruments—Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures,” which amended ASC Topic 326, Financial Instruments—Credit Losses. Once adopted, ASU 2022-02 will eliminate the need for financial institutions to identify and account for loan modifications as troubled debt restructuring (TDR) and will enhance disclosure requirements for certain modifications by creditors when a borrower is experiencing financial difficulty.
The proposed statement would include updated information about current industry loan workout practices and revisions to examples of CRE loan workouts. The examples in the proposed statement are intended to illustrate the application of existing guidance on (1) credit classification, (2) determination of nonaccrual status, and (3) determination of TDR status. The proposed statement also would revise the 2009 statement to provide Appendix 2, which contains an updated summary of selected references to relevant supervisory guidance and accounting standards for real estate lending, appraisals, restructured loans, fair value measurement, and regulatory reporting matters such as a loan's nonaccrual status.
The proposed statement would retain information in Appendix 3 about valuation concepts for income-producing real property included in the 2009 statement. Further, Appendix 4 of the proposed statement restates the Board's long-standing special mention and classification definitions that are referenced and applied in the examples in Appendix 1.
The proposed statement would be consistent with the
The Board requests comments on all aspects of the proposed statement and responses to the questions set forth below:
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) states that no agency may conduct or sponsor, nor is the respondent required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The Board has determined that this proposed policy statement does not create any new, or revise any existing, collections of information pursuant to the Paperwork Reduction Act. Consequently, no information collection request will be submitted to the OMB for review.
The text of the proposed Statement is as follows:
The Board of Governors of the Federal Reserve System (Board) recognizes that financial institutions
This statement provides a broad set of principles relevant to CRE loan accommodations and workouts in all business cycles, particularly in challenging economic environments. A variety of factors can drive challenging economic environments, including economic downturns, natural disasters, and local, national, and international events. This statement also describes how examiners will review CRE loan accommodation and workout arrangements and provides examples of CRE workout arrangements as well as useful references in the appendices.
The Board has found that prudent CRE loan accommodations and workouts are often in the best interest of the financial institution and the borrower. Examiners are expected to take a balanced approach in assessing the adequacy of a financial institution's risk management practices for loan accommodation and workout activities. Consistent with the
Consistent with the safety and soundness standards, this statement updates and supersedes existing supervisory guidance to assist financial institutions' efforts to modify CRE loans to borrowers who are, or may be, unable to meet a loan's current contractual payment obligations or fully repay the debt.
This statement addresses prudent risk management practices regarding short-term accommodations, risk management elements for loan workout programs, long-term loan workout arrangements, classification of loans, and regulatory reporting and accounting requirements and considerations. The statement also includes selected references and materials related to regulatory reporting.
Six appendices are incorporated into this statement:
• Appendix 1 contains examples of CRE loan workout arrangements illustrating the application of this statement to classification of loans, and determination of accrual treatment.
• Appendix 2 lists selected relevant rules as well as supervisory and accounting guidance for real estate lending, appraisals, allowance methodologies,
• Appendix 3 discusses valuation concepts for income-producing real property.
• Appendix 4 provides the classification definitions used by the Board.
• Appendices 5 and 6 address the relevant accounting and supervisory guidance on estimating loan losses for financial institutions that use the current expected credit losses (CECL) methodology, or incurred loss methodology, respectively.
The Board encourages financial institutions to work prudently with borrowers who are, or may be, unable to meet their contractual payment obligations during periods of financial stress. Such actions may entail loan accommodations that are generally short-term or temporary in nature but occur before a loan reaches a workout scenario. These actions can mitigate long-term adverse effects on borrowers by allowing them to address the issues affecting repayment capacity and are often in the best interest of financial institutions and their borrowers.
When entering into an accommodation with a borrower, it is prudent for the financial institution to provide clear, accurate, and timely information about the arrangement to the borrower and any guarantor. Any such accommodation must be consistent with applicable laws and regulations. Further, a financial institution should employ prudent risk management practices and appropriate internal controls over such accommodations. Failed or imprudent risk management practices and internal controls can adversely affect borrowers, and expose a financial institution to increases in credit, compliance, operational, or other risks. Imprudent practices that are widespread at a financial institution may also pose risk to its capital adequacy.
Prudent risk management practices and internal controls will enable financial institutions to identify, measure, monitor, and manage the credit risk of accommodated loans. Prudent risk management practices include developing appropriate policies and procedures, updating and assessing financial and collateral information, maintaining appropriate risk grading, and ensuring proper tracking and accounting for loan accommodations. Prudent internal controls related to loan accommodations include comprehensive policies and practices, proper management approvals, and timely and accurate reporting and communication.
When short-term accommodation measures are not sufficient or have not been successful to address credit problems, the financial institutions could proceed into longer-term or more complex loan arrangements with borrowers under a formal workout program. Loan workout arrangements can take many forms, including, but not limited to:
• Renewing or extending loan terms;
• Granting additional credit to improve prospects for overall repayment; or
• Restructuring
A financial institution's risk management practices for implementing workout arrangements should be appropriate for the scope, complexity, and nature of the financial institution's lending activity. Further, these practices should be consistent with safe-and-sound lending policies and guidance, real estate lending standards,
• A prudent workout policy that establishes appropriate loan terms and amortization schedules and that permits the financial institution to reasonably adjust the workout plan if sustained repayment performance is not demonstrated or if collateral values do not stabilize;
• Management infrastructure to identify, measure, and monitor the volume and complexity of workout activity;
• Documentation standards to verify a borrower's creditworthiness, including financial condition, repayment capacity, and collateral values;
• Management information systems and internal controls to identify and track loan performance and risk, including impact on concentration risk and the allowance;
• Processes designed to ensure that the financial institution's regulatory reports are consistent with regulatory reporting requirements;
• Loan collection procedures;
• Adherence to statutory, regulatory, and internal lending limits;
• Collateral administration to ensure proper lien perfection of the financial institution's collateral interests for both real and personal property; and
• An ongoing credit risk review function.
An effective loan workout arrangement should improve the lender's prospects for repayment of principal and interest, be consistent with sound banking and accounting practices, and comply with applicable laws and regulations. Typically, financial institutions consider loan workout arrangements after analyzing a borrower's repayment capacity, evaluating the support provided by guarantors, and assessing the value of any collateral pledged.
Consistent with safety and soundness standards, while loans in workout arrangements may be adversely classified, a financial institution will not be criticized for engaging in loan workout arrangements so long as management has:
• For each loan, developed a well-conceived and prudent workout plan that supports the ultimate collection of principal and interest and that is based on key elements such as:
➢ Updated and comprehensive financial information on the borrower, real estate project, and all guarantors and sponsors;
➢ Current valuations of the collateral supporting the loan and the workout plan;
➢ Appropriate loan structure (
➢ Appropriate legal analyses and agreements, including those for changes to loan terms;
• Analyzed the borrower's global debt
• Analyzed the available cash flow of guarantors;
• Demonstrated the willingness and ability to monitor the ongoing performance of the borrower and guarantor under the terms of the workout arrangement;
• Maintained an internal risk rating or loan grading system that accurately and consistently reflects the risk in the workout arrangement; and
• Maintained an allowance methodology that calculates (or measures) an allowance in accordance with GAAP for loans that have undergone a workout arrangement and recognizes loan losses in a timely
The primary focus of an examiner's review of a CRE loan, including binding commitments, is an assessment of the borrower's ability to repay the loan. The major factors that influence this analysis are the borrower's willingness and capacity to repay the loan under reasonable terms and the cash flow potential of the underlying collateral or business. When analyzing a commercial borrower's repayment ability, examiners should consider the following factors:
• The borrower's character, overall financial condition, resources, and payment history;
• The nature and degree of protection provided by the cash flow from business operations or the collateral on a global basis that considers the borrower's total debt obligations;
• Market conditions that may influence repayment prospects and the cash flow potential of the business operations or underlying collateral; and
• The prospects for repayment support from guarantors.
Examiners should review the financial attributes of guarantees and sponsorships in considering the loan classification. The presence of a legally enforceable guarantee from a financially responsible guarantor may improve the prospects for repayment of the debt obligation and may be sufficient to preclude classification or reduce the severity of classification. A financially responsible guarantor possesses the financial capacity, the demonstrated willingness, and the incentive to provide support for the loan through ongoing payments, curtailments, or re-margining.
Examiners also review the financial attributes and economic incentives of sponsors that support a loan. Even if not legally obligated, financially responsible sponsors are similar to guarantors in that they may also possess the financial capacity, the demonstrated willingness, and may have an incentive to provide support for the loan through ongoing payments, curtailments, or re-margining.
Financial institutions that have sufficient information on the guarantor's global financial condition, income, liquidity, cash flow, contingent liabilities, and other relevant factors (including credit ratings, when available) are better able to determine the guarantor's financial capacity to fulfill the obligation. An effective assessment includes consideration of whether the guarantor has the financial capacity to fulfill the total number and amount of guarantees currently extended by the guarantor. A similar analysis should be made for any material sponsors that support the loan.
Examiners should consider whether a guarantor has demonstrated the willingness to fulfill all current and previous obligations, has sufficient economic incentive, and has a significant investment in the project. An important consideration is whether any previous performance under its guarantee(s) was voluntary or the result of legal or other actions by the lender to enforce the guarantee(s).
As the primary sources of loan repayment decline, the importance of collateral value as another repayment source increases when analyzing credit risk and developing an appropriate workout plan. Examiners will analyze real estate collateral values based on the financial institution's original appraisal or evaluation, any subsequent updates, additional pertinent information (
The Board's appraisal regulations require financial institutions to review appraisals for compliance with the Uniform Standards of Professional Appraisal Practice.
CRE loans in workout arrangements consider current project plans and market conditions in a new or updated appraisal or evaluation, as appropriate. In determining whether to obtain a new appraisal or evaluation, a prudent financial institution considers whether there has been material deterioration in the following factors: the performance of the project; conditions for the geographic market and property type; variances between actual conditions and original appraisal assumptions; changes in project specifications (
The market value provided by an appraisal and the fair value for accounting purposes are based on similar valuation concepts.
Financial institutions typically use the market value conclusion (and not the fair value) that corresponds to the workout plan objective and the loan commitment. For example, if the financial institution intends to work with the borrower so that a project will achieve stabilized occupancy, then the financial institution can consider the “as stabilized” market value in its collateral assessment for credit risk grading after confirming that the appraisal's assumptions and conclusions are reasonable. Conversely, if the financial institution intends to foreclose, then it is more appropriate for the financial institution to use the fair value (less costs to sell)
If weaknesses are noted in the financial institution's supporting documentation or appraisal or evaluation review process, examiners should direct the financial institution to address the weaknesses, which may require the financial institution to obtain a new collateral valuation. However, if the financial institution is unable or unwilling to address deficiencies in a timely manner, examiners will have to assess the degree of protection that the collateral affords when analyzing and classifying the loan. In performing this assessment of collateral support, examiners may adjust the collateral's value to reflect current market conditions and events. When reviewing the reasonableness of the facts and assumptions associated with the value of an income-producing property, examiners evaluate:
• Current and projected vacancy and absorption rates;
• Lease renewal trends and anticipated rents;
• Effective rental rates or sale prices, considering sales and financing concessions;
• Time frame for achieving stabilized occupancy or sellout;
• Volume and trends in past due leases;
• Net operating income of the property as compared with budget projections, reflecting reasonable operating and maintenance costs; and
• Discount rates and direct capitalization rates (refer to Appendix 3 for more information).
Assumptions, when recently made by qualified appraisers (and, as appropriate, by the financial institution) and when consistent with the discussion above, should be given reasonable deference by examiners. Examiners should also use the appropriate market value conclusion in their collateral assessments. For example, when the financial institution plans to provide the resources to complete a project, examiners can consider the project's prospective market value and the committed loan amount in their analysis.
Examiners generally are not expected to challenge the underlying assumptions, including discount rates and capitalization rates, used in appraisals or evaluations when these assumptions differ only marginally from norms generally associated with the collateral under review. The estimated value of the collateral may be adjusted for credit analysis purposes when the examiner can establish that any underlying facts or assumptions are inappropriate and when the examiner can support alternative assumptions.
Many CRE borrowers may have their commercial loans secured by owner occupied real estate or other business assets, such as inventory and accounts receivable, or may have CRE loans also secured by furniture, fixtures, and equipment. For these loans, the financial institution should have appropriate policies and practices for quantifying the value of such collateral, determining the acceptability of the assets as collateral, and perfecting its security interests. The financial institution also should have appropriate procedures for ongoing monitoring of this type of collateral and the financial institution's interests and security protection.
Loans that are adequately protected by the current sound worth and debt service capacity of the borrower, guarantor, or the underlying collateral generally are not adversely classified. Similarly, loans to sound borrowers that are modified in accordance with prudent underwriting standards should not be adversely classified unless well-defined weaknesses exist that jeopardize repayment. However, such loans could be flagged for management's attention or other designated “watch lists” of loans that management is more closely monitoring.
Further, examiners should not adversely classify loans solely because the borrower is associated with a particular industry that is experiencing financial difficulties. When a financial institution's loan modifications are not supported by adequate analysis and documentation, examiners are expected to exercise reasonable judgment in reviewing and determining loan classifications until such time as the financial institution is able to provide information to support management's conclusions and internal loan grades. Refer to Appendix 4 for the classification definitions.
The loan's record of performance to date should be one of several considerations when determining whether a loan should be adversely classified. As a general principle, examiners should not adversely classify or require the recognition of a partial charge-off on a performing commercial loan solely because the value of the underlying collateral has declined to an amount that is less than the loan balance. However, it is appropriate to classify a performing loan when well-defined weaknesses exist that jeopardize repayment.
One perspective of loan performance is based upon an assessment as to whether the borrower is contractually current on principal or interest payments. For many loans, this definition is sufficient and accurately portrays the status of the loan. In other cases, being contractually current on payments can be misleading as to the credit risk embedded in the loan. This may occur when the loan's underwriting structure or the liberal use of extensions and renewals masks credit weaknesses and obscures a borrower's inability to meet reasonable repayment terms.
For example, for many acquisition, development, and construction projects, the loan is structured with an “interest reserve” for the construction phase of the project. At the time the loan is originated, the lender establishes the interest reserve as a portion of the initial loan commitment. During the construction phase, the lender recognizes interest income from the interest reserve and capitalizes the interest into the loan balance. After completion of the construction, the lender recognizes the proceeds from the sale of lots, homes, or buildings for the repayment of principal, including any of the capitalized interest. For a commercial construction loan where the property has achieved stabilized occupancy, the lender uses the proceeds from permanent financing for repayment of the construction loan or converts the construction loan to an amortizing loan.
However, if the development project stalls and management fails to evaluate the collectability of the loan, interest income may continue to be recognized from the interest reserve and capitalized into the loan balance, even though the project is not generating sufficient cash flows to repay the loan. In such cases, the loan will be contractually current due to the interest payments being funded from the reserve, but the repayment of principal may be in jeopardy, especially when leases or sales have not occurred as projected and property values have dropped below the market value reported in the original collateral valuation. In these situations, adverse classification of the loan may be appropriate.
A second perspective for assessing a loan's classification is to consider the borrower's expected performance and ability to meet its obligations in accordance with the modified terms over the loan's tenure. Therefore, the loan classification is meant to measure risk over the term of the loan rather than just reflecting the loan's payment history. As a borrower's expected performance is dependent upon future events, examiners' credit analyses should focus on:
• The borrower's financial strength as reflected by its historical and projected balance sheet and income statement outcomes; and
• The prospects for a CRE property in light of events and market conditions that reasonably may occur during the term of the loan.
Loans to commercial borrowers can have short maturities, including short-term working capital loans to businesses, financing for CRE construction projects, or loans to finance recently completed CRE projects for the period to achieve stabilized occupancy. When there has been deterioration in collateral values, a borrower with a maturing loan amid an economic downturn may have difficulty obtaining short-term financing or adequate sources of long-term credit, despite their demonstrated and continued ability to service the debt. In such cases, financial institutions may determine that the most appropriate course is to restructure or renew the loans. Such actions, when done prudently, are often in the best interest of both the financial institution and the borrower.
A restructured loan typically reflects an elevated level of credit risk, as the borrower may not be, or has not been, able to perform according to the original contractual terms. The assessment of each loan should be based upon the fundamental characteristics affecting the collectability of that loan. In general, renewals or restructurings of maturing loans to commercial borrowers who have the ability to repay on reasonable terms will not automatically be subject to adverse classification by examiners. However, consistent with safety and soundness standards, such loans are identified in the financial institution's internal credit grading system and may warrant close monitoring. Adverse classification of a renewed or restructured loan would be appropriate, if, despite the renewal or restructuring, well-defined weaknesses exist that jeopardize the orderly repayment of the loan pursuant to reasonable modified terms.
As a general classification principle for a troubled CRE loan that is dependent on the sale of the collateral for repayment, any portion of the loan balance that exceeds the amount that is adequately secured by the fair value of the real estate collateral less the costs to sell should be classified “loss.” This principle applies to loans that are collateral dependent based on the sale of the collateral in accordance with GAAP and there are no other available reliable sources of repayment such as a financially capable guarantor.
The portion of the loan balance that is adequately secured by the fair value of the real estate collateral less the costs to sell generally should be adversely classified no worse than “substandard.” The amount of the loan balance in excess of the fair value of the real estate collateral, or portions thereof, should be adversely classified “doubtful” when the potential for full loss may be mitigated by the outcomes of certain pending events, or when loss is expected but the amount of the loss cannot be reasonably determined. If warranted by the underlying circumstances, an examiner may use a “doubtful” classification on the entire loan balance. However, examiners should use a “doubtful” classification infrequently and for a limited time period to permit the pending events to be resolved.
Based on consideration of all relevant factors, an assessment may indicate that a loan has well-defined weaknesses that jeopardize collection in full of all amounts contractually due and may result in a partial charge-off as part of a restructuring. When well-defined weaknesses exist and a partial charge-off has been taken, the remaining recorded balance for the restructured loan generally should be classified no more severely than “substandard.” A more severe classification than “substandard” for the remaining recorded balance would be appropriate if the loss exposure cannot be reasonably determined. Such situations may occur where significant remaining risk exposures are identified but are not quantified, such as bankruptcy or a loan collateralized by a property with potential environmental concerns.
A restructuring may involve a multiple note structure in which, for example, a troubled loan is restructured into two notes. Lenders may separate a portion of the current outstanding debt into a new, legally enforceable note (
In contrast, the loan should remain on, or be placed on, nonaccrual status if the lender does not split the loan into separate notes, but internally recognizes a partial charge-off. A partial charge-off would indicate that the financial institution does not expect full repayment of the amounts contractually due. If facts change after the charge-off is taken such that the full amounts contractually due, including the amount charged off, are expected to be collected and the loan has been brought contractually current, the remaining balance of the loan may be returned to accrual status without having to first receive payment of the charged-off
Financial institution management is responsible for preparing regulatory reports in accordance with GAAP and regulatory reporting requirements. Management also is responsible for establishing and maintaining an appropriate governance and internal control structure over the preparation of regulatory reports. The Board has observed this governance and control structure commonly includes policies and procedures that provide clear guidelines on accounting matters. Accurate regulatory reports are critical to the transparency of a financial institution's financial position and risk profile and imperative for effective supervision. Decisions related to loan workout arrangements may affect regulatory reporting, particularly interest accruals, and loan loss estimates. Therefore, it is important that loan workout staff appropriately communicate with the accounting and regulatory reporting staff concerning the financial institution's loan restructurings and that the reporting consequences of restructurings are presented accurately in regulatory reports.
In addition to evaluating credit risk management processes and validating the accuracy of internal loan grades, examiners are responsible for reviewing management's processes related to accounting and regulatory reporting. While similar data are used for loan risk monitoring, accounting, and reporting systems, this information does not necessarily produce identical outcomes. For example, loss classifications may not be equivalent to the associated allowance measurements.
Examiners need to have a clear understanding of the differences between credit risk management and accounting and regulatory reporting concepts (such as accrual status, restructurings, and the allowance) when assessing the adequacy of the financial institution's reporting practices for on- and off-balance sheet credit exposures. Refer to the appropriate Appendix that provides a summary of the allowance standards under the incurred loss methodology (Appendix 6) or the CECL methodology for institutions that have adopted ASC Topic 326,
A financial institution needs to consider whether a loan that was accruing interest prior to the loan restructuring should be placed in nonaccrual status at the time of modification to ensure that income is not materially overstated. Consistent with Call Report Instructions, a loan that has been restructured so as to be reasonably assured of repayment and performance according to prudent modified terms need not be placed in nonaccrual status. Therefore, for a loan to remain on accrual status, the restructuring and any charge-off taken on the loan have to be supported by a current, well-documented credit assessment of the borrower's financial condition and prospects for repayment under the revised terms. Otherwise, in accordance with outstanding Call Report instructions, the restructured loan must be placed in nonaccrual status.
A restructured loan placed in nonaccrual status should not be returned to accrual status until the borrower demonstrates a period of sustained repayment performance for a reasonable period prior to the date on which the loan is returned to accrual status. A sustained period of repayment performance generally would be a minimum of six months and would involve payments of cash or cash equivalents. It may also include historical periods prior to the date of the loan restructuring. While an appropriately designed restructuring should improve the collectability of the loan in accordance with a reasonable repayment schedule, it does not relieve the financial institution from the responsibility to promptly charge off all identified losses. For more detailed instructions about placing a loan in nonaccrual status and returning a nonaccrual loan to accrual status, refer to the instructions for the FFIEC Call Report.
The examples in this Appendix are provided for illustrative purposes only and are designed to demonstrate an examiner's analytical thought process to derive an appropriate classification and evaluate implications for interest accrual and appropriate regulatory reporting, such as whether a loan should be reported as a troubled debt restructuring (TDR).
Examiners should use caution when applying these examples to “real-life” situations, consider all facts and circumstances of the loan being evaluated, and exercise judgment before reaching conclusions related to loan classifications, accrual treatment, and TDR reporting.
The TDR determination requires consideration of all of the facts and circumstances surrounding the modification. No single factor, by itself, is determinative of whether a modification is a TDR. To make this determination, the lender assesses whether (a) the borrower is
A review of the leases reflects that most tenants are stable occupants, with long-term leases and sufficient cash flow to pay their rent. The major tenants have not adopted hybrid work-from-home arrangements for their employees given the nature of the businesses. A recent appraisal reported an “as stabilized” market value of $13.3 million for the property for an LTV of 102 percent. This reflects current market conditions and the resulting decline in cash flow.
At the time of origination, the appraisal reported an “as stabilized” market value of $13.5 million for the property. In addition, the borrower had a take-out commitment that would provide permanent financing at maturity. A condition of the take-out lender was that the shopping mall had to achieve a 75 percent occupancy level.
Due to weak economic conditions and a shift in consumer behavior to a greater reliance on e-commerce, the property only reached a 55 percent occupancy level at the end of the 12-month lease up period. As a result, the original takeout commitment became void. In addition, there has been a considerable tightening of credit for these types of loans, and the borrower has been unable to obtain permanent financing elsewhere since the loan matured. To date, the few interested lenders are demanding significant equity contributions and much higher pricing.
In addition, current financial statements reflect that the builder, who personally guarantees the debt, has cash on deposit at the lender plus other unencumbered liquid assets. These assets provide sufficient cash flow to service the borrower's global debt service requirements on a principal and interest basis, if necessary, for the next 12 months. The guarantor covered the initial cash flow shortfalls from the project and provided a good faith principal curtailment of $200,000 at renewal, reducing the loan balance to $9.8 million. A recent appraisal on the shopping mall reports an “as is” market value of $10 million and an “as stabilized” market value of $11 million, resulting in LTVs of 98 percent and 89 percent, respectively.
Current financial statements indicate the builder, who personally guarantees the debt, cannot cover any cash flow shortfall. The builder is highly leveraged, has limited cash or unencumbered liquid assets, and has other projects with delinquent payments. A recent appraisal on the shopping mall reports an “as is” market value of $9 million, which results in an LTV ratio of 111 percent.
At the original loan's maturity, the lender restructured the $10 million debt into two notes. The lender placed the first note of $7 million (
The lender plans to stop disclosing the on-book loan as a TDR after the regulatory reporting defined time period expires because the loan was restructured with a market interest rate and is in compliance
The loan can be returned to accrual status
At the end of the five-year term, the borrower's annualized DSC ratio was 0.95x. Due to competition from a well-known 4-star hotel that recently opened within one mile of the property, occupancy rates have declined. The borrower progressively reduced room rates to maintain occupancy rates, but continued to lose daily bookings. Both occupancy and Revenue per Available Room (RevPAR)
The borrower had paid principal and interest as agreed throughout the first five years, and the principal balance had reduced to $7 million at the end of the five-year term.
The most recent hotel appraisal, dated as of the time of the first restructuring, reports an “as stabilized” appraised value of $7.2 million ($6.7 million for the real estate and $500,000 for the tangible personal property of furniture, fixtures, and equipment), resulting in an LTV of 97 percent. The appraisal does not account for the diminished occupancy, and its assumptions significantly differ from current projections. A new valuation is needed to ascertain the current value of the property.
Estimated time for development is 12 months; the appraiser estimated absorption of two lots per month for total sell-out to occur within three years (thus, the loan would be repaid upon settlement of the 40th unit, or the 32nd month of the loan term). The borrower is required to curtail the A&D loan by six lots, or $720,000, at the 24th month, and another six lots, or $720,000, by the 30th month.
At maturity, the lender renewed the $4.8 million outstanding A&D loan balance and the $2.4 million construction revolver for 24
Development is now complete, and construction has commenced on eight units (two “spec” units and six pre-sold units). Combined borrower and guarantor liquidity show they can cover any debt service shortfall until the units begin to settle and the project is cash flowing. The lender estimates that the property's current “as complete” value is $6 million, resulting in an 80 percent LTV. The curtailment schedule was re-set to eight lots, or $960,000, by month 12, and another eight lots, or $960,000, by month 18. A new appraisal has not been ordered; however, the lender noted in the file that, if the borrower does not meet the absorption projections of six lots/quarter within six months of booking the renewed loan, the lender will obtain a new appraisal.
At maturity, the lender renewed the $4.8 million A&D loan balance and $2.4 million construction revolver on a 12-month interest-only basis at a market interest rate, with another 12-month option predicated upon $1 million in curtailments having occurred during the first renewal term (the lender had waived the initial term curtailment requirements). The lender also renewed the construction revolver for a one-year term and reduced the number of “spec” units to just one, which also will serve as the model. A recent appraisal estimates that absorption has dropped to four lots per quarter for the first two years and assigns an “as complete” value of $5.3 million, for an LTV of 91 percent. The interest reserve is depleted, and the borrower has been paying interest out-of-pocket for the past few months. Updated borrower and guarantor financial statements indicate the continued ability to cover interest-only payments for the next 12 to 18 months.
The borrower then sold an additional 10 units to an investor; the loan officer (new to the financial institution) mistakenly marked these units as pre-sold and allowed construction to commence on all 10 units. Market conditions then deteriorated quickly, and the investor defaulted under the terms of the bulk contract. The units were completed, but the builder has been unable to re-sell any of the units, recently dropping the sales price by 10 percent and engaging a new marketing firm, which is working with several potential buyers.
A recent appraisal estimates that absorption has dropped to three lots per quarter and assigns an “as complete” value of $2.3 million for the remaining 28 lots, resulting in an LTV of 156 percent. A bulk appraisal of the 10 units assigns an “as-is” value of the units of $4.0 million ($400,000/unit). The loans are cross-defaulted and cross-collateralized; the LTV on a combined basis is 95 percent ($6 million outstanding debt (A&D plus revolver) divided by $6.3 million in combined collateral value). Updated borrower and guarantor financial statements indicate a continued ability to cover interest-only payments for the next 12 months at the reduced rate; however, this may be limited in the future given other troubled projects in the borrower's portfolio that have been affected by market conditions.
The lender modified the release price for each unit to net proceeds; any additional proceeds as units are sold will go towards repayment of the A&D loan. Assuming the units sell at a 10 percent reduction, the lender calculates the average sales price would be $450,000. The financial institution's prior release price was $320,000 ($120,000 for the A&D loan and $200,000 for the construction revolver). As such (by requiring net proceeds), the financial institution will be receiving an additional $130,000 per lot, or $1.3 million for the completed units, to repay the A&D loan ($450,000 average sales price less $320,000 bank's release price equals $130,000). Assuming the borrower will have to pay $30,000 in related sales/settlement costs leaves approximately $100,000 remaining per unit to apply towards the A&D loan, or $1 million total for the remaining 10 units ($100,000 times 10).
At the second restructuring, the lender determined that the borrower was not
The developer experienced cost overruns on the project and subsequently determined it was in the best interest to halt construction with the property 80 percent completed. The outstanding loan balance is $44 million with funds used to pay construction costs, including cost overruns and interest. The borrower estimates an additional $10 million is needed to complete construction. Current financial information reflects that the developer does not have sufficient cash flow to pay interest (the interest reserve has been depleted); and, while the developer does have equity in other assets, there is doubt about the borrower's ability to complete the project.
The lender obtained a recent appraisal on the condominium building that reported a prospective “as complete” market value of $65 million, reflecting a 24-month sell-out period and projected selling costs of 15 percent of the sales price. Comparing the $54 million loan amount against the $65 million “as complete” market value plus the $5 million pledged in additional collateral (totaling $70 million) results in an LTV of 77 percent. The lender used the prospective “as complete” market value in its analysis and decision to fund the completion and sale of the units and to maximize its recovery on the loan.
In return, the lender advanced the borrower $10 million, which is needed to finish construction and convert the project to an apartment complex. The lender also agreed to extend the $54 million loan for 12 months at a market interest rate that provides for the incremental risk, to give the borrower time to lease the apartments. Interest payments are deferred. The $60 million “as complete” market value plus the $5 million in other collateral results in an LTV of 83 percent. The prospective “as complete” market value is primarily relied on as the loan is funding the conversion of the condominium to apartment building.
Leases are typically 12-month terms with an additional 12-month renewal option. The property is 88 percent leased (22 of 25 units rented). Due to poor economic conditions, delinquencies have risen from two units to eight units, as tenants have struggled to make ends meet. Six of the eight units are 90 days past due, and these tenants are facing eviction.
Several conceptual issues arise during the process of reviewing a real estate loan and in using the net present value approach of collateral valuation. The following discussion sets forth the meaning and use of those key concepts.
The direct income capitalization method calculates the value of a property by dividing an estimate of its “stabilized” annual income by a factor called a “cap” rate. Stabilized annual income generally is defined as the yearly net operating income produced by the property at normal occupancy and rental rates; it may be adjusted upward or downward from today's actual market conditions. The “cap” rate, usually defined for each property type in a market area, is viewed by some analysts as the required rate of return stated in terms of current income. The “cap” rate can be considered a direct observation of the required earnings-to-price ratio in current income terms. The “cap” rate also can be viewed as the number of cents per dollar of today's purchase price investors would require annually over the life of the property to achieve their required rate of return.
The “cap” rate method is an appropriate valuation technique if the net operating income to which it is applied is representative of all future income streams or if net operating income and the property's selling price are expected to increase at a fixed rate. The use of this technique assumes that either the stabilized annual income or the “cap” rate used accurately captures all relevant characteristics of the property relating to its risk and income potential. If the same risk factors, required rate of return, financing arrangements, and income projections are used, the net present value approach and the direct capitalization technique will yield the same results.
The direct capitalization technique is not an appropriate valuation technique for troubled real estate since income generated by the property is not at normal or stabilized levels. In evaluating troubled real estate, ordinary discounting typically is used for the period before the project reaches its full income potential. A “terminal cap rate” is then utilized to estimate the value of the property (its reversion or sales price) at the end of that period.
Other factors affecting the “cap” rate (but not the discount rate) include the useful life of the property and financing arrangements. The useful life of the property being evaluated affects the magnitude of the “cap” rate because the income generated by a property, in addition to providing the required return on investment, has to be sufficient to compensate the investor for the depreciation of the property over its useful life. The longer the useful life, the smaller is the depreciation in any one year, hence, the smaller is the annual income required by the investor, and the lower is the “cap” rate. Differences in terms and the extent of debt financing and the related costs are also taken into account.
The Board uses the following definitions for assets adversely classified for supervisory purposes as well as those assets listed as special mention:
A Special Mention asset has potential weaknesses that deserve management's close attention. If left uncorrected, these potential weaknesses may result in deterioration of the repayment prospects for the asset or in the institution's credit position at some future date. Special Mention assets are not adversely classified and do not expose an institution to sufficient risk to warrant adverse classification.
This appendix addresses the relevant accounting and regulatory guidance for financial institutions that have adopted Accounting Standards Update (ASU) 2016-13,
Expected credit losses on loans under ASC Topic 326 are estimated under the same CECL methodology as all other loans in the portfolio. Loans, including loans modified in a restructuring, should be evaluated on a collective basis unless they do not share similar risk characteristics with other loans. Changes in credit risk, borrower circumstances, recognition of charge-offs, or cash collections that have been fully applied to principal, often require reevaluation to determine if the modified loan should be included in a different pool of assets with similar risks for measuring expected credit losses.
Although ASC Topic 326 allows a financial institution to use any appropriate loss estimation method to estimate the ACL, there are some circumstances when specific measurement methods are required. If a financial asset is collateral dependent,
Financial institutions also should consider the need to recognize an allowance for expected credit losses on off-balance sheet credit exposures, such as loan commitments, in other liabilities consistent with ASC Topic 326.
This Appendix addresses the relevant accounting and regulatory guidance for financial institutions using the incurred loss methodology to estimate the allowance for loan and lease losses under ASC Subtopics 310-10,
The restructuring of a loan or other debt instrument should be undertaken in ways that improve the likelihood that the maximum credit repayment will be achieved under the modified terms in accordance with a reasonable repayment schedule. A financial institution should evaluate each restructured loan to determine whether the loan should be reported as a TDR. For reporting purposes, a restructured loan is considered a TDR when the financial institution, for economic or legal reasons related to a borrower's financial difficulties, grants a concession to the borrower in modifying or renewing a loan that the financial institution would not otherwise consider. To make this determination, the financial institution assesses whether (a) the borrower is
The determination of whether a restructured loan is a TDR requires consideration of all relevant facts and circumstances surrounding the modification. No single factor, by itself, is determinative of whether a restructuring is a TDR. An overall general decline in the economy or some deterioration in a borrower's financial condition does not automatically mean that the borrower is
Guidance for the financial institution's estimate of loan losses and examiners' responsibilities to evaluate these estimates is presented in
Financial institutions are required to estimate credit losses based on a loan-by-loan assessment for certain loans and on a group basis for the remaining loans in the held-for-investment loan portfolio. All loans that are reported as TDRs are considered impaired and are typically evaluated on an individual loan basis in accordance with ASC Subtopics 310-40, and 310-10. Generally, if an individually assessed loan
For an individually evaluated impaired collateral dependent loan,
Financial institutions also should consider the need to recognize an allowance for estimated credit losses on off-balance sheet credit exposures, such as loan commitments in other liabilities consistent with ASC Subtopic 825-10,
For performing CRE loans, supervisory policies do not require automatic increases in the ALLL solely because the value of the collateral has declined to an amount that is less than the recorded investment in the loan. However, declines in collateral values should be considered when applying qualitative factors to calculate loss rates for affected groups of loans when estimating loan losses under ASC Subtopic 450-20.
By order of the Board of Governors of the Federal Reserve System.
Board of Governors of the Federal Reserve System.
Notice, request for comment.
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Payments Research Survey (FR 3067; OMB No. 7100-0355).
Comments must be submitted on or before November 14, 2022.
You may submit comments, identified by FR 3067, by any of the following methods:
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All public comments are available from the Board's website at
Additionally, commenters may send a copy of their comments to the Office of Management and Budget (OMB) Desk Officer for the Federal Reserve Board, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503, or by fax to (202) 395-6974.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829.
On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
During the comment period for this proposal, a copy of the proposed PRA OMB submission, including the draft reporting form and instructions, supporting statement, and other documentation, will be made available on the Board's public website at
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;
b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Board should modify the proposal.
• Section 609 of the Expedited Funds Availability Act;
• Title VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act;
• Sections 904 and 920 of the Electronic Fund Transfer Act;
• Section 7 of the Bank Service Company Act;
• Section 15 of the Check Clearing for the 21st Century Act;
• Sections 2A, 11, 11A, 13, and 16 of the Federal Reserve Act.
The FR 3067 surveys are voluntary. Individual respondents may request confidential treatment in accordance with the Board's Rules Regarding Availability of Information.
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 November 14, 2022.
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, you 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
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Each month CMS deems individuals automatically eligible for the full subsidy, based on data from State Medicaid Agencies and the Social Security Administration (SSA). The SSA sends a monthly file of Supplementary Security Income-eligible beneficiaries to CMS. Similarly, the State Medicaid agencies submit Medicare Modernization Act files to CMS that identify full subsidy beneficiaries. CMS deems the beneficiaries as having full subsidy and auto-assigns these beneficiaries to bench mark Part D plans. Part D plans receive premium amounts based on the monthly assessments.
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In the final rule, the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017 (CMS-9937-P), we finalized network adequacy standards for qualified health plan (QHP) issuers, including stand-alone dental plans (SADPs) mostly focused on issuers in QHPs in the Federally-facilitated Exchanges (FFEs). This information collection notice is for two of the standards from the rule: one applying in the FFE and one applying to all QHPs. Specifically, under 45 CFR 156.230(d) and 156.230(e), we require notification requirements for enrollees in cases where a provider leaves the network and for cases where an enrollee might be seen by an out of network ancillary provider in an in-network setting. These standards will help inform consumers about his or her health plan coverage to better make cost effective choices. The Centers for Medicare and Medicaid Services (CMS) is updating an information collection request (ICR) in connection with these standards. The burden estimates for this ICR included in this package reflects the additional time and effort for QHP issuers to provide these notifications to enrollees.
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Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for bacitracin for injection.
Sungjoon Chi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6216, Silver Spring, MD 20993-0002, 240-402-9674,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
Bacitracin for injection, 10,000 units/vial and 50,000 units/vial, is the subject of ANDA 060733 (originally NDA 6-483), held by Pharmacia and Upjohn Company (a subsidiary of Pfizer Inc.), and was initially approved on July 29, 1948. Bacitracin for injection is an antibiotic for intramuscular administration, the use of which is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible
Bacitracin for injection poses serious risks, including nephrotoxicity and anaphylactic reactions. Healthcare professionals generally no longer use bacitracin for injection to treat infants with pneumonia and empyema because other effective FDA-approved treatments are available that do not have these risks. Out of concern about these risks, on January 31, 2020, FDA requested that all application holders of bacitracin for injection voluntarily request withdrawal of approval of their applications under § 314.150(d) (21 CFR 314.150(d)). Two approved applications for bacitracin for injection had been withdrawn prior to January 31, 2020 (see 61 FR 40649, August 5, 1996, and 57 FR 6228, February 21, 1992) and therefore FDA did not need to request their withdrawal. In a letter dated February 7, 2020, Pfizer requested withdrawal of approval of ANDA 060733 (originally NDA 6-483) for bacitracin for injection under § 314.150(d) and waived its opportunity for a hearing. In separate letters dated February 5, 2020, Akorn Inc. and Mylan ASI LLC requested that FDA withdraw approval of ANDAs 206719 and 090211, respectively, under § 314.150(d) and waived their opportunity for a hearing. Additionally, in separate letters dated February 7, 2020, X-GEN Pharmaceuticals, Inc. and Fresenius Kabi USA, LLC requested that FDA withdraw approval of ANDAs 064153 and 065116, respectively, under § 314.150(d) and waived their opportunity for a hearing. In the
In a letter dated June 14, 2021, the only remaining application holder, Xellia Pharmaceuticals USA, LLC, requested that FDA withdraw approval of ANDA 203177 under § 314.150(d) and waived its opportunity for a hearing. In the
After reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn for reasons of safety or effectiveness. We have reviewed our files for records concerning the withdrawal of bacitracin for injection from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. Based on a thorough evaluation of this information, including information presented to FDA's Antimicrobial Drugs Advisory Committee and the recommendations of that committee, and an evaluation of the latest version of the drug product's labeling, we have determined that bacitracin for injection, 10,000 units/vial and 50,000 units/vial, would not be considered safe and effective if it were introduced to the market today in the absence of new preclinical or clinical studies to address safety or effectiveness concerns identified during our review.
Accordingly, the Agency will remove bacitracin for injection, 10,000 units/vial and 50,000 units/vial, from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of its most recent periodic reassessment of the definition of “small number of animals” for minor use in major species (contained in our existing regulation for new animal drugs for minor use and minor species). We also are announcing that the small number of animals upper limit thresholds (small numbers) for horses and the food-producing major species (cattle, pigs, turkeys, and chickens) will remain the same. We are separately issuing a direct final rule and a companion proposed rule to revise (
Submit either electronic or written comments on the notice at any time.
You may submit comments 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
Margaret Oeller, Center for Veterinary Medicine (HVF-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0566, email:
The Minor Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282) (the MUMS Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide incentives for the development of new animal drugs for use in minor animal species and for minor uses in major animal species. The MUMS Act defines “minor use” as the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually (see section 201(pp) of the FD&C Act (21 U.S.C. 321(pp)).
In the
In our final rule, in response to comments, we agreed that periodic reassessment of the small numbers is appropriate and that such reassessments should occur approximately every 5 years. We conducted our first reassessment in 2013 and published the results in the
We conducted our second reassessment of the “small number of animals” definition in 2018-2019 (current reassessment), and the results of that reassessment are summarized in our memorandum “2018-2019 Reassessment of Small Numbers of Animals for Minor Use Determination” (Ref. 1). FDA developed different processes for establishing small numbers for the major species of companion animals and the major species of food-producing animals, and we continue to use those processes for our periodic reassessments of the small numbers. Both processes are described in detail in the preamble to the proposed rule that published in the
Based on our current reassessment, there is not an adequate basis to propose revisions to the currently published small numbers for horses and the food-producing major species. The small numbers for horses and the four food-producing major species as established in the current “small number of animals” definition in § 516.3(b) are listed in table 1.
In separate documents published elsewhere in this issue of the
While this notice of reassessment of the small numbers contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this notice. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR 516.20 have been approved under OMB control number 0910-0605.
The following reference is on display at the Dockets Management Staff (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q3D(R2) Guideline for Elemental Impurities.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance revises the guidance for industry “Q3D(R1) Elemental Impurities” issued in March 2020 to provide Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration. It also provides relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. The guidance is intended to provide recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products and for conducting risk assessments.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• 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 this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
FDA is announcing the availability of a final guidance for industry entitled “Q3D(R2) Guideline for Elemental Impurities.” The guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and
The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (
ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.
As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
In September 2020, the ICH Assembly endorsed the draft guideline entitled “Q3D(R2) Guideline for Elemental Impurities” and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Q3D(R2) Working Group of the ICH. In the
The guidance revises the guidance for industry “Q3D(R1) Elemental Impurities” issued in March 2020 to provide PDEs for the cutaneous and transcutaneous routes of administration. It also provides relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration and corrects errors to previously identified PDEs for gold (oral, parenteral, and inhalation routes), silver (parenteral route), and nickel (inhalation route). The final guidance is intended to provide recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products and for conducting risk assessments.
This guidance represents the current thinking of FDA on “Q3D(R2) Guideline for Elemental Impurities.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information relating to good laboratory practice have been approved under OMB control number 0910-0119. The collections of information pertaining to current good manufacturing practice have been approved under OMB control number 0910-0139. The collections of information for new drug applications and biologics license applications have been approved under OMB control numbers 0910-0001 and 0910-0338, respectively.
Persons with access to the internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held virtually on November 1, 2022, from 9 a.m. to 6 p.m. eastern time.
Please note that due to the impact of the COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings, including information regarding special accommodations due to a disability, may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2022-N-2110. The docket will close on December 1, 2022. Either electronic or written comments on this public meeting must be submitted by December 1, 2022. Please note that late, untimely filed comments will not be considered. The
Comments received on or before October 18, 2022, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
You may submit comments 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.” FDA 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
Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 301-636-0512,
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of or after the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Ann Marie Williams, at
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CAPLYTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 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, CAPLYTA (lumateperone tosylate). CAPLYTA is indicated for the treatment of schizophrenia. Subsequent to this approval, the USPTO received a patent term restoration application for CAPLYTA (U.S. Patent Nos. 8,598,119 and 8,648,077) from Intra-Cellular Therapies, Inc., 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 CAPLYTA 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 CAPLYTA is 4,421 days. Of this time, 3,970 days occurred during the testing phase of the regulatory review period, while 451 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 applications for patent extension, this applicant seeks 1,294 days or 1,329 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 TAVALISSE 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 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 TAVALISSE (fostamatinib disodium hexahydrate). TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Subsequent to this approval, the USPTO received a patent term restoration application for TAVALISSE (U.S. Patent No. 7,449,458) from Rigel Pharmaceuticals, Inc. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated June 12, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TAVALISSE 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 TAVALISSE is 4,564 days. Of this time, 4,198 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 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
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Request for public comment on Draft Health Center Program Scope of Project and Telehealth Policy Information Notice.
HRSA is inviting public comment on the Draft Health Center Program Scope of Project and Telehealth Policy Information Notice (Telehealth PIN). The purpose of the Telehealth PIN is to establish policy for health centers that provide services via telehealth within the HRSA-approved scope of project. The Telehealth PIN also describes considerations and criteria health centers must meet for providing services via telehealth within the Health Center Program scope of project.
The Health Center Program is authorized by section 330 of the Public Health Service Act, 42 U.S.C. 254b. HRSA provides federal award funding to health centers to deliver required primary care and additional health services to medically underserved areas and populations. HRSA also certifies entities that it has determined to meet section 330 requirements as Health Center Program look-alikes. Health centers provide required primary care and additional health services to residents of the area served by the health center.
Each health center is responsible for maintaining its operations, including developing and implementing its own operating procedures for providing health services through telehealth, in compliance with all Health Center Program requirements and all other applicable federal, state, and local laws and regulations.
Health centers are increasingly using telehealth as a means of delivering required and additional services to health center patients. Providing health care via telehealth
Submit comments no later than November 14, 2022.
The PIN is available at the Scope of Project and Telehealth PIN Public Comments web page. Written comments should be submitted through the HRSA Bureau of Primary Health Care Contact Form (
Jennifer Joseph, Director, Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; email:
HRSA provides grants to eligible applicants under section 330 of the PHS Act, as amended (42 U.S.C. 254b), to support the delivery of preventive and primary care services to the nation's underserved individuals and families. HRSA also certifies eligible applicants under the Health Center Look-Alike Program (see sections 1861(aa)(4)(B) and 1905(l)(2)(B) of the Social Security Act). Look-alikes do not receive Health Center Program funding but must meet the Health Center Program statutory and regulatory requirements. Nearly 1,400 Health Center Program-funded health centers and approximately 100 Health Center Program look-alike organizations collectively operate over 14,000 service delivery sites that provide care to over 30 million patients in every U.S. state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. Note that for the purposes of this document, the term “health center” refers to entities that receive a federal award under section 330 of the PHS Act, as amended, as well as subrecipients and organizations designated as look-alikes, unless otherwise stated.
Section A of the Telehealth PIN includes considerations for health centers delivering services via telehealth within the HRSA-approved scope of project. Each health center is responsible for maintaining its operations, including developing and implementing its own operating procedures for telehealth, in compliance with all Health Center Program
Section B of the Telehealth PIN includes criteria for health centers delivering services via telehealth within the HRSA-approved scope of project. PIN 2008-01: Defining Scope of Project and Policy for Requesting Changes provides the parameters of what may be included in a health center's scope of project and how to accurately document a health center's scope of project. Health centers may deliver in-scope services via telehealth to individuals who have previously presented for care at a health center site and to individuals who have not previously presented for care at a health center site. Services delivered via telehealth generally would be within the scope of the health center project if all of the criteria are met as described in the policy.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, 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 October 17, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice 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.
A 60-day notice published in the
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 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 of the Reproduction, Andrology, and Gynecology Study Section.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
Transportation Security Administration, DHS.
Notice, temporary exemption.
TSA is granting a temporary exemption from requirements regarding the expiration of TSA Security Threat Assessments (STAs) for Hazardous Materials Endorsement (HME) holders, subject to requirements set forth in this exemption. For the duration of this exemption, states may extend the expiration date of an HME that expires between July 1, 2022 and December 27, 2022, for a period of up to 180 days. TSA has determined it is in the public interest to grant the exemption at this time to ensure that the HME renewal process does not exacerbate the current difficulties with the transfer and movement of cargo nationwide and at the ports. TSA may extend this exemption depending on HME enrollment volumes and supply chain challenges.
This exemption becomes effective on September 15, 2022 and remains in effect through December 27, 2022, unless otherwise modified by TSA through a notice published in the
Stephanie Hamilton, 571-227-2851,
Approximately 80 percent of goods are shipped by truck in the United States today. These shipments include necessities, such as food, medicine, and protective equipment, as well as discretionary goods. Consumer purchases of discretionary goods fell dramatically during the height of the Coronavirus 2019 (COVID-19) pandemic, but spiked following the development of vaccines and as a gradual return to normal daily life progressed. Meanwhile, the pandemic exacerbated longstanding challenges in the trucking industry, such that demand for drivers with a valid state-issued commercial driver's license (CDL) with an HME has increased significantly. These supply chain issues and increasing consumer demands have increased pressure on motor carriers who require qualified, trained, and licensed drivers to transport goods. As a result, there is a significant need for commercial drivers who are authorized to transport all goods, including hazardous materials.
The USA PATRIOT Act of 2001 requires individuals who transport hazardous materials via commercial motor vehicle to undergo an STA conducted by TSA.
An individual seeking renewal of an HME must initiate an STA at least 60 days before expiration of their current HME.
Supply chain issues, have increased the demand for drivers with a valid state-issued CDL with an HME. The pandemic exacerbated longstanding challenges in the trucking industry, including high turnover rates, an aging workforce, long hours away from home, and time spent waiting—often unpaid—to load and unload at congested ports, warehouses, and distribution centers. As a result of the increased demand, more than 50,000 CDLs and Learners Permits have been issued each month in 2021, which is 20 percent higher than the 2019 monthly average and 72 percent higher than the 2020 monthly average.
Even though all shipments do not include hazardous materials, employers want to have commercial drivers with HMEs available as a matter of efficiency to ensure any driver is authorized to carry any shipment. Similar to the demand for CDLs, enrollments for HMEs have increased from approximately 15,000 per month to 20,000 per month in calendar years 2021 and 2022. Despite a nearly 30 percent decrease in HME enrollments during the pandemic, new enrollments and renewals are exceeding historical volumes to meet the demand for qualified drivers. The increased demand for HMEs, as well as other credentialling requiring STAs conducted by TSA, has increased processing times for some individuals with potential disqualifying factors. Some applications require 60 days for TSA to complete the adjudication of potential disqualifying factors and make an eligibility determination.
As noted above, current regulatory requirements prohibit states from issuing or renewing an HME until TSA makes its final eligibility determination.
TSA published a similar temporary exemption for HME renewals on April 8, 2020, to provide regulatory relief during the height of the COVID-19 pandemic
TSA may grant an exemption from a regulation if TSA determines that the exemption is in the public interest.
This exemption permits states to extend the expiration date for an HME for up to 180 days for eligible individuals with an HME that expires between July 1, 2022 and December 27, 2022, even if the individual did not initiate or complete submission of required information for an STA at least 60 days before expiration of the HME.
The purpose of this exemption is to allow states to provide commercial drivers with up to six months of relief from action necessary to meet TSA's STA renewal requirements during a period of increased demand for commercial drivers. It allows for the 60 days TSA needs to complete processing of the individual's application for STA renewal once it is submitted. The exemption permits, but does not require, states to extend the expiration date for HMEs.
By permitting states to extend the expiration date of HMEs within the scope of this exemption, TSA better positions states to ensure that CDL holders with HMEs will be able to continue to provide their critical services amid supply chain pressures and increased demand for STAs, licenses, and endorsements. TSA has determined that there is little risk to transportation security associated with the exemption. The exemption is subject to the following conditions:
(1) The extension applies only to individuals who currently hold an HME;
(2) The extension is for a limited time, dependent on the duration and scope of supply chain pressures and increased HME enrollment volumes for drivers, and subject to possible modification by TSA before the closure of the effective period; and
(3) TSA will continue to conduct security threat checks of these during the period of the extension and retain its full authority to immediately revoke or suspend an individual's STA (Determination of No Security Threat) and to order a state to revoke an individual's HME.
For purposes of this exemption, an
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA). With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The ESA also requires that we invite public comment before issuing permits for any activity otherwise prohibited by the ESA with respect to any endangered species.
We must receive comments by October 17, 2022.
•
•
For more information, see Public Comment Procedures under
Brenda Tapia, by phone at 703-358-2185 or via email at
We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
You may submit your comments and materials by one of the methods in
When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. Provide sufficient information to allow us to authenticate any scientific or commercial data you include. The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) those that include citations to, and analyses of, the applicable laws and regulations.
You may view and comment on others' public comments at
If you submit a comment at
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(c) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
We invite comments on the following applications.
The applicant requests a permit to export five captive-bred male Jamaican iguanas (
The applicant requests a permit to import biological samples collected from wild American crocodiles (
The following applicants request permits to import sport-hunted trophies of male bontebok (
After the comment period closes, we will make decisions regarding permit issuance. If we issue permits to any of the applicants listed in this notice, we will publish a notice in the
We issue this notice under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Bureau of Indian Affairs, Interior.
Notice of virtual public meeting.
In accordance with the Federal Advisory Committee Act, the Self-Governance PROGRESS Act Negotiated Rulemaking Committee (Committee), will hold their second virtual public meeting to negotiate and advise the Secretary of the Interior (Secretary) on a proposed rule to
•
•
Send your comments to the Designated Federal Officer, Vickie Hanvey, by any of the following methods:
•
• Mail, hand-carry or use an overnight courier service to the Designated Federal Officer, Ms. Vickie Hanvey, Office of Self-Governance, Office of the Assistant Secretary—Indian Affairs, 1849 C Street NW, Mail Stop 3624, Washington, DC 20240.
Vickie Hanvey, Designated Federal Officer,
This meeting is being held under the PROGRESS Act (Pub. L. 116-180), the Negotiated Rulemaking Act (5 U.S.C. 561
The PROGRESS Act amends subchapter I of the Indian Self-Determination and Education Assistance Act (ISDEAA), 25 U.S.C. 5301
This meeting is open to the public. Detailed information about the Committee, including meeting agendas can be accessed at
Please make requests in advance for sign language interpreter services, assistive listening devices, or other reasonable accommodations. We ask that you contact the person listed in the
Depending on the number of people who want to comment and the time available, the amount of time for individual oral comments may be limited. Requests to address the Committee during the meeting will be accommodated in the order the requests are received. Individuals who wish to expand upon their oral statements, or those who had wished to speak but could not be accommodated on the agenda, may submit written comments to the Designated Federal Officer up to 30 days following the meeting. Written comments may be sent to Vickie Hanvey listed in the
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Park Service, Interior.
Notice; amendment.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University has amended a Notice of Inventory Completion published in the
Disposition of the human remains and associated funerary objects in this notice may occur on or after October 17, 2022.
Patricia Capone, PMAE, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-3702, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Peabody Museum of Archaeology and Ethnology, Harvard University. The National Park Service is not responsible for the determinations in this notice. Additional information on the amendments and determinations in this
This notice amends the determinations published in a Notice of Inventory Completion in the
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes, the Peabody Museum of Archaeology and Ethnology, Harvard University has determined that:
• The human remains represent the physical remains of 215 individuals of Native American ancestry.
• The 475 objects are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• No relationship of shared group identity can be reasonably traced between the human remains and associated funerary objects and any Indian Tribe.
• The human remains and associated funerary objects were removed from the aboriginal land of the Cherokee Nation; Eastern Band of Cherokee Indians; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
Written requests for disposition of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization, or who shows that the requestor is an aboriginal land Indian Tribe.
Disposition of the human remains and associated funerary objects in this notice to a requestor may occur on or after October 17, 2022. If competing requests for disposition are received, the Peabody Museum of Archaeology and Ethnology, Harvard University must determine the most appropriate requestor prior to disposition. Requests for joint disposition of the human remains and associated funerary objects are considered a single request and not competing requests. The Peabody Museum of Archaeology and Ethnology, Harvard University is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.
National Park Service, Interior.
Notice; amendment.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University has amended a Notice of Inventory Completion published in the
Disposition of the human remains and associated funerary objects in this notice may occur on or after October 17, 2022.
Patricia Capone, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-3702, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Peabody Museum of Archaeology and Ethnology, Harvard University. The National Park Service is not responsible for the determinations in this notice. Additional information on the amendments and determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Peabody Museum of Archaeology and Ethnology, Harvard University.
This notice amends the determinations published in a Notice of Inventory Completion in the
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes, the Peabody Museum of Archaeology and Ethnology, Harvard University has determined that:
• The human remains represent the physical remains of four individuals of Native American ancestry.
• The 19 objects are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• No relationship of shared group identity can be reasonably traced between the human remains and associated funerary objects and any Indian Tribe.
• The human remains and associated funerary objects were removed from the aboriginal land of the Cherokee Nation; Eastern Band of Cherokee Indians; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
Written requests for disposition of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization, or who shows that the requestor is an aboriginal land Indian Tribe.
Disposition of the human remains and associated funerary objects in this notice to a requestor may occur on or after October 17, 2022. If competing requests for disposition are received, the Peabody Museum of Archaeology and Ethnology, Harvard University must determine the most appropriate requestor prior to disposition. Requests for joint disposition of the human remains and associated funerary objects are considered a single request and not competing requests. The Peabody Museum of Archaeology and Ethnology, Harvard University is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.
National Park Service, Interior.
Notice; amendment.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University has amended a Notice of Inventory Completion published in the
Disposition of the human remains and associated funerary objects in this notice may occur on or after October 17, 2022.
Patricia Capone, PMAE, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-3702, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Peabody Museum of Archaeology and Ethnology, Harvard University. The National Park Service is not responsible for the determinations in this notice. Additional information on the amendments and determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Peabody Museum of Archaeology and Ethnology, Harvard University.
This notice amends the determinations published in a Notice of Inventory Completion in the
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes, the Peabody Museum of Archaeology and Ethnology, Harvard University has determined that:
• The human remains represent the physical remains of 23 individuals of Native American ancestry.
• The 92 objects are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• No relationship of shared group identity can be reasonably traced between the human remains and associated funerary objects and any Indian Tribe.
• The human remains and associated funerary objects were removed from the aboriginal land of the Cherokee Nation; Eastern Band of Cherokee Indians; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
Written requests for disposition of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization, or who shows that the requestor is an aboriginal land Indian Tribe.
Disposition of the human remains and associated funerary objects in this notice to a requestor may occur on or after October 17, 2022. If competing requests for disposition are received, the Peabody Museum of Archaeology and Ethnology, Harvard University must determine the most appropriate requestor prior to disposition. Requests for joint disposition of the human remains and associated funerary objects are considered a single request and not competing requests. The Peabody Museum of Archaeology and Ethnology, Harvard University is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.
U.S. International Trade Commission.
Notice.
Notice is hereby given that on September 9, 2022, the presiding administrative law judge (“ALJ”) issued an Initial Determination on Violation of section 337. The ALJ also issued a Recommended Determination on remedy and bonding should a violation be found in the above-captioned investigation. The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation. This notice is soliciting comments from the public only.
Clint Gerdine, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708-2310. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
Section 337 of the Tariff Act of 1930 provides that, if the Commission finds a violation, it shall exclude the articles concerned from the United States:
The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation, specifically: (1) limited exclusion orders directed to certain fitness devices, streaming components thereof, and systems containing same imported, sold for importation, and/or sold after importation by respondents iFIT Inc., FreeMotion Fitness, Inc., and NordicTrack, Inc., all of Logan, Utah; lululemon athletica inc. (“lululemon”) of Vancouver, Canada; and Curiouser Products Inc. d/b/a MIRROR and Peloton Interactive, Inc., both of New York, New York (collectively, the “Respondents”) that infringe one or more of asserted claims 1 and 3-5 of U.S. Patent No. 9,407,564; claims 1-2 and 4-5 of U.S. Patent No. 10,757,156; claims 16-17 and 20 of U.S. Patent No. 10,469,554; and claims 10-11 and 14-15 of U.S. Patent No. 10,469,555; and (2) cease and desist orders directed to Respondents with respect to these asserted claims. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4).
The Commission is interested in further development of the record on the public interest in this investigation. Accordingly, members of the public are invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the ALJ's Recommended Determination on Remedy and Bonding issued in this investigation on September 9, 2022. Comments should address whether issuance of the recommended remedial orders in this investigation, should the Commission find a violation, would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the recommended remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third-party suppliers have the capacity to replace the volume of articles potentially subject to the recommended orders within a commercially reasonable time; and
(v) explain how the recommended orders would impact consumers in the United States.
Written submissions must be filed no later than by the close of business on October 11, 2022.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the investigation number (“Inv. No. 337-TA-1265”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. A redacted non-confidential version of the document must also be filed simultaneously with any confidential filing. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that on August 12, 2022, the presiding administrative law judge (“ALJ”) issued an Initial Determination on Violation of section 337. On August 26, 2022, the ALJ also issued a Recommended Determination on Remedy, Bonding, and the Public Interest should a violation be found in the above-captioned investigation. The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation. This notice is soliciting comments from the public only.
Carl P. Bretscher, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202)
Section 337 of the Tariff Act of 1930 provides that, if the Commission finds a violation, it shall exclude the articles concerned from the United States:
The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation, specifically: (1) a limited exclusion order directed to certain power inverters and converters, vehicles containing same, and components imported, sold for importation, and/or sold after importation by respondents Audi AG and Audi of America, LLC (collectively, “Audi”); Automobili Lamborghini America, LLC and Automobili Lamborghini S.p.A (collectively, “Lamborghini”); Bayerische Motoren Werke AG and BMW of North America, LLC (collectively, “BMW”); Bentley Motors Ltd. and Bentley Motors, Inc. (collectively, “Bentley”); Daimler AG and Mercedes-Benz USA, LLC (collectively, “Mercedes”); General Motors LLC (“General Motors”); and Volkswagen AG and Volkswagen Group of America (“Volkswagen” or “VW”); and (2) cease and desist orders directed to respondents Audi, BMW, Mercedes, General Motors, and Volkswagen, but not to Bentley or Lamborghini. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4).
The RD further finds that the public interest factors support a delay of six (6) months in the implementation of any remedial orders for the accused fully electric vehicles (“BEVs”) and plug-in hybrid vehicles (“PHEVs”) if the supply of BEV and PHEV vehicles continues to be impacted by the global semiconductor shortage.
The Commission is interested in further development of the record on the public interest in this investigation. Accordingly, members of the public are invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the ALJ's Recommended Determination on Remedy and Bonding issued in this investigation on August 26, 2022. Comments should address whether issuance of the recommended remedial orders in this investigation, should the Commission find a violation, would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the recommended remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third-party suppliers have the capacity to replace the volume of articles potentially subject to the recommended orders within a commercially reasonable time; and
(v) explain how the recommended orders would impact consumers in the United States.
Written submissions must be filed no later than by close of business on October 10, 2022.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the investigation number (“Inv. No. 337-TA-1267”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. Any non-party wishing to submit comments containing confidential information must serve those comments on the parties to the investigation pursuant to the applicable Administrative Protective Order. A redacted non-confidential version of the document must also be filed simultaneously with any confidential filing and must be served in accordance with Commission Rule 210.4(f)(7)(ii)(A) (19 CFR 210.4(f)(7)(ii)(A)). All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 9, 2022, under the Tariff Act of 1930, as amended, on behalf of Google LLC of Mountain View, California. A supplement was filed on August 24, 2022. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain audio players and components thereof by reason of the infringement of certain claims of U.S. Patent No. 11,024,311 (“the '311 patent”); U.S. Patent No. 9,812,128 (“the '128 patent”); U.S. Patent No. 9,632,748 (“the '748 patent”); and U.S. Patent No. 11,050,615 (“the '615 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and a cease and a desist order.
The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at
Jessica Mullan, Office of Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1-3, 8-12, 14-18, and 20 of the '311 patent; claims 1-3, 5-8, 10-13, and 15 of the '128 patent; claims 1-4, 7, 9-12, 14, and 15 of the '748 patent; and claims 1-3, 5-9, 11, 15-17, and 19 of the '615 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “audio player devices—specifically, voice controllable audio player devices and networked audio player devices”;
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: Google LLC, 1600 Amphitheatre Parkway, Mountain View, CA 94043.
(b) The respondent is the following entity alleged to be in violation of section 337, and is the party upon which the complaint is to be served: Sonos, Inc., 614 Chapala Street, Santa Barbara, CA 93101.
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondent in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of the respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Katherine M. Hiner, Acting Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of OPEX Corporation on September 9, 2022. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of regarding certain automated put walls and automated storage and retrieval systems, associated vehicles, associated control software, and component parts thereof. The complainant names as respondents: HC Robotics (a.k.a. Huicang Information Technology Co., Ltd.) of China and Invata, LLC (d/b/a Invata Intralogistics) of Conshohocken, PA. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders and impose a bond upon respondent's alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3638”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 9, 2022, under the Tariff Act of 1930, as amended, on behalf of Google LLC of Mountain View, California. A supplement was filed on August 24, 2022. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain audio players and components thereof by reason of the infringement of certain claims of U.S.
The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at
Jessica Mullan, Office of Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1-7, 9-15, 17, and 18 of the '330 patent; claims 1-5, 7-13, and 15-20 of the '398 patent; and claims 1, 3-7, 9-15, and 18 of the '565 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “audio player devices—specifically voice controllable audio player devices and battery powered audio player devices”;
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: Google LLC, 1600 Amphitheatre Parkway, Mountain View, CA 94043.
(b) The respondent is the following entity alleged to be in violation of section 337, and is the party upon which the complaint is to be served: Sonos, Inc., 614 Chapala Street, Santa Barbara, CA 93101.
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondent in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of the respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
Notice is hereby given that, on August 30, 2022, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
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 RailPulse intends to file additional written notifications disclosing all changes in membership.
On April 20, 2021, RailPulse 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 January 7, 2022. A notice was published in the
Notice is hereby given that, on August 26, 2022, pursuant to section 6(a) of the
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 AFEV intends to file additional written notifications disclosing all changes in membership.
On June 16, 2021, AFEV 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 March 29, 2022. A notice was published in the
Notice is hereby given that, on August 19, 2022, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
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 CBI intends to file additional written notifications disclosing all changes in membership.
On May 24, 2019, CBI 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 March 4, 2022. A notice was published in the
Notice is hereby given that, on August 30, 2022, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Coresystem Technology Limited, Kowloon, Hong Kong, HONG KONG SAR; and A-Com International Co., Ltd., Hsinchu County, TAIWAN 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 DVD CCA intends to file additional written notifications disclosing all changes in membership.
On April 11, 2001, DVD CCA 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 April 28, 2022. A notice was published in the
Notice is hereby given that, on August 19, 2022, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
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 AIIA intends to file additional written notifications disclosing all changes in membership.
On January 5, 2022, AIIA 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 June 7, 2022. A notice was published in the
On June 15, 2021, the Drug Enforcement Administration (hereinafter, DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (hereinafter, collectively OSC) to Rayford ACP
A hearing was held before DEA Administrative Law Judge Teresa A. Wallbaum (hereinafter, the ALJ). On January 25, 2022, the ALJ issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (hereinafter, “RD”), which recommended revocation of Respondent's registration. RD, at 69. Respondent filed Exceptions to the RD
Pursuant to 21 U.S.C. 823(f), 824(a)(4), the Government seeks revocation of Respondent's DEA registration because Respondent allegedly committed acts rendering its continued registration inconsistent with the public interest, including repeatedly filling prescriptions for controlled substances for seventeen patients in the face of unresolved red flags of abuse and diversion in violation of 21 CFR 1306.04(a) and 1306.06, and Tex. Health & Safety Code 481.074(a). OSC, at 2, 7.
The Government presented its case through records and testimony from two witnesses, a DEA Diversion Investigator (hereinafter, DI), Tr. 33-63, and Dr. DiGi Graham, D.Ph., Tr. 64-573, 1494-1552, who testified as an expert witness in retail pharmacy, hospice pharmacy care, and the practice of pharmacy in the State of Texas. RD, at 15-18.
Respondent presented its case through testimony from four witnesses; including two experts, Ms. Jenna Head, RPh., BCGP (qualified as an expert in Texas pharmacy law, hospice pharmacy, and a pharmacy's corresponding obligation), Tr. 585-1029, and William C. Yarborough, III, Pharm.D, J.D. (qualified as an expert in Texas and federal law and retail pharmacy), Tr. 1406-1430; Tronown Thomas, Respondent's owner and Pharmacist-in-Chief (PIC), Tr. 1032-1402, 1485-1492; and Shawn Stevens, RN, a fact witness regarding early refills, Tr. 1480-1485. RD, at 18-25.
The Agency credits Dr. Graham's testimony that both federal and Texas law impose an independent, corresponding responsibility on pharmacists to ensure that a prescription is issued for a legitimate medical purpose and within the usual course of professional practice before dispensing.
The Agency agrees with and incorporates the findings of the RD and, based on the evidence in the record, finds that Respondent's dispensing of each of the subject controlled substance prescriptions to each of the relevant patients was outside of the usual course of professional practice of pharmacy in Texas and in violation of Respondent's corresponding responsibility. Respondent dispensed controlled substances on numerous occasions without documenting the resolution of the following red flags: cocktail prescribing for patients J.C., C.G., D.M., M.I., M.W., D.H., I.G., M.M., B.H., T.T., and M.J.; therapeutic duplication for patients D.M., M.I., M.W., D.H., I.G., J.L., M.G., B.H., T.T., M.J., K.B., and L.F.; early refills for patients D.M., and J.L.; and long distances for Patient J.G. and J.T. RD, at 34-54. For example, the Government established that Respondent dispensed at least thirty-nine prescriptions to Patient D.M. without documenting the resolution of multiple red flags, including combination prescribing, therapeutic duplication, and/or early refills.
In accordance with Dr. Graham's credible expert testimony, the ALJ's analysis, and the records as a whole, the Agency finds that in dispensing the subject controlled substance prescriptions without documenting the resolution of the applicable red flag(s), Respondent's pharmacists did not fulfill their corresponding responsibility and Respondent did not dispense the subject prescriptions in the usual course of professional practice and within the applicable standard of care.
Section 304(a) of the Controlled Substances Act (hereinafter, CSA) provides that “[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a). In the case of a practitioner, which includes a pharmacy, the CSA requires the Agency consider the following factors in determining whether Respondent's registration would be inconsistent with the public interest:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting research with respect to controlled substances.
(3) The [registrant's] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
The DEA considers these public interest factors in the disjunctive.
The Government has the burden of proving that the requirements for revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21 CFR 1301.44(e). When the Government has
While the Agency has considered all of the public interest factors, the Government's case invoking the public interest factors of 21 U.S.C. 823(f) seeks revocation of Respondent's registration based solely under Public Interest Factors Two and Four.
Factors 2 and 4 are often analyzed together.
As the Agency found above, as supported by credible, expert testimony, both federal and Texas law impose an independent, corresponding responsibility on pharmacists to ensure that a prescription is issued for a legitimate medical purpose and within the usual course of professional practice. Texas Health & Safety Code § 481.074(a); 21 CFR 1306.04; RD, at 26-27, 57; Tr. 97-98. “The language in 21 CFR 1306.04 and caselaw could not be more explicit. A pharmacist has his own responsibility to ensure that controlled substances are not dispensed for non-medical reasons.”
To prove a pharmacist violated his or her corresponding responsibility, the Government must show that the pharmacist acted with the requisite degree of scienter.
Specifically, the Agency has found based on credible expert testimony and Texas law that a Texas pharmacy exercising its corresponding responsibility and acting within the standard of care must review for cocktail prescriptions, therapeutic duplication, early refills, and distance; must resolve these red flags prior to dispensing; and must document their resolution. RD, at 30; Tr. 100, 183-84, 340-41, 343, 400-01, 407-08, 1499-1502, 1523-24;
In this matter, the Government did not allege that Respondent dispensed the subject prescriptions having actual knowledge that the prescriptions lacked a legitimate medical purpose. Instead, the Government alleged that Respondent violated the corresponding responsibility regulation for each of the patients at issue in this matter by “repeatedly dispens[ing] controlled substances without addressing or resolving clear red flags.” Gov Prehearing, at 16;
Moreover, Texas law explicitly states that “the geographical distance between the practitioner and the patient or between the pharmacy and the patient” is a reason to suspect that a prescription may have been authorized in violation of the practitioner's standard of practice. 22 Tex. Admin. Code § 291.29(c)(4);
The Agency agrees with the RD that Respondent dispensed controlled substances on numerous occasions without documenting a resolution of red flags for cocktail prescribing, therapeutic duplication, early refills,
Where, as here, the Government has established grounds to revoke Respondent's registration, the burden shifts to the respondent to show why it can be entrusted with the responsibility carried by a registration.
Here, Respondent has failed to unequivocally accept responsibility. Respondent did admit that it violated its corresponding responsibility with respect to retail patients J.C. and C.G., Tr. 1087, 1091, but then proceeded to deny that retail patient J.T.'s prescriptions presented a red flag based on distance in spite of clear Texas law to the contrary. RD, at 66 (internal citations omitted). Respondent also consistently denied that the controlled substance prescriptions for its hospice patients presented any red flags. Tr. 1377-78; ALJ Ex. 30, at 2-5;
Furthermore, Respondent's misconduct was far from a one-time occurrence. Respondent filled multiple prescriptions for Schedule II controlled substances presenting numerous red flags.
In sanction determinations, the Agency has historically considered its interest in deterring similar acts, both with respect to the respondent in a particular case and the community of registrants.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration FL1670341 issued to Rayford ACP. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I further hereby deny any pending applications for renewal or modification of this registration, as well as any other pending application of Rayford ACP for registration in Texas. This order is effective October 17, 2022.
This document of the Drug Enforcement Administration was signed on September 8, 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
On March 16, 2022, the Drug Enforcement Administration (hereinafter, DEA or Government)
The Agency makes the following findings of fact based on the uncontroverted evidence submitted by the Government in its Request for Final Agency Action (RFAA), submitted July 18, 2022.
On February 15, 2022, the Texas Medical Board issued an Order of Temporary Suspension suspending Registrant's license to practice medicine in Texas. RFAAX C (Temporary Suspension Order), at 6. According to Texas's online records, of which the Agency takes official notice, Registrant's Texas medical license is still suspended.
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (hereinafter, CSA) “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration.
According to Texas statute, “dispense” means “the delivery of a controlled substance in the course of professional practice or research, by a practitioner or person acting under the lawful order of a practitioner, to an ultimate user or research subject. The term includes the prescribing, administering, packaging, labeling or compounding necessary to prepare the substance for delivery.” Tex. Health & Safety Code § 481.002(12) (2022). Further, a “practitioner” means a “a physician, . . . licensed, registered, or otherwise permitted to distribute, dispense, analyze, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in this state.”
Here, the undisputed evidence in the record is that Registrant currently lacks authority to practice medicine in Texas. A person must be a licensed practitioner to dispense a controlled substance in Texas. Thus, because Registrant lacks authority to practice medicine in Texas and, therefore, is not authorized to handle controlled substances in Texas, Registrant is not eligible to maintain a DEA registration. Accordingly, the Agency will order that Registrant's DEA registration be revoked.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FN0738344 issued to Reginald James Newsome, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending applications of Reginald James Newsome, M.D., to renew or modify this registration, as well as any other pending application of Reginald James Newsome, M.D., for additional registration in Texas. This Order is effective October 17, 2022.
This document of the Drug Enforcement Administration was signed on September 8, 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
On November 10, 2021, the Drug Enforcement Administration (hereinafter, DEA or Government),
A hearing was held before an Administrative Law Judge (hereinafter, the ALJ) on March 1, 2022. On May 19, 2022, the ALJ issued his Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (hereinafter, Recommended Decision or RD), which recommended that the Agency revoke Respondent's registration. RD, at 19. Neither party filed exceptions.
The Government presented its case through the testimony of a single witness, a DEA Diversion Investigator (hereinafter, the DI). Tr. 13-23. The ALJ found the DI's testimony to be credible and afforded it considerable weight. RD, at 5. Respondent presented her case through the testimony of a single witness, herself. Tr. 24-41. The ALJ noted some minor inconsistencies in Respondent's testimony regarding the status of her registration, as well as in Respondent's testimony regarding the dollar amount of kickbacks that she received. RD, at 9. Nonetheless, the ALJ found Respondent's testimony to be generally consistent, genuine, and credible and afforded it significant weight.
Respondent is a Texas physician who holds a DEA registration to handle controlled substances in Schedules II-V. Government Exhibit (hereinafter, GX) 1 (Respondent's COR FI1112084);
On October 3, 2017, Respondent pled guilty to one count of conspiracy to commit healthcare fraud in violation of 18 U.S.C. 1349. GX 2 (Criminal Judgment Against Respondent), at 1;
Following her criminal conviction, Texas permitted Respondent to continue practicing medicine.
Regarding Respondent's controlled substance prescribing, Respondent noted that her criminal conviction did not relate at all to controlled substances and that the Texas Medical Board did not restrict her ability to prescribe controlled substances.
Under Section 824(a) of the Controlled Substances Act (hereinafter, CSA), a registration “may be suspended or revoked” upon a finding of one or more of five grounds. 21 U.S.C. 824. The ground in 21 U.S.C. 824(a)(5) requires that the registrant “has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a-7(a) of Title 42.”
The Government has established grounds to deny a registration; therefore, the Agency will review any evidence and argument the Respondent submitted to determine whether or not the Respondent has presented “sufficient mitigating evidence to assure the Administrator that [she] can be trusted with the responsibility carried by such a registration.”
Here, Respondent stated multiple times that she takes full responsibility for her actions and said, “I learned that you can't just sign signatures like I signed to get me in trouble, and you can't just accept money for signing signatures that I signed. And that has been a very big lesson on my part.” Tr. 27, 40-41;
Early in her testimony, Respondent stated that she was convicted because she “wasn't so sure of homeboundedness,” but noted that she pled guilty because “it was [her] signature.” Tr. 27. However, Respondent also testified that she properly evaluated the files of these patients and that when she signed an order related to their “homeboundedness,” it was based on a proper medical assessment.
In addition to acceptance of responsibility, the Agency considers both specific and general deterrence when determining an appropriate sanction.
The Agency also looks to the egregiousness and the extent of the misconduct as significant factors in determining the appropriate sanction.
As discussed above, to avoid sanction when grounds for revocation exist, a respondent must convince the Administrator that she can be entrusted with a registration. The Agency finds that Respondent has not met this burden. Accordingly, the Agency shall order the sanctions the Government requested, as contained in the Order below.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FI1112084 issued to Bernadette U. Iguh, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending application to renew or modify this registration, as well as any other pending application of Bernadette U. Iguh, M.D., for registration in Texas. This Order is effective October 17, 2022.
This document of the Drug Enforcement Administration was signed on September 8, 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
On July 19, 2021, the Drug Enforcement Administration (hereinafter, DEA or Government) issued an Order to Show Cause (hereinafter, OSC) to Mohammad H. Said, M.D. (hereinafter, Registrant). OSC, at 1, 3. The OSC proposed the revocation of Registrant's Certificate of Registration No. AS9144786 at the registered address of 524 East Division, P.O. Box 40, Ephrata, Washington 98823.
The Agency makes the following findings of fact based on the uncontroverted evidence submitted by the Government in its Request for Final Agency Action (RFAA), submitted August 1, 2022.
On January 28, 2021, the State of Washington, Department of Health, Washington Medical Commission, issued an Order indefinitely suspending Registrant's license to practice medicine in Washington. RFAAX 4 (State of Washington, Dept. of Health Order dated January 28, 2021), at 2, 13-14. According to Washington's online records, of which the Agency takes official notice, Registrant's license is still suspended.
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (hereinafter, CSA) “upon a finding that the registrant . . . has had his State license or registration
According to Washington statute, “A practitioner may dispense or deliver a controlled substance to or for an individual or animal only for medical treatment or authorized research in the ordinary course of that practitioner's profession.” Wash. Rev. Code § 69.50.308(j) (2022). Further, a “prescription” means “an order for controlled substances issued by a practitioner duly authorized by law or rule in the state of Washington to prescribe controlled substances within the scope of his or her professional practice for a legitimate medical purpose.”
Here, the undisputed evidence in the record is that Registrant currently lacks authority to practice medicine in Washington. As already discussed, a physician must be a licensed practitioner to dispense or prescribe a controlled substance in Washington. Thus, because Registrant lacks authority to practice medicine in Washington and, therefore, is not authorized to handle controlled substances in Washington, Registrant is not eligible to maintain a DEA registration. Accordingly, the Agency will order that Registrant's DEA registration be revoked.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. AS9144786 issued to Mohammad H. Said, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending applications of Mohammad H. Said, M.D., to renew or modify this registration, as well as any other pending application of Mohammad H. Said, M.D., for additional registration in Washington. This Order is effective October 17, 2022.
This document of the Drug Enforcement Administration was signed on September 8, 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
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 “The Consumer Expenditure Surveys: The Quarterly Interview and the Diary.” 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 November 14, 2022.
Send comments to Nora Kincaid, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE, Washington, DC 20212. Written comments also may be transmitted by email to
Nora Kincaid, BLS Clearance Officer, at 202-691-7628 (this is not a toll free number). (See
The Consumer Expenditure (CE) Surveys collect data on consumer expenditures, demographic information, and related data needed by the Consumer Price Index (CPI) and other public and private data users. The continuing surveys provide a constant measurement of changes in consumer expenditure patterns for economic analysis and to obtain data for future CPI revisions. The CE Surveys have been ongoing since 1979.
The data from the CE Surveys are used (1) for CPI revisions, (2) to provide a continuous flow of data on income and expenditure patterns for use in economic analysis and policy formulation, and (3) to provide a flexible consumer survey vehicle that is available for use by other Federal Government agencies. Public and private users of price statistics, including Congress and the economic policymaking agencies of the Executive branch, rely on data collected in the CPI in their day-to-day activities. Hence, data users and policymakers widely accept the need to improve the process used for revising the CPI. If the CE Surveys were not conducted on a
In the Quarterly Interview Survey, each consumer unit (CU) in the sample is interviewed every three months over four calendar quarters. The sample for each quarter is divided into three panels, with CUs being interviewed every three months in the same panel of every quarter. The Quarterly Interview Survey is designed to collect data on the types of expenditures that respondents can be expected to recall for a period of three months or longer. In general the expenses reported in the Interview Survey are either relatively large, such as property, automobiles, or major appliances, or are expenses which occur on a fairly regular basis, such as rent, utility bills, or insurance premiums.
The Diary (or recordkeeping) Survey is completed at home by the respondent family for two consecutive one-week periods. The primary objective of the Diary Survey is to obtain expenditure data on small, frequently purchased items which normally are difficult to recall over longer periods of time.
Office of Management and Budget clearance is being sought to continue the Consumer Expenditure Surveys: The Quarterly Interview (CEQ) and the Diary (CED) and to make modifications to the CEQ.
The continuing CE Surveys provide a constant measurement of changes in consumer expenditure patterns for economic analysis and obtain data for future CPI revisions.
In the CEQ, CE is seeking clearance to make the below changes.
The CE requests clearance to modify point of purchase questions for utilities, to remove collection of data related to residential business properties, to collect all expenditures including sales tax, update wording on motorized versus non-motorized campers, collect the name of the foreign country when the point-of-service outlet is outside of the US, and update bracket ranges to more accurately reflect distributions of reported data on assets and liabilities.
The CE is also seeking clearance to streamline the CEQ questionnaire by grouping similar items together, rewording items to make collection easier cognitively, and aggregating collection of items previously collected separately where feasible. As a result, several questions were eliminated from the survey and two additional sections were added and one section was modified as listed below:
• Adding a new section, Family Care and Education that combines questions previously asked across the interview on education, day care and camps, babysitting, school meals, adult day care and in-home care for invalids.
• Adding a new section on Transportation that combines questions on vehicle operating expenses with questions on transportation via taxis, limousines, app-based ride shares, bike, scooter or moped rental using sharing services, and public transport.
• Revising the Expense Patterns section to simplify the questions on usual weekly expenses for groceries, food or beverages consumed away from home, alcohol consumed at home, cigarettes and tobacco products.
No changes will be made in Diary (CED).
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.
Institute of Museum and Library Services, National Foundation on the Arts and the Humanities.
Submission for OMB Review, request for comments, collection of information.
The Institute of Museum and Library Services announces the following information collection has been submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. 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. This Notice proposes the clearance of the Guidelines for IMLS Grants to States Five-Year Evaluation.
A copy of the proposed information collection request can be obtained by contacting the individual listed below in the
Written comments must be submitted to the office listed in the
Written comments and recommendations for proposed information collection requests should be sent within 30 days of publication of this Notice to
OMB is particularly interested in comments that help the agency to:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
Teresa DeVoe, Associate Deputy Director of State Programs, Office of Library Services, Institute of Museum and Library Services, 955 L'Enfant Plaza North SW, Suite 4000, Washington, DC 20024-2135. Ms. DeVoe can be reached by telephone at 202-653-4778, or by email at
The Institute of Museum and Library Services is the primary source of federal support for the nation's libraries and museums. We advance, support, and empower America's museums, libraries, and related organizations through grant making, research, and policy development. To learn more, visit
Each SLAA is required, under 20 U.S.C. 9101
The agency has taken into consideration the one comment received under this notice.
Office of Science and Technology Policy (OSTP).
Notice of Request for Information (RFI).
The White House Office of Science and Technology Policy, on behalf of the Subcommittee on Microelectronics Leadership (SML) of the National Science and Technology Council (NSTC), requests comments from the public on
Interested persons and organizations are invited to submit comments on or before 5:00 p.m. ET, October 17, 2022.
You may submit comments by any of the following methods:
•
•
This Request for Public Comment is not accepting applications for financial assistance or financial incentives. OSTP may post responses to this request for public comment without change, online. OSTP therefore requests that no business proprietary information, copyrighted information, or personally identifiable information be submitted in response to this Request for Public Comment. Please note that the U.S. Government will not pay for response preparation, or for the use of any information contained in the response. Comments submitted in response to this notice are subject to the Freedom of Information Act (FOIA).
Corey Stambaugh (Executive Secretary for the SML) at
The final
OSTP seeks comment from the public on
1. Does
2. What additional approaches should be considered to develop and expand the microelectronics workforce at all levels, including advanced degrees?
3. Are there additional mechanisms that should be considered to ensure rapid transition of R&D to industry?
4. Do you have any additional suggestions on how the final
On February 23, 2022, New York Stock Exchange LLC (“NYSE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On April 26, 2022, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change, as modified by Amendment No. 1, so that it has sufficient time to consider the proposed rule change, as modified by Amendment No. 1. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's port-related fees, at Equity 7, Section 3, and Options 7, Section 9, as described further below. The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to (i) amend Equity 7, Section 3, and Options 7, Section 9, to prorate port fees for the first month of service, (ii) add language to Equity 7, Section 3, and Options 7, Section 9, to clarify that port fees for cancelled services will continue to be charged for the remainder of month, and (iii) clarify that Nasdaq Testing Facility (“NTF”) ports are provided at no cost in Options 7, Section 9.
Currently, the Exchange does not prorate port connectivity fees under either its equity or options rules. Thus, participants are assessed a full month's fee if they direct the Exchange to make the subscribed connectivity live on any day of the month, including the last day thereof. Participants are also assessed a full month's port fee if they cancel service during the month.
The Exchange proposes to provide prorated port fees for the first month of service for new requests. By prorating the first month's fees, the Exchange would charge participants port fees only for the days in which the participants are connected to the Exchange during the first month of service. The Exchange proposes to continue the current practice of charging port fees for the remainder of the month upon cancellation. If a participant starts and cancels service in the same month, the participant would not be billed for those days prior to the service start date but would be billed for the remainder of the month, including after the service is cancelled.
Currently, the SQF Port Fee in Options 7, Section 9B(i)(2) is only assessed for SQF ports that receive inbound quotes at any time within that month. The Exchange is not proposing to change this practice. Participants would continue to be assessed the SQF Port Fee only during months where the SQF port is active.
The Exchange believes it is important for participants to have the option to establish new connections to the Exchange at any time during the month without being hampered by a full month charge irrespective of when during the month service begins. Moreover, other exchanges also charge new ports on a prorated basis for the first month of service.
The Exchange also proposes to add language to Options 7, Section 9B(iv) to clarify the Exchange's existing practice that NTF Ports are provided at no cost. The NTF provides subscribers with a virtual System test environment that closely approximates the production environment on which they may test their automated systems that integrate with the Exchange. For example, the NTF provides subscribers a virtual System environment for testing upcoming releases and product enhancements, as well as testing firm software prior to implementation. The Exchange proposes adding express language in the options Rules to provide increased clarity to market participants.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposed changes to its port fee schedule are reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for options and equity securities transaction services that constrain its pricing determinations in that market. The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
The Exchange believes that it is reasonable to prorate port fees for the first month of connectivity. As discussed above, the Exchange believes it is important for participants to have the flexibility to establish new connections to the Exchange at any time during the month without being hampered by a full month charge. For example, the Exchange believes it is reasonable to charge a user who begins a subscription on the last day of the month to be charged only for use of a port for that day. As noted above, other exchanges already charge their customers for new ports on a prorated basis for the first month of service.
The Exchange believes that the proposal is also equitable and not unfairly discriminatory because the proposed change to prorate port fees for the first month of service and continue to charge for the remainder of the month upon cancellation will apply uniformly to all similarly situated participants. Removing the requirement to pay a full month's port fee if a user joins any day other than the first of the month is user-friendly and provides users incentive to subscribe at their convenience. The Exchange believes that prorating the fees for the first month of a user's subscription will ensure that the fees are more equitable to a user's utilization of the products. All users will benefit from the proration of the first month of their subscription.
The Exchange also believes that it is just and equitable, and in the interests of market participants, for the Exchange to clarify the Exchange's existing practice to provide NTF ports at no cost to Options 7, Section 9B(iv), codifying existing practice where it is not expressly stated in the Rule. The Exchange believes that market participants will benefit from increased clarity, which will help limit any potential confusion in the future.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange does not believe that its proposal will place any category of Exchange participants at a competitive disadvantage. The proposed change to prorate port fees for the first month of service will apply uniformly to all similarly situated participants. All users will receive the benefit of a proration for the first month of port connectivity, which will enable users to save money that they otherwise would incur under the Exchange's current rules that do not provide for proration. The proposed language describing the Exchange's practice to bill for the remainder of the month upon cancellation, as well as the proposed language to the options Rules that NTF ports are provided at no cost, merely codify and clarify existing practices of the Exchange.
The Exchange believes that the proposed change to its port fee schedule to provide proration for the first month of port connectivity will not impose a burden on competition because the Exchange's execution services are completely voluntary and subject to extensive competition both from the other live exchanges and from off-exchange venues, which include alternative trading systems that trade national market system stock. Moreover,
The proposed change to the Exchange's port fee schedule is reflective of this competition because, as a threshold issue, the Exchange is a relatively small market so its ability to burden intermarket competition is limited. In this regard, even the largest U.S. equities exchange by volume only has 17-18% market share, which in most markets could hardly be categorized as having enough market power to burden competition. Accordingly, the Exchange does not believe that the proposed change will impair the ability of members, participants, or competing order execution venues to maintain their competitive standing in the financial markets.
The proposed change to clarify that NTF ports are provided at no cost is designed to expressly state existing practice without changing its operation and, therefore, the Exchange believes that the proposed change will not impose a burden on competition.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 18, 2022, the Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change SR-OCC-2022-009 pursuant to Section 19(b) of the Securities Exchange Act of 1934 (“Exchange Act”)
In 2021, the Commission approved a rule change proposed by the Cboe Exchange, Inc. (“Cboe”) providing for the listing of non-FLEX options with a multiplier of one (“micro-options”).
Currently, OCC's rules provide for the automatic exercise of index options and flexibly-structured index options with a settlement value of $1 or more without regard to the size of the index multiplier.
OCC proposes to amend Rule 1804, which provides expiration exercise procedures for cash-settled options, to accommodate the automatic exercise of One Multiplier Options by adding a new threshold for automatic exercise. Currently, Rule 1804(b) allows for the automatic exercise of expiring cash-settled index options with standard expiration dates that are listed in a Clearing Member's Expiration Exercise Report if the option's expiration date is in-the-money by $1.00 or more per contract.
OCC's proposed amendments to Rule 1804(b) and (c) would facilitate automatic exercise procedures for One Multiplier Options. OCC proposes to add a new threshold that would trigger automatic exercise of One Multiplier Options. Specifically, proposed Rule 1804(b) would explicitly state that for cash-settled options
OCC believes the amendments to Rule 1804 are necessary to accommodate the decrease in product size as the result of the smaller multiplier.
Section 19(b)(2)(C) of the Exchange Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Exchange Act and the rules and regulations thereunder applicable to such organization.
Section 17A(b)(3)(F) of the Exchange Act requires, among other things, that a clearing agency's rules are designed to promote the prompt and accurate clearance and settlement of securities transactions and, to the extent applicable, derivative agreements, contracts, and transactions.
The Commission believes that, in amending Rule 1804(b) and (c) to introduce a $0.01 automatic exercise threshold for One Multiplier Options, the proposed rule aligns OCC's expiration processing of One Multiplier Options with already-existing procedures applicable to options with multipliers other than one, including multipliers of 100. The introduction of an automatic exercise threshold consistent with the size of One Multiplier Options would extend the operational convenience provided for other options to One Multiplier Options without removing a Clearing Member's ability to prevent the exercise of an in-the-money option that would otherwise be deemed exercised by submitting
The Commission believes, therefore, that the proposal is consistent with the requirements of Section 17A(b)(3)(F) of the Exchange Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as modified by Partial Amendment No. 1, is consistent with the Exchange Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to: Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
The Commission finds good cause, pursuant to Section 19(b)(2) of the Exchange Act,
For similar reasons as discussed above, the Commission finds that Partial Amendment No. 1 is consistent with the requirement that OCC's rules be designed to promote the prompt and accurate clearance and settlement of securities transactions under Section 17A(b)(3)(F) of the Exchange Act.
On the basis of the foregoing, the Commission finds that the proposed rule change, as modified by Partial Amendment No. 1, is consistent with the requirements of the Exchange Act, and in particular, the requirements of Section 17A of the Exchange Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend: (i) the Exchange's transaction credits at Equity 7, Section 118(a), and (ii) the Exchange's port-related fees at Options 7, Section 3, as described further below. The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend the Exchange's transaction credits at Equity 7, Section 118(a) and amend the Exchange's port-related fees at Options 7, Section 3. Specifically, the Exchange proposes to (1) modify the volume requirement to achieve an existing credit for displayed quotes/orders that provide liquidity and (2) amend the options Rules to clarify that Nasdaq Testing Facility (“NTF”) ports are provided at no cost.
Currently, the Exchange provides a $0.0029 per share executed credit for a member with shares of liquidity provided in all securities through one or more of its Nasdaq Market Center MPIDs that represent 0.625% or more of Consolidated Volume during the month, including shares of liquidity provided with respect to securities that are listed on exchanges other than Nasdaq or NYSE that represent 0.15% or more of Consolidated Volume. The Exchange proposes to amend the requirement for a member to have shares of liquidity that represent 0.625% or more of Consolidated Volume during the month by increasing this requirement from 0.625% to 0.75%. The proposed change would be applicable to Tape A, Tape B and Tape C. The Exchange hopes that this change will incentivize members to increase their liquidity providing activity on the Exchange, which will improve market quality.
The Exchange also proposes to add language to Options 7, Section 3(iv) to clarify the Exchange's existing practice that NTF Ports are provided at no cost. The NTF provides subscribers with a virtual System test environment that closely approximates the production environment on which they may test their automated systems that integrate with the Exchange. For example, the NTF provides subscribers a virtual System environment for testing upcoming releases and product enhancements, as well as testing firm software prior to implementation. The Exchange proposes adding express language in the options Rules to provide increased clarity to market participants.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposed changes to its fee schedule are reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for equity securities transaction services that constrain its pricing determinations in that market. The fact that this market is competitive has long been recognized by the courts. In
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Numerous indicia demonstrate the competitive nature of this market. For example, clear substitutes to the Exchange exist in the market for equity security transaction services. The Exchange is only one of several equity venues to which market participants may direct their order flow. Competing equity exchanges offer similar tiered pricing structures to that of the Exchange, including schedules of rebates and fees that apply based upon members achieving certain volume thresholds.
Within this environment, market participants can freely and often do shift their order flow among the Exchange and competing venues in response to changes in their respective pricing schedules. As such, the proposal represents a reasonable attempt by the Exchange to increase its liquidity and market share relative to its competitors.
The Exchange believes that it is reasonable to require a member to provide shares of liquidity in all securities through one or more of its Nasdaq Market Center MPIDs that represent 0.75% (rather than 0.625%) or more of Consolidated Volume during the month, including shares of liquidity provided with respect to securities that are listed on exchanges other than Nasdaq or NYSE that represent 0.15% or more of Consolidated Volume in order to qualify for the existing $0.0029 per share executed credit. The Exchange believes that it is reasonable to create a stricter qualification for the credit to ensure that this credit remains relevant to current levels of liquidity providing activity on the Exchange and continues to incentivize liquidity adding activity. To the extent that this proposal results in an increase in liquidity adding and quoting activity on the Exchange, this will improve the quality of the Nasdaq market and increase its attractiveness to existing and prospective participants.
The Exchange believes its proposal will allocate its charges and credits fairly among its market participants. The Exchange believes that it is an equitable allocation to increase the volume threshold to qualify for an existing $0.0029 transaction credit because the proposal will encourage members to add displayed liquidity to the Exchange. To the extent that the
The Exchange believes that its proposal is not unfairly discriminatory. As an initial matter, the Exchange believes that nothing about its volume-based tiered pricing model is inherently unfair; instead, it is a rational pricing model that is well-established and ubiquitous in today's economy among firms in various industries—from co-branded credit cards to grocery stores to cellular telephone data plans—that use it to reward the loyalty of their best customers that provide high levels of business activity and incent other customers to increase the extent of their business activity. It is also a pricing model that the Exchange and its competitors have long employed with the assent of the Commission. It is fair because it enhances price discovery and improves the overall quality of the equity markets.
The Exchange believes that its proposal to increase the volume threshold to qualify for an existing $0.0029 transaction credit is not unfairly discriminatory because the credit is available to all members. Moreover, the proposal stands to improve the overall market quality of the Exchange, to the benefit of all market participants, by incentivizing members to increase their liquidity adding activity on the Exchange.
The Exchange also believes that it is just and equitable, and in the interests of market participants, for the Exchange to clarify the Exchange's existing practice to provide NTF ports at no cost in Options 7, Section 3(iv), codifying existing practice where it is not expressly stated in the Rule. The Exchange believes that market participants will benefit from increased clarity, which will help limit any potential confusion in the future.
Any Participant that is dissatisfied with the proposal is free to shift their order flow to competing venues that provide more generous pricing or less stringent qualifying criteria.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange does not believe that its proposal will place any category of Exchange participant at a competitive disadvantage.
As noted above, the Exchange's proposal to increase the volume threshold to qualify for an existing $0.0029 transaction credit is intended to have market-improving effects, to the benefit of all members. Any member may elect to achieve the levels of liquidity required in order to qualify for the credit. In addition, the proposed language to the options Rules that NTF ports are provided at no cost merely codifies and clarifies an existing practice of the Exchange.
The Exchange notes that its members are free to trade on other venues to the extent they believe that the credits are not attractive. As one can observe by looking at any market share chart, price competition between exchanges is fierce, with liquidity and market share moving freely between exchanges in reaction to fee and credit changes.
In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The proposed change to the qualifying criteria for an existing credit is reflective of this competition because, as a threshold issue, the Exchange is a relatively small market so its ability to burden intermarket competition is limited. In this regard, even the largest U.S. equities exchange by volume only has 17-18% market share, which in most markets could hardly be categorized as having enough market power to burden competition. Moreover, as noted above, price competition between exchanges is fierce, with liquidity and market share moving freely between exchanges in reaction to fee and credit changes. This is in addition to free flow of order flow to and among off-exchange venues which comprises more than 40% of industry volume in recent months.
The Exchange's proposal to modify the qualifying criteria for an existing credit is pro-competitive in that the Exchange intends for the change to increase liquidity addition activity on the Exchange, thereby rendering the Exchange a more attractive and vibrant venue to market participants.
In addition, the proposed change to the options Rules to clarify that NTF ports are provided at no cost is designed to expressly state existing practice without changing its operation and, therefore, the Exchange believes that the proposed change will not impose a burden on competition.
If the changes proposed herein are unattractive to market participants, it is likely that the Exchange will lose market share as a result. Accordingly, the Exchange does not believe that the proposed changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of amendments to NSCC's Rules & Procedures (“Rules”) in order to make a number of clarifications and enhancements to the Rules. Specifically, the proposed rule change would (i) clarify the confidential treatment of non-public information provided by participants to NSCC as part of ongoing membership requirements; (ii) remove outdated rules and procedures related to the maintenance of Sponsored Accounts; (iii) update NSCC's rules concerning the acceptance and reliance upon instructions provided by its members; (iv) modify certain rules and procedures related to the DTCC Limit Monitoring Risk Management Tool; (v) remove rules, procedures, fees, and addenda related to the inactive Global Clearance Network Service; (vi) remove rules and fees related to the inactive International Link Service; (vii) clarify certain CNS Accounting Operation procedures; (viii) consolidate rules concerning the imposition of fines; (ix) clarify rules concerning admission to NSCC's premises; (x) remove reference to certain special services no longer provided by NSCC; and (xi) modify procedures concerning two-sided trade data received from service bureaus. NSCC is filing the proposed rule change for immediate effectiveness pursuant to Section 19(b)(3)(A) of the Act
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 proposed rule change consists of modifications to NSCC's Rules to (i) clarify the confidential treatment of non-public information provided by participants to NSCC as part of ongoing membership requirements; (ii) remove outdated rules and procedures related to the maintenance of Sponsored Accounts; (iii) update NSCC's rules concerning the acceptance and reliance upon instructions provided by its members; (iv) modify certain rules and procedures related to the DTCC Limit Monitoring Risk Management Tool; (v) remove rules, procedures, fees, and addenda related to the inactive Global Clearance Network Service; (vi) remove rules and fees related to the inactive International Link Service; (vii) clarify certain CNS Accounting Operation procedures; (viii) consolidate rules concerning the imposition of fines; (ix) clarify rules concerning admission to NSCC's premises; (x) remove reference to certain special services no longer provided by NSCC; and (xi) modify procedures concerning two-sided trade data received from service bureaus. The proposed changes are discussed in detail below.
NSCC recently adopted a proposed rule change to, among other things, revise certain provisions in the Rules relating to the confidentiality of information furnished by applicants, Members, and Limited Members (collectively, “participants”) to NSCC.
In addition to the requirements above, Section 2 of Rule 2B requires that participants submit to NSCC certain reports and information as part of their ongoing membership requirements and monitoring. Some of the reporting required by Section 2 of Rule 2B includes non-public information of participants. NSCC proposes to add conforming language to Rule 2B to clarify the confidential treatment of such information consistent with the requirements of Section 1.C. of Rule 2A and Section 3 of Rule 15. Specifically, NSCC proposes to amend Section 2.A. of Rule 2B to state that “[a]ny non-public information furnished to the Corporation pursuant to this Rule shall be held in confidence as may be required under the laws, rules and regulations applicable to the Corporation that relate to the confidentiality of records.” Non-public information may include certain reports, opinions and tax and cybersecurity confirmations as required by the Rules and any material non-public information or other information and data that NSCC reasonably determines is not made available to the public. The proposed change would further NSCC's goal of setting forth one consistent standard that NSCC would apply uniformly to all participants, which assures participants that such information would be held in confidence with appropriate control.
NSCC's Rules refer to certain circumstances under which it has the discretionary authority to maintain Sponsored Accounts for its Members at The Depository Trust Company (“DTC”). NSCC Rule 29 provides that each Member shall be a participant in a Qualified Securities Depository (
In addition, Procedure IX.B. provides procedures for the maintenance of Sponsored Accounts, including for Members that may choose not to maintain direct membership in a Qualified Securities Depository. Pursuant to this procedure, each Member would be assigned a Qualified Securities Depository account number and use that account as if it were a direct participant of the Qualified Securities Depository; however, the account would be maintained under the jurisdiction of NSCC, which would be solely responsible for all liabilities arising from the use of the account including the payment of fees to the Qualified Securities Depository. NSCC Rule 4 also contains several footnotes concerning the treatment of Clearing Fund deposits for such Sponsored Accounts. Section 7 of Rule 4 further provides, in part, that NSCC may retain for up to two (2) years the Actual Deposits from Members who have Sponsored Accounts at DTC.
As a practical matter, NSCC does not currently maintain any Sponsored Accounts or plan to utilize Sponsored Accounts in the foreseeable future. NSCC does not believe there would be a plausible scenario in which it would continue to act for a Member and sponsor an account at DTC to settle for a Member whose participation at DTC has been terminated (whether voluntarily or through DTC ceasing to act for the participant). In the event that an NSCC Member was no longer an active participant of DTC, NSCC would cease to act for such Member pursuant to its authority under Rule 29 and implement the close-out procedures contemplated in Rule 18 and related NSCC policies and procedures (which do not currently contemplate the use of Sponsored Accounts). NSCC therefore proposes to revise the last sentence of Rule 29 to delete the reference to the discretionary use of Sponsored Accounts in a cease to act scenario and revise Rule 46 to remove references to NSCC's authority to require a participant to effect securities settlement through a Sponsored Account, rather than through its own depository account, as part of a suspension or prohibition/limitation of a participant's access to services.
NSCC also proposes to delete Procedure IX.B. concerning the procedures for maintaining Sponsored Accounts for Members that choose not to maintain direct membership in a Qualified Securities Depository. As noted above, NSCC Rule 29 provides that each Member shall be a participant in a Qualified Securities Depository, and all current NSCC Members are participants of DTC. NSCC does not currently provide Sponsored Accounts for any of its Members and does not have plans to provide any new Sponsored Accounts at this time.
NSCC believes that removing rules and procedures related to inactive services and operations would improve the accuracy and clarity of its rules. Moreover, NSCC believes that removing Rules concerning inactive Sponsored Account services would avoid potential confusion with the sponsored membership program for NSCC's Securities Financing Transaction Clearing Service.
NSCC Rule 39 provides, in part, that NSCC may accept or rely upon any instruction given by a participant, including wire transmission, physical delivery or delivery by other means of instructions recorded on magnetic tape or other media or of facsimile copies of instructions, in form acceptable to NSCC and that NSCC will not act upon any instruction purporting to have been given by a participant which is received by wire transmission or in the form of facsimile copies or magnetic tape or media other than written instructions.
NSCC proposes to revise Rule 39 to remove specific examples of methods of transmission of instructions to NSCC and instead provide that NSCC may accept or rely upon any instruction given in any form acceptable to the Corporation and in accordance with the Procedures. The proposed rule change is intended to remove outdated methods of submitting instructions (such as magnetic tape and facsimile copies) from the Rules and provide flexibility to accommodate alternative and evolving methods of submitting instructions to NSCC. NSCC believes the proposed change would promote the ongoing accuracy and clarity of its rules regarding the transmission of instructions to NSCC.
NSCC provides its Members with a risk management tool called DTCC Limit Monitoring, which enables Members to monitor trading activity on an intraday basis of their organizations and/or their correspondent firms through review of post-trade data.
DTCC Limit Monitoring is available to all NSCC Members; however, Rule 54 requires certain categories of Members to register for the DTCC Limit Monitoring tool. This requirement applies to: (1) any Member that clears trades for others; (2) any Member that submits transactions to NSCC's trade capture system either as a Qualified Special Representative (“QSR”) or Special Representative, pursuant to Procedure IV (Special Representative Service); and (3) any Member that has established a 9A/9B relationship in order to allow another Member (either a QSR or Special Representative) to submit locked in trade data on its behalf. In addition, Procedure XVII requires, among other things, that Members registered for DTCC Limit Monitoring create and establish Risk Entities,
NSCC proposes to revise Rule 54 and Procedure XVII to eliminate the requirement that certain specified Members register for the DTCC Limit Monitoring tool (
As noted above, DTCC Limit Monitoring was developed as part of a broader industry-wide effort to develop tools and strategies to mitigate and address trading risks. Since the implementation of DTCC Limit Monitoring in 2014, U.S. equity exchanges have also implemented risk controls to mitigate risks inherent with direct exchange transaction flow (such controls include, but are not limited to, credit limits, single order limits, and kill switch functionality).
NSCC Rule 62 and Addendum U discuss the Global Clearance Network Service (“GCN Service”), which was a foreign clearing, settlement, and custody
The GCN Service is a dormant service that is no longer utilized by NSCC's Members. NSCC therefore proposes to delete Rule 62 and Addendum U and any related fees for the GCN Service in Addendum A. NSCC believes that removing rules, procedures, and fees for this inactive service would improve the accuracy and clarity of the Rules. In the event NSCC would choose to resume offering these services, NSCC would reevaluate the rules, procedures and operational processes necessary to provide such services and would file any necessary proposed rule changes to effectuate the change.
NSCC Rule 61 discusses the establishment of links and the provision of certain services to Foreign Financial Institutions, including the International Link Service (“ILS”). ILS, like the GCN Service, was a service provided by ISCC. ISCC previously sponsored accounts at DTC for the purpose of providing Foreign Financial Institutions with custody services for their U.S. securities. ISCC transferred the ILS service, along with the GCN Service, to NSCC when it withdrew from registration as a clearing agency.
Rule 61 currently provides, in part, that to the extent NSCC provides access to a Qualified Security Depository (
Section D of Procedure VII describes the procedures for controlling deliveries to CNS, including the process by which Members may submit instructions to NSCC to indicate which short positions they do not wish to settle and should be exempt from delivery. CNS provides for two levels of Exemption. Level 1 Exemptions allow a Member to designate that a portion of its short positions should not be automatically settled against its current Designated Depository position or against any securities which may be received into its Designated Depository account as a result of other depository activity. Level 2 Exemptions allow a Member to designate that a portion of its short positions should not be automatically settled against its current depository position, but that such a position may be satisfied by certain types of “qualified” activity in its Designated Depository account. Section D.2(b) of Procedure VII discusses the four types of qualified activity, which allow short positions carrying Level 2 Exemptions to be settled. The list of qualified activity currently includes, among other things, “Receipts from Member's Sub-Account,” which provides that, as a result of CNS sub-accounting, a Member may have a long position in a given security in one CNS account and a short position in the same security in another CNS account, and since both CNS accounts settle against a single Designated Depository Account, the Member may receive securities from itself.
As noted above, Section D of Procedure VII is intended to describe certain Member rights and obligations associated with the
NSCC's processing day is divided into two parts. It begins with a night cycle on the evening preceding the settlement day for which the work is being processed and is followed by a day cycle which ends on the settlement day for which the work is processed. Pursuant to Section E.5 of Procedure VII, if a Member with a long position and/or a position due for settlement on the next settlement day, in anticipation of receiving securities from NSCC as a result of the allocation process during the night or day cycle for that settlement day, instructs that securities within its possession or control be delivered on the next day and is subsequently not allocated the securities during the night or following day cycle, the Member may, in order to meet the “customer segregation” requirements of Rule 15c3-3 of the Exchange Act, during the day cycle for that settlement day instruct NSCC to transfer the position(s) which has not been allocated to a special CNS sub-account known as the “Long Free Account.” NSCC will then debit the Member's settlement account for the value of the position in the Long Free Account.
Section E.5 of Procedure VII contains the following note related to the use of the Long Free Account.
The SEC has stated that: “any broker/dealer that takes advantage of proposed rule NSCC-82-25 must recall deficits from bank loan within shorter time intervals than those presently allowed under Rule 15c3-3(d)(1) of the Exchange Act. In the case of bank loan, broker/dealers will be expected to effect a
The note refers to a no action letter issued by the Commission's Division of Trading and Markets (formerly, the Division of Market Regulation)
NSCC proposes to delete this note from Section E.5 of Procedure VII. The note is potentially confusing to readers as it (1) refers to a “proposed rule” as opposed to the approved and existing procedure and (2) does not clearly identify the source of this Commission statement. Moreover, NSCC does not typically refer to Commission relief in its Rules. NSCC believes the proposed change would improve the clarity of its Rules and would conform Section E.5 of Procedure VII to more standard drafting practices for NSCC's Rules.
Section J.1 of Procedure VII provides procedures for the recording of buy-ins for equities and corporate debt securities in CNS. The procedure provides, in part, that a Buy-In Retransmittal Notice shall include such information as NSCC may determine from time to time, including the identity of the entity that initiated the Buy-In against the Member.
NSCC proposes to revise this section of the procedure to clarify that Buy-In Retransmittal Notices must also be submitted within such times as determined by NSCC. NSCC believes the proposed change would improve its Rules by aligning the procedural language and requirements for Buy-In Retransmittal Notices with other submission requirements in the Rules (
NSCC Rule 17 discusses NSCC's authority to impose fines on a Member or Limited Member pursuant to the Rules. Pursuant to Rule 17, fines shall be payable in the manner and at such time as determined by NSCC from time to time. NSCC Rule 48 further discusses NSCC's authority to impose disciplinary proceedings for a Member of Limited Member for, among other things, a violation of the Rules. Section 1 of Rule 48 provides that such disciplinary proceedings may result in expulsion, suspension, limitation of or restriction on activities, functions and operations, fine or censure or any other fitting sanction.
NSCC proposes to delete Rule 17 and relocate the second sentence of Rule 17, which provides that fines shall be payable in the manner and at such time as determined by the Corporation from time to time, to Section 1 of Rule 48. NSCC would also make conforming changes to Rule 15 and Rule 56 to update and remove references to Rule 17, respectively. The proposed change is intended to consolidate the rules concerning NSCC's authority to impose fines into NSCC's disciplinary proceeding rules. The proposed change is not intended to result in a substantive change to NSCC's rules.
NSCC Rule 27 provides, in part, that no person will be permitted to enter the premises of NSCC as the representative of any participant unless he has first been approved by NSCC and has been issued such credentials as NSCC may from time to time prescribe and such credentials have not been canceled or revoked. In addition, such credentials must be shown on demand, and may limit the portions of the premises to which access is permitted thereunder.
NSCC proposes to revise Rule 27 to clarify that, to gain entry to NSCC's premises, such credentials must be prominently displayed while on NSCC's premises. NSCC does not believe the proposed change would impose any new material obligation or burden on its Members since Members are already required to obtain such credentials and display them on demand. The proposed rule change is simply intended to codify this expectation in NSCC's rules.
Section A of Procedure IX discusses NSCC's provision of Clearing Centers in a number of cities to serve as input/output facilities for the convenience of Members located near that office. Procedure XIII further provides definitions for the terms “Clearing Center”
Addendum J to the Rules contains a policy statement regarding the acceptance of trade data from service bureaus. Pursuant to Section 6 of Rule 7, NSCC may accept locked-in trade data from self-regulatory organizations (“SROs”) on a Member's behalf for input into NSCC's comparison system. NSCC has also previously received requests from Members to accept two-sided trade data from service bureaus in addition to locked-in data. In response, NSCC adopted the policy statements in Addendum J setting forth certain minimum requirements for service bureaus submitting two-sided trade data to NSCC. NSCC proposes to make certain clarifying updates to the Addendum.
NSCC proposes to revise the introductory paragraph of Addendum J to clarify that NSCC may accept from SROs and/or service bureaus, initial or supplemental trade data on behalf of Members for input into the Corporation's Comparison Operation
Addendum J also currently requires that a service bureau must (a) be or become a Member of NSCC or (b) be affiliated with a Member of the Corporation. In addition, the Member (either the service bureau itself or its affiliated Member) must make a Clearing Fund deposit with NSCC. NSCC proposes to delete these requirements from Addendum J. NSCC does not believe it is necessary for a service bureau to be, or be affiliated with, a Member or to maintain a Clearing Fund deposit. The Members, on behalf of which a service bureau may submit trade data to NSCC, and not the service bureau itself, are responsible for maintaining Clearing Fund deposits to cover the risk associated with such positions. Moreover, the last paragraph of Addendum J currently provides NSCC with the authority to waive these requirements if it is in the best interests of NSCC and its Members to approve a service bureau so as to assure the prompt, accurate, and orderly processing and settlement of securities transactions or to otherwise carry out the functions of the Corporation. NSCC is proposing to eliminate these requirements as a matter of rule rather than through individual waivers, to improve the transparency and clarity of its Rules. Finally, NSCC would revise Addendum J to make certain non-substantive typographical corrections in the rule text.
NSCC would implement the proposed changes no earlier than thirty (30) days after the date of filing, or such shorter time as the Commission may designate. As proposed, a legend would be added to each affected Rule stating there are changes that were effective upon filing but have not yet been implemented. The legend would also state that NSCC would implement the proposed changes no earlier than thirty (30) days after the date of filing, or such shorter time as the Commission may designate. The legend would state that the legend would automatically be removed upon the implementation of the proposed changes. NSCC would announce the implementation date of the proposed changes by Important Notice posted to its website.
NSCC believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. Section 17A(b)(3)(F) of Act
The proposed addition of confidentiality requirements for participant information to NSCC Rule 2B would enable NSCC to maintain one consistent standard to apply uniformly to all participants, which assures participants that such information would be held in confidence with appropriate control. NSCC believes the proposed rule change would therefore help NSCC meet its obligations and help each participant better understand NSCC's obligations for maintaining the confidential information it shares with NSCC, which, in turn, may facilitate the sharing of such information and improve NSCC's ability to evaluate its participants' eligibility to maintain access to NSCC's clearance and settlement services. NSCC therefore believes the proposed rule change is consistent with promoting the prompt and accurate clearance and settlement of securities transactions by NSCC.
The proposed rule change would remove outdated rules, footnotes, procedures, addenda, and fees related to inactive services, such as the provision of Sponsored Accounts, Clearing Centers, and the GCN Service and ILS. The proposed rule change would also remove outdated methods of submitting instructions to NSCC from the Rules and provide flexibility to accommodate both current alternative and evolving methods of submitting instructions to NSCC. These proposed changes are designed to improve the accuracy, clarity, and transparency of the NSCC Rules and thereby allow Members to conduct their business more efficiently and effectively in accordance with the Rules, which NSCC believes would promote the prompt and accurate clearance and settlement of securities transactions.
The proposed rule change would also provide additional clarity to NSCC's CNS Accounting Operation Procedures. First, the proposed rule change would clarify NSCC's rules by deleting Section D.2(b)(iv) of Procedure VII, which discusses the possibility of a Member receiving such securities from itself through CNS. As noted above, Section D of Procedure VII is intended to describe certain Member rights and obligations associated with the
Second, the proposed rule change would remove from Section E.5 of Procedure VII a note referring to a no action letter issued by the Commission's Division of Trading and Markets (formerly, the Division of Market Regulation).
Third, to the proposed rule change would revise Section J.1 of Procedure VII concerning CNS Buy-Ins to clarify that Buy-In Retransmittal Notices must also be submitted within such times as determined by NSCC. NSCC believes the proposed change would improve its Rules by aligning the procedural language and requirements for Buy-In Retransmittal Notices with other submission requirements in the Rules (
Taken together, the proposed changes are designed to improve the accuracy, clarity, and transparency of NSCC's CNS Accounting Operation Procedures. NSCC believes the proposed rule change would allow Members to conduct their business more efficiently and effectively in accordance with the Rules and thereby promote the prompt and accurate clearance and settlement of securities transactions.
NSCC proposes to revise Rule 54 and Procedure XVII to eliminate the requirement that certain Members register for the DTCC Limit Monitoring tool. NSCC would also make conforming changes to Procedure XVII to reflect that Members may, but are not required to, create and establish Risk Entities, designate parameters to associate with each Risk Entity, review reports and alerts on an on-going basis and, as necessary, modify established parameters to reflect current trading activities within each of their Risk Entities, and identify primary and secondary contacts within their firm for DTCC Limit Monitoring.
As described above, DTCC Limit Monitoring was developed as part of a broader industry-wide effort to develop tools and strategies to mitigate and address trading risks. Since the implementation of DTCC Limit Monitoring in 2014, U.S. equity exchanges have also implemented risk controls to mitigate risks inherent with direct exchange transaction flow to assist them in monitoring and managing their risks.
NSCC believes that providing DTCC Limit Monitoring on an optional basis is appropriate and consistent with industry practice. NSCC also notes that while certain Members are currently required to register for DTCC Limit Monitoring, NSCC does not require Members to take any particular actions based on the output of the limit monitoring tool. Any actions Members determine to take in response to these alerts is their responsibility and is taken away from NSCC. Moreover, NSCC does not use the DTCC Limit Monitoring tool for internal risk management purposes. NSCC therefore believes the proposed rule change would continue to provide NSCC's Members with a valuable risk management tool to supplement its own internal systems and procedures or other tools available to the Member for managing its risks, would not impact any actions taken as a result of Limit Monitoring, and would not have any impact on NSCC's own internal risk management activities. For these reasons, NSCC believes the proposed rule change would continue 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.
NSCC proposes non-material clarifying changes to its Rules concerning the payment of fines and admission to its premises. NSCC would eliminate Rule 17 and relocate the second sentence of Rule 17, which provides that fines shall be payable in the manner and at such time as determined by the Corporation from time to time, to Section 1 of Rule 48 and make conforming changes to Rules 15 and 56. The proposed change is intended to consolidate the rules concerning NSCC's authority to impose fines into NSCC's disciplinary proceeding rules and is not intended to result in a substantive change to NSCC's rules. NSCC also proposes to revise Rule 27 to clarify that, to gain entry to NSCC's premises, a Member representative's credentials must be prominently displayed while on NSCC's premises. NSCC does not believe the proposed change would impose any new significant obligation or burden on its Members since Members are already required to obtain such credentials and display them on demand. The proposed changes are intended to improve the accuracy, clarity, and transparency of NSCC's Rules. The proposed changes would therefore allow Members to conduct their business more efficiently and effectively in accordance with the Rules and thereby promote the prompt and accurate clearance and settlement of securities transactions.
Finally, NSCC proposes several clarifying changes to Addendum J, which contains a policy statement regarding the acceptance of trade data from service bureaus. Specifically, NSCC proposes to revise the introductory paragraph of the Addendum to clarify that NSCC may accept from SROs and/or service bureaus, initial or supplemental trade data on behalf of Members for input into the Corporation's Comparison Operation
NSCC would also delete the requirements that a service bureau must (a) be or become a Member of NSCC or (b) be affiliated with a Member of the Corporation and that the Member (either the service bureau itself or its affiliated Member) must make a Clearing Fund deposit with NSCC. NSCC does not believe it is necessary for a service bureau to be, or be affiliated with, a Member or to maintain a Clearing Fund deposit. The Members, on behalf of which a service bureau may submit trade data to NSCC, and not the service bureau itself, are responsible for maintaining Clearing Fund deposits to cover the risk associated with such positions. Moreover, the last paragraph of Addendum J currently provides NSCC with the authority to waive these requirements if it is in the best interests of NSCC and its Members to approve a service bureau so as to assure the prompt, accurate, and orderly processing and settlement of securities transactions or to otherwise carry out the functions of the Corporation. NSCC is proposing to eliminate these requirements as a matter of rule rather than through individual waivers, to improve the transparency and clarity of its Rules. NSCC believes the proposed rule change would continue to promote the prompt and accurate clearance and settlement of securities transactions and assure the safeguarding of securities and
For the reasons set forth above, NSCC believes the proposed rule change would promote the prompt and accurate clearance and settlement of securities transactions and assure the safeguarding of securities and funds which are in the custody or control of the clearing agency or for which it is responsible, consistent with the requirements of Section 17A(b)(3)(F) of the Act.
NSCC does not believe that the proposed rule change would have any adverse impact, or impose any burden, on competition. These proposed changes are primarily designed to improve the accuracy, clarity, and transparency of the NSCC Rules. Specifically, the proposed changes to Rule 2B concerning NSCC's obligations for maintaining non-public information of its participants would only impose obligations on NSCC and would not impose any new requirements on its participants. Additionally, the proposed rule change would remove outdated rules, procedures, addenda, and fees related to inactive services or outdated methods of data transmission. The proposed rule change would also provide additional clarity to NSCC's CNS Accounting Operation Procedures, which would be equally applicable to all Members. In addition, the proposed rule change would remove certain requirements around the DTCC Limit Monitoring tool and make Limit Monitoring available to all Members on an optional basis. The proposed changes to Limit Monitoring would not impose any new requirements on Members or impact the actions Members may take in response to Limit Monitoring. In addition, the proposed rule change would consolidate the rules concerning NSCC's authority to impose fines into NSCC's disciplinary proceeding rules and clarify the requirements for admission to NSCC's premises. These proposed changes would apply equally to all Members and would not impose any new significant obligation or burden on Members. The proposed changes are simply intended to improve the accuracy, clarity, and transparency of NSCC's Rules. Finally, the proposed rule change would clarify policy statements regarding the acceptance of trade data from service bureaus. These proposed changes would not impose any new requirements on service bureaus and would in fact eliminate certain requirements for service bureaus. The proposed rule change therefore would not materially affect the rights or obligations of NSCC Members. As a result, NSCC does not believe that the proposed rule change would have any adverse impact, or impose any burden, on competition.
NSCC has 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,
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
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.
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 May 26, 2022, Fixed Income Clearing Corporation (“FICC”) filed with the Securities and Exchange Commission (“Commission”) proposed rule change SR-FICC-2022-004 (the “Proposed Rule Change”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On July 14, 2022, pursuant to Section 19(b)(2) of the Act,
As described in the Notice, FICC proposes to amend (1) the Clearing Agency Stress Testing Framework (Market Risk) (“ST Framework”) and the Clearing Agency Liquidity Risk Management Framework (“LRM Framework,” and, together with the ST Framework, the “Frameworks”) of FICC and its affiliates, The Depository Trust Company (“DTC”) and National Securities Clearing Corporation (“NSCC,” and together with FICC and DTC, the “Clearing Agencies”), and (2) the Clearing Rules of the Mortgage-Backed Securities Division of FICC (“MBSD”).
First, the proposed changes would amend both the ST Framework and the LRM Framework to move descriptions of the Clearing Agencies' liquidity stress testing activities from the LRM Framework to the ST Framework. In connection with this proposed change, the Clearing Agencies propose to recategorize the stress scenarios used for liquidity risk management, such that all such stress scenarios are described as either regulatory or informational scenarios.
Second, the proposed changes would amend the ST Framework to (1) enhance stress testing for the Government Securities Division of FICC (“GSD”) to obtain certain data utilized in stress testing from external vendors and implement a back-up stress testing calculation that would be utilized in the event such data is not supplied by its vendors, and amend the ST Framework to reflect these practices for both GSD and MBSD; (2) reflect that a stress testing team is primarily responsible for the actions described in the ST Framework, and (3) make other revisions to update and clarify the statements in the ST Framework.
Third, the proposed changes would amend the LRM Framework to update and clarify certain statements in the LRM Framework.
Finally, the proposed changes would amend the Clearing Rules of MBSD (“MBSD Rules”) to remove disclosures regarding the stress testing program, which would be described in the ST Framework.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
• Section 17A(b)(3)(F) of the Act,
• Rule 17Ad-22(e)(4) of the Act,
• Rule 17Ad-22(e)(7) of the Act,
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues
Interested persons are invited to submit written data, views, and arguments regarding whether the Proposed Rule Change should be approved or disapproved by October 6, 2022. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by October 20, 2022.
The Commission asks that commenters address the sufficiency of FICC's statements in support of the Proposed Rule Change, which are set forth in the Notice,
Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On May 26, 2022, The Depository Trust Company (“DTC”) filed with the Securities and Exchange Commission (“Commission”) proposed rule change SR-DTC-2022-006 (the “Proposed Rule Change”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On July 14, 2022, pursuant to Section 19(b)(2) of the Act,
As described in the Notice, DTC proposes to amend the Clearing Agency Stress Testing Framework (Market Risk) (“ST Framework”) and the Clearing Agency Liquidity Risk Management Framework (“LRM Framework,” and, together with the ST Framework, the “Frameworks”) of DTC and its affiliates, National Securities Clearing Corporation (“NSCC”) and Fixed Income Clearing Corporation (“FICC,” and together with NSCC and DTC, the “Clearing Agencies”).
First, the proposed changes would amend both the ST Framework and the LRM Framework to move descriptions of the Clearing Agencies' liquidity stress testing activities from the LRM Framework to the ST Framework. In connection with this proposed change, the Clearing Agencies propose to recategorize the stress scenarios used for liquidity risk management, such that all such stress scenarios are described as either regulatory or informational scenarios.
Second, the proposed changes would amend the ST Framework to (1) enhance stress testing for the Government Securities Division of FICC (“GSD”) to obtain certain data utilized in stress testing from external vendors and implement a back-up stress testing calculation that would be utilized in the event such data is not supplied by its vendors, and amend the ST Framework to reflect these practices for both GSD and the Mortgage-Backed Securities Division of FICC (“MBSD”); (2) reflect that a stress testing team is primarily responsible for the actions described in the ST Framework, and (3) make other revisions to update and clarify certain statements in the ST Framework.
Third, the proposed changes would amend the LRM Framework to update and clarify certain statements in the LRM Framework.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
• Section 17A(b)(3)(F) of the Act,
• Rule 17Ad-22(e)(4) of the Act,
• Rule 17Ad-22(e)(7) of the Act,
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the Proposed Rule Change. In particular, the Commission invites the written views of interested persons concerning whether the Proposed Rule Change is consistent with Section 17A(b)(3)(F) of the Act,
Interested persons are invited to submit written data, views, and arguments regarding whether the Proposed Rule Change should be approved or disapproved by October 6, 2022. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by October 20, 2022.
The Commission asks that commenters address the sufficiency of DTC's statements in support of the Proposed Rule Change, which are set forth in the Notice,
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 18a-1 establishes net capital requirements for nonbank security-based swap dealers that are not also broker-dealers registered with the Commission (“stand-alone SBSDs”). First, under paragraphs (a)(2) and (d) of Rule 18a-1, a stand-alone SBSD may apply to the Commission to be authorized to use internal value-at-risk (“VaR) models to compute net capital and a stand-alone SBSD authorized to use internal models must review and update the models it uses to compute market and credit risk, as well as back-test the models. Second, under paragraph (f) of Rule 18a-1, a stand-alone SBSD is required to comply with certain requirements of Exchange Act Rule 15c3-4 (17 CFR 240.15c3-4). Rule 15c3-4 requires OTC derivatives dealers and firms subject to its provisions to establish, document, and maintain a system of internal risk management controls to assist the firm in managing the risks associated with business activities, including market, credit, leverage, liquidity, legal, and operational risks. Third, for purposes of calculating “haircuts” on credit default swaps, paragraph (c)(1)(vi)(B)(1)(
The aggregate annual burden for all respondents is estimated to be 21,024 hours. The aggregate annual cost burden for all respondents is estimated to be $ 2,598,500.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
On May 26, 2022, National Securities Clearing Corporation (“NSCC”) filed with the Securities and Exchange Commission (“Commission”) proposed rule change SR-NSCC-2022-006 (the “Proposed Rule Change”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On July 14, 2022, pursuant to Section 19(b)(2) of the Act,
As described in the Notice, NSCC proposes to amend the Clearing Agency Stress Testing Framework (Market Risk) (“ST Framework”) and the Clearing Agency Liquidity Risk Management Framework (“LRM Framework,” and, together with the ST Framework, the “Frameworks”) of NSCC and its affiliates, The Depository Trust Company (“DTC”) and Fixed Income Clearing Corporation (“FICC,” and together with NSCC and DTC, the “Clearing Agencies”).
First, the proposed changes would amend both the ST Framework and the LRM Framework to move descriptions of the Clearing Agencies' liquidity stress testing activities from the LRM Framework to the ST Framework. In connection with this proposed change, the Clearing Agencies propose to recategorize the stress scenarios used for liquidity risk management, such that all such stress scenarios are described as either regulatory or informational scenarios.
Second, the proposed changes would amend the ST Framework to (1) enhance stress testing for the Government Securities Division of FICC (“GSD”) to obtain certain data utilized in stress testing from external vendors and implement a back-up stress testing calculation that would be utilized in the event such data is not supplied by its vendors, and amend the ST Framework to reflect these practices for both GSD
Third, the proposed changes would amend the LRM Framework to update and clarify certain statements in the LRM Framework.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
• Section 17A(b)(3)(F) of the Act,
• Rule 17Ad-22(e)(4) of the Act,
• Rule 17Ad-22(e)(7) of the Act,
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the Proposed Rule Change. In particular, the Commission invites the written views of interested persons concerning whether the Proposed Rule Change is consistent with Section 17A(b)(3)(F) of the Act,
Interested persons are invited to submit written data, views, and arguments regarding whether the Proposed Rule Change should be approved or disapproved by October 6, 2022. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by October 20, 2022.
The Commission asks that commenters address the sufficiency of NSCC's statements in support of the Proposed Rule Change, which are set forth in the Notice,
Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's port-related fees, at Equity 7, Section 115, and Options 7, Section 3, as described further below. The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to (i) amend Equity 7, Section 115, and Options 7, Section 3, to prorate port fees for the first month of service, (ii) add language to Equity 7, Section 115, and Options 7, Section 3, to clarify that port fees for cancelled services will continue to be charged for the remainder of month, and (iii) clarify that Nasdaq Testing Facility (“NTF”) ports are provided at no cost in Options 7, Section 3.
Currently, the Exchange does not prorate port connectivity fees under either its equity or options rules. Thus, participants are assessed a full month's fee if they direct the Exchange to make the subscribed connectivity live on any day of the month, including the last day thereof. Participants are also assessed a full month's port fee if they cancel service during the month.
The Exchange proposes to provide prorated port fees for the first month of service for new requests. By prorating the first month's fees, the Exchange would charge participants port fees only for the days in which the participants are connected to the Exchange during the first month of service. The Exchange proposes to continue the current practice of charging port fees for the remainder of the month upon cancellation. If a participant starts and cancels service in the same month, the participant would not be billed for those days prior to the service start date but would be billed for the remainder of the month, including after the service is cancelled.
The Exchange believes it is important for participants to have the option to establish new connections to the Exchange at any time during the month without being hampered by a full month charge irrespective of when during the month service begins. Moreover, other exchanges also charge new ports on a prorated basis for the first month of service.
The Exchange also proposes to add language to Options 7, Section 3(iv) to clarify the Exchange's existing practice that NTF Ports are provided at no cost. The NTF provides subscribers with a virtual System test environment that closely approximates the production environment on which they may test their automated systems that integrate with the Exchange. For example, the NTF provides subscribers a virtual System environment for testing upcoming releases and product enhancements, as well as testing firm software prior to implementation. The Exchange proposes adding express language in the options Rules to provide increased clarity to market participants.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposed changes to its port fee schedule are reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for options and equity securities transaction services that constrain its pricing determinations in that market. The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
The Exchange believes that it is reasonable to prorate port fees for the first month of connectivity. As discussed above, the Exchange believes it is important for participants to have the flexibility to establish new connections to the Exchange at any time during the month without being hampered by a full month charge. For example, the Exchange believes it is reasonable to charge a user who begins a subscription on the last day of the month to be charged only for use of a port for that day. As noted above, other exchanges already charge their customers for new ports on a prorated basis for the first month of service.
The Exchange believes that the proposal is also equitable and not unfairly discriminatory because the proposed change to prorate port fees for the first month of service and continue to charge for the remainder of the month upon cancellation will apply uniformly to all similarly situated participants. Removing the requirement to pay a full month's port fee if a user joins any day other than the first of the month is user-friendly and provides users incentive to subscribe at their convenience. The Exchange believes that prorating the fees for the first month of a user's subscription will ensure that the fees are more equitable to a user's utilization of the products. All users will benefit from the proration of the first month of their subscription.
The Exchange also believes that it is just and equitable, and in the interests of market participants, for the Exchange to clarify the Exchange's existing practice to provide NTF ports at no cost in Options 7, Section 3(iv), codifying existing practice where it is not expressly stated in the Rule. The Exchange believes that market participants will benefit from increased clarity, which will help limit any potential confusion in the future.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange does not believe that its proposal will place any category of Exchange participants at a competitive disadvantage. The proposed change to prorate port fees for the first month of service will apply uniformly to all similarly situated participants. All users will receive the benefit of a proration for the first month of port connectivity, which will enable users to save money that they otherwise would incur under the Exchange's current rules that do not provide for proration. The proposed language describing the Exchange's practice to bill for the remainder of the month upon cancellation, as well as the proposed language to the options Rules that NTF ports are provided at no cost, merely codify and clarify existing practices of the Exchange.
The Exchange believes that the proposed change to its port fee schedule to provide proration for the first month of port connectivity will not impose a burden on competition because the Exchange's execution services are completely voluntary and subject to extensive competition both from the other live exchanges and from off-exchange venues, which include alternative trading systems that trade national market system stock. Moreover, as noted above, other exchanges currently charge new ports on a prorated basis for the first month of service.
The proposed change to the Exchange's port fee schedule is reflective of this competition because, as a threshold issue, the Exchange is a relatively small market so its ability to burden intermarket competition is limited. In this regard, even the largest U.S. equities exchange by volume only has 17-18% market share, which in most markets could hardly be categorized as having enough market power to burden competition. Accordingly, the Exchange does not believe that the proposed change will impair the ability of members, participants, or competing order execution venues to maintain their competitive standing in the financial markets.
The proposed change to clarify that NTF ports are provided at no cost is designed to expressly state existing practice without changing its operation and, therefore, the Exchange believes that the proposed change will not impose a burden on competition.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary display in the exhibition “Picasso Cut Papers” at the Armand Hammer Museum of Art and Cultural Center, Los Angeles, California, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Chi D. Tran, Program Administrator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice; withdrawal.
The Department of State published a document in the
Elizabeth Linske, (202) 344-9852 or Sigrid Simpson, (202) 881-6592.
Withdrawal.
In the
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. We are requesting comments on this collection from all interested individuals and organizations in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow 60 days for public comment preceding submission of this collection to OMB.
The Department will accept comments from the public up to
You may submit comments by any of the following methods:
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You must include the information collection title (Request for Commodity Jurisdiction Determination), form number (DS-4076), and the OMB control number (1405-0163) in all correspondence.
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 Andrea Battista, who may be reached at 202-992-0973, or
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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
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including by the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this notice will be part of the public record. Before including any detailed personal information, you should be aware that your comments as submitted, including any personal information you provide, will be available for public review.
Pursuant to ITAR § 120.4, a person, as defined by ITAR § 120.14, may request a written determination from the Department of State stating whether a particular article or defense service is covered by the United States Munitions List (USML). Form DS-4076 is the means by which respondents may submit this request. Information submitted via DS-4076 will be shared with the Department of Defense, Department of Commerce, and other USG agencies, as needed, during the commodity jurisdiction process. Determinations will be made on a case-by-case basis based on the commodity's form, fit, function, and performance capability.
Respondents must generally submit the DS-4076 electronically through DDTC's electronic system. Respondents may access the DS-4076 on DDTC's website,
Midland Railroad LLC (MRR), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to acquire and operate as a common carrier over 11.09 miles of rail line owned by the Midland Historical Railway Association (MHRA) between milepost 14.95 near Baldwin City, Kan., and milepost 26.04 at Ottawa, Kan. (the Line).
According to the verified notice, MRR and MHRA have reached an agreement pursuant to which MRR will acquire the Line and, upon consummation of the acquisition transaction, replace Leavenworth, Lawrence & Galveston Railroad d/b/a the Baldwin City & Southern Railroad Company (BC&S) as the common carrier service provider on the Line. The verified notice indicates that MHRA controls BC&S and that BC&S does not object to the proposed transaction by which it would be replaced by MRR as operator on the Line.
MRR certifies that the agreement governing the proposed transaction does not have an interchange commitment. MRR further certifies that its projected annual revenues resulting from the transaction will not exceed $5 million and will not result in MRR's becoming a Class I or Class II rail carrier. Under 49 CFR 1150.32(b), a change in operator requires that notice be given to shippers. MRR states that there are currently no customers on the Line, and accordingly, no shippers to notify of the transaction.
The earliest this transaction may be consummated is September 29, 2022. MRR states that it expects to consummate its acquisition of, and commence common carrier operations over, the Line on or after that date.
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than September 22, 2022 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36640, must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on MRR's representative, Robert A. Wimbish, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 800, Chicago, IL 60606.
According to MRR, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available at
By the Board, Mai T. Dinh, Director, Office of Proceedings.
Tennessee Valley Authority (TVA).
Notice of meeting.
The TVA Regional Energy Resource Council (RERC) will hold a meeting on October 3 and 4, 2022, regarding regional energy related issues in the Tennessee Valley.
The meeting will be held in Chattanooga, Tennessee, at TVA's Missionary Ridge Building on Monday, October 3, 2022, from 8 a.m. to 3:15 p.m. ET and Tuesday, October 4, 2022, from 8:00 a.m. to 11:30 a.m. ET. RERC members are invited to attend the meeting in person. The public is invited to view the meeting virtually or attend in person. Health and safety protocols may be required for those who attend in-person as TVA is following CDC guidance on masking and social distancing. A 1-hour public listening session for the public to present comments virtually or in person will be held October 3, 2022, at 2 p.m. ET. A link and instructions to view the meeting will be posted one week prior on TVA's RERC website at
The meeting will be held at TVA's Missionary Ridge Auditorium at
Bekim Haliti,
The RERC was established to advise TVA on its energy resource activities and the priorities among competing objectives and values. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. app.2.
The meeting agenda includes the following:
The RERC will hear views of citizens by providing a 1-hour public comment session starting October 3 at 2 p.m. ET. Persons wishing to speak in person or virtually must register by sending an email at
Office of the United States Trade Representative.
Notice.
The Office of the United States Trade Representative (USTR), through the Trade Policy Staff Committee (TPSC), publishes the National Trade Estimate Report on Foreign Trade Barriers (NTE Report) each year. USTR invites comments to assist it and the TPSC in identifying significant foreign barriers to, or distortions of, U.S. exports of goods and services, U.S. foreign direct investment, and U.S. electronic commerce for inclusion in the NTE Report. USTR also will consider responses to this notice as part of the annual review of the operation and effectiveness of all U.S. trade agreements regarding telecommunications products and services that are in force with respect to the United States.
The deadline for submission of comments is Friday, October 28, 2022, at 11:59 p.m. ET.
USTR strongly prefers electronic submissions made through the Federal eRulemaking Portal:
Spencer Smith at
Section 181 of the Trade Act of 1974, as amended (19 U.S.C. 2241), requires USTR annually to publish the NTE Report, which sets out an inventory of significant foreign barriers to, or distortions of, U.S. exports of goods and services, including agricultural commodities and U.S. intellectual property; foreign direct investment by U.S. persons, especially if such investment has implications for trade in goods or services; and U.S. electronic commerce. The inventory facilitates U.S. negotiations aimed at reducing or eliminating these barriers and is a valuable tool in enforcing U.S. trade laws and agreements and strengthening the rules-based trading system. You can find the 2022 NTE Report on USTR's website at
To assist USTR in preparing the NTE Report, commenters should submit information related to one or more of the following categories of foreign trade barriers:
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Please provide, if available, the titles of relevant laws or measures and a description of the concerns with which the laws or measures relate to the significant foreign barriers or distortions identified. Commenters should place particular emphasis on any practices that may violate U.S. trade agreements. USTR also is interested in receiving new or updated information pertinent to the barriers covered in the 2022 NTE Report as well as information on new barriers. If USTR does not include in the 2023 NTE Report information that it receives pursuant to this notice, it will maintain the information for potential use in future discussions or negotiations with trading partners.
Commenters should submit information related to one or more of the following export markets to be covered in the report: Algeria, Angola, the Arab League, Argentina, Australia, Bahrain, Bangladesh, Bolivia, Brazil, Brunei, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, the European Union, Ghana, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Laos, Malaysia, Mexico, Morocco, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, the Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Vietnam. Commenters may submit information related to significant barriers or distortions in export markets other than those listed in this paragraph.
In addition, section 1377 of the Omnibus Trade and Competitiveness Act of 1988 (19 U.S.C. 3106) (Section 1377) requires USTR annually to review the operation and effectiveness of U.S. telecommunications trade agreements that are in force with respect to the United States. The purpose of the review is to determine whether any foreign government that is a party to one of those agreements is failing to comply with that government's obligations or is otherwise denying, within the context of a relevant agreement, “mutually advantageous market opportunities” to U.S. telecommunication products or services suppliers. USTR will consider responses to this notice in the review called for in Section 1377 and highlight both ongoing and emerging barriers to U.S. telecommunication services and goods exports in the 2023 NTE Report.
To the extent possible, each comment should include an estimate of the potential increase in U.S. exports of goods or services, foreign direct investment, or electronic commerce that would result from removing any significant foreign trade barrier the comment identifies, as well as a description of the methodology the commenter used to derive the estimate. Commenters should express estimates within the following value ranges: less than $25 million; $25 million to $100 million; $100 million to $500 million; and over $500 million.
Comments must be in English and must identify on the first page of the submission `Comments Regarding Foreign Trade Barriers to U.S. Exports for 2023 Reporting—[Name of country or countries discussed]'. Commenters providing information on foreign trade barriers in more than one country should, whenever possible, provide a separate attachment for each country as part of the same submission. USTR strongly encourages commenters to provide only one submission.
The submission deadline is Friday, October 28, 2022 at 11:59 p.m. ET. USTR strongly encourages commenters to make online submissions, using
Filers submitting comments that do not contain business confidential information (BCI) should name their file using the name of the person or entity submitting the comment, and the name of the country or countries discussed. For any comments submitted electronically that contain BCI, the file name of the business confidential version should begin with the characters `BCI.' Clearly mark any page containing BCI with `BUSINESS CONFIDENTIAL' on the top of that page. Filers of submissions containing BCI also must submit a public version of their comments that USTR will place in the docket for public inspection. The file name of the public version should begin with the character `P.' Follow the `BCI' and `P' with the name of the person or entity submitting the comments.
USTR will post comments in the docket for public inspection, except properly designated BCI. You can view comments on
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of renewal of the Aviation Rulemaking Advisory Committee charter.
The FAA announces the charter renewal of the Aviation Rulemaking Advisory Committee (ARAC), a Federal advisory committee that works with industry and the public to improve the development of the FAA's regulations. This charter renewal will take effect on September 14, 2022, and will expire after 2 years unless otherwise renewed.
Lakisha Pearson, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, telephone (202) 267-4191; fax (202) 267-5075; email
Pursuant to section 14(a)(2)(A) of the Federal Advisory Committee Act (Pub. L. 92-463), the FAA is giving notice of the charter renewal for the ARAC. The ARAC was established to provide advice and recommendations to FAA on regulatory matters. The ARAC is composed of representatives from member organizations and associations that represent the various aviation industry segments. The diversity of the Committee ensures the requisite range of views and expertise necessary to discharge its responsibilities. See the ARAC website for details on pending tasks at
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed airworthiness criteria.
The FAA announces the availability of and requests comments on proposed airworthiness criteria for the MissionGO Model MGV100 unmanned aircraft (UA). This document proposes the airworthiness criteria the FAA finds to be appropriate and applicable for the UA design.
Send comments on or before October 17, 2022.
Send comments identified by docket number FAA-2022-0353 using any of the following methods:
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Christopher J. Richards, Emerging Aircraft Strategic Policy Section, AIR-618, Strategic Policy Management Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 6020 28th Avenue South, Room 103, Minneapolis, MN 55450, telephone (612) 253-4559.
The FAA invites interested people to take part in the development of these airworthiness criteria by sending written comments, data, or views. The most helpful comments reference a specific portion of the airworthiness
Except for Confidential Business Information as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will file in the docket all comments received, as well as a report summarizing each substantive public contact with FAA personnel concerning these proposed airworthiness criteria. Before acting on this proposal, the FAA will consider all comments received on or before the closing date for comments. The FAA will consider comments filed late if it is possible to do so without incurring delay. The FAA may change these airworthiness criteria based on received comments.
Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to these proposed airworthiness criteria contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to these proposed airworthiness criteria, 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 these proposed airworthiness criteria. Submissions containing CBI should be sent to the individual listed under
MissionGO applied to the FAA on November 4, 2020, for a special class type certificate under 14 CFR 21.17(b) for the Model MGV100 UA.
The Model MGV100 consists of a rotorcraft UA and its associated elements (AE) including communication links and components that control the UA. The Model MGV100 UA has a maximum gross takeoff weight of 54 pounds. It has a rotor diameter of approximately 76.5 inches. It is approximately 66.5 inches in fuselage length and 28.5 inches in height. The Model MGV100 UA is battery-powered using electric motors for vertical takeoff, landing, and forward flight. The unmanned aircraft system (UAS) operations would rely on high levels of automation and include a single UA operated by a single pilot. MissionGO anticipates operators will use the Model MGV100 for delivering packages. The proposed concept of operations for the Model MGV100 identifies a maximum operating altitude of 400 feet above ground level, a maximum cruise speed of 38 knots, operations beyond visual line of sight of the pilot, and operations over human beings. MissionGO has not requested type certification for flight into known icing for the Model MGV100.
The FAA establishes airworthiness criteria to ensure the safe operation of aircraft in accordance with 49 U.S.C. 44701(a) and 44704. UA are type certificated by the FAA as special class aircraft for which airworthiness standards have not been established by regulation. Under the provisions of 14 CFR 21.17(b), the airworthiness standards for special class aircraft are those the FAA finds to be appropriate and applicable to the specific type design.
The applicant has proposed a design with constraints upon its operations and an unusual design characteristic: the pilot is remotely located. The FAA developed existing airworthiness standards to establish an appropriate level of safety for each product and its intended use. The FAA's existing airworthiness standards did not envision aircraft with no pilot in the flight deck and the technologies associated with that capability.
The FAA has reviewed the proposed design and assessed the potential risk to the National Airspace System. The FAA considered the size of the proposed aircraft, its maximum airspeed and altitude, and operational limitations to address the number of unmanned aircraft per operator and address operations in which the aircraft would operate beyond the visual line of sight of the pilot. These factors allowed the FAA to assess the potential risk the aircraft could pose to other aircraft and to human beings on the ground. Using these parameters, the FAA developed airworthiness criteria to address those potential risks to ensure the aircraft remains reliable, controllable, safe, and airworthy.
The proposed criteria focus on mitigating hazards by establishing safety outcomes that must be achieved, rather than by establishing prescriptive requirements that must be met. This is in contrast to many current airworthiness standards, used to certificate traditional aircraft systems, which prescribe specific indicators and instruments for a pilot in a flight deck that would be inappropriate for UA. The FAA finds that the proposed criteria are appropriate and applicable for the UA design, based on the intended operational concepts for the UA as identified by the applicant.
The FAA selected the particular airworthiness criteria proposed by this notice for the following reasons:
As explained in FAA Policy Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA will approve either the specific AE or minimum specifications for the AE, as identified by the applicant, as part of the type certificate by including them as an operating limitation in the type certificate data sheet and flight manual. The FAA may impose additional operating limitations specific to the AE through conditions and limitations for inclusion in the operational approval (
The current regulations for the certification of systems, equipment, and installations (
To address the risks to the UA associated with intentional unauthorized electronic interactions, the applicant would be required to design the UAS's systems and networks to protect against intentional unauthorized electronic interactions and mitigate potential adverse effects. The FAA based the language for the proposed criteria on recommendations in the final report dated August 22, 2016, from the Aircraft System Information Security/Protection (ASISP) working group under the FAA's Aviation Rulemaking Advisory Committee. Although the recommendations pertained to manned aircraft, the FAA has reviewed the report and determined the recommendations are also appropriate for UA. The wireless connections used by UA make these aircraft susceptible to the same cyber security risks, and therefore require similar criteria as manned aircraft.
To address the risks associated with loss of communication between the pilot and the UA, and thus the pilot's inability to control the UA, the proposed criteria would require that the UA be designed to automatically execute a predetermined action. Because the pilot needs to be aware of the particular predetermined action the UA will take when there is a loss of communication between the pilot and the UA, the proposed criteria would require that the applicant identify the predetermined action in the UA Flight Manual. The proposed criteria would also include requirements for preventing takeoff when quality of service is inadequate.
For some aircraft design requirements imposed by existing airworthiness standards (
Flight testing will be used to determine the aircraft's ability to withstand flight loads across the range of operating limits and the flight envelope. Because small UA may be subjected to significant ground loads when handled, lifted, carried, loaded, maintained, and transported physically by hand, the proposed criteria would require that the aircraft used for testing endure the same worst-case ground loads as those the UA will experience in operation after type certification.
The proposed criteria contain functions that would allow the pilot to command the UA to deviate from its flight plan or from its pre-programmed flight path. For example, in the event the pilot needs to deconflict the airspace, the UA must respond to pilot inputs that override any pre-programming.
In the event an applicant requests approval for certain features, such as geo-fencing or external cargo, the proposed criteria contain requirements to address the associated risks. The proposed criteria in this section would also require the design of the UA to safeguard against unintended discontinuation of flight or release of cargo, whether by human action or malfunction.
These airworthiness criteria, established under the provisions of § 21.17(b), are applicable to the Model MGV100 UA. Should MissionGO apply at a later date for a change to the type certificate to include another model, these airworthiness criteria would apply to that model as well, provided the FAA finds them appropriate in accordance with the requirements of subpart D to part 21.
This action affects only the airworthiness criteria for the one model UA. It is not a standard of general applicability.
The authority citation for these airworthiness criteria is as follows:
The FAA proposes to establish the following airworthiness criteria for type certification of the MissionGO Model MGV100 UA. The FAA proposes that compliance with the following would mitigate the risks associated with the proposed design and Concept of Operations appropriately and would provide an equivalent level of safety to existing rules:
The applicant must define and submit to the FAA a concept of operations (CONOPS) proposal describing the unmanned aircraft system (UAS) operation in the national airspace system for which unmanned aircraft (UA) type certification is requested. The CONOPS proposal must include, at a minimum, a description of the following information in sufficient detail to determine the parameters and extent of testing and operating limitations:
(a) The intended type of operations;
(b) UA specifications;
(c) Meteorological conditions;
(d) Operators, pilots, and personnel responsibilities;
(e) Control station, support equipment, and other associated elements (AE) necessary to meet the airworthiness criteria;
(f) Command, control, and communication functions;
(g) Operational parameters (such as population density, geographic operating boundaries, airspace classes, launch and recovery area, congestion of proposed operating area, communications with air traffic control, line of sight, and aircraft separation); and
(h) Collision avoidance equipment, whether onboard the UA or part of the AE, if requested.
For purposes of these airworthiness criteria, the following definitions apply.
(a)
(b)
The UA must be designed to monitor and transmit to the AE all information required for continued safe flight and operation. This information includes, at a minimum, the following:
(a) Status of all critical parameters for all energy storage systems;
(b) Status of all critical parameters for all propulsion systems;
(c) Flight and navigation information as appropriate, such as airspeed, heading, altitude, and location; and
(d) Communication and navigation signal strength and quality, including contingency information or status.
(a) The applicant must identify and submit to the FAA all AE and interface conditions of the UAS that affect the airworthiness of the UA or are otherwise necessary for the UA to meet these airworthiness criteria. As part of this requirement—
(1) The applicant may identify either specific AE or minimum specifications for the AE.
(i) If minimum specifications are identified, they must include the critical requirements of the AE, including performance, compatibility, function, reliability, interface, operator alerting, and environmental requirements.
(ii) Critical requirements are those that if not met would impact the ability to operate the UA safely and efficiently.
(2) The applicant may use an interface control drawing, a requirements document, or other reference, titled so that it is clearly designated as AE interfaces to the UA.
(b) The applicant must show the FAA the AE or minimum specifications identified in paragraph (a) of this section meet the following:
(1) The AE provide the functionality, performance, reliability, and information to assure UA airworthiness in conjunction with the rest of the design;
(2) The AE are compatible with the UA capabilities and interfaces;
(3) The AE must monitor and transmit to the operator all information required for safe flight and operation, including but not limited to those identified in D&R.100; and
(4) The minimum specifications, if identified, are correct, complete, consistent, and verifiable to assure UA airworthiness.
(c) The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual.
(d) The applicant must develop any maintenance instructions necessary to address implications from the AE on the airworthiness of the UA. Those instructions will be included in the instructions for continued airworthiness (ICA) required by D&R.205.
To minimize the existence of software errors, the applicant must:
(a) Verify by test all software that may impact the safe operation of the UA;
(b) Utilize a configuration management system that tracks, controls, and preserves changes made to software throughout the entire life cycle; and
(c) Implement a problem reporting system that captures and records defects and modifications to the software.
(a) UA equipment, systems, and networks, addressed separately and in relation to other systems, must be protected from intentional unauthorized electronic interactions that may result in an adverse effect on the security or airworthiness of the UA. Protection must be ensured by showing that the security risks have been identified, assessed, and mitigated as necessary.
(b) When required by paragraph (a) of this section, procedures and instructions to ensure security protections are maintained must be included in the ICA.
(a) The UA must be designed so that, in the event of a loss of the command and control (C2) link, the UA will automatically and immediately execute a safe predetermined flight, loiter, landing, or termination.
(b) The applicant must establish the predetermined action in the event of a loss of the C2 link and include it in the UA Flight Manual.
(c) The UA Flight Manual must include the minimum performance requirements for the C2 data link defining when the C2 link is degraded to a level where remote active control of the UA is no longer ensured. Takeoff when the C2 link is degraded below the minimum link performance requirements must be prevented by design or prohibited by an operating limitation in the UA Flight Manual.
(a) Except as provided in paragraph (b) of this section, the UA must have design characteristics that will protect the UA from loss of flight or loss of control due to lightning.
(b) If the UA has not been shown to protect against lightning, the UA Flight Manual must include an operating limitation to prohibit flight into weather conditions conducive to lightning activity.
(a) For purposes of this section, “adverse weather conditions” means rain, snow, and icing.
(b) Except as provided in paragraph (c) of this section, the UA must have design characteristics that will allow the UA to operate within the adverse weather conditions specified in the
(c) For adverse weather conditions for which the UA is not approved to operate, the applicant must develop operating limitations to prohibit flight into known adverse weather conditions and either:
(1) Develop operating limitations to prevent inadvertent flight into adverse weather conditions; or
(2) Provide a means to detect any adverse weather conditions for which the UA is not certificated to operate and show the UA's ability to avoid or exit those conditions.
(a) A flight essential part is a part, the failure of which could result in a loss of flight or unrecoverable loss of UA control.
(b) If the type design includes flight essential parts, the applicant must establish a flight essential parts list. The applicant must develop and define mandatory maintenance instructions or life limits, or a combination of both, to prevent failures of flight essential parts. Each of these mandatory actions must be included in the Airworthiness Limitations Section of the ICA.
The applicant must provide a Flight Manual with each UA.
(a) The UA Flight Manual must contain the following information:
(1) UA operating limitations;
(2) UA operating procedures;
(3) Performance information;
(4) Loading information; and
(5) Other information that is necessary for safe operation because of design, operating, or handling characteristics.
(b) Those portions of the UA Flight Manual containing the information specified in paragraph (a)(1) of this section must be approved by the FAA.
The applicant must prepare ICA for the UA in accordance with Appendix A to part 23, as appropriate, that are acceptable to the FAA. The ICA may be incomplete at type certification if a program exists to ensure their completion prior to delivery of the first UA or issuance of a standard airworthiness certificate, whichever occurs later.
The UA must be designed to be durable and reliable when operated under the limitations prescribed for its operating environment, as documented in its CONOPS and included as operating limitations on the type certificate data sheet and in the UA Flight Manual. The durability and reliability must be demonstrated by flight test in accordance with the requirements of this section and completed with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area.
(a) Once a UA has begun testing to show compliance with this section, all flights for that UA must be included in the flight test report.
(b) Tests must include an evaluation of the entire flight envelope across all phases of operation and must address, at a minimum, the following:
(1) Flight distances;
(2) Flight durations;
(3) Route complexity;
(4) Weight;
(5) Center of gravity;
(6) Density altitude;
(7) Outside air temperature;
(8) Airspeed;
(9) Wind;
(10) Weather;
(11) Operation at night, if requested;
(12) Energy storage system capacity; and
(13) Aircraft to pilot ratio.
(c) Tests must include the most adverse combinations of the conditions and configurations in paragraph (b) of this section.
(d) Tests must show a distribution of the different flight profiles and routes representative of the type of operations identified in the CONOPS.
(e) Tests must be conducted in conditions consistent with the expected environmental conditions identified in the CONOPS, including electromagnetic interference (EMI) and high intensity radiated fields (HIRF).
(f) Tests must not require exceptional piloting skill or alertness.
(g) Any UAS used for testing must be subject to the same worst-case ground handling, shipping, and transportation loads as those allowed in service.
(h) Any UA used for testing must use AE that meet, but do not exceed, the minimum specifications identified under D&R.105. If multiple AE are identified, the applicant must demonstrate each configuration.
(i) Any UAS used for testing must be maintained and operated in accordance with the ICA and UA Flight Manual. No maintenance beyond the intervals established in the ICA will be allowed to show compliance with this section.
(j) If cargo operations or external-load operations are requested, tests must show, throughout the flight envelope and with the cargo or external-load at the most critical combinations of weight and center of gravity, that—
(1) The UA is safely controllable and maneuverable; and
(2) The cargo or external-load is retainable and transportable.
The UA must be designed such that a probable failure will not result in a loss of containment or control of the UA. This must be demonstrated by test.
(a) Probable failures related to the following equipment, at a minimum, must be addressed:
(1) Propulsion systems;
(2) C2 link;
(3) Global Positioning System (GPS);
(4) Flight control components with a single point of failure;
(5) Control station; and
(6) Any other AE identified by the applicant.
(b) Any UA used for testing must be operated in accordance with the UA Flight Manual.
(c) Each test must occur at the critical phase and mode of flight, and at the highest aircraft-to-pilot ratio.
(a) All of the following required UAS capabilities and functions must be demonstrated by test:
(1) Capability to regain command and control of the UA after the C2 link has been lost.
(2) Capability of the electrical system to power all UA systems and payloads.
(3) Ability for the pilot to safely discontinue the flight.
(4) Ability for the pilot to dynamically re-route the UA.
(5) Ability to safely abort a takeoff.
(6) Ability to safely abort a landing and initiate a go-around.
(b) The following UAS capabilities and functions, if requested for approval, must be demonstrated by test:
(1) Continued flight after degradation of the propulsion system.
(2) Geo-fencing that contains the UA within a designated area, in all operating conditions.
(3) Positive transfer of the UA between control stations that ensures only one control station can control the UA at a time.
(4) Capability to release an external cargo load to prevent loss of control of the UA.
(5) Capability to detect and avoid other aircraft and obstacles.
(c) The UA must be designed to safeguard against inadvertent discontinuation of the flight and inadvertent release of cargo or external load.
The structure of the UA must be shown to withstand the repeated loads expected during its service life without failure. A life limit for the airframe must be established, demonstrated by test, and included in the ICA.
The performance, maneuverability, stability, and control of the UA within the flight envelope described in the UA Flight Manual must be demonstrated at a minimum of 5% over maximum gross weight with no loss of control or loss of flight.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Denial of petition.
FCA US, LLC, (f/k/a Chrysler Group, LLC) “FCA,” has determined that certain Mopar branded headlamp assemblies sold as aftermarket equipment and installed as original equipment in certain model year (MY) 2017-2018 Dodge Journey motor vehicles do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 108,
Leroy Angeles, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), (202) 366-5304,
FCA has determined that certain MY 2017-2018 Dodge Journey motor vehicles and replacement Dodge Journey headlamp assemblies do not fully comply with paragraph S8.1.11 of FMVSS No. 108,
Notice of receipt of FCA's petition was published with a 30-day public comment period, on February 28, 2020, in the
Approximately 16,604 Mopar headlamp assemblies sold as aftermarket equipment, manufactured between August 2, 2017, and July 6, 2018, are potentially involved. Approximately 84,908 MY 2017-2018 Dodge Journey motor vehicles, manufactured between August 2, 2017, and July 6, 2018, are potentially involved.
FCA explains that its subject vehicles and equipment are noncompliant because the subject headlamp assemblies, sold as aftermarket equipment and equipped in certain MY 2017-2018 Dodge Journey motor vehicles, contain a front amber side reflex reflector that does not meet the photometric requirements specified in paragraph S8.1.11 of FMVSS No. 108. Specifically, the reflex reflector, in the subject headlamp assemblies, does not meet the minimum photometry requirements at the observation angle of 0.2 degrees.
Paragraph S8.1.11 of FMVSS No. 108 includes the requirements relevant to this petition. Each reflex reflector must be designed to conform to the photometry requirements of Table XVI-a, when tested according to the procedure in paragraph S14.2.3 of FMVSS No. 108, for the reflex reflector.
The following views and arguments presented in this section, “V. Summary of FCA's Petition,” are the views and arguments provided by FCA. They do not reflect the views of NHTSA.
FCA described the subject noncompliance and stated that the noncompliance is inconsequential as it relates to motor vehicle safety. FCA submitted the following views and arguments in support of its petition:
1. FCA cites a prior NHTSA decision
2. Per FCA, the reflex reflectors on the subject vehicles “perform adequately to meet the safety purpose of the standard because they permit the early detection of an unlighted motor vehicle at an intersection or when parked, notwithstanding their deviation from certain photometric requirements.”
3. FCA believes that “the failure of these reflex reflectors to meet the photometric requirements does not reduce their effectiveness in providing the necessary visibility for oncoming vehicles and that the difference between the reflectivity provided by a compliant reflector is not distinguishable from the reflectivity provided by a noncompliant reflector.” FCA compared the performance of two Dodge Journey vehicles, one equipped with a compliant front side reflex reflector and the other a noncompliant front side reflex reflector parked front end-to-front end across a road's surface. Observers
4. With regard to FCA's evaluation, FCA chose vehicles with varying mounting heights, which included a 2019 Jeep Cherokee with LED projector headlamps, a 2019 Ram 1500 Pickup Truck with LED reflector headlamps, and a 2019 Alfa Romeo Giulia with Bi-Xenon projector headlamps as sources of illumination. Sixteen FCA employees (and only eight for the Alfa Romeo tests) volunteered as evaluators and stood immediately in front of, and at the centerline of, the vehicles whose headlamps were being used as the source of illumination. None of the evaluators were able to distinguish any luminous intensity differences in the light being reflected in any of the scenarios. FCA believes that these vehicles cover the range of typical headlamp mounting heights for vehicles on the road today.
The burden of establishing the inconsequentiality of a failure to comply with a
An important issue to consider in determining inconsequentiality based upon NHTSA's prior decisions on noncompliance issues is the safety risk to individuals who experience the type of event against which the recall would otherwise protect.
The primary function of a reflex reflector is to prevent crashes by permitting early detection of an unlighted motor vehicle at an intersection or when parked on or by the side of a road. The purpose of these reflectors is to accurately depict the size of a vehicle when parked or disabled in the dark, which minimizes the risk of motor vehicle crashes.
The subject reflex reflectors failed 5 out of the 10 required test points where the photometry measurements were, at best, 68.6% below the minimum requirement. In other words, at specific test points, the reflex reflectors provide less than one-third of the illuminance that a compliant reflex reflector provides (
NHTSA does not find FCA's subjective evaluation described above sufficiently compelling to grant this petition. FCA's evaluation attempts to show that the average human eye cannot discern a difference in the luminous intensity between FCA's noncompliant reflectors and other compliant reflectors that meet the minimum safety standard. However, FCA's evaluation was limited to occupants standing no more than 100 feet from the test vehicles, and only at certain angles. While FMVSS No. 108 specifies a measurement distance for reflex reflector photometry of 100 feet, real world performance is not limited to a static distance measurement established in a minimum safety standard. For these reasons, NHTSA does not believe that FCA's subjective evaluation is sufficient to support a determination of inconsequential noncompliance.
As previously stated, the subject reflex reflectors failed by a significant margin to meet the minimum safety requirement at multiple required test points. Compared to a reflex reflector that meets the minimum safety standard, the subject reflex reflectors, at some test points, provided less than one-third of the required illuminance of a compliant reflex reflector. Therefore, NHTSA's evaluation of consequentiality of the subject noncompliance is based, in part, on NHTSA's determination that the performance failure of the subject reflex reflectors deviates to such a significant degree that it would be noticeable to drivers of other motor vehicles. Consequently, the subject noncompliance creates a risk to motor vehicle safety.
Another factor considered in the evaluation of this petition is a NHTSA study on the effectiveness of side marker lamps,
In summary, given the magnitude of the performance failure of the subject reflex reflectors, the subject reflex reflectors create a risk that drivers of other vehicles will not detect a parked and unlighted motor vehicle early enough to avoid a vehicle crash. Consequently, NHTSA has determined that the subject noncompliance creates a risk to motor vehicle safety by failing to prevent motor vehicle crashes, which was the purpose of NHTSA's FMVSS No. 108 standard.
In consideration of the foregoing, NHTSA finds that FCA has not met its burden of persuasion that the subject FMVSS No. 108 noncompliance of the affected equipment and vehicles is inconsequential to motor vehicle safety. Accordingly, FCA's petition is hereby denied. FCA is consequently obligated to provide notification of, and a free remedy for, that noncompliance, pursuant to 49 U.S.C. 30118 and 30120.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment; correction.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and 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 “Securities Exchange Act Disclosure Rules.” OCC also gives notice that it has sent the collection to OMB for review.
Comments must be received on or before October 17, 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 May 23, 2022, the OCC published a 60-day notice for this information collection, 87 FR 31298. 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.
• Viewing Comments Electronically: Go to
• For assistance in navigating
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 that 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 that OMB extend its approval of the collection in this notice.
The Securities and Exchange Commission (SEC) is required by statute to collect, in accordance with its regulations, certain information and documents from any firm that is required to register its stock with the SEC.
12 CFR part 11 ensures that a national bank or Federal savings association whose securities are subject to registration provides adequate information about its operations to current and potential shareholders and the public. The OCC reviews the information to ensure that it complies with Federal law and makes public all information required to be filed under the rule.
On May 23, 2022, the OCC published a 60-day notice for this information collection, 87 FR 31298. No comments were received. Comments continue to be invited 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;
(d) Ways to minimize the burden of information collections on respondents,
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Departmental Offices, Department of the Treasury.
Notice of information collection; request for comment.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to comment on the proposed information collections listed below, in accordance with the Paperwork Reduction Act of 1995.
Comments should be received on or before November 14, 2022 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to Treasury PRA Clearance Officer, 1750 Pennsylvania Ave. NW, Suite 8100, Washington, DC 20220, or email at
The Department of the Treasury maintains a CFIUS Case Management System, featuring an online public portal for external parties to submit declarations and file notices with CFIUS in a standard form. Use of this online system is mandatory for all CFIUS submissions and filings.
Office of Financial Research, Treasury.
The reopening of the solicitation of applications for committee membership of the Financial Research Advisory Committee.
The Office of Financial Research is soliciting applications for membership on its Financial Research Advisory Committee. This notice reopens the solicitation of applications for Committee membership. The deadline to apply is September 30, 2022.
Melissa Avstreih, Designated Federal Officer, Office of Financial Research, Department of the Treasury, (202) 425-2483.
Pursuant to the Federal Advisory Committee Act, (Pub. L. 92-463, 5 U.S.C. app. 2 1-16, as amended), the Treasury Department established a Financial Research Advisory Committee (FRAC, or Committee) to provide advice and recommendations to the Office of Financial Research (OFR) and to assist the OFR in carrying out its duties and authorities.
The OFR was established under Title I of the Dodd-Frank Wall Street Reform
The FRAC was established to advise the OFR on issues related to the responsibilities of the office. It may provide its advice, recommendations, analysis, and information directly to the OFR and the OFR may share the Committee's advice and recommendations with the Secretary of the Treasury or other Treasury officials. The OFR will share information with the Committee as the OFR Director determines will be helpful in allowing the FRAC to carry out its role.
The FRAC is an advisory committee that was originally established on April 6, 2012. Its charter was renewed several times, most recently on January 26, 2022. The OFR is currently soliciting applications for membership in order to provide for rotation of membership, as provided in its original and current charter, as well as to provide for a diverse and balanced body with a variety of interests, backgrounds, and viewpoints represented. Providing for such diversity enhances the views and advice offered by the FRAC.
Treasury seeks applications from individuals representative of a constituency within the fields of economics, financial institutions and markets, statistical analysis, financial markets analysis, econometrics, applied sciences, risk management, data management, information standards, technology, or other areas related to OFR's duties and authorities. The terms of members chosen to serve are typically three years. No member of the Committee serving in their individual capacity (as opposed to those members specifically appointed to represent the interests of a nongovernmental entity, a recognizable group of persons, or nongovernmental entities) may be a Federally-registered lobbyist. Membership on the Committee is limited to the individuals appointed and is non-transferrable. Regular attendance is essential to the effective operation of the Committee. Some members of the Committee may be required to adhere to the conflict of interest rules applicable to Special Government Employees, as such employees are defined in 18 U.S.C. 202(a). These rules include relevant provisions in 18 U.S.C. related to criminal activity, Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR part 2635), and Executive Order 12674 (as modified by Executive Order 12731).
To apply, an applicant must submit an appropriately detailed resume and a cover letter describing their interest, reasons for application, and qualifications. In accordance with Department of Treasury Directive 21-03, a clearance process includes criminal and subversive name checks or fingerprint checks with the Federal Bureau of Investigation for proposed advisory committee members, as well as pre-appointment tax checks with the Internal Revenue Service for all proposed and reappointed members.
The application period for interested candidates will close on September 30, 2022. Applications should be submitted in sufficient time to be received by the close of business on the closing date and should be sent to
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 1717 H Street NW, Washington, DC 20006, (202) 266-4688 or email
No substantive changes have been made to this form. The respondent burden has increased due to the estimated number of receivables averaged over the past year.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The
By direction of the Secretary.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of proposed rulemaking.
This action proposes revised uniform procedures implementing State highway safety grant programs, as a result of enactment of the Infrastructure Investment and Jobs Act (IIJA, also referred to as the Bipartisan Infrastructure Law or BIL). It also reorganizes, streamlines and updates some grant requirements. The agency requests comments on the proposed rule.
Comments in response to this notice of proposed rulemaking must be submitted by October 31, 2022. In compliance with the Paperwork Reduction Act, NHTSA is also seeking comment on a new information collection. See the Paperwork Reduction Act section under Regulatory Analyses and Notices below. Comments concerning the new information collection requirements are due October 31, 2022 to NHTSA and to the Office of Management and Budget (OMB) at the address listed in the
You may submit written comments, identified by docket number or RIN, by any of the following methods:
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Comments on the proposed information collection requirements should be submitted to: Office of Management and Budget at
For comments on the proposed collection of information, all submissions must include the agency name and docket number for the proposed collection of information. Note that all comments received will be posted without change to
We face a crisis on our roadways. NHTSA projects that an estimated 42,915 people died in motor vehicle crashes in 2021.
On November 15, 2021, the President signed into law the “Infrastructure Investment and Jobs Act” (known also as the Bipartisan Infrastructure Law, or BIL), Public Law 117-58. The BIL provides for a once-in-a-generation investment in highway safety, including a significant increase in the amount of funding available to States under NHTSA's highway safety grants. It introduced expanded requirements for public and community participation in funding decisions, holding the promise of ensuring better and more equitable use of Federal funds to address highway safety problems in the locations where they occur. The BIL amended the highway safety grant program (23 U.S.C. 402 or Section 402) and the National Priority Safety Program grants (23 U.S.C. 405 or Section 405). The BIL significantly changed the application structure of the grant programs that were in place under MAP-21 and the FAST Act. The legislation replaced the current annual Highway Safety Plan
• Maintenance of Effort—Removed the maintenance of effort requirement for the Occupant Protection, State Traffic Safety Information System Improvements Grants, and Impaired Driving Grants;
• Occupant Protection Grants—Expanded allowable uses of funds and specified that at least 10% of grant funds must be used to implement child occupant protection programs for low-income and underserved populations;
• State Traffic Safety Information System Improvements Grants—Streamlined application requirements (
• Impaired Driving Countermeasures Grants—Expanded allowable uses of funds;
• Alcohol-Ignition Interlock Law Grants—Added criteria for States to qualify for grants (
• 24-7 Sobriety Programs Grants—Amended allocation formula;
• Distracted Driving Grants—Amended definitions, changed allocation formula, and amended requirements for qualifying laws;
• Motorcyclist Safety Grants—Added an eligibility criterion (
• State Graduated Driver Licensing Incentive Grants—Discontinued grant;
• Nonmotorized Safety Grants—Amended the definition of nonmotorized road user and expanded allowable uses of funds;
• Preventing Roadside Deaths—Established new grant; and
• Driver and Officer Safety Education—Established new grant.
In addition, the BIL amended the racial profiling data collection grant authorized under the “Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users” (SAFETEA-LU), Sec. 1906, Public Law 109-59 (Section 1906), as amended by the FAST Act, to expand the allowable uses of funds and amend the cap on grant award amounts. It also removed the time limit for States to qualify for a 1906 grant using assurances.
As in past authorizations, the BIL requires NHTSA to implement the grants pursuant to rulemaking. On April 21, 2022, the agency published a notification of public meeting and request for comments (RFC). 87 FR 23780. In that document, the agency sought comment on several aspects relating to this rulemaking. Today's action proposes regulatory language to implement the BIL provisions and addresses comments received at the public meeting and in response to the RFC.
This Notice of Proposed Rulemaking (NPRM) proposes application, approval, and administrative requirements for all 23 U.S.C. Chapter 4 grants and the Section 1906 grants, consistent with the requirements set forth in the BIL. Section 402, as amended by the BIL, continues to require each State to have an approved highway safety program designed to reduce traffic crashes and the resulting deaths, injuries, and property damage. Section 402 sets forth minimum requirements with which each State's highway safety program must comply. Under new procedures established by the BIL, each State must submit for NHTSA approval a triennial Highway Safety Plan (“triennial HSP”) that identifies highway safety problems, establishes performance measures and targets, describes the State's countermeasure strategies for programming funds to achieve its performance targets, and reports on the State's progress in achieving the targets set in the prior HSP. 23 U.S.C. 402(k). Each State must also submit for NHTSA approval an annual grant application that provides any necessary updates to the triennial HSP, identifies all projects and subrecipients to be funded by the State with highway safety grant funds during the fiscal year, describes how the State's strategy to use grant funds was adjusted based on the State's latest annual report, and includes an application for additional grants available under Chapter 4. (23 U.S.C. 402(l)) The agency proposes to reorganize and rewrite subpart B of part 1300, as well as 23 CFR 1300.35 to implement these changes.
As noted above, the BIL expanded the allowable uses of funds for many of the National Priority Safety Program grants, amended allocation formulas, added criteria for some grants and streamlined application requirements for others, deleted one grant, and established two new grants. For Section 405 grants with additional flexibility (Occupant Protection Grants, State Traffic Safety Information System Improvements Grants, Impaired Driving Countermeasures Grants, Alcohol-Ignition Interlock Law Grants, Distracted Driving Grants, Motorcyclist Safety Grants, Nonmotorized Safety Grants, and Racial Profiling Data Collection Grants) and for the new grants (Preventing Roadside Deaths Grants and Driver and Officer Safety Education Grants), where the BIL identified specific qualification requirements, today's action proposes adopting the statutory language with limited changes. The agency is also proposing aligning the application requirements for all Section 405 and Section 1906 grants with the new triennial HSP and annual grant application framework.
While many procedures and requirements continue unchanged by today's action, this NPRM makes limited changes to administrative provisions to address changes due to the triennial framework and changes made by revisions to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 2 CFR part 200.
In response to the RFC, the following submitted comments to the public docket on
NHTSA received communications directly from three organizations prior to the Request for Comment. (
In this preamble, NHTSA addresses all comments and identifies any proposed changes made to the existing regulatory text in part 1300.
Many commenters provided general input about the rulemaking process or to overarching aspects of highway safety that cannot be tied to a single regulatory provision. Those comments are discussed below.
Several commenters
AASHTO, GHSA and SafetyBeltSafe U.S.A. all submitted comments supporting increased public participation and opportunity to comment in NHTSA's rulemaking process. AASHTO encouraged NHTSA to consider all comments received, which we do in this action and will continue to do throughout the rulemaking process. GHSA expressed support for NHTSA's intention to publish a NPRM rather than publishing an Interim Final Rule, noting that it will provide opportunity for public comment. And SafetyBeltSafe U.S.A. expressed appreciation for the public meetings NHTSA held as part of its RFC, noting that they provided an opportunity to bring different parts of the traffic safety community together. NHTSA appreciates these comments and the comments received in response to the RFC, and we encourage comments responding to this NPRM. We commit to considering all comments carefully and thoughtfully.
GHSA requested that NHTSA complete the rulemaking process quickly in order to facilitate States in their highway safety planning and application processes. GHSA specifically sought first, publication of the final rule by October 2022, and in a later comment, publication by the end of December 2022. NHTSA appreciates the need to finalize the rule with sufficient time for States to rely on the rule in completing their fiscal year (FY) 2024 triennial HSPs and Annual Grant Applications, due July 1 and August 1, 2023, respectively. While it is not possible to complete the full rulemaking process, in accordance with the Administrative Procedure Act (5 U.S.C. 553), within the timeline proposed by GHSA, NHTSA plans to publish a Final Rule with sufficient time for States to rely on the rule for their FY24 grant applications.
GHSA further recommended that NHTSA establish an effective date of Federal fiscal year 2024 for the rule. Consistent with the BIL, the final rule, when published, will be effective for fiscal year 2024 and later grants.
GHSA and the NY GTSC stressed the importance of uniform and consistent guidance so that States can rely on the same interpretations. AASHTO recommended that the agency focus on providing program-level guidance while allowing for effective collaboration and coordination of State programs. GHSA further suggested several specific NHTSA guidance documents that it would like the agency to review or create in light of the statutory changes implemented in the BIL and based on past experience. The agency recognizes that some existing guidance may require modification or recission as a result of changes to the statute and this rule. We intend to begin reviewing existing guidance after this rulemaking is complete and will keep the specific
NHTSA received several comments stressing the importance of equity in traffic safety programs. The Transportation Equity Caucus noted that the concept of public safety may be defined differently in different communities and recommended that NHTSA be guided by Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through Federal Government. NHTSA strongly supports the policies and commitment to equity laid out in the Executive Order and is committed to fulfilling our responsibilities under the Order and to following its principles. For example, NHTSA's Office of Civil Rights (NCR) recently hired a Division Chief to focus on the enforcement of Title VI of the Civil Rights Act of 1964, which prohibits recipients of Federal financial assistance from discriminating against persons on the basis of race, color, or national origin (including limited English proficiency). NCR is also hiring a Division Chief to serve as principal staff advisor on all activities related to the Americans with Disabilities Act and Section and Section 504 of the Rehabilitation Act of 1973. Additionally, NHTSA's Office of Grants Management and Operations is preparing to hire two program analysts to focus on stakeholder engagement, equity in traffic safety, and the needs of populations that are overrepresented in traffic fatalities and serious injuries.
In addition, NHTSA was guided, in part, by the Order's requirement to increase opportunities for public engagement when we decided to hold three hearings and publish an RFC in advance of drafting this notice of proposed rulemaking. As a result of those hearings and the RFC, NHTSA received numerous comments from groups specifically focused on equity, from representatives of non-profit community groups, and from members of the public. Many commenters emphasized the importance of equity in highway traffic safety, and several made specific recommendations for the agency to consider. Many of the comments touch on different areas of NHTSA's work that have an impact on the grant program, including NHTSA's research and technical assistance activities. A number of the comments relate to NHTSA activities that fall outside the scope of the rulemaking, which is limited to applications and grant management in the highway safety grant program. In recognition of the importance of the topic, and in appreciation for the thoughtful consideration that went into submission of those comments, we will nonetheless summarize and briefly respond to all comments we received relating to equity.
Many commenters submitted comments asking NHTSA to place less emphasis on enforcement as a traffic safety countermeasure
NHTSA's partnerships with law enforcement and advocacy communities are an important part of traffic safety work, and equity must be at the forefront in that work. The public must be able to trust that law enforcement will treat all persons fairly, regardless of race, color, sex, age, national origin, religion or disability. NHTSA engages in an ongoing dialog with the Center for Policing Equity regarding advancing equity in traffic safety enforcement. NHTSA is also working to center equity in its ongoing relationship with both the National Sheriffs' Association and the International Association of Chiefs of Police, as the National Sheriffs' Association recommended in its comment.
Equally important are the States' partnerships and relationships of trust with their own law enforcement resources. Fundamentally, recipients of Federal grant funds are prohibited from using the funds in a discriminatory manner. As a result, all State grant recipients must ensure that the law enforcement agencies to which they provide highway safety grant funds have strong equity-based enforcement practices. NHTSA's highway safety grant funds may only be used for permissible traffic safety purposes. Use of NHTSA grant funds for discriminatory practices, including those associated with pretextual policing, violates Federal civil rights laws and NHTSA will seek repayment of any grant funds that are found to be used for such purposes and refer any discriminatory incidents to the Department of Justice.
DDACTS is a law enforcement operational model that integrates location-based traffic-crash and crime data to determine the most effective methods for deploying law enforcement and other resources. It focuses on community collaboration to reinforce the role that partnerships play in improving the quality of life in communities and encourages law enforcement agencies to use effective engagement and new strategies. NHTSA continuously reviews the content of DDACTS training and works to ensure that the training focuses on community engagement and the appropriate application of fair and equitable traffic enforcement strategies. Note, however, that not all DDACTS-related activities are eligible uses of NHTSA's highway traffic safety grant funds. NHTSA's grant funds may only be used for traffic safety activities; any other use of law enforcement is not eligible for funding under the highway traffic safety grants. NHTSA will continue to evaluate DDACTS to ensure that it promotes only enforcement that is implemented fairly and equitably.
Both the Vision Zero Network and Safe Routes Partnerships stressed the importance of meaningful community engagement in designing equitable traffic safety programs. The BIL added a requirement for States to include meaningful public participation and engagement in State highway safety programs. 23 U.S.C. 402(b)(1)(B). In addition, Title VI of the Civil Rights Act of 1964 (Title VI), as implemented through DOT Order 1000.12C, requires that recipients of Federal funding submit a Community Participation Plan to ensure diverse views are heard and considered throughout all stages of the consultation, planning, and decision-making process. NHTSA agrees with the commenters that increased community engagement can help ensure that State highway safety programs are more equitable, and proposes regulatory provisions to implement BIL's requirement along with the Community Participation requirements from Title VI of the Civil Rights Act of 1964.
The Vision Zero Network recommended several strategies to rethink and expand the ways education and enforcement are utilized in traffic safety. Among other things, it
The NY GTSC recommended some specific actions that the State has implemented to support the inclusion of equity in its highway safety program, including creation of groups such as the New York State Equity Subcommittee, to ensure programming reaches underserved communities that are overrepresented in traffic crashes. In addition, New York recommended that States expand the data sources they consider, to include census and demographic information, as well as anecdotal information combined with localized crash data in order to conduct outreach efforts. NHTSA appreciates these examples and the efforts that the State already has underway. The agency supports all States looking into additional ways to identify and reach non-traditional highway safety partners and will work to encourage the sharing of effective programs among the States.
The Vision Zero Network recommended that NHTSA take action on the equity-related suggestions in the Federal Highway Administration's report titled “Integrating the Safe System Approach with the Highway Safety Improvement Program.” While that report is targeted to FHWA's HSIP program, NHTSA nonetheless agrees with the overarching principles, including the need to include equity considerations throughout all aspects of the highway safety grant program. This proposal supports these efforts through the increased emphasis on public participation in highway safety planning and through explicitly including demographic data as a resource for States to consult during problem identification.
Finally, the League of American Bicyclists recommended that NHTSA consider discriminatory outcomes of countermeasures when promoting our
NHTSA appreciates the thoughtful feedback from several commenters regarding the Department's implementation of the National Roadway Safety Strategy (NRSS) and the Safe System Approach (SSA). While the substance of the Department's strategy laid out in the NRSS and the SSA is not within the scope of this rulemaking, the activities carried out through the grant program play an important role in implementing the NRSS and the SSA. The objectives of the NRSS/SSA are inherently intertwined with NHTSA's data-driven mission to save lives, prevent injuries, and reduce economic costs due to road traffic crashes through education, research, safety standards, and enforcement. To address the unacceptable increases in fatalities on our nation's roadways, the NRSS/SSA adopts a data-driven, holistic, and comprehensive approach focused on reducing the role that human mistakes play in negative traffic outcomes and in recognizing the vulnerability of humans on the roads. We recognize all the contributing factors involved with a safe system approach: equity, engineering, education, enforcement, and emergency medical services.
Four commenters
The League of American Bicyclists recommended that NHTSA allow States to use highway safety grant funds to provide education on the ways that the built environment can influence safe behaviors. Similarly, Vision Zero Network recommended that NHTSA and States shift the focus from education and enforcement to speed management and roadway design changes. NHTSA notes that while highway safety grant funds may not be used for roadway design, Section 402 grant funds (and in some cases Section 405 grant funds) may be used to fund educational efforts on the interaction between the built environment and behavior, provided such activities are part of a countermeasure strategy for programming funds that is supported by problem ID.
GHSA raised the concern that the SSA framing that people make mistakes will be misunderstood to absolve drivers from responsibility for safe driving
Four commenters suggested that NHTSA undertake activities to help States implement the NRSS and the SSA. CA OTS, GHSA, and Vision Zero Network all suggested that NHTSA support State efforts to implement the SSA by undertaking research to identify best practices and then providing guidance to States on those best practices. Vision Zero Network and WA TSC recommended that NHTSA train the State highway safety offices (HSOs) on the SSA and that the HSOs in turn train their subrecipients. In May 2022, as part of NHTSA's ongoing efforts to provide resources to assist states with implementing the NRSS and the SSA, NHTSA announced an expanded safety program technical assistance offered to States. This technical assistance aligns with the priorities and objectives of the NRSS. We will continue to assess States' needs and offer assistance in implementing the NRSS and SSA where possible as States implement their programs.
The BIL expanded the transparency requirements for Section 402. Specifically, the BIL requires NHTSA to publicly release, on a DOT website, all approved triennial HSPs and annual reports. 23 U.S.C. 402(n)(1). In addition, the website must allow the public to search specific information included in those documents: performance measures, the State's progress towards meeting the performance targets, program areas and expenditures, and a description of any sources of funds other than NHTSA highway safety grant funds that the State proposes to use to carry out the triennial HSP.
Both Advocates and the NSC submitted comments that broadly supported increased transparency, noting that transparency is vital for the public to measure the success of the highway safety grant program. Several commenters provided recommendations for information that they believe would help allow States and stakeholders to compare programs between States. The League of American Bicyclists recommended that NHTSA require States to provide information in the annual application that will show who receives grant funding and what the funding is used for in a manner that allows comparisons between States. NHTSA agrees, and believes that the project information, including subrecipients and information on the eligible use of funds, that BIL and the proposed regulation require for each project will serve this purpose.
GHSA noted that transitioning to an electronic grant management system would enable greater transparency in the use of NHTSA highway safety grant funds by allowing State program information contained in that system to be aggregated, organized, and made available to the public in a user-friendly manner. NHTSA agrees and is currently in the process of working to update our grant management system. We expect that this will facilitate greater cross-state collaboration and data analysis in addition to greater transparency in the use of program funding. In the meantime, NHTSA requests comment on a potential approach to develop a standardized template, codified as an appendix to the regulation, that States could use to provide information in a uniform manner similar to what we hope will be enabled by a future E-grant system. This would also potentially respond to comments from the League of American Bicyclists, Safe Routes Partnership, and Vision Zero Network seeking reports that are easier to read and that enable comparison between States in a useful manner.
Twenty-one commenters provided comments related to various aspects of emergency medical services, post-crash care, and 911 systems. These comments covered three general themes: eligibility for NHTSA grant funds, allowable use of grant funds, and NHTSA's actions related to emergency medical services (EMS) and 911.
Eight commenters discussed eligibility for funding under NHTSA's
Eighteen commenters
Six commenters
GHSA requested amendments to appendices A and B, both of which are required components of State's annual grant application submission. Specifically, GHSA asked that NHTSA format the Appendices, which serve as application documents, so that the signature page is separate from the other pages of the document in order to streamline State approval. The Appendices, consisting of the Certifications and Assurances for Highway Safety Grants and the Application Requirements for Section 405 and Section 1906 Grants, serve as official documents for State grant applications. The signature on those documents serves as a formal, legal attestation from the Governor's Representative that the contents of the State's application are accurate and that the State agrees to comply with all applicable laws, regulations, and financial and programmatic requirements. It is therefore necessary that the signatory see the entire document and that the document not be edited after a signature is appended. NHTSA therefore declines to adopt this suggestion.
Separately, GHSA noted that the BIL expanded the eligible use of Section 154 and Section 164 grant funds to include measures to reduce drug-impaired driving, and requested that NHTSA clarify that those changes had immediate effect. NHTSA affirms GHSA's interpretation; the BIL changes to Section 154/164 took effect immediately upon enactment of the BIL.
This NPRM proposes to add definitions for several terms. Some of these definitions (automated traffic enforcement system (ATES) and Indian country) merely incorporate statutory definitions into NHTSA's regulation. 23 U.S.C. 402(c)(4)(A) and 23 U.S.C. 402(h)(1), respectively. Other definitions (annual grant application, countermeasure strategy for programming funds, and triennial Highway Safety Plan (triennial HSP) were drawn from statutory program requirements. The proposed definition for countermeasure strategy for programming funds was informed by a comment from GHSA asking the agency to clarify its applicability to traffic records programs. Lorrie Walker asked the agency to define “underserved populations,” while GHSA recommended that NHTSA allow States to identify “underserved populations” on a State by State basis and to articulate their rationale because data sources and populations may vary from State to State. After considering these comments, the agency proposes a broad definition for “underserved populations” that is based on the definition used in Executive Order 13985. This high-level definition should provide States with guidance in identifying the specific populations within their jurisdictions, while providing flexibility for different State situations. NHTSA developed definitions for two additional terms to clarify potential sources of confusion for States regarding grant program requirements. The definition of community is intended to build upon the common understanding of the term. The agency developed the definition for political subdivision of a State after consulting definitions codified by other Federal agencies and making adjustments to tailor the definition to the highway safety grant program.
Today's action also proposes to amend some existing definitions, such as those for performance target, problem identification, and program area, to provide further clarity to States. The definition for project was amended to incorporate the BIL's statutory definition of “funded project.” 23 U.S.C. 406(a). The agency proposes to amend the definition for serious injuries to reflect the publication of the 5th Edition of the Model Minimum Uniform Crash Criteria (MMUCC) Guideline.
Finally, this NPRM proposes to delete the definitions for three terms that are not used in the regulatory text: fatality rate, five-year (5 year) rolling average, and number of serious injuries. NHTSA also proposes to delete the definition for “number of fatalities” as we believe it is self-explanatory.
Today's action proposes updates to the authorities and functions of the State Highway Safety Agency, also referred to as the State Highway Safety Office (State HSO or SHSO). The NPRM explicitly adds the requirement that the Governor's Representative (GR) is responsible for coordinating with the Governor and other State agencies, and clarifies that the GR may not be positioned in an entity that would create a conflict of interest with the SHSO; however, these are not new requirements. Section 402 requires that the Governor of the State imbue the State highway safety agency with adequate powers and that it be suitably equipped and organized to carry out the State's highway safety program. 23 U.S.C. 402(b)(1)(A). Recognizing that Governors delegate this responsibility, NHTSA long ago created the requirement for the Governor to designate a GR. In order to carry out the requirements of Section 402, the GR must have the authority to coordinate with the Governor and other State agencies in carrying out the highway safety program. Conflict of interest restrictions are a fundamental component of Federal grant law.
The creation of a new triennial framework is the most significant change that BIL made to the highway safety grant program. In BIL, Congress replaced the annual Highway Safety Plan (HSP), which serves as both a planning and application document under MAP-21 and the FAST Act, with a Triennial HSP and Annual Grant Application. As part of this framework, Congress increased community participation requirements and codified the annual reporting requirement.
Under the new procedures established by BIL, each State must submit for NHTSA approval a triennial Highway Safety Plan (“triennial HSP” or “3HSP”) that identifies highway safety problems, establishes performance measures and targets, describes the State's countermeasure strategies for programming funds to achieve its performance targets, and reports on the State's progress in achieving the targets set in the prior HSP. (23 U.S.C. 402(k)) Each State must also submit for NHTSA approval an annual grant application that provides any necessary updates to the triennial HSP, identifies all projects and subrecipients to be funded by the State with highway safety grant funds during the fiscal year, describes how the State's strategy to use grant funds was adjusted by the State's latest annual report, and includes an application for additional grants available under Chapter 4. (23 U.S.C. 402(l)(1)) Finally, each State must submit an annual report that assesses the progress made by the State in achieving the performance targets set out in the triennial HSP and describes how that progress aligns with the triennial HSP, including any plans to adjust the State's countermeasure strategy for programming funds in order to meet those targets. (23 U.S.C. 402(l)(2))
This new framework continues many of the requirements that States previously were required to meet under the annual HSP requirement, but distributes them between the triennial HSP and the annual application. This redistribution requires NHTSA to update language throughout the regulation in order to clarify to which submission a particular requirement applies. References to the HSP have now been updated to refer to either the triennial HSP or, more frequently, the annual grant application. In addition, NHTSA has removed all references to planned activities throughout the regulation. This will address GHSA's comments that the concept of planned activities was burdensome to States. NHTSA had created the concept of planned activities in the final rule implementing the FAST Act in response to comments from States that they did not have project-level information available at the time of drafting the HSP. However, the BIL now explicitly requires project information in the annual grant application, as described in more detail below. As a result, references to planned activities in the HSP have been updated throughout the regulation to refer to projects in the annual grant application. References to “countermeasure strategies” now link to the triennial HSP instead of the HSP.
In addition, NHTSA has reorganized subpart B of part 1300 to accommodate the new triennial framework. Where previously subpart B was fully directed at the HSP, the subpart now includes separate sections for the triennial HSP, the annual grant application, and specific requirements for Section 402. Section 1300.10 provides that, in order to apply for any highway safety grant under Chapter 4 and Section 1906, a State must submit both a triennial Highway Safety Plan and an annual grant application. The requirements for the triennial HSP and annual grant application, including deadline, contents, and review and approval procedures, are set out in §§ 1300.11 and 1300.12, respectively. Section 1300.13 lays out the special funding conditions for Section 402 grants, and Section 1300.15 provides the rules for NHTSA's apportionment and obligation of Federal funds under Section 402. The agency reserves § 1300.14. The contents of each section will be discussed in more depth below.
There appears to be some confusion among commenters about the timeframes envisioned by BIL for submissions under this framework. AASHTO and GHSA, supported by many State commenters, recommended that for the first year of each triennial cycle, States only be required to submit a triennial HSP along with appendix B, with no annual grant application. They then agreed that States would submit annual applications in the second and third years. This is inconsistent with the statutory requirement. As laid out in BIL, States must submit both a triennial HSP and an annual application in the first year of a triennial cycle, with only an annual grant application for years two and three.
In addition to the broad comments that the agency ensure fidelity to the law in drafting the regulatory text, GHSA specifically requested that NHTSA refrain from requiring application or reporting requirements beyond those explicitly authorized by law. NHTSA has striven to do so. However, we note that relevant legal requirements are not limited to the BIL. For example, OMB's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR part 200) provide many requirements applicable to the grant program, both for States as award recipients and to NHTSA as the awarding agency. We have included several of those requirements throughout this regulation.
NHTSA believes that the triennial framework created by the BIL, with annual projects tied to longer-range planning based on performance targets and countermeasure strategies, is a valuable tool for States as they and NHTSA work to address the recent increase in traffic fatalities. It has never been more important for States to carry out strong, data-driven and performance-based highway safety programs. While NHTSA has worked to implement the statutory requirements and avoid adding unnecessary burden on States, we are committed to ensuring through our review and approval authority that State triennial HSPs and annual grant applications provide for data-driven and performance based highway safety programs. NHTSA will not approve a triennial HSP that has worsening performance targets or where countermeasure strategies are not sufficient to allow the State to meet its targets or are not supported by evidence that they are effective. NHTSA also will not approve an annual grant application where the projects provided are not sufficient to carry out the countermeasure strategy in an approved triennial HSP.
NHTSA proposes revisions to 23 CFR 1300.10 to provide, according to the BIL, that in order to apply for a highway safety grant under 23 U.S.C. Chapter 4 and Section 1906, a State must submit both a triennial Highway Safety Plan and an annual grant application.
The triennial HSP documents the State's planning for a three-year period of the State's highway safety program that is data-driven in establishing performance targets and selecting the countermeasure strategies for programming funds to meet those performance targets. As many commenters noted,
NHTSA incorporates the July 1 deadline set by the BIL. 23 U.S.C. 402(k)(2).
As with previous HSPs submitted annually, the triennial HSP must include the State's problem identification that will serve as the basis for setting performance targets, selecting countermeasure strategies and, later, developing projects. This ensures that the State's highway safety program is data-driven, consistent with 23 U.S.C. 402(b)(1)(B). NHTSA proposes to retain the requirements that the State describe the processes, data sources and information used in its highway safety planning and describe and analyze the State's overall highway safety problems through analysis of data (
The WA TSC commented that NHTSA will need to change the way it evaluates States' problem ID in order to acknowledge factors that shape human behavior outside of raw crash data. NHTSA agrees that data other than crash data are valuable for State's problem ID, but does not agree that NHTSA has limited the types of data States may use to conduct problem ID so strictly. States are encouraged to utilize all data and information sources to conduct problem identification. The WA TSC also stated that raw crash data such as number of crashes and the outcomes of those crashes are outside the control of the SHSO. NHTSA disagrees with this premise. While States may not control all of the factors that contribute to raw crash numbers, such as population or increased VMT, State highway safety programs must be designed to account for those factors and adjust as necessary in order to address the myriad other factors that contribute to increases in traffic fatalities and injuries. As the WA TSC also noted, States can and should submit data in the triennial HSP that demonstrates that the State has conducted a careful analysis of traffic safety problems in the State and then has chosen strategies that are designed to address the specific behaviors that form the root cause of those problems.
NASEMSO and League of American Bicyclists recommended, respectively, that States be required to include consideration of post-crash care issues and perceptions of safety in bicycling and walking as part of their problem identification and, therefore, in their countermeasure strategies. NHTSA encourages States to consider the full constellation of State highway safety problems. However, in order to ensure that States have the needed flexibility to assess data to determine the problems within their borders, the agency declines to specify problem areas for consideration outside those mandated by Congress.
Drew Dawson recommended that NHTSA require States to provide the strategy laying out how the State will continue regular data assessments, including who will perform the analysis, what sources they will consult, and at what intervals. NHTSA does not believe this is necessary because States are already required to submit annual reports that assess their progress in meeting performance targets. 23 CFR 1300.35.
In BIL, Congress added a requirement that State highway safety programs result from meaningful public participation and engagement from affected communities, particularly those most significantly impacted by traffic crashes resulting in injuries and fatalities. 23 U.S.C. 402(b)(1)(B). Relatedly, Title VI of the Civil Rights
NHTSA proposes to incorporate these statutory requirements into the highway safety grant rule in three ways. First, NHTSA proposes a public participation and engagement section in the triennial HSP that would ensure States meet both requirements through a single submission. 23 CFR 1300.11(b)(2). NHTSA proposes to require that the triennial HSP include a description of the starting goals and a plan for integrating public engagement into the State's planning processes, a description of the activities conducted and the outcomes of those activities, and a plan for continuing public participation and engagement activities throughout the three years covered by the triennial HSP. Second, in order to ensure that the public participation and engagement that the State conducts for the triennial HSP plays a meaningful role in the choice and implementation of projects, not just at the planning stage, NHTSA also proposes to require States to describe in the annual report how the projects that were implemented were informed by the State's public participation and engagement. 23 CFR 1300.35(b)(1)(iii). Finally, in order to ensure that SHSOs have the necessary authority to carry out these requirements, NHTSA proposes to add a requirement that each State Highway Safety agency be authorized to foster meaningful public participation and engagement from affected communities. 23 CFR 1300.4(b)(3).
NHTSA received many comments about the BIL's requirement for meaningful public participation in the States' highway safety grant programs. Because they span multiple sections of the rule, NHTSA will address all engagement-related comments here. MN DPS and GHSA both stated their strong support for the requirement and were joined by Brandy Nannini, CA OTS, and NY GTSC in calling for flexibility and for NHTSA to take a long-term view for States' implementation of the requirement. The NSC signaled support for the requirement by advising NHTSA to encourage States to incorporate viewpoints of multiple stakeholders in identifying key safety needs and countermeasures. GHSA and NY GTSC noted that States are already including public participation as part of their highway safety programs, but that each State is doing so differently because they have different landscapes of communities and differing staffing and funding resources. GHSA and NSC both recommended that NHTSA allow States to carry out the required public participation directly, through partner subrecipients, or as part of a multidisciplinary effort run by the State DOT. The Transportation Equity Caucus recommended that States create models to transfer ownership of highway safety planning processes to communities and neighborhoods. Other commenters recommended that NHTSA require States to spend a specified amount of funds to carry out public participation and engagement in areas with the most need, where a certain percentage of fatalities or injuries take place, or in the communities where safety programs are intended to be implemented.
Commenters also provided input on how to measure State public participation efforts. GHSA cautioned that States cannot compel participation and asked NHTSA not to measure compliance by volume of comments or engagement. Other commenters suggested that States be required to report their public participation efforts, including: how they advertised and facilitated public engagement opportunities, what engagement took place, and the impact of that participation on the State's program.
NHTSA received many comments about the need to provide funding for BIL's increased public engagement requirements. GHSA noted that States would need additional funding in order to carry out the required public engagement efforts, while the National Safety Council recommended that States
Commenters provided several suggestions for States about how to conduct their public participation efforts. NHTSA encourages States to consider any and all methods when planning their public engagement efforts. Suggestions included: ensuring that online tools are easy to use (Mari Lynch), publicizing the planning process and explaining how the public can provide input (Drew Dawson, League of American Bicyclists), presenting at schools or other community gathering locations (anonymous), widespread use of social media outlets and other communication channels (NASEMSO), regular opportunities for local information gathering (NSC), joining regional public health or EMS authority meetings (Drew Dawson), and elevating the voices of non-profits and representatives of marginalized groups in State committees and advisory groups (NASEMSO). NASEMSO and an anonymous commenter also recommended that States could increase community engagement through disseminating easy to understand and compelling safety data, including correlation of policies to data improvements.
NHTSA received many comments suggesting non-traditional partners that States should consider including in their planning processes. Recommendations spanned from national to State to local and community levels and are summarized below. NHTSA encourages States to consider all of these groups as they plan their public participation and engagement activities and as they implement their programs. NHTSA will work to share effective means of increasing participation with States.
The League of American Bicyclists and National Sheriffs' Association both recommended using national stakeholder organizations to advertise participation opportunities to their local members. The League of American Bicyclists recommended focusing on national organizations focused on equity and transportation safety. The National Sheriffs' Association specifically recommended using themselves and the International Association of Chiefs of Police to filter funding and messaging down to the local level. Drew Dawson recommended that States work with national-level 911 organizations.
State-level partners recommended by commenters included State agencies, such as transportation, public health, EMS, rural health, economic development, and State law enforcement agencies.
The Vision Zero Network recommended that States prioritize local needs, and suggested that they work with local transportation, health, and policy organizations and community leaders. The League of American Bicyclists also emphasized the importance of working collaboratively with local community organizations, recommending that NHTSA require States to get letters of support for work undertaken within local communities. While NHTSA encourages collaboration with local community groups and supports the Share to Local requirement described in more detail later in this notice, it is beyond our authority to impose such a requirement. An anonymous commenter recommended that States work with local governments, which in turn should work with schools, community centers, churches, and non-profits within their jurisdiction in order to reach communities that may have less resources to interact directly with the State government. Drew Dawson identified local Public Safety Answering Points (PSAPs) and local or regional emergency medical organizations as helpful partners. Finally, the NSC recommended that States seek out existing local or regional task forces.
Many commenters recommended that States build relationships with affected communities beyond traditional partners, such as governmental entities and public figures, in order to gain the benefit of lived experiences.
NHTSA supports and encourages States to reach out to and seek input from a full and diverse range of traffic safety stakeholders, both traditional and non-traditional. States should use all available resources to engage with new stakeholders and increase community engagement. NHTSA acknowledges that many States have already begun working to increase engagement and build community partnerships, and encourages them to continue those efforts. NHTSA will also work to share best practices and effective strategies to increase community engagement.
The BIL also added a related but separate requirement that States support data-driven traffic safety enforcement programs that foster effective community collaboration to increase public safety. 23 U.S.C. 402(b)(1)(E). This provision is essential to ensuring that highway safety programs carried out by law enforcement agencies are equitable and community-based. NHTSA proposes to implement this statutory provision by requiring States to discuss in the annual report the community collaboration efforts that are part of the States' evidence-based enforcement program. 23 CFR 1300.35(b)(2). GHSA recommended that States be allowed to count their efforts in meeting the separate requirement for meaningful public engagement in their triennial HSP in order to show compliance with the community collaboration requirement for enforcement programs. NHTSA disagrees. Congress created two separate and independent requirements: a requirement for a State to provide for a comprehensive, data-driven traffic safety program that results from meaningful public participation (23 U.S.C. 402(b)(1)(B); and a requirement that the State's highway safety program support data-driven traffic safety enforcement programs that foster effective community collaboration to increase public safety (23 U.S.C. 402(b)(1)(E)(i)). Collapsing the two requirements into the broader meaningful public engagement requirement would undermine Congress' intent that States address these as two separate requirements. As described above, States have broad latitude in how to provide meaningful public participation and engagement in the State traffic safety program. It may be possible, though difficult, that some efforts involved in the broader meaningful engagement may be specific enough to be part of the required community collaboration in enforcement programs. If a State is able to fulfill the requirements for both regulatory provisions with the same activities, it may do so; but NHTSA will evaluate the two statutory requirements separately.
States have been using a performance-based planning process in their highway safety plans for many years now. While some States were using performance measures on a voluntary basis already, Congress mandated the use of performance measures for all States in MAP-21 and continued the requirements under the FAST Act. While the BIL separated the planning process and the grant application into the triennial HSP and annual grant application, respectively, it maintained the reliance on performance measures as a fundamental component of State highway safety program planning in the triennial HSP. The BIL maintains the existing structure that requires States to provide documentation of the current safety levels for each performance measure, quantifiable performance targets for each performance measure, and a justification for each performance target. However, the BIL now specifies that performance targets must demonstrate constant or improved performance. 23 U.S.C. 402(d)(4)(A)(ii). Although the BIL makes no other changes to the statutory text specifically related to performance measures, the move from an annual to a triennial HSP presents some practical implications for performance measures as well. NHTSA received many comments on both changes, statutory and practical, and discusses them in more detail below.
As a preliminary matter, instead of the annual performance measures provided in the prior annual HSP, States now must provide performance measures that cover the three-year period covered by the triennial HSP. NHTSA proposes to allow States to set a single three-year target, with informal annual benchmarks provided in the triennial HSP against which they can assess progress in the annual report.
The BIL provides that States must set performance targets that demonstrate constant or improved performance and provide a justification for each performance target that explains why the target is appropriate and evidence-based. 23 U.S.C. 402(k)(4)(A)(ii) and (iii). This is consistent with the NRSS, which sets an ambitious long-term goal of reaching zero roadway fatalities by 2050. Transportation performance management focuses agencies on desired outcomes, outlines how to attain results, and clarifies necessary resources in the near-term. It allows for transparent and open discussions about desired outcomes and the direction an agency should take now. In an era of increasing fatalities, it is vital that performance targets offer realistic expectations that work toward the long-term goal of zero roadway fatalities and provide a greater understanding of how safety issues are being addressed. Several commenters
Other commenters
AASHTO, CT HSO, GHSA and OR DOT expressed concern that the requirement to set performance measures that demonstrate constant or improved performance will cause States to have to set aggressive performance targets and that States will face penalties if they fail to meet aggressive targets. While Section 402 requires States to assess the progress made in achieving performance targets in the annual report (23 U.S.C. 402(l)(2)), and NHTSA is required to publicly release an evaluation of State achievement of performance targets (23 U.S.C. 402(n)(1)), there are no monetary or programmatic penalties for failure to achieve a performance target in the highway safety grant program. The WA TSC commented that States that set a goal of zero traffic deaths will not be punished with additional administrative burdens. The long-term goal of zero traffic deaths is central to the NRSS and SSA. NHTSA acknowledges and appreciates that many states would like to plan and set targets aimed at that goal. We therefore encourage states to thoughtfully consider targets for their triennial HSPs that keep this long-term goal in mind while using a data-based approach based on achievable targets in the short-term. Finally, AASHTO points out that States may face monetary consequences under FHWA's Highway Safety Improvement Program (HSIP) for failure to achieve a common performance measure. However, as a point of clarification, States do not face a monetary penalty under the FHWA's HSIP; they do, however, lose flexibility to redirect safety funds to other programs. NHTSA does not have discretion to undermine the statutory requirement that all performance measures show constant or improved performance.
Several commenters
NHTSA received many comments related to the data that States use to set and assess progress towards meeting performance measures. Several commenters noted that States frequently do not have access to up-to-date FARS or other data available when setting targets or at the time of performance reporting and asked that States be allowed to use the latest available data regardless of data source for these purposes.
Several commenters provided feedback on other aspects of performance measure data. WA TSC noted that since FARS data are provided by NHTSA, States should not be required to report FARS data back to NHTSA. However, the statute and the regulation require not just data reporting, but analysis of the data.
Many commenters
Finally, OR DOT recommended that NHTSA reconcile its definition for “vulnerable road user” with the definition used by FHWA. NHTSA does not provide, nor does it propose, a definition for “vulnerable road user” in the regulation. As such, there is no contradiction with any definitions provided by FHWA. For purposes of the highway safety grant program, States have flexibility to define “vulnerable road users” based on the highway safety challenges identified by their problem ID.
The BIL requires each State to submit, as part of the triennial HSP, a countermeasure strategy for programming funds for projects that will allow the State to meet the performance targets set in the triennial HSP, including data and analysis supporting the effectiveness of the proposed countermeasures and a description of the Federal funds that the State plans to use to carry out the strategy. 23 U.S.C. 402(k)(4)(B-D). NHTSA proposes to incorporate this requirement into the regulation by requiring States to provide, for each countermeasure strategy: identification of the problem ID that the countermeasure strategy addresses and a description of the link between the problem ID and the countermeasure strategy; a list of the countermeasures that the State will implement as part of the countermeasure strategy; identification of the performance targets the countermeasure strategy will address with a description of the link between the countermeasure strategy and the target; a description of the Federal funds the State plans to use; a description of the considerations the State will use to determine what projects to fund to implement the countermeasure strategy; and a description of the manner in which the countermeasure strategy was informed by the uniform guidelines issued by NHTSA in accordance with 23 U.S.C. 402(a)(2).
GHSA recommended that NHTSA amend the definition of countermeasure strategy in order to clarify that it includes innovative countermeasures, and to explain how States can justify the use of innovative countermeasures. While NHTSA has amended the definition of countermeasure strategy for programming funds (see definition section for explanation), that definition does not incorporate the considerations GHSA recommends. Instead, NHTSA proposes to make these suggested clarifications directly in the regulatory
GHSA noted that the BIL removed the previous requirement that States have a traffic safety enforcement program (TESP) (previously 23 U.S.C. 402(b)(1)(E)), and requested that NHTSA remove the related regulatory requirement that the HSP include a specific TSEP section (current 23 CFR 1300.11(d)(5)). Instead, GHSA recommended that States be required only to provide an assurance in Appendix A that the triennial HSP provides for sustained enforcement, and to provide any required information for Section 405 grant applications. NHTSA agrees that it is not necessary to require a dedicated section of the triennial HSP to cover the TSEP. However, we disagree that an assurance is sufficient for States to meet the requirement for States to have a traffic safety enforcement program. The BIL requires that a State program support data-driven traffic safety enforcement programs that foster effective community collaboration to increase public safety. 23 U.S.C. 402(b)(1)(E). NHTSA believes that this statutory requirement represents a step forward in ensuring equitable outcomes in traffic enforcement. While NHTSA agrees that a separate section of the triennial HSP is not required to satisfy this requirement, the agency will not approve a triennial HSP that does not include such a traffic safety enforcement program as part of its countermeasure strategies. The flexibility allowed by removing the separate section requirement will allow States to structure countermeasure strategies that rely on enforcement as only one part of a multi-countermeasure strategy. In recognition that community collaboration efforts may depend on the specific enforcement projects that States implement, NHTSA proposes to require States to discuss the community collaboration efforts that were conducted as part of their evidence-based enforcement programs in the annual report, rather than in the triennial HSP.
GHSA also pointed out that the BIL removed the requirement to describe non-Federal funds that the State intends to use to carry out countermeasure strategies in the triennial HSP. NHTSA has drafted proposed text accordingly.
WA TSC recommended that NHTSA adopt a model of behavior change for State countermeasure strategies, by requiring States to create a theory of change for each countermeasure submitted, including a clear statement of assumptions and a description of how the chosen strategy will influence public behavior. The League of American Bicyclists recommended that NHTSA use the triennial HSP to implement the Safe Systems Approach by promoting the use of the rubric presented by GHSA in its report titled “Putting the Pieces Together: Addressing the Role of Behavioral Safety in the Safe System Approach.” While NHTSA does not endorse any specific strategies over others, the agency supports States thinking outside of the box and encourages States to work together to identify opportunities to learn from each other and share new or innovative ideas. NHTSA will also work with states to identify strategies that incorporate the Safe Systems Approach and to facilitate the sharing of innovative strategies among states.
The BIL requires that the triennial HSP include a report on the State's success in meeting its safety goals and performance targets set forth in the most recently submitted highway safety plan. NHTSA has incorporated this statutory requirement into the proposed regulatory text, adding that the report must contain the level of detail provided in the annual report.
The BIL provides that NHTSA must review and approve or disapprove a State's triennial HSP within no more than 60 days. It further provides that NHTSA may request a State to provide additional information needed for review of the triennial HSP and may extend the deadline for approval by no more than an additional 90 days as a result. The BIL further sets out a requirement that States respond to any requests for additional information within 7 business days of receiving the request. NHTSA proposes to adopt this language in the regulation at 23 CFR 1300.11(c). This is consistent with GHSA's request that NHTSA do so.
The BIL retained the previous statutory approval and disapproval requirements. NHTSA proposes to retain the regulatory provisions incorporating those requirements with only one amendment. In order to meet the approval deadline, NHTSA proposes to require that where NHTSA
The annual grant application provides project level information about the State's highway safety program and demonstrates alignment with the most recent triennial HSP. NHTSA proposes to require the following 4 components be provided in the State's annual grant application: (1) updates to the triennial HSP (for the second and third year annual grant applications); (2) project and subrecipient information; (3) grant application for section 405 and 1906 grant programs; and (4) certifications and assurances.
The BIL allows NHTSA to set the due date for the annual grant application, subject to the requirement that the deadline must enable NHTSA to provide the grants early in the fiscal year.
The BIL provides that States must include, in their annual grant applications, any updates necessary to any analysis in the State's triennial HSP. 23 U.S.C. 402(l)(1)(C)(i). Separately, the BIL requires States to include a description of the means by which the strategy of the State to use grant funds was adjusted and informed by the previous annual report. 23 U.S.C. 402(l)(1)(C)(iii). Because the countermeasure strategy referred to here is part of the triennial HSP, NHTSA proposes to group these two statutory requirements into one requirement. Accordingly, NHTSA proposes that, at a minimum, States must provide a description of the means by which the strategy for programming funds was adjusted and informed by the most recent annual report, or an explanation of why the State made no adjustments. Where a State determined, in its annual report, that it was on track to meet all performance targets, it need merely briefly state that fact. However, in order to give weight to Congress' intent, NHTSA will require any State that is not on track to meet all performance targets to either explain how it will adjust the strategy for programming funds or explain why it is not doing so.
In addition, NHTSA proposes to specify allowable updates related to performance measures. As described more fully in the performance measures section, above, as a general rule, performance measures must be set in the triennial HSP and remain the same throughout the three years covered by the HSP. States can then adjust their countermeasure strategy for programming funds in order to ensure that they remain on track to meet those performance measures. However, NHTSA recognizes that in some cases, a State may identify new highway safety problems during the triennial cycle. In that case, a State may wish to update its analysis to provide new problem ID, with a new performance target and corresponding countermeasure strategy for programming funds. The need for new (or annual) performance targets may additionally arise as a result of the State's application for a motorcyclist safety grant under Section 1300.25. For these reasons, NHTSA proposes to allow States to add new performance measures. Additionally, as described above, NHTSA recognizes the difficulty for States in setting common performance measures with the three year performance measures required for NHTSA's triennial HSP and the annual performance measures required for FHWA's HSIP. As a result, NHTSA proposes to allow States to amend common performance measures. States may not amend any other performance measures, but instead, should consider adjustments to countermeasure strategies for programming funds to meet the targets set.
GHSA stated that the statute provides that the State, not NHTSA, determines what additional analysis might be necessary. NHTSA disagrees with GHSA's interpretation. The statute is silent as to who determines what additional analysis is necessary. Further, the statute requires NHTSA to approve or disapprove of a State's annual grant application in part on the basis of whether it demonstrates alignment with the approved triennial HSP. 23 U.S.C. 402(l)(1)(A)(i). NHTSA will not approve an annual grant application that is inconsistent with the approved triennial HSP.
The BIL requires States to submit, as part of their annual grant application, identification of each project and subrecipient to be funded by the State using grants during the fiscal year covered by the application. The statute further provides that States may submit information for additional projects throughout the grant year as that information becomes available.
GHSA and WI BOTS Patrol both requested that NHTSA commit to not performing granular review of projects on the merits. GHSA stated that States have expressed frustration in the past with NHTSA approving programs or planned activities in the HSP and then later disapproving projects after the project agreement has been signed. They argued that States should be able to rely on NHTSA's regulatory decisions. GHSA argued that NHTSA should use the project level information provided in the annual grant application for financial management, transparency, or program analysis, not for administratively burdensome preapproval. GHSA further stated that, rather than a front-end burden to preapprove State projects, NHTSA should allow States more flexibility to implement compliant activities and that States should face consequences for non-compliance. When approving the annual grant application, NHTSA is looking to see whether the State's submitted projects are sufficient to reasonably carry out the countermeasure strategies in the State's triennial HSP, as well as checking for high-level regulatory compliance issues such as proper funding source. NHTSA review and approval of annual grant applications, similar to our current approval of annual HSPs, does not equate to approval of all projects or activities listed in the application. GHSA is correct in stating that NHTSA approval of the annual grant application should not and does not conflate with specific approval of projects. States have an independent obligation to expend
NHTSA proposes to require States to submit the following information in order to satisfy the statutory requirement to identify projects and subrecipients: project name and description, project agreement number, subrecipient(s), Federal funding source(s), amount of Federal funds, eligible use of funds, identification of P & A costs, identification of costs subject to Section 1300.41(b), and the countermeasure strategy that the project supports. 23 CFR 1300.12(2) These proposed requirements are intended to ensure that NHTSA is able to understand whether the identified projects are sufficient for the State to carry out the countermeasure strategies in the triennial HSP, to identify projects against later submitted vouchers, and to meet statutory transparency requirements. GHSA recommended that NHTSA be guided, and limited by, the project information required for project agreements in the OMB Uniform Administrative Requirements at 2 CFR 200.332(a)(1). GHSA specifically recommended a list of signed project agreements with subrecipient identification, program area classification, project agreement number, amount of federal funds by funding source, and eligible use of funds. NHTSA agrees that the Uniform Administrative Requirements are a valuable source for identifying useful information and proposes to include all of the information suggested by GHSA. The WA TSC recommended providing a link to the countermeasure strategy that the project supports. NHTSA agrees and proposes to include that in the proposed regulation.
The WA TSC also advised NHTSA not to use zip codes as a measure for identifying high priority areas. The WA TSC stated that it would be challenging to account for zip codes for efforts conducted by statewide entities. NHTSA believes that zip codes and other identifying location information are a valuable part of a project description and help ensure that States are implementing programs in the areas that are identified by the State's problem ID. However, NHTSA recognizes that there are many grant-funded activities that are Statewide or, like data system projects, have no physical location. Therefore, NHTSA proposes to include zip codes as an example of information that may be provided as part of a project description, but does not require it for all projects.
Brian Maguire, et. al recommended that NHTSA require States to provide the dollar amount of funding dedicated to each of the five objectives of the NRSS, particularly post-crash care. NHTSA believes that such a parsing would be too burdensome and would not provide sufficient benefit as dollar value, alone, does not align with safety improvements.
The Transportation Equity Council recommended that, in order to facilitate comparison, NHTSA provide a sample list of organization and use of fund types that States should include as project information. NHTSA agrees that such a list is useful. Currently, States use categories provided in the Grants Tracking System to identify eligible use of funds. NHTSA also proposes examples of subrecipient types to be provided in 23 CFR 1300.12(b)(2)(iii).
Finally, GHSA notes that the statute allows states to provide project information throughout the grant year. As noted in 23 CFR 1300.12(d), NHTSA intends to implement this at 23 CFR 1300.32 and will discuss the amendment process and comments in more detail there.
The BIL requires States to provide the application for the Section 405 and Section 1906 grants as part of the annual grant application. 23 U.S.C. 402(l)(1)(C)(iv). As in the past, NHTSA incorporates the requirements for the Section 405 and Section 1906 grants in subpart C and appendix B of part 1300.
As under MAP-21 and the FAST Act, NHTSA continues the requirement for States to submit certifications and assurances for all 23 U.S.C. Chapter 4 and Section 1906 grants, signed by the Governor's Representative for Highway Safety, certifying the annual grant application contents and providing assurances that the State will comply with applicable laws and regulations, financial and programmatic requirements and any special funding conditions. 23 CFR 1300.12(b)(4). The certifications and assurances are provided in appendix A to part 1300. NHTSA has proposed general updates to the certifications and assurances in appendix A to reflect current Federal requirements. Specifically, NHTSA has updated the Nondiscrimination certifications to reflect DOT Order 1050.2A, “DOT Standard Title VI Assurances and Non-Discrimination Provisions.” NHTSA also added a certification on conflict of interest, consistent with the requirement in 2 CFR 200.112. Neither certification creates a new requirement for States; instead, the certifications merely make clear the existing requirements that apply.
Finally, NHTSA proposes updates to the Section 402 requirements consistent with statutory changes in the BIL. NHTSA deletes the requirement that political subdivisions of the State be formally authorized to carry out local highway safety programs, consistent with the BIL's removal of that requirement at former 23 U.S.C. 402(b)(1)(B). However, as described below, this does not remove the requirement for political subdivision participation, which remains an important focus. NHTSA updates the certification regarding the traffic safety enforcement program to reflect the new statutory requirements at 23 U.S.C. 402(b)(1)(E). NHTSA adds the requirement that States (with the exception of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the United States Virgin Islands) participate in the FARS. 23 U.S.C. 402(b)(1)(F)(vi). Finally, NHTSA amends the certification regarding automated traffic enforcement systems to reflect the changes in 23 U.C.S. 402(c)(4).
The BIL provides that NHTSA must review and approve or disapprove an annual grant application within 60 days. 23 U.S.C. 402(l)(D). NHTSA proposes to implement this deadline and additionally proposes to provide procedures for NHTSA to request additional information from States if necessary for review. GHSA is correct in noting that the BIL has language specifically allowing the agency to request additional information in order to review the triennial HSP, but no similar language concerning the annual application. GHSA argued that requests
While Section 402 provides broad flexibility for States to use grant funds to conduct approved highway safety programs, it has long included some specific requirements related to use of funds. NHTSA's grant regulation previously included some, but not all, of these requirements in various parts of the regulation. In addition, the BIL added two new requirements regarding specific uses of grant funds. With this action, we propose to consolidate the statutory funding conditions for Section 402 grant funds into 23 CFR 1300.13 so that State recipients may see these statutory requirements in one place. As part of this effort, NHTSA proposes to delete Appendices C and D and to move those provisions (participation by political subdivisions and P & A costs, respectively) into the main body of the regulatory text. (23 CFR 1300.13(a) and (b)). In addition, NHTSA has added regulatory provisions to incorporate the statutory requirements related to use of grant funds for reducing marijuana-impaired driving, an unattended passengers program, use of funds to check for motorcycle helmet usage, a teen traffic safety program, and the prohibition on the use of grant funds for automated traffic enforcement systems.
In moving Appendix D (Planning and Administration (P & A) costs), into 23 CFR 1300.13(a), NHTSA has streamlined the regulatory language by removing duplicative language. The substance of the provision remains the same. Three commenters (GHSA, MN DPS, and WI BOTS) requested that NHTSA increase the percentage of funds that can be allocated to Planning and Administration (P & A) costs from 15% to 18% in order to cover increased costs due to the increase in grant funding provided by BIL, inflation, technological demands, and expenses associated with remote work. NHTSA notes that the significant increase in 402 funding provided by BIL provides a proportional increase in the total dollar value that is eligible to be used for P & A activities. We do not believe that an increase in the percentage of funds that can be used for non-programmatic activities is warranted at this time. However, if commenters provide additional data in support of this request, we will take it into consideration for the final rule.
NHTSA's highway safety grant program has included a statutory requirement that 40 percent of Section 402 grant funds apportioned to a State be expended by the State's political subdivisions to carry out approved local highway safety programs since the inception of the program with the passage of the Highway Safety Act of 1966.
The BIL amended the statutory requirement underlying this provision by removing the requirement that the local highway safety programs funded with these funds be approved by the Governor. The existing grant regulation provides four avenues for States to demonstrate participation by political subdivisions: (1) direct expenditure, (2) active voice participation by the specific political subdivision, (3) active voice participation by other political subdivisions that is incorporated by request of a different political subdivision; and (4) request by a political subdivision as part of an approved local highway safety program. The statutory change would nullify the fourth avenue, significantly altering the construction of the requirement. In addition, NHTSA also received comments from both GHSA and the League of American Bicyclists related to this requirement. GHSA's comments focused on the difficulty States face in documenting active voice participation by political subdivisions in the expenditure of grant funds due to the large number of local subrecipients. It suggested that NHTSA allow States to meet this requirement through documentation at levels above the individual subrecipient level. It also requested that State-sponsored communication efforts, including those related to HVE campaigns, be allowed to count towards the 40 percent requirement. NHTSA recognizes that States face a large task in coordinating with so many political subdivisions; however, it was clearly the intent of Congress, sustained over decades, that State highway safety programs ensure that Federal funds make their way into the hands (and decision-making authority) of political subdivisions. The statutory requirement is focused on the expenditure of funds, which is not consistent with GHSA's recommendation to allow compliance with this requirement above the subrecipient level. Similarly, a State-sponsored communication effort, tied to a State HVE campaign, by definition, does not meet the condition that the funds be expended by political subdivisions. However, NHTSA recognizes that the existing regulatory requirement to demonstrate “active voice” participation may be unclear or confusing for States and political subdivisions. As described in more detail below, NHTSA is proposing a
Offering a different perspective, the League of American Bicyclists recommended that NHTSA require additional reporting from States on how they meet the local expenditure requirement, including demonstration of community support for the work performed and proof of coordination. While NHTSA agrees that States must provide evidence that political subdivisions directed the expenditure of funds to qualify under this requirement, requiring additional demonstration of community support in order to qualify for this requirement exceeds NHTSA's statutory authority and could impose an unnecessary burden on the communities it is intended to support.
As a result of the BIL's amendments to this requirement, the new triennial framework for highway safety programs, NHTSA's experience administering this requirement, and comments received through the RFC (addressed below), NHTSA proposes a new conceptualization of this statutory requirement. Under the proposed rule, States would show compliance with the statutory local expenditure requirement either through direct expenditure by political subdivisions (
While the statute provides that 40 percent of funds must be expended by the political subdivisions (or 95 percent, in the case of tribal governments), NHTSA recognizes that in some cases it may be advantageous for both the State and the political subdivisions to allow States to expend grant funds on behalf of the political subdivisions. This would enable smaller political subdivisions that may have fewer resources to direct grant funds towards their highway traffic safety needs and would also allow political subdivisions to benefit from the economies of scale that a State-run program can provide. In order to provide the most flexibility for political subdivisions and States, consistent with the statutory limitations, NHTSA proposes to allow expenditures by States to count towards the 40 percent local expenditure requirement so long as there is adequate evidence of the political subdivision's role in the process leading to implementation of the activity. States may demonstrate that expenditures meet this requirement in two ways.
First, the State may provide evidence that the political subdivision was involved in the State's highway safety program planning processes. States can incorporate this into existing processes, such as the public participation component of the triennial HSP, the planning process to determine projects for annual applications, or during the State's ongoing program planning processes. The State would then enter into projects based on the identification of need and implementation notes by the political subdivision during the planning process. Finally, to ensure that the activities implemented do meet the needs of the specific political subdivision, the State must obtain written acceptance by that political subdivision for the project that the State is implementing.
Second, the State may demonstrate that a political subdivision directed the expenditure of funds through a documented request by the political subdivision for an activity to be carried out on its behalf. The request need not be a formal application, but must contain a description of the political subdivision's problem identification and a description of how or where the activity should be deployed within the political subdivision.
During NHTSA's administration of this requirement over time, many States and subrecipients have expressed confusion about which entities qualify as political subdivisions. To resolve this confusion, NHTSA proposes to add a definition of political subdivision to the definitions at 1300.3. In drafting this definition, NHTSA consulted regulatory definitions by other Federal agencies and made adjustments to tailor the definition to the highway traffic safety program.
In order to streamline the regulation, NHTSA proposes to move the Participation by Political Subdivisions regulatory text out of the Appendices and into the body of the regulation at 23 CFR 1300.13(b), along with the other funding conditions for Section 402 grants.
The BIL provides new and amended specified uses of Section 402 grant funds. First, the BIL requires States that have legalized medicinal or recreational marijuana to consider implementing programs to educate drivers and reduce injuries and deaths resulting from marijuana-impaired driving. 23 U.S.C. 402(a)(3). Second, the BIL requires each State to use a portion of Section 402 grant funds to carry out a program to educate the public about the risks of leaving a child or passenger unattended in a vehicle. 23 U.S.C. 402(o). Finally, as explained further below, the BIL amended the prohibition on funding automated traffic enforcement systems. 23 U.S.C. 402(c)(4).
GHSA submitted comments regarding the new requirements related to funding programs related to marijuana-impaired driving and unattended passengers. GHSA noted that all States currently have efforts underway related to drug-impaired driving, so it should not be difficult for them to comply with the new requirement. GHSA asked that NHTSA not specify a required minimum amount that States must expend on unattended passenger awareness because such activities may be tied into larger safety campaigns, so long as States can show that they are implementing a sound countermeasure strategy. NHTSA agrees and does not propose to require a specific monetary amount or specific activities that States must implement to satisfy this requirement. However, States will need to clearly state in their triennial HSPs and annual grant applications which countermeasure strategies and projects address this requirement.
GHSA requested that NHTSA reconsider the decision, formalized in a memo from the Chief Counsel on June 26, 2018, that NHTSA's statutory authority under Section 4007 of the FAST Act prohibits the use of NHTSA grant funds to conduct motorcycle helmet use surveys. As the legislative prohibition has not been rescinded, NHTSA does not have authority to allow NHTSA funds to be used for statutorily-prohibited uses.
The FAST Act prohibited States from expending Section 402 grant funds on automated traffic enforcement systems (ATES) and required each State to either certify that ATES were not used on any public roads within the State or to conduct a biennial ATES survey. The BIL provides a new exception to the prohibition on ATES, allowing States to use Section 402 grant funds to carry out a program to purchase, operate, or maintain an ATES in a work zone or school zone, consistent with guidelines established by the Secretary. The BIL also removed the certification and biennial survey requirement. This action proposes to incorporate these statutory changes. Three commenters (GHSA, Vision Zero Network, and NACTO) requested simplified and updated guidance for the use of ATES. FHWA publishes ATES guidelines in
While one commenter suggested that pedestrians and bicyclists receive a share of all funding at least equal to the proportion of fatalities on the network (Rebecca Sanders), NHTSA does not have the authority to require this type of funding directive. States determine grant fund expenditures on various highway safety problems within their borders based on data. However, the BIL does designate that seven percent of the National Priority Safety Programs be expended on nonmotorized safety grants, and today's proposal incorporates this requirement.
The BIL further provides that in order to be approved, a State highway safety program must support data collection and analysis to ensure transparency, identify disparities in law enforcement, and inform traffic enforcement policies, procedures, and activities. 23 U.S.C. 402(b)(1)(E). As an anonymous commenter noted, better records and data are important to efforts to increase safety. NHTSA received many comments relating to data sources that States should be required to consult or report to NHTSA. Some commenters specified particular documents, while most recommended the same data be included in each submission to NHTSA or did not specify. Many commenters tied their suggestions to improved transparency. In addition, many commenters recommended that NHTSA initiate or require States to work toward improved consistency in their data systems. As these comments appear to be broadly focused, we address them here as a group, in the context of the triennial framework as a whole.
GHSA, WI BTS, 5-State DOTs; MN DPS all recommended that NHTSA provide flexibility as to which data sources States are required to consult in order to meet their planning, application and reporting requirements for NHTSA highway safety grant funds. These commenters explained that data system resources and capabilities, including the specific data captured and how it is shared, vary from State to State and that State Highway Safety Offices have limited control over most, if not all, of the data systems involved in assessing highway safety problems. They specifically noted that States are at varying levels of readiness to meet any potential requirement for universal traffic stop data, particularly because it depends on getting buy-in from law enforcement agencies at all levels of government, not just at the State level. (
Two groups, NACTO and NASEMSO, appear to acknowledge that State data capabilities are not yet at a level to provide all the data that they would like to see reported in State applications and annual reports. NACTO recommended that States work to enhance data collection and reporting procedures, including through requiring all State and local law enforcement agencies to collect and publicly report data for all stops in order to ensure that enforcement actions have a demonstrable public safety impact. Similarly, NASEMSO recommended that States identify the steps that they are taking in preparation for a forthcoming universally unique identifier (UUIS) that would link EMS patient care reports and trauma registry records to crash records. As noted below, NHTSA cannot require States to do so, but these may be eligible uses of grant funds.
NASEMSO recommended that NHTSA require States to provide baseline data from traditional sources such as State crash, vehicle, driver, roadway, and citation & adjudication databases in order to ensure projects are funded in the areas of most need. This is the underlying rationale for the requirement for States to conduct data-driven problem identification in the triennial HSP (see 23 CFR 1300.11(b)(1)). NHTSA notes, however, as described below, that States should consider not only traditional highway safety data sources, but also other data that may provide useful information.
In general, NHTSA seeks to balance the need for data and other information that will help the States and the public understand how and where NHTSA grant funds are being used and the outcomes of the highway safety grant programs being carried out with Federal funds with the need to minimize administrative burdens on both States and their subrecipients so that they can focus efforts on implementing needed highway safety programs. As is described more fully in the sections of this preamble that discuss the proposed requirements for the triennial HSP, annual grant application, and annual report, the information that NHTSA is proposing that States submit in those documents is based on statutory requirements from Section 402 and Section 405, administrative grant requirements in the OMB's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, and, in limited instances, the agency's experience with fielding requests for information from Congress and auditors.
Numerous commenters provided specific recommendations for data that NHTSA should require States to submit or otherwise share with the public. While NHTSA proposes to allow States flexibility to use the data sources that will best inform their highway safety work, NHTSA will relay the recommendations of the commenters below so that States may have the advantage of these diverse suggestions.
The League of American Bicyclists and the TEC both recommended that States should collect and report demographic data in order to identify disparities in traffic safety and in the application of countermeasures, including law enforcement. Both groups recommended that States consult demographic data on traffic stops and citations. The TEC further recommended that States consult a variety of data sources, including traffic stops, citation and adjudication systems, and crash records, aggregated by race, income, geography and other relevant factors in order to inform the State's problem identification and to identify traffic safety disparities. The OR DOT similarly recommended that States add human characteristics to existing crash data by including demographic data, such as income and race, in States' problem identification and program planning. Safe Kids Worldwide and Rebecca Sanders recommended that States include age and race in assessments of fatality and injury numbers. NHTSA agrees that demographic information is invaluable to State highway safety problem identification and program planning. We encourage States to think expansively and seek out all available data sources. However, given the broad reach of the highway safety programs, NHTSA does not propose to require States to provide demographic information for all projects, such as a Statewide paid media campaign, though we do encourage States to provide demographic information as part of a project description where it is relevant. (
Other commenters stressed the importance of including data elements relating to the built environment in order to better understand traffic safety needs. The League of American Bicyclists and Rebecca Sanders both recommended that States look at road design, road speed, and the presence of ped/bike facilities. Rebecca Sanders further recommended that States break down crash data by mode (
Several commenters recommended that States either consider or be required to use a combination of data from law enforcement crash records, NEMSIS and the State trauma registry, both in recognition of the role that post-crash care plays in State highway traffic safety and to provide a better understanding of all parts of the system that play a role in State fatality and serious injury rates. (
NASEMSO submitted several recommendations for detailed project-related data that it believes NHTSA should require States to provide. This includes information on trainings funded by the grant, including number of enrollments, number of participants who completed the course, and a delta that shows the knowledge change for participants. NASEMSO also recommended that NHTSA require measures that show the penetration of State programs, such as the percentage of all target organizations that are eligible to apply for grants, the percentage of organizations that actually applied, the percentage of applicants who received a grant, and the percent of awardees who completed their grant activities. Further, NASEMSO recommended that NHTSA seek equipment availability and usage rate information, including the percentage of vehicles or shifts for which equipment was used and the type and frequency of use for all equipment used to link EMS, trauma and crash records data. Brian Maguire, et. al recommended that NHTSA require States to provide data regarding EMS professionals in the annual report. NHTSA agrees that much of this information could be informative for States and their subrecipients in implementing and supporting their programs or projects, and some of this information (such as equipment use) may be required to support allowability of certain uses of funds during the life of the grant. However, NHTSA believes that requiring this level of information in application or annual report documents would unduly burden States and their subrecipients. NHTSA is especially concerned that this level of reporting would severely discourage smaller or less resourced, often community-led groups, including many EMS organizations, from seeking highway safety grant funds from States. We therefore decline to require this level of information in the proposed regulation.
Finally, Rebecca Sanders recommended that States provide information on community outreach and feedback, including use of community perception surveys. States may consider gathering and using this sort of information.
The Section 405 and Section 1906 grant programs provide incentive grants that focus on National priority safety areas identified by Congress. Under this heading, we describe the requirements proposed in today's action for the grants under Section 405—Occupant Protection, State Traffic Safety Information System Improvements, Impaired Driving Countermeasures, Distracted Driving, Motorcyclist Safety, Nonmotorized Safety, Preventing Roadside Deaths, and Driver and Officer Safety Education, and the Section 1906 grant—Racial Profiling Data Collection. The subheadings and explanatory paragraphs contain references to the relevant sections of this NPRM where a procedure or requirement is implemented, as appropriate.
NHTSA received several comments that apply to all Section 405 and Section 1906 grants. GHSA suggested that, in order to decrease burden, NHTSA allow States to certify compliance with Section 405 eligibility requirements that remain static rather than restating information from prior years. NHTSA declines to do so. Congress authorized the Section 405 grants as annual grants with an annual grant application and annual qualification. NHTSA therefore must review full applications for the Section 405 grants every fiscal year. Where specific Section 405 grants allow for a specific criterion to serve as a qualifying criterion in multiple years of
GHSA urged NHTSA to create a complete qualification checklist for each Section 405 grant program in order to assist States in developing and providing the required information. Appendix B is formatted to serve as the application framework for States and provides a list of application requirements at a high, checklist-style level. However, for full details on application criteria and requirements, NHTSA stresses that States must read the relevant statutory and regulatory text, which provide all application criteria. In rare occasions, the preamble may provide additional clarification, but NHTSA has striven to ensure that the regulation is an easy-to-read, one-stop resource for States to consult in developing and submitting grant applications.
GHSA requested that appendix B be amended to provide States with a checklist of potential reasons for not applying for a grant under Section 405 so that that information can be captured in the grant determination chart that NHTSA publishes online consistent with Section 4010(2) of the FAST Act, as amended by the BIL.
Advocates recommended that NHTSA provide States with a full explanation when they fail to qualify for a grant and to provide guidance on how to meet qualifying criteria. As explained above, NHTSA is required to publish a list of all deficiencies that caused a State to fail to qualify for a grant. In addition, NHTSA has been and remains willing to provide technical assistance to States who seek to resolve any deficiencies identified for future grant cycles.
ESS encouraged NHTSA to express the importance of fully investing Section 405 funds for the Congressionally expressed purposes and to streamline and make efficient the administration of the Section 405 grants. Congress authorized the Section 405 grant programs in response to identified National highway safety priority areas and prescribed allowed uses of funds that address those areas. NHTSA encourages States to use all Section 405 grant funds available.
Some common provisions apply to most or all of the grants authorized under Sections 405 and 1906. The agency proposes changes to only two paragraphs of this section.
The agency proposes to move the definition of personal wireless communications device to 23 CFR 1300.24—distracted driving grants—for ease of reference.
As described in more detail in the relevant grant programs, below, new grant programs and amendments to existing grant programs have led to more diversity in the statutory formulas that NHTSA applies for award determinations under Section 405 and Section 1906. As a result, NHTSA proposes to add provisions setting out the statutory award determination information in each grant program, as opposed to in this section. Therefore, the agency proposes to retitle this paragraph as Transfer of Funds and to delete paragraphs 1 and 2.
The 5-State DOTs requested that NHTSA continue to transfer any remaining Section 405 grant funds to Section 402. NHTSA will continue to do so consistent with statute. 23 U.S.C. 405(a)(10) and 23 CFR 1300.20(e). Currently, the regulation provides that NHTSA shall distribute remaining funds in proportion to the amount each State received under Section 402 for fiscal year 2009. In this action, NHTSA proposes to update the regulation to require distribution in proportion to the amount each State received under Section 402 for fiscal year 2022. This will ensure that distribution is based on more current population and public road mileage and matches the distribution basis that Congress provided in the new grant programs.
As in previous authorizations, in the event that all grant funds authorized for Section 1906 grants are not distributed, the BIL does not authorize NHTSA to reallocate unawarded Section 1906 funds to other State grant programs. Rather, any such funds will be returned for use under 23 U.S.C. 403, and do not fall within the scope of this proposal.
Under the FAST Act, States were required to provide an assurance that they would maintain their aggregate State-level expenditures (Maintenance of Effort, or MOE). The BIL removed this requirement and with this action, the agency proposes to remove the requirement from the regulatory text as well. This would resolve the comment from the 5-State DOTs requesting that NHTSA remove the MOE requirement.
GHSA requested that NHTSA provide clarity on how the FAST Act's MOE requirement applies to oversight of existing grant funds. Since the BIL amendments take effect for the FY24 grant cycle, FAST Act requirements (including MOE) will continue to apply to FY22 and FY23 grant funds.
The BIL continues the MAP-21 and FAST Act Occupant Protection Grants with three substantive amendments. The BIL removed the maintenance of effort requirement that was in effect under the FAST Act, extended the period of time between occupant protection assessments for the assessment criterion for lower seat belt use states, and expanded the allowable uses of funds under this grant program. This NPRM proposes amendments to the existing regulatory language to implement those changes and to update existing requirements to align with the new triennial HSP and annual application framework.
NHTSA received comments related to the Occupant Protection Grants from four commenters.
To qualify for an Occupant Protection grant, all States must meet several requirements. As a result of the new triennial HSP framework created by the BIL, NHTSA made some conforming amendments to these requirements. In addition to replacing “planned activities” with “projects,” as described in more detail above, NHTSA also proposes to clarify that the State's occupant protection plan must be updated annually. The Section 405 grants are annual grants, so NHTSA interprets all application requirements to be annual requirements. That said, not all components of the occupant protection plan must be updated annually. A State could rely on the problem ID, performance measures, targets, and countermeasure strategies laid out in its triennial HSP for the period covered by the triennial HSP. In that case, it would only be required to update the projects component of the occupant protection plan on an annual basis.
To qualify for an Occupant Protection Grant, all States must meet several requirements, as noted above. In addition to meeting the requirements applicable to all States, States with a seat belt use rate below 90 percent must meet at least three of six criteria to qualify for grant funds. The BIL amended one of those criteria, the requirement to complete an assessment of the State's occupant protection program by expanding the time period between assessments from three to five years. In this action, the agency proposes to amend the regulatory requirement to reflect this statutory change.
As mentioned above, NHTSA proposes to move the award amount provisions from 23 CFR 1300.20 into each individual grant program. NHTSA proposes to incorporate the statutory award allocation provision without change.
The BIL made amendments to increase the emphasis on child passenger safety programs aimed at serving low-income and underserved populations. It did so by requiring that all States, including high belt use States, spend at least 10 percent of grant funds to carry out child passenger safety program activities aimed at serving low-income and underserved populations and adding eligible uses for such programs.
Specifically, all States are now required to use at least 10 percent of their occupant protection funds to carry out specified activities related to child passenger safety programs aimed at serving low-income and underserved populations. High belt use rate States may continue to use the remaining 90 percent of their occupant protection funds for any project or activity eligible for funding under section 402. Low belt use rate States must use the remaining 90 percent of their occupant protection funds for eligible occupant protection activities.
GHSA recommended that NHTSA not set out a strict definition of “low-income and underserved populations”, but instead allow States to articulate their rationale for their own definition because data sources and populations may vary from State to State. While NHTSA agrees that data sources and populations vary from State to State, the agency proposes to provide a high-level definition that will provide States with guidance in identifying the specific populations within their jurisdiction.
SafetyBeltSafe U.S.A. and Safe Kids Worldwide submitted comments expressing support for BIL's emphasis on underserved populations and encouraged broader community engagement in child occupant protection. Both commenters suggested increased use of community members as CPS technicians in order to better engage communities, including low-income and underserved populations, in child passenger safety. Safe Kids Worldwide suggested the agency and States work with stakeholders to expand virtual child passenger safety checks. NHTSA encourages States to consider these recommendations when planning their child passenger safety program activities.
SafetyBeltSafe U.S.A. commented that the agency should avoid “siloing” interconnected safety issues such as occupant protection and impaired driving and that occupant protection programs should consider more categories of affected populations, such as pregnant people. NHTSA agrees that traffic safety issues may intersect or be interconnected and that countermeasure strategies may need to go beyond strict program boundaries. Occupant Protection grant funds may be used only for the specified occupant protection uses laid out in statute and should consider all relevant aspects of the State's occupant protection problem ID, including, where applicable, any contributing factors.
The BIL continues, with some changes, the traffic safety information system improvements grant program originally authorized under SAFETEA-LU and extended through MAP-21 and the FAST Act. The purpose of this program remains to support State efforts to improve the data systems needed to help identify priorities for Federal, State and local highway and traffic safety programs and to evaluate the effectiveness of such efforts, to link intra-State data systems, to improve the compatibility and interoperability of State data systems with national data systems and the data systems of other States, and to enhance the ability to observe and analyze national trends in crash occurrences, rates, outcomes, and circumstances. (23 CFR 1300.22(a)).
As explained in more detail below, the BIL streamlined the application requirements by allowing States to submit a certification regarding the State traffic records coordinating committee (TRCC) and the State traffic records strategic plan and removing the FAST Act requirement that States have an assessment of their highway safety data and traffic records system. States must still submit documentation demonstrating a quantitative improvement in relation to a significant data program attribute of a core highway safety database. The BIL removed the maintenance of effort requirement that was in effect under the FAST Act. It also expanded the allowable uses of funds under this grant program.
Finally, while not addressed in the regulatory text of this NPRM, the BIL also provided authorization for NHTSA to provide technical assistance to States with respect to improving the program attributes of State safety data. States are encouraged to reach out to their Regional Office for more information on the types of assistance available and how to request that assistance.
In response to the agency's RFC, commenters generally expressed support for fully implementing and encouraging BIL's expansion of allowable costs under this grant program. Those comments are addressed under the relevant heading below.
The role of the TRCC in the State Traffic Safety Information System Improvements Grant program under this NRPM remains the same as it was under the FAST Act, but the application requirements have been streamlined. The BIL streamlined the application requirements by allowing States to submit certifications relating to the structure and responsibilities of the State traffic records coordinating committee (TRCC) and the contents of the State traffic record strategic plan. NHTSA proposes to adopt those changes in this NPRM. While States are still responsible for ensuring that the TRCC and strategic plan meet grant eligibility requirements, and these requirements may be subject to NHTSA oversight activities, States are no longer required to provide NHTSA with supporting documentation at the time of application.
State must still have a traffic records strategic plan that has been approved by the TRCC and describes specific quantifiable and measurable anticipated improvements in the State's core safety databases. Previously, States requested guidance from NHTSA on traffic records strategic planning. In response, NHTSA developed a practical guide titled “State Traffic Records Coordinating Committee Strategic Planning Guide” (DOT HS 812 773a)
The BIL retained the requirement that States demonstrate quantitative progress in a significant data program attribute of a core highway safety database. This NPRM proposes no substantive changes to this application criteria. However, based on prior questions from States, NHTSA would like to clarify that a State need only submit required documentation demonstrating quantitative improvement in a single data attribute of a core highway safety database.
NHTSA continues to strongly encourage States to submit one or more voluntary interim progress reports to their Regional office prior to the application due date documenting performance measures and supporting data that demonstrate quantitative progress in relation to one or more of the six significant data program attributes. However, Regional office review of an interim progress report does not constitute pre-approval of the performance measure for the grant application.
As mentioned above, NHTSA proposes to move the award amount provisions from 23 CFR 1300.20 into each individual grant program. NHTSA proposes to incorporate the statutory award allocation provision without change.
Four commenters addressed the use of Section 405(c) grant funds. GHSA expressed support for the expanded use of funds and specifically noted the new provisions allowing purchase of equipment for use by law enforcement for near-real time electronic reporting of crash data. WI BOTS similarly encouraged use of Section 405(c) grant funds to improve citation and crash reporting. GHSA also requested that NHTSA revise the guidance it previously issued on expenditures under the Section 405(c) grant program. The agency will review whether it needs to rescind or revise the guidance after this rule is finalized. Two commenters (FL DOH and NASEMSO) emphasized the importance of BIL's addition of the National Emergency Medical Services Information System (NEMSIS) into the Section 405(c) grant statute and encouraged use of Section 405(c) grant funds to make data quality improvements, expand access, and support applied research using NEMSIS data. The IAFC encouraged NHTSA to promote greater direct access to NEMSIS data by EMS practitioners. The regulation mirrors the BIL's inclusion of NEMSIS as a traffic safety data system.
As the commenters noted, the BIL expanded the allowable uses of grant funds awarded under this paragraph by specifying several additional allowable uses of funds. This NPRM proposes to incorporate the allowable uses of funds directly from the statute. States should note that the statute, as well as this NPRM, provides that these specified allowable uses are only allowable to the extent that they make data program improvements to core highway safety databases (including crash, citation and adjudication, driver, EMS or injury surveillance system, roadway and vehicle databases) in one of the significant data program attributes (
The impaired driving countermeasures grant program was created by the Drunk Driving Prevention Act of 1988 and codified at 23 U.S.C. 410. As originally conceived, States could qualify for basic and supplemental grants under this program. Since the inception of the Section 410 program, it has been amended several times to change the grant criteria and grant award amounts. With MAP-21, the impaired driving countermeasures grant program was consolidated into one grant program with other traffic safety grants and codified at 23 U.S.C. 405. The FAST Act made only targeted amendments to the existing grant program under MAP-21, adding flexibility to a separate grant program for States with mandatory ignition interlock laws and creating a new grant program for States with 24-7 sobriety programs.
With the recent passage of the BIL, additional targeted amendments were made to the program with the most significant changes occurring to the interlock grant program that include additional means of compliance and a use of funds section that adds several additional funding categories.
The average impaired driving fatality rate, the basis for most grant awards under this section, refers to the number of fatalities in motor vehicle crashes in a State that involve a driver with a blood alcohol concentration of at least 0.08 percent for every 100,000,000 vehicle miles traveled (VMT). Rate determinations based on FARS data from the most recently reported three calendar years for a State are then averaged to determine a final rate. These determinations are used to identify States as either low-, mid- or high-range States in accordance with the BIL requirements. The agency expects to make rate information available to the States by January each year. If there is any delay in the availability of FARS data in a given year such that it may have an effect on the awarding of grants, the agency may consider allowing the use of rate calculations from the preceding year.
The BIL continues to use the same definitions for low-, mid-, and high-range States. As the agency has noted previously, the agency will not round any rates for the purposes of determining how a State should be classified among these ranges.
The agency proposes to slightly amend the definition of a 24-7 sobriety program to note that State or local courts can carry out a program, consistent with the BIL. 23 U.S.C. 405(d)(7)(A). The agency also proposes to delete the definitions for alcohol and drugs. These definitions were carried over from prior authorizations and are not applicable to these grant requirements. As a basis for the use of grant funds under this section, the agency has deferred to the applicable State law definitions and how the State applies the terms to define various offenses for many years. No changes to any other definitions are proposed for this section.
States that have an average impaired driving fatality rate of 0.30 or lower are considered low-range States. As noted above, the agency will inform each State that qualifies for a grant as a low-range State. These States are not required to provide any additional information in order to receive grant funds. However, States will continue to be required to provide an assurance that they will use grants funds awarded under this section only for the implementation and enforcement of programs authorized under the statute.
The above requirements that apply to low-range States are the minimum requirements that apply to all States that receive a grant under this section.
States that have an average impaired driving fatality rate that is higher than 0.30 and lower than 0.60 are considered mid-range States. In accordance with the statutory requirements, States qualifying as mid-range States are required to submit a statewide impaired driving plan that addresses the problem of impaired driving. The plan must have been developed by a statewide impaired driving task force within the three years prior to the application due date. If the State has not developed and submitted a plan that meets the requirements at the time of the application deadline, then it must provide an assurance that one will be developed and submitted to NHTSA by August 1 of the grant year. Consistent with the statute, this assurance-based method of compliance is only available during the first year of the grant, covering fiscal year 2024 grants only. No assurance-based compliance is available after the first year, regardless of circumstance. If the State fails to submit the plan related to the first-year grant, the agency will seek the return of any grant funds that the State qualified for based on its assurance that it would submit the plan by the deadline, and will redistribute the grant funds to other qualifying States under this section.
In accordance with the BIL, the agency has reviewed the requirements associated with the impaired driving task force and statewide impaired driving plan and determined that some changes are necessary. The proposed changes recognize the continuing serious problem of impaired driving on our nation's roadways and the need to ensure that the approaches taken to combat the problem are sufficiently comprehensive.
For the statewide impaired driving plan, the plan continues to be organized in accordance with the general areas laid out in NHTSA's Uniform Guidelines for State Highway Safety Programs No. 8—Impaired Driving. The proposed changes to the plan requirements make clear that program management and strategic direction, as well as community engagement, are specific requirements. Although these components are features of the existing Uniform Guideline and some States have included specific related sections in their existing statewide plans, the agency seeks to reinforce the importance of these areas to the development of a comprehensive approach to the problem of impaired driving. Program management and strategic direction, in part, cover things like the development of management policies and procedures that ensure program activities are equitably and effectively undertaken and that the activities pursued have maximum value to the public. These policies also focus on identifying needs in the State to ensure sufficient funding and staffing exist to support the impaired driving activities identified. In addition, the proposal adds community engagement as a specific part of the prevention section. Although this approach follows the Uniform Guideline, States are free to identify community engagement as a separate section in their plan. A plan that provides for community engagement and seek community-supported enforcement stands a better chance of overall success. It also reinforces the BIL's requirement that States support data-driven traffic safety enforcement programs that foster effective community collaboration. 23 U.S.C. 402(b)(E)(i). Similarly, the activities should strive to include all demographics and engage prevention strategies through a variety of means.
All qualifying plans also must be developed by a statewide impaired driving task force. As part of a more comprehensive strategy for addressing impaired driving, the proposal increases the number of required members of the task force. In addition to key stakeholders from the State highway safety office, State and local law enforcement, and representatives of the criminal justice system, public health officials, experts in drug-impaired driving countermeasures (such as a DRE coordinator), and specialists in communications and community engagement must be included. Public health officials and experts in drug-impaired countermeasures recognize the increasing prevalence of drug intoxication in impaired driving offenses, while communications and community engagement specialists add expertise on means to ensure that activities are understood and supported at local levels.
NHTSA continues the streamlined approach it took under prior authorizations for the application, only requiring the submission of one document (in addition to any required assurances and certifications)—a Statewide impaired driving plan—to demonstrate compliance with the statute. The plan document should be self-contained, including all required information without the need for appendices or references to information unless it is already contained elsewhere in the impaired driving countermeasures grant application. Within the plan document, there should be three separate sections.
The first section requires the State to provide a narrative statement that explains the authority of the task force to operate and describes the process used by the task force to develop and approve the plan. The State must also identify the date of approval of the plan. The information will help the agency to determine compliance with the requirement that the impaired driving plan be developed by a task force within three years prior to the application due date.
In comments submitted to the agency, GHSA indicated that States must include a “statutory authority” to convene the impaired driving task force and recommended that NHTSA provide a means to allow States to use a “non-statutorily established impaired driving task force.” As with the prior regulation, the agency's proposal continues the requirement that a State simply identify the authority and basis for operation of the task force. This requirement does not specify that a task force have a statutory basis and only seeks a narrative statement that explains the authority. For example, if the authority is derived from the Governor's executive powers as opposed to a State law, the narrative statement can describe this basis. The critical aspect is that the State provide a reasonably clear explanation of its authority to operate and the basis to provide guidance to State and local officials on addressing impaired driving issues in the State.
The second section requires a list of task force members that includes names, titles and organizations for each person. The information must allow the agency to determine that the task force includes key stakeholders from the identified areas. The State may include other individuals on the task force, as determined appropriate, from areas such as 24-7 sobriety programs, driver licensing, data and traffic records, ignition interlock, treatment and rehabilitation, and alcohol beverage control. The goal is that the State has identified individuals from different backgrounds that will bring varying perspectives to impaired driving countermeasure activities such that a comprehensive treatment of the problem is assured.
GHSA commented on the requirement to include a list of task force members, indicating that States should be allowed to certify to the list in their HSPs if the information is already included in the impaired driving plan submission. While the agency does not have an issue with an approach where a State provides a cross-reference in one section to identical information found elsewhere in its application, we are not familiar with a specific requirement to provide the task force member information in the HSP. Without more information about the concern, we cannot fully address it in this proposal. The agency notes that with HSPs moving to a triennial requirement, the need to provide similar information in various parts of the application is lessened.
The final section requires the State to provide its statewide plan to reduce and prevent impaired driving. As noted above, the plan is required to be organized in accordance with the Highway Safety Program Guideline No 8—Impaired Driving, and cover the specified areas. Each area is defined within the guideline. Plans that do not cover the required areas are not eligible to receive a grant. States may cover other areas in their plans provided the areas meet the qualifying uses of funds (as identified in the BIL).
States that have an average impaired driving fatality rate that is 0.60 or higher are considered high-range States. In accordance with the statutory requirements, a State qualifying as high-range State is required to have conducted a NHTSA-facilitated assessment of its impaired driving program within the three years prior to the application due date or provide an assurance that it will conduct an assessment during the first grant year.
High-range States are also required to submit a statewide impaired driving plan that addresses the problem of impaired driving. The plan must have been developed by a statewide impaired driving task force (both the task force and plan requirements are described in the preceding section under mid-range States). If the State has not developed and submitted a plan that meets the requirements at the time of the application deadline, then similar to a mid-range State, the State must provide an assurance that one will be developed and submitted to NHTSA by August 1 of the grant year in order to receive a grant. Consistent with the statute, these assurances for high-range States are only available during the first year of the grant, covering fiscal year 2024 grants. No assurance-based compliance is available after the first year, regardless of circumstance. If the State fails to submit the plan, the agency will seek the return of any grant funds that it qualified for based on its assurance, and will redistribute the grant funds to other qualifying States under this section.
In addition to meeting the requirements associated with developing a statewide impaired driving plan, the plan also must address any recommendations from the required assessment. The plan also must include a detailed strategy for spending grant funds and include a description of how such spending supports the statewide impaired driving programs and will contribute to the State meeting its impaired driving program performance targets.
High-range States must update the plan in each subsequent year of the grant and then submit the updated statewide plan for NHTSA's review.
Under the BIL, a separate grant for States with alcohol-ignition interlock laws has been extended. The BIL made
Under the BIL, two additional bases for compliance have been added to the grant. A State can receive a grant if it restricts driving privileges of individuals convicted of driving under the influence of alcohol or of driving while intoxicated until the individual installs on each motor vehicle registered, owned, or leased an ignition interlock for a period of not less than 180 days. 23 U.S.C. 405(d)(6)(ii). Separately, a State can receive a grant by requiring individuals that refuse a test to determine the presence or concentration of an intoxicating substance to install an interlock for a period of not less than 180 days. 23 U.S.C. 405(d)(6)(iii). This grant criterion also requires the State to have a compliance-based removal program that requires an individual convicted of a DUI to have an interlock installed for not less than 180 days and to serve a minimum period of interlock use without program violations before removal of the interlock.
The agency received several comments on the new grant criteria. Brandy Nannini expressed general support for the increased number of grant criteria and the potential that more States might receive awards. A joint comment submitted by GHSA, Responsibility Initiatives, National Alliance to Stop Impaired Driving, Mothers Against Drunk Driving, National Safety Council, and Council of Ignition Interlock Manufacturers (hereinafter “group commenters”) noted the two additional methods of compliance. The group commenters also encouraged NHTSA “to utilize . . . funding to the fullest extent possible.” The proposal would incorporate into the regulation the statutory language of the additional grant criteria with only clarifying changes. The agency plans to provide grant awards to all States that demonstrate compliance.
The group commenters also provided comments on the first new criterion that requires an offender to meet an installation requirement of not less than 180 days before receiving licensing privileges. The group commenters noted that the requirement does not apply to all offenders but simply to “an individual required to show proof of installation of an interlock after conviction. . . .” As noted above, NHTSA proposes to use the statutory language as the basis for compliance determinations. To the degree the group commenters are noting the statutory basis for compliance and urging its use as the basis for determinations, the agency agrees with such an approach. Accordingly, the agency's proposal only applies the requirement to those offenders that are required to use an interlock as a result of their conviction for driving under the influence.
The agency also received comments on the second new criterion. As a general matter, the group commenters noted that the criterion “components are to be read together” and the State must satisfy both requirements to qualify for a grant. The agency agrees that the structure of the criterion has three distinct requirements, and the State must demonstrate compliance with each to receive a grant. The group commenters also noted that the statute is clear “that the State law only requires a sanction be imposed” and that criminal convictions are not necessary. The agency agrees with the observation that the criterion covers more than just the individuals convicted of a refusal and that the installation requirement also covers those administratively sanctioned for test refusal. In order to meet this component, in accordance with the statute, State law must show that for each type of offender required to install an interlock, the interlock period must be for not less than 180 days.
For the compliance-based removal program, the agency received comments from the group commenters and, individually, from GHSA. The group commenters touted the compliance-based removal process as something that “will better ensure that individuals who are at risk of recidivism remain on the ignition interlock until behavior has changed to better ensure public safety.” The group commenters also noted that “this criterion is met if an individual is required to meet a States' compliance based removal standard rather than the requirement that it is mandatory for all individuals who install an ignition interlock.” In accordance with the statute, the agency's proposal does not apply to all individuals who install interlocks, but only to those convicted of the specified offenses
The agency's proposal continues a separate grant for States with 24-7 sobriety programs consistent with the statutory requirement. Although the definition of a 24-7 sobriety program has been slightly amended to note that State or local courts can carry out a program, this does not affect the qualifying basis for a grant. 23 CFR 1300.23(b).
The first requirement mandates that a State enact and enforce a law that requires all individuals convicted of driving under the influence of alcohol or of driving while intoxicated to receive a restriction on driving privileges for at least 30 days. The second requirement mandates that a State provide a 24-7 sobriety program. States should continue to submit information identifying a State law or program that authorizes a 24-7 sobriety program in line with the statutory requirement.
GHSA commented that States should qualify on the basis of identifying a State statute authorizing “local 24/7 sobriety programs.” The basis for compliance is a determination of whether the State law or program meets the definition of a 24-7 sobriety program. The entities that carry out the State law or program are not part of the evaluation. A State law could be submitted that authorizes local courts to carry out a 24-7 sobriety program, for example. Provided the State law meets the statutory definition of a 24-7 sobriety program it would be eligible for a grant.
As in the explanation for 23 CFR 1300.20, above, in today's action, the agency proposes to move award allocation provisions from the general section of the rule into the specific grant programs. We propose to incorporate the statutory allocation provisions without substantive change.
The BIL specifies the eligible uses of the grant funds, and the agency's proposal codifies those uses without change. With the exceptions discussed below, grant funds may be distributed among any of the uses identified in the BIL. The agency has adopted in its proposal the statutory basis for using grant funds depending on whether the State has qualified as a low-, med- or high-range State or is receiving separate grant funds as a State with either alcohol-ignition interlock laws or 24-7 sobriety programs. No changes have been made to these requirements.
The agency received comments related to the specific uses of grant funds that were added in the BIL. Brandy Nannini submitted a comment that expressed support for some of these new grant uses as being important to state success. The comment specifically mentioned the ability to use funds to backfill officers during drug recognition expert (DRE) training and, separately, to purchase new screening and testing technologies. In a related comment, GHSA urged that NHTSA should “allow the use of [grant] funding to temporarily replace officers in DRE training or serving as a DRE instructor” to include “funding for compensation for officers who are not involved in grant-eligible activities.” Under the BIL, a new provision allows grant funding to be used to provide compensation for a law enforcement officer to carry out safety grant activities while another law enforcement officer involved in safety grant activities is away receiving drug recognition expert training or participating as an instructor in drug recognition expert training. This backfill provision allows police agencies to send officers to training without sacrificing overall levels of service. By its terms, however, the statutory provision limits compensation to law enforcement officers that carry out
GHSA also provided a comment indicating that “States have expressed a sense of ambiguity whether they can spend federal funds in support of oral fluid testing programs and other leading technological applications to address impaired driving that may often not yet be considered `proven effective countermeasures.' ” GHSA recommends that NHTSA allow funds to be used to test and implement new allowable initiatives. Under the BIL, a new provision allows funds to be used for “testing and implementing programs, and purchasing technologies, to better identify, monitor, or treat impaired drivers, including . . . oral fluid-screening technologies.” 23 U.S.C. 405(4)(xi). On that basis, States are allowed to use funds for such expenditures. However, all requirements associated with grant expenditures under this regulation and 2 CFR part 200 would apply to such uses. Because such expenditures have the potential to result in wasteful uses of Federal taxpayer funds, States should expect NHTSA to apply the uniform administration requirements to such activities, including such general concepts as reasonableness, allowability, and allocability of any proposed funding. In addition, States are reminded that equipment only purchases are not permitted and any such purchases would need to be carried out as part of an approved traffic safety activity that meets all associated requirements. Further, the statute explicitly states that these technologies are eligible as part of “developing and implementing
The National Sheriffs' Association recommended that NHTSA consider funding to encourage State legislation related to stricter penalties for impaired driving. NHTSA notes that this is not a specified allowable use of funds under the BIL and that Federal grant funds may not be spent on lobbying.
MAP-21 established a new program authorizing incentive grants to States that enact and enforce laws prohibiting distracted driving. Few States qualified for a distracted driving grant under the statutory requirements of MAP-21. The FAST Act amended the qualification criteria for a distracted driving grant, revising the requirements for a Comprehensive Distracted Driving Grant and providing for Special Distracted Driving Grants for States that do not qualify for a Comprehensive Distracted Driving Grant. While more States qualified for grants under the FAST Act, the criteria remained difficult for States to meet.
The BIL resets the distracted driving incentive grant program by significantly amending the statutory compliance criteria. The statute establishes two types of distracted driving grants—distracted driving awareness on the driver's license examination and distracted driving laws. A State may qualify for both types of distracted driving grants. At least 50 percent of the Section 405(e) funds are available to States that include distracted driving awareness as part of the driver's license examination, and not more than 50 percent of the Section 405(e) funds are available to States for distracted driving laws.
The basis for a Distracted Driving Awareness Grant (“Awareness Grant”) is the requirement that the State test for distracted driving awareness as part of the State driver's license examination.
In a letter to NHTSA, GHSA interpreted the changes in the BIL as automatically distributing 50 percent of the section 405(e) funds to all States but limiting State expenditure to the authorized uses under Section 405(e)(8). This interpretation is not supported by the statutory language. The Section 405(e)(2)
The BIL sets out three different types of laws for which a State may qualify for a Distracted Driving Law Grant (“Law Grant”): (1) prohibition on texting while driving; (2) prohibition on handheld phone use while driving; and (3) prohibition on youth cell phone use while driving. 23 U.S.C. 405(e)(3)(B). In its letter, GHSA interpreted the changes in the BIL as allocating the “remaining 50%” among States with a qualifying distracted driving law for banning texting, banning handheld use, or banning teen cell phone use. GHSA further claimed that States are eligible for an “extra 25% of their apportionment” if the State prohibits a driver from viewing a device while driving. NHTSA agrees with GHSA that a State can qualify for a grant under Section 405(e) with a either law banning texting while driving, handheld use while driving, OR youth cell phone use while driving. However, the agency does not agree that States are eligible for an extra 25 percent for prohibiting viewing while driving. Such an interpretation is not supported by the language of the statute. Section 405(e)(3)(B)(iv) states that “the allocation under this subparagraph to a State that enacts and enforces a law that prohibits a driver from viewing a personal wireless communications device (except for purposes of navigation)
While this statutory language is not without ambiguity,
Accordingly, the agency proposes making a grant to a State for a conforming law that prohibits one of the following: (1) texting while driving; (2) handheld phone use while driving; (3) youth cell phone use while driving; or (4) viewing while driving. The agency further proposes that a State that is able to meet more than one of these eligibility requirements would be approved for the award that results in the highest grant amount. The statute prescribes in detail the criteria for a conforming law, including definitions and exceptions. As discussed below, the agency proposes to adopt the criteria, including definitions and exceptions, without change.
The statute defines the terms driving, personal wireless communications device, text, and text message.
The BIL retained much of the FAST Act requirements for a conforming law prohibiting texting while driving. In order to qualify, the statute provides that the State law must prohibit a driver from texting through a personal wireless communications device while driving; must establish a fine for a violation of the law; and must not provide for an exemption that specifically allows a driver to use a personal wireless communications device for texting while stopped in traffic. The BIL changed the FAST Act requirement for a minimum fine by striking “minimum.” To implement this change, the agency deletes the existing
The prohibition on handheld phone use while driving is new under the BIL. The statutory language is clear that the State law must prohibit a driver from holding a personal wireless communications device while driving in order to satisfy this component for a conforming law prohibiting handheld phone use while driving. The State law must also satisfy two additional components for a qualifying law, the same as those for a prohibition on texting while driving law—establish a fine for a violation of the law and not provide an exemption that specifically allows a driver to use a personal wireless communications device for texting while stopped in traffic. NHTSA proposes to adopt these provisions without change.
As with the prohibition on texting while driving law, the BIL retained much of the FAST Act requirements for a conforming law prohibiting youth cell phone use while driving. However, the BIL amended the requirement for a youth law by striking the reference to the State Graduated Driver Licensing Incentive Grant, which was repealed. Instead, the State law must now prohibit a driver from using a personal wireless communications device while driving if the driver is under 18 years of age or in the State's learner's permit or intermediate license stage in order to qualify for a grant. Graduated driver licensing, also known as a multi-stage licensing process, is a three-phase system for beginning drivers consisting of a learner's permit, an intermediate or provisional license, and a full license. A learner's permit allows driving only while supervised by a fully licensed driver. An intermediate or provisional license allows unsupervised driving under certain restrictions, such as nighttime or passenger restrictions. While the graduated driver licensing program differs from State to State, the agency does not intend to define any specific requirements for the learner's permit or intermediate license stages. In order to satisfy this component, the State law must prohibit a younger driver in the State's learner's permit or intermediate license stage from any use of a personal wireless communications device while driving. Note that the State law must not provide an exemption for hands-free use. Similar to the texting law discussed above, the BIL also strikes “minimum” from the fine requirement and removes primary enforcement from the qualification requirements, and the agency proposes to adopt these changes without change.
As discussed above, the statute is not specific regarding the allocation for a State that enacts and enforces a law that “prohibits a driver from viewing a personal wireless communications device (except for purposes of navigation).” The BIL incentivizes States to enact and enforce three different types of laws (prohibition on texting while driving, handheld phone use while driving, and youth cell phone use while driving), with higher grant amounts for the strictest of these laws,
For both grants, the BIL specifies how grant funds are allocated among the States—based on the proportion that the apportionment of the State under section 402 for fiscal year 2009 bears to the apportionment of all States under section 402 for that fiscal year. 23 U.S.C. 405(e)(3). In determining the grant award under each distracted driving grant, NHTSA proposes to apply the section 402 apportionment formula for fiscal year 2009 as if all States qualified for grants and then make awards to qualifying States based on the application of the formula.
The BIL made no changes to the use of funds for a distracted driving grant. However, NHTSA proposes to amend the language for demonstrating conformance with MMUCC. In 2020, NHTSA mapped States' conformance with the most recent MMUCC. Instead of requiring States to complete the NHTSA-developed MMUCC Mapping spreadsheet within 30 days, NHTSA proposes to require States to submit its most recent crash report with the distracted driving data element(s) within 30 days of award. NHTSA can then confirm whether the State's distracted driving data element(s) conform(s) to the most recent MMUCC.
In 2005, Congress enacted SAFETEA-LU, which authorized the Motorcyclist Safety Grants under section 2010. This grant program has largely remained unchanged since it was established, despite several revisions to the National Priority Safety Programs (23 U.S.C. 405).
Under BIL, Congress amended the Motorcyclist Safety Grants by increasing the number of criteria available for a state to qualify for a grant to seven from six and made a minor terminology change to “crash” from accident in two paragraphs. A State is eligible under the new criterion if a State has a helmet law that requires the use of a helmet for each motorcycle rider under the age of 18. 23 U.S.C. 405(f)(3)(C). With the addition of this criterion, States qualify for a grant by meeting two of the following seven grant criteria: Motorcycle Rider Training Course; Motorcyclists Awareness Program; Helmet Law; Reduction of Fatalities and Crashes Involving Motorcycles; Impaired Driving Program; Reduction of Fatalities and Crashes Involving Impaired Motorcyclists; and Use of Fees Collected from Motorcyclists for Motorcycle Programs. The BIL made no additional amendments to the Motorcyclist Safety Grants. Today the agency proposes amendments to 1300.25 to incorporate these changes and to update references to planned activities in the annual HSP for the new triennial framework. We discuss the new Helmet Law criterion in further detail below. NHTSA received no comments related to the Motorcycle Safety Grants.
To be eligible for a Motorcyclist Safety Grant under this criterion, the BIL requires that a “State shall have a law requiring the use of a helmet for each motorcycle rider under the age of 18.”
As described above, NHTSA proposes to address award amounts in the grant-specific sections. NHTSA therefore proposes to incorporate the statutory award distribution formula and limitation for the motorcyclist safety grant in the regulatory text at 23 CFR 1300.25(l).
The FAST Act introduced the nonmotorized safety grant as part of the National Priority Safety Programs, recognizing the need for a stand-alone safety grant for roadway users outside the motor vehicle. The BIL changed the nonmotorized safety grant to help address the recent exponential rise in pedestrian and bicyclist fatalities and the growing use of low-powered or nonmotorized personal transportation devices such as e-scooters and electric bicycles (which it defines as non-motorized). Pedestrian and bicyclist fatalities have continued to rise, from 14 percent of total motor-vehicle-related traffic fatalities in 2009 to approximately 19 percent today. Further, micromobility, which includes such vehicles as e-scooters, e-bikes and other low-speed personal transporters, is a mode of transportation that both holds promise for users with physical challenges and offers more affordable mobility. However, micromobility is changing rapidly and growing in use, and States are struggling to keep pace with these emerging modes of transportation and their safety implications.
Research-driven and innovative countermeasures and strategies that address safety and accessibility problems can significantly differ for pedestrians, bicyclists, or micromobility users. States often make significant roadway infrastructure improvements, such as raised crosswalks, narrowing lanes, separated bike lanes, or pedestrian refuge islands, to create safe, accessible and equitable transportation for nonmotorized users. However, behavioral safety countermeasures, such as outreach, education, community engagement, enforcement, and data analysis are essential for a comprehensive approach to nonmotorized road user safety. The Section 405(g) grant aims to address the unique needs of nonmotorized roadway users with non-infrastructure investments.
Similar to the grant under the FAST Act, States are eligible for a nonmotorized safety grant under the BIL if the State's nonmotorized road user fatalities in the State exceed 15 percent of the total annual crash fatalities in the State, based on the most recent final FARS data. However, while the FAST Act specified combined pedestrian and bicyclist fatalities, the BIL expands the definition of nonmotorized road user to a pedestrian; an individual using a nonmotorized mode of transportation, including a bicycle, scooter, or personal conveyance; and an individual using a low-speed or low-horse powered motorized vehicle, including an electric bicycle, electric scooter, personal mobility assistance device, personal transporter, or all-terrain vehicle. NHTSA plans to adopt this definition without change. Using FARS data, NHTSA proposes to calculate the percentage of each State's annual nonmotorized road user fatalities in relation to the State's annual total crash fatalities, using Statistical Analysis System (SAS) software and truncating the calculation. Consistent with the statute, all States that exceed 15 percent will be eligible for a grant.
The agency proposes to inform each State that is eligible for a grant prior to the application due date.
To qualify for a grant under this section, NHTSA proposes to change the self-certification as the application for a nonmotorized safety grant under the previous regulation and require States to submit a list of project(s) and subrecipient(s) information the State plans to conduct in the fiscal year of the grant consistent with § 1300.12(b)(2). NHTSA believes that this aligns the application requirements for the nonmotorized safety grants with the other highway safety grants.
The BIL makes significant amendments to the use of funds for the nonmotorized safety grant program. Under the FAST Act, the statute limited the use of funds to activities related to
The Safe System Approach intentionally broadens the focus of addressing highway safety problems, such as nonmotorized road user safety, to more systemic, community-level strategies. Using the Safe System Approach and a comprehensive problem identification process as guiding principles, each community's nonmotorized safety grant project within each State's highway safety program will likely be unique.
Several organizations and members of the public commented on the use of funds for the nonmotorized safety grant. One commenter, Tom Schwerdt, recommended that designs need to be changed to get cyclists and pedestrians out of the roadway. The BIL specifies eligible uses for the nonmotorized grant funds, and the statute does not allow them to be used for infrastructure designs. However, States may use grant funds to raise public awareness and provide education to inform road users of infrastructure designed to improve nonmotorized road user safety.
The BIL created a new Preventing Roadside Death grant program, authorizing grants to prevent death and injury from crashes involving motor vehicles striking other vehicles and individuals stopped at the roadside. The purpose of the new grant program is to support State efforts to decrease roadside deaths involving vehicles and pedestrians on the side of the road. NHTSA proposes a new § 1300.27 to implement the Preventing Roadside Death grant program.
The agency received several comments that acknowledge the safety risk posed by disabled vehicles and supported the Preventing Roadside Death grant program for both first responders and civilians.
The BIL did not define terms in section 23 U.S.C. 405(h). In order to provide clarity, today's proposal includes definitions for digital alert technology, optical visibility, and public information campaign. The agency developed these definitions based on what we consider common understanding of the terms. We seek comment on these proposed definitions.
As directed by the BIL, a State is eligible for a Preventing Roadside Death grant if it submits a plan that describes the method by which the State will use grant funds according to the eligible uses identified in the statute. 23 U.S.C. 405(h). Consistent with the BIL, NHTSA proposes that States submit a plan that requires information familiar to States and is consistent with the type of information States provide in other plans provided to NHTSA. Accordingly, we propose that the State's plan, at a minimum, list the eligible use(s) selected, identify the specific safety problems to be addressed, and specify the performance measures and targets, and the countermeasure strategies and projects that implement those strategies, that the State will use to address those problems. We seek comments on the proposed criteria to be included in the State's plan and whether additional information should be included in the plan.
The agency incorporates the statutory award allocation provision into the regulation.
The BIL specifies with particularity how States may use Preventing Roadside Death grant funds. 23 U.S.C. 405(h)(4). Today, we propose to adopt the BIL language without change.
NHTSA received several comments related to use of funds under this grant program. ESS notes that the statute authorizes the use of funds to “pilot and incentivize measures, including optical visibility measures, to increase the visibility of stopped and disabled vehicles” (23 U.S.C. 405(h)(4)(E)) and encourages the agency to promote the grant to address the disabled vehicle safety issue. Another vendor, Haas Alert, encourages NHTSA to address impediments that exist for a State to apply for a grant such as contract administration costs and the inability of private industry to subcontract with States. Meanwhile, Paul Hoffman encourages the agency to promote enforcement and educational activities under the Preventing Roadside Death grant. The International Association of Fire Chiefs also encourages driver education to improve first responder safety. The use of grant funds authorized by Congress in BIL, and incorporated by the agency into the proposed rule, covers all of the activities (and also supports data collection activities) that were raised by commenters. As is typical of all Federal grants, States must adhere to 2 CFR part 200 requirements when administering grant funds awarded under the Preventing Roadside Deaths grant. These requirements apply to all Federal grantees and address contract administration and subrecipient requirements. NHTSA notes that Federal rules do not prohibit States from contracting with private entities.
The BIL created a new driver and officer safety education grant program, authorizing incentive grants to States
This NPRM proposes to adopt the definition of “peace officer” directly from the statute. 23 U.S.C. 405(i)(1). NHTSA also provides a definition for driver education and driving safety course to clarify the types of courses/programs that can qualify for the grant.
The BIL provides that States may qualify for a driver and officer safety education grant in one of two ways: (a) a current law or program that requires specified information to be provided in either driver education and driving safety courses or peace officer training programs; or, (b) for a period not to exceed 5 years, by providing proof that the State is taking meaningful steps towards establishing such a law or program. 23 U.S.C. 405(i)(4). We discuss these qualification criteria in more detail below.
The BIL provides that one way a State may qualify for a grant under this section is with a law or program requiring that driver education and driver safety courses provided by educational and motor vehicle agencies of the State include instruction and testing materials relating to law enforcement practicing during traffic stops, covering the role of law enforcement, duties and responsibilities of peace officers, the legal rights of individuals, best practices for civilians and peace officers during interactions, consequences for failure to comply with the law or program, and information regarding how to file complaints or compliments relating to a police officer. 23 U.S.C. 405(i)(4)(A). NHTSA incorporates the requirements for the State's law or program directly from the statute. NHTSA proposes regulatory text to provide clarity to States regarding how to demonstrate compliance with the requirements, whether applying with a legal citation or with documentation, including a certification from the GR and course materials demonstrating that the State is implementing a compliant program.
The BIL provides that another way a State may qualify for a grant under this section is by having either a law or program requiring that the State develop and implement a training program for peace officers and reserve law enforcement officers with respect to proper interaction with civilians during traffic stops. 23 U.S.C. 405(i)(4)(B). NHTSA proposes to incorporate those requirements without change. NHTSA proposes regulatory text to provide clarity to States regarding how to demonstrate compliance with the requirements, whether applying with a legal citation or with documentation, including a certification from the GR and course materials demonstrating that the State is implementing a compliant training program.
If a State is unable to apply for a grant under the two options described above, the BIL provides a third, though time-limited way, for a State to qualify for a grant under this section. The BIL allows a State that has not fully enacted or adopted a compliant law or program to qualify for a grant if it can demonstrate that it has taken meaningful steps toward full implementation of such a law or program, including establishment of a timetable for implementation. 23 U.S.C. 405(i)(7). States may only receive a grant under this section for 5 years.
The BIL provides that the Federal share of the cost of carrying out an activity funded through a grant under this program may not exceed 80 percent. 23 U.S.C. 405(i)(3). NHTSA proposes to implement this requirement without change.
The BIL specifies that grant funds under this section shall be allocated in proportion to the apportionment of that State under Section 402 in fiscal year 2022. 23 U.S.C. 405(i)(6). The BIL further specifies, however, that NHTSA shall withhold 50 percent of grant funds that would be allocated under that formula from States that qualify as a “qualifying State” (
The BIL laid out specific allowable uses of grant funds under this grant program. Specifically, BIL provides that States may use driver and officer safety education grant funds for the production of educational materials and training of staff and for the implementation of a qualifying law or program. 23 U.S.C. 405(i)(5). This NPRM proposes to incorporate the uses of funds directly from the statute without change.
Section 1906 of SAFETEA-LU established an incentive grant program to prohibit racial profiling. The BIL continues the intent of the Section 1906 grant program, which is to encourage States to enact and enforce laws that prohibit the use of racial profiling in traffic law enforcement and to maintain and allow public inspection of statistical information regarding the race and ethnicity of the driver for each motor vehicle stop in the State. BIL revised several aspects of the Section 1906 Program.
For Section 1906, the BIL, like the FAST Act, does not specify how the grant awards are to be allocated. Under the FAST Act, NHTSA allocated Section 1906 grant awards in the same manner as the Section 405 grants. However, as described elsewhere in this preamble, the BIL diversified the allocation formulas for the Section 405 grants so that there is no longer a default formula. In order to ensure the most up-to-date distribution of funds, NHTSA proposes to apply the same formula that Congress developed for the two new Section 405
The FAST Act placed two limitations on States' ability to receive grant funds under Section 1906. The BIL removed the limitation that provided that a State may not receive a grant by providing assurances for more than 2 fiscal years. The BIL amended the other limitation, which provided a 5 percent maximum amount limitation on a State's total grant award. Specifically, the BIL specified that the total amount provided to a State that qualifies using official documentation may not exceed 10 percent of the amount made available to carry out this section in that fiscal year; and that the total amount provided to a State that qualifies by providing assurances may not exceed 5 percent of the amount made available to carry out this section in that fiscal year. The agency proposes to incorporate these revisions into the regulatory text.
The BIL extended the allowable uses of the grant funds awarded under the Section 1906 Program by allowing States to expend grant funds to develop and implement programs, public outreach, and training to reduce the impact of traffic stops. This NPRM proposes to incorporate those uses directly from the statutes. States should note the specific allowable uses of the grant funds are only allowed to the extent that they carry out the intent of the grant program, which is to reduce the disparate impact of racial profiling during traffic stops and to encourage States to maintain and allow public inspection of statistical information on the race and ethnicity of the driver for all motor vehicle stops on Federal-Aid Highways. For example, States may conduct outreach to law enforcement agencies that is geared toward data collection, evaluation of data reports, and implementation of changes to address issues found in data reports.
Several commenters (Institute for Municipal and Regional Policy (IMRP), GHSA, and TEC) expressed broad support for the 1906 grant program and the expanded use of funds authorized by the BIL. Specifically, both IMRP and the Vision Zero Network submitted comments recommending the use of 1906 grant funds for efforts beyond data collection and analysis, such as police training programs, community outreach and engagement, collection and analysis of pedestrian data. The League of American Bicyclists called for NHTSA to encourage States to apply the 1906 Program not just to traffic stops of motor vehicle drivers, but to traffic stops of pedestrians and bicyclists. As stated above, NHTSA proposes to incorporate the new statutorily allowed use of funds provision that allows use of funds to develop and implement programs to reduce the impact of racial profiling during traffic stops. Traffic stops of nonmotorized road users, including pedestrians and bicyclists, may potentially be included in the data collection as they are a component of traffic safety. However, States should be aware that statutory use of funds provision is limited to traffic stops, so any stop of a nonmotorized road user that is covered by the program would have to occur in that context.
Multiple commenters
Finally, the IMRP called for the data collected under the 1906 Grant Program to be submitted to a national data repository to help NHTSA and other Federal and State partners access data to continue furthering research on practices to achieve a safe, fair, and equitable traffic enforcement system. While NHTSA appreciates the value such a repository would provide, the BIL does not provide NHTSA with the authority to require States to submit such data and no such national data repository currently exists.
Subparts D, E and F provide post-award requirements for NHTSA's highway traffic safety grant program. This includes rules governing the administration and closeout of the grants, as well as consequences for non-compliance with grant requirements.
With the exception of the sections discussed below, NHTSA proposes only nonsubstantive changes to the regulatory requirements in subparts D, E, and F. The nonsubstantive changes are limited to updating references to the annual HSP to adjust for the new triennial framework and providing updated citations resulting from OMB's revisions to the Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards, 2 CFR part 200.
The agency is responsible for overseeing and monitoring implementation of the grant programs to help ensure that recipients are meeting program and accountability requirements. Oversight procedures for monitoring the recipients' use of awarded funds can help the agency determine whether recipients are operating efficiently and effectively. Effective oversight procedures based on internal control standards for monitoring recipients' use of awarded funds are key to ensuring that program funds are being spent in a manner consistent with statute and regulation. In order to improve oversight of grantee activities and management of Federal funds and to implement requirements of the BIL, this NPRM proposes updates to the following procedures for administering the highway safety grant programs.
NHTSA proposes to add a sentence to make clear that equipment may only be purchased if necessary to perform eligible grant activities or if specifically authorized as an allowable use of funds. 23 CFR 1300.32(b). This is not a new requirement; the proposed addition merely incorporates and makes clearer a long-standing requirement into NHTSA's grant rule.
Under the FAST Act, NHTSA provided a regulatory procedure for States to submit amendments to the annual HSP. Under the BIL, States must, at a minimum, be allowed to amend the
GHSA commented that NHTSA should maintain the current HSP amendment process for annual grant applications, but should also allow HSP amendments to be submitted between application submissions. As noted above, NHTSA agrees. GHSA specified that NHTSA should not require States to provide formal quarterly submissions of HSP amendments, but should continue to require States to amend the annual grant application prior to beginning project performance. NHTSA agrees. The agency proposes very limited revisions to the existing regulatory text in order to update the text for the BIL's triennial framework. We replace all but one reference to the HSP (
The CT HSO and GHSA both expressed concern about the amount of time it currently takes NHTSA to approve amendments, with GHSA recommending that NHTSA respond to HSP amendments within 5 business days and resolve amendments within 30 days. NHTSA appreciates the feedback and strives and will continue to strive to respond promptly to States. However, some amendments present novel issues or complexities, and NHTSA's ability to resolve amendments is dependent on receiving all information required to adequately assess the request.
WI BOTS requested clarification regarding the types of substantive changes to the triennial HSP and annual grant application that would require amendments. States are required to provide project and subrecipient information for all projects funded during the grant year; the BIL provides that States may submit this information throughout the grant year as the information becomes available.
NHTSA proposes two limited changes to the requirements relating to vouchers and project agreements. First, NHTSA proposes that, in addition to the information currently required to be in a voucher, States also provide the eligible use(s) of funds that the voucher covers. 23 CFR 1300.33(b)(3). This addition is to ensure that NHTSA has the information necessary to understand the costs that are being vouchered for prior to approving reimbursements and to assist subsequent audits and reviews.
In addition, NHTSA proposes to extend the deadline for States to submit a final voucher from 90 days to 120 days, consistent with the extension for closeout provided in 2 CFR 200.344.
The agency deleted the regulatory provision on program income in the last rulemaking, opting instead to rely on the OMB Uniform Administrative Requirements to address program income. However, in the years since finalizing the last rule, NHTSA has found that the removal increased confusion for grantees about which rules relating to program income apply to NHTSA grant funds. Accordingly, NHTSA now proposes to reinstate the regulatory language on program income, targeted at the use of program income within NHTSA's grant programs. The proposed language is modelled on the prior regulatory language, but has been updated to reflect updates to 2 CFR 200.307 and 2 CFR 1201.80.
The most significant change to the administrative requirements for NHTSA's grant program is the BIL's codification of the annual report. Consistent with OMB rules that apply to all Federal grants,
The NSC commented that States should be required to provide regular annual information on programs, including participants, use of funds, and updates on tracked performance measures. NHTSA notes that the annual report fulfills these functions. NASEMSO suggested that NHTSA require annual report content to be provided in a well-structured format, including qualitative explanations related to obstacles and successes in order to assist with future planning in the State and to serve as a resource to other States. NHTSA agrees that a well-structured format will make annual reports more accessible to stakeholders, the public, and other States in terms of allowing ease of reading and comparison between State reports. The agency has therefore proposed a structure for the report that provides for two sections: a performance report and an activity report. In the past, NHTSA has provided States with a voluntary
GHSA noted that the BIL provides 120 days for States to submit an annual report after the end of the fiscal year and requested that NHTSA implement that provision. NHTSA has done so. In addition, GHSA noted that the BIL's codification of the annual report is limited to performance reporting and requested that NHTSA remove all aspects of the prior annual report that are not explicitly required by the BIL. GHSA opined, however, that NHTSA could retain the requirement to report HVE activities because it places a low burden on States who already collect that information.
NHTSA notes that the annual report serves many purposes for NHTSA's grant program. As provided in the BIL, it serves as the State's required annual performance report, consistent with 2 CFR 200.329. In order to satisfy the requirements of 2 CFR 200.329, NHTSA proposes to also require States to describe how the projects funded under the grant contributed to meeting the States' performance targets. States are also required, as a condition of receiving Federal grant funds, to submit annual financial reports.
Additionally, because NHTSA has implemented several grant requirements through certifications and assurances, it is important for grant oversight that NHTSA get year-end information to ensure that States have met those assurances. As a result, NHTSA proposes the activity report section of the annual report. As part of the annual activity report, NHTSA proposes to require States to provide a description of all projects and activities funded and implemented for each countermeasure strategy, including the total amount of Federal funds expended and the zip codes in which projects were performed (or identification as a State-wide project), an explanation of reasons for projects that were planned but not implemented, and a description of how the projects were informed by the meaningful public participation and engagement described in the State's triennial HSP. The intent of the requirement to provide location information via zip code is for NHTSA to understand where the funding is being utilized compared with the State's problem ID and performance targets. The agency seeks comment on whether there is a better metric to achieve this same goal. The agency requires an explanation as to why projects were not implemented in order to understand why the State has veered from the projects it identified to apply for the grant. The agency proposes to require the State to provide a description of how projects were informed by meaningful public participation and engagement in order to ensure that the public participation and engagement described in the State's planning process in the triennial HSP impacted the State's highway safety program in implementation, not just planning.
GHSA requested two amendments to the regulatory appeal process at 23 CFR 1300.36 that provides the process for formal appeals of the written decisions of NHTSA Regional Administrators to the NHTSA Associate Administrator, Regional Operations and Program Delivery. GHSA requested a requirement that NHTSA responses to State appeals be made in writing, not via an informal email or in a phone call. NHTSA agrees. A formal written appeal that meets the requirements of section 1300.36 is entitled to the same level of response as required of the appeal. We propose regulatory text to clarify that NHTSA must reply in writing. Second, GHSA requested that NHTSA amend the regulation to allow States to appeal decisions of the Associate Administrator to the Administrator. The agency declines to accept this recommendation. The Associate Administrator is delegated authority to exercise the powers and perform the duties of the Administrator with respect to the grants to States under chapter 4 of title 23.
NHTSA proposes to extend the deadline for submitting a final voucher from 90 days to 120 days in order to align with the timeframe for closeout in 2 CFR 200.344. GHSA requested that NHTSA ensure that notifications regarding unexpended funds under 23 CFR 1300.41(b)(2) be sent to the State highway safety office director, not solely to the Governor's Representative. NHTSA notes that the GR is required to be responsible for the State's highway safety program and must therefore maintain communication with the SHSO director. That said, NHTSA will be mindful to include all appropriate contacts in communications with the State.
Historically, NHTSA was unable to request comments on regulations implementing these grant programs in connection with new authorizations due to lead-time constraints. As BIL afforded the necessary lead-time, the agency was pleased to issue the earlier RFC and associated public meetings as the first step in this process, and the comments we received informed today's notice. NHTSA is equally pleased to now request comments on all aspects of this NPRM from all interested stakeholders. This section describes how you can participate in the process.
How do I prepare and submit comments?
Your comments must be written in English.
When submitting comments, please remember to:
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified in the
If you submit your comments to NHTSA's docket by mail and wish DOT Docket Management to notify you upon receipt of your comments, please enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, at the address given above under
In addition, you should submit a copy from which you have deleted the claimed confidential business information to the Docket by one of the methods set forth above.
NHTSA will consider all comments received before the close of business on the comment closing date indicated above under
You may read the materials placed in the dockets for this document (
NHTSA has considered the impact of this rulemaking action under Executive Order 12866, Executive Order 13563, and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed under Executive Order 12866 or Executive Order 13563. This action establishes revised uniform procedures implementing State highway safety grant programs, as a result of enactment of the Infrastructure Investment and Jobs Act (IIJA, also referred to as the Bipartisan Infrastructure Law or BIL). While this Notice of Proposed Rulemaking (NPRM) would establish minimum criteria for highway safety grants, most of the criteria are based on statute. NHTSA has no discretion over the grant amounts, and its implementation authority is limited and non-controversial. Therefore, this rulemaking has been determined to be not “significant” under the Department of Transportation's regulatory policies and procedures and the policies of the Office of Management and Budget.
The Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. 601
This NPRM is a rulemaking that will establish revised uniform procedures implementing State highway safety grant programs, as a result of enactment of the Infrastructure Investment and Jobs Act (IIJA, also referred to as the Bipartisan Infrastructure Law or BIL). Under these grant programs, States will receive funds if they meet the application and qualification requirements. These grant programs will affect only State governments, which are not considered to be small entities as that term is defined by the RFA. Therefore, I certify that this action will not have a significant impact on a substantial number of small entities and find that the preparation of a Regulatory Flexibility Analysis is unnecessary.
Executive Order 13132 on “Federalism” requires NHTSA to develop an accountable process to
The agency has analyzed this rulemaking action in accordance with the principles and criteria set forth in Executive Order 13132. First, we note that the regulation implementing these grant programs is required by statute. Moreover, the agency has determined that this NPRM would not have sufficient Federalism implications as defined in the order to warrant formal consultation with State and local officials or the preparation of a federalism summary impact statement. Nevertheless, NHTSA notes that it has consulted with States representatives through public meetings, continues to engage with State representatives regarding general implementation of the BIL, including these grant programs, and expects to continue these informal dialogues.
Pursuant to Executive Order 12988 (61 FR 4729 (February 7, 1996)), “Civil Justice Reform,” the agency has considered whether this proposed rule would have any retroactive effect. I conclude that it would not have any retroactive or preemptive effect, and judicial review of it may be obtained pursuant to 5 U.S.C. 702. That section does not require that a petition for reconsideration be filed prior to seeking judicial review. This action meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
Under the procedures established by the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501,
The BIL alters the structure of the Section 402 grant program, replacing the current annual Highway Safety Plan (HSP), which serves as both a planning and application document, with a triennial HSP and an annual grant application. The BIL also removes one grant program and adds two new grant programs (preventing roadside deaths and driver and officer safety education), but otherwise does not significantly change the structure of the Section 405 grants. The statute provides that States must submit two documents to apply for Section 402, Section 405 and Section 1906 grants: a triennial Highway Safety Plan (HSP), which serves as a planning document, and an annual grant application. It further codifies an annual report that States must submit at the end of the grant year.
The information collected under this proposed rulemaking is to include a triennial HSP consisting of information on the highway safety planning process, public participation, performance plan, countermeasure strategies, and a performance report.
The estimated burden hours for the collection of information for State applicants are based on all eligible respondents for each of the grants:
• Section 402 grants: 57 (fifty States, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and the Secretary of the Interior);
• Section 405 Grants (except Motorcyclist Safety Grants) and Section 1906 Grant: 56 (fifty States, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands); and
• Section 405, Motorcyclist Safety Grants: 52 (fifty States, the District of Columbia, and Puerto Rico).
We estimate that it will take each State respondent approximately 320 hours in the first year of a triennial cycle and 100 hours per year for the second and third years of the triennial cycle to collect, review and submit the required information to NHTSA for the Section 402 program. We estimate that it will take each respondent approximately 270 hours to collect, review and submit the required information to NHTSA for the Section 405 and Section 1906 program every year. We estimate that it will take each respondent approximately 88 hours per assessment to collect, review and submit the required information for the Section 405 assessments.
Based on the above information, the total estimated annual burden hours averaged over the triennial cycle for all State respondents is 30,704 hours annually. The total estimated annual burden hours for all respondents in the first year is 39,064 hours; and the total estimated burden hours for all respondents in the second and third years of the cycle is 26,524 per year.
The estimated annual burden hours averaged over the triennial cycle for each State respondent is 523.3 hours, with no more than 176 additional hours if the respondent submits two assessments in a given year. The estimated annual burden hours for each respondent in the first year of the triennial cycle is 670 hours and the estimated annual burden hours for each respondent in the second and third years of the cycle is 450 hours per year. To estimate annual burden hours for each respondent, the agency has added the burden hours for the Section 402 Program, the Section 405 and Section 1906 Program and the annual reports. For each Section 405 assessment submitted by a respondent (no more than 2 assessments in a five-year period), an additional 88 hours should be added.
Assuming the average salary of individuals responsible for submitting the information is $55.17 per hour,
These estimates are based on every eligible respondent submitting the required information for every available grant every year. However, not all States apply for and receive a grant each year under each of these programs. Similarly, under Section 405 grants, some requirements allow States to submit a criterion covering multiple years, allowing States to simply recertify or resubmit existing materials in subsequent years. Considering the agency's steps to streamline the submission process, these estimates represent the highest possible burden hours and amounts for States submitting the required information.
In addition to State applicant respondents, NHTSA estimates that there will be a total of 78 additional subject matter expert and administrative assistant respondents per year. These respondents (65 subject matter experts and 13 administrative assistants) conduct the Section 405 assessments for States and are recruited by NHTSA or the State and paid for their time. As stated above, NHTSA estimates that there will be a total of 13 assessments conducted in a year (9 assessments for Section 405 occupant protection grants, and 4 assessments for Section 405 impaired driving countermeasures grant). For these assessments, NHTSA estimates that the subject matter expert assessors spend 80 hours of time on each assessment and that the administrative assistants spend 46 hours on each assessment. Therefore, NHTSA estimates the total annual burden for the subject matter experts and administrative assistants who conduct State assessments to be 6,032 hours per year.
To calculate the estimated cost associated with the subject matter expert assessors and administrative assistants, NHTSA uses the amounts paid for these services. For assessments, the State pays each subject matter expert a flat rate of $2,700, and each administrative assistant a flat rate of $2,100. The total estimated costs associated with burden hours for all assessment respondents is $202,800.
Comments are invited on:
• 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.
• Whether the agency's estimate for the burden of the information collection is accurate.
• Ways to enhance the quality, utility, and clarity of the information to be collected.
• Ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
Please submit any comments, identified by the docket number in the heading of this document, by any of the methods described in the
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in expenditures by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted annually for inflation with base year of 1995). This NPRM would not meet the definition of a Federal mandate because the resulting annual State expenditures would not exceed the minimum threshold. The program is voluntary and States that choose to apply and qualify would receive grant funds.
NHTSA has considered the impacts of this rulemaking action for the purposes of the National Environmental Policy Act. The agency has determined that this NPRM would not have a significant impact on the quality of the human environment.
Executive Order 13211 (66 FR 28355, May 18, 2001) applies to any rulemaking that: (1) is determined to be economically significant as defined under Executive Order 12866, and is likely to have a significantly adverse effect on the supply of, distribution of, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. This rulemaking is not likely to have a significantly adverse effect on the supply of, distribution of, or use of energy. This rulemaking has not been designated as a significant energy action. Accordingly, this rulemaking is not subject to Executive Order 13211.
The agency has analyzed this NPRM under Executive Order 13175, and has determined that today's action would not have a substantial direct effect on one or more Indian tribes, would not impose substantial direct compliance costs on Indian tribal governments, and would not preempt tribal law. Therefore, a tribal summary impact statement is not required.
Executive Order 12866 and the President's memorandum of June 1, 1998, require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:
• Have we organized the material to suit the public's needs?
• Are the requirements in the rule clearly stated?
• Does the rule contain technical language or jargon that isn't clear?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?
• Would more (but shorter) sections be better?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rule easier to understand?
If you have any responses to these questions, please include them in your comments on this NPRM.
The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The BIL requires NHTSA to award highway safety grants pursuant to rulemaking. (Section 24101(d), BIL; and 23 U.S.C. 406). The Regulatory Information Service Center publishes the Unified Agenda in or about April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.
Please note that anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Grant programs—transportation, Highway safety, Intergovernmental relations, Reporting and recordkeeping requirements, Administrative practice and procedure, Alcohol abuse, Drug abuse, Motor vehicles—motorcycles.
3 U.S.C. 402; 23 U.S.C. 405; Sec. 1906, Pub. L. 109-59, 119 Stat. 1468, as amended by Sec. 4011, Pub. L. 114-94, 129 Stat. 1512; delegation of authority at 49 CFR 1.95.
This part establishes uniform procedures for State highway safety programs authorized under 23 U.S.C. Chapter 4 and Sec. 1906, Public Law 109-59, as amended by Sec. 4011, Public Law 114-94.
As used in this part—
(a)
(b)
(1) Develop and execute the triennial Highway Safety Plan, annual grant application, and highway safety program in the State;
(2) Manage Federal grant funds effectively and efficiently and in accordance with all Federal and State requirements;
(3) Foster meaningful public participation and engagement from affected communities;
(4) Obtain information about highway safety programs and projects administered by other State and local agencies;
(5) Maintain or have access to information contained in State highway safety data systems, including crash, citation or adjudication, emergency medical services/injury surveillance, roadway and vehicle recordkeeping systems, and driver license data;
(6) Periodically review and comment to the Governor on the effectiveness of programs to improve highway safety in the State from all funding sources that the State plans to use for such purposes;
(7) Provide financial and technical assistance to other State agencies and political subdivisions to develop and carry out highway safety strategies and projects; and
(8) Establish and maintain adequate staffing to effectively plan, manage, and provide oversight of projects implemented under the annual grant application and to properly administer the expenditure of Federal grant funds.
(c)
(1) Develop and prepare the triennial HSP and annual grant application based on evaluation of highway safety data, including crash fatalities and injuries, roadway, driver, demographics and other data sources to identify safety problems within the State;
(2) Establish projects to be funded within the State under 23 U.S.C. Chapter 4 based on identified safety problems and priorities and projects under Section 1906;
(3) Conduct risk assessments of subrecipients and monitor subrecipients based on risk, as provided in 2 CFR 200.332;
(4) Provide direction, information and assistance to subrecipients concerning highway safety grants, procedures for participation, development of projects and applicable Federal and State regulations and policies;
(5) Encourage and assist subrecipients to improve their highway safety planning and administration efforts;
(6) Review, approve, and evaluate the implementation and effectiveness of State and local highway safety programs and projects from all funding sources that the State plans to use under the triennial HSP and annual grant application, and approve and monitor the expenditure of grant funds awarded under 23 U.S.C. Chapter 4 and Section 1906;
(7) Assess program performance through analysis of highway safety data and data-driven performance measures;
(8) Ensure that the State highway safety program meets the requirements of 23 U.S.C. Chapter 4, Section 1906, and applicable Federal and State laws, including but not limited to the standards for financial management
(9) Ensure that all legally required audits of the financial operations of the State Highway Safety Agency and of the use of highway safety grant funds are conducted;
(10) Track and maintain current knowledge of changes in State statutes or regulations that could affect State qualification for highway safety grants or transfer programs;
(11) Coordinate the triennial HSP, annual grant application, and highway safety data collection and information systems activities with other federally and non-federally supported programs relating to or affecting highway safety, including the State SHSP as defined in 23 U.S.C. 148(a); and
(12) Administer Federal grant funds in accordance with Federal and State requirements, including 2 CFR parts 200 and 1201.
If any deadline or due date in this part falls on a Saturday, Sunday or Federal holiday, the applicable deadline or due date shall be the next business day.
To apply for any highway safety grant under 23 U.S.C. Chapter 4 and Section 1906, a State shall submit electronically and according to the due dates in the relevant sections below—
(a) A triennial Highway Safety Plan meeting the requirements of this subpart; and
(b) An annual grant application.
The State's triennial highway safety plan documents a three-year period of the State's highway safety program that is data-driven in establishing performance targets and selecting the countermeasure strategies for programming funds to meet those performance targets.
(a)
(b)
(1)
(ii) Description and analysis of the State's overall highway safety problems as identified through an analysis of data, including but not limited to fatality, injury, enforcement, judicial and sociodemographic data.
(2)
(A) A statement of the State's starting goals for the public engagement efforts, including how the public engagement efforts will contribute to the development of the State's countermeasure strategies for programming funds;
(B) Identification of the affected and potentially affected communities, including particular emphasis on underserved communities and communities overrepresented in the data, d (
(C) The steps taken by the State to reach and engage those communities, including accessibility measures implemented by the State both in outreach and in conducting engagement opportunities;
(ii) The results of the State's engagement efforts, including, as applicable—
(A) A list of the engagement opportunities conducted, including type of engagement (
(B) Identification of the actual participants (
(iii) A description of the public participation and engagement efforts the State plans to undertake during the three-year period covered by the triennial HSP, at the level of detail required in paragraph (b)(2)(i) of this section.
(3)
(ii) All performance measures developed by NHTSA in collaboration with the Governors Highway Safety Association (“Traffic Safety Performance Measures for States and Federal Agencies” (DOT HS 811 025)), as revised in accordance with 23 U.S.C. 402(k)(5) and published in the
(A) At least one performance measure and performance target that is data-driven shall be provided for each program area identified by the State during the planning process conducted under paragraph (b)(1) of this section that enables the State to track progress toward meeting the quantifiable annual target;
(B) For each program area performance measure, the State shall provide—
(C) State HSP performance targets are identical to the State DOT targets for common performance measures (fatality, fatality rate, and serious injuries) reported in the HSIP annual report, as coordinated through the State SHSP.
(iii) Additional performance measures not included under paragraph (b)(3)(ii) of this section. For program areas identified by the State where performance measures have not been jointly developed (
(4)
(i) The problem identified during the planning process described in paragraph (b)(1) of this section that the countermeasure strategy addresses and a description of the linkage between the problem identification and the countermeasure strategy;
(ii) A list of the countermeasures that the State will implement, including;
(A) For countermeasures rated 3 or more stars in
(B) For State-developed countermeasure strategies, justification supporting the countermeasure strategy, including data, data analysis, research, evaluation and/or substantive anecdotal evidence, that supports the effectiveness of the proposed countermeasure strategy;
(iii) Identification of the performance target(s) the countermeasure strategy will address, along with an explanation of the link between the effectiveness of the countermeasure strategy and the performance target;
(iv) A description of any Federal funds that the State plans to use to carry out the countermeasure strategy including, at a minimum, the funding source(s) (
(v) A description of considerations the State will use to determine what projects to fund to implement the countermeasure strategy, including, as applicable, public engagement, traffic safety data, affected communities, impacted locations, solicitation of proposals; and
(vi) A description of the manner in which the countermeasure strategy was informed by the uniform guidelines issued in accordance with 23 U.S.C. 402(a)(2) and, if applicable, NHTSA-facilitated programmatic assessments.
(5)
(c)
(2)
(3)
(i) A letter of approval, with conditions, if any, to the Governor's Representative for Highway Safety; or
(ii) A letter of disapproval to the Governor's Representative for Highway Safety informing the State of the reasons for disapproval and requiring resubmission of the triennial HSP with any modifications necessary for approval.
(4)
The State's annual grant application provides project level information on the State's highway safety program and demonstrates alignment with the State's most recent triennial HSP. Each fiscal year, the State shall submit an annual grant application, that meets the following requirements:
(a)
(b)
(1)
(i)
(B) If the State does not adjust the strategy for programming funds, a written explanation of why the State made no adjustments.
(ii)
(2)
(i) Project name and description (
(ii) Project agreement number (if necessary, may be provided in a later amendment to the annual grant application);
(iii) Subrecipient(s) (including name and type of organization;
(iv) Federal funding source(s) (
(v) Amount of Federal funds;
(vi) Eligible use of funds;
(vii) Whether the costs are P & A costs pursuant to § 1300.13(a) and the amount;
(viii) Whether the project will be used to meet the requirements of § 1300.41(b); and
(ix) The countermeasure strategy or strategies for programming funds identified in the most recently submitted triennial HSP under § 1300.11(b)(4) or in an update to the
(3)
(4)
(c)
(2)
(d)
The State's highway safety program under Section 402 shall be subject to the following conditions, and approval under § 1300.12 shall be deemed to incorporate these conditions:
(a)
(ii)
(2) Federal participation in P & A activities shall not exceed 50 percent of the total cost of such activities, or the applicable sliding scale rate in accordance with 23 U.S.C. 120. The Federal contribution for P & A activities shall not exceed 15 percent of the total funds the State receives under Section 402. In accordance with 23 U.S.C. 120(i), the Federal share payable for projects in the U.S. Virgin Islands, Guam, American Samoa and the Commonwealth of the Northern Mariana Islands shall be 100 percent. The Indian Country is exempt from the provisions of P & A requirements. NHTSA funds shall be used only to fund P & A activities attributable to NHTSA programs.
(3) P & A tasks and related costs shall be described in the P & A module of the State's annual grant application. The State's matching share shall be determined on the basis of the total P & A costs in the module.
(4) A State may allocate salary and related costs of State highway safety agency employees to one of the following, depending on the activities performed:
(i) If an employee works solely performing P & A activities, the total salary and related costs may be programmed to P & A;
(ii) If the employee works performing program management activities in one or more program areas, the total salary and related costs may be charged directly to the appropriate area(s); or
(iii) If an employee works on a combination of P & A and program management activities, the total salary and related costs may be charged to P & A and the appropriate program area(s) based on the actual time worked under each area. If the State Highway Safety Agency elects to allocate costs based on actual time spent on an activity, the State Highway Safety Agency must keep accurate time records showing the work activities for each employee.
(b)
(2)
(3)
(i) The specific political subdivision is involved in the planning process of the State's highway safety program (for example, as part of the public participation described in § 1300.11(b)(2), as part of the State's planning for the annual grant application, or as part of ongoing planning processes), and the State then enters into agreements based on identification of need by the political subdivision and implements the project or activity accordingly. The State must maintain documentation that shows the political subdivision's participation in the planning processes (
(ii) The political subdivision is not involved in the planning process of the State's highway safety program, but submits a request for the State to implement a project on its behalf. The request does not need to be a formal application but should, at minimum, contain a description of the political subdivision's problem identification and a description of where and/or how the project or activity should be deployed to have effect within political subdivision (may include: identification of media outlets to run advertising, locations for billboard/sign placement or enforcement activities, schools or other venues to provide educational programming, specific sporting events/venues, etc.).
(4)
(5)
(c)
(1) Educate drivers regarding the risks associated with marijuana-impaired driving; and
(2) Reduce injuries and deaths resulting from marijuana-impaired driving.
(d)
(e)
(f)
(g)
(a) Except as provided in paragraph (b) of this section, on October 1 of each fiscal year, or soon thereafter, the NHTSA Administrator shall, in writing, distribute funds available for obligation under 23 U.S.C. Chapter 4 and Section 1906 to the States and specify any conditions or limitations imposed by law on the use of the funds.
(b) In the event that authorizations exist but no applicable appropriation act has been enacted by October 1 of a fiscal year, the NHTSA Administrator may, in writing, distribute a part of the funds authorized under 23 U.S.C. Chapter 4 and Section 1906 contract authority to the States to ensure program continuity, and in that event shall specify any conditions or limitations imposed by law on the use of the funds. Upon appropriation of grant funds, the NHTSA Administrator shall, in writing, promptly adjust the obligation limitation and specify any conditions or limitations imposed by law on the use of the funds.
(c) Funds distributed under paragraph (a) or (b) of this section shall be available for expenditure by the States to satisfy the Federal share of expenses under the approved annual grant application, and shall constitute a contractual obligation of the Federal Government, subject to any conditions or limitations identified in the distributing document. Such funds shall be available for expenditure by the States as provided in § 1300.41(b), after which the funds shall lapse.
(d) Notwithstanding the provisions of paragraph (c) of this section, payment of State expenses of 23 U.S.C. Chapter 4 or Section 1906 funds shall be contingent upon the State's submission of up-to-date information about approved projects in the annual grant application, in accordance with §§ 1300.12(b)(2) and 1300.32.
(a)
(b)
(c)
(2)
(i) The Governor's Representative for Highway Safety, on behalf of the State, shall sign and submit with the annual grant application, the information required under appendix B of this part.
(ii) If the State is relying on specific elements of the annual grant application or triennial HSP as part of its application materials for grants under this subpart, the State shall identify the specific location where that information is located in the relevant document.
(d)
(e)
(f)
(2) The Federal share of the costs of activities or programs funded with grants awarded to the U.S. Virgin Islands, Guam, American Samoa and the Commonwealth of the Northern Mariana Islands shall be 100 percent.
(a)
(b)
(i) Populations meeting a threshold income level that is at least as inclusive as the U.S. Department of Health and Human Services Poverty Guidelines
(ii) Populations sharing a particular characteristic or geographic location, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life.
(c)
(d)
(1)
(i) Identifies the safety problems to be addressed, performance measures and targets, and the countermeasure strategies the State will implement to address those problems, at the level of detail required under § 1300.11(b); and
(ii) Identifies the projects, provided under § 1300.12(b)(2), that the State will implement during the fiscal year to carry out the plan.
(2)
(3)
(A) The total number of planned inspection stations and/or events in the State; and
(B) Within the total in paragraph (d)(3)(i)(A) of this section, the number of planned inspection stations and/or inspection events serving each of the following population categories: urban, rural, and at-risk.
(ii) Certification, signed by the Governor's Representative for Highway Safety, that the inspection stations/events are staffed with at least one current nationally Certified Child Passenger Safety Technician.
(4)
(e)
(1)
(2)
(i) Require—
(A) Each occupant riding in a passenger motor vehicle who is under eight years of age, weighs less than 65 pounds and is less than four feet, nine inches in height to be secured in an age-appropriate child restraint;
(B) Each occupant riding in a passenger motor vehicle other than an occupant identified in paragraph (e)(2)(i)(A) of this section to be secured in a seat belt or age- appropriate child restraint;
(C) A minimum fine of $25 per unrestrained occupant for a violation of the occupant protection statutes described in this paragraph (e)(2)(i).
(ii) Notwithstanding paragraph (e)(2)(i) of this section, permit no exception from coverage except for—
(A) Drivers, but not passengers, of postal, utility, and commercial vehicles that make frequent stops in the course of their business;
(B) Persons who are unable to wear a seat belt or child restraint because of a medical condition, provided there is written documentation from a physician;
(C) Persons who are unable to wear a seat belt or child restraint because all other seating positions are occupied by persons properly restrained in seat belts or child restraints;
(D) Emergency vehicle operators and passengers in emergency vehicles during an emergency;
(E) Persons riding in seating positions or vehicles not required by Federal Motor Vehicle Safety Standards to be equipped with seat belts; or
(F) Passengers in public and livery conveyances.
(3)
(4)
(i) Drivers on rural roadways;
(ii) Unrestrained nighttime drivers;
(iii) Teenage drivers;
(iv) Other high-risk populations identified in the occupant protection program area plan required under paragraph (d)(1) of this section.
(5)
(i) Date of NHTSA-facilitated program assessment that was conducted within five years prior to the application due date that evaluates the occupant protection program for elements designed to increase seat belt use in the State;
(ii) Multi-year strategic plan based on input from Statewide stakeholders (task force), updated on a triennial basis, under which the State developed—
(A)
(B)
(C)
(iii) The name and title of the State's designated occupant protection coordinator responsible for managing the occupant protection program in the State, including developing the occupant protection program area of the triennial HSP and overseeing the execution of the projects designated in the annual grant application; and
(iv) A list that contains the names, titles and organizations of the Statewide occupant protection task force membership that includes agencies and organizations that can help develop, implement, enforce and evaluate occupant protection programs.
(6)
(f)
(g)
(i) To support high-visibility enforcement mobilizations, including paid media that emphasizes publicity for the program, and law enforcement;
(ii) To train occupant protection safety professionals, police officers, fire and emergency medical personnel, educators, and parents concerning all aspects of the use of child restraints and occupant protection;
(iii) To educate the public concerning the proper use and installation of child restraints, including related equipment and information systems;
(iv) To provide community child passenger safety services, including programs about proper seating positions for children and how to reduce the improper use of child restraints;
(v) To implement programs—
(A) To recruit and train nationally certified child passenger safety technicians among police officers, fire and other first responders, emergency medical personnel, and other individuals or organizations serving low-income and underserved populations;
(B) To educate parents and caregivers in low-income and underserved populations regarding the importance of proper use and correct installation of child restraints on every trip in a motor vehicle;
(C) To purchase and distribute child restraints to low-income and underserved populations; or
(vi) To establish and maintain information systems containing data about occupant protection, including the collection and administration of
(2)
(i) A State that qualifies for grant funds must use not less than 10 percent of grant funds awarded under this section to carry out activities described in paragraph (g)(1)(v) of this section.
(ii) A State that qualifies for grant funds as a high seat belt use rate State may elect to use no more than 90 percent of grant funds awarded under this section for any eligible project or activity under Section 402.
(a)
(b)
(1)
(i) A functioning
(ii) Designated a traffic records coordinating committee coordinator; and
(iii) Established a State traffic records strategic plan, updated annually, that has been approved by the TRCC and describes specific, quantifiable and measurable improvements anticipated in the State's core safety databases, including crash, citation or adjudication, driver, emergency medical services or injury surveillance system, roadway, and vehicle databases; and
(2)
(i) A written description of the performance measure(s) that clearly identifies which performance attribute for which core database the State is relying on to demonstrate progress using the methodology set forth in the “Model Performance Measures for State Traffic Records Systems” (DOT HS 811 441), as updated; and
(ii) Supporting documentation covering a contiguous 12-month performance period starting no earlier than April 1 of the calendar year prior to the application due date, that demonstrates quantitative improvement when compared to the comparable 12-month baseline period.
(c)
(d)
(1) Software or applications to identify, collect, and report data to State and local government agencies, and enter data into State core highway safety databases, including crash, citation or adjudication, driver, emergency medical services or injury surveillance system, roadway, and vehicle data;
(2) Purchasing equipment to improve a process by which data are identified, collated, and reported to State and local government agencies, including technology for use by law enforcement for near-real time, electronic reporting of crash data;
(3) Improving the compatibility and interoperability of the core highway safety databases of the State with national data systems and data systems of other States, including the National EMS Information System;
(4) Enhancing the ability of a State and the Secretary to observe and analyze local, State, and national trends in crash occurrences, rates, outcomes, and circumstances;
(5) Supporting traffic records improvement training and expenditures for law enforcement, emergency medical, judicial, prosecutorial, and traffic records professionals;
(6) Hiring traffic records professionals for the purpose of improving traffic information systems (including a State Fatal Accident Reporting System (FARS) liaison);
(7) Adoption of the Model Minimum Uniform Crash Criteria, or providing to the public information regarding why any of those criteria will not be used, if applicable;
(8) Supporting reporting criteria relating to emerging topics, including—
(i) Impaired driving as a result of drug, alcohol, or polysubstance consumption; and
(ii) Advanced technologies present on motor vehicles; and
(9) Conducting research relating to State traffic safety information systems, including developing programs to improve core highway safety databases and processes by which data are identified, collected, reported to State and local government agencies, and entered into State core safety databases.
(a)
(b)
(i) Abstain totally from alcohol or drugs for a period of time; and
(ii) Be subject to testing for alcohol or drugs at least twice per day at a testing location, by continuous transdermal alcohol monitoring via an electronic monitoring device, by drug patch, by urinalysis, by ignition interlock monitoring (provided the interlock is able to require tests twice a day without vehicle operation), by other types of electronic monitoring, or by an alternative method approved by NHTSA.
(c)
(d)
(e)
(i) Section that describes the authority and basis for the operation of the Statewide impaired driving task force, including the process used to develop and approve the plan and date of approval;
(ii) List that contains names, titles, and organizations of all task force members, provided that the task force includes stakeholders from the following groups:
(A) State Highway Safety Office;
(B) State and local law enforcement;
(C) Criminal justice system (
(D) Public health;
(E) Drug-impaired driving countermeasure expert (
(F) Communications and community engagement specialist.
(iii) Strategic plan based on the most recent version of Highway Safety Program Guideline No. 8—Impaired Driving, which, at a minimum, covers the following:
(A) Program management and strategic planning;
(B) Prevention, including community engagement and coalitions;
(C) Criminal justice systems;
(D) Communications programs;
(E) Alcohol and other drug misuse, including screening, treatment, assessment and rehabilitation; and
(F) Program evaluation and data.
(2)
(3)
(f)
(i) Review that addresses in each plan area any related recommendations from the assessment of the State's impaired driving program;
(ii) Projects implementing impaired driving activities listed in paragraph (j)(4) of this section that must include high-visibility enforcement efforts, at the level of detail required under § 1300.12(b)(2); and
(iii) Description of how the spending supports the State's impaired driving program and achievement of its performance targets.
(2)
(3)
(g)
(i) All individuals who are convicted of driving under the influence of alcohol or of driving while intoxicated are permitted to drive only motor vehicles equipped with alcohol-ignition interlocks for a period of not less than 180 days; or
(ii) All individuals who are convicted of driving under the influence of alcohol or of driving while intoxicated and who are ordered to use an alcohol-ignition interlock are not permitted to receive any driving privilege or driver's license unless each such individual installs on each motor vehicle registered, owned, or leased by the individual an alcohol-ignition interlock for a period of not less than 180 days; or
(iii)(A) All individuals who are convicted of, or whose driving privileges have been revoked or denied for, refusing to submit to a chemical or other appropriate test for the purpose of determining the presence or concentration of any intoxicating substance and who are ordered to use an alcohol-ignition interlock are required to install on each motor vehicle to be operated by each such individual an alcohol-ignition interlock for a period of not less than 180 days; and
(B) All individuals who are convicted of driving under the influence of alcohol or of driving while intoxicated and who are ordered to use an alcohol-ignition interlock must—
(
(
(2)
(i) The individual is required to operate an employer's motor vehicle in the course and scope of employment and the business entity that owns the vehicle is not owned or controlled by the individual;
(ii) The individual is certified in writing by a physician as being unable to provide a deep lung breath sample for analysis by an ignition interlock device; or
(iii) A State-certified ignition interlock provider is not available within 100 miles of the individual's residence.
(h)
(1) Legal citation(s) to State statute demonstrating that the State has enacted and is enforcing a statute that requires all individuals convicted of driving under the influence of alcohol or of driving while intoxicated to receive a restriction on driving privileges, unless an exception in paragraph (g)(2) of this section applies, for a period of not less than 30 days; and
(2) Legal citation(s) to State statute or submission of State program information that authorizes a Statewide 24-7 sobriety program.
(i)
(2) The amount available for grants under 23 U.S.C. 405(d)(6)(A) shall not exceed 12 percent of the total amount made available to States under 23 U.S.C. 405(d) for the fiscal year.
(3) The amount available for grants under 23 U.S.C. 405(d)(6)(B) shall not exceed 3 percent of the total amount made available to States under 23 U.S.C. 405(d) for the fiscal year.
(j)
(i) High-visibility enforcement efforts;
(ii) Hiring a full-time or part-time impaired driving coordinator of the State's activities to address the enforcement and adjudication of laws regarding driving while impaired by alcohol, drugs or the combination of alcohol and drugs;
(iii) Court support of impaired driving prevention efforts, including—
(A) Hiring criminal justice professionals, including law enforcement officers, prosecutors, traffic safety resource prosecutors, judges, judicial outreach liaisons, and probation officers;
(B) Training and education of those professionals to assist the professionals in preventing impaired driving and handling impaired driving cases, including by providing compensation to a law enforcement officer to carry out
(C) Establishing driving while intoxicated courts;
(iv) Alcohol ignition interlock programs;
(v) Improving blood alcohol and drug concentration screening and testing, detection of potentially impairing drugs (including through the use of oral fluid as a specimen), and reporting relating to testing and detection;
(vi) Paid and earned media in support of high-visibility enforcement efforts, conducting initial and continuing standardized field sobriety training, advanced roadside impaired driving evaluation training, law enforcement phlebotomy training, and drug recognition expert training for law enforcement, and equipment and related expenditures used in connection with impaired driving enforcement;
(vii) Training on the use of alcohol and drug screening and brief intervention;
(viii) Training for and implementation of impaired driving assessment programs or other tools designed to increase the probability of identifying the recidivism risk of a person convicted of driving under the influence of alcohol, drugs, or a combination of alcohol and drugs and to determine the most effective mental health or substance abuse treatment or sanction that will reduce such risk;
(ix) Developing impaired driving information systems;
(x) Costs associated with a 24-7 sobriety program; or
(xi) Testing and implementing programs, and purchasing technologies, to better identify, monitor, or treat impaired drivers, including—
(A) Oral fluid-screening technologies;
(B) Electronic warrant programs;
(C) Equipment to increase the scope, quantity, quality, and timeliness of forensic toxicology chemical testing;
(D) Case management software to support the management of impaired driving offenders; or
(E) Technology to monitor impaired-driving offenders, and equipment and related expenditures used in connection with impaired-driving enforcement.
(2)
(i) Grant funds awarded under 23 U.S.C. 405(d) for programs designed to reduce impaired driving based on problem identification, in accordance with § 1300.11; and
(ii) Up to 50 percent of grant funds awarded under 23 U.S.C. 405(d) for any eligible project or activity under Section 402.
(3)
(4)
(i) High-visibility enforcement efforts; and
(ii) Any of the eligible uses described in paragraph (j)(1) of this section or programs designed to reduce impaired driving based on problem identification, in accordance with § 1300.11, if all proposed uses are described in a Statewide impaired driving plan submitted to and approved by NHTSA in accordance with paragraph (f) of this section.
(5)
(i) Increasing the timely and accurate reporting to Federal, State, and local databases of crash information, including electronic crash reporting systems that allow accurate real-or near-real-time uploading of crash information, or impaired driving criminal justice information; or
(ii) Researching or evaluating impaired driving countermeasures.
(6)
(a)
(b)
(c)
(d)
(1)
(i) Prohibit a driver from texting through a personal wireless communications device while driving;
(ii) Establish a fine for a violation of the statute; and
(iii) Not provide for an exemption that specifically allows a driver to use a personal wireless communication device for texting while stopped in traffic.
(2)
(i) Prohibit a driver from holding a personal wireless communications device while driving;
(ii) Establishes a fine for a violation of that law; and
(iii) Not provide for an exemption that specifically allows a driver to use a personal wireless communications device for texting while stopped in traffic.
(3)
(i) Prohibit a driver who is younger than 18 years of age or in the learner's permit or intermediate license stage from using a personal wireless communications device while driving;
(ii) Establish a fine for a violation of the statute; and
(iii) Not provide for an exemption that specifically allows a driver to use a personal wireless communication device for texting while stopped in traffic.
(4)
(5)
(i) A driver who uses a personal wireless communications device during an emergency to contact emergency services to prevent injury to persons or property;
(ii) Emergency services personnel who use a personal wireless communications device while operating an emergency services vehicle and engaged in the performance of their duties as emergency services personnel;
(iii) An individual employed as a commercial motor vehicle driver or a school bus driver who uses a personal wireless communications device within the scope of such individual's employment if such use is permitted under the regulations promulgated pursuant to 49 U.S.C. 31136;
(iv) A driver who uses a personal wireless communications device for navigation;
(v) except for a law described in paragraph (d)(3) of this section (prohibition on youth cell phone use while driving), the use of a personal wireless communications device in a hands-free manner, with a hands-free accessory, or with the activation or deactivation of a feature or function of the personal wireless communications device with the motion of a single swipe or tap of the finger of the driver.
(e)
(ii) A State may be eligible for a distracted driving awareness grant under paragraph (c) of this section and for one additional distracted driving law grant under paragraph (d) of this section.
(2)
(ii)
(iii)
(B) A State that qualifies for a distracted driving law grant under paragraph (d)(1), (2), or (3) of this section and enforces the law as a secondary offense shall receive 50 percent of the amount under paragraph (e)(2)(ii) of this section.
(C) A State that qualifies for a prohibition on viewing devices while driving law grant under paragraph (d)(4) of this section shall receive 25 percent of the amount under paragraph (e)(2)(ii) of this section.
(f)
(2)
(3)
(a)
(b)
(c)
(d)
(e)
(1) A certification identifying the head of the designated State authority over motorcyclist safety issues and stating that the head of the designated State authority over motorcyclist safety issues has approved and the State has adopted one of the following introductory rider curricula:
(i) Motorcycle Safety Foundation Basic Rider Course;
(ii) TEAM OREGON Basic Rider Training;
(iii) Idaho STAR Basic I;
(iv) California Motorcyclist Safety Program Motorcyclist Training Course;
(v) A curriculum that has been approved by the designated State authority and NHTSA as meeting NHTSA's Model National Standards for Entry-Level Motorcycle Rider Training; and
(2) A list of the counties or political subdivisions in the State where motorcycle rider training courses will be conducted during the fiscal year of the grant and the number of registered motorcycles in each such county or political subdivision according to official State motor vehicle records, provided that the State must offer at least one motorcycle rider training course in counties or political subdivisions that collectively account for a majority of the State's registered motorcycles.
(f)
(1) A certification identifying the head of the designated State authority over motorcyclist safety issues and stating that the State's motorcyclist awareness program was developed by or in coordination with the designated State authority over motorcyclist safety issues; and
(2) One or more performance measures and corresponding performance targets developed for motorcycle awareness at the level of detail required under § 1300.11(b)(3) that identifies, using State crash data, the counties or political subdivisions within the State with the highest number of motorcycle crashes involving a motorcycle and another motor vehicle. Such data shall be from the most recent calendar year for which final State crash data are available, but must be data no older than three calendar years prior to the application due date (
(3) Projects, at the level of detail required under § 1300.12(b)(2), demonstrating that the State will implement data-driven programs in a majority of counties or political subdivisions where the incidence of crashes involving a motorcycle and another motor vehicle is highest. The State shall submit a list of counties or political subdivisions in the State ranked in order of the highest to lowest number of crashes involving a motorcycle and another motor vehicle per county or political subdivision. Such data shall be from the most recent calendar year for which final State crash data are available, but data must be no older than three calendar years prior to the application due date (
(g)
(h)
(1) Submit State data and a description of the State's methods for collecting and analyzing the data, showing the total number of motor vehicle crashes involving motorcycles in the State for the most recent calendar year for which final State crash data are available, but data no older than three calendar years prior to the application due date and the same type of data for the calendar year immediately prior to that calendar year (
(2) Experience a reduction of at least one in the number of motorcyclist fatalities for the most recent calendar year for which final FARS data are available as compared to the final FARS data for the calendar year immediately prior to that year; and
(3) Based on State crash data expressed as a function of 10,000 motorcycle registrations (using FHWA motorcycle registration data), experience at least a whole number reduction in the rate of crashes involving motorcycles for the most recent calendar year for which final State crash data are available, but data no older than three calendar years prior to the application due date, as compared to the calendar year immediately prior to that year.
(i)
(1) One or more performance measures and corresponding
(2) Projects, at the level of detail required under § 1300.12(b)(2), demonstrating that the State will implement data-driven programs designed to reach motorcyclists in those jurisdictions where the incidence of motorcycle crashes involving an impaired operator is highest (
(j)
(1) Submit State data and a description of the State's methods for collecting and analyzing the data, showing the total number of reported crashes involving alcohol-and drug-impaired motorcycle operators in the State for the most recent calendar year for which final State crash data are available, but data no older than three calendar years prior to the application due date and the same type of data for the calendar year immediately prior to that year (
(2) Experience a reduction of at least one in the number of fatalities involving alcohol-impaired and drug-impaired motorcycle operators for the most recent calendar year for which final FARS data are available as compared to the final FARS data for the calendar year immediately prior to that year; and
(3) Based on State crash data expressed as a function of 10,000 motorcycle registrations (using FHWA motorcycle registration data), experience at least a whole number reduction in the rate of reported crashes involving alcohol- and drug-impaired motorcycle operators for the most recent calendar year for which final State crash data are available, but data no older than three calendar years prior to the application due date, as compared to the calendar year immediately prior to that year.
(k)
(1) To demonstrate compliance as a Law State, the State shall submit, in accordance with part 7 of appendix B to this part, the legal citation to the statutes or regulations requiring that all fees collected by the State from motorcyclists for the purposes of funding motorcycle training and safety programs are to be used for motorcycle training and safety programs and the legal citations to the State's current fiscal year appropriation (or preceding fiscal year appropriation, if the State has not enacted a law at the time of the State's application) appropriating all such fees to motorcycle training and safety programs.
(2) To demonstrate compliance as a Data State, the State shall submit, in accordance with part 7 of appendix B to this part, data or documentation from official records from the previous State fiscal year showing that all fees collected by the State from motorcyclists for the purposes of funding motorcycle training and safety programs were, in fact, used for motorcycle training and safety programs. Such data or documentation shall show that revenues collected for the purposes of funding motorcycle training and safety programs were placed into a distinct account and expended only for motorcycle training and safety programs.
(l)
(m)
(i) Improvements to motorcyclist safety training curricula;
(ii) Improvements in program delivery of motorcycle training to both urban and rural areas, including—
(A) Procurement or repair of practice motorcycles;
(B) Instructional materials;
(C) Mobile training units; and
(D) Leasing or purchasing facilities for closed-course motorcycle skill training;
(iii) Measures designed to increase the recruitment or retention of motorcyclist safety training instructors; or
(iv) Public awareness, public service announcements, and other outreach programs to enhance driver awareness of motorcyclists, including “share-the-road” safety messages developed using Share-the-Road model language available on NHTSA's website at
(2)
(3)
(a)
(b)
(2) For purposes of this section, a nonmotorized road user means a pedestrian; an individual using a nonmotorized mode of transportation, including a bicycle, a scooter, or a personal conveyance; and an individual using a low-speed or low-horsepower motorized vehicle, including an electric bicycle, electric scooter, personal mobility assistance device, personal transporter, or all-terrain vehicle.
(c)
(d)
(e)
(1) Training of law enforcement officials relating to nonmotorized road user safety, State laws applicable to nonmotorized road user safety, and infrastructure designed to improve nonmotorized road user safety;
(2) Carrying out a program to support enforcement mobilizations and campaigns designed to enforce State traffic laws applicable to nonmotorized road user safety;
(3) Public education and awareness programs designed to inform motorists and nonmotorized road users regarding—
(i) Nonmotorized road user safety, including information relating to nonmotorized mobility and the importance of speed management to the safety of nonmotorized road users;
(ii) The value of the use of nonmotorized road user safety equipment, including lighting, conspicuity equipment, mirrors, helmets, and other protective equipment, and compliance with any State or local laws requiring the use of that equipment;
(iii) State traffic laws applicable to nonmotorized road user safety, including the responsibilities of motorists with respect to nonmotorized road users; and
(iv) Infrastructure designed to improve nonmotorized road user safety; and
(4) The collection of data, and the establishment and maintenance of data systems, relating to nonmotorized road user traffic fatalities.
(a)
(b)
(c)
(d)
(e)
(1) To purchase and deploy digital alert technology that—
(i) Is capable of receiving alerts regarding nearby first responders; and
(ii) In the case of a motor vehicle that is used for emergency response activities, is capable of sending alerts to civilian drivers to protect first responders on the scene and en route;
(2) To educate the public regarding the safety of vehicles and individuals stopped at the roadside in the State through public information campaigns for the purpose of reducing roadside deaths and injuries;
(3) For law enforcement costs related to enforcing State laws to protect the safety of vehicles and individuals stopped at the roadside;
(4) For programs to identify, collect, and report to State and local government agencies data related to crashes involving vehicles and individuals stopped at the roadside; and
(5) To pilot and incentivize measures, including optical visibility measures, to increase the visibility of stopped and disabled vehicles.
(a)
(b)
(c)
(d)
(1)
(A) The role of law enforcement and the duties and responsibilities of peace officers;
(B) The legal rights of individuals concerning interactions with peace officers;
(C) Best practices for civilians and peace officers during those interactions;
(D) The consequences for failure of an individual or officer to comply with the law or program; and
(E) How and where to file a complaint against, or a compliment relating to, a peace officer.
(ii)
(iii)
(A) A certification signed by the GR attesting that the State has developed and is implementing a driver education and driving safety course throughout the State that meets the requirements described in paragraph (d)(1)(i) of this section; and
(B) Curriculum or course materials, along with citations to where the requirements described in paragraph (d)(1)(i) of this section are located within the curriculum.
(2)
(ii)
(iii)
(A) A certification signed by the GR attesting that the State has developed and is implementing a peace officer training program throughout the State that meets the requirements described in paragraph (d)(2)(i) of this section; and
(B) Curriculum or course materials, along with citations to where the requirements described in paragraph (d)(2)(i) of this section.
(e)
(1) Evidence that the State has taken meaningful steps towards the full implementation of such a law or program. To demonstrate compliance with this criterion, the State shall submit one or more of the following—
(i) A proposed bill that has been introduced in the State, but has not yet been enacted into law, that meets the requirements in paragraph (d)(1) or (2) of this section; or
(ii) Planning or strategy document(s) that identify meaningful steps the State has taken as well as actions the State plans to take to develop and implement a law or program that meets the requirements in paragraph (d)(1) or (2) of this section; and
(2) A timetable for implementation of such a law or program within 5 years of first applying as a qualifying State under this paragraph (e).
(f)
(g)
(2)
(3)
(h)
(1) The production of educational materials and training of staff for driver education and driving safety courses and peace officer training described in paragraph (d) of this section; and
(2) The implementation of a law or program described in paragraph (d) of this section.
(a)
(b)
(1) Official documents (
(2) Assurances that the State will undertake activities during the fiscal year of the grant to comply with the requirements of paragraph (b)(1) of this section, and projects, at the level of detail required under § 1300.12(b)(2), supporting the assurances.
(c)
(2) Notwithstanding paragraph (c)(1) of this section, the total amount of a grant awarded to a State under this section in a fiscal year may not exceed—
(i) For a State described in paragraph (b)(1) of this section, 10 percent of the amount made available to carry out this section for the fiscal year; and
(ii) For a State described in paragraph (b)(2) of this section, 5 percent of the amount made available to carry out this section for the fiscal year.
(d)
(1) Collecting and maintaining data on traffic stops;
(2) Evaluating the results of the data; and
(3) Developing and implementing programs, public outreach, and training to reduce the impact of traffic stops described in paragraph (a) of this section.
Subject to the provisions of this subpart, the requirements of 2 CFR parts 200 and 1201 govern the implementation and management of State highway safety programs and projects carried out under 23 U.S.C. Chapter 4 and Section 1906.
(a)
(b)
(c)
(d)
(1) Purchases shall receive prior written approval from the Regional Administrator;
(2) Dispositions shall receive prior written approval from the Regional Administrator unless the equipment has exceeded its useful life as determined under State law and procedures.
(e)
(1) The equipment shall be identified in the grant or otherwise made known to the State in writing;
(2) The Regional Administrator shall issue disposition instructions within 120 calendar days after the equipment is determined to be no longer needed for highway safety purposes, in the absence of which the State shall follow the applicable procedures in 2 CFR parts 200 and 1201.
(f)
(1) Title shall remain vested in the Federal Government;
(2) Management shall be in accordance with Federal rules and procedures, and an annual inventory listing shall be submitted by the State;
(3) The State or its subrecipient shall request disposition instructions from the Regional Administrator when the item is no longer needed for highway safety purposes.
(a) During the fiscal year of the grant, States may amend the annual grant application, except performance targets, after approval under § 1300.12. States shall document changes to the annual grant application electronically.
(b) The State shall amend the annual grant application, prior to beginning project performance, to provide complete and updated information at the level of detail required by § 1300.12(b)(2), about each project agreement it enters into.
(c) Amendments and changes to the annual grant application are subject to approval by the Regional Administrator before approval of vouchers for payment. Regional Administrators will disapprove changes and projects that are inconsistent with the triennial HSP, as updated, or that do not constitute an appropriate use of highway safety grant funds. States are independently responsible to ensure that projects constitute an appropriate use of highway safety grant funds.
(a)
(b)
(1) Project agreement number for which work was performed and payment is sought;
(2) Amount of Federal funds sought, up to the amount identified in § 1300.12(b)(2);
(3) Eligible use of funds;
(4) Amount of Federal funds allocated to local benefit (provided no less than mid-year (by March 31) and with the final voucher); and
(5) Matching rate (or special matching writeoff used,
(c)
(d)
(e)
(2) Vouchers that request payment for projects whose project agreement numbers or amounts claimed do not match the projects or exceed the estimated amount of Federal funds provided under § 1300.12 (b)(2) shall be rejected, in whole or in part, until an amended project and/or estimated amount of Federal funds is submitted to and approved by the Regional Administrator in accordance with § 1300.32.
(3) Failure to meet the deadlines specified in paragraph (d) of this section may result in delayed payment.
(a)
(b)
(c)
(d)
(2)
Within 120 days after the end of the fiscal year, each State shall submit electronically an Annual Report providing—
(a)
(i) An explanation of the extent to which the State's progress in achieving those targets aligns with the triennial HSP (
(ii) A description of how the projects funded under the prior year annual grant application contributed to meeting the State's highway safety performance targets.
(2) An explanation of how the state plans to adjust the strategy for programming funds to achieve the performance targets, if the State has not met or is not on track to meet its performance targets; or, an explanation of why no adjustments are needed to achieve the performance targets.
(b)
(i) The amount of Federal funds expended and the zip code(s) in which the projects were performed, or, if the project is State-wide, identification as such;
(ii) An explanation of reasons for projects that were not implemented; and
(iii) A description of how the projects were informed by meaningful public participation and engagement in the planning processes described in the State's triennial HSP.
(2) A description of the State's evidence-based enforcement program activities, including discussion of community collaboration efforts and efforts to support data collection and analysis to ensure transparency, identify disparities in traffic enforcement, and inform traffic enforcement policies, procedures, and activities; and
(3) Submission of information regarding mobilization participation (
The State shall submit an appeal of any written decision by a Regional Administrator regarding the administration of the grants in writing, signed by the Governor's Representative for Highway Safety, to the Regional Administrator. The Regional Administrator shall promptly forward the appeal to the NHTSA Associate Administrator, Regional Operations and Program Delivery. The decision of the NHTSA Associate Administrator shall be final and shall be transmitted in writing to the Governor's Representative for Highway Safety through the Regional Administrator.
(a) The State's annual grant application for a fiscal year and the State's authority to incur costs under that application shall expire on the last day of the fiscal year.
(b) Except as provided in paragraph (c) of this section, each State shall submit a final voucher which satisfies the requirements of § 1300.33(b) within 120 days after the expiration of the annual grant application. The final voucher constitutes the final financial reconciliation for each fiscal year.
(c) The Regional Administrator may extend the time period for no more than 30 days to submit a final voucher only in extraordinary circumstances, consistent with 2 CFR 200.344 and 200.345. States shall submit a written request for an extension describing the extraordinary circumstances that necessitate an extension. The approval of any such request for extension shall be in writing, shall specify the new deadline for submitting the final voucher, and shall be signed by the Regional Administrator.
(a)
(b)
(2) NHTSA shall notify States of any such unexpended grant funds no later than 180 days prior to the end of the period of availability specified in paragraph (b)(1) of this section and inform States of the deadline for commitment. States may commit such unexpended grant funds to a specific project by the specified deadline, and shall provide documentary evidence of that commitment, including a copy of an executed project agreement, to the Regional Administrator.
(3) Grant funds committed to a specific project in accordance with paragraph (b)(2) of this section shall remain committed to that project and must be expended by the end of the succeeding fiscal year. The final voucher for that project shall be submitted within 120 days after the end of that fiscal year.
(4) NHTSA shall deobligate unexpended balances at the end of the time period in paragraph (b)(1) or (3) of this section, whichever is applicable, and the funds shall lapse.
The expiration of an annual grant application does not affect the ability of NHTSA to disallow costs and recover funds on the basis of a later audit or
Notwithstanding the expiration of an annual grant application, the provisions in 2 CFR parts 200 and 1201 and 23 CFR part 1300, including but not limited to equipment and audit, continue to apply to the grant funds authorized under 23 U.S.C. Chapter 4 and Section 1906.
Where a State is found to be in non-compliance with the requirements of the grant programs authorized under 23 U.S.C. Chapter 4 or Section 1906, or with other applicable law, the sanctions in §§ 1300.51 and 1300.52, and any other sanctions or remedies permitted under Federal law, including the specific conditions of 2 CFR 200.208 and 200.339, may be applied as appropriate.
(a)
(2) If the Administrator has apportioned funds under Section 402 to a State and subsequently determines that the State is not implementing an approved highway safety program, the Administrator shall reduce the apportionment by an amount equal to not less than 20 percent until such time as the Administrator determines that the State is implementing an approved highway safety program. The Administrator shall consider the gravity of the State's failure to implement an approved highway safety program in determining the amount of the reduction.
(i) When the Administrator determines that a State is not implementing an approved highway safety program, the Administrator shall issue to the State an advance notice, advising the State that the Administrator expects to withhold funds from apportionment or reduce the State's apportionment under Section 402. The Administrator shall state the amount of the expected withholding or reduction.
(ii) The State may, within 30 days after its receipt of the advance notice, submit documentation demonstrating that it is implementing an approved highway safety program. Documentation shall be submitted to the NHTSA Administrator, 1200 New Jersey Avenue SE, Washington, DC 20590.
(b)
(2)(i) If the Administrator concludes, after reviewing all relevant documentation submitted by the State or if the State has not responded to the advance notice, that the State did not correct its failure to have or implement an approved highway safety program, the Administrator shall issue a final notice, advising the State of the funds being withheld from apportionment or of the reduction of apportionment under Section 402 by July 31 of the fiscal year for which the funds were withheld.
(ii) The Administrator shall reapportion the withheld funds to the other States, in accordance with the formula specified in 23 U.S.C. 402(c), not later than the last day of the fiscal year.
(a)
(i) Financial stability;
(ii) Quality of management systems and ability to meet management standards prescribed in this part and in 2 CFR part 200;
(iii) History of performance. The applicant's record in managing funds received for grant programs under this part, including findings from Management Reviews;
(iv) Reports and findings from audits performed under 2 CFR part 200, subpart F, or from the reports and findings of any other available audits; and
(v) The State's ability to effectively implement statutory, regulatory, and other requirements imposed on non-Federal entities.
(2) If a State is determined to pose risk, NHTSA may increase monitoring activities and may impose any of the specific conditions of 2 CFR 200.208, as appropriate.
(b)
[
By submitting an application for Federal grant funds under 23 U.S.C. Chapter 4 or Section 1906, Pub. L. 109-59, as amended by Section 25024, Pub. L. 117-58, the State Highway Safety Office acknowledges and agrees to the following conditions and requirements. In my capacity as the Governor's Representative for Highway Safety, I hereby provide the following Certifications and Assurances:
The State will comply with applicable statutes and regulations, including but not limited to:
The State has submitted appropriate documentation for review to the single point of contact designated by the Governor to review Federal programs, as required by Executive Order 12372 (Intergovernmental Review of Federal Programs).
The State will comply with FFATA guidance,
• Name of the entity receiving the award;
• Amount of the award;
• Information on the award including transaction type, funding agency, the North American Industry Classification System code or Catalog of Federal Domestic Assistance number (where applicable), program source;
• Location of the entity receiving the award and the primary location of performance under the award, including the city, State, congressional district, and country; and an award title descriptive of the purpose of each funding action;
• Unique entity identifier (generated by
• The names and total compensation of the five most highly compensated officers of the entity if:
(i) the entity in the preceding fiscal year received—
(I) 80 percent or more of its annual gross revenues in Federal awards;
(II) $25,000,000 or more in annual gross revenues from Federal awards; and
(ii) the public does not have access to information about the compensation of the senior executives of the entity through periodic reports filed under section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986;
• Other relevant information specified by OMB guidance.
The State highway safety agency [and its subrecipients] will comply with all Federal statutes and implementing regulations relating to nondiscrimination (“Federal Nondiscrimination Authorities”). These include but are not limited to:
• Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d
• 49 CFR part 21 (entitled
• 28 CFR 50.3 (U.S. Department of Justice Guidelines for Enforcement of Title VI of the Civil Rights Act of 1964);
• The Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, (42 U.S.C. 4601), (prohibits unfair treatment of persons displaced or whose property has been acquired because of Federal or Federal-aid programs and projects);
• Federal-Aid Highway Act of 1973, (23 U.S.C. 324
• Section 504 of the Rehabilitation Act of 1973, (29 U.S.C. 794
• The Age Discrimination Act of 1975, as amended, (42 U.S.C. 6101
• The Civil Rights Restoration Act of 1987, (Pub. L. 100-209), (broadens scope, coverage and applicability of Title VI of the Civil Rights Act of 1964, The Age Discrimination Act of 1975 and Section 504 of the Rehabilitation Act of 1973, by expanding the definition of the terms “programs or activities” to include all of the programs or activities of the Federal aid recipients, subrecipients and contractors, whether such programs or activities are Federally-funded or not);
• Titles II and III of the Americans with Disabilities Act (42 U.S.C. 12131-12189) (prohibits discrimination on the basis of disability in the operation of public entities, public and private transportation systems, places of public accommodation, and certain testing) and 49 CFR parts 37 and 38;
• Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (preventing discrimination against minority populations by discouraging programs, policies, and activities with disproportionately high and adverse human health or environmental effects on minority and low-income populations);
• Executive Order 13166, Improving Access to Services for Persons with Limited English Proficiency (requiring that recipients of Federal financial assistance provide meaningful access for applicants and beneficiaries who have limited English proficiency (LEP));
• Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities through the Federal Government (advancing equity across the Federal government); and
• Executive Order 13988, Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation (clarifying that sex discrimination includes discrimination on the grounds of gender identity or sexual orientation).
The preceding statutory and regulatory cites hereinafter are referred to as the “Acts” and “Regulations,” respectively.
In accordance with the Acts, the Regulations, and other pertinent directives, circulars, policy, memoranda, and/or guidance, the Recipient hereby gives assurance that it will promptly take any measures necessary to ensure that:
The Civil Rights Restoration Act of 1987 clarified the original intent of Congress, with respect to Title VI of the Civil Rights Act of 1964 and other non-discrimination requirements (the Age Discrimination Act of 1975, and Section 504 of the Rehabilitation Act of 1973), by restoring the broad, institutional-wide scope and coverage of these nondiscrimination statutes and requirements to include all programs and activities of the Recipient, so long as any portion of the program is Federally assisted.
More specifically, and without limiting the above general Assurance, the Recipient agrees with and gives the following Assurances with respect to its Federally assisted Highway Safety Grant Program:
1. The Recipient agrees that each “activity,” “facility,” or “program,” as defined in § 21.23(b) and (e) of 49 CFR part 21 will be (with regard to an “activity”) facilitated, or will be (with regard to a “facility”) operated, or will be (with regard to a “program”) conducted in compliance with all requirements imposed by, or pursuant to the Acts and the Regulations.
2. The Recipient will insert the following notification in all solicitations for bids, Requests For Proposals for work, or material subject to the Acts and the Regulations made in connection with all Highway Safety Grant Programs and, in adapted form, in all proposals for negotiated agreements regardless of funding source:
3. The Recipient will insert the clauses of Appendix A and E of this Assurance (also referred to as DOT Order 1050.2A)
4. The Recipient will insert the clauses of Appendix B of DOT Order 1050.2A, as a covenant running with the land, in any deed from the United States effecting or recording a transfer of real property, structures, use, or improvements thereon or interest therein to a Recipient.
5. That where the Recipient receives Federal financial assistance to construct a facility, or part of a facility, the Assurance will extend to the entire facility and facilities operated in connection therewith.
6. That where the Recipient receives Federal financial assistance in the form of, or for the acquisition of, real property or an interest in real property, the Assurance will extend to rights to space on, over, or under such property.
7. That the Recipient will include the clauses set forth in Appendix C and Appendix D of this DOT Order 1050.2A, as a covenant running with the land, in any future deeds, leases, licenses, permits, or similar instruments entered into by the Recipient with other parties:
a. for the subsequent transfer of real property acquired or improved under the applicable activity, project, or program; and
b. for the construction or use of, or access to, space on, over, or under real property
8. That this Assurance obligates the Recipient for the period during which Federal financial assistance is extended to the program, except where the Federal financial assistance is to provide, or is in the form of, personal property, or real property, or interest therein, or structures or improvements thereon, in which case the Assurance obligates the Recipient, or any transferee for the longer of the following periods:
a. the period during which the property is used for a purpose for which the Federal financial assistance is extended, or for another purpose involving the provision of similar services or benefits; or
b. the period during which the Recipient retains ownership or possession of the property.
9. The Recipient will provide for such methods of administration for the program as are found by the Secretary of Transportation or the official to whom he/she delegates specific authority to give reasonable guarantee that it, other recipients, sub-recipients, sub-grantees, contractors, subcontractors, consultants, transferees, successors in interest, and other participants of Federal financial assistance under such program will comply with all requirements imposed or pursuant to the Acts, the Regulations, and this Assurance.
10. The Recipient agrees that the United States has a right to seek judicial enforcement with regard to any matter arising under the Acts, the Regulations, and this Assurance.
By signing this ASSURANCE, the State highway safety agency also agrees to comply (and require any sub-recipients, sub-grantees, contractors, successors, transferees, and/or assignees to comply) with all applicable provisions governing NHTSA's access to records, accounts, documents, information, facilities, and staff. You also recognize that you must comply with any program or compliance reviews, and/or complaint investigations conducted by NHTSA. You must keep records, reports, and submit the material for review upon request to NHTSA, or its designee in a timely, complete, and accurate way. Additionally, you must comply with all other reporting, data collection, and evaluation requirements, as prescribed by law or detailed in program guidance.
The State highway safety agency gives this ASSURANCE in consideration of and for obtaining any Federal grants, loans, contracts, agreements, property, and/or discounts, or other Federal-aid and Federal financial assistance extended after the date hereof to the recipients by the U.S. Department of Transportation under the Highway Safety Grant Program. This ASSURANCE is binding on the State highway safety agency, other recipients, sub-recipients, sub-grantees, contractors, subcontractors and their subcontractors', transferees, successors in interest, and any other participants in the Highway Safety Grant Program. The person(s) signing below is/are authorized to sign this ASSURANCE on behalf of the Recipient.
The State will provide a drug-free workplace by:
a. Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the grantee's workplace, and specifying the actions that will be taken against employees for violation of such prohibition;
b. Establishing a drug-free awareness program to inform employees about:
1. The dangers of drug abuse in the workplace;
2. The grantee's policy of maintaining a drug-free workplace;
3. Any available drug counseling, rehabilitation, and employee assistance programs;
4. The penalties that may be imposed upon employees for drug violations occurring in the workplace;
5. Making it a requirement that each employee engaged in the performance of the grant be given a copy of the statement required by paragraph (a);
c. Notifying the employee in the statement required by paragraph (a) that, as a condition of employment under the grant, the employee will—
1. Abide by the terms of the statement;
2. Notify the employer of any criminal drug statute conviction for a violation occurring in the workplace no later than five days after such conviction;
d. Notifying the agency within ten days after receiving notice under subparagraph (c)(2) from an employee or otherwise receiving actual notice of such conviction;
e. Taking one of the following actions, within 30 days of receiving notice under subparagraph (c)(2), with respect to any employee who is so convicted—
1. Taking appropriate personnel action against such an employee, up to and including termination;
2. Requiring such employee to participate satisfactorily in a drug abuse assistance or rehabilitation program approved for such purposes by a Federal, State, or local health, law enforcement, or other appropriate agency;
f. Making a good faith effort to continue to maintain a drug-free workplace through implementation of all of the paragraphs above.
The State will comply with provisions of the Hatch Act (5 U.S.C. 1501-1508), which limits the political activities of employees whose principal employment activities are funded in whole or in part with Federal funds.
The undersigned certifies, to the best of his or her knowledge and belief, that:
1. No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement;
2. If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, “Disclosure Form to Report Lobbying,” in accordance with its instructions;
3. The undersigned shall require that the language of this certification be included in the award documents for all sub-awards at all tiers (including subcontracts, subgrants, and contracts under grant, loans, and cooperative agreements) and that all subrecipients shall certify and disclose accordingly.
This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.
None of the funds under this program will be used for any activity specifically designed to urge or influence a State or local legislator to favor or oppose the adoption of any specific legislative proposal pending before any State or local legislative body. Such activities include both direct and indirect (
1. By signing and submitting this proposal, the prospective primary tier participant is providing the certification set out below and
2. The inability of a person to provide the certification required below will not necessarily result in denial of participation in this covered transaction. The prospective primary tier participant shall submit an explanation of why it cannot provide the certification set out below. The certification or explanation will be considered in connection with the department or agency's determination whether to enter into this transaction. However, failure of the prospective primary tier participant to furnish a certification or an explanation shall disqualify such person from participation in this transaction.
3. The certification in this clause is a material representation of fact upon which reliance was placed when the department or agency determined to enter into this transaction. If it is later determined that the prospective primary tier participant knowingly rendered an erroneous certification, in addition to other remedies available to the Federal Government, the department or agency may terminate this transaction for cause or default or may pursue suspension or debarment.
4. The prospective primary tier participant shall provide immediate written notice to the department or agency to which this proposal is submitted if at any time the prospective primary tier participant learns its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.
5. The terms
6. The prospective primary tier participant agrees by submitting this proposal that, should the proposed covered transaction be entered into, it shall not knowingly enter into any lower tier covered transaction with a person who is proposed for debarment under 48 CFR part 9, subpart 9.4, debarred, suspended, declared ineligible, or voluntarily excluded from participation in this covered transaction, unless authorized by the department or agency entering into this transaction.
7. The prospective primary tier participant further agrees by submitting this proposal that it will include the clause titled “Instructions for Lower Tier Participant Certification” including the “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion—Lower Tier Covered Transaction,” provided by the department or agency entering into this covered transaction, without modification, in all lower tier covered transactions and in all solicitations for lower tier covered transactions and will require lower tier participants to comply with 2 CFR parts 180 and 1200.
8. A participant in a covered transaction may rely upon a certification of a prospective participant in a lower tier covered transaction that it is not proposed for debarment under 48 CFR part 9, subpart 9.4, debarred, suspended, ineligible, or voluntarily excluded from the covered transaction, unless it knows that the certification is erroneous. A participant is responsible for ensuring that its principals are not suspended, debarred, or otherwise ineligible to participate in covered transactions. To verify the eligibility of its principals, as well as the eligibility of any prospective lower tier participants, each participant may, but is not required to, check the System for Award Management Exclusions website (
9. Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render in good faith the certification required by this clause. The knowledge and information of a participant is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.
10. Except for transactions authorized under paragraph 6 of these instructions, if a participant in a covered transaction knowingly enters into a lower tier covered transaction with a person who is proposed for debarment under 48 CFR part 9, subpart 9.4, suspended, debarred, ineligible, or voluntarily excluded from participation in this transaction, in addition to other remedies available to the Federal government, the department or agency may terminate the transaction for cause or default.
(1) The prospective primary tier participant certifies to the best of its knowledge and belief, that it and its principals:
(a) Are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participating in covered transactions by any Federal department or agency;
(b) Have not within a three-year period preceding this proposal been convicted of or had a civil judgment rendered against them for commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) transaction or contract under a public transaction; violation of Federal or State antitrust statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, or receiving stolen property;
(c) Are not presently indicted for or otherwise criminally or civilly charged by a governmental entity (Federal, State, or local) with commission of any of the offenses enumerated in paragraph (1)(b) of this certification; and
(d) Have not within a three-year period preceding this application/proposal had one or more public transactions (Federal, State, or local) terminated for cause or default.
(2) Where the prospective primary tier participant is unable to certify to any of the Statements in this certification, such prospective participant shall attach an explanation to this proposal.
1. By signing and submitting this proposal, the prospective lower tier participant is providing the certification set out below and agrees to comply with the requirements of 2 CFR parts 180 and 1200.
2. The certification in this clause is a material representation of fact upon which reliance was placed when this transaction was entered into. If it is later determined that the prospective lower tier participant knowingly rendered an erroneous certification, in addition to other remedies available to the Federal government, the department or agency with which this transaction originated may pursue available remedies, including suspension or debarment.
3. The prospective lower tier participant shall provide immediate written notice to the person to which this proposal is submitted if at any time the prospective lower tier participant learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.
4. The terms
5. The prospective lower tier participant agrees by submitting this proposal that, should the proposed covered transaction be entered into, it shall not knowingly enter into any lower tier covered transaction with a person who is proposed for debarment under 48 CFR part 9, subpart 9.4, debarred, suspended, declared ineligible, or voluntarily excluded from participation in this covered transaction, unless authorized by the department or agency with which this transaction originated.
6. The prospective lower tier participant further agrees by submitting this proposal that it will include the clause titled “Instructions for Lower Tier Participant Certification” including the “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion—Lower Tier Covered Transaction,” without modification, in all lower tier covered transactions and in all solicitations for lower tier covered transactions and will require lower tier participants to comply with 2 CFR parts 180 and 1200.
7. A participant in a covered transaction may rely upon a certification of a prospective participant in a lower tier covered transaction that it is not proposed for debarment under 48 CFR part 9, subpart 9.4, debarred, suspended, ineligible, or voluntarily excluded from the covered transaction, unless it knows that the certification is erroneous. A participant is responsible for ensuring that its principals are not suspended, debarred, or otherwise ineligible to participate in covered transactions. To verify the eligibility of its principals, as well as the eligibility of any prospective lower tier participants, each participant may, but is not required to, check
8. Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render in good faith the certification required by this clause. The knowledge and information of a participant is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.
9. Except for transactions authorized under paragraph 5 of these instructions, if a participant in a covered transaction knowingly enters into a lower tier covered transaction with a person who is proposed for debarment under 48 CFR part 9, subpart 9.4, suspended, debarred, ineligible, or voluntarily excluded from participation in this transaction, in addition to other remedies available to the Federal government, the department or agency with which this transaction originated may pursue available remedies, including suspension or debarment.
1. The prospective lower tier participant certifies, by submission of this proposal, that neither it nor its principals is presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participating in covered transactions by any Federal department or agency.
2. Where the prospective lower tier participant is unable to certify to any of the statements in this certification, such prospective participant shall attach an explanation to this proposal.
The State and each subrecipient will comply with the Buy America requirement (23 U.S.C. 313) when purchasing items using Federal funds. Buy America requires a State, or subrecipient, to purchase with Federal funds only steel, iron and manufactured products produced in the United States, unless the Secretary of Transportation determines that such domestically produced items would be inconsistent with the public interest, that such materials are not reasonably available and of a satisfactory quality, or that inclusion of domestic materials will increase the cost of the overall project contract by more than 25 percent. In order to use Federal funds to purchase foreign produced items, the State must submit a waiver request that provides an adequate basis and justification for approval by the Secretary of Transportation.
No employee, officer or agent of a State or its subrecipient who is authorized in an official capacity to negotiate, make, accept or approve, or to take part in negotiating, making, accepting or approving any subaward, including contracts or subcontracts, in connection with this grant shall have, directly or indirectly, any financial or personal interest in any such subaward. Such a financial or personal interest would arise when the employee, officer, or agent, any member of his or her immediate family, his or her partner, or an organization which employs or is about to employ any of the parties indicated herein, has a financial or personal interest in or a tangible personal benefit from an entity considered for a subaward. Based on this policy:
1. The recipient shall maintain a written code or standards of conduct that provide for disciplinary actions to be applied for violations of such standards by officers, employees, or agents.
a. The code or standards shall provide that the recipient's officers, employees, or agents may neither solicit nor accept gratuities, favors, or anything of monetary value from present or potential subawardees, including contractors or parties to subcontracts.
b. The code or standards shall establish penalties, sanctions or other disciplinary actions for violations, as permitted by State or local law or regulations.
2. The recipient shall maintain responsibility to enforce the requirements of the written code or standards of conduct.
No State or its subrecipient, including its officers, employees or agents, shall perform or continue to perform under a grant or cooperative agreement, whose objectivity may be impaired because of any related past, present, or currently planned interest, financial or otherwise, in organizations regulated by NHTSA or in organizations whose interests may be substantially affected by NHTSA activities. Based on this policy:
1. The recipient shall disclose any conflict of interest identified as soon as reasonably possible, making an immediate and full disclosure in writing to NHTSA. The disclosure shall include a description of the action which the recipient has taken or proposes to take to avoid or mitigate such conflict.
2. NHTSA will review the disclosure and may require additional relevant information from the recipient. If a conflict of interest is found to exist, NHTSA may (a) terminate the award, or (b) determine that it is otherwise in the best interest of NHTSA to continue the award and include appropriate provisions to mitigate or avoid such conflict.
3. Conflicts of interest that require disclosure include all past, present or currently planned organizational, financial, contractual or other interest(s) with an organization regulated by NHTSA or with an organization whose interests may be substantially affected by NHTSA activities, and which are related to this award. The interest(s) that require disclosure include those of any recipient, affiliate, proposed consultant, proposed subcontractor and key personnel of any of the above. Past interest shall be limited to within one year of the date of award. Key personnel shall include any person owning more than a 20 percent interest in a recipient, and the officers, employees or agents of a recipient who are responsible for making a decision or taking an action under an award where the decision or action can have an economic or other impact on the interests of a regulated or affected organization.
The State and each subrecipient will not use 23 U.S.C. Chapter 4 grant funds for programs to check helmet usage or to create checkpoints that specifically target motorcyclists.
In accordance with Executive Order 13043, Increasing Seat Belt Use in the United States, dated April 16, 1997, the Grantee is encouraged to adopt and enforce on-the-job seat belt use policies and programs for its employees when operating company-owned, rented, or personally-owned vehicles. The National Highway Traffic Safety Administration (NHTSA) is responsible for providing leadership and guidance in support of this Presidential initiative. For information and resources on traffic safety programs and policies for employers, please contact the Network of Employers for Traffic Safety (NETS), a public-private partnership dedicated to improving the traffic safety practices of employers and employees. You can download information on seat belt programs, costs of motor vehicle crashes to employers, and other traffic safety initiatives at
In accordance with Executive Order 13513, Federal Leadership On Reducing Text Messaging While Driving, and DOT Order 3902.10, Text Messaging While Driving, States are encouraged to adopt and enforce workplace safety policies to decrease crashes caused by distracted driving, including policies to ban text messaging while driving company-owned or rented vehicles, Government-owned, leased or rented vehicles, or privately-owned vehicles when on official Government business or when performing any work on or behalf of the Government. States are also encouraged to conduct workplace safety initiatives in a manner commensurate with the size of the business, such as establishment of new rules and programs or re-evaluation of existing programs to prohibit text messaging while driving, and education, awareness, and other outreach to employees about the safety risks associated with texting while driving.
1. To the best of my personal knowledge, the information submitted in the annual grant application in support of the State's application for a grant under 23 U.S.C. 402 is accurate and complete.
2. The Governor is the responsible official for the administration of the State highway safety program, by appointing a Governor's Representative for Highway Safety who shall
3. At least 40 percent of all Federal funds apportioned to this State under 23 U.S.C. 402 for this fiscal year will be expended by or for the benefit of political subdivisions of the State in carrying out local highway safety programs (23 U.S.C. 402(b)(1)(C)) or 95 percent by and for the benefit of Indian tribes (23 U.S.C. 402(h)(2)), unless this requirement is waived in writing. (This provision is not applicable to the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.)
4. The State's highway safety program provides adequate and reasonable access for the safe and convenient movement of physically handicapped persons, including those in wheelchairs, across curbs constructed or replaced on or after July 1, 1976, at all pedestrian crosswalks. (23 U.S.C. 402(b)(1)(D))
5. As part of a comprehensive program, the State will support a data-based traffic safety enforcement program that fosters effective community collaboration to increase public safety, and data collection and analysis to ensure transparency, identify disparities in traffic enforcement, and inform traffic enforcement policies, procedures, and activities. (23 U.S.C. 402(b)(1)(E))
6. The State will implement activities in support of national highway safety goals to reduce motor vehicle related fatalities that also reflect the primary data-related crash factors within the State, as identified by the State highway safety planning process, including:
• Participation in the National high-visibility law enforcement mobilizations as identified annually in the NHTSA Communications Calendar, including not less than 3 mobilization campaigns in each fiscal year to—
○ Reduce alcohol-impaired or drug-impaired operation of motor vehicles; and
○ Increase use of seat belts by occupants of motor vehicles;
• Submission of information regarding mobilization participation into the HVE Database;
• Sustained enforcement of statutes addressing impaired driving, occupant protection, and driving in excess of posted speed limits;
• An annual Statewide seat belt use survey in accordance with 23 CFR part 1340 for the measurement of State seat belt use rates, except for the Secretary of Interior on behalf of Indian tribes;
• Development of Statewide data systems to provide timely and effective data analysis to support allocation of highway safety resources;
• Coordination of Highway Safety Plan, data collection, and information systems with the State strategic highway safety plan, as defined in 23 U.S.C. 148(a); and
• Participation in the Fatality Analysis Reporting System (FARS), except for American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, or the United States Virgin Islands. (23 U.S.C. 402(b)(1)(F))
7. The State will actively encourage all relevant law enforcement agencies in the State to follow the guidelines established for vehicular pursuits issued by the International Association of Chiefs of Police that are currently in effect. (23 U.S.C. 402(j))
8. The State will not expend Section 402 funds to carry out a program to purchase, operate, or maintain an automated traffic enforcement system, except in a work zone or school zone. (23 U.S.C. 402(c)(4))
I understand that my statements in support of the State's application for Federal grant funds are statements upon which the Federal Government will rely in determining qualification for grant funds, and that knowing misstatements may be subject to civil or criminal penalties under 18 U.S.C. 1001. I sign these Certifications and Assurances based on personal knowledge, and after appropriate inquiry.
Issued in Washington, DC, under authority delegated in 49 CFR 1.95.
(a) bolster and coordinate Federal investment in key research and development (R&D) areas of biotechnology and biomanufacturing in order to further societal goals;
(b) foster a biological data ecosystem that advances biotechnology and biomanufacturing innovation, while adhering to principles of security, privacy, and responsible conduct of research;
(c) improve and expand domestic biomanufacturing production capacity and processes, while also increasing piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice;
(d) boost sustainable biomass production and create climate-smart incentives for American agricultural producers and forest landowners;
(e) expand market opportunities for bioenergy and biobased products and services;
(f) train and support a diverse, skilled workforce and a next generation of leaders from diverse groups to advance biotechnology and biomanufacturing;
(g) clarify and streamline regulations in service of a science- and risk-based, predictable, efficient, and transparent system to support the safe use of products of biotechnology;
(h) elevate biological risk management as a cornerstone of the life cycle of biotechnology and biomanufacturing R&D, including by providing for research and investment in applied biosafety and biosecurity innovation;
(i) promote standards, establish metrics, and develop systems to grow and assess the state of the bioeconomy; to better inform policy, decision-making, and investments in the bioeconomy; and to ensure equitable and ethical development of the bioeconomy;
(j) secure and protect the United States bioeconomy by adopting a forward-looking, proactive approach to assessing and anticipating threats, risks, and potential vulnerabilities (including digital intrusion, manipulation, and exfiltration efforts by foreign adversaries), and by partnering with the private sector and other relevant stakeholders to jointly mitigate risks to protect technology leadership and economic competitiveness; and
(k) engage the international community to enhance biotechnology R&D cooperation in a way that is consistent with United States principles and values and that promotes best practices for safe and secure biotechnology and biomanufacturing research, innovation, and product development and use.
(b) Each report specified in subsection (a) of this section shall identify high-priority basic research and technology development needs to achieve the overall objectives described in subsection (a) of this section, as well as opportunities for public-private collaboration. Each of these reports shall also include recommendations for actions to enhance biosafety and biosecurity to reduce risk throughout the biotechnology R&D and biomanufacturing lifecycles.
(c) Within 100 days of receiving the reports required under subsection (a) of this section, the Director of OSTP, in coordination with the Director of OMB, the APNSA, the APEP, the APDP, and the heads of appropriate agencies as determined through the NSM-2 process, shall develop a plan (implementation plan) to implement the recommendations in the reports. The development of this implementation plan shall also include the solicitation of input from external experts regarding potential ethical implications or other societal impacts, including environmental sustainability and environmental justice, of the recommendations contained in the reports required under subsection (a) of this section. The implementation plan shall include assessments and make recommendations regarding any such implications or impacts.
(d) Within 90 days of the date of this order, the Director of OMB, in consultation with the heads of appropriate agencies as determined through
(e) The APNSA, in coordination with the Director of OMB, the APEP, the APDP, and the Director of OSTP, shall review the reports required under subsection (a) of this section and shall submit the reports to the President in an unclassified form, but may include a classified annex.
(f) The APNSA, in coordination with the Director of OMB, the APEP, the APDP, and the Director of OSTP, shall include a cover memorandum for the reports submitted pursuant to subsection (a) of this section, along with the implementation plan required under subsection (c) of this section, in which they make any additional overall recommendations for advancing biotechnology and biomanufacturing.
(g) Within 2 years of the date of this order, agencies at which recommendations are directed in the implementation plan required under subsection (c) of this section shall report to the Director of OMB, the APNSA, the APEP, the APDP, and the Director of OSTP on measures taken and resources allocated to enhance biotechnology and biomanufacturing, consistent with the implementation plan described in subsection (c) of this section.
(h) Within 180 days of the date of this order, the President's Council of Advisors on Science and Technology shall submit to the President and make publicly available a report on the bioeconomy that provides recommendations on how to maintain United States competitiveness in the global bioeconomy.
(b) The Secretary of Homeland Security, in coordination with the Secretary of Defense, the Secretary of Agriculture, the Secretary of Commerce (acting through the Director of the National Institute of Standards and Technology (NIST)), the Secretary of HHS, the Secretary of Energy, and the Director of OMB, shall identify and recommend relevant cybersecurity best practices for biological data stored on Federal Government information systems, consistent with applicable law and Executive Order 14028 of May 12, 2021 (Improving the Nation's Cybersecurity).
(c) The Secretary of Commerce, acting through the Director of NIST and in coordination with the Secretary of HHS, shall consider bio-related software, including software for laboratory equipment, instrumentation, and data management, in establishing baseline security standards for the development of software sold to the United States Government, consistent with section 4 of Executive Order 14028.
(b) Agencies identified in subsections (b)(i)-(iv) of this section shall direct resources, as appropriate and consistent with applicable law, towards the creation or expansion of programs that support a vibrant domestic biomanufacturing ecosystem, as informed by the strategy developed pursuant to subsection (a) of this section:
(c) Within 1 year of the date of this order, the Secretary of Agriculture, in consultation with the heads of appropriate agencies as determined by the Secretary, shall submit a plan to the President, through the APNSA and the APEP, to support the resilience of the United States biomass supply chain for domestic biomanufacturing and biobased product manufacturing, while also advancing food security, environmental sustainability, and the needs of underserved communities. This plan shall include programs to encourage climate-smart production and use of domestic biomass, along with budget estimates, including accounting for funds appropriated for Fiscal Year (FY) 2022 and proposed in the President's FY 2023 Budget.
(d) Within 180 days of the date of this order, the Secretary of Homeland Security, in coordination with the heads of appropriate agencies as determined by the Secretary, shall:
(b) Procuring agencies shall require that, within 2 years of the date of this order, all appropriate staff (including contracting officers, purchase card managers, and purchase card holders) complete training on biobased product purchasing. The Office of Federal Procurement Policy, within OMB, in cooperation with the Secretary of Agriculture, shall provide training materials for procuring agencies.
(c) Within 180 days of the date of this order and annually thereafter, procuring agencies shall report previous fiscal year spending to the Director of OMB on the following:
(d) The requirements in subsection (c) of this section shall not apply to purchase card transactions and other “[a]ctions not reported” to the Federal Procurement Data System pursuant to 48 CFR 4.606(c).
(e) Within 1 year of the date of this order and annually thereafter, the Director of OMB shall publish information on biobased procurement resulting from the data collected under subsection (c) of this section and information reported under 7 U.S.C. 8102, along with other related information, and shall use scorecards or similar systems to encourage increased biobased purchasing.
(f) Within 1 year of the date of this order and annually thereafter, procuring agencies shall report to the Secretary of Agriculture specific categories of biobased products that are unavailable to meet their procurement needs, along with desired performance standards for currently unavailable products and other relevant specifications. The Secretary of Agriculture shall publish this information annually. When new categories of biobased products become commercially available, the Secretary of Agriculture shall designate new product categories for preferred Federal procurement, as prescribed by 7 U.S.C. 8102.
(g) Procuring agencies shall strive to increase by 2025 the amount of biobased product obligations or the number or dollar value of biobased-only contracts, as reflected in the information described in subsection (c) of this section, and as appropriate and consistent with applicable law.
(b) Within 2 years of the date of this order, agencies that support relevant Federal education and training programs as described in subsection (a) of this section shall report to the President through the APNSA, in coordination with the Director of OMB, the ADPD, and the Director of OSTP, on measures taken and resources allocated to enhance workforce development pursuant to the plan described in subsection (a) of this section.
(a) within 180 days of the date of this order, identify areas of ambiguity, gaps, or uncertainties in the January 2017 Update to the Coordinated Framework for the Regulation of Biotechnology or in the policy changes made pursuant to Executive Order 13874 of June 11, 2019 (Modernizing the Regulatory Framework for Agricultural Biotechnology Products), including by engaging with developers and external stakeholders, and through horizon scanning for novel products of biotechnology;
(b) within 100 days of completing the task in subsection (a) of this section, provide to the general public plain-language information regarding the regulatory roles, responsibilities, and processes of each agency, including which agency or agencies are responsible for oversight of different types of products developed with biotechnology, with case studies, as appropriate;
(c) within 280 days of the date of this order, provide a plan to the Director of OMB, the ADPD, and the Director of OSTP with processes and timelines to implement regulatory reform, including identification of the regulations and guidance documents that can be updated, streamlined, or clarified; and identification of potential new guidance or regulations, where needed;
(d) within 1 year of the date of this order, build on the Unified website for Biotechnology Regulation developed pursuant to Executive Order 13874 by including on the website the information developed under subsection (b) of this section, and by enabling developers of biotechnology products to submit inquiries about a particular product and promptly receive a single, coordinated response that provides, to the extent practicable, information and, when appropriate, informal guidance regarding the process that the developers must follow for Federal regulatory review; and
(e) within 1 year of the date of this order, and annually thereafter for a period of 3 years, provide an update regarding progress in implementing this section to the Director of OMB, the United States Trade Representative (USTR), the APNSA, the ADPD, and the Director of OSTP. Each 1-year update shall identify any gaps in statutory authority that should be addressed to improve the clarity and efficiency of the regulatory process for biotechnology products, and shall recommend additional executive actions and legislative proposals to achieve such goals.
(b) Within 180 days of the date of this order, the Secretary of HHS and the Secretary of Homeland Security, in coordination with agencies that fund, conduct, or sponsor life sciences research, shall produce a plan for biosafety and biosecurity for the bioeconomy, including recommendations to:
(c) Within 1 year of the date of this order, agencies that fund, conduct, or sponsor life sciences research shall report to the APNSA, through the Assistant to the President and Homeland Security Advisor, on efforts to achieve the objectives described in subsection (a) of this section.
(b) The Chief Statistician of the United States, in coordination with the Secretary of Agriculture, the Secretary of Commerce, the Director of NSF, and the heads of other appropriate agencies as determined by the Chief Statistician, shall improve and enhance Federal statistical data collection designed to characterize the economic value of the United States bioeconomy, with a focus on the contribution of biotechnology to the bioeconomy. This effort shall include:
(A) Within 1 year of the date of this order, the ITWG shall recommend bioeconomy-related revisions to the North American Industry Classification System (NAICS) and the North American Product Classification System
(B) Within 18 months of the date of this order, the ITWG shall provide a report to the Chief Statistician of the United States describing the Federal statistical collections of information that take advantage of bioeconomy-related NAICS and NAPCS codes, and shall include recommendations to implement any bioeconomy-related changes as part of the 2022 revisions of the NAICS and NAPCS. As part of its work, the ITWG shall consult with external stakeholders.
(b) Within 240 days of the date of this order, the DNI shall provide classified assessments to the APNSA related to:
(c) Within 120 days of receiving the DNI's assessments, the APNSA shall coordinate with the heads of relevant agencies as determined through the NSM-2 process to develop and finalize a plan to mitigate risks to the United States bioeconomy, based upon the threat identification and impact assessments described in subsection (a) of this section, the vulnerability assessments described in section 5(d) of this order, and other relevant assessments or information. The plan shall identify where executive action, regulatory action, technology protection, or statutory authorities are needed to mitigate these risks in order to support the technology leadership and economic competitiveness of the United States bioeconomy.
(d) The United States Government contracts with a variety of providers to support its functioning, including by contracting for services related to the bioeconomy. It is important that these contracts are awarded according to full and open competition, as consistent with the Competition in Contracting Act of 1984 (Public Law 98-369, 98 Stat. 1175). In accordance with these objectives, and within 1 year of the date of this order, the Director of OSTP, in coordination with the Secretary of Defense, the Attorney General, the Secretary of HHS, the Secretary of Energy, the Secretary of Homeland Security, the DNI, the Administrator of NASA, and the Administrator of General Services, shall review the national security implications of existing requirements related to Federal procurement—including requirements contained in the Federal Acquisition Regulation (FAR) and the Defense Federal Acquisition Regulation Supplement—and shall recommend updates to those requirements to the FAR Council, the Director of OMB, and the heads of other appropriate agencies as determined through the NSM-2 process. The recommendations shall aim to standardize pre-award data collection to enable due diligence review of conflict of interest; conflict of commitment; foreign ownership, control, or influence; or other potential national security
(e) The Director of OMB shall issue a management memorandum to agencies, or take other appropriate action, to provide generalized guidance based on the recommendations received pursuant to subsection (d) of this section.
(b) Within 180 days of the date of this order, the Secretary of State, in coordination with the USTR and the heads of other agencies as determined by the Secretary, as appropriate, shall submit to the APNSA a plan to support the objectives described in subsection (a) of this section with foreign partners, international organizations, and nongovernmental entities.
(a) The term “agency” has the meaning given that term by 44 U.S.C. 3502(1).
(b) The term “biotechnology” means technology that applies to or is enabled by life sciences innovation or product development.
(c) The term “biomanufacturing” means the use of biological systems to develop products, tools, and processes at commercial scale.
(d) The term “bioeconomy” means economic activity derived from the life sciences, particularly in the areas of biotechnology and biomanufacturing, and includes industries, products, services, and the workforce.
(e) The term “biological data” means the information, including associated descriptors, derived from the structure, function, or process of a biological system(s) that is measured, collected, or aggregated for analysis.
(f) The term “biomass” means any material of biological origin that is available on a renewable or recurring basis. Examples of biomass include plants, trees, algae, and waste material such as crop residue, wood waste, animal waste and byproducts, food waste, and yard waste.
(g) The term “biobased product” has the meaning given that term in 7 U.S.C. 8101(4).
(h) The term “bioenergy” means energy derived in whole or in significant part from biomass.
(i) The term “multiomic information” refers to combined information derived from data, analysis, and interpretation of multiple omics measurement technologies to identify or analyze the roles, relationships, and functions of biomolecules (including nucleic acids, proteins, and metabolites) that make up a cell or cellular system. Omics are disciplines in biology that include genomics, transcriptomics, proteomics, and metabolomics.
(j) The term “key R&D areas” includes fundamental R&D of emerging biotechnologies, including engineering biology; predictive engineering of complex biological systems, including the designing, building, testing, and modeling of entire living cells, cell components, or cellular systems; quantitative and theory-driven multi-disciplinary research to maximize convergence with other enabling technologies; and regulatory science, including the development of new information, criteria, tools, models, and approaches to inform and assist regulatory decision-making. These R&D priorities should be coupled with advances in predictive modeling, data analytics, artificial intelligence, bioinformatics, high-performance and other advanced computing systems, metrology and data-driven standards, and other non-life science enabling technologies.
(k) The terms “equity” and “underserved communities” have the meanings given those terms by sections 2(a) and 2(b) of Executive Order 13985.
(l) The term “Tribal Colleges and Universities” has the meaning given that term by section 5(e) of Executive Order 14049 of October 11, 2021 (White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Native Americans and Strengthening Tribal Colleges and Universities).
(m) The term “Historically Black Colleges and Universities” has the meaning given that term by section 4(b) of Executive Order 14041 of September 3, 2021 (White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity Through Historically Black Colleges and Universities).
(n) The term “minority serving institution” has the meaning given that term by 38 U.S.C. 3698(f)(4).
(o) The term “foreign adversary” has the meaning given that term by section 3(b) of Executive Order 14034 of June 9, 2021 (Protecting Americans' Sensitive Data From Foreign Adversaries).
(p) The term “life sciences” means all sciences that study or use living organisms, viruses, or their products, including all disciplines of biology and all applications of the biological sciences (including biotechnology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and techniques), but excluding scientific studies associated with radioactive materials or toxic chemicals that are not of biological origin or synthetic analogues of toxins.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.