87
79
Monday, April 25, 2022
Contents
Army

Army Department

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24285-24286
2022-08733
2022-08734
Centers Disease

Centers for Disease Control and Prevention

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24305-24308
2022-08704
2022-08705
Meetings:
Community Preventive Services Task Force,
24306-24307
2022-08729
Centers Medicare

Centers for Medicare & Medicaid Services

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24308-24309
2022-08683
Children

Children and Families Administration

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Comprehensive Child Welfare Information System Automated Function Checklist and Data Quality Plan,
24310
2022-08732
Electronic Document Exchange,
24309-24310
2022-08770
Civil Rights

Civil Rights Commission

NOTICES
Meetings:
Iowa Advisory Committee,
24279-24280
2022-08675
Tennessee Advisory Committee,
24279
2022-08674
Commerce

Commerce Department

See
First Responder Network Authority

See
International Trade Administration

See
National Oceanic and Atmospheric Administration

See
National Telecommunications and Information Administration

See
Patent and Trademark Office
Council Environmental

Council on Environmental Quality

NOTICES
Climate and Economic Justice Screening Tool Beta Version,
24284-24285
2022-08774
Defense Department

Defense Department

See
Army Department

See
Navy Department

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24286-24288
2022-08755
2022-08756
2022-08758
2022-08759
Education Department

Education Department

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Native Hawaiian Education and Alaska Native Education Annual Performance Report,
24290-24291
2022-08696
Energy Department

Energy Department

See
Federal Energy Regulatory Commission

NOTICES
Guidance:
First Award Period of the Civil Nuclear Credit Program,
24291
2022-08773
Meetings:
Environmental Management Site-Specific Advisory Board Chairs; Correction,
24291
2022-08699
Environmental Protection

Environmental Protection Agency

RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
Utah; Emissions Statement Rule and NNSR Requirements for the 2015 8-Hour Ozone NAAQS for the Uinta Basin, Northern Wasatch Front and Southern Wasatch Front Nonattainment Areas,
24273-24275
2022-08697

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
National Emission Standards for Hazardous Air Pollutants for Asbestos,
24299-24300
2022-08701
National Emission Standards for Hazardous Air Pollutants for Paper and Other Web Coating,
24296
2022-08700
National Emission Standards for Hazardous Air Pollutants for Reinforced Plastic Composites Production,
24293-24294
2022-08706
New Source Performance Standards for Secondary Lead Smelters,
24295
2022-08702
Safer Choice Program Product and Partner Recognition Activities,
24298-24299
2022-08709
Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects,
24297-24298
2022-08707
Technical Assistance Needs Assessments at Superfund Remedial or Removal Sites,
24296-24297
2022-08708
April 2022 Alternative Compliance Demonstration Approach for Certain Small Refineries under the Renewable Fuel Standard Program,
24294-24295
2022-08687
April 2022 Denial of Petitions for Small Refinery Exemptions under the Renewable Fuel Standard Program,
24300-24301
2022-08686
Pesticide Product Registration:
Applications for New Active Ingredients—March 2022,
24301-24302
2022-08762
Federal Aviation

Federal Aviation Administration

RULES
Airspace Designations and Reporting Points:
Greenville, PA,
24270-24271
2022-08710
Airworthiness Directives:
The Boeing Company Airplanes,
24267-24270
2022-08694

PROPOSED RULES
Airworthiness Directives:
The Boeing Company Airplanes,
24276-24278
2022-08658

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Airport Concession Disadvantaged Business Enterprise Program; Correction,
24388
2022-08771
Federal Communications

Federal Communications Commission

NOTICES
Request for Information:
6 GHz Band Order,
24302-24303
2022-08673
Federal Energy

Federal Energy Regulatory Commission

NOTICES
Combined Filings,
24291-24293
2022-08749
2022-08752
Petition for Declaratory Order:
Roaring Fork Midstream, LLC,
24292-24293
2022-08751
FIRSTNET

First Responder Network Authority

NOTICES
Meetings:
Combined Board and Board Committees,
24280
2022-08777
Fish

Fish and Wildlife Service

NOTICES
Permits; Applications, Issuances, etc.:
Endangered and Threatened Species,
24327-24337
2022-08689
Endangered and Threatened Species; Desert Tortoise; Habitat Conservation Plan and Environmental Assessment; Bellefield Solar Energy Project, Kern County, CA,
24337-24338
2022-08688
Marine Mammal Protection Act and Wild Bird Conservation Act,
24338-24339
2022-08738
Food and Drug

Food and Drug Administration

RULES
Medical Devices:
General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use,
24271-24273
2022-08731

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Export Notification and Recordkeeping Requirements,
24321-24322
2022-08739
Medical Device User Fee Small Business Qualification and Certification,
24310-24311
2022-08726
Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation,
24316-24320
2022-08737
Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion,
24313-24316
2022-08728
Drugs for Human Use; Drug Efficacy Study Implementation:
Oral Prescription Drugs Containing an Anticholinergic or Antispasmodic in Combination with a Sedative, and Single-Entity Antispasmodic Drug Products, in Oral Dosage Form,
24311-24313
2022-08740
Withdrawal of Approval of 14 Abbreviated New Drug Applications:
Baxter Healthcare Corporation, et al.,
24320-24321
2022-08744
General Services

General Services Administration

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Acquisition Regulation; Construction Contract Administration,
24303-24304
2022-08711
Government Ethics

Government Ethics Office

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
OGE Form 319 Request for a Medical Exception to the Covid-19 Vaccination Requirement,
24304-24305
2022-08754
Health and Human

Health and Human Services Department

See
Centers for Disease Control and Prevention

See
Centers for Medicare & Medicaid Services

See
Children and Families Administration

See
Food and Drug Administration

See
National Institutes of Health
Homeland

Homeland Security Department

See
U.S. Immigration and Customs Enforcement
Indian Affairs

Indian Affairs Bureau

NOTICES
Indian Gaming:
Tribal-State Class III Gaming Compact in the State of Wisconsin; Approval,
24339
2022-08736
Request for Proposals:
Native American Business Development Institute Grant,
24339-24344
2022-08735
Interior

Interior Department

See
Fish and Wildlife Service

See
Indian Affairs Bureau
International Trade Adm

International Trade Administration

NOTICES
Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
Certain Vertical Shaft Engines between 99cc and up to 225cc, and Parts Thereof, from the People's Republic of China,
24280-24282
2022-08698
Justice Department

Justice Department

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24344-24345
2022-08667
2022-08668
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Transactions Among Licensees/Permittees, Limited,
24345-24346
2022-08669
Labor Department

Labor Department

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
No Surprises Act: Independent Dispute Resolution Process,
24346
2022-08684
Maritime

Maritime Administration

NOTICES
Deepwater Port License Application:
New Fortress Energy Louisiana FLNG, LLC,
24388-24390
2022-08757
National Credit

National Credit Union Administration

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24346-24347
2022-08753
National Endowment for the Arts

National Endowment for the Arts

NOTICES
Meetings:
Federal Advisory Committee on International Exhibitions,
24347-24348
2022-08775
National Foundation

National Foundation on the Arts and the Humanities

See
National Endowment for the Arts
National Highway

National Highway Traffic Safety Administration

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Barriers and Solutions for Submitting Toxicology Data to the Fatality Analysis Reporting System Pursuant to Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities,
24390-24394
2022-08776
National Institute

National Institutes of Health

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
International Research Fellowship Award Program of the National Institute on Drug Abuse,
24323-24324
2022-08779
Meetings:
Center for Scientific Review,
24322-24323, 24325-24326
2022-08716
2022-08718
National Center for Advancing Translational Sciences,
24324
2022-08715
National Center for Complementary and Integrative Health,
24324
2022-08721
National Institute on Aging,
24324-24325
2022-08719
2022-08722
National Oceanic

National Oceanic and Atmospheric Administration

NOTICES
Meetings:
Atlantic Highly Migratory Species Advisory Panel,
24282-24283
2022-08760
National Telecommunications

National Telecommunications and Information Administration

NOTICES
Meetings:
Combined Board and Board Committees,
24280
2022-08777
Navy

Navy Department

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24288-24290
2022-08745
2022-08746
2022-08748
Nuclear Regulatory

Nuclear Regulatory Commission

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Cooperation with States at Commercial Nuclear Power Plants and Other Nuclear Production and Utilization Facilities, Policy Statement,
24348-24349
2022-08772
Patent

Patent and Trademark Office

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Madrid Protocol,
24284
2022-08725
Practitioner Conduct and Discipline,
24283
2022-08730
Pension Benefit

Pension Benefit Guaranty Corporation

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Medical Exception Request,
24349-24350
2022-08671
Postal Regulatory

Postal Regulatory Commission

NOTICES
Service Standard Changes,
24350-24351
2022-08765
Securities

Securities and Exchange Commission

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24351-24352, 24368-24369
2022-08666
2022-08670
Meetings; Sunshine Act,
24351
2022-08855
Self-Regulatory Organizations; Proposed Rule Changes:
Cboe BYX Exchange, Inc.,
24366-24368
2022-08682
Cboe BZX Exchange, Inc.,
24351-24354
2022-08676
2022-08680
Cboe EDGA Exchange, Inc.,
24354-24357
2022-08679
Cboe EDGX Exchange, Inc.,
24382-24384
2022-08681
Fixed Income Clearing Corp.,
24369-24382
2022-08677
NYSE Arca, Inc.,
24357-24366
2022-08678
Small Business

Small Business Administration

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24385-24386
2022-08717
Delegation of Authority,
24386-24387
2022-08692
Disaster Declaration:
Massachusetts; Public Assistance Only,
24385
2022-08724
South Carolina,
24385
2022-08723
State Department

State Department

NOTICES
Determinations:
Foreign Assistance Act of 1961 to Provide Military Assistance to Ukraine,
24387
2022-08769
Surface Transportation

Surface Transportation Board

NOTICES
Exemption:
Abandonment; New England Central Railroad, Inc., Franklin County, VT,
24387-24388
2022-08742
Transportation Department

Transportation Department

See
Federal Aviation Administration

See
Maritime Administration

See
National Highway Traffic Safety Administration
Treasury

Treasury Department

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
24394
2022-08693
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Community Development Financial Institutions Funds Certificate of Material Events Form,
24394-24395
2022-08690
Immigration

U.S. Immigration and Customs Enforcement

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Designation of Attorney in Fact/Revocation of Designation of Attorney in Fact,
24326
2022-08672

Reader Aids
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.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
87
79
Monday, April 25, 2022
Rules and Regulations
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2021-0828; Project Identifier AD-2021-00303-T; Amendment 39-21973; AD 2022-06-07]
RIN 2120-AA64
Airworthiness Directives; The Boeing Company Airplanes

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Final rule.

SUMMARY:
The FAA is superseding Airworthiness Directive (AD) 2016-09-01, which applied to certain The Boeing Company Model 777-200 and -300 series airplanes. AD 2016-09-01 required repetitive inspections for cracking of the left- and right-side forward outer chords of the pivot bulkhead, and related investigative and corrective actions if necessary. AD 2016-09-01 also provided a modification of the pivot bulkhead, which terminated the repetitive inspections. This AD was prompted by reports of fatigue cracking of the forward outer chord of the station (STA) 2370 pivot bulkhead, and the determination that the compliance times need to be reduced, post-modification inspections must be done, and the inspections areas need to be expanded due to additional cracking found prior to the inspection times required by AD 2016-09-01. This AD retains certain requirements of AD 2016-09-01. This AD also requires doing repetitive detailed and high frequency eddy current (HFEC) inspections of the longeron fitting, and, for post-repair and post-modification inspections, the bulkhead assembly structure, for any cracking, and doing all applicable on-condition actions. The FAA is issuing this AD to address the unsafe condition on these products.

DATES:
This AD is effective May 31, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of May 31, 2022.

ADDRESSES:
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 https://www.myboeingfleet.com. 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 https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0828.

Examining the AD Docket
You may examine the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0828; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, any comments received, and other information. The address for Docket Operations is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:
Luis Cortez-Muniz, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: (206) 231-3958; email: Luis.A.Cortez-Muniz@faa.gov.

SUPPLEMENTARY INFORMATION:

Background
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2016-09-01, Amendment 39-18499 (81 FR 26109, May 2, 2016) (AD 2016-09-01). AD 2016-09-01 applied to certain The Boeing Company Model 777-200 and -300 series airplanes. The NPRM published in the Federal Register on October 14, 2021 (86 FR 57078). The NPRM was prompted by reports of fatigue cracking of the forward outer chord of the STA 2370 pivot bulkhead, and the determination that the compliance times need to be reduced, post-modification inspections must be done, and the inspections areas need to be expanded due to additional cracking found prior to the inspection times required by AD 2016-09-01. In the NPRM, the FAA proposed to retain certain requirements of AD 2016-09-01. The NPRM also proposed to require doing repetitive detailed and HFEC inspections of the longeron fitting and, for certain airplanes, the bulkhead assembly structure, for any cracking and doing all applicable on-condition actions. The FAA is issuing this AD to address fatigue cracking of the outer flanges of the left and right side forward outer chords of the STA 2370 pivot bulkhead, which could result in a severed forward outer chord and consequent loss of horizontal stabilizer control.

Discussion of Final Airworthiness Directive

Comments
The FAA received comments from an anonymous commenter, The Air Line Pilots Association, International (ALPA), and United Airlines who supported the NPRM without change.
The FAA received additional comments from three commenters, including Air France, Boeing, and an individual. The following presents the comments received on the NPRM and the FAA's response to each comment.

Request To Revise the Compliance Time
Air France requested that Boeing and the FAA increase the inspection threshold to 1,000 flight cycles in the proposed AD. Air France stated that the proposed AD specifies that operators accomplish the nondestructive testing inspection within 500 flight cycles and that this threshold is not compatible in case of findings; this drives an operator to ground the airplane for a long period of time if a corrective action needs to be accomplished before further flight. Air France commented that a minimum of 300 man-hours are required to accomplish the corrective actions specified in Boeing Service Bulletin 777-53-0076 [which is referenced in Boeing Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 2021].
Air France stated that its request allows operators to plan a C-check maintenance visit during a time when a repair or the terminating action specified in Boeing Service Bulletin 777-53-0076 can be performed without disturbing airplane operations.
The FAA disagrees with the commenter's request. As specified in Boeing Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 2021, the compliance time of 500 flight cycles is a grace period and is only applicable when the airplane exceeds the inspection threshold. In addition, in developing an appropriate compliance time, the FAA coordinated with the manufacturer to provide a compliance time that maintains an acceptable level of safety. However, under the provisions of paragraph (i) of this AD, the FAA will consider requests for approval of an extension of the compliance time, if sufficient data are submitted to substantiate that the change would provide an acceptable level of safety. The FAA has not changed this final rule in this regard.

Request To Increase Frequency of Testing and Nondestructive Examining (NDE) Techniques
An individual requested that Boeing increase the frequency of its testing in addition to exploring additional NDE techniques ( e.g., ultrasonic testing) for identifying early indication of high cycle fatigue. The commenter stated that when looking at probability of failure, Boeing has identified at least 32 instances of cracking under the current inspection frequency; however, one of the biggest issues with the high cyclic fatigue cracking is that it is self-identifying. The individual commented that while there are various NDE tools and techniques that can be used to identify cracks once they have started to propagate, it is incredibly difficult to identify degraded conditions prior to fracture propagation. The commenter concluded that the probability of a crack developing unnoticed under the current inspection frequency should be considered moderate to high.
While the FAA acknowledges the commenter's concern, this AD already incorporates reduced compliance times for the repetitive detailed and HFEC inspections, adds new inspection areas for any cracking and also adds repetitive post-modification inspections to the previous requirements of AD 2016-09-01. The determination of the mitigating actions and compliance times were coordinated with the manufacturer and determined to provide an appropriate interval of time while maintaining an acceptable level of safety. The FAA has not changed this AD in this regard.

Request To Clarify Certain Inspection Requirements
Boeing requested that the SUMMARY section of the NPRM be revised to change the words, “for certain airplanes, the bulkhead assembly structure” to “for post-repair and post-modification inspections, the bulkhead assembly structure.” Boeing stated that the requested change is to clarify that the inspection of the bulkhead assembly structure is only required for airplanes that have accomplished the small crack repair option using Boeing Alert Service Bulletin 777-53A0075, Revision 1, dated December 14, 2015, or the modification using Boeing Service Bulletin 777-53-0076.
The FAA agrees that the proposed wording provides clarity and has revised the SUMMARY section of this AD accordingly.

Request To Correct Typographical Error
Boeing requested that the FAA remove the words “of the” in the first sentence under the “Proposed AD Requirements in this NPRM” paragraph in the NPRM. Boeing stated that the sentence should be revised from “retain certain of the requirements of AD 2016-09-01,” to “retain certain requirements of AD 2016-09-01.”
The FAA acknowledges that “of the” in the first sentence under the “Proposed AD Requirements in this NPRM” paragraph in the NPRM should be removed; however, that paragraph is not carried over into this final rule.

Request To Revise Exception Language
Boeing requested that the FAA revise paragraph (h)(1) of the proposed AD, which specifies using the effective date of this AD rather than the Revision 2 date of the service information, to remove the reference to the “Effectivity” paragraph and the Condition columns in the “Compliance” paragraph. Boeing stated that the phrase “the Revision 2 date of this Service Bulletin” is not used in those locations of the service information.
The FAA agrees with the commenter's request and has revised paragraph (h)(1) of this AD accordingly.

Conclusion
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.

Related Service Information Under 1 CFR Part 51
The FAA reviewed Boeing Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 2021. This service information specifies procedures for, depending on configuration, doing repetitive detailed and HFEC inspections of the STA 2370 pivot bulkhead forward outer chord and the longeron fitting for any cracking; doing repetitive post-repair inspections of the pivot bulkhead forward outer chord, longeron fitting, and bulkhead assembly structure for any cracking; doing repetitive post-modification inspections of the pivot bulkhead forward outer chord, longeron fitting, and bulkhead assembly structure for any cracking; and doing all applicable on-condition actions. On-condition actions include modifying the left and right forward outer chords and upper splice angles, 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 ADDRESSES .

Costs of Compliance
The FAA estimates that this AD affects 63 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
Estimated Costs
Action | Labor cost | Parts cost | Cost per product | Cost on U.S. operators
Detailed and HFEC inspections of the longeron fitting and pivot bulkhead forward chord | Up to 15 work-hours × $85 per hour = Up to $1,275 per inspection cycle | $0 | Up to $1,275 per inspection cycle | Up to $80,325 per inspection cycle.
| Post-repair inspections | Up to 13 work-hours × $85 per hour = Up to $1,105 per inspection cycle | $0 | Up to $1,105 per inspection cycle | Up to $69,615 per inspection cycle.
Post-modification inspections | 18 work-hours × $85 per hour = $1,530 per inspection cycle | $0 | $1,530 per inspection cycle | $96,390 per inspection cycle.
The FAA estimates the following costs to do any necessary modifications that would be required based on the results of the inspection. The FAA has no way of determining the number of aircraft that might need this modification:
On-Condition Costs
Action | Labor cost | Parts cost | Cost per product
Modification | Up to 137 work-hours × $85 per hour = Up to $11,645 | $34,086 | Up to $45,731.
The FAA has received no definitive data on which to base the cost estimates for the repairs specified in this AD.
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Authority for This Rulemaking
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.

Regulatory Findings
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.

List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

The Amendment
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39—AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:

Authority:
49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by:
a. Removing Airworthiness Directive (AD) 2016-09-01, Amendment 39-18499 (81 FR 26109, May 2, 2016); and
b. Adding the following new AD:
2022-06-07 The Boeing Company: Amendment 39-21973; Docket No. FAA-2021-0828; Project Identifier AD-2021-00303-T.

(a) Effective Date
This airworthiness directive (AD) is effective May 31, 2022.

(b) Affected ADs
This AD replaces AD 2016-09-01, Amendment 39-18499 (81 FR 26109, May 2, 2016) (AD 2016-09-01).

(c) Applicability
This AD applies to The Boeing Company Model 777-200 and -300 series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 2021.

(d) Subject
Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition
This AD was prompted by reports of fatigue cracking of the forward outer chord of the station (STA) 2370 pivot bulkhead, and the determination that the compliance times need to be reduced, post-modification inspections must be done, and the inspections areas need to be expanded due to additional cracking found prior to the inspection times required by AD 2016-09-01. The FAA is issuing this AD to address fatigue cracking of the outer flanges of the left and right side forward outer chords of the STA 2370 pivot bulkhead, which could result in a severed forward outer chord and consequent loss of horizontal stabilizer control.

(f) Compliance
Comply with this AD within the compliance times specified, unless already done.

(g) Required Actions
Except as specified by paragraph (h) of this AD: At the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 2021, do all applicable actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of Boeing Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 2021.

(h) Exceptions to Service Information Specifications
(1) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 2021, use the phrase “the Revision 2 date of this Service Bulletin,” this AD requires using “the effective date of this AD.”
(2) Where Boeing Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 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 (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)
(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 Related Information. Information may be emailed to: 9-ANM-Seattle-ACO-AMOC-Requests@faa.gov.
(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.
(4) Except as specified by paragraph (h) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (i)(4)(i) and (ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

(j) Related Information
For more information about this AD, contact Luis Cortez-Muniz, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: (206) 231-3958; email: Luis.A.Cortez-Muniz@faa.gov.

(k) Material Incorporated by Reference
(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 Alert Service Bulletin 777-53A0075, Revision 2, dated February 22, 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 https://www.myboeingfleet.com.
(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 fr.inspection@nara.gov , or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
Issued on March 10, 2022.
Lance T. Gant,

Director, Compliance & Airworthiness Division, Aircraft Certification Service.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2022-0038; Airspace Docket No. 22-AEA-1]
RIN 2120-AA66
Amendment of Class E Airspace; Greenville, PA

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Final rule.

SUMMARY:
This action amends the Class E airspace at Greenville, PA. This action is the result of an airspace review caused by the decommissioning of the Youngstown VHF omnidirectional range (VOR) navigation aids as part of the VOR Minimum Operational Network (MON) Program.

DATES:
Effective 0901 UTC, July 14, 2022. The Director of the Federal Register approves this incorporation by reference action under 1 CFR 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.

ADDRESSES:
FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.

FOR FURTHER INFORMATION CONTACT:
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace extending upward from 700 feet above the surface at Greenville Municipal Airport, Greenville, PA, to support instrument flight rule operations at this airport.

History
The FAA published a notice of proposed rulemaking in the Federal Register (87 FR 7400; February 9, 2022) for Docket No. FAA-2022-0038 to amend the Class E airspace at Greenville, PA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.
Class E airspace designations are published in paragraph 6005 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11F.

Availability and Summary of Documents for Incorporation by Reference
This document amends FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule
This amendment to 14 CFR 71 amends the Class E airspace extending upward from 700 feet above the surface at Greenville Municipal Airport, Greenville, PA, by removing the Youngstown VORTAC and the associated extension from the airspace legal description.
This action is the result of an airspace review caused by the decommissioning of the Youngstown VOR, which provided navigation information for the instrument procedures at this airport, as part of the VOR MON Program.
FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

Regulatory Notices and Analyses
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS
1. The authority citation for part 71 continues to read as follows:

Authority:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
71.1
[Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.
* * * * *

AEA PA E5 Greenville, PA [Amended]
Greenville Municipal Airport, PA
(Lat. 41°26′48″ N, long. 80°23′28″ W)
That airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Greenville Municipal Airport.
Issued in Fort Worth, Texas, on April 20, 2022.
Martin A. Skinner,

Acting Manager, Operations Support Group, ATO Central Service Center.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2021-N-1011]
Medical Devices; General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Final amendment; final order.

SUMMARY:
The Food and Drug Administration (FDA or we) is classifying the autofluorescence detection device for general surgery and dermatological use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the autofluorescence detection device for general surgery and dermatological use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

DATES:
This order is effective April 25, 2022. The classification was applicable on November 2, 2018.

FOR FURTHER INFORMATION CONTACT:
Jessica Mavadia-Shukla, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4643, Silver Spring, MD 20993-0002, 301-348-1596, Jessica.Mavadia-Shukla@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background
Upon request, FDA has classified the autofluorescence detection device for general surgery and dermatological use as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification
On September 27, 2017, FDA received AiBiomed, Corp.'s request for De Novo classification of the Parathyroid Detection (Model PTeye) System. Subsequently, on December 22, 2017, FDA received Fluoptics's similar request for De Novo classification of the Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System. FDA reviewed both requests in order to classify the devices under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the requests, we determined that the devices can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the devices.
Therefore, on November 2, 2018, FDA issued orders to both requesters classifying the devices into class II. In this final order, FDA is codifying the classification of these devices by adding 21 CFR 878.4550. ^1 We have named the generic type of device autofluorescence detection device for general surgery and dermatological use, and it is identified as an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
^1 FDA notes that the ACTION caption for this final order is styled as “Final amendment; final order,” rather than “Final order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Registers (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
Table 1—Autofluorescence Detection Device for General Surgery and Dermatological Use Risks and Mitigation Measures
Identified risks | Mitigation measures
Electrical, mechanical, or thermal hazards leading to user injury or discomfort | Electromagnetic compatibility testing; Electrical, mechanical and thermal safety testing; Software verification, validation, and hazard analysis; and Labeling.
Tissue, skin burn, or eye injury due to light and laser exposure | Light and laser exposure safety testing and Labeling.
Infection and cross contamination | Sterilization validation, Shelf life testing, and Labeling.
Adverse tissue reaction | Biocompatibility evaluation.
False identification of target tissues or structures leading to errors in patient management ( e.g. , removal of healthy tissue or not removing diseased tissue) | In vivo performance testing; Software verification, validation, and hazard analysis; and Labeling.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) 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.

IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

PART 878—GENERAL AND PLASTIC SURGERY DEVICES
1. The authority citation for part 878 continues to read as follows:

Authority:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
2. Add § 878.4550 to subpart E to read as follows:
§ 878.4550
Autofluorescence detection device for general surgery and dermatological use.
(a) Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when used as intended; and
(iii) A shelf life for any sterile components.
Dated: April 19, 2022.
Lauren K. Roth,

Associate Commissioner for Policy.
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[EPA-R08-OAR-2021-0775; FRL-9330-02-R8]
Approval and Promulgation of Implementation Plans; Utah; Emissions Statement Rule and Nonattainment New Source Review Requirements for the 2015 8-Hour Ozone National Ambient Air Quality Standard for the Uinta Basin, Northern Wasatch Front and Southern Wasatch Front Nonattainment Areas

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Final rule.

SUMMARY:
The Environmental Protection Agency (EPA) is approving state implementation plan (SIP) revisions submitted by the State of Utah. The revisions fulfill the emissions statement rule and nonattainment new source review (NNSR) requirements for the 2015 8-hour ozone national ambient air quality standard (NAAQS) for the Uinta Basin, Northern Wasatch Front, and Southern Wasatch Front Marginal nonattainment areas. Utah submitted an emissions statement rule revision and a separate NNSR certification to meet, in part, the nonattainment requirements for Marginal ozone nonattainment areas under the 2015 8-hour ozone NAAQS. The State's submission of the emissions statement rule revision also included revisions to emissions reporting requirements for stationary sources, which are being approved in this final rule as well. The EPA is taking this action pursuant to sections 110, 172, and 182 of the Clean Air Act (CAA).

DATES:
This rule is effective on May 25, 2022.

ADDRESSES:
The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2021-0775. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional availability information.

FOR FURTHER INFORMATION CONTACT:
Matthew Lang, Air and Radiation Division, EPA, Region 8, Mailcode 8ARD-IO, 1595 Wynkoop Street, Denver, Colorado, 80202-1129, telephone number: (303) 312-6709, email address: lang.matthew@epa.gov.

SUPPLEMENTARY INFORMATION:
Throughout this document “we”, “us”, and “our” means the EPA.

I. Background
The background for this action is discussed in detail in our February 1, 2022 proposal. ^1 In that document we proposed to approve the SIP revision submitted by Utah which included changes to Rule R307-150 concerning the level of detail of inventory data reported by certain sources as well as implementation of an annual ozone emissions statement rule for stationary sources in ozone nonattainment areas. Additionally, we proposed to approve the SIP revision submitted by Utah certifying that the state's previously approved NNSR permit program meets the requirement stemming from the Marginal ozone nonattainment designations of the Uinta Basin, Northern Wasatch Front, and Southern Wasatch Front areas. We proposed to approve the revisions because they were prepared in accordance with the requirements in sections 182(a)(3)(B), 172(c)(5) and 172(b) of the CAA.
^1 Approval and Promulgation of Implementation Plans; Utah; Emissions Statement Rule and Nonattainment New Source Review Requirements for the 2015 8-Hour Ozone National Ambient Air Quality Standards for the Uinta Basin, Northern Wasatch Front and Southern Wasatch Front Nonattainment Areas, 87 FR 5435 (February 1, 2022).
EPA held a 30-day comment period on the proposed rulemaking beginning on February 1, 2022 and closing on March 3, 2022. We did not receive any comments on the proposed rulemaking during the comment period.

II. Final Action
The EPA is finalizing approval of revisions to Rule R307-150 submitted by the State of Utah on November 3, 2020, including a revision to implement an emissions statement rule which was prepared in accordance with section 182(a)(3)(B) of the CAA. The EPA is also finalizing approval of the NNSR permit program certification submitted by the State of Utah on August 2, 2021, because the certified NNSR Permit Program was prepared in accordance with requirements of sections 172(c)(5) and 173 of the CAA and fulfills the specific minimum SIP requirements of 40 CFR 51.165.

III. Incorporation by Reference
In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Rule R307-150 described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 8 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the State Implementation Plan, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. ^2
^2 62 FR 27968 (May 22, 1997).

IV. Statutory and Executive Order Reviews
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 24, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide, Greenhouse gases, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Dated: April 11, 2022.
K.C. Becker,

Regional Administrator, Region 8.
40 CFR part 52 is amended as follows:

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS
1. The authority citation for part 52 continues to read as follows:

Authority:
42 U.S.C. 7401 et seq.

Subpart TT—Utah
2. Amend § 52.2320 by:
a. In the table in paragraph (c):
i. Revising the entries “R307-150-01”, “R307-150-02”, “R307-150-03”, “R307-150-04”, “R307-150-05”, “R307-150-06”, and “R307-150-07” under the heading entitled “R307-150. Emission Inventories”.
ii. Adding the entry “R307-150-09”.
b. In the table in paragraph (e), adding the entry “Ozone (8-hour, 2015) NNSR Certification” under the heading entitled “Summary of Criteria Pollutant Attainment Plans” at the end of the table.
The revisions and additions read as follows:
§ 52.2320
Identification of plan.
* * * * *
(c) * * *
Rule No. | Rule title | State effective date | Final rule citation, date | Comments
* * * * * * *
R307-150. Emission Inventories
R307-150-01 | Purpose and General Requirements | 9/3/2020 | [insert Federal Register citation], 4/25/2022
R307-150-02 | Definitions | 9/3/2020 | [insert Federal Register citation], 4/25/2022
R307-150-03 | Applicability | 9/3/2020 | [insert Federal Register citation], 4/25/2022
R307-150-04 | Sulfur Dioxide Milestone Inventory Requirements | 9/3/2020 | [insert Federal Register citation], 4/25/2022
R307-150-05 | Sources Identified in R307-150-3(2), Large Major Source Inventory Requirements | 9/3/2020 | [insert Federal Register citation], 4/25/2022
R307-150-06 | Sources Identified in R307-150-3(3) | 9/3/2020 | [insert Federal Register citation], 4/25/2022
R307-150-07 | Exempted Hazardous Air Pollutants | 9/3/2020 | [insert Federal Register citation], 4/25/2022
* * * * * * *
R307-150-09 | Annual Ozone Emission Statement | 9/3/2020 | [insert Federal Register citation], 4/25/2022
* * * * * * *
* * * * *
(e) * * *
Rule title | State effective date | Final rule citation, date | Comments
* * * * * * *
Summary of Criteria Pollutant Attainment Plans
* * * * * * *
Ozone (8-hour, 2015) NNSR Certification | 7/29/2021 | [insert Federal Register citation], 4/25/2022
87
79
Monday, April 25, 2022
Proposed Rules
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2022-0458; Project Identifier AD-2021-00633-T]
RIN 2120-AA64
Airworthiness Directives; The Boeing Company Airplanes

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Notice of proposed rulemaking (NPRM).

SUMMARY:
The FAA proposes to adopt a new airworthiness directive (AD) for all The Boeing Company Model 767 airplanes. This proposed AD was prompted by reports of inoperative manual and alternate horizontal stabilizer trim switches. This proposed AD would require repetitive inspections for immersion of each limit switch and position transmitter module (LSPTM) and of the LSPTM electrical wiring, repetitive inspections for blockage of the drain holes and cleaning of each drain hole, repetitive inspections for loose or cracked leveling compound, and applicable on-condition actions. For certain airplanes, this proposed AD would also require installing two new drain holes, performing repetitive inspections for blockage of the drain holes and cleaning each drain hole, and applicable on-condition actions. The FAA is proposing this AD to address the unsafe condition on these products.

DATES:
The FAA must receive comments on this proposed AD by June 9, 2022.

ADDRESSES:
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
• Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
• Fax: 202-493-2251.
• Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
• Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
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 https://www.myboeingfleet.com. You may view this referenced 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 https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0458.

Examining the AD Docket
You may examine the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0458; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, any comments received, and other information. The street address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT:
Hassan Ibrahim, Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3653; email: hassan.m.ibrahim@faa.gov.

SUPPLEMENTARY INFORMATION:

Comments Invited
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0458; Project Identifier AD-2021-00633-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.
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 https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

Confidential Business Information
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Hassan Ibrahim, Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3653; email: hassan.m.ibrahim@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

Background
This proposed AD was prompted by reports of inoperative manual and alternate horizontal stabilizer trim switches on the Boeing Model 767. An investigation found that drain holes in the area aft of body station (STA) 1725.5 were blocked and caused water to accumulate and eventually submerge the three LSPTMs, which affected their function. Loose pieces of leveling compound in the area were found detached and blocking the drain holes. Collected water or ice could damage the LSPTMs and cause stabilizer trim position sensors to generate corrupt or erroneous signals to the flight crew. This condition, if not addressed, could result in misleading or confusing flight deck indications, a high speed overrun during takeoff, or a low altitude stall immediately after takeoff.

FAA's Determination
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.

Related Service Information Under 1 CFR Part 51
The FAA reviewed Boeing Alert Requirements Bulletin 767-27A0240 RB, dated January 19, 2021, which specifies procedures for repetitive general visual inspections (GVIs) for immersion in water or ice of each LSPTM and of the LSPTM electrical wiring, repetitive GVIs for blockage of the three drain holes and cleaning of each drain hole, repetitive GVIs for loose or cracked leveling compound, and applicable on-condition actions. On-condition actions include removing any water or ice, doing a detailed inspection for damage (corrosion or water damage) of any immersed LSPTM or LSPTM electrical wiring, installing a serviceable LSPTM, repairing or replacing any damaged LSPTM electrical wiring, clearing any drain hole blockages, and repairing any loose or cracked leveling compound.
The FAA also reviewed Boeing Alert Requirements Bulletin 767-27A0243 RB, dated May 28, 2021. This service information specifies procedures for installing two new drain holes, performing repetitive GVIs for blockage of the five drain holes and cleaning each drain hole, and applicable on-condition actions. On-condition actions include clearing any drain hole blockages.
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 ADDRESSES .

Proposed AD Requirements in This NPRM
This proposed AD would require, for Model 767-200, -300, -300F, and -400ER airplanes, accomplishing the actions specified in the service information already described. For the airplanes identified in Boeing Alert Requirements Bulletin 767-27A0243 RB, dated May 28, 2021, this proposed AD would require the concurrent accomplishment of the actions in Boeing Alert Requirements Bulletin 767-27A0240 RB, dated January 19, 2021. For Model 767-2C airplanes, this proposed AD would require inspections and applicable on-condition actions accomplished in accordance with a method approved by the Manager, Seattle ACO Branch, FAA. For information on the procedures and compliance times, see this service information at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0458.

Costs of Compliance
The FAA estimates that this AD, if adopted as proposed, would affect 613 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
Estimated Costs
Action | Labor cost | Parts cost | Cost per product | Cost on U.S. operators
Drill drain holes | 5 work-hours × $85 per hour = $425 | $2,770 | $3,195 | Up to $1,958,535.
Repetitive GVI and cleaning of 5 drain holes | 2 work-hours × $85 per hour = $170 per inspection cycle | 0 | 170 per inspection cycle | Up to $104,210 per inspection cycle.
Repetitive GVI of LSPTM | 1 work-hour × $85 per hour = $85 per inspection cycle | 0 | 85 per inspection cycle | 52,105 per inspection cycle.
Repetitive GVI of LSPTM electrical wiring | 1 work-hour × $85 per hour = $85 per inspection cycle | 0 | 85 per inspection cycle | 52,105 per inspection cycle.
Repetitive GVI and cleaning of 3 drain holes | 1 work-hour × $85 per hour = $85 per inspection cycle | 0 | 85 per inspection cycle | 52,105 per inspection cycle.
Repetitive GVI of leveling compound | 1 work-hour × $85 per hour = $85 per inspection cycle | 0 | 85 per inspection cycle | 52,105 per inspection cycle.
The FAA estimates the following costs to do any necessary inspections that would be required based on the results of the proposed inspection. The agency has no way of determining the number of aircraft that might need these inspections:
On-Condition Costs
Action | Labor cost | Parts cost | Cost per product
Detailed inspection of LSPTM or LSPTM electrical wiring | 1 work-hour × $85 per hour = $85 | $0 | $85
The FAA has received no definitive data on which to base the cost estimates for the other on-condition actions specified in this proposed AD.

Authority for This Rulemaking
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.

Regulatory Findings
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.

List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

The Proposed Amendment
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39—AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:

Authority:
49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive:
The Boeing Company: Docket No. FAA-2022-0458; Project Identifier AD-2021-00633-T.

(a) Comments Due Date
The FAA must receive comments on this airworthiness directive (AD) by June 9, 2022.

(b) Affected ADs
None.

(c) Applicability
This AD applies to all The Boeing Company Model 767-200, -300, -300F, -400ER, and -2C series airplanes, certificated in any category.

(d) Subject
Air Transport Association (ATA) of America Code 27, Flight controls;

(e) Unsafe Condition
This AD was prompted by reports of inoperative manual and alternate horizontal stabilizer trim switches; an investigation found that certain drain holes were blocked, causing water and ice to collect and subsequently cover the limit switch and position transmitter modules (LSPTMs), which affected their function. The FAA is issuing this AD to address collected water or ice that could damage the LSPTMs and cause stabilizer trim position sensors to generate corrupt or erroneous signals to the flight crew. This condition, if not addressed, could result in misleading or confusing flight deck indications, a high speed overrun during takeoff, or a low altitude stall immediately after takeoff.

(f) Compliance
Comply with this AD within the compliance times specified, unless already done.

(g) Required Actions
(1) For all Model 767-200, -300, -300F, and -400ER airplanes: Except as specified by paragraph (h) of this AD, at the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 767-27A0240 RB, dated January 19, 2021, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletin 767-27A0240 RB, dated January 19, 2021.
Note 1 to paragraph (g)(1): Guidance for accomplishing the actions required by this AD can be found in Boeing Alert Service Bulletin 767-27A0240, dated January 19, 2021, which is referred to in Boeing Alert Requirements Bulletin 767-27A0240 RB, dated January 19, 2021.
(2) For Model 767-200, -300, -300F, and -400ER airplanes, as identified in Boeing Alert Requirements Bulletin 767-27A0243, dated May 28, 2021: Except as specified by paragraph (h) of this AD, at the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 767-27A0243, dated May 28, 2021, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletin 767-27A0243, dated May 28, 2021. Accomplishing the installation of two new drain holes required by this paragraph terminates the repetitive inspections of the drain holes required by paragraph (g)(1) of this AD.
Note 2 to paragraph (g)(2): Guidance for accomplishing the actions required by this AD can be found in Boeing Alert Service Bulletin 767-27A0243, dated May 28, 2021, which is referred to in Boeing Alert Requirements Bulletin 767-27A0243, dated May 28, 2021.
(3) For Model 767-2C airplanes: Within 90 days after the effective date of this AD, inspect the LSPTMs, LSPTM electrical wiring, drain holes, and leveling compound; install two new drain holes as applicable; and do applicable on-condition actions in accordance with a method approved by the Manager, Seattle ACO Branch, FAA.

(h) Exceptions to Service Information Specifications
(1) Where Boeing Alert Requirements Bulletin 767-27A0243 RB, dated May 28, 2021, uses the phrase “the original issue date of the Requirements Bulletin 767-27A0243 RB,” this AD requires using “the effective date of this AD.”
(2) Where Boeing Alert Requirements Bulletin 767-27A0240 RB, dated January 19, 2021, uses the phrase “the original issue date of the Requirements Bulletin 767-27A0240 RB,” this AD requires using “the effective date of this AD.”
(3) Where Boeing Alert Requirements Bulletin 767-27A0243 RB, dated May 28, 2021, specifies a compliance time for Action 1, for this AD do Action 1 as specified in paragraph (g)(1) of this AD.

(i) Alternative Methods of Compliance (AMOCs)
(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: 9-ANM-Seattle-ACO-AMOC-Requests@faa.gov.
(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.

(j) Related Information
(1) For more information about this AD, contact Hassan Ibrahim, Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3653; email: hassan.m.ibrahim@faa.gov.
(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 https://www.myboeingfleet.com. You may view this referenced 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.
Issued on April 7, 2022.
Lance T. Gant,

Director, Compliance & Airworthiness Division, Aircraft Certification Service.
87
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Monday, April 25, 2022
Notices
COMMISSION ON CIVIL RIGHTS
Notice of Public Meeting of the Tennessee Advisory Committee

AGENCY:
Commission on Civil Rights.

ACTION:
Announcement of meeting.

SUMMARY:
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 Tennessee Advisory Committee to the Commission will hold two virtual (online) meetings on Wednesday, May 11, 2022, at 11:00 a.m.-1:00 p.m. (CT) and on Wednesday, May 25, 2022 at 11:00 a.m.-1:00 p.m. (CT). The purpose of the meetings is for the Committee to hear testimony regarding Voting Rights in the state of Tennessee.

DATES:
The meetings will be held on:
Wednesday, May 11, 2022, 11:00 a.m. CT, https://civilrights.webex.com/civilrights/j.php?MTID=m85bcb751a907bc57ec86fcac2374dcda
Join via phone: 800-360-9505 USA Toll Free; Access Code: 2764 191 0901#
Wednesday, May 25, 2022, 11:00 a.m. CT, https://civilrights.webex.com/civilrights/j.php?MTID=mb8dea20690b4d89e9e8b1f5854a364c9
Join via phone: 800-360-9505 USA Toll Free; Access Code: 2763 146 6616#

FOR FURTHER INFORMATION CONTACT:
Victoria Moreno at vmoreno@usccr.gov or by phone at 434-515-0204.

SUPPLEMENTARY INFORMATION:
This meeting is available to the public through the WebEx link 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 above for the meeting.
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 respective meeting. Written comments may be emailed to Victoria Moreno at vmoreno@usccr.gov. All written comments received will be available to the public.
Persons who desire additional information may contact the Regional Programs Unit at (202) 809-9618. Records and documents discussed during the meeting will be available for public viewing as they become available at the www.facadatabase.gov. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Regional Programs Unit at the above phone number or email address.

Agenda

Wednesday, May 11, 2022 and May 25, 2022; 11:00 a.m. (CT)
1. Welcome & Roll Call
2. Panel—Voting Rights in Tennessee
3. Public Comment
4. Adjourn
Dated: April 19, 2022.
David Mussatt,

Supervisory Chief, Regional Programs Unit.
COMMISSION ON CIVIL RIGHTS
Notice of Public Meeting of the Iowa Advisory Committee to the U.S. Commission on Civil Rights

AGENCY:
U.S. Commission on Civil Rights.

ACTION:
Announcement of meeting.

SUMMARY:
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 Iowa Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a meeting on Thursday, May 5, 2022 at 12:00 p.m.-1:00 p.m. Central time. The purpose is the Committee will meet to continue planning for their third web hearing focused on employment discrimination and administrative closures.

DATES:
The meeting will take place on Thursday, May 5, 2022, from 12:00 p.m.-1:00 p.m. Central time.
Online Regisration (Audio/Visual): https://tinyurl.com/z9z52nmp.
Telephone (Audio Only): Dial 800-360-9505 USA Toll Free; Access code: 2763 826 7077.

FOR FURTHER INFORMATION CONTACT:
Ana Victoria Fortes, DFO, at afortes@usccr.gov or 202-681-0857.

SUPPLEMENTARY INFORMATION:
Members of the public can listen to these discussions. Committee meetings are available to the public through the above call in number. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. 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 conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Corrine Sanders at csanders@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311.
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Pennsylvania Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Agenda
I. Welcome
II. Discussion and Planning for third web hearing
III. Public Comment
IV. Next Steps
V. Adjournment
Dated: April 19, 2022.
David Mussatt,

Supervisory Chief, Regional Programs Unit.
DEPARTMENT OF COMMERCE
National Telecommunications and Information Administration
First Responder Network Authority; Public Combined Board and Board Committees Meeting

AGENCY:
First Responder Network Authority (FirstNet Authority), National Telecommunications and Information Administration (NTIA), U.S. Department of Commerce.

ACTION:
Announcement of meeting.

SUMMARY:
The FirstNet Authority Board will convene an open public meeting of the Board and Board Committees.

DATES:
May 4, 2022; 11:00 a.m. to 1:00 p.m. Eastern Standard Time (EST); Durham, New Hampshire.

ADDRESSES:
The meeting will be held at the University of New Hampshire—Durham located at 105 Main Street, Durham, NH 03824. Due to restrictions on the number of people who can be present, members of the public will not be able to attend in person but may listen to the meeting and view the presentation by visiting the URL: https://stream2.sparkstreetdigital.com/20220504-firstnet.html. If you experience technical difficulty, contact support@sparkstreetdigital.com. WebEx information can also be found on the FirstNet Authority website ( FirstNet.gov ).

FOR FURTHER INFORMATION CONTACT:
General information: Janell Smith, (202) 257-5929, Janell.Smith@FirstNet.gov.
Media inquiries: Ryan Oremland, (571) 665-6186, Ryan.Oremland@FirstNet.gov.

SUPPLEMENTARY INFORMATION:
Background: The Middle-Class Tax Relief and Job Creation Act of 2012 (codified at 47 U.S.C. 1401 et seq. ) (Act) established the FirstNet Authority as an independent authority within NTIA. The Act directs the FirstNet Authority to ensure the building, deployment, and operation of a nationwide interoperable public safety broadband network. The FirstNet Authority Board is responsible for making strategic decisions regarding the operations of the FirstNet Authority.
Matters to be Considered: The FirstNet Authority will post a detailed agenda for the Combined Board and Board Committees Meeting on FirstNet.gov prior to the meeting. The agenda topics are subject to change. Please note that the subjects discussed by the Board and Board Committees may involve commercial or financial information that is privileged or confidential, or other legal matters affecting the FirstNet Authority. As such, the Board may, by majority vote, close the meeting only for the time necessary to preserve the confidentiality of such information, pursuant to 47 U.S.C. 1424(e)(2).
Other Information: The public Combined Board and Board Committees Meeting is accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Janell Smith at (202) 257-5929 or email: Janell.Smith@FirstNet.gov at least five (5) business days (April 27) before the meeting.
Records: The FirstNet Authority maintains records of all Board proceedings. Minutes of the Combined Board and Board Committees Meeting will be available on FirstNet.gov.
Dated: April 18, 2022.
Janell Smith,

Board Secretary, First Responder Network Authority.
DEPARTMENT OF COMMERCE
International Trade Administration
[A-570-124, C-570-125]
Certain Vertical Shaft Engines Between 99cc and Up To 225cc, and Parts Thereof, From the People's Republic of China: Initiation of Circumvention Inquiry of the Antidumping and Countervailing Duty Orders—Dual-Piston Engines

AGENCY:
Enforcement and Compliance, International Trade Administration, Department of Commerce.

SUMMARY:
In response to a circumvention inquiry request from Briggs & Stratton, LLC, the Department of Commerce (Commerce) is initiating a country-wide circumvention inquiry to determine whether dual-piston engines exported from the People's Republic of China (China) will circumvent the antidumping (AD) and countervailing duty (CVD) orders on certain vertical shaft engines between 99cc and up to 225cc, and parts thereof (small vertical engines) from China.

DATES:
Applicable April 25, 2022.

FOR FURTHER INFORMATION CONTACT:
Paul Gill, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5673.

SUPPLEMENTARY INFORMATION:

Background
On March 4, 2022, Briggs & Stratton, LLC, the petitioner in the less-than-fair-value (LTFV) and CVD investigations, requested that Commerce initiate a circumvention inquiry with respect to dual-piston engines produced in and exported from China. ^1 The petitioner alleges that dual-piston engines constitute merchandise altered in form or appearance in such minor respects that they should be included within the scope of the Orders, ^2 pursuant to section 781(c) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.226(j). In addition, the petitioner alleges that dual-piston engines are later-developed merchandise and should be included within the scope of the Orders, pursuant to section 781(d) of the Act and 19 CFR 351.226(k).
^1 See Petitioner's Letter, “Request for Anti-Circumvention Inquiry Pursuant to Section 781(c) and/or Section 781(d) of the Tariff Act of 1930,” dated March 4, 2022.
^2 See Certain Vertical Shaft Engines Between 99cc and Up to 225cc, and Parts Thereof from the People's Republic of China: Antidumping and Countervailing Duty Orders, 86 FR 23675 (May 4, 2021) ( Orders ).
On March 28, 2022, we extended the deadline to initiate this circumvention inquiry by 15 days, in accordance with the 19 CFR 351.226(d)(1), to April 18, 2022. ^3 On April 7, 2022, FNA Group, Inc. (FNA) submitted comments asking that Commerce reject the petitioner's request that Commerce initiate a country-wide circumvention inquiry. ^4
^3 See Memorandum, “Correction to Extended Date to Determine Whether to Initiate Circumvention Inquiry,” dated April 7, 2022. Commerce initially submitted a memorandum on March 28, 2022 to extend the initiation deadline, but the extended deadline was incorrectly listed as April 19, 2022. See Memorandum, “Extension of Time to Determine Whether to Initiate Circumvention Inquiry,” dated March 28, 2022.
^4 See FNA's Letter, “Request to Reject Anti-Circumvention Inquiry Request,” dated April 7, 2022. FNA initially submitted comments on March 29, 2022, but Commerce rejected these comments because they contained untimely new factual information. See Commerce's Letter, “Rejection Letter,” dated April 6, 2022. We intend to address FNA's comments from its April 7, 2022 letter post-initiation because they relate to the substance of the petitioner's allegation.

Scope of the Orders
The products subject to the Orders are small vertical engines from China. For a complete description of the scope of the Orders, see the appendix to this notice.

Merchandise Subject to the Circumvention Inquiry
This circumvention inquiry covers dual-piston engines produced in China and exported to the United States.

Statutory and Regulatory Framework
Section 351.226(d) of Commerce's regulations states that if Commerce determines that a request for a circumvention inquiry satisfies the requirements of 19 CFR 351.226(c), then Commerce “will accept the request and initiate a circumvention inquiry.” Section 351.226(c)(1) of Commerce's regulations, in turn, requires that each request for a circumvention inquiry allege “that the elements necessary for a circumvention determination under section 781 of the Act exist” and be “accompanied by information reasonably available to the interested party supporting these allegations.” The petitioner alleges circumvention pursuant to sections 781(c) (merchandise altered in form or appearance in minor respects) and 781(d) (merchandise developed after an investigation is initiated) of the Act.
Section 351.226(m)(2) of Commerce's regulations states, for companion AD and CVD duty proceedings, that “the Secretary will initiate and conduct a single inquiry with respect to the product at issue for both orders only on the record of the antidumping proceeding.” Further, once “the Secretary issues a final circumvention determination on the record of the antidumping duty proceeding, the Secretary will include a copy of that determination on the record of the countervailing duty proceeding.” Accordingly, once Commerce concludes this circumvention inquiry, Commerce intends to place its final circumvention determination on the record of the companion CVD proceeding.
Section 781(c)(1) of the Act provides that the class or kind of merchandise subject to an AD or CVD order shall include articles that have been “altered in form or appearance in minor respects . . . whether or not included in the same tariff classification.” Section 781(c)(2) of the Act provides an exception that section 781(c)(1) of the Act “shall not apply with respect to altered merchandise if the administering authority determines that it would be unnecessary to consider the altered merchandise within the scope of the {order}.” Concerning the allegation of minor alteration under section 781(c) of the Act and 19 CFR 351.226(j), Commerce may consider criteria including, but not limited to: (1) Overall physical characteristics of the merchandise; (2) expectations of ultimate users; (3) use of the merchandise; (4) channels of marketing; and (5) cost of any modification relative to the value of the imported products.
Section 781(d) of the Act provides that Commerce may find circumvention of an AD or CVD order when merchandise is developed after an investigation is initiated. In conducting a later-developed merchandise inquiry under section 781(d)(1) of the Act and 19 CFR 351.226(k), Commerce will consider whether: (1) The later-developed merchandise has the same general physical characteristics as the merchandise with respect to which the order was originally issued; (2) the expectations of the ultimate purchasers of the later-developed merchandise are the same as for the earlier product; (3) the ultimate use of the earlier product and the later-developed merchandise are the same; (4) the later-developed merchandise is sold through the same channels of trade as the earlier product; and (5) the later-developed merchandise is advertised and displayed in a manner similar to the earlier product. ^5 First, however, Commerce determines whether the merchandise subject to the inquiry was commercially available at the time of the initiation of the underlying LTFV or CVD investigation ( i.e., the product was present in the commercial market or the product was tested and ready for commercial production). ^6
^5 See section 781(d)(1) of the Act.
^6 See 19 CFR 351.226(k).

Analysis
After analyzing the record evidence and the petitioner's allegation, we determine that there is sufficient information to warrant initiation of a circumvention inquiry based on both allegations: (1) Minor alterations, pursuant to section 781(c) of the Act and 19 CFR 351.226(j); and (2) later-developed merchandise, pursuant to section 781(d) of the Act and 19 CFR 351.226(k). For a full discussion of the basis for our decision to initiate a circumvention inquiry regarding both the later-developed merchandise and minor alterations allegations, see the Initiation Decision Memorandum. ^7
^7 See Memorandum, “Decision Memorandum for Initiation of Circumvention Inquiry,” dated concurrently with, and hereby adopted by, this notice (Initiation Decision Memorandum), available at https://access.trade.gov/public/FRNoticesListLayout.aspx .
As explained in the Initiation Decision Memorandum, the information provided by the petitioner also warrants initiating this circumvention inquiry on a country-wide basis. Commerce has taken this approach in prior circumvention inquiries, when the facts warranted initiation on a country-wide basis. ^8
^8 See, e.g., Aluminum Extrusions from the People's Republic of China: Affirmative Final Determination of Circumvention of the Antidumping and Countervailing Duty Orders and Rescission of Minor Alterations Anti-Circumvention Inquiry, 82 FR 4630 (July 26, 2017), and accompanying Issues and Decision Memorandum at Comment 4.
Commerce intends to establish a schedule for questionnaires and comments on the issues related to this inquiry. A company's failure to respond completely to Commerce's requests for information may result in the application of partial or total facts available, pursuant to section 776(a) of the Act, which may include adverse inferences, pursuant to section 776(b) of the Act.

Suspension of Liquidation
Pursuant to 19 CFR 351.226(l)(1), Commerce intends to notify U.S. Customs and Border Protection (CBP) of this initiation and direct CBP to continue the suspension of liquidation of entries of products subject to this circumvention inquiry that were already subject to the suspension of liquidation under the Orders and to apply the cash deposit rates that would be applicable if the products were determined to be covered by the scope of the Orders. Should Commerce issue preliminary or final circumvention determinations, Commerce will follow the suspension of liquidation rules under 19 CFR 351.226(l)(2)-(4).

Notification to Interested Parties
In accordance with 19 CFR 351.226(d) and sections 781(c) and (d) of the Act, Commerce determines that the petitioner's request for a circumvention inquiry satisfies the requirements of 19 CFR 351.226(c). Accordingly, Commerce is notifying all interested parties of the initiation of this circumvention inquiry to determine whether dual-piston engines produced in and exported from China will circumvent the Orders. In addition, we have included a description of the products that are the subject to this inquiry and an explanation of Commerce's decision to initiate this inquiry as provided in the accompanying Initiation Decision Memorandum. In accordance with 19 CFR 351.226(e)(1), Commerce intends to issue its preliminary circumvention determination no later than 150 days from the date of publication of the notice of initiation of this circumvention inquiry in the Federal Register .
This notice is published in accordance with sections 781(c) and (d) of the Act, and 19 CFR 351.226(d)(1)(ii).
Dated: April 18, 2022.
Lisa W. Wang,

Assistant Secretary for Enforcement and Compliance.

Appendix

Scope of the Orders
The merchandise covered by these Orders consists of spark-ignited, non-road, vertical shaft engines, whether finished or unfinished, whether assembled or unassembled, whether mounted or unmounted, primarily for walk-behind lawn mowers. Engines meeting this physical description may also be for other non-hand-held outdoor power equipment, including but not limited to, pressure washers. The subject engines are spark ignition, single-cylinder, air cooled, internal combustion engines with vertical power take off shafts with a minimum displacement of 99 cubic centimeters (cc) and a maximum displacement of up to, but not including, 225cc. Typically, engines with displacements of this size generate gross power of between 1.95 kilowatts (kw) to 4.75 kw.
Engines covered by these Orders normally must comply with and be certified under Environmental Protection Agency (EPA) air pollution controls title 40, chapter I, subchapter U, part 1054 of the Code of Federal Regulations standards for small non-road spark-ignition engines and equipment. Engines that otherwise meet the physical description of the scope but are not certified under 40 CFR part 1054 and are not certified under other parts of subchapter U of the EPA air pollution controls are not excluded from the scope of the orders. Engines that may be certified under both 40 CFR part 1054 as well as other parts of subchapter U remain subject to the scope of the orders.
Certain small vertical shaft engines, whether or not mounted on non-hand-held outdoor power equipment, including but not limited to walk-behind lawn mowers and pressure washers, are included in the scope. However, if a subject engine is imported mounted on such equipment, only the engine is covered by the scope. Subject merchandise includes certain small vertical shaft engines produced in the subject country whether mounted on outdoor power equipment in the subject country or in a third country. Subject engines are covered whether or not they are accompanied by other parts.
For purposes of these Orders, an unfinished engine covers at a minimum a sub-assembly comprised of, but not limited to, the following components: Crankcase, crankshaft, camshaft, piston(s), and connecting rod(s). Importation of these components together, whether assembled or unassembled, and whether or not accompanied by additional components such as a sump, carburetor spacer, cylinder head(s), valve train, or valve cover(s), constitutes an unfinished engine for purposes of these orders. The inclusion of other products such as spark plugs fitted into the cylinder head or electrical devices ( e.g., ignition coils) for synchronizing with the engine to supply tension current does not remove the product from the scope. The inclusion of any other components not identified as comprising the unfinished engine subassembly in a third country does not remove the engine from the scope.
Specifically excluded from the scope of these orders are “Commercial” or “Heavy Commercial” engines under 40 CFR 1054.107 and 1054.135 that have (1) a displacement of 160 cc or greater, (2) a cast iron cylinder liner, (3) an automatic compression release, and (4) a muffler with at least three chambers and volume greater than 400 cc.
The engines subject to these Orders are predominantly classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheading 8407.90.1010. The engine subassemblies that are subject to these Orders are classified under HTSUS subheading 8409.91.9990. The mounted engines that are subject to these Orders are classified under HTSUS subheadings 8433.11.0050, 8433.11.0060, and 8424.30.9000. Engines subject to these Orders may also be classified under HTSUS subheadings 8407.90.1020, 8407.90.9040, and 8407.90.9060. The HTSUS subheadings are provided for convenience and customs purposes only, and the written description of the merchandise is dispositive.
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
[RTID 0648-XB965]
Atlantic Highly Migratory Species; Meeting of the Atlantic Highly Migratory Species Advisory Panel

AGENCY:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:
Notice of public meeting and webinar/conference call.

SUMMARY:
NMFS will hold a 3-day Atlantic Highly Migratory Species (HMS) Advisory Panel (AP) meeting in May 2022. The intent of the meeting is to consider options for the conservation and management of Atlantic HMS. The meeting is open to the public.

DATES:
The AP meeting and webinar will be held from 10 a.m. to 5 p.m. on Wednesday, May 18, from 9:30 a.m. to 5 p.m. on Thursday, May 19, and from 9 a.m. to 12 p.m. on Friday, May 20.

ADDRESSES:
The meeting will be held at the DoubleTree by Hilton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring, MD 20910. The meeting will also be accessible via WebEx webinar/conference call. Conference call and webinar access information are available at: https://www.fisheries.noaa.gov/event/may-2022-hms-advisory-panel-meeting.
Participants accessing the webinar are strongly encouraged to log/dial in 15 minutes prior to the meeting. NMFS will show the presentations via webinar and allow public comment during identified times on the agenda.

FOR FURTHER INFORMATION CONTACT:
Peter Cooper at (301) 427-8503 or Peter.Cooper@noaa.gov.

SUPPLEMENTARY INFORMATION:
Atlantic HMS fisheries are managed under the dual authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) and the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ). The 2006 Consolidated Atlantic HMS Fishery Management Plan (2006 Consolidated HMS FMP) and its amendments are implemented by regulations at 50 CFR part 635.
The Magnuson-Stevens Act requires the establishment of APs and requires NMFS to consult with and consider the comments and views of AP members during the preparation and implementation of FMPs or FMP amendments. 16 U.S.C. 1854(g)(1)(A)-(B). NMFS meets with the HMS AP approximately twice each year to consider potential alternatives for the conservation and management of Atlantic tunas, swordfish, billfish, and shark fisheries, consistent with the Magnuson-Stevens Act.
For this meeting, we anticipate discussing:
• Bluefin tuna management activities including the Amendment 13 Final Environmental Impact Statement
• The Marine Recreational Information Program HMS Regional Implementation Plan
• Shark depredation
• Equity and Environmental Justice
We also anticipate inviting other NMFS offices and the United States Coast Guard to provide updates, if available, on their activities relevant to HMS fisheries. Additional information on the meetings and a copy of the draft agenda will be posted prior to the meeting at: https://www.fisheries.noaa.gov/event/may-2022-hms-advisory-panel-meeting.
Dated: April 20, 2022.
Jennifer M. Wallace,

Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
DEPARTMENT OF COMMERCE
Patent and Trademark Office
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Practitioner Conduct and Discipline
The United States Patent and Trademark Office (USPTO) will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The USPTO invites comment on this information collection renewal, which helps the USPTO assess the impact of its information collection requirements and minimize the public's burden. Public comments were previously requested via the Federal Register on February 8, 2022 during a 60-day comment period. This notice allows an additional 30 days for public comments.
Agency: United States Patent and Trademark Office, Department of Commerce.
Title: Practitioner Conduct and Discipline.
OMB Control Number: 0651-0017.
Needs and Uses: The Director of the USPTO has the authority to establish regulations governing the conduct and discipline of agents, attorneys, or other persons representing applicants and other parties before the USPTO (35 U.S.C. 2 and 32-33). The USPTO Rules of Professional Conduct, set forth in subpart D, part 11 of title 37 of the Code of Federal Regulations, prescribe the manner in which agents, attorneys, and other persons (collectively, “practitioners”) representing applicants and other parties before the USPTO should conduct themselves professionally. Part 11 outlines practitioners' responsibilities for recordkeeping and reporting violations or complaints of misconduct to the USPTO. Subpart C of part 11 sets forth the manner by which the USPTO investigates misconduct and imposes discipline. The USPTO Rules of Professional Conduct require all practitioners to maintain complete records of all funds, securities, and other properties of clients coming into his or her possession, and to render appropriate accounts to the client regarding the funds, securities, and other properties of clients coming into the practitioner's possession, collectively known as “client property.” These recordkeeping requirements are necessary to maintain the integrity of client property. State bars require attorneys to perform similar recordkeeping. Part 11 also requires a practitioner to report knowledge of certain violations of the USPTO Rules of Professional Conduct to the USPTO. The USPTO Director may, after notice and opportunity for a hearing, suspend, exclude, or disqualify any practitioner from further practice before the USPTO based on non-compliance with the USPTO Rules of Professional Conduct. Practitioners who have been excluded or suspended from practice before the USPTO, practitioners transferred to disability inactive status, and practitioners who have resigned must maintain records of their compliance with the suspension or exclusion order, transfer to disability inactive status, or resignation. These records are necessary to demonstrate eligibility for reinstatement. Reports of alleged violations of the USPTO Rules of Professional Conduct are used by the Director of OED to conduct investigations and disciplinary hearings, as appropriate.
This information collection covers the various reporting and recordkeeping requirements set forth in Part 11 for practitioners representing applicants and other parties before the USPTO. Also covered are petitions for reinstatement for suspended or excluded practitioners and the means for reporting violations or complaints of misconduct to the USPTO.
Forms: No Forms.
Type of Review: Extension and revision of a currently approved information collection.
Affected Public: Individuals or households.
Respondent's Obligation: Required to obtain or retain benefits.
Frequency: On occasion.
Estimated Number of Annual Respondents: 13,190 respondents.
Estimated Number of Annual Responses: 13,190 responses.
Estimated Time per Response: The USPTO estimates that the responses in this information collection will take the public approximately between 1 (60 minutes) to 3 hours (240 minutes) to complete. This includes the time to gather the necessary information, create the document, and submit the completed request to the USPTO. The USPTO Rules of Professional Conduct require practitioner agents to maintain various records to maintain the integrity of client property and meet other requirements. Additional recordkeeping requirements are also given for practitioners who are under suspension or exclusion. The USPTO estimates that it will take a practitioner between 1 (60 minutes) and 20 hours (1,200 minutes) to perform these recordkeeping actions.
Estimated Total Annual Respondent Burden Hours: 14,192 hours.
Estimated Total Annual Respondent Non-Hourly Cost Burden: $8,419.
This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Commerce, USPTO information collections currently under review by OMB.
Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function and entering either the title of the information collection or the OMB Control Number 0651-0017.
Further information can be obtained by:
• Email: InformationCollection@uspto.gov. Include “0651-0017 information request” in the subject line of the message.
• Mail: Kimberly Hardy, Office of the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Kimberly Hardy,

Information Collections Officer, Office of the Chief Administrative Officer, United States Patent and Trademark Office.
DEPARTMENT OF COMMERCE
Patent and Trademark Office
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Madrid Protocol
The United States Patent and Trademark Office (USPTO) will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The USPTO invites comment on this information collection renewal, which helps the USPTO assess the impact of its information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the Federal Register on February 9, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments.
Agency: United States Patent and Trademark Office, Department of Commerce.
Title: Madrid Protocol.
OMB Control Number: 0651-0051.
Needs and Uses: This collection of information is required by the Trademark Act of 1946, 15 U.S.C. 1051 et seq., which provides for the Federal registration of trademarks, service marks, collective trademarks and service marks, collective membership marks, and certification marks. The Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks (Madrid Protocol) is an international treaty that allows a trademark owner to seek registration in any of the participating countries by filing a single international application. The International Bureau (IB) of the World Intellectual Property Organization (WIPO) in Geneva, Switzerland, administers the international registration system. The Madrid Protocol Implementation Act of 2002 amended the Trademark Act to provide that: (1) The owner of a U.S. application or registration may seek protection of its mark in any of the participating countries by submitting a single international application through the USPTO and (2) the holder of an international registration may request an extension of protection of the international registration to the United States. The Madrid Protocol came into effect in the United States on November 2, 2003, and is implemented under 15 U.S.C. 1141 et seq. and 37 CFR parts 2 and 7. Individuals and businesses that use or intend to use such marks in commerce may file an application to register the marks with the USPTO. Both the register and the information provided in pending applications for registration can be accessed by the public in order to determine the availability of a mark and lessen the likelihood of initiating the use of a mark previously adopted by another.
Forms:
• PTO/1663 (Declaration of Continued Use/Excusable Nonuse of Mark in Commerce Under Section 71)
• PTO/1683 (Combined Declaration of Continued Use/Excusable Nonuse and Incontestability Under Sections 71 and 15)
• PTO/2131 (Application for International Registration)
• PTO/2132 (Application for Subsequent Designation)
• PTO/2133 (Response to Notice of Irregularity)
• PTO/2314 (Replacement Request)
• PTO/2315 (Transformation Request)
• PTO/2316 (Petition to Director to Review Denial of Certification of International Application)
• PTO/2317 (Petition to Director for an International Application/Registration)
Type of Review: Extension and revision of a currently approved information collection.
Affected Public: Private sector; individuals or households.
Respondent's Obligation: Required to obtain or retain benefits.
Frequency: On occasion.
Estimated Number of Annual Respondents: 54,082 respondents.
Estimated Number of Annual Responses: 54,082 responses.
Estimated Time per Response: The USPTO estimates that the responses in this information collection will take the public between 40 minutes (0.66 hours) and 75 minutes (1.25 hours) to complete. This includes the time to gather the necessary information, create the document, and submit the completed request to the USPTO.
Estimated Total Annual Respondent Burden Hours: 48,671 hours.
Estimated Total Annual Respondent Non-Hourly Cost Burden: $21,516,380.
This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Commerce, USPTO information collections currently under review by OMB.
Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function and entering either the title of the information collection or the OMB Control Number 0651-0051.
Further information can be obtained by:
• Email: InformationCollection@uspto.gov. Include “0651-0051 information request” in the subject line of the message.
• Mail: Kimberly Hardy, Office of the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Kimberly Hardy,

Information Collections Officer, Office of the Chief Administrative Officer, United States Patent and Trademark Office.
COUNCIL ON ENVIRONMENTAL QUALITY
[CEQ-2022-0002]
Climate and Economic Justice Screening Tool Beta Version

AGENCY:
Council on Environmental Quality.

ACTION:
Notice of extension for request for information (RFI).

SUMMARY:
On February 23, 2022, the Council on Environmental Quality published a request for information (RFI) to solicit feedback on the beta version of the Climate and Economic Justice Screening Tool. This notice extends the deadline date for receiving comments until May 25, 2022.

DATES:
Responses to this RFI should be received by May 25, 2022.

ADDRESSES:
You may submit comments, identified by docket number CEQ-2022-0002, by any of the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
• Fax: 202-456-6546.
• Mail: Council on Environmental Quality, 730 Jackson Place NW, Washington, DC 20503.
All submissions received must include the agency name, “Council on Environmental Quality,” and the docket number, CEQ-2022-0002, for this RFI. All comments received will be posted without change to https://www.regulations.gov, including any personal information provided. Do not submit electronically any information you consider to be private, Confidential Business Information (CBI), or other information the disclosure of which is restricted by statute.
You may respond to some or all of the questions listed in the RFI. You may include references to academic literature or links to online material (such as datasets) but please ensure all links are publicly available. Each response should include:
• The name of the individual(s) or entity responding.
• A brief description of the responding individual(s) or entity's mission or areas of expertise.
• A contact for questions or other follow-up on your response.

FOR FURTHER INFORMATION CONTACT:
Issues regarding submission or questions on this RFI can be sent to Sharmila L. Murthy at 202-395-5750 or Sharmila.L.Murthy@ceq.eop.gov.

SUPPLEMENTARY INFORMATION:
On February 23, 2022, the Council on Environmental Quality published an RFI to solicit feedback on the beta version of the Climate and Economic Justice Screening Tool (CEJST) (87 FR 10176). The original deadline to submit responses was April 25, 2022. This notice extends the period for response by 30 days to provide the public with additional time to provide feedback on the beta version of the CEJST. CEQ is providing this additional time in response to public requests for an extension of the response period. Written responses should be submitted on or before May 25, 2022.
Matthew G. Lee-Ashley,

Chief of Staff.
DEPARTMENT OF DEFENSE
Department of the Army
[Docket ID: USA-2022-HQ-0009]
Proposed Collection; Comment Request

AGENCY:
Department of the Army, Department of Defense (DoD).

ACTION:
60-day information collection notice.

SUMMARY:
In compliance with the Paperwork Reduction Act of 1995, the Army & Air Force Exchange Service (Exchange) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

DATES:
Consideration will be given to all comments received by June 24, 2022.

ADDRESSES:
You may submit comments, identified by docket number and title, by any of the following methods:
Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
Mail: Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Attn: Mailbox 24, Suite 08D09, Alexandria, VA 22350-1700.
Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

FOR FURTHER INFORMATION CONTACT:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Army & Air Force Exchange Service, Office of the General Counsel, Compliance Division, ATTN: Teresa Schreurs, 3911 South Walton Walker Blvd., Dallas, TX 75236-1598 or call the Exchange Compliance Division at 800-967-6067, Extension 5.

SUPPLEMENTARY INFORMATION:
Title: Associated Form; And OMB Number: Exchange Security Verification; Exchange Form 3900-013, Exchange Form 3900-002, Exchange Form 3900-006; OMB Control Number 0702-0135.
Needs and Uses: The information collection requirement is necessary for the processing of all Army and Air Force Exchange Service security clearance actions, to record security clearances issued or denied, and to verify eligibility for access to classified information or assignments to sensitive positions.
Affected Public: Individuals or households; Business or other for-profit.
Annual Burden Hours: 1,450.
Number of Respondents: 2,900.
Responses per Respondent: 1.
Annual Responses: 2,900.
Average Burden per Response: 30 minutes.
Frequency: On occasion
Respondents are individuals and/or households affiliated with Army and Air Force Exchange Service (Exchange) by assignment, employment contractual relationship, or because of an interservice support agreement on which personnel security clearance determination has been completed or is pending. Information collected is utilized to process the personnel security clearance of contractors and/or vendors to work at an Exchange facility, record the security clearances issued or denied, and to verify the eligibility for access to classified information or assignment to a sensitive position. In addition to utilizing the information for processing security clearances, the information may be used by Exchange executives for adverse personnel actions such as removal from sensitive duties, removal from contract agreement, denial to a restricted or sensitive area, and revocation of security clearance.
Dated: April 19. 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF DEFENSE
Department of the Army
[Docket ID: USA-2022-HQ-0010]
Proposed Collection; Comment Request

AGENCY:
Department of the Army, Department of Defense (DoD).

ACTION:
60-Day information collection notice.

SUMMARY:
In compliance with the Paperwork Reduction Act of 1995, the Army & Air Force Exchange Service (Exchange) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

DATES:
Consideration will be given to all comments received by June 24, 2022.

ADDRESSES:
You may submit comments, identified by docket number and title, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.
Mail: Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Attn: Mailbox 24, Suite 08D09, Alexandria, VA 22350-1700.
Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

FOR FURTHER INFORMATION CONTACT:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Army & Air Force Exchange Service, Office of the General Counsel, Compliance Division, ATTN: Teresa Schreurs, 3911 South Walton Walker Blvd., Dallas, TX 75236-1598 through email to PrivacyManager@aafes.com, or call the Exchange Compliance Division at 800-967-6067, Option 5.

SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB Number: Exchange Employee and Retirement Benefit System; Exchange Form 1450-011, Exchange Form 1700-012; OMB Control Number 0702-0139.
Needs and Uses: The information collection requirement is necessary to administer several different benefits, pay, and retirement entitlements to eligible Exchange associates, former associates (retirees), their dependents, beneficiaries, spouses, and ex-spouses.
Affected Public: Individuals or households.
Annual Burden Hours: 3,446.67.
Number of Respondents: 10,340.
Responses per Respondent: 1.
Annual Responses: 10,340.
Average Burden per Response: 20 minutes.
Frequency: On occasion.
Respondents are active, former/retired or terminated Exchange personnel, which includes family members, beneficiaries, and survivors. Respondents provide Annuity Application and Beneficiary Designation on manual forms. Other benefits such as enrollment in health coverage, beneficiary designation, and other retirement options are done so primarily through electronic means. Health and 401K retirement collections are maintained by the service provider.
Dated: April 19, 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD-2022-OS-0022]
Submission for OMB Review; Comment Request

AGENCY:
Office of the Under Secretary of Defense for Research and Engineering (OUSD(R&E)), Department of Defense (DoD).

ACTION:
30-Day information collection notice.

SUMMARY:
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:
Consideration will be given to all comments received by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Angela Duncan, 571-372-7574, whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB Number: Research Performance Progress Report; OMB Control Number 0704-0527.
Type of Request: Extension.
Number of Respondents: 2,000.
Responses per Respondent: 2.
Annual Responses: 4,000.
Average Burden per Response: 6 hours.
Annual Burden Hours: 24,000.
Needs and Uses: The information collection requirement is necessary to: (a) Monitor Federal awards and ensure compliance with applicable terms and conditions of award regulations, policies, and procedures; (b) evaluate progress/completion in accordance with goals, aims, and objectives set forth in competing applications and to determine if the grantee satisfactorily met the objectives of the program; (c) evaluate grantee plans for the next budget period and any significant changes; (d) manage scientific programs; (e) plan future scientific initiatives; (f) determine funding for the next budget segment; (g) identify any publications, inventions, property disposition, and other required elements to close out the grant in a timely manner; and (h) complete reports to Congress, the public, and other Federal agencies.
Affected Public: Business or other for-profit; not-for-profit institutions; and state, local, or tribal government.
Frequency: Semi-annually.
Respondent's Obligation: Required to obtain or retain benefits.
OMB Desk Officer: Ms. Jasmeet Seehra.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.
DOD Clearance Officer: Ms. Angela Duncan.
Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.
Dated: April 19, 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD-2022-OS-0017]
Submission for OMB Review; Comment Request

AGENCY:
Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)), Department of Defense (DoD).

ACTION:
30-day information collection notice.

SUMMARY:
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:
Consideration will be given to all comments received by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Angela Duncan, 571-372-7574, whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB Number: Enlisted Retention and Promotion Barrier Analysis; OMB Control Number 0704-ERPB.
Type of Request: New.
Number of Respondents: 340.
Responses per Respondent: 1.
Annual Responses: 340.
Average Burden per Response: 88 minutes.
Annual Burden Hours: 498.67 hours.
Needs and Uses: The Fiscal Year 2021 National Defense Authorization Act (NDAA) (Section 551) requires DoD to conduct a barrier analysis to review demographic diversity patterns across the military life cycle, starting with enlistment or accession into the Armed Forces in order to: (i) Identify barriers to increasing diversity; (ii) develop and implement plans and processes to resolve or eliminate any barriers to diversity; and (iii) review the progress of the Armed Forces in implementing previous plans and processes to resolve or eliminate barriers to diversity. DoD's Office for Diversity, Equity, and Inclusion will carry out the NDAA requirement by completing the information collection ( i.e., Enlisted Retention and Promotion Barrier Analysis Study). Additionally, the DoD Board on Diversity and Inclusion, in its December 2020 report, recommended DoD address barriers confronted by minority members in the workplace.
Affected Public: Individuals or households.
Frequency: On occasion.
Respondent's Obligation: Voluntary.
OMB Desk Officer: Ms. Jasmeet Seehra.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.
DOD Clearance Officer: Ms. Angela Duncan.
Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.
Dated: April 19, 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD-2022-OS-0023]
Submission for OMB Review; Comment Request

AGENCY:
Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)), Department of Defense (DoD).

ACTION:
30-Day information collection notice.

SUMMARY:
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:
Consideration will be given to all comments received by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Angela Duncan, 571-372-7574, whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB Number: Request for a Medical Exemption or Delay to the COVID-19 Vaccination Requirement; DD Form 3176; OMB Control Number 0704-0619.
Type of Request: Extension.
Number of Respondents: 180,000.
Responses per Respondent: 1.
Annual Responses: 180,000.
Average Burden per Response: 5 minutes.
Annual Burden Hours: 15,000.
Needs and Uses: Consistent with Executive Order 14043, of September 9, 2021, “Requiring Coronavirus Disease 2019 Vaccination for Federal Employees”, and included within the Safer Federal Workforce Task Force Guidance mandating all Federal employees be vaccinated by November 22, 2021, the DoD has established specific safety protocols for individuals fully vaccinated and not fully vaccinated against COVID-19. Individuals who are not fully vaccinated against COVID-19 by November 22, 2021, or who choose not to provide this information will be required to comply with applicable OMB. DoD is seeking approval of DD Form 3176, “Request for a Medical Exemption or Delay to the COVID-19 Vaccination Requirement,” which will be completed by employees who seek a medical exemption. The DD Form 3176 will be used by DoD staff and provided to employees to ensure they submit adequate information to support the exemption request. This form will also ensure the information collected is consistent among the components and minimize the need to seek additional evidence. Rendered decisions should be in accordance with guidelines established by the Safer Federal Workforce Task Force Guidance.
Affected Public: Individuals or households.
Frequency: On occasion.
Respondent's Obligation: Voluntary.
OMB Desk Officer: Ms. Jasmeet Seehra.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.
DOD Clearance Officer: Ms. Angela Duncan.
Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.
Dated: April 19, 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD-2022-OS-0021]
Submission for OMB Review; Comment Request

AGENCY:
Washington Headquarters Services (WHS), Department of Defense (DoD).

ACTION:
30-Day information collection notice.

SUMMARY:
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:
Consideration will be given to all comments received by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Angela Duncan, 571-372-7574, whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB Number: Vietnam War Commemoration Program Partner Events; DD Form 2956, DD Form 2957, DD Form 3027, DD Form 3028, DD Form 3029; OMB Control Number 0704-0500.
Type of Request: Extension.
DD Form 2956
Number of Respondents: 10,000.
Responses per Respondent: 2.
Annual Responses: 20,000.
Average Burden per Response: 15 minutes.
Annual Burden Hours: 5,000.
DD Form 2957
Number of Respondents: 4,000.
Responses per Respondent: 2.
Annual Responses: 8,000.
Average Burden per Response: 15 minutes.
Annual Burden Hours: 2,000.
DD Form 3027
Number of Respondents: 1,500.
Responses per Respondent: 1.
Annual Responses: 1,500.
Average Burden per Response: 15 minutes.
Annual Burden Hours: 375.
DD Form 3028
Number of Respondents: 500.
Responses per Respondent: 1.
Annual Responses: 500.
Average Burden per Response: 15 minutes.
Annual Burden Hours: 125.
DD Form 3029
Number of Respondents: 20.
Responses per Respondent: 1.
Annual Responses: 20.
Average Burden per Response: 15 minutes.
Annual Burden Hours: 5.
Needs and Uses: This information collection requirement is necessary to notify the United States of America Vietnam War Commemoration Program of Commemorative Partner's planned events. Information is submitted for inclusion on the program's events calendar and to request event support in the form of materials and/or speakers from the program. The information collection is necessary to obtain, vet, record, process and provide Certificates of Honor to be presented on behalf of a grateful nation by partner organizations. Additionally, this collection is necessary for the partner organizations to communicate to the Commemoration program the results of their events and lessons learned.
Affected Public: Businesses or other for-profits; Not-for-profit institutions; Federal Government; State, local or tribal government, or, by exception, eligible individuals or households.
Frequency: On occasion.
Respondent's Obligation: Voluntary.
OMB Desk Officer: Ms. Jasmeet Seehra.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.
DOD Clearance Officer: Ms. Angela Duncan.
Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.
Dated: April 19, 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF DEFENSE
Department of the Navy
[Docket ID: USN-2022-HQ-0004]
Submission for OMB Review; Comment Request

AGENCY:
Department of the Navy, Department of Defense (DoD).

ACTION:
30-Day information collection notice.

SUMMARY:
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:
Consideration will be given to all comments received by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Angela Duncan, 571-372-7574, whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB Number: Navy Family Ombudsman Program; OMB Control Number 0703-0070.
Type of Request: Revision.
Number of Respondents: 4,500.
Responses per Respondent: 1.
Annual Responses: 4,500.
Average Burden per Response: 30 minutes.
Annual Burden Hours: 2,250.
Needs and Uses: The information collection requirement is necessary to solicit and select a spouse for the volunteer Ombudsman position in Navy components. An Ombudsman is the spouse of an active duty or Selected Reserve member of the command, enlisted or officer. This requirement can be waived if, after a diligent search, no appropriate spouse volunteer is available. Family members, civilian employees affiliated with the command, and active duty service members may be considered for a waiver. As part of the selection process, prospective Ombudsmen will be notified of the request for an interview by either the commanding officer or another member of the Command Support Team. Prospective Ombudsmen may be interviewed by phone, or in person with the commanding officer. The information collection is also necessary to provide Ombudsmen with program information; communicate during natural disasters and crisis; collect program contact numbers and workload data; and maintain records of program training received. Numbers provided from the collection help identify the issues and concern of the families, trends during deployment and identify training which may be beneficial to the command families.
Affected Public: Individuals or households.
Frequency: On occasion.
Respondent's Obligation: Voluntary.
OMB Desk Officer: Ms. Jasmeet Seehra.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.
DOD Clearance Officer: Ms. Angela Duncan.
Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.
Dated: April 19, 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF DEFENSE
Department of the Navy
[Docket ID: USN-2022-HQ-0006]
Submission for OMB Review; Comment Request

AGENCY:
Department of the Navy, Department of Defense (DoD).

ACTION:
30-Day information collection notice.

SUMMARY:
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:
Consideration will be given to all comments received by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Angela Duncan, 571-372-7574, whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB Number: Marine Corps Lodging Guest Registration and Feedback; OMB Control Number 0703-0072.
Type of Request: Revision.
Number of Respondents: 15,000.
Responses per Respondent: 1.11.
Annual Responses: 16,650.
Average Burden per Response: 6.8 minutes.
Annual Burden Hours: 1,887.
Needs and Uses: The information collection is necessary to keep a record of Marine Corps lodging reservations to ensure orderly room assignment and avoid improper booking; to record registration and payment of accounts; to verify proper usage by eligible patrons; for cash control; to gather occupancy data; to determine occupancy breakdown; to account for rentals and furnishings; and to collect data for customer satisfaction and marketing.
Affected Public: Individuals or households.
Frequency: On occasion.
Respondent's Obligation: Voluntary.
OMB Desk Officer: Ms. Jasmeet Seehra.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https://www.regulations.gov as they are received without change, including any personal identifiers or contact information.
DOD Clearance Officer: Ms. Angela Duncan.
Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.
Dated: April 19, 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF DEFENSE
Department of the Navy
[Docket ID: USN-2022-HQ-0005]
Submission for OMB Review; Comment Request

AGENCY:
Department of the Navy, Department of Defense (DoD).

ACTION:
30-Day information collection notice.

SUMMARY:
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:
Consideration will be given to all comments received by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Angela Duncan, 571-372-7574, whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB Number: Non-Appropriated Fund Human Resource Management System; NAVMC Form 12000/499; OMB Control Number 0703-0071.
Type of Request: Revision.
Number of Respondents: 69,953.
Responses per Respondent: 1.
Annual Responses: 69,953.
Average Burden per Response: 30 minutes.
Annual Burden Hours: 34,976.5.
Needs and Uses: The information collection is necessary for Marine Corps Community Service (MCCS) to successfully manage and administer an effective and efficient recruiting and hiring process. MCCS's use of innovative technologies in the Non-Appropriated Fund Human Resource Management System (NAF HRMS) enables MCCS to streamline the employment application process, reduce processing and recruiter response times, and decrease the need for applicant calls and inquiries; therefore, improving the applicant's experience. The information collection is also necessary to allow MCCS retirees receiving an annuity to request changes to their current NAF Group medical, dental, or life insurance plans; their NAF Group Retirement plan; and/or their beneficiary information. Retirees request these changes via NAVMC Form 12000/499.
Affected Public: Business or other for-profit; individuals or households.
Frequency: On occasion.
Respondent's Obligation: Voluntary.
OMB Desk Officer: Ms. Jasmeet Seehra.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.
DOD Clearance Officer: Ms. Angela Duncan.
Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.
Dated: April 19, 2022.
Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.
DEPARTMENT OF EDUCATION
[Docket No. ED-2021-SCC-0162]
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Native Hawaiian Education and Alaska Native Education Annual Performance Report

AGENCY:
Office of Elementary and Secondary Education (OESE), Department of Education (ED).

ACTION:
Notice.

SUMMARY:
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new collection.

DATES:
Interested persons are invited to submit comments on or before May 25, 2022.

ADDRESSES:
Written comments and recommendations for proposed information collection requests should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain . Find this information collection request by selecting “Department of Education” under “Currently Under Review,” then check “Only Show ICR for Public Comment” checkbox. Comments may also be sent to ICDocketmgr@ed.gov .

FOR FURTHER INFORMATION CONTACT:
For specific questions related to collection activities, please contact Joanne Osborne, (202) 401-1265.

SUPPLEMENTARY INFORMATION:
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Title of Collection: Native Hawaiian Education and Alaska Native Education Annual Performance Report.
OMB Control Number: 1810-NEW.
Type of Review: New Collection.
Respondents/Affected Public: State, Local, and Tribal Governments.
Total Estimated Number of Annual Responses: 102.
Total Estimated Number of Annual Burden Hours: 510.
Abstract: This is a request for a new Annual Performance Report (APR) information collection for the Title VI, Part B of the ESEA (Native Hawaiian Education), Title VI, Part C of the ESEA (Alaska Native Education), and Title XI, Section 11006 of the American Rescue Plan Act of 2021. The information shared with the Rural, Insular, and Native Achievement Program (RINAP) division will help ensure Native Hawaiian and Alaska Native Education program grantees make progress toward meeting program goals and objectives. Information collected will also inform the selection and delivery of technical assistance to grantees, allowing RINAP to better monitor the connection between grant administration and intended outcomes. Collection of APR information will also allow RINAP to proactively engage with grantees to identify potential compliance issues ahead of more comprehensive monitoring, decreasing the need for enforcement action and minimizing burden for grantees.
Dated: April 20, 2022.
Kun Mullan,

PRA Coordinator, Strategic Collections and Clearance, Governance and Strategy Division, Office of Chief Data Officer, Office of Planning, Evaluation and Policy Development.
DEPARTMENT OF ENERGY
Environmental Management Site-Specific Advisory Board Chairs

AGENCY:
Office of Environmental Management, Department of Energy.

ACTION:
Notice of open meeting: Correction.

SUMMARY:
On April 11, 2022, the Department of Energy published a notice of open meeting announcing a meeting on May 3-4, 2022 of the Environmental Management Site-Specific Advisory Board Chairs (87 FR 21108). This document makes a correction to that notice.

FOR FURTHER INFORMATION CONTACT:
Alyssa Harris, EM SSAB Federal Coordinator. U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585. Email: Alyssa.Harris@em.doe.gov . Telephone: (202) 586-7627.

Corrections
In the Federal Register of April 11, 2022, in FR Doc. 2022-07564, on page 21108, please make the following correction:
In that notice under ADDRESSES , second column, third paragraph, the meeting address has been changed. The original address was The Carson Center—Myre River Room, 100 Kentucky Avenue, Paducah, KY 42003. The new address is Holiday Inn Paducah Riverfront—River Room, 600 North 4th Street, Paducah, KY 42001. The meeting will still be held in a hybrid format.
Signed in Washington, DC, on April 19, 2022.
LaTanya Butler,

Deputy Committee Management Officer.
DEPARTMENT OF ENERGY
Notice of Availability of Guidance for the First Award Period of the Civil Nuclear Credit Program

AGENCY:
Grid Deployment Office, Department of Energy.

ACTION:
Notice of availability (NOA).

SUMMARY:
The U.S. Department of Energy (DOE or the Department) announces the availability of the Guidance for the Civil Nuclear Credit (CNC) Program authorized under the Infrastructure Investment and Jobs Act (IIJA). The Department is issuing this NOA to provide notification of the issuance of the U.S. Department of Energy Guidance for the Civil Nuclear Credit Program covering the first award period Guidance on SAM.gov and on the CNC Program website. This Guidance describes the timelines, deliverables, and other requirements for owners or operators of nuclear reactors that are projected to cease operations due to economic factors to submit certification applications to become certified nuclear reactors, and instructions on formulating and submitting sealed bids to receive credit allocations.

DATES:
DOE invites eligible nuclear reactors operating in a competitive market that project the imminent cession of operations due to economic factors, to submit certification applications and sealed bids for credits starting on April 19, 2022, at SAM.gov. The last date for which certification applications and sealed bids will be received is May 19, 2022. DOE will announce conditional awards thereafter in accordance with the Guidance.

ADDRESSES:
Please see the Guidance posting at https://sam.gov/opp/09bd4b8d0afd4377aa722e4ab27d67be/view for contact information relating to certification applications and sealed bids. For information relating to the CNC Program, including a copy of the Guidance, please see https://www.energy.gov/ne/civil-nuclear-credit-program.

FOR FURTHER INFORMATION CONTACT:
For more information regarding the CNC Program Guidance please contact Suzette Olsen, (208) 526-7385, olsonsm@id.doe.gov.

SUPPLEMENTARY INFORMATION:

Background
The IIJA created the CNC Program to provide up to $6 billion to award support in the form of credits to certified nuclear reactors operating in a competitive market that are projected to cease operations due to economic factors. DOE published in the Federal Register , a Notice of Intent and Request for Information regarding the establishment of a Civil Nuclear Credit Program on February 15, 2022, to solicit public input into the CNC Program design. 87 FR 8570. The Department used the responses to help inform its approach in creating the Guidance. The Guidance describes the CNC Program, program eligibility, certification criteria and bid submissions requirements for the first certification and bidding process. For the first credit auction, DOE has narrowed the field of eligible reactors to those reactors operating in a competitive market that are projected to imminently cease operations due to economic factors.

Signing Authority
This document of the Department of Energy was signed on April 20, 2022, by Patricia A. Hoffman, Acting Director, Grid Deployment Office, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .
Signed in Washington, DC, on April 20, 2022.
Treena V. Garrett,

Federal Register Liaison Officer, U.S. Department of Energy.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
Combined Notice of Filings #1
Take notice that the Commission received the following electric corporate filings:
Docket Numbers: EC22-49-000.
Applicants: Pixelle Specialty Solutions Holding LLC.
Description: Supplement to April 1, 2022 Joint Application for Authorization Under Section 203 of the Federal Power Act of Pixelle Specialty Solutions Holding LLC, et al.
Filed Date: 4/18/22.
Accession Number: 20220418-5544.
Comment Date: 5 p.m. ET 4/28/22.
Docket Numbers: EC22-55-000.
Applicants: Sierra Pacific Power Company, Nevada Power Company.
Description: Joint Application for Authorization Under Section 203 of the Federal Power Act of Sierra Pacific Power Company, et al.
Filed Date: 4/18/22.
Accession Number: 20220418-5531.
Comment Date: 5 p.m. ET 5/9/22.
Take notice that the Commission received the following exempt wholesale generator filings:
Docket Numbers: EG22-100-000.
Applicants: LI Solar Generation, LLC.
Description: Notice of Self-Certification of Exempt Wholesale Generator Status of LI Solar Generation, LLC.
Filed Date: 4/18/22.
Accession Number: 20220418-5487.
Comment Date: 5 p.m. ET 5/9/22.
Take notice that the Commission received the following Complaints and Compliance filings in EL Dockets:
Docket Numbers: EL22-53-000.
Applicants: UBS Asset Management Inc.
Description: Petition for Declaratory Order of [UBS Asset Management Inc.
Filed Date: 4/14/22.
Accession Number: 20220414-5270.
Comment Date: 5 p.m. ET 5/16/22.
Take notice that the Commission received the following electric rate filings:
Docket Numbers: ER20-2550-003.
Applicants: Midcontinent Independent System Operator, Inc.
Description: Midcontinent Independent System Operator, Inc. submits tariff filing per 35.19a(b): Refund Report_Entergy Mississippi, LLC to be effective N/A.
Filed Date: 4/18/22.
Accession Number: 20220418-5511.
Comment Date: 5 p.m. ET 5/9/22.
Docket Numbers: ER21-1794-001.
Applicants: Midcontinent Independent System Operator, Inc.
Description: Midcontinent Independent System Operator, Inc. submits tariff filing per 35.19a(b): Refund Report White Oak Energy LLC to be effective N/A.
Filed Date: 4/18/22.
Accession Number: 20220418-5513.
Comment Date: 5 p.m. ET 5/9/22.
Docket Numbers: ER22-871-001.
Applicants: Jicarilla Solar 2 LLC.
Description: Notice of Non-Material Change in Status of Jicarilla Solar 2 LLC.
Filed Date: 4/18/22.
Accession Number: 20220418-5545.
Comment Date: 5 p.m. ET 5/9/22.
Docket Numbers: ER22-1095-000.
Applicants: KCE NY 6, LLC.
Description: Supplement to February 22, 2022 KCE NY 6, LLC tariff filing.
Filed Date: 4/7/22.
Accession Number: 20220407-5237.
Comment Date: 5 p.m. ET 4/28/22.
Docket Numbers: ER22-1657-000.
Applicants: Evergy Kansas Central, Inc., Evergy Kansas South, Inc.
Description: Application for the Establishment and Recovery of Regulatory Assets of Evergy Kansas Central, Inc., et al.
Filed Date: 4/15/22.
Accession Number: 20220415-5345.
Comment Date: 5 p.m. ET 5/6/22.
Docket Numbers: ER22-1658-000.
Applicants: Southwest Power Pool, Inc.
Description: § 205(d) Rate Filing: 2889 ITC Great Plains & Mid-Kansas Novation Cancellation to be effective 4/19/2022.
Filed Date: 4/19/22.
Accession Number: 20220419-5070.
Comment Date: 5 p.m. ET 5/10/22.
Docket Numbers: ER22-1659-000.
Applicants: Southwest Power Pool, Inc.
Description: § 205(d) Rate Filing: 3945 Skyview Wind Project and ITC Great Plains E&P Agreement to be effective 3/31/2022.
Filed Date: 4/19/22.
Accession Number: 20220419-5105.
Comment Date: 5 p.m. ET 5/10/22.
Docket Numbers: ER22-1660-000.
Applicants: PacifiCorp.
Description: § 205(d) Rate Filing: ESM Const Agmt Jim Bridger BAA Move Corrected to be effective 4/20/2022.
Filed Date: 4/19/22.
Accession Number: 20220419-5187.
Comment Date: 5 p.m. ET 5/10/22.
Docket Numbers: ER22-1661-000.
Applicants: Duke Energy Florida, LLC.
Description: Tariff Amendment: DEF- Winter Park Termination of RS No. 257 to be effective 6/19/2022.
Filed Date: 4/19/22.
Accession Number: 20220419-5190.
Comment Date: 5 p.m. ET 5/10/22.
Docket Numbers: ER22-1662-000.
Applicants: GB II New York LLC.
Description: Compliance filing: Notice of Succession to be effective 4/20/2022.
Filed Date: 4/19/22.
Accession Number: 20220419-5225.
Comment Date: 5 p.m. ET 5/10/22.
The filings are accessible in the Commission's eLibrary system ( https://elibrary.ferc.gov/idmws/search/fercgensearch.asp ) by querying the docket number.
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: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
Dated: April 19, 2022.
Debbie-Anne A. Reese,

Deputy Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
[Docket No. CP22-167-000]
Roaring Fork Midstream, LLC; Notice of Petition for Declaratory Order
Take notice that on April 13, 2022, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, Roaring Fork Midstream, LLC (RFM) filed a petition for declaratory order requesting the Commission issue an order stating that RFM's planned natural gas gathering pipelines in Weld County, Colorado, and Laramie County, Wyoming, will perform a gathering function and are not subject to the Commission's jurisdiction under section 7 of the Natural Gas Act, 15 U.S.C. 717b.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene, or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at https://www.ferc.gov. 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 Federal Register , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission's Home Page ( https://ferc.gov ) using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. At this time, the Commission has suspended access to the Commission's Public Reference Room, due to the proclamation declaring a National Emergency concerning the Novel Coronavirus Disease (COVID-19), issued by the President on March 13, 2020. For assistance, contact the Federal Energy Regulatory Commission at FERCOnlineSupport@ferc.gov or call tollfree, (886) 208-3676 or TYY, (202) 502-8659.
Comment Date: 5:00 p.m. Eastern time on May 19, 2022.
Dated: April 19, 2022.
Debbie-Anne A. Reese,

Deputy Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
Combined Notice of Filings
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings
Docket Numbers: RP22-824-000.
Applicants: Young Gas Storage Company, Ltd.
Description: Compliance filing: Pre-Filing Settlement Associated with Docket No. RP19-276 to be effective 12/31/9998.
Filed Date: 4/18/22.
Accession Number: 20220418-5251.
Comment Date: 5 p.m. ET 5/2/22.
Docket Numbers: RP22-825-000.
Applicants: Colorado Interstate Gas Company, L.L.C.
Description: Compliance filing: Pre-Filing Rate Case Settlement Associated with Docket No. RP16-1022 to be effective 12/31/9998.
Filed Date: 4/18/22.
Accession Number: 20220418-5281.
Comment Date: 5 p.m. ET 5/2/22.
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 ( https://elibrary.ferc.gov/idmws/search/fercgensearch.asp ) by querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: https://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
Dated: April 19, 2022.
Debbie-Anne A. Reese,

Deputy Secretary.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2021-0109; FRL-9788-01-OMS]
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Reinforced Plastic Composites Production (Renewal)

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Reinforced Plastic Composites Production (EPA ICR Number 1976.10, OMB Control Number 2060-0509), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through April 30, 2022. Public comments were previously requested, via the Federal Register , on April 13, 2021, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

DATES:
Additional comments may be submitted on or before May 25, 2022.

ADDRESSES:
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2021-0109, online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 2821T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-0833; email address: ali.muntasir@epa.gov.

SUPPLEMENTARY INFORMATION:
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 https://www.regulations.gov, or in person, at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: https://www.epa.gov/dockets.
Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for the regulations (40 CFR part 63, subpart WWWW) apply to both existing facilities and new facilities with reinforced plastic composites (RPC) production operations and processes. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP.
Form Numbers: 5900-566.
Respondents/affected entities: Owners and operators of reinforced plastic composites production operations and processes.
Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart WWWW).
Estimated number of respondents: 448 (total).
Frequency of response: Monthly, semiannually, annually.
Total estimated burden: 38,600 hours (per year). Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $4,570,000 (per year), which includes $0 for annualized capital/startup and/or operation & maintenance costs.
Changes in the Estimates: The increase in burden from the most-recently approved ICR is due to an increase in adjustment(s). The adjustment increase in burden from the most-recently approved ICR is due to a change in regulatory requirements stemming from the 2020 RTR ICR (EPA ICR No. 1976.09) and the incorporation of its burden into the currently-approved ICR. Items added include burden for work practice requirements and time to record information. Work practice requirements have had a significant impact on the burden since facilities are complying with the current regulations through pollution prevention measures rather than add-on control devices. The time to complete semiannual compliance reports and time to train personnel have also been adjusted. Reporting emissions exceedances or no emissions exceedances is included in the semiannual compliance reports, and the time to train personnel was adjusted to represent facilities of any size. In addition, capital/startup and operation and maintenance costs have decreased from the previous ICR. It is estimated no new facilities will be subject to the rule and that existing facilities are complying with the rule using compliant materials instead of add-on control devices.
Courtney Kerwin,

Director, Regulatory Support Division.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2021-0566; FRL-9720-01-OAR]
Notice of April 2022 Alternative Compliance Demonstration Approach for Certain Small Refineries Under the Renewable Fuel Standard Program

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
The Environmental Protection Agency (EPA) is providing notice of its action to provide an alternative compliance demonstration approach (the “Compliance Action”) to certain small refineries whose 2018 petitions for small refinery exemptions (SREs) under the Renewable Fuel Standard (RFS) program were denied in the April 2022 Denial of Petitions for RFS Small Refinery Exemptions (“SRE Denial”) after being remanded. EPA is providing this notice for public awareness of and the basis for the Compliance Action issued on April 7, 2022.

DATES:
April 25, 2022.

FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Transportation and Air Quality, Compliance Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4657; email address: nelson.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Background
The Clean Air Act (CAA) provides that a small refinery ^1 may at any time petition EPA for an extension of the exemption from the obligations of the RFS program for the reason of disproportionate economic hardship (DEH). ^2 In evaluating such petitions, the EPA Administrator, in consultation with the Secretary of Energy, will consider the findings of a Department of Energy (DOE) study and other economic factors. ^3 In a separate action issued on April 7, 2022, EPA denied 36 small refinery exemption (SRE) petitions for the 2018 compliance year by finding the petitioning refineries do not face DEH caused by compliance with their RFS obligations. ^4
^1 The CAA defines a small refinery as “a refinery for which the average aggregate daily crude oil throughput for a calendar year . . . does not exceed 75,000 barrels.” CAA section 211( o )(1)(K).
^2 CAA section 211( o )(9)(B)(i).
^3 CAA section 211( o )(9)(B)(ii).
^4 “April 2022 Denial of Petitions for RFS Small Refinery Exemptions,” EPA-420-R-22-005, April 2022 (hereinafter the “SRE Denial”).

II. Compliance Action
In the Compliance Action, ^5 EPA is providing 31 specific small refineries with an alternative approach to demonstrating compliance with their RFS renewable volume obligations created by the SRE Denial. Each of the specified small refineries had previously been granted an SRE for the 2018 compliance year; however, each of their petitions again came before the Agency as the result of court remand. The Compliance Action is necessary because EPA has determined there are extenuating circumstances that warrant an alternative compliance demonstration approach that the specified small refineries may use to meet their 2018 obligations without retiring any additional RINs.
^5 “April 2022 Alternative RFS Compliance Demonstration Approach for Certain Small Refineries,” EPA-420-R-22-006, April 2022.

III. Judicial Review
Section 307(b)(1) of the CAA governs judicial review of final actions by the EPA. This section provides, in part, that petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit: (i) When the agency action consists of “nationally applicable . . . final actions taken by the Administrator,” or (ii) when such action is locally or regionally applicable, but “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.” For locally or regionally applicable final actions, the CAA reserves to the EPA complete discretion whether to invoke the exception in (ii) described in the preceding sentence.
This final action is “nationally applicable” within the meaning of CAA section 307(b)(1). In the alternative, to the extent a court finds this final action to be locally or regionally applicable, the Administrator is exercising the complete discretion afforded to him under the CAA to make and publish a finding that this action is based on a determination of “nationwide scope or effect” within the meaning of CAA section 307(b)(1). ^6 This final action provides an alternative approach to demonstrating compliance with the 2018 obligations for 31 small refineries across the country and applies to small refineries located within 16 states in 7 of the 10 EPA regions and in 7 different Federal judicial circuits. ^7 This final action is based on the extenuating circumstances applicable to these 31 small refineries and the impacts their compliance with their newly created 2018 obligations under the existing compliance scheme would have on the RFS program. For these reasons, this final action is nationally applicable or, alternatively, the Administrator is exercising the complete discretion afforded to him by the CAA and hereby finds that this final action is based on a determination of nationwide scope or effect for purposes of CAA section 307(b)(1) and is hereby publishing that finding in the Federal Register .
^6 In deciding whether to invoke the exception by making and publishing a finding that this final action is based on a determination of nationwide scope or effect, the Administrator has also taken into account a number of policy considerations, including his judgment balancing the benefit of obtaining the D.C. Circuit's authoritative centralized review versus allowing development of the issue in other contexts and the best use of Agency resources.
^7 In the report on the 1977 Amendments that revised section 307(b)(1) of the CAA, Congress noted that the Administrator's determination that the “nationwide scope or effect” exception applies would be appropriate for any action that has a scope or effect beyond a single judicial circuit. See H.R. Rep. No. 95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-03.
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit by June 24, 2022.
Joseph Goffman,

Principal Deputy Assistant Administrator, Office of Air and Radiation.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2020-0662; FRL-9792-01-OMS]
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Secondary Lead Smelters (Renewal)

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Secondary Lead Smelters (EPA ICR Number 1128.13, OMB Control Number 2060-0080), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 31, 2022. Public comments were previously requested, via the Federal Register , on February 8, 2021, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

DATES:
Additional comments may be submitted on or before May 25, 2022.

ADDRESSES:
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2020-0662, online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 2821T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-0833; email address: ali.muntasir@epa.gov.

SUPPLEMENTARY INFORMATION:
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 https://www.regulations.gov, or in person at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: https://www.epa.gov/dockets.
Abstract: The New Source Performance Standards (NSPS) for Secondary Lead Smelters (40 CFR part 60, subpart L) apply to existing facilities and new secondary lead smelting facilities: Any pot furnace of more than 250 kg (550 lb) charging capacity, blast (cupola) furnaces, and reverberatory furnaces. The affected facilities include any facility producing lead from a lead bearing scrap material by smelting to the metallic form. Blast furnace means any furnace used to recover metal from slag. Reverberatory furnaces include furnaces of various types, e.g., stationary, rotating, rocking and tilting. New facilities include those that commenced construction, modification, or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 60, subpart L.
In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.
Form Numbers: None.
Respondents/affected entities: Secondary lead smelting facilities.
Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart L).
Estimated number of respondents: 10 (total).
Frequency of response: Initially.
Total estimated burden: 26 hours (per year). Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $3,130 (per year), which includes $0 in annualized capital/startup and/or operation & maintenance costs.
Changes in the Estimates: The adjustment decrease in burden from the most recently-approved ICR is due to a decrease in the number of sources. There is a decrease in the number of estimated sources from 12 to 10 due to consolidation within the sector. The reduced number of estimated sources also led to a decrease in the number of responses. There are no capital/startup and/or operation and maintenance costs associated with the rule.
Courtney Kerwin,

Director, Regulatory Support Division.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2021-0106; FRL—9789-01-OMS]
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Paper and Other Web Coating (Renewal)

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Paper and Other Web Coating (EPA ICR Number 1951.10, OMB Control Number 2060-0511), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through April 30, 2022. Public comments were previously requested, via the Federal Register , on April 13, 2021 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

DATES:
Additional comments may be submitted on or before May 25, 2022.

ADDRESSES:
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2021-0106, online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 2821T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-0833; email address: ali.muntasir@epa.gov.

SUPPLEMENTARY INFORMATION:
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 https://www.regulations.gov, or in person at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.
Abstract: Owners and operators of paper and other web coating facilities are required to comply with reporting and record keeping requirements for the General Provisions (40 CFR part 63, subpart A), as well as for the applicable specific standards in 40 CFR part 63 Subpart JJJJ. This includes submitting initial notifications, performance tests and periodic reports and results, maintaining records of materials usage, and any period during which the add-on control system is inoperative. These reports are used by EPA to determine compliance with these standards.
Form Numbers: 5900-532.
Respondents/affected entities: Owners and operators of new and existing paper and other web coating facilities.
Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart JJJJ).
Estimated number of respondents: 171 (total).
Frequency of response: Initially, semiannually.
Total estimated burden: 17,300 hours (per year). Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $3,030,000 (per year), which includes $975,000 in annualized capital/startup and/or operation & maintenance costs.
Changes in the Estimates: There is no significant change in burden from the most-recently approved ICR. The change in burden from the most-recently approved ICR, as currently-identified in the OMB Inventory of Approved Burdens, is due to an increase in the number of respondents that are subject to this rule. The rule was previously amended in 2020 on both July 09 and November 19. This ICR adjusts the burden to account for the growth rate within the industry following the July 9, 2020, final rule ICR. The rule is not anticipated to change over the next three years. The growth rate for this industry is low at one new source per year. Due to these adjustments, there is an overall increase in burden, although the rounded burden hours have not changed from the prior ICR. The capital/startup and operation and maintenance (O&M) costs have also been adjusted to account for growth. The overall result is an increase in costs.
Courtney Kerwin,

Director, Regulatory Support Division.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-SFUND-2012-0578; FRL-9791-01-OMS]
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Technical Assistance Needs Assessments (TANAs) at Superfund Remedial or Removal Sites (Renewal)

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Technical Assistance Needs Assessments (TANAs) at Superfund Remedial or Removal Sites (EPA ICR Number 2470.03, OMB Control Number 2050-0211) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 2022. Public comments were previously requested via the Federal Register on October 13, 2021, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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.

DATES:
Additional comments may be submitted on or before May 25, 2022.

ADDRESSES:
Submit your comments to EPA, referencing Docket ID Number EPA-HQ-SFUND-2012-0578, online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Callie Koller, Assessment and Remediation Division, Office of Superfund Remediation and Technology, Mail Code 28221T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-0970; email address: koller.callie@epa.gov.

SUPPLEMENTARY INFORMATION:
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 www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit https://www.epa.gov/dockets.
Abstract: This ICR covers the usage of TANAs to solicit feedback from members of the affected community in order to determine how the community is receiving technical information about a Superfund remedial or removal site; whether the community requires additional assistance in order to understand and respond to site-related technical information; and whether there are organizations in the community that are interested or involved in site-related issues and capable of acting as an appropriate conduit for technical assistance services to the affected community. EPA estimates that for each TANA it conducts, 20 individuals are interviewed per site via direct face-to-face interaction, phone, or virtual call at five sites, with an approximate total of 100 individuals interviewed each year. Responses to the collection of information are voluntary and the names of respondents will be protected by the Privacy Act. The information obtained from each TANA will help ensure the community's needs for technical information assistance are defined as early in the remedial/removal process as possible and enable meaningful community involvement in the Superfund decision-making process. Additionally, the TANA process produces a blueprint for designing a coordinated effort to meet the community's needs for additional technical assistance while minimizing the overlap of services provided.
Form Numbers: None.
Respondents/affected entities: Local, state, and tribal government officials, potentially responsible party (PRP) representatives, community organizations, businesses and individuals who may be impacted by a Superfund site or a removal action lasting 120 days or longer. These community members voluntarily participate in community involvement activities throughout the remedial phase of the Superfund process. SIC Codes are Occupational Safety and Health Administration's (OSHA's) Standard Industrial Classification System used to identify different groups. Local/state governments are categorized as Division J: Public Administration, Major Group 95: Administration of Environmental Quality, subgroup 9511: Air and Water Resource and Solid Waste Management. The other respondents, community members, do not have a SIC Code as they do not constitute an industry.
Respondent's obligation to respond: Voluntary.
Estimated number of respondents: 100. (20 per TANA at five sites).
Frequency of response: Once during either a removal cleanup lasting 120 days or longer or a remedial cleanup of a site. Each TANA interview is expected to last approximately one hour in duration.
Total estimated burden: 100 hours (per year). Burden is defined at 5 CFR 1320.03(b).
Total estimated cost: $2,587 (per year), includes $0 annualized capital or operation & maintenance costs.
Changes in the Estimates: A decrease of 450 hours in the total respondent burden hours is estimated during the three-year period as compared to the last collection period. The number of individual TANAs sharply declined, from 25 to five per year, thus decreasing the overall number of respondents voluntarily participating in this information request.
Courtney Kerwin,

Director, Regulatory Support Division.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2021-0315; FRL-9790-01-OMS]
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects (Renewal)

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects (EPA ICR Number 2195.06, OMB Control Number 2070-0169) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through April 30, 2022. Public comments were previously requested via the Federal Register on September 1, 2021, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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.

DATES:
Additional comments may be submitted on or before May 25, 2022.

ADDRESSES:
Submit your comments to EPA, referencing Docket ID Number EPA-HQ-OPP-2021-0315, online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Carolyn Siu, Mission Support Division (7101M), Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-1205; email address: siu.carolyn@epa.gov.

SUPPLEMENTARY INFORMATION:
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 www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit https://www.epa.gov/dockets.
Abstract: EPA is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). The EPA regulations at 40 CFR part 26 protect subjects of “third-party” research ( i.e., research that is not conducted or sponsored by EPA). In addition to other protections, the regulations require affected entities to submit information to EPA and an institutional review board (IRB) prior to initiating, and to the EPA upon the completion of, certain studies that involve human research participants. The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional exposure of human subjects, these individuals (respondents) are required to submit study protocols to the EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to the EPA. This renewal ICR estimates the third-party response burden from complying with the requirements in 40 CFR part 26.
Form Numbers: None.
Respondents/affected entities: Any entities that submits to EPA under FIFRA and/or FFDCA protocols and study reports for environmental research involving human subjects.
Respondent's obligation to respond: Mandatory under 40 CFR part 26.
Estimated number of respondents: 10 (total).
Frequency of response: On occasion.
Total estimated burden: 8,276 hours (per year). Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $859,215 (per year), includes $0 annualized capital or operation & maintenance costs.
Changes in the Estimates: There is an estimated decrease of 1,966 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is a result of the anticipated number of responses per year for the next three years based on comments received from stakeholders. This change is an adjustment.
Courtney Kerwin,

Director, Regulatory Support Division.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2021-0245; FRL-9784-01-OMS]
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's Safer Choice Program Product and Partner Recognition Activities

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Safer Choice Program Product and Partner Recognition Activities, (EPA ICR Number 2692.01, OMB Control Number 2070-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request to renew and combine the approval of two existing ICRs (2070-0178 and 2070-0189) that are currently approved through May 31, 2022, and November 30, 2022, respectively. Public comments were previously requested via the Federal Register on June 28, 2021, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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.

DATES:
Additional comments may be submitted on or before May 25, 2022.

ADDRESSES:
Submit your comments to EPA, referencing Docket ID No. EPA-HQ-OPPT-2021-0245, online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
EPA's policy is that all comments received will be included in the 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. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. For additional information about EPA's public docket, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
General contact: Katherine Sleasman, Mission Support Division, 7101M, Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-1204; email address: sleasman.katherine@epa.gov.
Technical contact: Linda Rutsch, Data Gathering and Analysis Division, 7406M, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 343-9924; email address: rutsch.linda@epa.gov.

SUPPLEMENTARY INFORMATION:
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 www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit https://www.epa.gov/dockets.
Abstract: This ICR will cover the information collection activities and burden associated with the reporting and recordkeeping obligations of individuals, businesses, organizations, and government entities participating in or collaborating with EPA's Safer Choice program. The programs are designed to: Improve data efficiency by electronic data collection via a cloud-based Salesforce system called the Safer Choice Community; monitor the public's awareness of the Safer Choice program and label; and clarify the Safer Choice Partner of the Year Awards application process and form.
Form numbers: 9600-017, 9600-018, 9600-019, 9600-020, 9600-21, 9600-022, and 9600-023.
Respondents/affected entities: The ICR provides a list of the North American Industrial Classification System (NAICS) codes associated with the various industries most likely affected by the paperwork activities covered in this ICR.
Respondent's obligation to respond: Voluntary.
Frequency of response: On occasion.
Estimated number of respondents: 7,566 (total).
Total estimated burden: 9,696 hours. Burden is defined at 5 CFR 1320.3(b).
Total estimated costs: $751,942 (per year). This includes an estimated burden cost of $206,342 and an estimated cost of $545,600 for non-burden hour paperwork costs, e.g., capital investment or maintenance and operational costs.
Changes in the estimates: The total combined burden from the two approved ICRs that are being combined in this request is 7,118 hours (4,788 hours and 2,330 hours, respectively). The total burden requested for this ICR is 9,696 hours, resulting in an overall increase of 2,578 hours from the estimated combined burden compared with that currently approved by OMB. The difference is primarily due to the inclusion of the activities and burden associated with Partner of the Year Award activities (1,575 hours) and minor adjustments were made in EPA's estimates of the number of respondents and of the burden. Specifically, the burden for previously approved EPA ICR No. 2487.02 increased by 1,003 hours (from 2,330 to 3,333 hours). The burden for previously approved EPA ICR No. 2302.03 has not changed, remaining at 4,788 hours. The total combined cost for the existing ICRs is $545,600 ($545,600 and $0, respectively). The total cost requested for this ICR remains the same. These changes are adjustments.
Courtney Kerwin,

Director, Regulatory Support Division.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2021-0096; FRL-9793-01-OMS]
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Asbestos (Renewal)

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Asbestos (EPA ICR Number 0111.16, OMB Control Number 2060-0101), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 31, 2022. Public comments were previously requested, via the Federal Register , on April 13, 2021, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

DATES:
Additional comments may be submitted on or before May 25, 2022.

ADDRESSES:
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2021-0096, online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 2821T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, 27711; telephone number: (919) 541-0833; email address: ali.muntasir@epa.gov.

SUPPLEMENTARY INFORMATION:
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 https://www.regulations.gov, or in person, at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: https://www.epa.gov/dockets.
Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Asbestos (40 CFR part 61, subpart M) regulations apply to either the demolition and/or renovation of facilities; the disposal of asbestos waste; asbestos milling, manufacturing and fabricating; the use of asbestos on roadways; asbestos waste converting facilities; and the use of asbestos insulation and sprayed-on materials. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP.
Form Numbers: None.
Respondents/affected entities: Owners and operators of demolition and renovation of facilities, asbestos cement (A/C) pipe replacement projects (ACPRPs), asbestos waste disposal, asbestos milling, manufacturing and fabricating, use of asbestos on roadways, asbestos waste converting facilities, and the use of asbestos insulation and sprayed-on materials.
Respondent's obligation to respond: Mandatory (40 CFR part 61, subpart M).
Estimated number of respondents: 9,771 (total).
Frequency of response: Quarterly, semiannually, annually.
Total estimated burden: 297,000 hours (per year). Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $35,100,000 (per year), which includes $0 in annualized capital/startup and/or operation & maintenance costs.
Changes in the Estimates: There is an increase in the total estimated burden as currently identified in the OMB Inventory of Approved Burdens. The change is due to the removal of burden associated with electronic reporting by either demolition or renovation facilities. The previous ICR renewal introduced a pilot program for demolition/renovation facilities, which allowed for voluntary submission of certain notifications using electronic reporting, as available. However, there are no regulatory requirements for electronic submission of reports in 40 CFR part 61, subpart M; therefore, this ICR does not assign a regulatory burden for electronic submittal of reports.
Courtney Kerwin,

Director, Regulatory Support Division.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2021-0566; FRL-9711-01-OAR]
April 2022 Denial of Petitions for Small Refinery Exemptions Under the Renewable Fuel Standard Program

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Denial of petitions.

SUMMARY:
The Environmental Protection Agency (EPA) is providing notice of its final action entitled April 2022 Denial of Petitions for RFS Small Refinery Exemptions (“SRE Denial”) in which EPA denied 36 small refinery exemption (SRE) petitions under the Renewable Fuel Standard (RFS) program. EPA is providing this notice for public awareness of and the basis for EPA's decision issued on April 7, 2022.

DATES:
April 25, 2022.

FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Transportation and Air Quality, Compliance Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4657; email address: nelson.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Background
The Clean Air Act (CAA) provides that a small refinery ^1 may at any time petition EPA for an extension of the exemption from the obligations of the RFS program for the reason of disproportionate economic hardship (DEH). ^2 In evaluating such petitions, the EPA Administrator, in consultation with the Secretary of Energy, will consider the findings of a Department of Energy (DOE) study and other economic factors. ^3
^1 The CAA defines a small refinery as “a refinery for which the average aggregate daily crude oil throughput for a calendar year . . . does not exceed 75,000 barrels.” CAA section 211( o )(1)(K).
^2 CAA section 211( o )(9)(B)(i).
^3 CAA section 211( o )(9)(B)(ii).

II. Decision
In the SRE Denial, ^4 we conducted an extensive analysis and review of information provided to EPA by small refineries in their SRE petitions and in the comments submitted in response to the Proposed Denial. ^5 We sought comment on all aspects of the Proposed Denial, including on our conclusions that the CAA requires small refineries to demonstrate that DEH is caused by compliance with the RFS program. We also sought comment on our economic analyses and conclusion that no small refineries face disproportionate costs of compliance due to the RFS program, no economic hardship, and, therefore, no DEH caused by RFS compliance. We requested additional data that would show the relationship between RFS compliance costs and the price of transportation fuel blendstocks. We also sought comment on our proposed change in approach to SRE eligibility based on receipt of the original statutory exemption, and our proposed decision to deny all pending SRE petitions based on the proportional nature of the RFS requirements and our findings regarding RIN cost passthrough. We considered all the comments received and have responded to them in the SRE Denial and its corresponding appendices.
^4 “April 2022 Denial of Petitions for RFS Small Refinery Exemptions,” EPA-420-R-22-005, April 2022.
^5 “Proposed RFS Small Refinery Exemption Decision,” EPA-420-D-21-001, December 2021 (hereinafter the “Proposed Denial”). 86 FR 70999 (December 14, 2021).
In the SRE Denial, we find that all refineries face the same costs to acquire RINs regardless of whether the RINs are created through the act of blending renewable fuels or are purchased on the open market. This happens because the market price for these fuels increases to reflect the cost of the RIN, much as it would increase in response to higher crude prices. In other words, this increased price for gasoline and diesel fuel allows obligated parties to recover their RIN costs through the market price of the fuel they produce. Because the market behaves this way for all parties subject to the RFS program, there is no disproportionate cost to any party, including small refineries, and no hardship given that the costs are recovered. As a result, we conclude that small refineries do not face DEH. Given this conclusion and the other reasons described in the SRE Denial, we have denied 36 SRE petitions by finding the petitioning refineries do not face DEH caused by compliance with their RFS obligations.

III. Judicial Review
Section 307(b)(1) of the CAA governs judicial review of final actions by the EPA. This section provides, in part, that petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit: (i) When the agency action consists of “nationally applicable . . . final actions taken by the Administrator,” or (ii) when such action is locally or regionally applicable, but “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.” For locally or regionally applicable final actions, the CAA reserves to the EPA complete discretion whether to invoke the exception in (ii) described in the preceding sentence.
This final action is “nationally applicable” within the meaning of CAA section 307(b)(1). In the alternative, to the extent a court finds this final action to be locally or regionally applicable, the Administrator is exercising the complete discretion afforded to him under the CAA to make and publish a finding that this action is based on a determination of “nationwide scope or effect” within the meaning of CAA section 307(b)(1). ^6 This final action denies petitions for exemptions from the RFS program for over 30 small refineries across the country and applies to small refineries located within 18 states in 7 of the 10 EPA regions and in 8 different Federal judicial circuits. ^7 This final action is based on EPA's revised interpretation of the relevant CAA provisions and the RIN discount and RIN cost passthrough principles that are applicable to all small refineries no matter the location or market in which they operate. For these reasons, this final action is nationally applicable or, alternatively, the Administrator is exercising the complete discretion afforded to him by the CAA and hereby finds that this final action is based on a determination of nationwide scope or effect for purposes of CAA section 307(b)(1) and is hereby publishing that finding in the Federal Register .
^6 In deciding whether to invoke the exception by making and publishing a finding that this final action is based on a determination of nationwide scope or effect, the Administrator has also taken into account a number of policy considerations, including his judgment balancing the benefit of obtaining the D.C. Circuit's authoritative centralized review versus allowing development of the issue in other contexts and the best use of Agency resources.
^7 In the report on the 1977 Amendments that revised section 307(b)(1) of the CAA, Congress noted that the Administrator's determination that the “nationwide scope or effect” exception applies would be appropriate for any action that has a scope or effect beyond a single judicial circuit. See H.R. Rep. No. 95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-03.
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit by June 24, 2022.
Joseph Goffman,

Principal Deputy Assistant Administrator, Office of Air and Radiation.
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2022-0160; FRL-9409-12-OCSPP]
Pesticide Product Registration; Receipt of Applications for New Active Ingredients—March 2022

AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Notice.

SUMMARY:
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.

DATES:
Comments must be received on or before May 25, 2022.

ADDRESSES:
Submit your comments, identified by the docket identification (ID) number and the File Symbol of the EPA registration Number of interest as shown in the body of this, through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.
Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is open to visitors by appointment only. For the latest status information on EPA/DC services and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
Charles Smith, Biopesticides and Pollution Prevention Division (BPPD) (7511P), main telephone number: (202) 566-2427, email address: BPPDFRNotices@epa.gov. The mailing address for each contact person is: Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. As part of the mailing address, include the contact person's name, division, and mail code. The division to contact is listed at the end of each pesticide petition summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).

B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications. For actions being evaluated under EPA's public participation process for registration actions, there will be an additional opportunity for public comment on the proposed decisions. Please see EPA's public participation website for additional information on this process ( https://www2.epa.gov/pesticide-registration/public-participation-process-registration-actions ).

A. Notice of Receipt—New Active Ingredients
1. File Symbol: 2375-A. Docket ID number: EPA-HQ-OPP-2022-0317. Applicant: Chr. Hansen, Inc., 16300 W Lincoln Ave., New Berlin, WI 53151. Product name: CH4000. Active ingredient: Fungicide and nematicide— Bacillus subtilis strain CH4000 at 100%. Proposed use: For seed treatment and applications to soil. Contact: BPPD.
2. File Symbol: 2375-L. Docket ID number: EPA-HQ-OPP-2022-0317. Applicant: Chr. Hansen, Inc., 16300 W Lincoln Ave., New Berlin, WI 53151. Product name: Kansas 3 SC. Active ingredient: Fungicide and nematicide— Bacillus subtilis strain CH4000 at 3.33%, Bacillus paralicheniformis strain CH2970 at 3.33%, and Bacillus paralicheniformis strain CH0273 at 3.33%. Proposed use: For seed treatment and applications to soil. Contact: BPPD.
3. File Symbol: 2375-T. Docket ID number: EPA-HQ-OPP-2022-0317. Applicant: Chr. Hansen, Inc., 16300 W Lincoln Ave., New Berlin, WI 53151. Product name: Kansas 3 WP. Active ingredient: Fungicide and nematicide— Bacillus subtilis strain CH4000 at 20%, Bacillus paralicheniformis strain CH2970 at 20%, and Bacillus paralicheniformis strain CH0273 at 20%. Proposed use: For seed treatment and applications to soil. Contact: BPPD.
4. File Symbol: 2375-U. Docket ID number: EPA-HQ-OPP-2022-0317. Applicant: Chr. Hansen, Inc., 16300 W Lincoln Ave., New Berlin, WI 53151. Product name: CH0273. Active ingredient: Fungicide and nematicide - Bacillus paralicheniformis strain CH0273 at 100%. Proposed use: For seed treatment and applications to soil. Contact: BPPD.
Authority: 7 U.S.C. 136 et seq.
Dated: April 15, 2022.
Delores Barber,

Director, Information Technology and Resources Management Division, Office of Program Support.
FEDERAL COMMUNICATIONS COMMISSION
[ET Docket No. 18-295, GN Docket No. 17-183; DA 22-253; FR ID 82111]
Office of Engineering and Technology Seeks Comment Following Court Remand of 6 GHz Band Order

AGENCY:
Federal Communications Commission.

ACTION:
Notice.

SUMMARY:
In this document, the Commission invites comments in connection with the remand by the United States Court of Appeals for the District of Columbia Circuit of the Commission's 6 GHz Report and Order. The 6 GHz Report and Order opened the 6 GHz band to the operation of unlicensed low power access points. The D.C. Circuit largely rejected a challenge of the 6 GHz Report and Order, but remanded to the Commission concerns raised by the National Association of Broadcasters (NAB) regarding interference to unlicensed devices in the 2.4 GHz band.

DATES:
Comments are due on or before May 25, 2022, and reply comments are due on or before June 9, 2022.

ADDRESSES:
You may submit comments, identified by ET Docket No. 18-295 and GN Docket No. 17-183, by any of the following methods:
• Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: http://apps.fcc.gov/ecfs/.
• Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing.
Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. See FCC Announces Closure of FCC Headquarters Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020). https://www.fcc.gov/document/fcc-closes-headquarters-open-window-and-changes-hand-delivery-policy.
People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).
People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (tty).

FOR FURTHER INFORMATION CONTACT:
Nicholas Oros, Office of Engineering and Technology, (202) 418-0636, email: Nicholas.Oros@fcc.gov.

SUPPLEMENTARY INFORMATION:
This is a summary of the Commission's document (Public Notice), in ET Docket No. 18-295 and GN Docket No. 17-183, DA 22-253, released on March 10, 2022. The full text of this document is available for public inspection and may be downloaded at: https://www.fcc.gov/document/oet-seeks-comment-following-court-remand-6-ghz-band-order.

Synopsis
In the Public Notice, the Office of Engineering and Technology invites comments in connection with the remand by the United States Court of Appeals for the District of Columbia Circuit of the Commission's 6 GHz Report and Order. On February 22, 2022, the court issued its mandate.
The Commission's 6 GHz Report and Order “open[ed up] the entire 6 GHz band [(5.925-7.125 GHz)] for unlicensed indoor lower power access points.” The Commission found that “[t]hese access points will be ideal for connecting devices in homes and businesses such [as] smartphones, tablet devices, laptops, and Internet-of-Things devices to the Internet.” The Commission adopted several requirements to “protect the various incumbent-licensed services in the band, including fixed microwave services, various other fixed and mobile services, and fixed-satellite services.”
Among other things, the 6 GHz Report and Order required that the operation of devices relying on indoor low power access points be: “(1) limited to indoor operation” whereby “the signals transmitted by these unlicensed devices will be significantly attenuated when passing through the walls of buildings[;]” “(2) required to use a contention-based protocol,” such as a “listen before talk . . . scheme[;]” and “(3) subject to low-power operation,” which, as relevant here, means “a maximum radiated power spectral density of 5 dBm per 1 megahertz.” The Commission concluded that “the[se] restrictions and requirements . . . for indoor use of low power access points eliminat[e] any significant risk of causing harmful interference.”
Petitioners representing licensed commercial wireless service providers, electric utilities, public safety entities, and broadcasters operating in the 6 GHz band sought judicial review, asserting that the 6 GHz Report and Order contravened the Communications Act of 1934, as amended, and the Administrative Procedure Act.
The D.C. Circuit largely rejected these challenges. Holding that “petitioners have failed to provide a basis for questioning the Commission's conclusion that the [ 6 GHz Report and Order ] will protect against a significant risk of harmful interference,” the court “den[ied] the petitions for review in all respects save one.”
The one issue as to which the court granted review involved a claim by the National Association of Broadcasters (NAB) “that because mobile operators frequently work indoors, the provisions of the [ 6 GHz Report and Order ] designed to restrict low-power routers to indoor operation offer mobile licensees little protection”, and that therefore, the Commission should have “reserve[d] a sliver of [the 6 GHz] band exclusively for mobile licensees.” In support of its claim, NAB argued that “after the Commission allowed unlicensed access in the 2.4 GHz band, `a contention-based protocol . . . failed to protect . . . licensed users[,] rendering that band partially unusable.' ”
The court ruled that “[t]he Commission never responded to [NAB's] complaints about interference in the 2.4 GHz band,” and that “[a]lthough the Commission cited a study to support its conclusion that the [ 6 GHz Report and Order ] sufficiently protects mobile operators, that study does not rebut the Association's claims about interference in the 2.4 GHz band.” The court nevertheless declined to vacate the 6 GHz Report and Order, observing that “ `[i]t is conceivable that the Commission may be able to explain' why its experience in the 2.4 GHz band supports its ability to protect licensed mobile operators from harmful interference” and agreeing with the Commission that “ ‘vacating this order would be incredibly disruptive given the fact that devices have already started to be deployed . . . .' ”
In the Public Notice, the Office of Engineering and Technology seeks comment on NAB's arguments in the Commission's proceeding regarding broadcasters' experience in the 2.4 GHz band, how that experience relates to the kinds of contention-based protocol operations prescribed for indoor use in the 6 GHz rules, and whether the 2.4 GHz experience warrants reservation of a portion of the 6 GHz band for mobile indoor operations or any other modification to the Commission's 6 GHz rules. The Office of Engineering and Technology emphasizes that, in light of the limited scope of the court's remand, it does not seek comment on any other aspects of the 6 GHz Report and Order.
Interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).
Ex Parte Rules. The proceeding this Notice initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b) of the Commission's rule. In proceedings governed by § 1.49(f) of the Commission's rule or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format ( e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.
Federal Communications Commission.
Ronald T. Repasi,

Acting Chief, Office of Engineering and Technology.
GENERAL SERVICES ADMINISTRATION
[OMB Control No. 3090-0308; Docket No. 2022-0001; Sequence No. 5]
Information Collection; General Services Administration Acquisition Regulation (GSAR); Construction Contract Administration

AGENCY:
Office of Acquisition Policy, General Services Administration (GSA).

ACTION:
Notice and request for comments.

SUMMARY:
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding OMB Control No. 3090-0308, Construction Contract Administration.

DATES:
Submit comments on or before: June 24, 2022.

ADDRESSES:
Submit comments identified by Information Collection 3090-0308 via https://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 3090-0308, Construction Contract Administration”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 3090-0308, Construction Contract Administration” on your attached document.
Instructions: Please submit comments only and cite Information Collection 3090-0308, Construction Contract Administration, in all correspondence related to this collection. Comments received generally will be posted without change to https://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two-to-three days after submission to verify posting.

FOR FURTHER INFORMATION CONTACT:
Mr. Marten Wallace, General Services Acquisition Policy Division, GSA, by phone at 202-286-5807 or by email at marten.wallace@gsa.gov.

SUPPLEMENTARY INFORMATION:

A. Purpose
The information collected is used by PBS to evaluate a contractor's proposals, negotiate contract modifications, evaluate a contractor's progress, and review payment requests during contract administration. The clause was previously GSAR 552.236-78 Shop Drawings, Coordination Drawings, and Schedules. The clause is simplified, including removing the requirement for a specific number of prints and copies of various submittals. This simplification will ease the compliance burden for the contractor during contract administration from the current state.

B. Annual Reporting Burden
Public reporting burden for GSAR 552.236-72 Submittals is estimated to average .25 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Respondents: 890.
Responses per respondent: 5.
Total annual responses: 4,452.
Preparation hours per response: .25.
Total response burden hours: 1,113.

C. Public Comments
Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.
Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division, by calling 202-501-4755 or emailing GSARegSec@gsa.gov.
Jeffrey A. Koses,

Senior Procurement Executive, Office of Acquisition Policy, Office of Government-wide Policy.
OFFICE OF GOVERNMENT ETHICS
Agency Information Collection Activities; Information Collection Renewal; Comment Request for OGE Form 319 Request for a Medical Exception to the Covid-19 Vaccination Requirement

AGENCY:
Office of Government Ethics (OGE).

ACTION:
Notice and request for comments.

SUMMARY:
After publication of this second round notice, the Office of Government Ethics (OGE) plans to request that the Office of Management and Budget (OMB) renew its approval under the Paperwork Reduction Act for an existing information collection, entitled the OGE Form 319 Request for a Medical Exception to the Covid-19 Vaccination Requirement. The form was originally granted emergency clearance on November 19, 2021.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Jennifer Matis at the U.S. Office of Government Ethics; telephone: 202-482-9216; TTY: 800-877-8339; Email: jmatis@oge.gov. A copy of the form may be obtained, without charge, by contacting Jennifer Matis.

SUPPLEMENTARY INFORMATION:
Title: Request for a Medical Exception to the Covid-19 Vaccination Requirement.
Agency Form Number: OGE Form 319.
Abstract: The OGE Form 319 collects information necessary to document the consideration, decision, and implementation of OGE employee requests for reasonable accommodation from the COVID vaccination requirement set forth in Executive Order 14043, Requiring Coronavirus Disease 2019 Vaccination for Federal Employees (Sept. 9, 2021).
OMB Control Number: 3209-0011.
Type of Information Collection: Extension of a currently approved collection.
Type of Review Request: Regular.
Affected public: Medical providers who are asked to provide documentation in support of an employee's request for a medical exception to the requirement for COVID-19 vaccination.
Estimated Annual Number of Respondents: 1 (based on an estimate of five respondents over a ten year period, rounded up).
Estimated Time per Response: 10 minutes.
Estimated Total Annual Cost Burden (in dollars): 17.
A Federal Register Notice with a 60-day comment period soliciting comments on this information collection was published on February 10, 2022 (87 FR 7838). OGE received one response to that notice. The comment did not address the substance of information collection; it opposed it on the basis of the outstanding injunction against implementation of the vaccination requirement issued pursuant to E.O. 14043. As noted in the first notice and again below, OGE will not process requests for a medical exception or request the submission of any medical information related to a request for an exception pursuant to E.O. 14043 while the injunction remains in place. But OGE may nevertheless receive information regarding a medical exception. Therefore, clearance of the information collection is necessary.
Request for Comments: OGE is publishing this second round notice of its intent to request paperwork clearance renewal for the OGE Form 319. Public comment is invited specifically on the need for and practical utility of this information collection, the accuracy of OGE's burden estimate, the enhancement of quality, utility and clarity of the information collected, and the minimization of burden (including the use of information technology). Comments received in response will become a matter of public record.
A Notice Regarding Injunctions: The vaccination requirement issued pursuant to E.O. 14043 is currently the subject of a nationwide injunction. While that injunction remains in place, OGE will not process requests for a medical exception from the COVID-19 vaccination requirement pursuant to E.O. 14043. OGE will also not request the submission of any medical information related to a request for an exception from the vaccination requirement pursuant to E.O. 14043 while the injunction remains in place. But OGE may nevertheless receive information regarding a medical exception. That is because, if OGE were to receive a request for an exception from the COVID-19 vaccination requirement pursuant to E.O. 14043 during the pendency of the injunction, OGE will accept the request, hold it in abeyance, and notify the employee who submitted the request that implementation and enforcement of the COVID-19 vaccination requirement pursuant to E.O. 14043 is currently enjoined and that an exception therefore is not necessary so long as the injunction is in place. In other words, during the pendency of the injunction, any information collection related to requests for medical exception from the COVID-19 vaccination requirement pursuant to E.O. 14043 is not undertaken to implement or enforce the COVID-19 vaccination requirement.
Approved: April 20, 2022.
Emory Rounds,

Director, U.S. Office of Government Ethics.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-0978]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Emerging Infections Program (EIP)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on January 31, 2022, to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project
Emerging Infections Program (OMB Control No. 0920-0978, Exp. 4/30/2022)—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description
The Emerging Infections Programs (EIPs) are population-based centers of excellence established through a network of state health departments collaborating with academic institutions; local health departments; public health and clinical laboratories; infection control professionals; and healthcare providers. EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases.
Activities of the EIPs fall into the following general categories: (1) Active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies. These activities are designed to: (1) Address issues that the EIP network is particularly suited to investigate; (2) maintain sufficient flexibility for emergency response and new problems as they arise; (3) develop and evaluate public health interventions to inform public health policy and treatment guidelines; (4) incorporate training as a key function; and (5) prioritize projects that lead directly to the prevention of disease.
A Revision is being submitted to make existing collection instruments clearer and to add several new forms specifically surveying laboratory practices. These forms will allow the EIP to better detect, identify, track changes in laboratory testing methodology, gather information about laboratory utilization in the EIP catchment area to ensure that all cases are being captured, and survey EIP staff to evaluate program quality.
Total estimated burden is 61,956 hours. There is no cost to respondents other than their time.
Estimated Annualized Burden Hours
Type of respondent | Form name | Number of respondents | Number of responses per respondent | Average burden per response (in hours)
State Health Department | ABCs Case Report Form | 10 | 809 | 20/60
| ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form | 10 | 127 | 10/60
| ABCs H.influenzae Neonatal Sepsis Expanded Surveillance Form | 10 | 6 | 10/60
| ABCs Severe GAS Infection Supplemental Form | 10 | 136 | 20/60
| ABCs Neonatal Infection Expanded Tracking Form | 10 | 37 | 20/60
| FoodNet Campylobacter | 10 | 970 | 21/60
| FoodNet Cyclospora | 10 | 42 | 10/60
| FoodNet Listeria monocytogenes | 10 | 16 | 20/60
| FoodNet Salmonella | 10 | 855 | 21/60
| FoodNet Shiga toxin producing E. coli | 10 | 290 | 20/60
| FoodNet Shigella | 10 | 234 | 10/60
| FoodNet Vibrio | 10 | 46 | 10/60
| FoodNet Yersinia | 10 | 55 | 10/60
| | FoodNet Hemolytic Uremic Syndrome Case Report Form | 10 | 10 | 1
| FoodNet Clinical Laboratory Practices and Testing Volume | 10 | 70 | 20/60
| FluSurv-NET Influenza Hospitalization Surveillance Network Case Report Form | 10 | 764 | 25/60
| FluSurv-NET Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (English) | 10 | 333 | 5/60
| FluSurv-NET Influenza Hospitalization Surveillance Project Vaccination Phone Script (Spanish) | 10 | 333 | 5/60
| Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults) | 10 | 333 | 5/60
| FluSurv-NET Laboratory Survey | 10 | 16 | 10/60
| HAIC—MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB) | 10 | 500 | 28/60
| HAIC—MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL/iEC) | 10 | 4200 | 25/60
| HAIC—Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form | 10 | 340 | 28/60
| HAIC—Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form | 10 | 584 | 28/60
| HAIC—CDI Case Report and Treatment Form | 10 | 1650 | 38/60
| HAIC Candidemia Case Report | 10 | 200 | 30/60
| HAIC—Annual Survey of Laboratory Testing Practices for C. difficile Infections | 10 | 16 | 19/60
| HAIC—CDI Annual Surveillance Officers Survey | 10 | 1 | 15/60
| HAIC—Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey (LTCF) | 10 | 45 | 5/60
| HAIC—Invasive Staphylococcus aureus Laboratory Survey | 10 | 11 | 20/60
| HAIC—Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey | 10 | 1 | 10/60
| HAIC—Laboratory Testing Practices for Candidemia Questionnaire | 10 | 20 | 12/60
| HAIC MuGSI CA CP-CRE Health interview (new) | 100 | 10 | 30/60
| HAIC MuGSI Supplemental Surveillance Officer Survey (new) | 10 | 1 | 15/60
| HAIC Death Ascertainment Variables | 10 | 8 | 1440/60
Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Meeting of the Community Preventive Services Task Force

AGENCY:
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:
Notice of meeting.

SUMMARY:
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the next meeting of the Community Preventive Services Task Force (CPSTF) on June 8-9, 2022.

DATES:
The meeting will be held on Wednesday, June 8, 2022, from 10:00 a.m. to 6:00 p.m. EDT, and Thursday, June 9, 2022, from 10:00 a.m. to 6:00 p.m. EDT.

ADDRESSES:
The meeting will be held virtually via web conference.

FOR FURTHER INFORMATION CONTACT:
Arielle Arnold, Office of the Associate Director for Policy and Strategy; Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS V25-5, Atlanta, GA 30329. Telephone: (404)498-4512; Email: CPSTF@cdc.gov.

SUPPLEMENTARY INFORMATION:
Meeting Accessibility: The CPSTF meeting will be held virtually via web conference.
CDC will send web conference information to registrants upon receipt of their registration. All meeting attendees must register by June 1, 2022 to receive the web conference information for meeting. CDC will email web conference information from the CPSTF@cdc.gov mailbox.
To register for the meeting, individuals should send an email to CPSTF@cdc.gov and include the following information: Name, title, organization name, organization address, phone, and email.
Public Comment: Individuals who would like to make public comments during the June meeting must state their desire to do so with their registration and provide their name and organizational affiliation and the topic to be addressed (if known). The requestor will receive instructions for the public comment process for this virtual meeting after the request is received. A public comment period follows the CPSTF's discussion of each systematic review and will be limited, up to three minutes per person. Public comments will become part of the meeting summary.
Background on the CPSTF: The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. The CPSTF was convened in 1996 by HHS to identify community preventive programs, services, and policies that increase health, longevity, save lives and dollars, and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the CPSTF. During its meetings, the CPSTF considers the findings of systematic reviews of existing research and practice-based evidence and issues recommendations. CPSTF recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and affected organizations and individuals can consider when they are determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The CPSTF's recommendations, along with the systematic reviews of the evidence on which they are based, are compiled on the Community Guide website ( www.thecommunityguide.org ).
Matters proposed for discussion: The agenda will consist of deliberation on systematic reviews of literature. Topics will include Cancer Screening; Nutrition, Physical Activity, and Obesity; Social Determinants of Health; Mental Health; and Substance Use. The meeting is open to the public. Information regarding the start and end times for each day, and any updates to agenda topics, will be available on the Community Guide website ( www.thecommunityguide.org ) closer to the date of the meeting.
The meeting agenda is subject to change without notice.
Dated: April 20, 2022.
Angela K. Oliver,

Executive Secretary, Centers for Disease Control and Prevention.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-1257]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on February 4, 2022, to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project
Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant (OMB Control No. 0920-1257, Exp. 04/30/2022)—Extension—Center for State, Tribal, Local and Territorial Support (CSTLTS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description
The Preventive Health and Health Services Block Grant (PHHS Block Grant) has provided funding for all 50 states, the District of Columbia, two American Indian tribes, five U.S. territories, and three freely associated states to address the unique public health needs of their jurisdictions in innovative and locally defined ways. First authorized by Congress in 1981 through the Public Health Service Act (Pub. L. 102-531), the fundamental and enduring purpose of the grant has been to provide grantees with localized control to address their priority public health needs. In 1992, Congress amended the law to align PHHS Block Grant funding priorities with the 22 chapters specified in Healthy People (HP) 2000, a set of national objectives designed to guide health promotion and disease prevention efforts. Additional amendments included funds specifically dedicated to sex offense prevention and victim services, thus requiring grantees receiving this support to include related HP objectives and activities as part of their PHHS Block Grant-funded local programs.
CDC has increased the accountability of the PHHS Block Grant by establishing a comprehensive, standardized method to collect data to describe select outputs and outcomes. The CDC PHHS Block Grant Measurement Framework is an innovative approach to: (1) Collecting data on public health infrastructure ( i.e., information systems, quality improvement, efficiency and effectiveness of programs, services, and operations); (2) emerging public health needs addressed; and (3) evidence-based public health interventions implemented.
The purpose of this information collection request (ICR) is to collect data that will assess select cross-cutting outputs and outcomes of the grant (as defined by the framework measures) and that demonstrate the utility of the grant on a national level. This data collection will describe the outcomes of the PHHS Block Grant as a whole—not individual grantee activities or outcomes.
The respondent universe consists of 61 PHHS Block Grant coordinators, or their designees, across 61 health departments (50 states, the District of Columbia, 2 tribes, 5 U.S. territories, and 3 freely associated states). The assessment will be administered to PHHS Block Grant coordinators electronically via a web-based questionnaire. A link to the assessment will be provided by email invitation. The survey will be completed once every two years. The total annualized estimated burden is 46 hours. There are no costs to respondents other than their time to participate.
Estimated Annualized Burden Hours
Type of respondents | Form name | Number of respondents | Number of responses per respondent | Average burden per response (in hours)
PHHS Block Grant Coordinators, or Designees | PHHS Block Grant Assessment | 61 | 1 | 45/60
Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10141, CMS-R-235 and CMS-10515]
Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).

ACTION:
Notice.

SUMMARY:
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 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

DATES:
Comments on the collection(s) of information must be received by the OMB desk officer by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:
1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Prescription Drug Benefit Program; Use: Plan sponsor and State information is used by CMS to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and ensure that correct information is disclosed to potential and current enrollees. Form Number: CMS-10141 (OMB control number: 0938-0964); Frequency: Annually; Affected Public: Private Sector and Business or other for-profit institutions; Number of Respondents: 11,771,497; Total Annual Responses: 675,231,213; Total Annual Hours: 9,261,354. (For policy questions regarding this collection contact Chad D. Buskirk at 410-786-1630.)
2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Data Use Agreement (DUA) Form, Research Identifiable Files Request Packet, and Data Management Plan; Use: CMS is permitted to disclose data files for approved research purposes in compliance with 45 CFR 164.512(i). Researchers requesting research identifiable files (RIF) must, as part of the request process, complete a research request packet that provides CMS with information pertaining to the research study, including describing how the research results/findings will be disseminated, as well as the data files being requested. Should CMS approve the research request, the data requestor enters into a Data Use Agreement (DUA). This data collection is necessary to ensure that disclosures of data for research purposes comply with federal laws and regulations as well as CMS policy.
Researchers requesting RIF files also must complete a Data Management Plan Self-Attestation Questionnaire (DMP SAQ). A DMP SAQ is required each time a DUA is established. Both the DUA and the DMP SAQ forms are valid for one year from the date of approval and are renewable at expiration. If the environment described in a DMP SAQ is the same for multiple DUAs from a single organization, the same DMP SAQ can be used across the DUAs, provided it has not expired.
The DMP SAQ is a technical, evidence-based questionnaire that DUA users must complete as part of the data request packet. The DMP SAQ will enable CMS to evaluate researcher data systems to ensure that CMS data are adequately secured and appropriately protected, as per the Privacy Act and the HIPAA Privacy Rule. The DMP SAQ also allows CMS to measure compliance through the implementation of security and privacy controls as outlined in the National Institute of Standards and Technology (NIST) Special Publication 800-53 and the Centers for Medicare & Medicaid Services (CMS) Information Security and Acceptable Risk Safeguards (ARS). The second component of the DMP SAQ is to provide ongoing oversight. All organizations will be subject to routine audits of the environments used to store and process CMS data, as described in their organizational-level DMP SAQ. Form Number: CMS-R-235 (OMB control number: 0938-0734); Frequency: Occasionally; Affected Public: Private Sector, State, Local, or Tribal Governments, Federal Government (Business or for-profits and Not-for-profit institutions); Number of Respondents: 9,655; Total Annual Responses: 9,655; Total Annual Hours: 3,875. (For policy questions regarding this collection, contact Kari A. Gaare at 410-786-8612.)
3. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Payment Collections Operations Contingency Plan; Use: Under sections 1401, 1411, and 1412 of the Patient Protection and Affordable Care Act (PPACA) and 45 CFR part 155 subpart D, an Exchange makes an advance determination of tax credit eligibility for individuals who enroll in QHP coverage through the Exchange and seek financial assistance. Using information available at the time of enrollment, the Exchange determines whether the individual meets the income and other requirements for advance payments and the amount of the advance payments that can be used to pay premiums. Advance payments are made periodically under section 1412 of the PPACA to the issuer of the QHP in which the individual enrolls. Section 1402 of the PPACA provides for the reduction of cost sharing for certain individuals enrolled in a QHP through an Exchange, and section 1412 of the PPACA provides for the advance payment of these reductions to issuers. The statute directs issuers to reduce cost sharing for essential health benefits for individuals with household incomes between 100 and 400 percent of the Federal poverty level (FPL) who are enrolled in a silver level QHP through an individual market Exchange and are eligible for advance payments of the premium tax credit. Until January 2016, HHS collected data required to meet these statutory requirements via a manual system in which issuers submitted data. HHS now has an automated system that does not require issuer data submission for FFE issuers. The data collection has been used by HHS to make payments or collect charges from SBE issuers under the following programs: Advance payments of the premium tax credit, advanced cost-sharing reductions, and Exchange user fees. The workbook template was used to make payments in January 2014 and will continue for issuers in states transitioning to a State-Based Exchange, as may be required based on HHS's operational progress. Form Number: CMS-10515 (OMB Control Number: 0938-1217); Frequency: Occasionally; Affected Public: Private Sector—Business or other for-profits and not-for-profit institutions; Number of Respondents: 50; Total Annual Responses: 600; Total Annual Hours: 3,051. (For policy questions regarding this collection contact Christelle Jang at 410-786-8438.)
Dated: April 19, 2022.
William N. Parham III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Electronic Document Exchange (OMB No.: 0970-0435)

AGENCY:
Office of Child Support Enforcement, Administration for Children and Families, HHS.

ACTION:
Request for public comment.

SUMMARY:
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to approve the Electronic Document Exchange (EDE), with minor revisions, for an additional three years. State child support agencies use the EDE to improve case processing. The current OMB approval expires on June 30, 2022.

DATES:
Comments due within 30 days of publication. OMB must make a decision about the collection of information between 30 and 60 days after publication of this document in the Federal Register . Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

SUPPLEMENTARY INFORMATION:
Description: The EDE provides a centralized, secure system for authorized users in state child support agencies to electronically exchange child support and spousal support case information with other state child support agencies. EDE benefits state child support agencies by reducing delays, costs, and barriers associated with interstate case processing, increasing state collections, improving document security, standardizing data sharing, increasing state participation, and improving case processing, resulting in better overall child and spousal support outcomes. OCSE made minor updates to the Portal screens to enhance functionality.
Respondents: State Child Support Agencies.
Annual Burden Estimates:
Instrument | Annual number of respondents | Annual number of responses per respondent | Average burden hours per response | Annual burden hours
EDE Screens | 49 | 4,662 | 0.017 | 3,883
Estimated Total Annual Burden Hours: 3,883.
Authority: 42 U.S.C. 652(a)(7); 42 U.S.C. 666(c)(1); and 45 CFR 303.7(a)(5).
Mary B. Jones,

ACF/OPRE Certifying Officer.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comprehensive Child Welfare Information System (CCWIS) Automated Function Checklist and Data Quality Plan (OMB #0970-0463)

AGENCY:
Children's Bureau, Administration for Children and Families, HHS.

ACTION:
Request for public comment.

SUMMARY:
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Comprehensive Child Welfare Information System (CCWIS) information collection (OMB #0970-0463, expiration 8/31/2022). The CCWIS information collection includes the Automated Function List and the Data Quality Plan. There are no required instruments associated with the data collection and no changes to the data collection.

DATES:
Comments due within 30 days of publication. OMB must make a decision about the collection of information between 30 and 60 days after publication of this document in the Federal Register . Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. You can also obtain copies of the proposed collection of information by emailing infocollection@acf.hhs.gov. Identify all emailed requests by the title of the information collection.

SUPPLEMENTARY INFORMATION:
Description: The CCWIS information collection includes two components:
• The Automated Function List update required pursuant to section 1355.52(i)(2); and
• The Data Quality Plan update required pursuant to section 1355.52(d)(5).
The CCWIS regulations require updates of this information to confirm that the project meets CCWIS requirements and that project costs are appropriately allocated to benefiting programs.
Respondents: Title IV-E agencies under the Social Security Act.
Annual Burden Estimates
Instrument | Total number of respondents | Annual number of responses per respondent | Average burden hours per response | Annual burden hours
Automated Function List section 1355.52(i)(2) | 55 | 1 | 10 | 550
Data Quality Plan section 1355.52(d)(5) | 55 | 1 | 40 | 2,200
Estimated Annual Burden Hours: 2,750.
Authority: 42 U.S.C. 620 et seq., 42 U.S.C. 670 et seq., 42 U.S.C. 1301 and 1302.
Mary B. Jones,

ACF/OPRE Certifying Officer.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4206]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification

AGENCY:
Food and Drug Administration, Health and Human Services (HHS).

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:
Fax written comments on the collection of information by May 25, 2022.

ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. All comments should be identified with the OMB control number 0910-0508. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-45, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Medical Device User Fee Small Business Qualification and Certification

OMB Control Number 0910-0508—Extension
This information collection helps support implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250) and FDA's Medical Device User Fee program. Current authorization for medical device user fees will be in place from October 1, 2017, until September 30, 2022.
Section 738(d)(2)(A) and (e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)(2)(A) and (e)(2)(A)) define a “small business” as an entity that reported $100 million or less of gross receipts or sales in its most recent Federal income tax return, including such returns of its affiliates, partners, and parent firms. If a firm's gross receipts or sales are no more than $30 million (including all affiliates, partners, and parent firms), they will also qualify for a waiver of the fee for their first (ever) premarket application, product development protocol, biological licensing application, or premarket report. A “small business” is eligible for reduced or waived fees. If an applicant does not provide information to FDA demonstrating to FDA's satisfaction that the applicant is a small business, the applicant must pay the standard (full) fee for any application it submits.
Forms FDA 3602 (“MDUFA Small Business Certification Request for a Business Headquartered in the United States”) and 3602A (“MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States”) are submitted to FDA to demonstrate that an applicant qualifies as a MDUFA small business. The guidance “Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments” ^1 describes the process by which a business may request certification as a small business and the criteria FDA will use to decide whether an entity qualifies as a MDUFA small business and is eligible for a reduction in user fees.
^1 The guidance “Medical Device User Fee Small Business Qualification and Certification Guidance for Industry, Food and Drug Administration Staff and Foreign Governments” is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification.
In the Federal Register of December 23, 2021 (86 FR 72983), we published a 60-day notice requesting public comment on the proposed collection of information. One comment was received, however it did not respond to the functional elements solicited in our 60-day notice or suggest a revision to our burden estimate.
We estimate the burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden ^1
FDA form No. | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours
FDA 3602—MDUFA Small Business Certification Request For a Business Headquartered in the United States | 2,500 | 1 | 2,500 | 1 | 2,500
FDA 3602A—MDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United States | 2,000 | 1 | 2,000 | 1 | 2,000
Total | | | | | 4,500
^1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden is based on the number of applications received in the last few years and includes the time we assume necessary to prepare and submit required information. Based on our experience with Forms FDA 3602 and 3602A, we assume it will take respondents 1 hour to complete either form. We have adjusted our estimated “No. of Respondents” to better reflect recent submission volume. This adjustment results in a 2,500-hour decrease to the information collection.
Dated: April 19, 2022.
Lauren K. Roth,

Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1975-N-0336 (formerly 1975N-0184)]
Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Containing an Anticholinergic or Antispasmodic in Combination With a Sedative, and Single-Entity Antispasmodic Drug Products, in Oral Dosage Form; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation

AGENCY:
Food and Drug Administration, Health and Human Services (HHS).

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests regarding drug products containing an anticholinergic or antispasmodic in combination with a sedative, and single-entity antispasmodic drug products, in oral dosage form, under Docket FDA-1975-N-0336 (formerly 75N-0184) (DESI 10837) have been withdrawn. Therefore, shipment in interstate commerce of any such product identified in Docket FDA-1975-N-0336 covered by DESI 10837, or any identical, related, or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the date of this notice. This notice does not affect products covered by DESI 597 under the same docket.

DATES:
This notice is applicable April 25, 2022.

ADDRESSES:
For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The most relevant background documents regarding this matter are available in the docket. However, additional background documents are available upon request (see FOR FURTHER INFORMATION CONTACT ).

FOR FURTHER INFORMATION CONTACT:
Jeffrey Trunzo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5111, Silver Spring, MD 20993-0002, 301-796-2029, email: Jeffrey.Trunzo@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background
When enacted in 1938, the Federal Food, Drug, and Cosmetic Act (FD&C Act) required that “new drugs” (21 U.S.C. 321(p)) be approved for safety by FDA before they could legally be sold in interstate commerce. Between 1938 and 1962, if a drug obtained approval, FDA considered drugs that were IRS (see 21 CFR 310.6(b)(1)) to the approved drug to be covered by that approval and allowed those IRS drugs to be marketed without independent approval.
In 1962, Congress amended the FD&C Act to require that new drugs be proven effective for their labeled indications, as well as safe, in order to obtain FDA approval. This amendment also required FDA to conduct a retrospective evaluation of the effectiveness of the drug products that FDA had approved as safe between 1938 and 1962. FDA contracted with the National Academy of Sciences/National Research Council (NAS/NRC) to make an initial evaluation of the effectiveness of over 3,400 products that had been approved only for safety between 1938 and 1962. The NAS/NRC reports for these drug products were submitted to FDA in the late 1960s and early 1970s. The Agency reviewed and reevaluated the reports and published its findings in Federal Register notices. FDA's administrative implementation of the NAS/NRC reports was called the Drug Efficacy Study Implementation (DESI). DESI covered the approximately 3,400 products specifically reviewed by the NAS/NRC, as well as the even larger number of IRS products that entered the market without FDA approval.
All drugs covered by the DESI review are “new drugs” under the FD&C Act. If FDA's final DESI determination classifies a drug product as lacking substantial evidence of effectiveness for one or more indications, that drug product and those IRS to it may no longer be marketed for such indications and are subject to enforcement action as unapproved new drugs. If FDA's final DESI determination classifies the drug product as effective for one or more of its labeled indications, the drug can be marketed for such indications, provided it is the subject of an application approved for safety and effectiveness. Sponsors of drug products that have been found to be effective for one or more indications through the DESI process may rely on FDA's effectiveness determinations, but typically must update their labeling to conform to the indication(s) found to be effective by FDA and include any additional safety information required by FDA. Those drug products with NDAs approved before 1962 for safety therefore require approved supplements to their original applications if one or more indications are found to be effective under DESI; IRS drug products require an approved NDA or ANDA, as appropriate. Furthermore, labeling for drug products classified as effective may contain only those indications for which the review found the product effective unless the firm marketing the product has received an approval for the additional indication(s).

II. Final Resolution of Hearing Requests Regarding Oral Prescription Drugs Containing an Anticholinergic or Antispasmodic in Combination With a Sedative, and Single-Entity Antispasmodic Drug Products, in Oral Dosage Form Under Docket No. FDA-1975-N-0336 (Formerly 75N-0184); DESI 10837
In a Federal Register notice published on June 22, 1971 (36 FR 11875) (1971 Federal Register notice), FDA announced its evaluation of reports received from NAS/NRC under DESI 10837, regarding anticholinergic drug products containing the following active ingredients: Prochlorperazine maleate and isopropamide iodide; oxyphencyclimine hydrochloride and meprobamate; oxyphencyclimine hydrochloride and hydroxyzine hydrochloride; tridihexethyl chloride and meprobamate; and propantheline bromide and thiopropazate hydrochloride. The drugs were found to be possibly effective as adjunctive therapy in peptic ulcer and in the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis, functional gastrointestinal disorders); functional diarrhea; drug induced diarrhea; ulcerative colitis, and urinary bladder spasm, and urethral spasm ( i.e., smooth muscle spasm). In addition, oxyphencyclimine and meprobamate preparations were found to be possibly effective for dysmenorrhea. These drugs were found to lack substantial evidence of effectiveness for their other labeled indications.
In a Federal Register notice published November 11, 1975 (40 FR 52644) (1975 Federal Register notice), the Agency explained that several of the products listed in the 1971 Federal Register notice may remain on the market while clinical studies were being conducted to determine their efficacy for the indications rated as “possibly effective,” because they were widely used in the treatment of peptic ulcer disease and functional bowel syndrome and were perceived as important and useful tools of therapy by many gastroenterologists and general practitioners (40 FR 52644 at 52648). In addition to the products from the 1971 Federal Register notice, the 1975 Federal Register notice included several products, among them Librax Capsules, NDA 12-750, containing clidinium bromide and chlordiazepoxide, now manufactured by Bausch Health Companies, Inc. (Bausch), that had been the subject of safety-only applications approved before 1962 and that had not been reviewed by NAS/NRC. Librax Capsules was included in the 1975 Federal Register notice notwithstanding the Stipulation for Dismissal in Hoffman-La Roche, Inc. v. Richardson, et. al., Civil Action 11-73 (D.N.J. August 2, 1973), discussed below. The 1975 Federal Register notice set forth a timetable for conducting clinical efficacy studies for drug products subject to the notice. In a Federal Register notice published June 20, 1978 (43 FR 26490) (1978 Federal Register notice), FDA announced a change in its previous policy for testing and marketing of the drugs that were subject of the November 11, 1975, notice ( e.g., Librax), including an extension of deadline for completion of the studies for 1 year.
In a Federal Register notice published January 16, 1981(46 FR 3977) (1981 Federal Register notice), FDA announced its evaluation of study reports received in response to the 1975 Federal Register notice. FDA concluded that there was a lack of substantial evidence demonstrating the effectiveness of the drugs listed in the 1975 notice, proposed to withdraw approval of the new drug applications, and offered an opportunity for hearing to manufacturers of the drugs listed in the notice, as well as to the manufacturers of IRS products.
As set forth in a Federal Register notice published July 24, 2012 (77 FR 43337) (2012 Federal Register notice), several companies submitted timely hearing requests in response to the 1981 Federal Register notice, but the only such request that had not been withdrawn as of July 2012, was the request regarding Librax Capsules, filed by Roche Laboratories, manufacturer of Librax Capsules in 1981 (77 FR 43337 at 43341). In response to the 2012 Federal Register notice, Valeant Pharmaceuticals North America LLC (now Bausch) affirmed the hearing request regarding Librax Capsules by letter dated August 22, 2012.
On May 23, 2016, FDA posted a Notice to Docket 1975-N-0336, explaining that Librax is not subject to review under DESI because a new drug application for Librax was approved by the Agency on September 1, 1966, and at that time the Agency determined that Librax was safe and effective for the indications set forth in its labeling, (consistent with the Stipulation for Dismissal in Hoffman-La Roche, Inc. v. Richardson, et al., Civil Action 11-73 (D.N.J. August 2, 1973)). On June 2, 2016, Valeant responded by withdrawing its hearing request.
There are no longer outstanding hearing requests pertaining to drug products containing an anticholinergic or antispasmodic in combination with a sedative, and single-entity antispasmodic drug products, in oral dosage form under Docket No. FDA-1975-N-0336, DESI 10837. Shipment in interstate commerce of any drug product identified in this docket under DESI 10837, or any IRS product, that is not the subject of an approved NDA or ANDA is unlawful as of the applicable date of this notice (see DATES ). Any person who wishes to determine whether a specific product is covered by this notice should write to Jeffrey Trunzo (see FOR FURTHER INFORMATION CONTACT ). Firms should be aware that, after the applicable date of this notice (see DATES ), FDA intends to take enforcement action without further notice against any firm that manufactures or ships in interstate commerce any unapproved product covered by this notice.

III. Discontinued Products
Firms must notify the Agency of certain product discontinuations in writing under section 506C(a) of the FD&C Act (21 U.S.C. 356c) (see https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm ). Some firms may have previously discontinued manufacturing or distributing products covered by this notice without discontinuing the listing as required under section 510(j) of the FD&C Act (21 U.S.C. 360(j)). Other firms may discontinue manufacturing or distributing listed products in response to this notice. All firms are required to electronically update the listing of their products under 510(j) of the FD&C Act to reflect discontinuation of unapproved products covered by this notice (21 CFR 207.57(b)). Questions on electronic drug listing updates should be sent to eDRLS@fda.hhs.gov. In addition to the required update, firms can also notify the Agency of product discontinuation by sending a letter, signed by the firm's chief executive officer and fully identifying the discontinued product(s), including the product National Drug Code (NDC) number(s), and stating that the manufacturing and/or distribution of the product(s) have been discontinued. The letter should be sent electronically to Jeffrey Trunzo (see FOR FURTHER INFORMATION CONTACT ). FDA plans to rely on its existing records, including its drug listing records, the results of any future inspections, or other available information, when it identifies violative products for enforcement action.

IV. Reformulated Products
FDA cautions firms against reformulating products and marketing under the same name or substantially the same name (including a new name that contains the old name). Reformulated products marketed under a name previously identified with a different active ingredient or combinations of active ingredients have the potential to confuse healthcare practitioners and harm patients.
Dated: April 20, 2022.
Lauren K. Roth,

Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0081]
Agency Information Collection Activities; Proposed Collection; Comment Request; Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion

AGENCY:
Food and Drug Administration, Health and Human Services (HHS).

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled “Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion.”

DATES:
Submit either electronic or written comments on the collection of information by June 24, 2022.

ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 24, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 24, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• 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”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• 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.”
Instructions: All submissions received must include the Docket No. FDA-2022-N-0081 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Regarding the information collection: Jonna Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, PRAStaff@fda.hhs.gov. For copies of the questionnaire: Office of Prescription Drug Promotion (OPDP) Research Team, DTCresearch@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, 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.

Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion

OMB Control Number 0910-NEW

I. Background
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.
The Office of Prescription Drug Promotion's (OPDP) mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission. Our research focuses in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience, and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first and second topic areas, advertising features and target populations.
Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved by using the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our home page, which can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register notices and peer-reviewed publications produced by our office.
The proposed research examines the relative importance of prescription drug product information such as prescription drug efficacy, risk, adherence, and patient preference claims in two medical conditions (type 2 diabetes and psoriasis) in consumer and physician samples. When confronted with an important decision, people tend to make choices that reflect a series of tradeoffs between certain desirable and undesirable attributes of a product, service, or experience. Pharmaceutical manufacturers provide information about prescription drug products, including side effects, contraindications, and effectiveness through product labeling and promotional materials (21 CFR 202.1(e)). The treatment preferences of diagnosed consumers and treating physicians have been shown to be influenced by certain characteristics, such as the perceived drug's impact on quality of life, complexity of dosage regimens, mode of administration, cost to family and self, and marketing claims unrelated to medicinal properties (Refs. 1 to 5). Although diagnosed consumers may weigh the risks, benefits, or other salient characteristics of prescription drug products differently than physicians, little research directly compares the treatment preferences of these two groups (Ref. 6). Understanding the tradeoffs among drug product characteristics diagnosed consumers make—and how the tradeoffs could potentially differ from the tradeoffs made by physicians—will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions.
We intend to examine these tradeoffs using a choice-based conjoint analysis, also known as a discrete choice experiment. Conjoint analysis is a broad class of survey-based techniques used to estimate how attractive or influential different features of choice options or product attributes are in determining purchase behavior or treatment choices (Ref. 7). Conjoint analysis can be used to examine the joint effects and tradeoffs of multiple variables or product attributes on decisions. A choice-based conjoint analysis is based on the principle that products are composed of a set of attributes, and each attribute can be described using a finite number of levels. In the proposed research, participants will be shown a carefully designed sequence of choice tasks containing up to five hypothetical product attributes—in this case, profiles describing fictitious prescription drug products for either type 2 diabetes or psoriasis. Using data from the choices that participants make across these tasks, we can use statistical techniques to draw inferences about the relative value they place on different product attributes, estimate the relative importance of different attributes, explore the tradeoffs that consumers and physicians are willing to make to avoid or accept specific attribute levels, and compare the preferences of these two groups (Ref. 8).
We estimate that participation in the study will take approximately 20 minutes. Adult participants aged 18 years or older will be recruited by email through an internet panel, and participant eligibility will be determined with a screener at the beginning of the online survey. The consumer sample will consist of adults who self-report as having been diagnosed by a healthcare provider with either psoriasis or type 2 diabetes. For the consumer sample, we will exclude individuals who work in healthcare settings because their knowledge and experiences may not reflect those of the average consumer. The physician sample will consist of primary care physicians and specialists who report treating patients with psoriasis or type 2 diabetes. For the physician sample, we will exclude individuals who spend less than 50 percent of their time on direct patient care. Department of Health and Human Services employees and individuals who work in the marketing, advertising, or pharmaceutical industries will be excluded from both respondent groups. Respondents will receive a survey invitation with a unique password protected link. All panel members are recruited following a double opt-in process. Sample sizes were estimated by combining approaches for conjoint analysis suggested by Orme (Ref. 9) and Johnson et al. (Ref. 10).
The target sample size for the main study is 800 physicians and 800 consumers, with half of each cohort focusing on treatments for psoriasis and the other half focusing on treatments for type 2 diabetes. Prior to conducting the main study, we will conduct at least one pretest. If the first pretest reveals that changes to the measurement instruments, stimuli, or procedures are required, a second pretest will be conducted with revised materials. The target sample size for each wave of pretests is 60 physicians and 60 consumers.
FDA estimates the burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden ^1
Activity | Number of respondents | Number of responses per respondent ^2 | Total annual responses | Average burden per response ^3 | Total hours
Pretest 1 Screener, Physicians ^4 | 95 | 1 | 95 | 0.08 (5 minutes) | 8
Pretest 1 Screener, Consumers ^4 | 95 | 1 | 95 | 0.08 (5 minutes) | 8
Physician Pretest 1 | 66 | 1 | 66 | 0.33 (20 minutes) | 22
Consumer Pretest 1 | 66 | 1 | 66 | 0.33 (20 minutes) | 22
Pretest 2 Screener, Physicians 4 5 | 95 | 1 | 95 | 0.08 (5 minutes) | 8
Pretest 2 Screener, Consumers 4 5 | 95 | 1 | 95 | 0.08 (5 minutes) | 8
Physician Pretest 2 ^4 | 66 | 1 | 66 | 0.33 (20 minutes) | 22
Consumer Pretest 2 ^4 | 66 | 1 | 66 | 0.33 (20 minutes) | 22
Physician Main Study Screener ^4 | 1,258 | 1 | 1,258 | 0.08 (5 minutes) | 101
Physician Main Study | 880 | 1 | 880 | 0.33 (20 minutes) | 290
Consumer Main Study Screener ^4 | 1,258 | 1 | 1,258 | 0.08 (5 minutes) | 101
Consumer Main Study | 880 | 1 | 880 | 0.33 (20 minutes) | 290
Total | | | 4,920 | | 902
^1 There are no capital costs or operating and maintenance costs associated with this collection of information.
^2 As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for both samples in the study.
^3 Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
^4 Number of screener respondents assumes a 70 percent eligibility rate with targeted recruitment.
^5 Pretest 2 will be conducted only if changes to study materials are made in response to the findings of Pretest 1.

II. References
The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.
1. Aikin, K.J., K.R. Betts, K.S. Ziemer, et al. (2019). “Consumer Tradeoff of Advertising Claim Versus Efficacy Information in Direct-to-Consumer Prescription Drug Ads.” Research in Social and Administrative Pharmacy, 15(12), 1484-1488. https://doi.org/10.1016/j.sapharm.2019.01.012.
*2. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, et al. (2017). “Conjoint Analysis to Understand Preferences of Patients With Multiple Sclerosis for Disease-Modifying Therapy Attributes in Spain: A Cross-Sectional Observational Study.” BMJ Open, 7(3), e014433. https://doi.org/10.1136/bmjopen-2016-014433.
3. Fraenkel, L., L. Suter, C.E. Cunningham, et al, (2014). “Understanding Preferences for Disease-Modifying Drugs in Osteoarthritis.” Arthritis Care & Research, 66(8), 1186-1192. https://pubmed.ncbi.nlm.nih.gov/24470354/.
4. Katz, D.A., C. Hamlin, M.W. Vander Weg, et al. (2020). “Veterans' Preferences for Tobacco Treatment in Primary Care: A Discrete Choice Experiment.” Patient Education and Counseling, 103(3), 652-660. https://doi.org/10.1016/j.pec.2019.10.002.
5. Wouters, H., G.A. Maatman, L. Van Dijk, et al. (2013). “Trade-Off Preferences Regarding Adjuvant Endocrine Therapy Among Women With Estrogen Receptor-Positive Breast Cancer.” Annals of Oncology, 24(9), 2324-2329. https://doi.org/10.1093/annonc/mdt195.
6. Gregorian, Jr., R.S., A. Gasik, W.J. Kwong, et al. (2010). “Importance of Side Effects in Opioid Treatment: A Trade-Off Analysis With Patients and Physicians.” The Journal of Pain, 11(11), 1095-1108. https://doi.org/10.1016/j.jpain.2010.02.007.
7. Johnson, FR, E. Lancsar, D. Marshall, et al. (2013). “Constructing Experimental Designs for Discrete-Choice Experiments: Report of the ISPOR Conjoint Analysis Experimental Design Good Research Practices Task Force.” Value in Health, 16(1), 3-13. https://doi.org/10.1016/j.jval.2012.08.2223.
8. Bridges, J.F.P., A.B. Hauber, D. Marshall, et al. (2011). “Conjoint Analysis Applications in Health—A Checklist: A Report of the ISPOR Good Research Practices for Conjoint Analysis Task Force.” Value in Health, 14(4), 403-413. https://doi.org/10.1016/j.jval.2010.11.013.
9. Orme, B. (2019). Getting Started With Conjoint Analysis: Strategies for Product Design and Pricing Research (Fourth ed.). Madison, WI: Research Publishers LLC.
10. Johnson, F., B. Kanninen, M. Bingham, et al. (2006). “Experimental Design for Stated-Choice Studies.” In: Valuing Environmental Amenities Using Stated Choice Studies (pp. 159-202). B.J. Kanninen (Ed.). Dordrecht: Springer.
Dated: April 19, 2022.
Lauren K. Roth,

Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0559]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation

AGENCY:
Food and Drug Administration, Health and Human Services (HHS).

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:
Submit written comments (including recommendations) on the collection of information by May 25, 2022.

ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0456. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Public Health Service (PHS) Guideline on Infectious Disease Issues in Xenotransplantation

OMB Control Number 0910-0456—Extension
This information collection helps support implementation of the Department of Health and Human Services' “PHS Guideline on Infectious Disease Issues in Xenotransplantation” dated January 19, 2001, available at: https://www.fda.gov/media/73803/download. FDA is authorized to collect this information under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 321 et seq. ). The guideline was developed by the PHS to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a risk to public health. The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public. The PHS guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collection of information described in this guideline is intended to provide general guidance on the following topics: (1) The development of xenotransplantation clinical protocols; (2) the preparation of submissions to FDA; and (3) the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures. The PHS guideline also describes an occupational health service program for the protection of health care workers involved in xenotransplantation procedures, caring for xenotransplantation product recipients, and performing associated laboratory testing. The PHS guideline is intended to protect the public health and to help ensure the safety of using xenotransplantation products in humans by preventing the introduction, transmission, and spread of infectious diseases associated with xenotransplantation.
The PHS guideline also recommends that certain specimens and records be maintained for 50 years beyond the date of the xenotransplantation. These include: (1) Records linking each xenotransplantation product recipient with relevant health records of the source animal, herd or colony, and the specific organ, tissue, or cell type included in or used in the manufacture of the product (3.2.7.1); (2) aliquots of serum samples from randomly selected animal and specific disease investigations (3.4.3.1); (3) source animal biological specimens designated for PHS use (3.7.1); (4) animal health records (3.7.2), including necropsy results (3.6.4); and (5) recipients' biological specimens (4.1.2). The retention period is intended to assist health care practitioners and officials in surveillance and in tracking the source of an infection, disease, or illness that might emerge in the recipient, the source animal, or the animal herd or colony after a xenotransplantation.
The recommendation for maintaining records for 50 years is based on clinical experience with several human viruses, such as human cytomegalovirus and BK polyoma virus, which have presented problems in human-to-human transplantation and are therefore thought to share certain characteristics with viruses that may pose potential risks in xenotransplantation. These characteristics include long latency periods and the ability to establish persistent infections. Several also share the possibility of transmission among individuals through intimate contact with human body fluids. Human immunodeficiency virus (HIV) and human T-lymphotropic virus are human retroviruses. Retroviruses contain ribonucleic acid that is reverse-transcribed into deoxyribonucleic acid (DNA) using an enzyme provided by the virus and the human cell machinery. That viral DNA can then be integrated into the human cellular DNA. Both viruses establish persistent infections and have long latency periods before the onset of disease, 10 years and 40 to 60 years, respectively. The human hepatitis viruses are not retroviruses, but several share with HIV the characteristic that they can be transmitted through body fluids, can establish persistent infections, and have long latency periods, e.g., approximately 30 years for hepatitis C.
In addition, the PHS guideline recommends that a record system be developed that allows easy, accurate, and rapid linkage of information among the specimen archive, the recipient's medical records, and the records of the source animal for 50 years. The development of such a record system is a one-time burden. Such a system is intended to cross-reference and locate relevant records of recipients, products, source animals, animal procurement centers, and significant nosocomial exposures.
Respondents to this collection of information are the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications (INDs) and xenotransplantation product procurement centers, referred to as source animal facilities. There are an estimated three respondents who are sponsors of INDs that include protocols for xenotransplantation in humans and five clinical centers doing xenotransplantation procedures. Other respondents for this collection of information are an estimated four source animal facilities which provide source xenotransplantation product material to sponsors for use in human xenotransplantation procedures. These four source animal facilities keep medical records of the herds/colonies as well as the medical records of the individual source animal(s). The burden estimates are based on FDA's records of xenotransplantation-related INDs and estimates of time required to complete the various reporting, recordkeeping, and third-party disclosure tasks described in the PHS guideline.
In the Federal Register of October 22, 2021 (86 FR 58666), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment letter, which contained multiple comments, in response to the notice. Several comments (recommendations for selection of xenograft recipients, hospital personnel and care providers, and handling of donor and recipient tissue) were not responsive to the four information collection topics solicited in the 60-day notice and therefore will not be addressed in this notice.
(Comment 1) One comment in the letter was supportive of expanded collection and testing of blood samples from xenograft recipients, their immediate family, close social/sexual contacts, as well as other persons at risk of exposure to infection.
(Response) We agree with the utility of blood sampling and testing to track the source of any long-term developing infections as a result of xenotransplantation. We have considered the comment and have determined that the comment does not present information that would warrant substantive changes to the guideline at this time.
(Comment 2) One comment in the letter recommended shortening the 50-year retention period for frozen samples of serum, cells, and tissues recommended by the PHS guideline. Among other reasons, the comment argued that transplant recipients generally manifest either donor-derived or opportunistic infections in the first-year post-transplantation; malignancies and uncommon infections may manifest later, but generally within 5-10 years; and patient survival post-organ transplantation is generally less than 20 years. The comment concluded that storage of samples beyond 20 years for initial studies should not be necessary.
(Response) We have considered the comment and have determined that the comment does not present information that would warrant substantive changes to the guideline at this time.
(Comment 3) One comment in the letter stated that the sponsor of the clinical trial or the hospital in which the trial is carried out should be relieved of the responsibility to store their records and samples. The comment argued that ongoing data and specimen collection, as well as the maintenance of repositories represents a significant burden on both sponsors and transplant programs with resultant significant cost and hardship that could deter xenotransplant progress. The comment concluded that storage of records and samples should be the responsibility of a recognized government authority or institution or an FDA-designated organization. The comment recommended the creation of a central repository for both data and specimen collection run by, or under contract with, the Federal government.
(Response) The comment did not provide any data that would support a change to the burden estimate in the 60-day notice. Thus, FDA has not changed the burden estimate in table 1 of this document. We have considered the comment and have determined that the comment does not present information that would warrant substantive changes to the guideline at this time.
FDA is requesting an extension of OMB approval for the following reporting, recordkeeping and third-party disclosure recommendations in the PHS guideline:
Table 1—Reporting Recommendations
PHS guideline section | Description
3.2.7.2 | Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations.
Table 2—Recordkeeping Recommendations
PHS guideline section | Description
3.2.7 | Establish records linking each xenotransplantation product recipient with relevant records.
4.3 | Sponsor to maintain cross-referenced system that links all relevant records (recipient, product, source animal, animal procurement center, and nosocomial exposures).
3.4.2 | Document results of monitoring program used to detect introduction of infectious agents which may not be apparent clinically.
3.4.3.2 | Document full necropsy investigations including evaluation for infectious etiologies.
3.5.1 | Justify shortening a source animal's quarantine period of 3 weeks prior to xenotransplantation product procurement.
3.5.2 | Document absence of infectious agent in xenotransplantation product if its presence elsewhere in source animal does not preclude using it.
3.5.4 | Add summary of individual source animal record to permanent medical record of the xenotransplantation product recipient.
3.6.4 | Document complete necropsy results on source animals (50-year record retention).
3.7 | Link xenotransplantation product recipients to individual source animal records and archived biologic specimens.
4.2.3.2 | Record baseline sera of xenotransplantation health care workers and specific nosocomial exposure.
4.2.3.3 and 4.3.2 | Keep a log of health care workers' significant nosocomial exposure(s).
4.3.1 | Document each xenotransplant procedure.
5.2 | Document location and nature of archived specimens in health care records of xenotransplantation product recipient and source animal.
Table 3—Disclosure Recommendations
PHS guideline section | Description
3.2.7.2 | Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations.
3.4 | Standard operating procedures (SOPs) of source animal facility should be available to review bodies.
3.5.1 | Include increased infectious risk in informed consent if source animal quarantine period of 3 weeks is shortened.
3.5.4 | Sponsor to make linked records described in section 3.2.7 available for review.
3.5.5 | Source animal facility to notify clinical center when infectious agent is identified in source animal or herd after xenotransplantation product procurement.
FDA estimates the burden of this collection of information as follows:
Table 4—Estimated Annual Reporting Burden ^1
PHS guideline section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours
3.2.7.2 ^2 | 1 | 1 | 1 | 0.5 (30 minutes) | 0.5
^1 There are no capital costs or operating and maintenance costs associated with this collection of information.
^2 FDA is using one animal facility or sponsor for estimation purposes.
Table 5—Estimated Annual Recordkeeping Burden ^1
PHS guideline section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours
3.2.7 ^2 | 1 | 1 | 1 | 16 | 16
4.3 ^3 | 3 | 1 | 3 | 0.75 (45 minutes) | 2.25
3.4.2 ^4 | 3 | 10.67 | 32 | 0.25 (15 minutes) | 8
3.4.3.2 ^5 | 3 | 2.67 | 8 | 0.25 (15 minutes) | 2
3.5.1 ^6 | 3 | 0.33 | 1 | 0.5 (30 minutes) | 0.50
3.5.2 ^6 | 3 | 0.33 | 1 | 0.25 (15 minutes) | 0.25
3.5.4 | 3 | 1 | 3 | 0.17 (10 minutes) | 0.51
3.6.4 ^7 | 3 | 2.67 | 8 | 0.25 (15 minutes) | 2
3.7 ^7 | 4 | 2 | 8 | 0.08 (5 minutes) | 0.64
| 4.2.3.2 ^8 | 5 | 25 | 125 | 0.17 (10 minutes) | 21.25
4.2.3.2 ^6 | 5 | 0.2 | 1 | 0.17 (10 minutes) | 0.17
4.2.3.3 and 4.3.2 ^6 | 5 | 0.2 | 1 | 0.17 (10 minutes) | 0.17
4.3.1 | 3 | 1 | 3 | 0.25 (15 minutes) | 0.75
5.2 ^9 | 3 | 4 | 12 | 0.08 (5 minutes) | 0.96
Total | | | | | 55.45
^1 There are no capital costs or operating and maintenance costs associated with this collection of information.
^2 A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA is using one new sponsor for estimation purposes.
^3 FDA estimates there is minimal recordkeeping burden associated with maintaining the record system.
^4 Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are approximately 6 sentinel animals per herd × 1 herd per facility × 4 facilities = 24 sentinel animals. There are approximately 8 source animals per year (see footnote 7 of this table); 24 + 8 = 32 monitoring records to document.
^5 Necropsy for animal deaths of unknown cause estimated to be approximately 2 per herd per year × 1 herd per facility × 4 facilities = 8.
^6 Has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
^7 On average two source animals are used for preparing xenotransplantation product material for one recipient. The average number of source animals is 2 source animals per recipient × 4 recipients annually = 8 source animals per year. (See footnote 5 of table 6.)
^8 FDA estimates there are 5 clinical centers doing xenotransplantation procedures × approximately 25 health care workers involved per center = 125 health care workers.
^9 Eight source animal records + 4 recipient records = 12 total records.
Table 6—Estimated Annual Third-Party Disclosure Burden ^1
PHS guideline section | Number of respondents | Number of disclosures per respondent | Total annual disclosures | Average burden per disclosure | Total hours
3.2.7.2 ^2 | 1 | 1 | 1 | 0.5 (30 minutes) | 0.5
3.4 ^3 | 4 | 0.25 | 1 | 0.08 (5 minutes) | 0.08
3.5.1 ^4 | 4 | 0.25 | 1 | 0.25 (15 minutes) | 0.25
3.5.4 ^5 | 4 | 1 | 4 | 0.5 (30 minutes) | 2
3.5.5 ^4 | 4 | 0.25 | 1 | 0.25 (15 minutes) | 0.25
Total | | | | | 3.08
^1 There are no capital costs or operating and maintenance costs associated with this collection of information.
^2 FDA is using one animal facility or sponsor for estimation purposes.
^3 FDA's records indicate that an average of one IND is expected to be submitted per year.
^4 To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
^5 Based on an estimate of 12 patients treated over a 3 year period, the average number of xenotransplantation product recipients per year is estimated to be 4.
Because of the potential risk for cross-species transmission of pathogenic persistent virus, the guideline recommends that health records be retained for 50 years. Since these records are medical records, the retention of such records for up to 50 years is not information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of the limited number of clinical studies with small patient populations, the number of records is expected to be insignificant at this time. Information collections in this guideline not included in tables 1 through 6 can be found under existing regulations and approved under the OMB control numbers as follows: (1) “Current Good Manufacturing Practice for Finished Pharmaceuticals,” 21 CFR 211.1 through 211.208, approved under OMB control number 0910-0139; (2) “Investigational New Drug Application,” 21 CFR 312.1 through 312.160, approved under OMB control number 0910-0014; and (3) information included in a biologics license application, 21 CFR 601.2, approved under OMB control number 0910-0338. (Although it is possible that a xenotransplantation product may not be regulated as a biological product ( e.g., it may be regulated as a medical device), FDA believes, based on its knowledge and experience with xenotransplantation, that any xenotransplantation product subject to FDA regulation within the next 3 years will most likely be regulated as a biological product.). However, FDA recognized that some of the information collections go beyond approved collections; assessments for these burdens are included in tables 1 through 6.
In table 7, FDA identifies those collection of information activities that are already encompassed by existing regulations or are consistent with voluntary standards which reflect industry's usual and customary business practice.
Table 7—Collection of Information Required by Current Regulations and Standards
PHS guideline section | Description | 21 CFR section (unless otherwise stated)
2.2.1 | Document offsite collaborations | 312.52.
2.5 | Sponsor ensures counseling patient + family + contacts | 312.62(c).
| 3.1.1 and 3.1.6 | Document well-characterized health history and lineage of source animals. | 312.23(a)(7)(a) and 211.84.
3.1.8 | Registration with and import permit from the Centers for Disease Control and Prevention. | 42 CFR 71.53.
3.2.2 | Document collaboration with accredited microbiology labs | 312.52.
3.2.3 | Procedures to ensure the humane care of animals | 9 CFR parts 1, 2, and 3 and PHS Policy ^1 .
3.2.4 | Procedures consistent for accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) and consistent with the National Research Council's (NRC) Guide | AAALAC International Rules of Accreditation ^2 and NRC Guide ^3 .
3.2.5, 3.4, and 3.4.1 | Herd health maintenance and surveillance to be documented, available, and in accordance with documented procedures; record standard veterinary care | 211.100 and 211.122.
3.2.6 | Animal facility SOPs | PHS Policy ^1 .
3.3.3 | Validate assay methods | 211.160(a).
3.6.1 | Procurement and processing of xenografts using documented aseptic conditions | 211.100 and 211.122.
3.6.2 | Develop, implement, and enforce SOPs for procurement and screening processes | 211.84(d) and 211.122(c).
3.6.4 | Communicate to FDA animal necropsy findings pertinent to health of recipient | 312.32(c).
3.7.1 | PHS specimens to be linked to health records; provide to FDA justification for types of tissues, cells, and plasma, and quantities of plasma and leukocytes collected | 312.23(a)(6).
4.1.1 | Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program life-long (justify >2 yrs.); investigator case histories (2 yrs. after investigation is discontinued) | 312.23(a)(6)(iii)(f) and (g), and 312.62(b) and (c).
4.1.2 | Sponsor to justify amount and type of reserve samples | 211.122.
4.1.2.2 | System for prompt retrieval of PHS specimens and linkage to medical records (recipient and source animal) | 312.57(a).
4.1.2.3 | Notify FDA of a clinical episode potentially representing a xenogeneic infection | 312.32.
4.2.2.1 | Document collaborations (transfer of obligation) | 312.52.
4.2.3.1 | Develop educational materials (sponsor provides investigators with information needed to conduct investigation properly) | 312.50.
4.3 | Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories | 312.57 and 312.62(b).
^1 The “Public Health Service Policy on Humane Care and Use of Laboratory Animals” ( https://olaw.nih.gov/policies-laws/phs-policy.htm ).
^2 AAALAC International Rules of Accreditation ( https://www.aaalac.org/accreditation-program/rules-of-accreditation/ ).
^3 The NRC's “Guide for the Care and Use of Laboratory Animals.”
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate other than to adjust total burden hours by one hour, from 60 to 59 total burden hours, to address an inadvertent error in disclosure burden in the previous submissions to OMB.
Dated: April 19, 2022.
Lauren K. Roth,

Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0413]
Baxter Healthcare Corporation, et al.; Withdrawal of Approval of 14 Abbreviated New Drug Applications

AGENCY:
Food and Drug Administration, Health and Human Service (HHS).

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 14 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES:
Approval is withdrawn as of May 25, 2022.

FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Application No. | Drug | Applicant
ANDA 075695 | Butorphanol Tartrate Injection, 1 milligram (mg)/milliliter (mL), and 2 mg/mL | Baxter Healthcare Corporation, One Baxter Pkwy., Deerfield, IL 60015.
ANDA 075697 | Butorphanol Tartrate Injection, 2 mg/mL | Do.
ANDA 077290 | Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg | Nesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock Rd., Bridgeton, MO 63044.
ANDA 078564 | Granisetron HCl Injection, Equivalent to (EQ) 1 mg base/mL (EQ 1 mg base/mL) | Morton Grove Pharmaceuticals Inc., 6451 Main St., Morton Grove, IL 60053.
ANDA 078565 | Granisetron HCl Injection, EQ 4 mg base/4 mL (EQ 1 mg base/mL) | Do.
ANDA 078566 | Granisetron HCl Injection, EQ 0.1 mg base/mL (EQ 0.1 mg base/mL) | Do.
ANDA 088342 | Fluoxymesterone Tablets, 10 mg | Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369.
ANDA 202032 | Lamivudine Tablets, 150 mg and 300 mg | Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520.
ANDA 205322 | Efavirenz Tablets, 600 mg | Do.
ANDA 205690 | Choline C-11 Injection, 4-100 millicurie/mL | University of Texas MD Anderson Cancer Center, 1881 East Rd., Unit 1903, Houston, TX 77054.
ANDA 207653 | Rosuvastatin Calcium Tablets, EQ 5 mg base, EQ 10 mg base, EQ 20 mg base, EQ 40 mg base | SciRegs International, Inc., 6333 Summercrest Dr., Columbia, MD 21045.
ANDA 208199 | Azelastine HCl Metered Spray, 0.2055 mg/spray | Amneal Pharmaceuticals LLC, 50 Horseblock Rd., Brookhaven, NY 11719.
ANDA 210032 | Azelastine HCl Metered Spray, 0.2055 mg/spray | Akorn Operating Company LLC, 1925 West Field Ct., Suite 300, Lake Forest, IL 60045.
ANDA 211461 | Bosentan Tablets, 62.5 mg and 125 mg | Syneos Health Global Headquarters, 1030 Sync St., Third Floor, Morrisville, NC 27560.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of May 25, 2022. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on May 25, 2022 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Dated: April 19, 2022.
Lauren K. Roth,

Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0801]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements

AGENCY:
Food and Drug Administration, Health and Human Services (HHS).

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:
Submit written comments (including recommendations) on the collection of information by May 25, 2022.

ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0482. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Export Notification and Recordkeeping Requirements

OMB Control Number 0910-0482—Extension
Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381 and 382) charge the Secretary of Health and Human Services, through FDA, with the responsibility of helping to ensure that exports of unapproved new drugs, biologics, devices, animal drugs, food, cosmetics, and tobacco products that are not to be sold in the United States meet the requirements of the country to which the product is to be exported. The respondents to this information collection are exporters who have notified FDA of their intent to export unapproved products that may not be sold or offered for sale in domestic commerce in the United States as allowed under section 801(e) of the FD&C Act. In general, the notification identifies the product being exported ( e.g., name, description, and in some cases, country of destination) and specifies where the notifications were sent. These notifications are sent only for an initial export. Subsequent exports of the same product to the same destination or to certain countries identified in section 802(b) of the FD&C Act would not result in a notification to FDA.
Respondents to the information collection are exporters of products that may not be sold in the United States and are regulated by FDA's Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine (CVM); Center for Food Safety and Applied Nutrition (CFSAN); and Center for Tobacco Products. Respondents to this collection of information maintain records demonstrating their compliance with the requirements in 21 CFR 1.101.
In the Federal Register of January 25, 2022 (87 FR 3811), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden ^1
21 CFR section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours
1.101(d) (CBER) | 4 | 35 | 140 | 15 | 2,100
1.101(d) (CDER) | 3 | 57 | 171 | 15 | 2,565
1.101(d) (CDRH) | 22 | 4 | 88 | 15 | 1,320
Total | | | | | 5,985
^1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2—Estimated Annual Recordkeeping Burden ^1
21 CFR section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours
1.101(b), (c), and (e) (CBER, CDER, CDRH, CFSAN, and CVM) | 181 | 4.12 | 746 | 22 | 16,412
1.101(b) Office of International Programs only | 1 | 65 | 65 | 22 | 1,430
1.101(b) (currently regulated Tobacco Products) | 322 | 3 | 966 | 22 | 21,252
Total | | | | | 39,094
^1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency data, we decreased our estimate by 24,251 burden hours. This decrease reflects an overall downward trend in the number of export certification requests across programs and commodities. The estimate for tobacco products remains steady.
Dated: April 19, 2022.
Lauren K. Roth,

Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
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.
Name of Committee: Center for Scientific Review Special Emphasis Panel; Special Topics: Vision Imaging, Bioengineering and Low Vision Technology Development.
Date: May 25-26, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Susan Gillmor, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 240-762-3076, susan.gillmor@nih.gov.
Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Gene and Drug Delivery Systems Study Section.
Date: June 13-14, 2022.
Time: 9:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jain Krotz, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (240) 672-8670 jain.krotz@nih.gov.
Name of Committee: Vascular and Hematology Integrated Review Group; Hemostasis, Thrombosis, Blood Cells and Transfusion Study Section.
Date: June 14-15, 2022.
Time: 10:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Katherine M Malinda, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD 20892, (301) 435-0912, malindakm@csr.nih.gov.
Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Instrumentation and Systems Development Study Section.
Date: June 16-17, 2022.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Kee Forbes, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5148, MSC 7806, Bethesda, MD 20892, 301-272-4865, pyonkh2@csr.nih.gov.
Name of Committee: Oncology 2—Translational Clinical Integrated Review Group; Cancer Biomarkers Study Section.
Date: June 16-17, 2022.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Lawrence Ka-Yun Ng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6152, MSC 7804, Bethesda, MD 20892, 301-357-9318 ngkl@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
Dated: April 19, 2022.
David W Freeman,

Program Analyst, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request International Research Fellowship Award Program of the National Institute on Drug Abuse (NIDA)

AGENCY:
National Institutes of Health, HHS.

ACTION:
Notice.

SUMMARY:
In compliance with the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

DATES:
Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Lindsey Friend, Research Training Program Officer, NIDA International Program, National Institute on Drug Abuse, National Institutes of Health, 3WFN MSC 6024, 301 North Stonestreet Avenue, Bethesda, Maryland 20892, or call non-toll-free number (301) 402-1428 or email your request, including your address to: lindsey.friend@nih.gov.

SUPPLEMENTARY INFORMATION:
This proposed information collection was previously published in the Federal Register on February 14, 2022, page 8267 (87 FR 8267) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
The National Institute on Drug Abuse (NIDA), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Proposed Collection: The International Research Fellowship Award Program of the National Institute on Drug Abuse (NIDA), 0925-0733, expiration date 07/31/2022, EXTENSION, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH).
Need And Use of Information Collection: These programs offer grants and traineeships necessary for growing the biomedical researcher workforce, and the diversity in this workforce. The application forms collect information of applicants for selecting those that would benefit most effectively from the programs. NIDA is requesting approval from OMB for application forms to be used by these programs that will recruit pre-college through post-doctoral underrepresented individuals and individuals of special populations into the research programs of the Institute for research training and research development, for forging mentor/mentee relationships and networking between newly funded underrepresented researchers and experienced investigators funded by NIDA; and for a fellowship program to train new researchers, and support experienced researchers of other nations, in research to advance the biomedical and behavioral science of drug abuse and addiction while fostering multinational research in this disease area. The application forms will be web-based.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total annualized burden hours are 33.
Estimated Annualized Burden Hours
Type of respondent | Number of respondents | Number of responses per respondent | Average time per response (in hours) | Total annual burden hour
Applicant Scientists | 25 | 1 | 1 | 25
Scientists | 25 | 1 | 20/60 | 8
Total | | 50 | | 33
Dated:April 20, 2022
Lanette A. Palmquist,

Project Clearance Liaison, National Institute on Drug Abuse, National Institutes of Health.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Center for Advancing Translational Sciences Advisory Council.
This meeting is being held virtually only; there is no in-person option. The open sessions will be videocast and may be accessed by the public from the NIH Videocasting and Podcasting website ( http://videocast.nih.gov ). Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be 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.
Name of Committee: National Center for Advancing Translational Sciences Advisory Council.
Date: May 19-20, 2022.
Closed: May 19, 2022, 11:00 a.m. to 12:30 p.m.
Agenda: To review, evaluate, and discuss internal operations. To review and evaluate grant applications.
Place: National Center for Advancing Translational Sciences, National Institutes of Health, One Democracy Plaza, Room 987/989, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Open: May 19, 2022, 1:00 p.m. to 5:00 p.m.
Agenda: Report from the Institute Director, Invited Speaker Presentation, and DPI Program Update.
Place: National Center for Advancing Translational Sciences, National Institutes of Health, One Democracy Plaza, Room 987/989, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Open: May 20, 2022, 1:00 p.m. to 5:00 p.m.
Agenda: OSI Program Update; view and discuss Clearance of Concepts.
Place: National Center for Advancing Translational Sciences, National Institutes of Health, One Democracy Plaza, Room 987/989, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive Secretary, National Center for Advancing Translational Sciences, National Institutes of Health One Democracy Plaza, Room 1072, 6701 Democracy Boulevard, Bethesda, MD 20892, 301-435-0809, anna.ramseyewing@nih.gov .
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice no later than 15 days after the meeting at NCATSCouncilInput@mail.nih.gov. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
(Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)
Dated: April 20, 2022.
Melanie J. Pantoja,

Program Analyst, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Center for Complementary and Integrative Health Special Emphasis Panel; HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management.
Date: May 19-20, 2022.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Center for Complementary and Integrative Democracy II, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shiyong Huang, Ph.D., Scientific Review Officer, Office of Scientific Review, Division of Extramural Activities, NCCIH/NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20817, shiyong.huang@nih.gov .
(Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS)
Dated: April 20, 2022.
Victoria E. Townsend,

Program Analyst, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Aging Special Emphasis Panel; 3D Aging and Alzheimer Brain Program.
Date: May 31, 2022.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Birgit Neuhuber, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, Ninds, NIH NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892, 301-496-3562, neuhuber@ninds.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
Dated: April 20, 2022.
Miguelina Perez,

Program Analyst, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Aging Special Emphasis Panel; longitudinal and peripheral AD biomarkers in a diverse cohort of subjects.
Date: June 1, 2022.
Time: 9:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate cooperative agreement applications.
Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Maurizio Grimaldi, MD, Ph.D., Scientific Review Officer, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Room 2C218, Bethesda, MD 20892, 301-496-9374, grimaldim2@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
Dated: April 20, 2022.
Miguelina Perez,

Program Analyst, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
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.
Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: The Molecular and Cellular Causal Aspects of Alzheimer's Disease.
Date: June 2, 2022.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Linda MacArthur, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4187, Bethesda, MD 20892, 301-537-9986, macarthurlh@csr.nih.gov.
Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Bioengineering, Technology and Surgical Sciences Study Section.
Date: June 6-7, 2022.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Khalid Masood, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5120, MSC 7854, Bethesda, MD 20892, 301-435-2392, masoodk@csr.nih.gov.
Name of Committee: Cell Biology Integrated Review Group; Development—2 Study Section.
Date: June 6-7, 2022.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rass M Shayiq, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, (301) 435-2359, shayiqr@csr.nih.gov.
Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Macromolecular Structure and Function A Study Section.
Date: June 6-7, 2022.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: David R Jollie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4166, MSC 7806, Bethesda, MD 20892, (301)-408-9072, jollieda@csr.nih.gov.
Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Modeling and Analysis of Biological Systems Study Section.
Date: June 7-8, 2022.
Time: 10:00 a.m. to 10:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Noffisat Oki, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (240) 627-3648, noffisat.oki@nih.gov.
Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Molecular and Cellular Neuropharmacology Study Section.
Date: June 9-10, 2022.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Vanessa S Boyce, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Rm. 4185, MSC 7850, Bethesda, MD 20892, (301) 402-3726, boycevs@csr.nih.gov.
Name of Committee: Infectious Diseases and Immunology A Integrated Review Group; Pathogenic Eukaryotes Study Section.
Date: June 9-10, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Tera Bounds, DVM, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD 20892, 301 435-2306, boundst@csr.nih.gov.
Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Imaging Probes and Contrast Agents Study Section.
Date: June 9-10, 2022.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Donald Scott Wright, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7854, Bethesda, MD 20892, (301) 435-8363, wrightds@csr.nih.gov.
Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Social Sciences and Population Studies A Study Section
Date: June 9-10, 2022.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Suzanne Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, (301) 435-1712, ryansj@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
Dated: April 20, 2022.
Miguelina Perez,

Program Analyst, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HOMELAND SECURITY
U.S. Immigration and Customs Enforcement
[OMB Control Number 1653-0041]
Agency Information Revision of a Currently Approved Collection: Designation of Attorney in Fact/Revocation of Designation of Attorney in Fact

AGENCY:
U.S. Immigration and Customs Enforcement, Department of Homeland Security.

ACTION:
30-Day notice.

SUMMARY:
In accordance with the Paperwork Reductions Act (PRA) of 1995 the Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE) will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance. This information collection was previously published in the Federal Register on February 15, 2022, allowing for a 60-day comment period. ICE received no comments in connection with the 60-day notice. The purpose of this notice is to allow an additional 30 days for public comments.

DATES:
Comments are encouraged and will be accepted until May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of the publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
If you have questions related to this collection, call, or email John Monette, Revenue Management Branch, (802) 288-7697, john.p.monette@ice.dhs.gov (This is not a toll-free number. Comments are not accepted via telephone message).

SUPPLEMENTARY INFORMATION:

Comments
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Overview of This Information Collection
(1) Type of Information Collection: Revision of a Currently Approved Collection.
(2) Title of the Form/Collection: Designation of Attorney in Fact/Revocation of Attorney in Fact.
(3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form I-312/I-312A; U.S. Immigration and Customs Enforcement.
(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: State, Local, or Tribal Government. Section § 103.6, the Immigration and Nationality Act (INA), provides for the posting of surety or cash bonds. All bonds posted in immigration cases shall be executed on Form I-352, Immigration Bond, and secured with some form of collateral by an Obligor. In the case of a cash bond, the Obligor will deposit with U.S. Immigration and Customs Enforcement (ICE) the face value of the bond. The Obligor can designate a third party as an Attorney in Fact to accept on their behalf the return of the collateral security deposited to secure the surety bond upon cancellation of the bond or performance of the Obligor. The Form I- 312, Designation of Attorney in Fact, is the instrument used by the Obligor to officially designate their Attorney in Fact. Upon receipt of a properly executed Form I-312, ICE Financial Operations will remit to the Attorney in Fact the principal and interest on the security deposit in the event of a bond cancellation, or the interest on the security deposit in the event of a bond breach. Immigration bonds might remain in place for years, and Obligors might choose to appoint a new Attorney in Fact as circumstances change. To ensure that ICE Financial Operations properly executes its fiduciary duties to the Obligor under the Form I-352 bond contract, and exercises due diligence in ensuring that remittances are made to the proper person, ICE uses Form I- 312A as the document by which the Obligor could expressly indicate that a previously valid Form I-312 Attorney in Fact designation had been revoked. The requested revisions are specific to the instructions concerning obligor requirements and the attorney's authority to perform acts necessary to receive proceeds of the bond. There are revisions to the I-312 instructions. The revisions relate to the obligor requirements and to the attorney's authority to perform acts necessary to received bond proceeds.
(5) An estimate of the total number of respondents and the time to respond: ICE estimates a total of 193 responses at 1 hour (60 minutes) per response.
(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden is 193 hours.
(7) An estimate of the total public burden (in cost) associated with the collections: $6,370.
Dated: April 19, 2022.
Scott Elmore,

ICE PRA Clearance Officer.
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS-R4-ES-2022-N017; FXES11140400000-223-FF04E00000]
Endangered Species; Recovery Permit Applications

AGENCY:
Fish and Wildlife Service, Interior.

ACTION:
Notice of receipt of permit applications; request for comments.

SUMMARY:
We, the U.S. Fish and Wildlife Service, have received applications for permits, permit renewals, and/or permit amendments to conduct activities intended to enhance the propagation or survival of endangered species under the Endangered Species Act of 1973, as amended. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.

DATES:
We must receive written data or comments on the applications by May 25, 2022.

ADDRESSES:
Reviewing Documents: Documents and other information submitted with the applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act. Submit a request for a copy of such documents to Karen Marlowe (see FOR FURTHER INFORMATION CONTACT ).
Submitting Comments: If you wish to comment, you may submit comments by one of the following methods:
• U.S. Mail: U.S. Fish and Wildlife Service Regional Office, Ecological Services, 1875 Century Boulevard, Atlanta, GA 30345 (Attn: Karen Marlowe, Permit Coordinator).
• Email: permitsR4ES@fws.gov. Please include your name and return address in your email message. If you do not receive a confirmation from the U.S. Fish and Wildlife Service that we have received your email message, contact us directly at the telephone number listed in FOR FURTHER INFORMATION CONTACT .

FOR FURTHER INFORMATION CONTACT:
Karen Marlowe, Permit Coordinator, 404-679-7097 (telephone), karen_marlowe@fws.gov (email), or 404-679-7081 (fax). Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.

SUPPLEMENTARY INFORMATION:
We invite review and comment from the public and local, State, Tribal, and Federal agencies on applications we have received for permits to conduct certain activities with endangered and threatened species under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), and our regulations in the Code of Federal Regulations (CFR) at 50 CFR part 17. With some exceptions, the ESA prohibits take of listed species unless a Federal permit is issued that authorizes such take. The ESA's definition of “take” includes hunting, shooting, harming, wounding, or killing, and also such activities as pursuing, harassing, trapping, capturing, or collecting.
A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to take endangered or threatened species while engaging in activities that are conducted for scientific purposes that promote recovery of species or for enhancement of propagation or survival of species. These activities often include the capture and collection of species, which would result in prohibited take if a permit were not issued. Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.

Permit Applications Available for Review and Comment
Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing these permits. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to these applications. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Permit application No. | Applicant | Species | Location | Activity | Type of take | Permit action
TE 054973-6 | Nicholas Haddad, Michigan State University, East Lansing, MI | Mitchell's satyr butterfly ( Neonympha mitchellii mitchellii ) and Saint Francis' satyr butterfly ( Neonympha mitchellii francisci ) | Alabama, Michigan, Mississippi, and North Carolina | Population monitoring, scientific research, captive propagation, and release into suitable habitat | Capture, mark, transport, release, recapture, and salvage | Renewal/Amendment.
TE 822525-7 | Joseph McGlincy, Wiregrass Ecological Services, Bainbridge, GA | Red-cockaded woodpecker ( Picoides borealis ) | Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, and Tennessee | Population management and monitoring | Capture, band, monitor nest cavities, construct and monitor artificial nest cavities and restrictors, recapture, and translocate | Renewal.
PER 0020528 | Kyle Edmonds, USDA Forest Service, Daniel Boone National Forest, London, KY | Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), northern long-eared bat ( Myotis septentrionalis ), Ozark big-eared bat. ( Corynorhinus ( =Plecotus ) townsendii ingens ), and Virginia big-eared bat ( Corynorhinus ( =Plecotus townsendii virginianus ) | Kentucky | Presence/probable absence surveys, studies to document habitat use, and population monitoring | Enter hibernacula or maternity roost caves, capture with mist nets or harp traps, handle, identify, band, and radio tag | New.
TE 206777-4 | Ralph Costa, Ralph Costa's Woodpecker Outfit, LLC, Mountain Rest, SC | Red-cockaded woodpecker ( Picoides borealis ) | Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, North Carolina, Oklahoma, South Carolina, Texas, and Virginia | Population management and monitoring | Capture, band, monitor nest cavities, construct and monitor artificial nest cavities and restrictors, recapture, collect buccal swabs, and translocate | Renewal/Amendment.
| TE 130300-6 | Paul Johnson, Alabama Aquatic Biodiversity Center, Marion, AL | Fish: Alabama sturgeon ( Scaphirhynchus suttkusi ), boulder darter ( Etheostoma wapiti ), Cahaba shiner ( Notropis cahabae ), chucky madtom ( Noturus crypticus ), palezone shiner ( Notropis albizonatus ), rush darter ( Etheostoma phytophilum ), vermilion darter ( Etheostoma chermocki ), watercress darter ( Etheostoma nuchale ); Mussels: Alabama lampmussel ( Lampsilis virescens ), Alabama pearlshell ( Margaritifera marrianae ), Appalachian monkeyface (pearlymussel) ( Quadrula sparsa ), birdwing pearlymussel ( Lemiox rimosus ), black clubshell ( Pleurobema curtum ), Canoe Creek clubshell ( Pleurobema athearni ), Choctaw bean ( Villosa choctawensis ), clubshell ( Pleurobema clava ), Coosa moccasinshell ( Medionidus parvulus ), cracking pearlymussel ( Hemistena lata ), Cumberland bean (pearlymussel) ( Villosa trabalis ), Cumberland elktoe ( Alasmidonta atropurpurea ), Cumberland monkeyface (pearlymussel) ( Quadrula intermedia ), Cumberlandian combshell ( Epioblasma brevidens ), dark pigtoe ( Pleurobema furvum ), dromedary pearlymussel ( Dromus dromas ), fanshell ( Cyprogenia stegaria ), fat threeridge (mussel) ( Amblema neislerii ), finerayed pigtoe ( Fusconaia cuneolus ), flat pigtoe ( Pleurobema marshalli ), Georgia pigtoe ( Pleurobema hanleyianum ), Gulf moccasinshell ( Medionidus penicillatus ), heavy pigtoe ( Pleurobema taitianum ), littlewing pearlymussel ( Pegias fabula ), Ochlockonee moccasinshell ( Medionidus simpsonianus ), orangefoot pimpleback (pearlymussel) ( Plethobasus cooperianus ), Ouachita rock pocketbook ( Arkansia wheeleri ), oval pigtoe ( Pleurobema pyriforme ), ovate clubshell ( Pleurobema perovatum ), oyster mussel ( Epioblasma capsaeformis ), pale lilliput (pearlymussel) ( Toxolasma cylindrellus ), pink mucket (pearlymussel) ( Lampsilis abrupta ), purple bean ( Villosa perpurpurea ), purple cat's paw (=purple cat's paw pearlymussel) ( Epioblasma obliquata obliquata ), ring pink (mussel) ( Obovaria retusa ), rough pigtoe ( Pleurobema plenum ), round ebonyshell ( Fusconaia rotulata ), scaleshell mussel ( Leptodea leptodon ), sheepnose mussel ( Plethobasus cyphyus ), shiny pigtoe ( Fusconaia cor ), shinyrayed pocketbook ( Lampsilis subangulata ), slabside pearlymussel ( Pleuronaia dolabelloides ), snuffbox mussel ( Epioblasma triquetra ), southern acornshell ( Epioblasma othcaloogensis ), southern clubshell ( Pleurobema decisum ), southern kidneyshell ( Ptychobranchus jonesi ), southern pigtoe ( Pleurobema georgianum ), southern sandshell ( Hamiota australis ), spectaclecase (mussel) ( Cumberlandia monodonta ), stirrupshell ( Quadrula stapes ), tan riffleshell ( Epioblasma florentina walkeri ( =E. walkeri )), triangular kidneyshell ( Ptychobranchus greenii ), tubercled blossom (pearlymussel) ( Epioblasma torulosa torulosa ), upland combshell ( Epioblasma metastriata ), white wartyback (pearlymussel) ( Plethobasus cicatricosus ), winged mapleleaf ( Quadrula fragosa ); Snails: Anthony's riversnail ( Athearnia anthonyi ), armored snail ( Pyrgulopsis ( =Marstonia ) pachyta ), cylindrical lioplax (snail) ( Lioplax cyclostomaformis ), flat pebblesnail ( Lepyrium showalteri ), interrupted (=Georgia) rocksnail ( Leptoxis foremani ), plicate rocksnail ( Leptoxis plicata ), rough hornsnail ( Pleurocera foremani ), royal marstonia (snail) ( Pyrgulopsis ogmorhaphe ), and slender campeloma ( Campeloma decampi ) | Alabama, Georgia, Mississippi, and Tennessee | Scientific research, captive propagation, relocation, and reintroduction | Collect, transport, hold in captivity for longer than 45 days, release, translocate, and euthanize | Renewal/Amendment.
TE 084054-4 | James Orr, AECOM, Franklin, TN | Anthony's riversnail ( Athearnia anthonyi ) and Nashville crayfish ( Orconectes shoupi ) | Alabama and Tennessee | Presence/probable absence surveys, population monitoring, and distribution studies | Capture, identify, measure, and release | Renewal.
TE 38642A-3 | Kenneth Meyer, Avian Research and Conservation Institute, Gainesville, FL | Audubon's crested caracara ( Polyborus plancus audubonii ) and Everglade snail kite ( Rostrhamus sociabilis plumbeus ) | Florida | Examine core foraging areas, roosts, nest sites, timing of destinations of long-distance movements throughout the year, habitat loss and degradation effects, methyl mercury levels, and genetic sex determination | Capture, weigh, measure, band, collect body coverts, blood, and egg albumen, attach solar-powered transmitters, and release | Amendment.
TE 62026D-2 | Catherine Haase, Austin Peay State University, Clarksville, TN | Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), and northern long-eared bat ( Myotis septentrionalis ) | Kentucky and Tennessee | Assess bat community structure and habitat use | Capture with mist nets, handle, identify, band, and radio tag | Amendment.
| TE 084047-5 | St. John's River Water Management District, Mount Dora, FL | Florida scrub-jay ( Aphelocoma coerulescens ) and red-cockaded woodpecker ( Picoides borealis ) | Florida | Population management and monitoring | Florida scrub-jay: Capture, band, and release; red-cockaded woodpecker: capture, band, monitor nest cavities, construct and monitor artificial nest cavities and restrictors, recapture, and translocate | Renewal/Amendment.
TE 810274-14 | ICF Jones and Stokes, Inc., Fisherville, KY | Bats: Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), northern long-eared bat ( Myotis septentrionalis ), Ozark big-eared bat ( Corynorhinus ( =Plecotus ) townsendii ingens ), and Virginia big-eared bat ( Corynorhinus ( =Plecotus) townsendii virginianus ); Fish: Blackside dace ( Phoxinus cumberlandensis ), Cumberland darter ( Etheostoma susanae ), diamond darter ( Crystallaria cincotta ), duskytail darter ( Etheostoma percnurum ), Kentucky arrow darter ( Etheostoma spilotum ), palezone shiner ( Notropis albizonatus ), relict darter ( Etheostoma chienense ), and snail darter ( Percina tanasi ); Mussels: Alabama lampmussel ( Lampsilis virescens ), Appalachian elktoe ( Alasmidonta raveneliana ), Appalachian monkeyface (pearlymussel) ( Quadrula sparsa ), birdwing pearlymussel ( Lemiox rimosus ), black clubshell ( Pleurobema curtum ), clubshell ( Pleurobema clava ), cracking pearlymussel ( Hemistena lata ), Cumberland bean (pearlymussel) ( Villosa trabalis ), Cumberland elktoe ( Alasmidonta atropurpurea ), Cumberland monkeyface (pearlymussel) ( Quadrula intermedia ), Cumberland pigtoe ( Pleurobema gibberum ), Cumberlandian combshell ( Epioblasma brevidens ), dark pigtoe ( Pleurobema furvum ), dromedary pearlymussel ( Dromus dromas ), fanshell ( Cyprogenia stegaria ), fat pocketbook ( Potamilus capax ), finelined pocketbook ( Lampsilis altilis ), finerayed pigtoe ( Fusconaia cuneolus ), flat pigtoe ( Pleurobema marshalli ), fluted kidneyshell ( Ptychobranchus subtentus ), green blossom (pearlymussel) ( Epioblasma torulosa gubernaculum ), heavy pigtoe ( Pleurobema taitianum ), Higgins eye (pearlymussel) ( Lampsilis higginsii ), inflated heelsplitter ( Potamilus inflatus ), littlewing pearlymussel ( Pegias fabula ), northern riffleshell ( Epioblasma torulosa rangiana ), orangefoot pimpleback (pearlymussel) ( Plethobasus cooperianus ), orangenacre mucket ( Lampsilis perovalis ), oyster mussel ( Epioblasma capsaeformis ), pale lilliput (pearlymussel) ( Toxolasma cylindrellus ), pink mucket (pearlymussel) ( Lampsilis abrupta ), purple bean ( Villosa perpurpurea ), purple cat's paw (=purple cat's paw pearlymussel) ( Epioblasma obliquata obliquata ), rabbitsfoot ( Quadrula cylindrica cylindrica ), rayed bean ( Villosa fabalis ), ring pink (mussel) ( Obovaria retusa ), rough pigtoe ( Pleurobema plenum ), rough rabbitsfoot ( Quadrula cylindrica strigillata ), scaleshell mussel ( Leptodea leptodon ), sheepnose mussel ( Plethobasus cyphyus ), shiny pigtoe ( Fusconaia cor ), slabside pearlymussel ( Pleuronaia dolabelloides ), snuffbox mussel ( Epioblasma triquetra ), southern combshell ( Epioblasma penita ), spectaclecase (mussel) (Cumberlandia monodonta), stirrupshell ( Quadrula stapes ), tan riffleshell ( Epioblasma florentina walkeri ( =E. walkeri )), tubercled blossom (pearlymussel) ( Epioblasma torulosa torulosa ), turgid blossom (pearlymussel) ( Epioblasma turgidula ), white catspaw (pearlymussel) ( Epioblasma obliquata perobliqua ), white wartyback (pearlymussel) ( Plethobasus cicatricosus ), winged mapleleaf ( Quadrula fragosa ), and yellow blossom (pearlymussel) ( Epioblasma florentina florentina ); and Crustaceans: Big Sandy crayfish ( Cambarus callainus ) | Bats: Alabama, Arkansas, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming; Fish: Georgia, Kentucky, North Carolina, Tennessee, and Virginia; Mussels: Arkansas, Kentucky, Illinois, Indiana, Iowa, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Ohio, Pennsylvania, Tennessee (except Upper Coosa River Basin and Tributaries), Virginia, West Virginia, and Wisconsin; Crustaceans: Kentucky, Virginia, and West Virginia | Bats: Presence/probable absence surveys, studies to document habitat use, and population monitoring; Fish, Mussels, and Crustaceans: Presence/probable absence surveys | Bats: Enter hibernacula or maternity roost caves, capture with mist nets or harp traps, handle, identify, band, and radio tag; Fish: Capture, identify, and release; Mussels: Capture, identify, mark, release, collect relict shells; Crustaceans: Capture via seining, handle, identify, and release | Renewal.
TE 43264B-1 | Nicole Riddle, Columbia, SC | Carolina heelsplitter ( Lasmigona decorata ) | South Carolina | Presence/probable absence surveys | Remove from substrate, handle, identify, release, and salvage shells | Renewal/Amendment.
| TE 089075-5 | Donna Oddy, Rockledge, FL | Alabama beach mouse ( Peromyscus polionotus ammobates ), Anastasia Island beach mouse ( Peromyscus polionotus phasma ), Choctawhatchee beach mouse ( Peromyscus polionotus allophrys ), Perdido Key beach mouse ( Peromyscus polionotus trissyllepsis ), St. Andrew beach mouse ( Peromyscus polionotus peninsularis ), and southeastern beach mouse ( Peromyscus polionotus niveiventris ) | Alabama and Florida | Long-term monitoring, presence/probable absence surveys, mark/recapture studies, and genetic analyses | Capture, tag, ear snip, collect hair, radio collar, release, and translocate | Renewal/Amendment.
TE 009638-12 | Appalachian Technical Services, Inc., Wise, VA | Bats: Indiana bat ( Myotis sodalis ), gray bat ( Myotis grisescens ), northern long-eared bat ( Myotis septentrionalis ), Virginia big-eared bat ( Corynorhinus ( =Plecotus ) townsendii virginianus ); Fish: Blackside dace ( Phoxinus cumberlandensis ), Cumberland darter ( Etheostoma susanae ), duskytail darter ( Etheostoma percnurum), Kentucky arrow darter ( Etheostoma spilotum ); Mussels: Appalachian monkeyface (pearlymussel) ( Quadrula sparsa ), birdwing pearlymussel ( Lemiox rimosus ), clubshell ( Pleurobema clava ), cracking pearlymussel ( Hemistena lata ), Cumberland bean (pearlymussel) ( Villosa trabilis ), Cumberland elktoe ( Alasmidonta atropurpurea ), Cumberland monkeyface (pearlymussel) ( Quadrula intermedia ), Cumberlandian combshell ( Epioblasma brevidens ), dromedary pearlymussel ( Dromus dromas ), fanshell ( Cyprogenia stegaria ), fat pocketbook ( Potamilus capax ), finerayed pigtoe ( Fusconaia cuneolus ), fluted kidneyshell ( Ptychobranchus subtentus ), littlewing pearlymussel ( Pegias fabula), northern riffleshell ( Epioblasma torulosa rangiana ), orangefoot pimpleback (pearlymussel) ( Plethobasus cooperianus ), oyster mussel ( Epioblasma capsaeformis ), pink mucket (pearlymussel) ( Lampsilis abrupta ), purple bean ( Villosa perpurpurea ), purple cat's paw (=purple cat's paw pearlymussel) ( Epioblasma obliquata obliquata ), rabbitsfoot ( Quadrula cylindrica cylindrica ), ring pink (mussel) ( Obovaria retusa ), rough pigtoe ( Pleurobema plenum ), rough rabbitsfoot ( Quadrula cylindrica strigillata ), sheepnose mussel ( Plethobasus cyphyus ), shiny pigtoe ( Fusconia cor ), slabside pearlymussel ( Pleuronaia dolabelloides ), snuffbox mussel ( Epioblasma triquetra ); Crustaceans: Guyandotte River crayfish ( Cambarus veteranus ) and Big Sandy crayfish ( Cambarus callainus ) | Alabama, Georgia, Indiana, Kentucky, Mississippi, North Carolina, Ohio, Pennsylvania, Tennessee, Virginia, and West Virginia | Presence/probable absence surveys and scientific research aimed at recovery of the species | Bats: Enter hibernacula, capture with mist nets or harp traps, handle, band, radio tag, and release; Fish: Capture via seining, netting, trapping, or electroshocking, handle, identify, and release; Mussels: Remove from substrate, handle, identify, data collection, tagging, and release; Crustaceans: Capture via seining, handle, identify, and release | Renewal.
TE 81492B-1 | Dylan Brooks, Sylva, NC | Indiana bat ( Myotis sodalis ) and northern long-eared bat ( Myotis septentrionalis ) | Alabama, Arkansas, Connecticut, Delaware, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, West Virginia, and Wisconsin | Presence/probable absence surveys, habitat use and assessment research, population monitoring, and studies to evaluate potential impacts of White-nose Syndrome or other potential threats | Capture with mist nets, handle, identify, band, and radio tag | Renewal/Amendment.
TE 03305C-1 | U.S. Army Corps of Engineers, Memphis District, Memphis, TN | Curtis pearlymussel ( Epioblasma florentina curtisii ), fanshell ( Cyprogenia stegaria ), fat pocketbook ( Potamilus capax ), fat threeridge (mussel) ( Amblema neislerii ), Higgins eye (pearlymussel) ( Lampsilis higginsii ), inflated heelsplitter ( Potamilus inflatus ), orangefoot pimpleback (pearlymussel) ( Plethobasus cooperianus ), Ouachita rock pocketbook ( Arkansia wheeleri ), pink mucket (pearlymussel) ( Lampsilis abrupta ), rabbitsfoot ( Quadrula cylindrica cylindrica ), rayed bean ( Villosa fabalis ), ring pink (mussel) ( Obovaria retusa ), scaleshell mussel ( Leptodea leptodon ), sheepnose mussel ( Plethobasus cyphyus ), snuffbox mussel ( Epioblasma triquetra ), southern clubshell ( Pleurobema decisum ), spectaclecase (mussel) ( Cumberlandia monodonta ), turgid blossom (pearlymussel) ( Epioblasma turgidula ), and winged mapleleaf ( Quadrula fragosa ) | Alabama, Arkansas, Florida, Illinois, Iowa, Kentucky, Louisiana, Mississippi, Missouri, and Tennessee, Wisconsin | Presence/probable absence surveys | Capture, identify, and release | Renewal/Amendment.
TE 81430B-1 | Heather Wallace, Raleigh, NC | Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), northern long-eared bat ( Myotis septentrionalis ), and Virginia big-eared bat ( Corynorhinus ( =Plecotus ) townsendii virginianus ) | Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, and Tennessee | Presence/probable absence surveys, population monitoring, genetic analyses, and White-nose Syndrome sampling | Enter hibernacula, capture with mist nets or harp traps, handle, identify, band, radio tag, collect hair samples, wing punch, and swab | Renewal/Amendment.
| TE 81500B-1 | Sara Samoray, Nashville, TN | Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), northern long-eared bat ( Myotis septentrionalis ), and Virginia big-eared bat ( Corynorhinus ( =Plecotus ) townsendii virginianus ) | Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming | Presence/probable absence surveys, studies to document habitat use, population monitoring, and to evaluate potential impacts of White-nose Syndrome or other threats | Capture with mist nets or harp traps, handle, identify, band, and radio tag | Renewal.
TE 178643-3 | Jeffrey West, Columbia, SC | Carolina heelsplitter ( Lasmigona decorata ) | North Carolina and South Carolina | Presence/probable absence surveys | Capture, handle, identify, and release | Renewal.
TE 81353B-1 | Stephanie Penk, Sylva, NC | Indiana bat ( Myotis sodalis ) and northern long-eared bat ( Myotis septentrionalis ) | Alabama, Arkansas, Connecticut, Delaware, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, West Virginia, and Wisconsin | Presence/probable absence surveys, habitat use and assessment research, population dynamics evaluation, and migration research | Capture with mist nets, handle, identify, band, and radio tag | Renewal.
TE 88796C-2 | Geological Survey of Alabama, Tuscaloosa, AL | Fish: Blue shiner ( Cyprinella caerulea ), Cahaba shiner ( Notropis cahabae ), goldline darter ( Percina aurolineata ), rush darter ( Etheostoma phytophilum ), vermilion darter ( Etheostoma chermocki ); Mussels: Alabama moccasinshell ( Medionidus acutissimus ), Coosa moccasinshell ( Medionidus parvulus ), dark pigtoe ( Pleurobema furvum ), finelined pocketbook ( Lampsilis altilis ), Georgia pigtoe ( Pleurobema hanleyianum ), heavy pigtoe ( Pleurobema taitianum ), inflated heelsplitter ( Potamilus inflatus ), orangenacre mucket ( Lampsilis perovalis ), ovate clubshell ( Pleurobema perovatum ), southern acornshell ( Epioblasma othcaloogensis ), southern clubshell ( Pleurobema decisum ), southern combshell ( Epioblasma penita ), southern pigtoe ( Pleurobema georgianum ), triangular kidneyshell ( Ptychobranchus greenii ), upland combshell ( Epioblasma metastriata ) | Alabama | Population surveys | Capture, handle, identify, and release | Amendment.
| PER 0036267 | Shane Kelley, Louisville, KY | Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), northern long-eared bat ( Myotis septentrionalis ), and Virginia big-eared bat ( Corynorhinus ( Plecotus ) townsendii virginianus ) | Alabama, Arkansas, Connecticut, Delaware, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming | Presence/probable absence surveys | Capture with mist nets or harp traps, handle, identify, band, and radio tag | New.
PER 0036268 | KFS LLC, Huntsville, AL | Alabama beach mouse ( Peromyscus polionotus ammobates ) | Alabama | Population monitoring, mark/recapture studies | Capture, tag, and release | New.
TE 42183A-2 | Eglin Air Force Base, Niceville, FL | Red-cockaded woodpecker ( Picoides borealis ) | Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, North Carolina, Oklahoma, South Carolina, Texas, and Virginia | Population management and monitoring | Capture, band, monitor nest cavities, construct and monitor artificial nest cavities and restrictors, recapture, and translocate | Renewal/Amendment.
TE 087194-5 | Florida Forest Service, Goethe State Forest, Dunnellon, FL | Red-cockaded woodpecker ( Picoides borealis ) | Goethe State Forest, Levy County, Florida | Population management and monitoring | Capture, band, construct and install artificial nest cavities and restrictors, monitor nest cavities, recapture, and translocate | Renewal/Amendment.
PER 0037085 | Mississippi Aquarium, Gulfport, MS | Green sea turtle ( Chelonia mydas ), hawksbill sea turtle ( Eretmochelys imbricata ), Kemp's ridley sea turtle ( Lepidochelys kempii ), leatherback sea turtle ( Dermochelys coriacea ), and loggerhead sea turtle ( Caretta caretta ) | Mississippi | Population monitoring should they be re-encountered and physiological research during rehabilitation | Insert PIT tag, attach flipper tag, and collect blood samples | New.
PER 0037218 | Alabama Department of Environmental Management, Decatur, AL | Alabama sturgeon ( Scaphirhynchus suttkusi ), blue shiner ( Cyprinella caerulea ), boulder darter ( Etheostoma wapiti ), Cahaba shiner ( Notropis cahabae ), goldline darter ( Percina aurolineata ), palezone shiner ( Notropis albizonatus ), rush darter ( Etheostoma phytophilum ), spring pygmy sunfish ( Elassoma alabamae ), trispot darter ( Etheostoma trisella ), vermilion darter ( Etheostoma chermocki ), watercress darter ( Etheostoma nuchale ) | Alabama | Presence/probable absence surveys and population monitoring | Capture, handle, identify, and release | New.
| PER 0037593 | Donald Hubbs, Camden, TN | Alabama lampmussel ( Lampsilis virescens ), Alabama moccasinshell ( Medionidus acutissimus ), Appalachian elktoe ( Alasmidonta raveneliana ), Appalachian monkeyface (pearlymussel) ( Quadrula sparsa ), birdwing pearlymussel ( Lemiox rimosus ), clubshell ( Pleurobema clava ), Coosa moccasinshell ( Medionidus parvulus ), cracking pearlymussel ( Hemistena lata ), Cumberland bean (pearlymussel) ( Villosa trabalis ), Cumberland elktoe ( Alasmidonta atropurpurea ), Cumberland monkeyface (pearlymussel) ( Quadrula intermedia ), Cumberland pigtoe ( Pleurobema gibberum ), Cumberlandian combshell ( Epioblasma brevidens ), dromedary pearlymussel ( Dromus dromas ), fanshell ( Cyprogenia stegaria ), fat pocketbook ( Potamilus capax ), finelined pocketbook ( Lampsilis altilis ), finerayed pigtoe ( Fusconaia cuneolus ), fluted kidneyshell ( Ptychobranchus subtentus ), Georgia pigtoe ( Pleurobema hanleyianum ), green blossom (pearlymussel) ( Epioblasma torulosa gubernaculum ), inflated heelsplitter ( Potamilus inflatus ), littlewing pearlymussel ( Pegias fabula ), orangefoot pimpleback (pearlymussel) ( Plethobasus cooperianus ), oyster mussel ( Epioblasma capsaeformis ), pale lilliput (pearlymussel) ( Toxolasma cylindrellus ), pink mucket (pearlymussel) ( Lampsilis abrupta ), purple bean ( Villosa perpurpurea ), purple cat's paw (purple cat's paw pearlymussel) ( Epioblasma obliquata obliquata ), rabbitsfoot ( Quadrula cylindrica cylindrica ), rayed bean ( Villosa fabalis ), ring pink (mussel) ( Obovaria retusa ), rough pigtoe ( Pleurobema plenum ), rough rabbitsfoot ( Quadrula cylindrica strigillata ), scaleshell mussel ( Leptodea leptodon ), sheepnose mussel ( Plethobasus cyphyus ), shiny pigtoe ( Fusconaia cor ), slabside pearlymussel ( Pleuronaia dolabelloides ), snuffbox mussel ( Epioblasma triquetra ), southern acornshell ( Epioblasma othcaloogensis ), southern clubshell ( Pleurobema decisum ), southern pigtoe ( Pleurobema georgianum ), spectaclecase (mussel) ( Cumberlandia monodonta ), tan riffleshell ( Epioblasma florentina walkeri ( E. walkeri )), triangular kidneyshell ( Ptychobranchus greenii ), tubercled blossom (pearlymussel) ( Epioblasma torulosa torulosa ), turgid blossom (pearlymussel) ( Epioblasma turgidula ), upland combshell ( Epioblasma metastriata ), white wartyback (pearlymussel) ( Plethobasus cicatricosus ), winged mapleleaf ( Quadrula fragosa ), and yellow blossom (pearlymussel) ( Epioblasma florentina florentina ) | Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, and Tennessee | Presence/probable absence surveys, scientific research, and collect for captive propagation and reintroduction | Remove from substrate, handle, identify, collect tissue, mark, release, collect for propagation at permitted Tennessee facility, transport, and release | New.
TE 88797B-2 | Amber Nolder, Harrisburg, PA | Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), and northern long-eared bat ( Myotis septentrionalis ) | Alabama, Arkansas, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming | Presence/probable absence surveys, habitat assessments, and habitat-use studies | Capture with mist nets and harp traps, handle, identify, band, mark with non-toxic paint, and radio tag | Renewal.
TE 142806-3 | James Cox, Tallahassee, FL | Red-cockaded woodpecker ( Picoides borealis ) | Florida and Georgia | Cross-fostering nestlings | Monitor, capture, weigh, band, release, translocate, and collect cloacal swabs | Amendment.
PER 0037739 | Arkansas State University, State University, AR | Lindera melissifolia (pondberry) | Arkansas | Scientific research and propagation | Collect root/rhizome tissue, and stem pieces | New.
| PER 0037719 | Kissimmee Prairie Preserve State Park, Okeechobee, FL | Florida grasshopper sparrow ( Ammodramus savannarum floridanus ) | Florida | Presence/probable absence surveys, population management and monitoring, and collection and transport of eggs, nestlings, and adults for captive breeding | Nest searching, deploy nest cameras, install predator fences, nest lifting, fire ant treatment, capture with mist nets and audio lures, handle, band, monitor nest cavities, install predator barriers, collect blood, feces, and buccal swabs, collect and transport eggs, nestlings, and adults for captive breeding at permitted White Oak Conservation Foundation facility | New.
PER 0037812 | Royal Ontario Museum, Toronto, ON | Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), and northern long-eared bat ( Myotis septentrionalis ) | Tennessee | Presence/probable absence surveys | Capture via mist nets and harp traps, handle, identify, and release | New.
PER 0037836 | Christopher Sheats, New Hill, NC | Amphibians: Neuse River waterdog ( Necturus lewisi ); Fish: Cape Fear shiner ( Notropis mekistocholas ), Carolina madtom ( Noturus furiosus ), Roanoke logperch ( Percina rex ), Waccamaw silverside ( Menidia extensa ); Mussels: Appalachian elktoe ( Alasmidonta raveneliana ), Atlantic pigtoe ( Fusconaia masoni ), Carolina heelsplitter ( Lasmigona decorata ), dwarf wedgemussel ( Alasmidonta heterodon ), James spinymussel ( Pleurobema collina ), littlewing pearlymussel ( Pegias fabula ), Tar River spinymussel ( Elliptio steinstansana ), and yellow lance ( Elliptio lanceolata ) | North Carolina and South Carolina | Presence/probable absence surveys | Amphibians: Capture via trap and baiting, handle, identify, and release; Fish: Capture via seining, or netting, handle, identify, and release; Mussels: Remove from substrate, handle, identify, mark, and release | New.
PER 0037837 | Justin Bagley, Jacksonville State University, Jacksonville, AL | Blue shiner ( Cyprinella caerulea ) and Cahaba shiner ( Notropis cahabae ) | Alabama | Presence/Probable absence surveys, genomic analyses, and increase museum collection | Capture via seining or netting, handle, identify, photograph, collect non-lethal fin clips, release, collect voucher specimens | New.
| TE 079863-4 | Michael Gangloff, Boone, NC | Mussels: Alabama lampmussel ( Lampsilis virescens ), Alabama moccasinshell ( Medionidus acutissimus ), Alabama pearlshell ( Margaritifera marrianae ), Altamaha spinymussel ( Elliptio spinosa ), Appalachian elktoe ( Alasmidonta raveneliana ), Appalachian monkeyface (pearlymussel) ( Quadrula sparsa ), birdwing pearlymussel ( Lemiox rimosus ), black clubshell ( Pleurobema curtum ), Carolina heelsplitter ( Lasmigona decorata ), Chipola slabshell ( Elliptio chipolaensis ), Choctaw bean ( Villosa choctawensis ), clubshell ( Pleurobema clava ), Coosa moccasinshell ( Medionidus parvulus ), cracking pearlymussel ( Hemistena lata ), Cumberland bean (pearlymussel) ( Villosa trabalis ), Cumberland elktoe ( Alasmidonta atropurpurea ), Cumberland monkeyface (pearlymussel) ( Quadrula intermedia ), Cumberland pigtoe ( Pleurobema gibberum ), Cumberlandian combshell ( Epioblasma brevidens ), dark pigtoe ( Pleurobema furvum ), dromedary pearlymussel ( Dromus dromas ), dwarf wedgemussel ( Alasmidonta heterodon ), fanshell ( Cyprogenia stegaria ), fat pocketbook ( Potamilus capax ), fat threeridge (mussel) ( Amblema neislerii ), finelined pocketbook ( Lampsilis altilis ), finerayed pigtoe ( Fusconaia cuneolus ), flat pigtoe ( Pleurobema marshalli ), fuzzy pigtoe ( Pleurobema strodeanum ), green blossom (pearlymussel) ( Epioblasma torulosa gubernaculum ), Gulf moccasinshell ( Medionidus penicillatus ), heavy pigtoe ( Pleurobema taitianum ), inflated heelsplitter ( Potamilus inflatus ), interrupted (=Georgia) rocksnail ( Leptoxis foremani ), James spinymussel ( Pleurobema collina ), littlewing pearlymussel ( Pegias fabula ), narrow pigtoe ( Fusconaia escambia ), Ochlockonee moccasinshell ( Medionidus simpsonianus ), orangefoot pimpleback (pearlymussel) ( Plethobasus cooperianus ), oval pigtoe ( Pleurobema pyriforme ), ovate clubshell ( Pleurobema perovatum ), oyster mussel ( Epioblasma capsaeformis ), pale lilliput (pearlymussel) ( Toxolasma cylindrellus ), pink mucket (pearlymussel) ( Lampsilis abrupta ), purple bankclimber (mussel) ( Elliptoideus sloatianus ), purple bean ( Villosa perpurpurea ), purple cat's paw (=purple cat's paw pearlymussel) ( Epioblasma obliquata obliquata ), ring pink (mussel) ( Obovaria retusa ), rough pigtoe ( Pleurobema plenum ), rough rabbitsfoot ( Quadrula cylindrica strigillata ), round ebonyshell ( Fusconaia rotulata ), scaleshell mussel ( Leptodea leptodon ), sheepnose mussel ( Plethobasus cyphyus ), shiny pigtoe ( Fusconaia cor ), shinyrayed pocketbook ( Lampsilis subangulata ), slabside pearlymussel ( Pleuronaia dolabelloides ), southern acornshell ( Epioblasma othcaloogensis ), southern clubshell ( Pleurobema decisum ), southern combshell ( Epioblasma penita ), southern kidneyshell ( Ptychobranchus jonesi ), southern pigtoe ( Pleurobema georgianum ), southern sandshell ( Hamiota australis ), stirrupshell ( Quadrula stapes ), tan riffleshell ( Epioblasma florentina walkeri ( =E. walkeri) ), tapered pigtoe ( Fusconaia burkei ), Tar River spinymussel ( Elliptio steinstansana ), triangular kidneyshell ( Ptychobranchus greenii ), tubercled blossom (pearlymussel) ( Epioblasma torulosa torulosa ), turgid blossom (pearlymussel) ( Epioblasma turgidula ), upland combshell ( Epioblasma metastriata ), white wartyback (pearlymussel) ( Plethobasus cicatricosus ), winged mapleleaf ( Quadrula fragosa ), and yellow blossom (pearlymussel) ( Epioblasma florentina florentina ); Snails: Anthony's riversnail ( Athearnia anthonyi ), armored snail ( Pyrgulopsis ( =Marstonia ) pachyta ), cylindrical lioplax (snail) ( Lioplax cyclostomaformis ), flat pebblesnail ( Lepyrium showalteri ), Lacy elimia (snail) ( Elimia crenatella ), painted rocksnail ( Leptoxis taeniata ), plicate rocksnail ( Leptoxis plicata ), rough hornsnail ( Pleurocera foreman ), round rocksnail ( Leptoxis ampla ), slender campeloma ( Campeloma decampi ), and tulotoma snail ( Tulotoma magnifica ) | Alabama, Florida, Georgia, Kentucky, Mississippi, Mississippi, North Carolina, South Carolina, Tennessee, and Virginia | Presence/probable absence surveys | Capture, identify, tag, collect buccal swabs, release, and salvage shells | Renewal.
TE 50300D-1 | Edward Wilson, Lexington, KY | Gray bat ( Myotis grisescens ), Indiana bat ( Myotis sodalis ), and northern long-eared bat ( Myotis septentrionalis ) | Kentucky, North Carolina, Ohio, South Carolina, Tennessee, Virginia, and West Virginia | Presence/probable absence surveys | Capture via mist nets and harp traps, handle, identify, and release | Amendment.
TE 087191-6 | Sandhills Ecological Institute, Southern Pines, NC | Red-cockaded woodpecker ( Picoides borealis ) | North Carolina and South Carolina | Population management and monitoring and research on Avian Keratin Disorder | Capture, recapture, band, construct and monitor artificial nest cavities and restrictors, monitor nest cavities, translocate, collect buccal and cloacal swabs, and capture and recapture birds that exhibit Avian Keratin Disorder to monitor their fate in the population | Renewal/Amendment.

Authority
We publish this notice under section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ).
John Tirpak,

Deputy Assistant Regional Director, Ecological Services.
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[Docket No. FWS-R8-ES-2022-0034; FXES11140800000-223-FF08ECAR00]
Endangered and Threatened Species; Incidental Take Permit Application for the Desert Tortoise; Draft Habitat Conservation Plan and Draft Environmental Assessment; Bellefield Solar Energy Project, Kern County, CA

AGENCY:
Fish and Wildlife Service, Interior.

ACTION:
Notice of availability; request for public comments.

SUMMARY:
We, the U.S. Fish and Wildlife Service (Service), have received an application from 8minute Solar Energy for an incidental take permit under the Endangered Species Act of 1973, as amended. The permit would authorize take of the federally threatened desert tortoise ( Gopherus agassizii ) incidental to otherwise lawful activities associated with construction, operation, maintenance, and decommissioning of the Bellefield Solar Energy Project. We invite comments on the draft habitat conservation plan and the draft environmental assessment, which we have prepared pursuant to the National Environmental Policy Act. We will take comments into consideration before deciding whether to issue an incidental take permit.

DATES:
To ensure consideration, please submit your written comments by May 25, 2022.

ADDRESSES:
Obtaining Documents: The application, application supporting materials, and any comments and other materials that we receive will be available for public inspection at https://www.regulations.gov in Docket No. FWS-R8-ES-2022-0034.
Submitting Comments: If you wish to submit comments on any of the documents, you may do so in writing by any of the following methods:
• Internet: https://www.regulations.gov. Search for and submit comments on Docket No. FWS-R8-ES-2022-0034.
• U.S. mail: Public Comments Processing, Attn: Docket No. FWS-R8-ES-2022-0034; U.S. Fish and Wildlife Service Headquarters, MS: PRB/3W; 5275 Leesburg Pike; Falls Church, VA 22041-3803.
We request that you send written comments by only one of the methods described above.

FOR FURTHER INFORMATION CONTACT:
Ray Bransfield, Fish and Wildlife Biologist, by mail at the Palm Springs Fish and Wildlife Office, 777 East Tahquitz Canyon Way, Suite 208, Palm Springs, CA 92262; by phone at 805-677-3398; or via email at ray_bransfield@fws.gov. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.

SUPPLEMENTARY INFORMATION:
We have received an application from 8minute Solar Energy (applicant) for an incidental take permit under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ). The application addresses the potential take of the federally threatened desert tortoise, incidental to otherwise lawful activities at the Bellefield Solar Energy Project (project), as described in the applicant's draft habitat conservation plan. The proposed project would be located east of the town of Mojave in Kern County, California.

Background
Section 9 of the ESA (16 U.S.C. 1538) and Federal regulations promulgated pursuant to section 4(d) of the ESA (16 U.S.C. 1533) prohibit the take of endangered and threatened animals without special exemption. Under section 10(a)(1)(B) of the ESA (16 U.S.C. 1539), we may issue permits to authorize take of listed fish and wildlife species that is incidental to, and not the purpose of, carrying out an otherwise lawful activity. Regulations governing permits for endangered and threatened species are set forth in title 50 of the Code of Federal Regulations (CFR) at part 17, sections 17.22 and 17.32.
The National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ) requires Federal agencies to analyze their proposed actions to determine whether the actions may significantly affect the human environment. In the NEPA analysis, the Federal agency will identify the effects, as well as possible mitigation for effects on environmental resources, that could occur with the implementation of the proposed action and alternatives. The Federal action in this case is the Service's proposed issuance of an incidental take permit for the federally threatened desert tortoise.

Permit Application
The applicant has submitted a draft habitat conservation plan that describes the activities covered by the permit, such as the construction of the solar field and generator tie-in line. To minimize the risk of incidental take, the applicant would employ qualified biologists to translocate desert tortoises to a safe location off site. The conservation plan also includes adaptive management to allow for maintaining the protection of desert tortoises if necessary. To mitigate the impact of the incidental take, the applicant proposes to fund the enhancement of desert tortoise habitat within a retired grazing allotment on lands managed by the Bureau of Land Management.
The draft conservation plan and the draft environmental assessment consider alternatives to the proposed action, including a no action alternative.
The Service prepared a draft environmental assessment to evaluate the impacts of issuing the proposed incidental take permit on the human environment, consistent with the purpose and goals of NEPA and pursuant to the Council on Environmental Quality's implementing NEPA regulations at 40 CFR parts 1500-1508. Additionally, the draft environmental assessment was prepared consistent with the Department of the Interior NEPA regulations (43 CFR part 46); longstanding Federal judicial and regulatory interpretations; and Administration priorities and policies, including Secretary's Order No. 3399, which requires bureaus and offices to use “the same application or level of NEPA that would have been applied to a proposed action before the 2020 Rule went into effect.”

Public Comments
If you wish to comment on the draft conservation plan and draft environmental assessment, you may submit comments by one of the methods in ADDRESSES .

Public Availability of Comments
You may submit comments by one of the methods shown under ADDRESSES . All comments and materials we receive in response to this request will become part of the decision record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can 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.

Authority
We issue this notice pursuant to section 10(c) of the ESA (16 U.S.C. 1539) and its implementing regulations (50 CFR 17.22), and NEPA (42 U.S.C. 4321 et seq. ) and its implementing regulations (40 CFR 1506.6 and 43 CFR 46.305).
Scott Sobiech,

Field Supervisor, Carlsbad Fish and Wildlife Office, Carlsbad, California.
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[Docket No. FWS-HQ-IA-2022-0007; FXIA16710900000-223-FF09A30000]
Marine Mammal Protection Act and Wild Bird Conservation Act; Receipt of Permit Applications

AGENCY:
Fish and Wildlife Service, Interior.

ACTION:
Notice of receipt of permit applications; request for comments.

SUMMARY:
We, the U.S. Fish and Wildlife Service (Service), invite the public to comment on foreign or native species for which the Service has jurisdiction under the Marine Mammal Protection Act (MMPA) and foreign bird species covered under the Wild Bird Conservation Act (WBCA). With some exceptions, the MMPA and WBCA prohibit activities with listed species unless Federal authorization is issued that allows such activities. These Acts also require that we invite public comment before issuing permits for any activity they otherwise prohibit with respect to any species.

DATES:
We must receive comments by May 25, 2022.

ADDRESSES:
Obtaining Documents: The application, application supporting materials, and any comments and other materials that we receive will be available for public inspection at https://www.regulations.gov in Docket No. FWS-HQ-IA-2022-0007.
Submitting Comments: When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. You may submit comments by one of the following methods:
• Internet: https://www.regulations.gov. Search for and submit comments on Docket No. FWS-HQ-IA-2022-0007.
• U.S. mail: Public Comments Processing, Attn: Docket No. FWS-HQ-IA-2022-0007; U.S. Fish and Wildlife Service Headquarters, MS: PRB/3W; 5275 Leesburg Pike; Falls Church, VA 22041-3803.
For more information, see Public Comment Procedures under SUPPLEMENTARY INFORMATION .

FOR FURTHER INFORMATION CONTACT:
Brenda Tapia, by phone at 703-358-2185 or via email at DMAFR@fws.gov. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TTD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.

SUPPLEMENTARY INFORMATION:

I. Public Comment Procedures

A. How do I comment on submitted applications?
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 ADDRESSES . We will not consider comments sent by email or fax, or to an address not in ADDRESSES . We will not consider or include in our administrative record comments we receive after the close of the comment period (see DATES ). 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.

B. May I review comments submitted by others?
You may view and comment on others' public comments at https://www.regulations.gov, unless our allowing so would violate the Privacy Act (5 U.S.C. 552a) or Freedom of Information Act (5 U.S.C. 552).

C. Who will see my comments?
If you submit a comment at https://www.regulations.gov, your entire comment, including any personal identifying information, will be posted on the website. If you submit a hardcopy comment that includes personal identifying information, such as your address, phone number, or email address, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Moreover, all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.

II. Background
To help us carry out our conservation responsibilities for affected species, and in consideration of section 104(c) of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ), and section 112(4) of the Wild Bird Conservation Act of 1992 (WBCA; 16 U.S.C. 4901-4916), we invite public comments on permit applications before final action is taken. With some exceptions, these Acts prohibit certain activities with listed species unless Federal authorization is issued that allows such activities. Service regulations regarding permits for any activity otherwise prohibited by the MMPA with respect to any marine mammals are available in title 50 of the Code of Federal Regulations in part 18. Service regulations regarding permits for any activity otherwise prohibited by the WBCA with respect to any wild birds are available in title 50 of the Code of Federal Regulations in part 15.
Concurrent with publishing this notice in the Federal Register , we are forwarding copies of the marine mammal applications to the Marine Mammal Commission and the Committee of Scientific Advisors for their review.

III. Permit Applications
We invite comments on the following applications.

A. Marine Mammal Protection Act

Applicant: Matson's Laboratory, Manhattan, MT; Permit No. 166346
The applicant requests to renew a permit to obtain samples of polar bears ( Ursus maritimus ) that have been legally harvested or were taken from the wild for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

Applicant: Alaska Department of Fish and Game, Fairbanks, AK; Permit No. 57198B
The applicant requests to renew a permit to deploy transmitters and collect skin biopsies to monitor the movement, timing, behavior, and habitat use of walruses ( Odobenus rosmarus ) in the wild for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

Applicant: Point Defiance Zoo and Aquarium, Tacoma, WA; Permit No. PER0028852
The applicant requests a permit to import and maintain one male and one female captive born live walrus ( Odobenus rosmarus ) for the purpose of public display. This notification covers activities to be conducted once within a 1-year time frame.

Applicant: USGS Alaska Science Center, Santa Cruz, CA; Permit No. PER0030527
The applicant requests to amend a permit to measure the oxygen consumption of two captive adult polar bears ( Ursus maritimus ) to inform data collected from wild polar bears on the energetic costs of swimming for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

B. Wild Bird Conservation Act

Applicant: Vernon Padgett, Atlanta, GA; Permit No. PER0026547
The applicant wishes to amend the Cooperative Breeding Program CB042 to add the following new species: Wreathed hornbill ( Rhyticeros undulatus ), wrinkled hornbill ( Rhabdotorrhinus corrugatus ), rhinoceros hornbill ( Buceros rhinoceros ), and Indian hornbill ( Buceros bicornis ), and to increase the approved number of imports for the Papuan hornbill ( Rhyticeros plicatus ) and rufous hornbill ( Buceros hydrocorax ) to their already existing program.

IV. Next Steps
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 Federal Register . You may locate the notice announcing the permit issuance by searching https://www.regulations.gov for the permit number listed above in this document. For example, to find information about the potential issuance of Permit No. 12345A, you would go to https://www.regulations.gov and search for “12345A”.

V. Authority
We issue this notice under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ), and its implementing regulations, and the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), and its implementing regulations.
Brenda Tapia,

Supervisory Program Analyst/Data Administrator, Branch of Permits, Division of Management Authority.
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
[223A2100DD/AAKC001030/A0A501010.999900]
Indian Gaming; Approval of Tribal-State Class III Gaming Compact in the State of Wisconsin

AGENCY:
Bureau of Indian Affairs, Interior.

ACTION:
Notice.

SUMMARY:
This notice publishes the approval of the Third Amendment to the Gaming Compact (Amendment) between the St. Croix Chippewa Indians of Wisconsin (Tribe) and the State of Wisconsin (State).

DATES:
The Amendment takes effect on April 25, 2022.

FOR FURTHER INFORMATION CONTACT:
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Deputy Assistant Secretary—Policy and Economic Development, Washington, DC 20240, paula.hart@bia.gov, (202) 219-4066.

SUPPLEMENTARY INFORMATION:
Under section 11 of the Indian Gaming Regulatory Act (IGRA), Public Law 100-497, 25 U.S.C. 2701 et seq., the Secretary of the Interior shall publish in the Federal Register notice of approved Tribal-State compacts for the purpose of engaging in Class III gaming activities on Indian lands. As required by 25 CFR 293.4, all compacts and amendments are subject to review and approval by the Secretary.
The Amendment provides for on-reservation remote and retail event wagering consistent with the Tribe's minimum internal control standards, contains several technical changes including removing obsolete language, and includes a forward-looking provision which positions the Tribe to offer state-wide hub and spoke event wagering if State law is changed to allow such gaming, another Tribe's compact with the State authorizes such gaming, and the Tribe's Compact is amended. The Amendment is approved.
Bryan Newland,

Assistant Secretary—Indian Affairs.
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
[212D0102DR/DS5A300000/DR.5A311.IA000118]
Native American Business Development Institute (NABDI) Grant; Solicitation of Proposals

AGENCY:
Bureau of Indian Affairs (BIA), Interior.

ACTION:
Notice.

SUMMARY:
The Office of Indian Energy and Economic Development (OIED), through its Native American Business Development Institute (NABDI), is soliciting grant proposals from eligible federally recognized Tribes and Tribal organizations. NABDI award funding will be used to explore economic development opportunities through feasibility studies and business plans. Feasibility studies may concern the viability of an economic development project or business, or the practicality of a technology, that a Tribe may choose to pursue to explore how a current Tribal business or enterprises could recover from and adapt to the challenges resulting from the COVID-19 pandemic. Business plans may concern goals for economic opportunity and recovery from the impacts of the COVID-19 pandemic.

DATES:
Applications will be accepted until 5 p.m. ET on Monday, June 27, 2022. OIED will not consider proposals received after this time and date.

ADDRESSES:
The required method of submitting proposals is through Grants.gov . For information on how to apply for grants in Grants.gov , see the instructions available at https://www.grants.gov/help/html/help/Applicants/HowToApplyForGrants.htm. Proposals must be submitted to Grants.gov by the deadline established in the DATES section.

FOR FURTHER INFORMATION CONTACT:
Mr. Dennis Wilson, Grant Management Specialist, Office of Indian Economic Development, telephone: (505) 917-3235; email: dennis.wilson@bia.gov. If you have questions regarding the application process, please contact Ms. Jo Ann Metcalfe, Grant Officer, telephone (401) 703-3390; email jo.metcalfe@bia.gov. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Additional Program information can be found at https://www.bia.gov/service/grants/nabdi.

SUPPLEMENTARY INFORMATION:
I. General Information
II. Number of Projects Funded
III. Background
IV. Eligibility for Funding
V. Who May Perform Feasibility Studies Funded by NABDI Grants?
VI. Applicant Procurement Procedures
VII. Limitations
VIII. NABDI Application Guidance
IX. Mandatory Components
X. Incomplete Applications
XI. Review and Selection Process
XII. Evaluation Criteria
XIII. Transfer of Funds
XIV. Reporting Requirements for Award Recipients
XV. Conflicts of Interest
XVI. Questions and Requests for OIED Assistance
XVII. Paperwork Reduction Act
XVIII. Authority
I. General Information.
Award Ceiling: $75,000.
Award Floor: $25,000.
CFDA Number: 15.032.
Cost Sharing or Matching Requirement: No.
Number of Awards: 20 to 35.
Category: Business Development.
II. Number of Projects Funded. OIED anticipates awarding approximately 20 to 35 grants under this announcement ranging in value from approximately $25,000 to $75,000. The program can fund projects only one year at a time. OIED will use a competitive evaluation process for awarding based on criteria described in the Review and Selection Process Section of this notice. Only one application will be accepted from an eligible Tribe, and only one application will be accepted from an eligible Tribal Organization of that Tribe.
III. Background. The Office of the Assistant Secretary—Indian Affairs, through OIED, is soliciting proposals from federally recognized Tribes listed as Indian Entities Recognized by and Eligible to Receive Services from the United States Bureau of Indian Affairs at 87 FR 4636 (January 28, 2022) and Tribal Organizations eligible for NABDI grants. Indian Tribes are referred to using the term “Tribe” throughout this notice. Tribal Organization is defined by 25 U.S.C. 5304( l ). Consultants may include, but are not limited to universities and colleges, private consulting firms, and non-academic non-profit entities. The feasibility studies will help facilitate informed decision-making regarding Tribes' economic futures. Feasibility studies may concern the viability of an economic development project or business, or the practicality of a technology, that a Tribe may choose to pursue to explore how a current Tribal business or enterprises could recover and adapt to the challenges resulting from the COVID-19 pandemic. NABDI awards may be used to develop business plans for eligible applicant's goals for economic opportunity and recovery, such as the economic impacts of the COVID-19 pandemic. The OIED administers this program through its Division of Economic Development (DED).
The funding periods and amounts referenced in this solicitation are subject to the availability of non-recurring appropriation funds of the BIA budget at the time of award, as well as the Department of the Interior (DOI) and Indian Affairs priorities at the time of the award. Neither DOI nor Indian Affairs will be held responsible for proposal or application preparation costs. Publication of this solicitation does not obligate DOI or Indian Affairs to award any specific grant or to obligate all or any part of available funds. Future funding is subject to the availability of appropriations and cannot be guaranteed. DOI or Indian Affairs may cancel or withdraw this solicitation at any time.
IV. Eligibility for Funding. The Office of the Assistant Secretary—Indian Affairs, through OIED, is soliciting proposals from federally recognized Tribes listed as Indian Entities Recognized by and Eligible to Receive Services from the United States Bureau of Indian Affairs at 87 FR 4636 (January 28, 2022) and Tribal Organizations eligible for NABDI grants. Indian Tribes are referred to using the term “Tribe” throughout this notice. Tribal Organization is defined by 25 U.S.C. 5304( l ).
V. Who may Perform Feasibility Studies or Develop Business Plans Funded by NABDI Grants? The applicant determines who will conduct its feasibility study or business plan. An applicant has several choices, including but not limited to:
• Universities and colleges;
• Private consulting firms; or
• Non-academic, non-profit entities.
VI. Applicant Procurement Procedures. The applicant is subject to the procurement standards in 2 CFR 200.318 through 200.326. In accordance with 2 CFR 200.318, an applicant must use its own documented procurement procedures which reflect Tribal laws and regulations, provided that the procurements conform to applicable Federal law and standards.
VII. Limitations. NABDI grant funding must be expended in accordance with applicable statutory and regulatory requirements, including 2 CFR part 200. As part of the grant application review process, OIED may conduct a review of an applicant's prior OIED grant awards(s).
Applicants that are currently under BIA sanction Level 2 or higher resulting from non-compliance with the Single Audit Act are ineligible for a NABDI award. Applicants at Sanction Level 1 will be considered for funding.
Only one application will be accepted from an eligible Tribe, and only one application will be accepted from an eligible Tribal Organization of that Tribe. Applications should address one project and any submissions that contain multiple project proposals will not be considered. OIED will apply the same objective ranking criteria to each proposal.
The purpose of NABDI grants is to fund feasibility studies and business plans for proposed economic development projects, businesses, technologies and for businesses recovering from the effects of the COVID-19 pandemic. An application can request funding for a feasibility study or a business plan.
NABDI awards may not be used for:
• Establishing or operating a Tribal Office;
• Indirect costs or administrative costs as defined by the Federal Acquisition Regulation (FAR);
• Purchase of equipment that is used to develop the feasibility studies, such as computers, vehicles, field gear, etc. (however, leasing of this type of equipment for the purpose of developing feasibility studies is allowed);
• Creating Tribal jobs to complete the project. A NABDI grant is not intended to create temporary administrative jobs or supplement employment for Tribal members;
• Legal fees;
• Application fees associated with permitting;
• Training;
• Contract negotiation fees;
• Feasibility studies of energy, mineral, energy legal infrastructure, or broadband related projects, businesses, or technologies that are addressed by OIED's Energy and Mineral Development Program (EMDP), Tribal Energy Development Capacity (TEDC); and
• Any other activities not authorized by the grant award letter.
VIII. NABDI Application Guidance. All applications must be submitted in digital form to grants.gov. For instructions, see https://www.grants.gov/help/html/help/Applicants/HowToApplyForGrants.htm.
IX. Mandatory Components. The mandatory components, and forms identified below, must be included in the proposal package. Links to the mandatory forms can be found under the “Related Package” tab on the NABDI FY2022 grant opportunity page at www.grants.gov. Any information in the possession of the BIA or submitted to the BIA throughout the process, including final work product, constitutes government records and may be subject to disclosure to third parties under the Freedom of Information Act (FOIA), 5 U.S.C. 552, and the Department of the Interior's FOIA regulations at 43 CFR part 2, unless a FOIA exemption or exception applies, or other provisions of law protect the information. Following are the names of the required forms:
• Cover Page
• Application for Federal Assistance (SF-424) [V4.0]
• Cover Letter
• Project Abstract Summary [V2.0]
• Project Narrative Attachment Form [V1.2]
• Budget Information for Non-Construction Programs (SF-424A) [V1.0]
• Attachments [V1.2]
• Key Contacts [V2.0]
Cover Page: A Cover Page must be included in the application and contain the following:
• Category of Funding for the NABDI application.
• Proposal Title.
• Total Amount of funding requested from the Program.
• Full and Proper Name of the applicant organization.
• Statement confirming the proposed work will have the potential to reach the intended goals and objectives.
• Confirm active registration in SAM, attaching print-out from sam.gov to the cover page. See instructions and registration instructions in Appendix.
• Provide active enrollment in ASAP and your Recipient ID with the BIA. Allow 3-4 weeks to complete all steps of enrollment prior to submission deadline. The organization must be enrolled in ASAP with BIA, current enrollment with other federal agencies is not sufficient. See instructions and registration instructions in Appendix.
• Confirmation of other completed Mandatory Components identified in this section (SF-424, Project Abstract Summary, etc).
• Identification of partnerships such as Tribes, other Tribal Organizations or Entities.

Application for Federal Assistance SF-424
Applicants are required complete the Application for Federal Assistance SF-424.
Please use a descriptive file name that includes tribal name and project description. For example: NABDISF424.Tribalname.Project. The SF-424 form requires the Congressional District number of the applicant, which can be found at https://www.house.gov/reprentatives/find-your-representative.
Cover Letter: A cover letter is not to exceed one (1) page that summarizes the interest and intent, complete with authorized signature(s) of organization leadership.

Project Abstract Summary and Project Narrative Attachment
The first paragraph of the project narrative must include the title and basic description of the proposed feasibility study or business plan. The Project Narrative must not exceed 15 pages. Supplemental information such as letters of support, graphs, charts, maps, photographs and other graphic and/or other relevant information may be included in an appendix and not counted against the 15-page Project Narrative Limit. At a minimum, it should include:
• A technical description of the project and, if applicable, an explanation of how the proposed study or business plan would benefit the applicant and does not duplicate previous work;
• A description of the project objectives and goals;
• Deliverable products that the consultant is expected to generate, including interim deliverables (such as status reports and technical data to be obtained) and final deliverables (the feasibility study or business plan); and
• Resumes of key consultants and personnel to be retained, if available, and the names of subcontractors, if applicable. This information may be included as an attachment to the application and will not be counted towards the 15-page limitation.
• Please use a descriptive file name that includes tribal name and project description. For example: NABDINarrative.Tribalname.Project.
In addition, unless prohibited by tribal procurement procedures, please include a description of the consultant(s) the applicant wishes to retain, including the consultant's contact information, technical expertise, training, qualifications, and suitability to undertake the feasibility study. These documents may be included at the end of the Project Narrative and will not be counted toward the 15-page limitation.
Project Narratives are not judged based on their length. Please do not submit any attachments or documents beyond what is listed above, e.g., Tribal history, unrelated photos and maps.

Budget Information for Non-Construction Programs (SF-424A) [V1.0] and Budget Narrative Attachment Form [V1.2]
Applicants are required to utilize the SF-424A for the budget submission. Please use a descriptive file name that includes tribal name and project description. For example: NABDIBudget.Tribalname.Project. The budget must identify the amount of grant funding requested and a comprehensive breakdown of all projected and anticipated expenditures, including contracted personnel fees, consulting fees (hourly or fixed), travel costs, data collection and analysis costs, computer rentals, report generation, drafting, advertising costs for a proposed project and other relevant project expenses, and their subcomponents.
• Travel costs should be itemized by airfare, vehicle rental, lodging, and per diem, based on the current Federal government per diem schedule.
• Data collection and analysis costs should be itemized in sufficient detail for the OIED review committee to evaluate the charges.
• Other expenses may include computer rental, report generation, drafting, and advertising costs for a proposed project.

Attachments [V1.2]
Utilize the attachments form to include the Tribal resolution issued in the fiscal year of the grant application, authorizing the submission of a NABDI 2022 grant application. It must be signed by authorized Tribal representative(s). The Tribal resolution must also include a description of the feasibility study or business plan to be developed. An application submitted without a Tribal Resolution will be considered incomplete. The attachments form can also be used to include any other attachments related to the proposal.

Required Grantee Travel and Attendance at a Business Development Annual Grantee Meeting
Grantees will be required to have two individuals who work directly on the project attend an in-person annual DOI/OIED-sponsored grantee 3-day meeting in Washington, DC, during the year of the grant award. Applicants must include costs in the budget to cover this requirement. Travel costs must not exceed $6,000 per person. Applicants should follow their own travel policies to budget for this 3-day meeting. Additional funds for these expenses will not be available once grant is awarded. In the event the meeting is converted to a virtual meeting due to timing or COVID related issues, those funds may be repurposed in the grant.

Special Notes
Please make sure that the System for Award Management (SAM) number used to apply is active, not expired, with a current Unique Entity Identifier (UEI) number on the SF-424.
Please make sure an active Automated Standard Application for Payment (ASAP) number is provided. Applicants must have an ASAP number and be enrolled with the BIA to be eligible.
Please list counties where the project is located and congressional district number where the project will be located.

Key Contacts
Applicants must include a critical information page that includes:
• Please use a descriptive file name that includes tribal name and identifies it is the critical information page (CIP). For example: NABDICIP.Tribalname.Project
• Project Manager's contact information including address, email, desk, and cell phone number;
• Please make sure the System for Award Management (SAM) number used to apply is active, not expired, with a current UEI number on the SF-424;
• Please make sure an active Automated Standard Application for Payment (ASAP) number is provided. Applicants must have an ASAP number for the BIA to be eligible;
• Please list the county(ies) where the project is located and congressional district number(s) where the project is located.
X. Incomplete Applications. Incomplete applications will not be accepted. Please ensure that all forms listed in the announcement are completed and submitted in grants.gov .
XI. Review and Selection Process. Upon receiving a NABDI application, OIED will determine whether the application is complete and that the proposed project does not duplicate or overlap previous or currently funded OIED technical assistance projects. Any proposal that is received after the date and time in the DATES section of this notice will not be reviewed.
The OIED Review Committee, comprised of OIED staff, staff from other Federal agencies, and subject matter experts, will evaluate the proposals against the ranking criteria. Proposals will be evaluated using the four ranking criteria listed below, with a maximum achievable total of 100 points.
Final award selections will be approved by the Assistant Secretary—Indian Affairs and the Associate Deputy Secretary, U.S. Department of the Interior. Applicants not selected for award will be notified in writing.
XII. Evaluation Criteria.
Proposals will be formally evaluated by an OIED review committee using the five criteria listed below. Each criterion provides a percentage of the total maximum rating of 100 points:
The Project's Economic Benefits: 50 points.
Project Deliverables: 20 Points.
Feasibility Process and Analysis: 10 points.
Costs of Proposal: 10 points.
Specificity: 10 points.

The Project's Economic Benefits: 50 Points
The reviewers will determine if the proposal's scope of work clearly states the opportunity to be studied. Factors that the reviewers will consider when awarding points are, but not limited to:
• Does the proposal describe how the project will potentially stimulate economic development?
• Does the proposal describe the benefits the project would have if implemented?
• Does the proposal include information how the project will reduce joblessness and stimulate economic activity within a Native community?
• Does the proposal describe the economic development challenges and how the study will address those conditions?
• Does the proposal describe if the applicant has the financial resources to conduct the study absent NABDI grant assistance?

Project Deliverables: 20 Points
The reviewers will determine if the proposal describes in detail applicable proposed deliverables. For example, a hotel feasibility study would include deliverables such as, but not limited to, site analysis, market demographics, drive-time market, regional competition, market demands, and a financial model that includes investment and return on investment projections.

Project Tasks and Timeline: 10 Points
The reviewers will determine if a comprehensive timeline has been developed to address tasks that are needed to successfully complete the objectives outlined in the scope of work.

Costs of Proposal/Budget: 10 Points
The reviewers will assess the costs listed in the budget to determine if the overall value of the project is competitively priced and in accordance with the goals stated within the proposal/scope of work.

Specificity: 10 Points
The reviewers understand applicants may retain consultant(s) that prepare the NABDI proposal to also conduct the feasibility study if the grant is awarded. This does not prejudice an applicant's chances of being selected as a grantee. However, the Committee will view unfavorably proposals that show little evidence of communication between the consultant(s) and the applicant or scant regard for the applicant community's unique circumstances. Facsimile applications prepared by the same consultant(s) and submitted by multiple applicants will receive scrutiny in this regard.
XIII. Transfer of Funds. OIED's obligation under this solicitation is contingent on receipt of congressionally appropriated funds. No liability on the part of the U.S. Government for any payment may arise until funds are made available to the awarding officer for this grant and until the recipient receives notice of such availability, to be confirmed in writing by the grant officer.
All payments under this agreement will be made by electronic funds transfer through the ASAP. All award recipients are required to have a current and accurate UEI number to receive funds. All payments will be deposited to the banking information designated by the applicant in the System for Award Management (SAM).
XIV. Reporting Requirements for Award Recipients. The applicant must deliver all products and data required by the Grant Agreement for the proposed NABDI feasibility study and business plan project to OIED within 30 days of the end of each reporting period and 120 days after completion of the project. The reporting periods will be established in the terms and conditions of the final award.
OIED requires that deliverable products be provided in digital format and submitted in the GrantSolutions system. Reports can be provided in either Microsoft Word or Adobe Acrobat PDF format. Spreadsheet data can be provided in Microsoft Excel, Microsoft Access, or Adobe PDF formats. All vector figures should be converted to PDF format. Raster images can be provided in PDF, JPEG, TIFF, or any of the Windows metafile formats. The contract between the grantee and the consultant conducting the NABDI funded feasibility study must include deliverable products and require that the products be prepared in the format described above.
The contract should include budget amounts for all printed and digital copies to be delivered in accordance with the grant agreement. In addition, the contract must specify that all products generated by a consultant belong to the grantee and cannot be released to the public without the grantee's written approval. Products include, but are not limited to, all reports and technical data obtained, maps, status reports, and the final report.
In addition, this funding opportunity and financial assistance award must adhere to the following provisions.
XV. Conflicts of Interest.

Applicability
• This section intends to ensure that non-Federal entities and their employees take appropriate steps to avoid conflicts of interest in their responsibilities under or with respect to Federal financial assistance agreements.
• In the procurement of supplies, equipment, construction, and services by recipients and by sub-recipients, the conflict of interest provisions in 2 CFR 200.318 apply.

Requirements
• Non-Federal entities must avoid prohibited conflicts of interest, including any significant financial interests that could cause a reasonable person to question the recipient's ability to provide impartial, technically sound, and objective performance under or with respect to a Federal financial assistance agreement.
• In addition to any other prohibitions that may apply with respect to conflicts of interest, no key official of an actual or proposed recipient or sub-recipient, who is substantially involved in the proposal or project, may have been a former Federal employee who, within the last one (1) year, participated personally and substantially in the evaluation, award, or administration of an award with respect to that recipient or sub-recipient or in development of the requirement leading to the funding announcement.
• No actual or prospective recipient or sub-recipient may solicit, obtain, or use non-public information regarding the evaluation, award, administration of an award to that recipient or sub-recipient or the development of a Federal financial assistance opportunity that may be of competitive interest to that recipient or sub-recipient.

Notification
• Non-Federal entities, including applicants for financial assistance awards, must disclose in writing any conflict of interest to the DOI awarding agency or pass-through entity in accordance with 2 CFR 200.112, Conflicts of Interest.
• Recipients must establish internal controls that include, at a minimum, procedures to identify, disclose, and mitigate or eliminate identified conflicts of interest. The recipient is responsible for notifying the Financial Assistance Officer in writing of any conflicts of interest that may arise during the life of the award, including those that have been reported by sub-recipients.
• Restrictions on Lobbying. Non-Federal entities are strictly prohibited from using funds under this grant or cooperative agreement for lobbying activities and must provide the required certifications and disclosures pursuant to 43 CFR part 18 and 31 U.S.C. 1352.
• Review Procedures. The Financial Assistance Officer will examine each conflict of interest disclosure on the basis of its particular facts and the nature of the proposed grant or cooperative agreement, and will determine whether a significant potential conflict exists and, if it does, develop an appropriate means for resolving it.
• Enforcement. Failure to resolve conflicts of interest in a manner that satisfies the Government may be cause for termination of the award. Failure to make the required disclosures may result in any of the remedies described in 2 CFR 200.338, Remedies for Noncompliance, including suspension or debarment (see also 2 CFR part 180).

Data Availability
• Applicability. The Department of the Interior is committed to basing its decisions on the best available science and providing the American people with enough information to thoughtfully and substantively evaluate the data, methodology, and analysis used by the Department to inform its decisions.
• Use of Data. The regulations at 2 CFR 200.315 apply to data produced under a Federal award, including the provision that the Federal Government has the right to obtain, reproduce, publish, or otherwise use the data produced under a Federal award as well as authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes.
• Availability of Data. The recipient shall make the data produced under this award and any subaward(s) available to the Government for public release, consistent with applicable law, to allow meaningful third-party evaluation and reproduction of the following:
○ The scientific data relied upon;
○ The analysis relied upon; and
○ The methodology, including models, used to gather and analyze data.
XVI. Questions and Requests for OIED Assistance. Technical consultation from OIED may include clarifying application requirements, confirming whether an applicant previously submitted the same or similar proposal, and registration information for SAM or ASAP. Technical assistance will be provided by the OIED contractor, Tribal Tech. The applicant is solely responsible for the preparation of its grant proposal. All eligible applicants will have access to scheduled training and can request assistance from the pre-application phase through the post-award close-out. It is strongly recommended that any assistance be a consolidation of items based off reasonably completed working drafts. Please complete an in-take form with Tribal Tech to request assistance: https://app.smartsheet.com/b/publish?EQBCT=98a8ecfd0f3d452693e589c6a0a678d8.
XVII. Paperwork Reduction Act: The information collection requirements contained in this notice have been reviewed and approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3504(h). The OMB control number is 4040-0004. The authorization expires on December 31, 2022. An agency may not conduct or sponsor, and you are not required to respond to, any information collection that does not display a currently valid OMB Control Number.
XVIII. Authority: This is a discretionary grant program authorized under the Snyder Act (25 U.S.C. 13) and the Consolidated Appropriations Act, 2022 (HR 2471-312). The Snyder Act authorizes the BIA to expend such moneys as Congress may appropriate for the benefit, care, and assistance of Indians for the purposes listed in the Act. NABDI grants facilitate two of the purposes listed in the Snyder Act: “General support and civilization, including education” and “industrial assistance and advancement.” The Consolidated Appropriations Act 2022 (HR 2471-312) authorizes the BIA “for expenses necessary for the operation of Indian programs, as authorized by law, including the Snyder Act of November 2, 1921 (25 U.S.C. 13) . . .”.
Bryan Newland,

Assistant Secretary—Indian Affairs.
DEPARTMENT OF JUSTICE
[OMB Number 1105-0084]
Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection

AGENCY:
United States Trustee Program, Department of Justice.

ACTION:
Notice.

SUMMARY:
The Department of Justice, United States Trustee Program, is submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

DATES:
The Department of Justice encourages public comment and will accept input until May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

SUPPLEMENTARY INFORMATION:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
—Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the United States Trustee Program, 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;
—Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; 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, e.g., permitting electronic submission of responses.

Overview of This Information Collection
1. Type of Information Collection: Revision of a currently approved collection.
2. The Title of the Form/Collection: Application for Approval as a Nonprofit Budget and Credit Counseling Agency (Application).
3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: There is no agency form number for this collection. The applicable component within the Department of Justice is the United States Trustee Program.
4. Affected public who will be asked or required to respond, as well as a brief abstract: Nonprofit agencies that wish to offer credit counseling services pursuant to the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 (“BAPCPA”), Public Law 109-8, 119 Stat. 23, 37, 38 (April 20, 2005), and codified at 11 U.S.C. 109(h) and 111, and Application Procedures and Criteria for Approval of Nonprofit Budget and Credit Counseling Agencies by United States Trustees, 78 FR 16,138 (March 14, 2013) (Rule).
The BAPCPA requires any individual who wishes to file for bankruptcy to obtain credit counseling, within 180 days before filing for bankruptcy relief, from a nonprofit budget and credit counseling agency that has been approved by the United States Trustee. The Application collects information from such agencies in order to ensure compliance with the law and the Rule.
5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 86 respondents will complete the Application; initial applicants will complete the Application in approximately ten (10) hours, standard renewal applicants will complete the Application in approximately four (4) hours and refreshed renewal applicants will complete the Application in approximately five (5) hours.
6. An estimate of the total public burden (in hours) associated with the collection: The estimated public burden associated with this collection is 373 hours.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.
Dated: April 19, 2022.
Melody Braswell,

Department Clearance Officer for PRA, U.S. Department of Justice.
DEPARTMENT OF JUSTICE
[OMB Number 1105-0085]
Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection

AGENCY:
United States Trustee Program, Department of Justice.

ACTION:
Notice.

SUMMARY:
The Department of Justice, United States Trustee Program, is submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

DATES:
The Department of Justice encourages public comment and will accept input until May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

SUPPLEMENTARY INFORMATION:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
—Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the United States Trustee Program, 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;
—Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; 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, e.g., permitting electronic submission of responses.

Overview of This Information Collection
1. Type of Information Collection: Revision of a currently approved collection.
2. The Title of the Form/Collection: Application for Approval as a Provider of a Personal Financial Management Instructional Course (Application).
3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: There is no agency form number for this collection. The applicable component within the Department of Justice is the United States Trustee Program.
4. Affected public who will be asked or required to respond, as well as a brief abstract: Individuals and businesses that wish to offer instructional courses to debtors concerning personal financial management pursuant to the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005 (“BAPCPA”), Public Law 109-8, 119 Stat. 23, 37, 38 (April 20, 2005), and codified at 11 U.S.C. 109(h) and 111, and Application Procedures and Criteria for Approval of Providers of a Personal Financial Management Instructional Course by United States Trustees, 78 FR 16,159 (March 14, 2013) (Rule).
The BAPCPA requires individual debtors in bankruptcy cases to complete a personal financial management instructional course given by a provider that has been approved by the United States Trustee as a condition of receiving a discharge. The Application collects information from such providers in order to ensure compliance with the law and the Rule.
5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 135 respondents will complete the Application; initial applicants will complete the Application in approximately ten (10) hours, standard renewal applicants will complete the Application in approximately four (4) hours and refreshing renewal applicants will complete the Application in approximately five (5) hours. In addition, it is estimated that approximately 602,344 debtors will complete a survey evaluating the effectiveness of an instructional course in approximately one (1) minute.
6. An estimate of the total public burden (in hours) associated with the collection: The estimated total annual public burden associated with this Application is 10,620 hours; the applicants' burden is 581 hours and the debtors' burden is 10,039 hours.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.
Dated: April 19, 2022.
Melody Braswell,

Department Clearance Officer for PRA, U.S. Department of Justice.
DEPARTMENT OF JUSTICE
[OMB 1140-0075]
Agency Information Collection Activities; Proposed eCollection of eComments Requested; Transactions Among Licensees/Permittees, Limited

AGENCY:
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.

ACTION:
60-Day notice.

SUMMARY:
The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection (IC) is also being published to obtain comments from the public and affected agencies.

DATES:
Comments are encouraged and will be accepted for 60 days until June 24, 2022.

FOR FURTHER INFORMATION CONTACT:
If you have additional comments regarding the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, contact: Anita Scheddel, Program Analyst, Firearms and Explosives Industry Division, Explosives Industry Programs Branch, Mailstop 6N-518, either by mail at 99 New York Ave. NE, Washington, DC 20226, or by email at eipbinformationcollection@atf.gov, or by telephone at (202) 648-7120.

SUPPLEMENTARY INFORMATION:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
—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;
—Evaluate whether and, if so, how the quality, utility, and clarity of the information to be collected can be enhanced; 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, e.g., permitting electronic submission of responses.

Overview of This Information Collection
1. Type of Information Collection (check justification or form 83) : Extension with Change of a Currently Approved Collection.
2. The Title of the Form/Collection: Transactions Among Licensees/Permittees, Limited.
3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:
Form number (if applicable): None.
Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.
4. Affected public who will be asked or required to respond, as well as a brief abstract:
Primary: Business or other for-profit.
Other (if applicable): None.
Abstract: This information collection outlines specific requirements regarding limited explosive permits, and also allows the Bureau of Alcohol, Tobacco, Firearms and Explosives to implement provisions of the Safe Explosives Act.
5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 100 respondents will respond to this collection once annually, and it will take each respondent approximately 30 minutes to complete their responses.
6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 50 hours, which is equal to 100 (total respondents) * 1(# of response per respondent) * .5 (30 minutes or the time taken to prepare each response).
7. An Explanation of the Change in Estimates: Due to fewer limited explosive permitees, both the total responses and burden hours have reduced by 25 and 13 hours respectively since the last renewal in 2019.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, Mail Stop 3.E-405A, Washington, DC 20530.
Dated: April 19, 2022.
Melody Braswell,

Department Clearance Officer for PRA, U.S. Department of Justice.
DEPARTMENT OF LABOR
Agency Information Collection Activities; Submission for OMB Review; Comment Request; No Surprises Act: IDR Process

ACTION:
Notice of availability; request for comments.

SUMMARY:
The Department of Labor (DOL) is submitting this Employee Benefits Security Administration (EBSA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

DATES:
The OMB will consider all written comments that the agency receives on or before May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) if the information will be processed and used in a timely manner; (3) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (4) ways to enhance the quality, utility and clarity of the information collection; and (5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

FOR FURTHER INFORMATION CONTACT:
Mara Blumenthal by telephone at 202-693-8538, or by email at DOL_PRA_PUBLIC@dol.gov.

SUPPLEMENTARY INFORMATION:
On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA), which includes the No Surprises Act, was signed into law. The No Surprises Act provides Federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise bills arise most frequently. Section 102 of the No Surprises Act added Code section 9816, ERISA section 716, and PHS Act section 2799A-1, which contain limitations on cost sharing and requirements for initial payments for emergency services. In addition, Section 103 of the No Surprises Act amended Code section 9816, ERISA section 716, and PHS Act section 2799A-1 to establish a Federal independent dispute resolution (Federal IDR) process that nonparticipating providers or facilities and group health plans and health insurance issuers in the group and individual market may use following the end of an unsuccessful open negotiation period to determine the out-of-network rate for certain services. The Federal IDR process requires a number of disclosures from plans, issuers, FEHB carriers, and nonparticipating providers or nonparticipating emergency facilities. For additional substantive information about this ICR, see the related notice published in the Federal Register on November 9, 2021 (86 FR 62206). On April 5, 2022, the Department of Labor submitted another emergency request to revise the ICR to remove language to be consistent with the federal court ruling in the U.S. District Court for the Eastern District of Texas on the Interim Final Rule, Requirements Related to Surprise Billing; Part II ( Texas Medical Association v. HHS ). The ICR Revision was approved by OMB on April 11, 2022. The Departments welcome comments on those revisions. For additional substantive information, see the related submission at https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1210-0169.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Agency: DOL-EBSA.
Title of Collection: No Surprises Act: IDR Process.
OMB Control Number: 1210-0169.
Affected Public: Private Sector—Businesses or other for-profits and not-for-profit institutions.
Total Estimated Number of Respondents: 22,428.
Total Estimated Number of Responses: 36,964.
Total Estimated Annual Time Burden: 68,193 hours.
Total Estimated Annual Other Costs Burden: $545,727.
(Authority: 44 U.S.C. 3507(a)(1)(D))
Dated: April 19, 2022.
Mara Blumenthal,

Senior PRA Analyst.
NATIONAL CREDIT UNION ADMINISTRATION
Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:
National Credit Union Administration (NCUA).

ACTION:
Notice and request for comment.

SUMMARY:
The National Credit Union Administration (NCUA), as part of a continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the following extensions of currently approved collections, as required by the Paperwork Reduction Act of 1995.

DATES:
Written comments should be received on or before June 24, 2022 to be assured consideration.

ADDRESSES:
Interested persons are invited to submit written comments on the information collection to Dawn Wolfgang, National Credit Union Administration, 1775 Duke Street, Suite 6032, Alexandria, Virginia 22314; email at PRAComments@NCUA.gov. Given the limited in-house staff because of the COVID-19 pandemic, email comments are preferred.

FOR FURTHER INFORMATION CONTACT:
Requests for additional information should be directed to Dawn Wolfgang at the address above or telephone 703-548-2279.

SUPPLEMENTARY INFORMATION:
OMB Number: 3133-0004.
Title: NCUA Call Report.
Form: NCUA Form 5300.
Type of Review: Extension of a currently approved collection.
Abstract: Sections 106 and 202 of the Federal Credit Union Act require federally insured credit unions to make financial reports to the NCUA. Section 741.5 prescribes the method in which federally insured credit unions must submit this information to the NCUA. NCUA Form 5300, Call Report, is used to file quarterly financial and statistical data through the NCUA's online portal, CUOnline.
The financial and statistical information is essential to the NCUA in carrying out its responsibility for supervising federal credit unions. The information also enables the NCUA to monitor all federally insured credit unions with National Credit Union Share Insurance Fund (NCUSIF) insured share accounts.
Affected Public: Private Sector: Not-for-profit institutions.
Estimated No. of Respondents: 5,097.
Estimated No. of Responses per Respondent: 4.
Estimated Total Annual Responses: 20,388.
Estimated Burden Hours per Response: 4.
Estimated Total Annual Burden Hours: 81,552.
Reason for Change: The Office of Management and Budget (OMB) approved a revision to this information collection requirement as an emergency in accordance with 5 CFR 1320.13, which is set to expire July 31, 2022. The Call Report was restructured to accommodate the Complex Credit Union Leverage Ratio (CCULR) Calculation schedule by adding a schedule for the CCULR Calculation and to reestablish the account code for the collection of Noncontrolling Interest in Consolidated Subsidiaries (previously described as Miscellaneous Equity and erroneously omitted from the Form 5300). The CCULR changes were attributed to a final rule published December 23, 2021, at 86 FR 72784, that provided a simplified measure of capital adequacy for federally insured, natural-person credit unions classified as complex.
OMB Number: 3133-0185.
Title: NCUA Vendor Registration Form.
Form: NCUA Form 1772.
Type of Review: Extension of a currently approved collection.
Abstract: Section 342 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Act) (Pub. L. 111-203) calls for agencies to promote the inclusion of minority and women-owned firms in their business activities. The Act also requires agencies to annually report to Congress the total amounts paid to minority and women-owned businesses. In order for NCUA to comply with this Congressional mandate, NCUA Form 1772 is used to collect certain information from its current and potential vendors, so that it can identify businesses that meet the criteria. The vendor information is to be submitted to the agency on a one-time basis and will be used to assign an ownership status to the vendor ( i.e., minority-owned business, woman-owned business) per the requirements of the Act. The NCUA will use the vendor-entered ownership status information to help calculate the total amounts of contracting dollars awarded and paid to minority-owned and women-owned businesses.
Affected Public: Private Sector: Businesses or other for-profits.
Estimated No. of Respondents: 200.
Estimated Annual Frequency: 1.
Estimated Annual Number of Responses: 200.
Estimated Burden Hours per Response: 10 minutes.
Estimated Total Annual Burden Hours: 33.
Request for Comments: Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will become a matter of public record. The public is invited to submit comments concerning: (a) Whether the collection of information is necessary for the proper execution of the function of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of the information on the respondents, including the use of automated collection techniques or other forms of information technology.
By Melane Conyers-Ausbrooks, Secretary of the Board, the National Credit Union Administration, on April 19, 2022.
Dated: April 20, 2022.
Dawn D. Wolfgang,

NCUA PRA Clearance Officer.
NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES
National Endowment for the Arts
Federal Advisory Committee on International Exhibitions Meeting

AGENCY:
National Endowment for the Arts

ACTION:
Notice of meeting.

SUMMARY:
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that one meeting of the Federal Advisory Committee on International Exhibitions will be held by teleconference or videoconference.

DATES:
See the SUPPLEMENTARY INFORMATION section for individual meeting times and dates. All meetings are Eastern time and ending times are approximate:

ADDRESSES:
National Endowment for the Arts, Constitution Center, 400 7th St. SW, Washington, DC, 20506.

FOR FURTHER INFORMATION CONTACT:
Further information with reference to this meeting can be obtained from Daniel Beattie, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC, 20506; beattied@arts.gov, or call 202/682-5688.

SUPPLEMENTARY INFORMATION:
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chair of March 11, 2022, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.
The upcoming meeting is:
Federal Advisory Committee on International Exhibitions (review of applications):
This meeting will be closed.
Date and time: May 12, 2022, 2:00 p.m. to 4:00 p.m.
Dated: April 20, 2022.
Daniel Beattie,

Director, National Endowment for the Arts.
NUCLEAR REGULATORY COMMISSION
[NRC-2022-0023]
Information Collection: Cooperation With States at Commercial Nuclear Power Plants and Other Nuclear Production and Utilization Facilities, Policy Statement

AGENCY:
Nuclear Regulatory Commission.

ACTION:
Renewal of existing information collection; request for comment.

SUMMARY:
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, “Cooperation with States at Commercial Nuclear Power Plants and Other Nuclear Production and Utilization Facilities, Policy Statement.”

DATES:
Submit comments by June 24, 2022. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

ADDRESSES:
You may submit comments by any of the following however, the NRC encourages electronic comment submission through the Federal rulemaking website:
• Federal rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2022-0023. Address questions about Docket IDs in Regulations.gov to Stacy Schumann; telephone: 301-415-0624; email: Stacy.Schumann@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.
• Mail comments to: David Cullison, Office of the Chief Information Officer, Mail Stop: T-6 A10M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:
David C. Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: Infocollects.Resource@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Obtaining Information and Submitting Comments

A. Obtaining Information
Please refer to Docket ID NRC-2022-0023 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2022-0023. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2022-0023 on this website.
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to PDR.Resource@nrc.gov. A copy of the collection of information and related instructions may be obtained without charge by accessing ADAMS Accession No. ML22088A049. The supporting statement is available in ADAMS under Accession No. ML22021B056.
• NRC's PDR: You may examine and purchase copies of public documents, by appointment, at the NRC's PDR, Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal holidays.
• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: Infocollects.Resource@nrc.gov.

B. Submitting Comments
The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2022-0023, in your comment submission.
The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at https://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.
If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

II. Background
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized below.
1. The title of the information collection: Cooperation with States at Commercial Nuclear Power Plants and Other Nuclear Production and Utilization Facilities, Policy Statement.
2. OMB approval number: 3150-0163.
3. Type of submission: Extension.
4. The form number, if applicable: Not applicable.
5. How often the collection is required or requested: On occasion, when a State or Federally recognized Indian Tribe wishes to observe NRC inspections or perform inspections for the NRC or when a State or Federally recognized Indian Tribe wishes to negotiate an agreement to observe or perform inspections. States with an instrument of cooperation or a State Resident Engineer have both regular reporting and occasion-specific reporting.
6. Who will be required or asked to respond: States and Federally recognized Tribes interested in observing or performing inspections.
7. The estimated number of annual responses: 207.
8. The estimated number of annual respondents: 33.
9. The estimated number of hours needed annually to comply with the information collection requirement or request: 1,291.
10. Abstract: States and Federally recognized Indian Tribes are involved and interested in monitoring the safety status of nuclear power plants and other nuclear production and utilization facilities. This involvement is, in part, in response to the States' and Tribes' public health and safety responsibilities and, in part, in response to their citizens' desire to become more knowledgeable about the safety of nuclear power plants and other nuclear production and utilization facilities. States and Tribes have identified NRC inspections as one possible source of knowledge for their personnel regarding NRC licensee activities, and the NRC, through the policy statement, “Cooperation With States at Commercial Nuclear Power Plants and Other Nuclear Production or Utilization Facilities” (57 FR 6462; February 25, 1992), has been amenable to accommodating States' and Tribes' needs in this regard. The NRC uses the information collected under this information collection requirement to allow States and Federally recognized Indian Tribes to participate in or observe inspections at NRC-licensed facilities. The types of information collected include written requests identifying specific inspections States and Tribes wish to observe; identification-related information required for site access to NRC-licensed facilities; training and qualifications of State and Tribal personnel participating in inspections; information required to define inspection roles for States and Tribes; and information to coordinate NRC and State and Tribal inspections.

III. Specific Requests for Comments
The NRC is seeking comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the estimate of the burden of the information collection accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
Dated: April 20, 2022.
For the Nuclear Regulatory Commission.
David C. Cullison,

NRC Clearance Officer, Office of the Chief Information Officer.
PENSION BENEFIT GUARANTY CORPORATION
Submission of Information Collection for OMB Review; Comment Request; Medical Exception Request

AGENCY:
Pension Benefit Guaranty Corporation.

ACTION:
Notice of request for extension of OMB approval of information collection.

SUMMARY:
The Pension Benefit Guaranty Corporation (PBGC) is requesting that the Office of Management and Budget (OMB) extend approval, without change, under the Paperwork Reduction Act (PRA), of a collection of information for its employees to request a medical exception to the COVID-19 vaccination requirement.

DATES:
Comments must be submitted by May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
A copy of the request will be posted on PBGC's website at https://www.pbgc.gov/prac/laws-and-regulation/federal-register-notices-open-for-comment. It may also be obtained without charge by writing to the Disclosure Division of the Office of the General Counsel of PBGC, 1200 K Street NW, Washington, DC 20005-4026; or, calling 202-229-4040 during normal business hours. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.

FOR FURTHER INFORMATION CONTACT:
Melissa Rifkin ( rifkin.melissa@pbgc.gov ), Attorney, Regulatory Affairs Division, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW, Washington, DC 20005-4026; 202-229-6563. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.

SUPPLEMENTARY INFORMATION:
Under Executive Order 14043, every Federal agency must “implement, to the extent consistent with applicable law, a program to require COVID-19 vaccination for all of its Federal employees, with exceptions only as required by law.” In following this directive, the Pension Benefit Guaranty Corporation (PBGC) imposed a requirement that its employees must receive and submit proof of a COVID-19 vaccination. As required by 29 U.S.C. 701 et seq. and 29 CFR part 1630, PBGC allows an exception from the vaccination requirement for employees who demonstrate medical reasons or disabilities that would make the COVID-19 vaccine unsafe for them. To obtain this exception, employees must complete the Request for Medical Exception to COVID-19 Vaccination Requirement form. PBGC uses the information on this form to verify employees' assertions that they are entitled to an exception to the COVID-19 vaccination requirement because of their medical or disability statuses.
The medical exception request collection of information has been approved by OMB under control number 1212-0075 (expires May 31, 2022). On February 14, 2022, PBGC published in the Federal Register (at 87 FR 8303) a notice informing the public of its intent to request an extension of this collection of information. PBGC received one comment, and the commenter expressed support for the exemption, noting that some employees may have disabling conditions. PBGC is requesting that OMB extend approval of the collection for 3 years. 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.
PBGC estimates that an average of 2 employees each year will submit Request for Medical Exception to COVID-19 Vaccination Requirement forms. The total estimated annual burden of the collection of information is 0.5 hours and $0.

A Notice Regarding Injunctions
As of the date that PBGC submitted this notice to the Federal Register , the vaccination requirement issued pursuant to E.O. 14043 is currently the subject of a nationwide injunction. While that injunction remains in place, PBGC will not process requests for a medical exception from the COVID-19 vaccination requirement pursuant to E.O. 14043. PBGC will also not request the submission of any medical information related to a request for an exception from the vaccination requirement pursuant to E.O. 14043 while the injunction remains in place. But PBGC may nevertheless receive information regarding a medical exception. That is because, if PBGC were to receive a request for an exception from the COVID-19 vaccination requirement pursuant to E.O. 14043 during the pendency of the injunction, PBGC will accept the request, hold it in abeyance, and notify the employee who submitted the request that implementation and enforcement of the COVID-19 vaccination requirement pursuant to E.O. 14043 is currently enjoined and that an exception therefore is not necessary so long as the injunction is in place. In other words, during the pendency of the injunction, any information collection related to requests for medical exception from the COVID-19 vaccination requirement pursuant to E.O. 14043 is not undertaken to implement or enforce the COVID-19 vaccination requirement.
Issued in Washington, DC.
Hilary Duke,

Assistant General Counsel for Regulatory Affairs, Pension Benefit Guaranty Corporation.
POSTAL REGULATORY COMMISSION
[Docket No. N2022-1; Presiding Officer's Ruling No. 1]
Service Standard Changes

AGENCY:
Postal Regulatory Commission.

ACTION:
Notice.

SUMMARY:
The Commission is providing notice that a hearing and certain procedural events have been removed from the procedural schedule in this proceeding. This notice informs the public of the modified procedural schedule.

ADDRESSES:
For additional information, Presiding Officer's Ruling No. 1 can be accessed electronically through the Commission's website at https://www.prc.gov.

FOR FURTHER INFORMATION CONTACT:
David A. Trissell, General Counsel, at 202-789-6820.

SUPPLEMENTARY INFORMATION:
On April 14, 2022, the Postal Service filed a motion for consideration of its stipulation and agreement regarding the advisory opinion in this proceeding in accordance with 39 CFR 3010.320. ^1 The Stipulation and Agreement, negotiated between the only two parties in this proceeding—the Postal Service and the Public Representative, concerns certain procedural and evidentiary matters. Specifically, the Postal Service and the Public Representative agree that the direct testimony of Postal Service witnesses, supporting Library References, and any designated response to the Presiding Officer's Information Requests provide substantial evidence supporting an advisory opinion. Motion, Stipulation and Agreement at 2.
^1 Motion of the United States Postal Service for Consideration of the Stipulation and Agreement as the Basis for Advisory Opinion, April 14, 2022 (Motion).
They also agree that neither a hearing nor oral argument or examination are necessary in determining whether the proposed service standard changes are in accordance with the policies of Title 39 of the United States Code and in furtherance of the public interest. Id. In addition, they agree that they will file no further discovery requests or testimony, unless requested by the Commission. However, both parties reserve the right to submit initial or reply briefs, if necessary. Id.
The Postal Service states that it will move for the admission into record evidence the testimonies and supporting documentation. Id. The Postal Service also states that it will move for the adoption of a revised procedural schedule, removing the dates for the hearing, modifying the deadline to file designated materials, and shortening the time to file reply briefs, if necessary:
• Deadline of Discovery Requests: April 18, 2022
• Deadline for Discovery Responses: April 25, 2022
• Notice of Designations: April 26, 2022
• Filing Designated Materials: April 27, 2022
• Initial Brief: May 11, 2022
• Statements of Position: May 11, 2022
• Reply Brief (if needed): May 13, 2022
Id. at 2-3. The Motion is granted. Having considered the Stipulation and Agreement, the Presiding Officer finds that, based on the agreement between parties, certain procedural events can be removed from the schedule. See 39 CFR 3020.110(b). Moreover, adopting the Stipulation and Agreement will not affect the ability of interested parties to participate ( i.e., file statements of position) in this proceeding.
Accordingly, the Presiding Officer adopts the revised schedule as proposed by the Postal Service. ^2 Accompanying this Ruling is an updated version of the Procedural Schedule (Attachment) for Docket No. N2022-1.
^2 The Postal Service has not yet filed its motion to admit evidence into the record. On April 15, 2022, the Postal Service filed a notice of revisions to certain direct testimonies and stated that the revised pages will be incorporated into the final version of those testimonies when they are presented for inclusion into the evidentiary record. See Notice of the United States Postal Service of Revisions to Certain Pages of USPS-T-1 and USPS-T-3—Errata, April 15, 2022, at 1-2. The Presiding Officer will rule on the Postal Service's motion once it has been filed.

Ruling
It is ordered:
1. The Motion of the United States Postal Service for Consideration of the Stipulation and Agreement as the Basis for Advisory Opinion, filed April 14, 2022, is granted.
2. The modified procedural schedule for this proceeding is set forth below the signature of this Ruling.
3. The Secretary shall arrange for publication of this Ruling in the Federal Register .
Erica A. Barker,

Secretary.
Procedural Schedule for Docket No. N2022-1
[Updated April 19, 2022]
Discovery Deadlines for the Postal Service's Direct Case:
Filing of Discovery Requests | April 18, 2022.
Filing of the Postal Service's Answers to Discovery | April 25, 2022.
Deadlines in Preparation for Hearing (assuming no rebuttal case):
Filing of Notice of Designations | April 26, 2022.
Filing of Notices of Designated Materials | April 27, 2022.
Briefing Deadlines:
Filing of Initial Briefs | May 11, 2022.
| Filing of Reply Briefs | May 13, 2022.
Statement of Position Deadline:
Filing of Statement of Position | May 11, 2022.
Advisory Opinion Deadline:
Filing of Advisory Opinion (absent determination of good cause for extension) | June 21, 2022.
SECURITIES AND EXCHANGE COMMISSION
[Release No. 34-94744; File No. SR-CboeBZX-2022-017]
Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Designation of Longer Period for Commission Action on a Proposed Rule Change To Amend BZX Rule 11.17, Clearly Erroneous Executions
April 19, 2022.
On March 7, 2022, Cboe BZX Exchange, Inc. (“BZX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) ^1 and Rule 19b-4 thereunder, ^2 a proposed rule change to (i) make the current clearly erroneous execution (“CEE”) pilot program permanent, and (ii) limit the circumstances where CEE reviews would continue to be available during Regular Trading Hours. ^3 The proposed rule change was published for comment in the Federal Register on March 11, 2022. ^4 The Commission has received no comment letters on the proposed rule change.
^1 15 U.S.C. 78s(b)(1).
^2 17 CFR 240.19b-4.
^3 The term “Regular Trading Hours” means the time between 9:30 a.m. and 4:00 p.m. Eastern Time. See BZX Rule 1.5(w).
^4 See Securities Exchange Act Release No. 94374 (March 7, 2022), 87 FR 14062.
Section 19(b)(2) of the Act ^5 provides that, within 45 days of the publication of notice of the filing of a proposed rule change, or within such longer period up to 90 days as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or as to which the self-regulatory organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether the proposed rule change should be disapproved. The 45th day after publication of the notice for this proposed rule change is April 25, 2022.
^5 15 U.S.C. 78s(b)(2).
The Commission hereby is extending the 45-day time period for Commission action on the proposed rule change. The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, pursuant to Section 19(b)(2) of the Act, ^6 the Commission designates June 9, 2022, as the date by which the Commission shall either approve or disapprove, or institute proceedings to determine whether to disapprove, the proposed rule change (File No. SR-CboeBZX-2022-017).
^6 Id.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. ^7
^7 17 CFR 200.30-3(a)(31).
J. Matthew DeLesDernier,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
Sunshine Act Meetings

TIME AND DATE:
2 p.m. on Thursday, April 28, 2022.

PLACE:
The meeting will be held via remote means and/or at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS:
This meeting will be closed to the public.

MATTERS TO BE CONSIDERED:
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at https://www.sec.gov.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
The subject matter of the closed meeting will consist of the following topics:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to examinations and enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting agenda items that may consist of adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION:
For further information; please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Authority: 5 U.S.C. 552b.
Dated: April 21, 2022.
Vanessa A. Countryman,

Secretary.
SECURITIES AND EXCHANGE COMMISSION
[SEC File No. 270-448, OMB Control No. 3235-0507]
Proposed Collection; Comment Request
Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736
Extension:
Rule 19b-5 and Form PILOT
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501 et seq. ), the Securities and Exchange Commission (“SEC”) is soliciting comments on the existing collection of information provided for in Rule 19b-5 (17 CFR 240.19b-5) and Form PILOT (17 CFR 249.821) under the Securities Exchange Act of 1934 (“Exchange Act”) (15 U.S.C. 78a et seq. ). The SEC plans to submit this existing collection of information to the Office of Management and Budget (“OMB”) for extension and approval.
Rule 19b-5 provides a temporary exemption from the rule-filing requirements of Section 19(b) of the Exchange Act (15 U.S.C. 78s(b)) to self-regulatory organizations (“SROs”) wishing to establish and operate pilot trading systems. Rule 19b-5 permits an SRO to develop a pilot trading system and to begin operation of such system shortly after submitting an initial report on Form PILOT to the SEC. During operation of any such pilot trading system, the SRO must submit quarterly reports of the system's operation to the SEC, as well as timely amendments describing any material changes to the system. Within two years of operating such pilot trading system under the exemption afforded by Rule 19b-5, the SRO must submit a rule filing pursuant to Section 19(b)(2) of the Exchange Act (15 U.S.C. 78s(b)(2)) to obtain permanent approval of the pilot trading system from the SEC.
The collection of information is designed to allow the SEC to maintain an accurate record of all new pilot trading systems operated by SROs and to determine whether an SRO has properly availed itself of the exemption afforded by Rule 19b-5, is operating a pilot trading system in compliance with the Exchange Act, and is carrying out its statutory oversight obligations under the Exchange Act.
The respondents to the collection of information are national securities exchanges and national securities associations.
There are 24 SROs which could avail themselves of the exemption under Rule 19b-5 and the use of Form PILOT. The SEC estimates that approximately one of these SROs each year will file on Form PILOT one initial report ( i.e., 1 report total, for an estimated annual burden of 24 hours total), four quarterly reports ( i.e., 4 reports total, for an estimated annual burden of 12 hours total (3 hours per report)), and two amendments ( i.e., 2 reports total, for an estimated annual burden of 6 hours total (3 hours per report)). Thus, the estimated annual time burden resulting from Form PILOT is 42 hours for the estimated sole SRO respondent. The SEC estimates that the aggregate annual internal cost of compliance for the sole SRO respondent is approximately $12,880 (42 hours at an average of $306.67 per hour). In addition, the SEC estimates that the sole SRO respondent will incur, in the aggregate, printing, supplies, copying, and postage expenses of $2,287 per year for filing initial reports, $1,142 per year for filing quarterly reports, and $571 per year for filing notices of material systems changes, for a total annual cost burden of $4,000.
Written comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the SEC, including whether the information shall have practical utility; (b) the accuracy of the SEC's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted by June 24, 2022.
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.
Please direct your written comments to: David Bottom, Director/Chief Information Officer, Securities and Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC 20549, or send an email to: PRA_Mailbox@sec.gov.
Dated: April 19, 2022.
J. Matthew DeLesDernier,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[Release No. 34-94749; File No. SR-CboeBZX-2022-028]
Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Current Pilot Program Related to BZX Rule 11.17, Clearly Erroneous Executions, to the Close of Business on July 20, 2022
April 19, 2022.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”), ^1 and Rule 19b-4 thereunder, ^2 notice is hereby given that on April 18, 2022, Cboe BZX Exchange, Inc. (the “Exchange” or “BZX”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange filed the proposal as a “non-controversial” proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act ^3 and Rule 19b-4(f)(6) thereunder. ^4 The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
^1 15 U.S.C. 78s(b)(1).
^2 17 CFR 240.19b-4.
^3 15 U.S.C. 78s(b)(3)(A)(iii).
^4 17 CFR 240.19b-4(f)(6).

I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change
Cboe BZX Exchange, Inc. (“BZX” or the “Exchange”) is filing with the Securities and Exchange Commission (the “Commission”) a proposed rule change to extend the current pilot program related to BZX Rule 11.17, Clearly Erroneous Executions, to the close of business on July 20, 2022. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website ( http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/ ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change
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.

A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

1. Purpose
The purpose of this filing is to extend the effectiveness of the Exchange's current rule applicable to Clearly Erroneous Executions to the close of business on July 20, 2022. Portions of Rule 11.17, explained in further detail below, are currently operating as a pilot program set to expire on April 20, 2022. ^5
^5 See Securities Exchange Act Release No. 93343 (October 15, 2021), 86 FR 58347 (October 21, 2021) (SR-CboeBZX-2021-070).
On September 10, 2010, the Commission approved, on a pilot basis, changes to BZX Rule 11.17 that, among other things: (i) Provided for uniform treatment of clearly erroneous execution reviews in multi-stock events involving twenty or more securities; and (ii) reduced the ability of the Exchange to deviate from the objective standards set forth in the rule. ^6 In 2013, the Exchange adopted a provision designed to address the operation of the Plan. ^7 Finally, in 2014, the Exchange adopted two additional provisions providing that: (i) A series of transactions in a particular security on one or more trading days may be viewed as one event if all such transactions were effected based on the same fundamentally incorrect or grossly misinterpreted issuance information resulting in a severe valuation error for all such transactions; and (ii) in the event of any disruption or malfunction in the operation of the electronic communications and trading facilities of an Exchange, another SRO, or responsible single plan processor in connection with the transmittal or receipt of a trading halt, an Officer, acting on his or her own motion, shall nullify any transaction that occurs after a trading halt has been declared by the primary listing market for a security and before such trading halt has officially ended according to the primary listing market. ^8
^6 See Securities Exchange Act Release No. 62886 (September 10, 2010), 75 FR 56613 (September 16, 2010) (SR-BATS-2010-016).
^7 See Securities Exchange Act Release No. 68797 (January 31, 2013), 78 FR 8635 (February 6, 2013) (SR-BATS-2013-008).
^8 See Securities Exchange Act Release No. 72434 (June 19, 2014), 79 FR 36110 (June 25, 2014) (SR-BATS-2014-014).
On December 26, 2018, the Commission published the proposed Eighteenth Amendment ^9 to the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS under the Act (the “Limit Up-Limit Down Plan” or the “Plan”) ^{10} to allow the Plan to operate on a permanent, rather than pilot, basis. On April 8, 2019, the Exchange amended BZX Rule 11.17 to untie the pilot program's effectiveness from that of the Plan and to extend the pilot's effectiveness to the close of business on October 18, 2019 in order allow the Exchange and other national securities exchanges additional time to consider further amendments, if any, to the clearly erroneous execution rules in light of the proposed Eighteenth Amendment to the Plan. ^{11} On April 17, 2019, the Commission published an approval of the Eighteenth Amendment to allow the Plan to operate on a permanent, rather than pilot, basis. ^{12} On October 21, 2019, the Exchange amended BZX Rule 11.17 to extend the pilot's effectiveness to the close of business on April 20, 2020. ^{13} On March 18, 2020, the Exchange amended BZX Rule 11.17 to extend the pilot's effectiveness to the close of business on October 20, 2020. ^{14} On October 20, 2020, the Exchange amended BZX Rule 11.17 to extend the pilot's effectiveness to the close of business on April 20, 2021. ^{15} On April 14, 2021 the Exchange amended BZX Rule 11.17 to extend the pilot's effectiveness to the close of business on October 20, 2021. ^{16} Finally, on October 15, 2021 the Exchange amended BZX Rule 11.17 to extend the pilot's effectiveness to the close of business on April 20, 2022. ^{17}
^9 See Securities Exchange Act Release No. 84843 (December 18, 2018), 83 FR 66464 (December 26, 2018) (File No. 4-631) (“Eighteenth Amendment”).
^{10} See Securities Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6, 2012) (the “Limit Up-Limit Down Release”).
^{11} See Securities Exchange Act Release No. 85543 (April 8, 2019), 84 FR 15018 (April 12, 2019) (SR-CboeBZX-2019-022).
^{12} See Securities Exchange Act Release No. 85623 (Apr. 11, 2019), 84 FR 16086 (Apr. 17, 2019) (File No. 4-631).
^{13} See Securities Exchange Act Release No. 87365 (October 21, 2019), 84 FR 57540 (October 25, 2019) (SR-CboeBZX-2019-089).
^{14} See Securities Exchange Act Release No. 88497 (March 27, 2020), 85 FR 18602 (April 2, 2020) (SR-CboeBZX-2020-026).
^{15} See Securities Exchange Act Release No. 90230 (October 20, 2020), 85 FR 67802 (Oct. 26, 2020) (SR-CboeBZX-2020-077).
^{16} See Securities Exchange Act Release No. 20583 (April 14, 2021), 86 FR 20580 (April 20, 2021) (SR-CboeBZX-2021-027).
^{17} See supra note 5.
Other self-regulatory organizations (“SROs”), including the Exchange, have worked on a proposed rule change to make the pilot rules permanent. The Exchange filed such a proposed rule change on March 7, 2022. ^{18} The Exchange now proposes to amend BZX Rule 11.17 to extend the pilot's effectiveness an additional three months to the close of business on July 20, 2022 while the Commission considers the Exchange's proposal to make the pilot rules permanent. The Exchange understands that the other national securities exchanges and Financial Industry Regulatory Authority (“FINRA”) have filed or plan to file similar proposals to extend their respective clearly erroneous execution pilot programs, the substance of which are identical to BZX Rule 11.17. The Exchange does not propose any additional changes to BZX Rule 11.17. The Exchange believes the benefits to market participants from the more objective clearly erroneous executions rule should continue on a limited three month pilot basis.
^{18} See Securities Exchange Act Release No. 94374 (March 7, 2022), 87 FR 14062 (March 11, 2022) (SR-CboeBZX-2022-017).

2. Statutory Basis
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act. ^{19} Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) ^{20} requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) ^{21} requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
^{19} 15 U.S.C. 78f(b).
^{20} 15 U.S.C. 78f(b)(5).
^{21} Id.
In particular, the Exchange believes that extending the clearly erroneous execution pilot under BZX Rule 11.17 for an additional three months would help assure that the determination of whether a clearly erroneous trade has occurred will be based on clear and objective criteria, and that the resolution of the incident will occur promptly through a transparent process. The proposed rule change would also help assure consistent results in handling erroneous trades across the U.S. equities markets, thus furthering fair and orderly markets, the protection of investors and the public interest. Based on the foregoing, the Exchange believes the amended clearly erroneous executions rule should continue to be in effect on a pilot basis while the Exchange and the other national securities exchanges consider and develop a permanent proposal for clearly erroneous execution reviews.

B. Self-Regulatory Organization's Statement on Burden on Competition
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange understands that FINRA and other national securities exchanges have or will also file similar proposals to extend their respective clearly erroneous execution pilot programs. Thus, the proposed rule change will help to ensure consistency across market centers without implicating any competitive issues.

C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others
Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act ^{22} and Rule 19b-4(f)(6) thereunder. ^{23} Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act ^{24} and subparagraph (f)(6) of Rule 19b-4 thereunder. ^{25}
^{22} 15 U.S.C. 78s(b)(3)(A)(iii).
^{23} 17 CFR 240.19b-4(f)(6).
^{24} 15 U.S.C. 78s(b)(3)(A)(iii).
^{25} 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Commission has waived the five-day prefiling requirement in this case.
A proposed rule change filed under Rule 19b-4(f)(6) ^{26} normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii), ^{27} the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange asked that the Commission waive the 30 day operative delay so that the proposal may become operative immediately upon filing. Waiver of the 30-day operative delay would extend the protections provided by the current pilot program, without any changes, while the Exchange and other self-regulatory organizations consider whether further amendments to these rules are appropriate. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change as operative upon filing. ^{28}
^{26} 17 CFR 240.19b-4(f)(6).
^{27} 17 CFR 240.19b-4(f)(6)(iii).
^{28} For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments
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:

Electronic Comments
• Use the Commission's internet comment form ( http://www.sec.gov/rules/sro.shtml ); or
• Send an email to rule-comments@sec.gov. Please include File Number SR-CboeBZX-2022-028 on the subject line.

Paper Comments
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-CboeBZX-2022-028. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website ( http://www.sec.gov/rules/sro.shtml ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeBZX-2022-028 and should be submitted on or May 16, 2022.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. ^{29}
^{29} 17 CFR 200.30-3(a)(12).
J. Matthew DeLesDernier,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[Release No. 34-94748; File No. SR-CboeEDGA-2022-009]
Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Current Pilot Program Related to EDGA Rule 11.15, Clearly Erroneous Executions, to the Close of Business on July 20, 2022
April 19, 2022.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”), ^1 and Rule 19b-4 thereunder, ^2 notice is hereby given that on April 18, 2022, Cboe EDGA Exchange, Inc. (the “Exchange” or “EDGA”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange filed the proposal as a “non-controversial” proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act ^3 and Rule 19b-4(f)(6) thereunder. ^4 The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
^1 15 U.S.C. 78s(b)(1).
^2 17 CFR 240.19b-4.
^3 15 U.S.C. 78s(b)(3)(A)(iii).
^4 17 CFR 240.19b-4(f)(6).

I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change
Cboe EDGA Exchange, Inc. (“EDGA” or the “Exchange”) is filing with the Securities and Exchange Commission (the “Commission”) a proposed rule change to extend the current pilot program related to EDGA Rule 11.15, Clearly Erroneous Executions, to the close of business on July 20, 2022. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website ( http://markets.cboe.com/us/equities/regulation/rule_filings/edga/ ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change
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.

A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

1. Purpose
The purpose of this filing is to extend the effectiveness of the Exchange's current rule applicable to Clearly Erroneous Executions to the close of business on July 20, 2022. Portions of Rule 11.15, explained in further detail below, are currently operating as a pilot program set to expire on April 20, 2022. ^5
^5 See Securities Exchange Act Release No. 93344 (October 15, 2021), 86 FR 58352 (October 21, 2021) (SR-CboeEDGA-2021-022).
On September 10, 2010, the Commission approved, on a pilot basis, changes to EDGA Rule 11.15 that, among other things: (i) Provided for uniform treatment of clearly erroneous execution reviews in multi-stock events involving twenty or more securities; and (ii) reduced the ability of the Exchange to deviate from the objective standards set forth in the rule. ^6 In 2013, the Exchange adopted a provision designed to address the operation of the Plan. ^7 Finally, in 2014, the Exchange adopted two additional provisions providing that: (i) A series of transactions in a particular security on one or more trading days may be viewed as one event if all such transactions were effected based on the same fundamentally incorrect or grossly misinterpreted issuance information resulting in a severe valuation error for all such transactions; and (ii) in the event of any disruption or malfunction in the operation of the electronic communications and trading facilities of an Exchange, another SRO, or responsible single plan processor in connection with the transmittal or receipt of a trading halt, an Officer, acting on his or her own motion, shall nullify any transaction that occurs after a trading halt has been declared by the primary listing market for a security and before such trading halt has officially ended according to the primary listing market. ^8
^6 See Securities Exchange Act Release No. 62886 (September 10, 2010), 75 FR 56613 (September 16, 2010) (SR-EDGA-2010-03).
^7 See Securities Exchange Act Release No. 68806 (February 1, 2013), 78 FR 8670 (February 6, 2013) (SR-EDGA-2013-05).
^8 See Securities Exchange Act Release No. 72434 (June 19, 2014), 79 FR 36110 (June 25, 2014) (SR-EDGA-2014-11).
On December 26, 2018, the Commission published the proposed Eighteenth Amendment ^9 to the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS under the Act (the “Limit Up-Limit Down Plan” or the “Plan”) ^{10} to allow the Plan to operate on a permanent, rather than pilot, basis. On April 8, 2019, the Exchange amended EDGA Rule 11.15 to untie the pilot program's effectiveness from that of the Plan and to extend the pilot's effectiveness to the close of business on October 18, 2019 in order allow the Exchange and other national securities exchanges additional time to consider further amendments, if any, to the clearly erroneous execution rules in light of the proposed Eighteenth Amendment to the Plan. ^{11} On April 17, 2019, the Commission published an approval of the Eighteenth Amendment to allow the Plan to operate on a permanent, rather than pilot, basis. ^{12} On October 21, 2019, the Exchange amended EDGA Rule 11.15 to extend the pilot's effectiveness to the close of business on April 20, 2020. ^{13} On March 18, 2020, the Exchange amended EDGA Rule 11.15 to extend the pilot's effectiveness to the close of business on October 20, 2020. ^{14} On October 20, 2020, the Exchange amended EDGA Rule 11.15 to extend the pilot's effectiveness to the close of business on April 20, 2021. ^{15} On April 14, 2021 the Exchange amended EDGA Rule 11.15 to extend the pilot's effectiveness to the close of business on October 20, 2021. ^{16} Finally, on October 15, 2021 the Exchange amended EDGA Rule 11.15 to extend the pilot's effectiveness to the close of business on April 20, 2022. ^{17}
^9 See Securities Exchange Act Release No. 84843 (December 18, 2018), 83 FR 66464 (December 26, 2018) (File No. 4-631) (“Eighteenth Amendment”).
^{10} See Securities Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6, 2012) (the “Limit Up-Limit Down Release”).
^{11} See Securities Exchange Act Release No. 85544 (April 8, 2019), 84 FR 15011 (April 12, 2019) (SR-CboeEDGA-2019-005).
^{12} See Securities Exchange Act Release No. 85623 (Apr. 11, 2019), 84 FR 16086 (Apr. 17, 2019) (File No. 4-631).
^{13} See Securities Exchange Act Release No. 87366 (October 21, 2019), 84 FR 57538 (October 25, 2019) (SR-CboeEDGA-2019-017).
^{14} See Securities Exchange Act Release No. 88499 (March 27, 2020), 85 FR 18604 (April 2, 2020) (SR-CboeEDGA-2020-009).
^{15} See Securities Exchange Act Release No. 90235 (October 21, 2021), 85 FR 68097 (October 27, 2020) (SR-CboeEDGA-2020-027).
^{16} See Securities Exchange Act Release No. 91556 (April 14, 2021), 86 FR 20550 (April 20, 2021) (SR-CboeEDGA-2021-008).
^{17} Supra note 5.
Other self-regulatory organizations (“SROs”), including the Exchange, have worked on a proposed rule change to make the pilot rules permanent. Cboe BZX Exchange, Inc., (“BZX”) filed such a proposed rule change on March 7, 2022. ^{18} The Exchange now proposes to amend EDGA Rule 11.15 to extend the pilot's effectiveness an additional three months to the close of business on July 20, 2022 while the Commission considers the BZX proposal. The Exchange understands that the other national securities exchanges and Financial Industry Regulatory Authority (“FINRA”) have filed or plan to file similar proposals to extend their respective clearly erroneous execution pilot programs, the substance of which are identical to EDGA Rule 11.15. The Exchange does not propose any additional changes to EDGA Rule 11.15. The Exchange believes the benefits to market participants from the more objective clearly erroneous executions rule should continue on a limited three month pilot basis.
^{18} See Securities Exchange Act Release No. 94374 (March 7, 2022), 87 FR 14062 (March 11, 2022) (SR-CboeBZX-2022-017).

2. Statutory Basis
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act. ^{19} Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) ^{20} requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) ^{21} requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
^{19} 15 U.S.C. 78f(b).
^{20} 15 U.S.C. 78f(b)(5).
^{21} Id.
In particular, the Exchange believes that extending the clearly erroneous execution pilot under EDGA Rule 11.15 for an additional three months would help assure that the determination of whether a clearly erroneous trade has occurred will be based on clear and objective criteria, and that the resolution of the incident will occur promptly through a transparent process. The proposed rule change would also help assure consistent results in handling erroneous trades across the U.S. equities markets, thus furthering fair and orderly markets, the protection of investors and the public interest. Based on the foregoing, the Exchange believes the amended clearly erroneous executions rule should continue to be in effect on a pilot basis while the Exchange and the other national securities exchanges consider and develop a permanent proposal for clearly erroneous execution reviews.

B. Self-Regulatory Organization's Statement on Burden on Competition
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange understands that FINRA and other national securities exchanges have or will also file similar proposals to extend their respective clearly erroneous execution pilot programs. Thus, the proposed rule change will help to ensure consistency across market centers without implicating any competitive issues.

C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others
Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act ^{22} and Rule 19b-4(f)(6) thereunder. ^{23} Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act ^{24} and subparagraph (f)(6) of Rule 19b-4 thereunder. ^{25}
^{22} 15 U.S.C. 78s(b)(3)(A)(iii).
^{23} 17 CFR 240.19b-4(f)(6).
^{24} 15 U.S.C. 78s(b)(3)(A)(iii).
^{25} 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Commission has waived the five-day prefiling requirement in this case.
A proposed rule change filed under Rule 19b-4(f)(6) ^{26} normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii), ^{27} the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange asked that the Commission waive the 30 day operative delay so that the proposal may become operative immediately upon filing. Waiver of the 30-day operative delay would extend the protections provided by the current pilot program, without any changes, while the Exchange and other self-regulatory organizations consider whether further amendments to these rules are appropriate. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change as operative upon filing. ^{28}
^{26} 17 CFR 240.19b-4(f)(6).
^{27} 17 CFR 240.19b-4(f)(6)(iii).
^{28} For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments
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:

Electronic Comments
• Use the Commission's internet comment form ( http://www.sec.gov/rules/sro.shtml ); or
• Send an email to rule-comments@sec.gov. Please include File Number SR-CboeEDGA-2022-009 on the subject line.

Paper Comments
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-CboeEDGA-2022-009. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website ( http://www.sec.gov/rules/sro.shtml ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeEDGA-2022-009 and should be submitted on or May 16, 2022.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. ^{29}
^{29} 17 CFR 200.30-3(a)(12).
J. Matthew DeLesDernier,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[Release No. 34-94746; File No. SR-NYSEArca-2021-73]
Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To List and Trade Shares of the Franklin Responsibly Sourced Gold ETF Under NYSE Arca Rule 8.201-E (Commodity-Based Trust Shares)
April 19, 2022.

I. Introduction
On August 23, 2021, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) ^1 and Rule 19b-4 thereunder, ^2 a proposed rule change to list and trade shares of the Franklin Responsibly Sourced Gold ETF under NYSE Arca Rule 8.201-E (Commodity-Based Trust Shares). The proposed rule change was published for comment in the Federal Register on September 8, 2021. ^3 On September 29, 2021, pursuant to Section 19(b)(2) of the Act, ^4 the Commission designated a longer period within which to approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to approve or disapprove the proposed rule change. ^5 On December 6, 2021, the Commission instituted proceedings pursuant to Section 19(b)(2)(B) of the Act ^6 to determine whether to approve or disapprove the proposed rule change. ^7 On February 23, 2022, pursuant to Section 19(b)(2) of the Act, ^8 the Commission designated a longer period within which to issue an order approving or disapproving the proposed rule change. ^9 On March 25, 2022, the Exchange filed Amendment No. 1 to the proposed rule change. ^{10} This Amendment No. 1, set forth in Item II below, replaces SR-NYSE Arca-2021-73 as originally filed and supersedes such filing in its entirety. The Commission has received no comment letters on the proposal. The Commission is publishing this notice to solicit comments on the proposed rule change, as modified by Amendment No. 1, from interested persons, and is approving the proposed rule change, as modified by Amendment No. 1, on an accelerated basis.
^1 15 U.S.C. 78s(b)(1).
^2 17 CFR 240.19b-4.
^3 See Securities Exchange Act Release No. 92840 (September 1, 2021), 86 FR 50385.
^4 15 U.S.C. 78s(b)(2).
^5 See Securities Exchange Act Release No. 93179, 86 FR 55033 (October 5, 2021).
^6 15 U.S.C. 78s(b)(2)(B).
^7 See Securities Exchange Act Release No. 93720, 86 FR 70555 (December 10, 2021).
^8 15 U.S.C. 78s(b)(2).
^9 See Securities Exchange Act Release No. 94302, 87 FR 11761 (March 2, 2022). The Commission designated May 6, 2022, as the date by which the Commission shall either approve or disapprove the proposed rule change.
^{10} Amendment No. 1 is available on the Commission's website at https://www.sec.gov/comments/sr-nysearca-2021-73/srnysearca202173.htm. Among other things, Amendment No. 1 to the proposed rule change provided greater detail with respect to the operation of the Trust (as defined herein) and the Fund (as defined herein), including the assets held by the Fund, the LBMA Responsible Sourcing Programme (as described herein), the Responsible Gold Guidance (as described herein), creations and redemptions of the Fund's Shares (as defined herein), determination of net asset value of the Fund's Shares, and availability of information for the Fund's Shares. Amendment No. 1 also made additional and revised representations, including that all gold held by the Fund will be London Good Delivery bars and the information related to the Shares that will be provided on the Fund's website. Finally, Amendment No. 1 provided clarifications and technical edits to the proposed rule change.

II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change

1. Purpose
The Exchange proposes to list and trade shares (“Shares”) of the Franklin Responsibly Sourced Gold ETF (the “Fund”), under NYSE Arca Rule 8.201-E. ^{11} The Fund is a series of the Franklin Templeton Holdings Trust, a Delaware statutory trust (the “Trust”). Under NYSE Arca Rule 8.201-E, the Exchange may propose to list and/or trade Commodity-Based Trust Shares pursuant to unlisted trading privileges (“UTP”). ^{12}
^{11} On April 22, 2021, the Trust submitted to the Commission its confidential draft registration statement on Form S-1 (the “Registration Statement”) under the Securities Act of 1933 (15 U.S.C. 77a) (the “Securities Act”). The Registrant confidentially submitted amendments to the Registration Statement on September 7, 2021, October 5, 2021, January 14, 2022 and February 22, 2022. The Jumpstart Our Business Startups Act, enacted on April 5, 2012, added Section 6(e) to the Securities Act. Section 6(e) of the Securities Act provides that an “emerging growth company” may confidentially submit to the Commission a draft registration statement for confidential, non-public review by the Commission staff prior to public filing, provided that the initial confidential submission and all amendments thereto shall be publicly filed not later than 21 days before the date on which the issuer conducts a road show, as such term is defined in Securities Act Rule 433(h)(4), or 15 days prior to anticipated effectiveness in the case of an issuer who will not conduct a road show. An emerging growth company is defined in Section 2(a)(19) of the Securities Act as an issuer with less than $1,070,000,000 total annual gross revenues during its most recently completed fiscal year. The Fund meets the definition of an emerging growth company and consequently has submitted its Form S-1 Registration Statement on a confidential basis with the Commission. The Registration Statement in [sic] not yet effective and the Shares will not trade on the Exchange until such time that the Registration Statement is effective.
^{12} Commodity-Based Trust Shares are securities issued by a trust that represent investors' discrete identifiable and undivided beneficial ownership interest in the commodities deposited into the trust.
The Fund will not be registered as an investment company under the Investment Company Act of 1940, as amended, ^{13} and is not required to register under such act. The Fund is not a commodity pool for purposes of the Commodity Exchange Act, as amended. ^{14}
^{13} 15 U.S.C. 80a-1.
^{14} 17 U.S.C. 1.
The sponsor of the Fund is Franklin Holdings, LLC, a Delaware limited liability company (“Sponsor”). BNY Mellon Asset Servicing, a division of The Bank of New York Mellon (“BNYM”), serves as the Fund's administrator (the “Administrator”) and transfer agent (the “Transfer Agent”). Delaware Trust Company, a subsidiary of the Corporation Service Company, serves as trustee of the Trust (the “Trustee”). The custodian of the Fund's gold bullion (“Custodian”) currently is the London branch of J.P. Morgan Chase Bank, N.A. ^{15} BNYM will serve as the custodian of the Fund's cash, if any (the “Cash Custodian”).
^{15} The Custodian is responsible for safekeeping the Fund's gold bullion. The Custodian will facilitate the transfer of gold in and out of the Fund through (i) the unallocated gold accounts it may maintain for each Authorized Participant (as defined below) or unallocated gold accounts that may be maintained for an Authorized Participant by another London Precious Metals Clearing Limited (“LPMCL”) clearing bank, and (ii) the unallocated and allocated gold accounts it will maintain for the Fund. As used herein, “Fund Allocated Account” means the allocated gold account of the Trust established with the Custodian on behalf of the Fund to be used to hold gold that is transferred from the Fund Unallocated Account to be held by the Fund in allocated form; the “Fund Unallocated Account” means the unallocated gold account of the Trust established with the Custodian on behalf of the Fund to be used to facilitate the transfer of gold in and out of the Fund Allocated Account. The Custodian is responsible for allocating specific bars of gold into and out of the Fund Allocated Account. The Custodian will provide the Fund with regular reports detailing the gold transfers into and out of the Fund Unallocated Account and the Fund Allocated Account and identifying the gold bars held in the Fund Allocated Account.
The Commission has previously approved listing on the Exchange under NYSE Arca Rules 5.2-E(j)(5) and 8.201-E of the shares of other precious metals and gold-based commodity trusts, including the GraniteShares Gold MiniBAR Trust; ^{16} GraniteShares Gold Trust; ^{17} Merk Gold Trust; ^{18} ETFS Gold Trust; ^{19} ETFS Platinum Trust ^{20} and ETFS Palladium Trust (collectively, the “ETFS Trusts”); ^{21} APMEX Physical-1 oz. Gold Redeemable Trust; ^{22} Sprott Gold Trust; ^{23} SPDR Gold Trust (formerly the streetTRACKS Gold Trust); ^{24} iShares Silver Trust; ^{25} iShares COMEX Gold Trust; ^{26} and Long Dollar Gold Trust. ^{27} Prior to their listing on the Exchange, the Commission approved listing of shares of the streetTRACKS Gold Trust on the New York Stock Exchange (“NYSE”) ^{28} and listing of shares of iShares COMEX Gold Trust and iShares Silver Trust on the American Stock Exchange LLC. ^{29} In addition, the Commission has approved trading of shares of the streetTRACKS Gold Trust and iShares Silver Trust on the Exchange pursuant to UTP. ^{30}
^{16} Securities Exchange Act Release No. 84257 (September 21, 2018), 83 FR 48877 (September 27, 2018) (SR-NYSEArca-2018-55).
^{17} Securities Exchange Act Release No. 81077 (July 5, 2017), 82 FR 32024 (July 11, 2017) (SR-NYSEArca-2017-55).
^{18} Securities Exchange Act Release No. 71378 (January 23, 2014), 79 FR 4786 (January 29, 2014) (SR-NYSEArca-2013-137).
^{19} Securities Exchange Act Release No. 59895 (May 8, 2009), 74 FR 22993 (May 15, 2009) (SR-NYSEArca-2009-40).
^{20} Securities Exchange Act Release No. 61219 (December 22, 2009), 74 FR 68886 (December 29, 2009) (SR-NYSEArca-2009-95).
^{21} Securities Exchange Act Release No. 61220 (December 22, 2009), 74 FR 68895 (December 29, 2009) (SR-NYSEArca-2009-94).
^{22} Securities Exchange Act Release No 66930 (May 7, 2012), 77 FR 27817 (May 11, 2012) (SR-NYSEArca-2012-18).
^{23} Securities Exchange Act Release No. 61496 (February 4, 2010), 75 FR 6758 (February 10, 2010) (SR-NYSEArca-2009-113).
^{24} See Securities Exchange Act Release No. 56224 (August 8, 2007), 72 FR 45850 (August 15, 2007) (SR-NYSEArca-2007-76).
^{25} See Securities Exchange Act Release No. 58956 (November 14, 2008), 73 FR 71074 (November 24, 2008) (SR-NYSEArca-2008-124) (approving listing on the Exchange of the iShares Silver Trust).
^{26} See Securities Exchange Act Release No. 56224 (August 8, 2007), 72 FR 45850 (August 15, 2007) (SR-NYSEArca-2007-76) (approving listing on the Exchange of the streetTRACKS Gold Trust); Securities Exchange Act Release No. 56041 (July 11, 2007), 72 FR 39114 (July 17, 2007) (SR-NYSEArca-2007-43) (order approving listing on the Exchange of iShares COMEX Gold Trust).
^{27} See Securities Exchange Act Release No. 79518 (December 9, 2016), 81 FR 90876 (December 15, 2016) (SR-NYSEArca-2016-84) (order approving listing and trading of shares of the Long Dollar Gold Trust).
^{28} See Securities Exchange Act Release No. 50603 (October 28, 2004), 69 FR 64614 (November 5, 2004) (SR-NYSE-2004-22) (order approving listing of streetTRACKS Gold Trust on the NYSE).
^{29} See Securities Exchange Act Release Nos. 51058 (January 19, 2005), 70 FR 3749 (January 26, 2005) (SR-Amex-2004-38) (order approving listing of iShares COMEX Gold Trust on the American Stock Exchange LLC); 53521 (March 20, 2006), 71 FR 14967 (March 24, 2006) (SR-Amex-2005-72) (approving listing on the American Stock Exchange LLC of the iShares Silver Trust).
^{30} See Securities Exchange Act Release Nos. 53520 (March 20, 2006), 71 FR 14977 (March 24, 2006) (SR-PCX-2005-117) (approving trading on the Exchange pursuant to UTP of the iShares Silver Trust); 51245 (February 23, 2005), 70 FR 10731 (March 4, 2005) (SR-PCX-2004-117) (approving trading on the Exchange of the streetTRACKS Gold Trust pursuant to UTP).
The Exchange represents that the Shares will satisfy the requirements of NYSE Arca Rule 8.201-E and thereby will qualify for listing on the Exchange. ^{31}
^{31} With respect to the application of Rule 10A-3 (17 CFR 240.10A-3) under the Act, the Fund relies on the exemption contained in Rule 10A-3(c)(7).

Operation of the Trust and Fund 32
^{32} The description of the operation of the Trust, the Fund, the Shares, and the gold market contained herein are based, in part, on the Registration Statement. See note 11, supra.
The investment objective of the Fund will be for the Shares to reflect the performance of the price of gold bullion, less the Fund's expenses. The Fund's only ordinary recurring expense is the Sponsor's annual fee. The assets of the Fund include only gold bullion and cash, if any. Shares of the Fund will represent units of fractional undivided beneficial interest in and ownership of the net assets of the Fund.
The Fund seeks to hold only “responsibly sourced gold” in its Fund Allocated Account. The Fund defines responsibly sourced gold for this purpose as London Good Delivery gold bullion bars that were refined on or after January 1, 2012 (referred to herein as “post-2012 gold”). ^{33} All post-2012 gold has been refined in accordance with London Bullion Market Association's (“LBMA”) Responsible Gold Guidance (the “Gold Guidance”). ^{34} To facilitate this, in transferring gold into and out of the Fund Allocated Account, the Custodian will, on a best efforts basis and subject to available liquidity, seek to allocate post-2012 gold. If, due to a lack of liquidity, the Custodian is unable to allocate post-2012 gold, the Custodian will do so as soon as reasonably practicable. All gold held by the Fund will be London Good Delivery bars.
^{33} LBMA Good Delivery gold bullion bars refined prior to January 1, 2012 are referred to herein as “pre-2012 gold.”
^{34} LBMA Good Delivery gold bars are currently fungible in the London OTC gold market. The Fund is not aware of and does not anticipate bifurcated pricing to develop with respect to the trading of the post-2012 gold to be held by the Fund. In the London market, precious metals are traded directly between two parties, without the involvement of an exchange. This system depends on all the bars having exactly the same specification. As described further herein, the requirements for a Good Delivery listed bar (of approximately 400 troy ounces for gold) cover: Fine ounce weight; purity; and physical appearance (including marking and surface quality). No other refined gold products produced by accredited refiners fall within the scope of the Good Delivery List as defined herein. Per World Gold Council estimates, the London OTC market comprises approximately 70% of global gold notional trading volume. As noted above, the market in London trades 400 ounce Good Delivery gold bars which are stored in the member vaults of the LPMCL and the Bank of England. Only gold bars that meet the LBMA's Good Delivery standards are acceptable in settlement of a loco London contract ( i.e., where the bullion traded is physically held in London). Currently, there are no pricing distinctions in the London OTC gold market based on individual features or characteristics of particular gold bars that are accepted as LBMA Good Delivery gold bars in settlement of a loco London contract such as country of origin or the date on which the gold was refined. Specifically, both pre-2012 gold and post-2012 gold are acceptable in settlement of OTC transactions in the London gold market, and there is no separate pricing or trading market for post-2012 gold. The Fund has no indication or basis to expect that separate markets will develop, particularly given that the Gold Guidance under the LBMA Responsible Sourcing Programme has been in existence for over nine years and to date there has been no deviation, even with the operation of similar gold-based exchange-traded funds in the US and Europe. See, for example, VanEck Merk® Gold Trust (OUNZ) ( https://www.vaneck.com/us/en/blogs/gold-investing/ounz-holds-responsibly-sourced-gold/ ) and Invesco Physical Gold ETC ( https://www.invesco.com/uk/en/etf/insights/our-commitment-towards-responsible-gold.html ), both of which state in fund website and marketing materials that they hold 100% LBMA gold refined/minted in 2012 or later. To the Fund's knowledge, these funds have not encountered any issues in holding only post-2012 gold.
Under normal market conditions, the Fund therefore expects to hold only post-2012 gold in the Fund Allocated Account. The Fund, however, may temporarily deviate from this policy in unusual market conditions, such as in the event of a temporary supply constraint or lack of availability, in which case the Fund will seek to come back into conformity with the policy as soon as reasonably practical. For example, at the time of a creation transaction in the Fund's Shares, only pre-2012 gold may be readily available to the Custodian. In such circumstances, the Custodian would allocate such gold to the Fund Allocated Account on a temporary basis until such time as the Custodian is able to swap out the pre-2012 gold for post-2012 gold (including, but not limited to, in connection with redemption transactions).

The LBMA Responsible Sourcing Programme and Responsible Gold Guidance
As described above, the Fund seeks to hold only post-2012 gold. The Gold Guidance is the specific document that underpins the LBMA's Responsible Sourcing Programme, a mandatory governance framework and audit program applicable to LBMA approved Good Delivery refiners designed to promote the ethical sourcing of the global supply chain for the wholesale gold markets. The Responsible Sourcing Programme is based on the five-step framework for risk-based due diligence codified in the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (2010) and the requirements detailed in the OECD Gold Supplement (2012). The Gold Guidance includes measures to address environmental and sustainability considerations (for example, management of harmful chemicals or pollutants associated with the gold mining process), avoid materials from conflict-afflicted areas, and combat money laundering, financing of terrorism, and human rights abuses, including child labor. Since January 1, 2012, each LBMA Good Delivery refinery has been required to undergo a comprehensive audit, at least annually, in order to confirm compliance with the LBMA's minimum requirements related to the responsible sourcing of gold as set forth in the Gold Guidance and to publicly report results (audits are made available on the LBMA website). The audits, among other aspects, focus on the refiner's management systems and controls, and whether they are robust and appropriate to address the refiner's risk profile with respect to priority focus areas as identified above. Additional information regarding the LBMA's efforts to promote ethical sourcing of gold and a copy of the current version of the Gold Guidance is available at https://www.lbma.org.uk/responsible-sourcing.
The Fund will not trade in gold futures, options, or swap contracts on any futures exchange or over-the-counter (“OTC”). The Fund will not hold or trade in commodity futures contracts, “commodity interests,” or any other instruments regulated by the Commodity Exchange Act. As stated above, the Fund's Cash Custodian may hold cash proceeds from gold sales and other cash received by the Fund. The Fund's gold will be held in London.
The Fund is not a proxy for investing in physical gold. Rather, the Shares are intended to provide a cost-effective means of obtaining investment exposure through the securities markets that is similar to an investment in gold. Specifically, the Shares are intended to constitute a simple and cost-efficient means of gaining investment benefits similar to those of holding gold bullion directly, by providing investors an opportunity to participate in the gold market through an investment in the Shares, instead of the traditional means of purchasing, storing and insuring gold.

Operation of the Gold Market
The global gold trading market consists of OTC transactions in spot, forwards, and options and other derivatives, together with exchange-traded futures and options.
The OTC gold market includes spot, forward, and option and other derivative transactions conducted on a principal-to-principal basis. While this is a global, nearly 24-hour per day market, its main centers are London, New York, and Zurich.
According to the Registration Statement, most OTC market trades are cleared through London. The LBMA plays an important role in setting OTC gold trading industry standards. A London Good Delivery Bar (as described below), which is acceptable for delivery in settlement of any OTC transaction, will be acceptable for delivery to the Fund, as discussed below.
The most significant gold futures exchange is COMEX, operated by Commodities Exchange, Inc., a subsidiary of New York Mercantile Exchange, Inc., and a subsidiary of the Chicago Mercantile Exchange Group (the “CME Group”). Other commodity exchanges include the Tokyo Commodity Exchange (“TOCOM”), the Multi Commodity Exchange of India (“MCX”), the Shanghai Futures Exchange, the Shanghai Gold Exchange, ICE Futures US (the “ICE”), and the Dubai Gold & Commodities Exchange. The CME Group and ICE are members of the Intermarket Surveillance Group (“ISG”).

The London Gold Bullion Market
According to the Registration Statement, most trading in physical gold is conducted on the OTC market and is predominantly cleared through London. In addition to coordinating market activities, the LBMA acts as the principal point of contact between the market and its regulators. A primary function of the LBMA is its involvement in the promotion of refining standards by maintenance of the “London Good Delivery Lists,” which are the lists of LBMA accredited melters and assayers of gold (“Good Delivery List”). The LBMA also coordinates market clearing and vaulting, promotes good trading practices and develops standard documentation.
The term “loco London” refers to gold bars physically held in London that meet the specifications for weight, dimensions, fineness (or purity), identifying marks (including the assay stamp of an LBMA acceptable refiner), and appearance set forth in the good delivery rules promulgated by the LBMA from time to time. Gold bars meeting these requirements are known as “London Good Delivery Bars.”
The unit of trade in London is the troy ounce, whose conversion between grams is: 1,000 grams = 32.1507465 troy ounces and 1 troy ounce = 31.1034768 grams. A London Good Delivery Bar is acceptable for delivery in settlement of a transaction on the OTC market. Typically referred to as 400-ounce bars, a London Good Delivery Bar must contain between 350 and 430 fine troy ounces of gold, with a minimum fineness (or purity) of 995 parts per 1,000 (99.5%), be of good appearance and be easy to handle and stack. The fine gold content of a gold bar is calculated by multiplying the gross weight of the bar (expressed in units of 0.025 troy ounces) by the fineness of the bar.

Creation and Redemption of Shares
According to the Registration Statement, the Fund will create and redeem Shares on a continuous basis in one or more Creation Units. A Creation Unit equals a block of 50,000 Shares. The Fund will issue Shares in Creation Units to certain authorized participants (“Authorized Participants”) on an ongoing basis. Each Authorized Participant must be a registered broker-dealer or other securities market participant such as a bank or other financial institution which is not required to register as a broker-dealer to engage in securities transactions, a participant in The Depository Trust Company (“DTC”), and have entered into an agreement with the Sponsor and the Administrator (the “Participant Agreement”), and have established an unallocated gold account with the Custodian or another LPMCL clearing bank.
Creation Units may be created or redeemed only by Authorized Participants. The creation and redemption of Creation Units is only made in exchange for the delivery to the Fund or the distribution by the Fund of the amount of gold represented by the Creation Units being created or redeemed. The amount of gold required to be delivered to the Fund in connection with any creation, or paid out upon redemption, is based on the combined net asset value of the number of Shares included in the Creation Units being created or redeemed as determined on the day the order to create or redeem Creation Units is properly received and accepted. Orders must be placed by 3:59:59 p.m. New York time. The day on which the Administrator receives a valid purchase or redemption order is the order date. Creation Units may only be issued or redeemed on a day that the Exchange is open for regular trading.
According to the Registration Statement, the Fund only holds gold and cash, and transacts in-kind. Each outstanding Share represents a fractional, undivided interest in the gold bullion held by the Fund. The in-kind creation and redemption transactions in Creation Unit aggregations are based on a specified quantity/number of ounces of gold bullion, which proportionately reflects the amount of gold bullion represented by the Shares outstanding at the time of creation or redemption. ^{35} The total deposit required to create each Creation Unit, or a “Creation Unit Gold Delivery Amount,” is an amount of gold and cash, if any, that is in the same proportion to the total assets of the Fund (net of estimated accrued expenses and other liabilities) on the date the order to purchase is properly received as the number of Shares to be created under the purchase order is in proportion to the total number of Shares outstanding on the date the order is received. An Authorized Participant who places a purchase order is responsible for transferring the Creation Unit Gold Delivery Amount to the Fund Unallocated Account. ^{36} Upon receipt, the Administrator will direct DTC to credit the number of Creation Units ordered to the Authorized Participant's DTC account. The Custodian will transfer the Creation Unit Gold Delivery Amount from the Fund Unallocated Account to the Fund Allocated Account by allocating to the Fund Allocated Account specific bars of gold which the Custodian holds, or instructing a sub-custodian to allocate specific bars of gold held by or for the sub-custodian. As noted above, the Custodian will, on a best efforts basis and subject to available liquidity, seek to allocate post-2012 gold to the Fund Allocated Account.
^{35} The amount of gold represented by each Share of the Fund will decrease over the life of the Fund due to the sales of gold necessary to pay the Sponsor's fee and Fund expenses. The gradual decline in the amount of gold bullion represented by the Shares will occur regardless of whether the trading price of the Shares rises or falls in response to changes in the price of gold.
^{36} Authorized Participants will not deliver specific physical gold bars to the Fund Unallocated Account in connection with creation transactions; rather, the Authorized Participant must maintain a designated unallocated account with the Custodian in order to transact in the Fund's Shares and with the Fund Unallocated Account which functions like a ledger, and the Custodian is then solely responsible for allocating specific gold bars with the requested features ( i.e., post-2012 gold) from the Fund Unallocated Account (which, again, functions like a ledger) to the Fund Allocated Account. Gold is delivered to and distributed by the Fund through credits and debits between the Authorized Participant's unallocated account and the Fund Unallocated Account. When an Authorized Participant creates a Creation Unit aggregation of Fund Shares, gold will be transferred from the Authorized Participant to the Custodian via a debit to the Authorized Participant's unallocated account and a credit to the Fund Unallocated Account. Typically on the same business day, the Custodian then allocates the gold to the Fund Allocated Account and stores the gold for safekeeping. All gold represented by a credit to any unallocated account represents a right to receive a specified quantity of fine ounces of gold. Thus, there is no way for Authorized Participants to deposit specified pre- or post-2012 gold with the Fund in exchange for Creation Units, as Authorized Participants have no role in (or control over) the process of selecting or allocating specific gold bars for delivery to the Fund Allocated Account.
The redemption distribution from the Fund consists of a credit to the redeeming Authorized Participant's unallocated account in the amount of the Creation Unit Gold Delivery Amount. The Creation Unit Gold Delivery Amount for redemptions is the number of ounces of gold held by the Fund to be paid out upon redemption of a Creation Unit. The Custodian will transfer the redemption amount from the Fund Allocated Account to the Fund Unallocated Account and, thereafter, to the redeeming Authorized Participant's unallocated account.

Net Asset Value (“NAV”)
To determine the Fund's NAV, the Administrator will value the gold held by the Fund on the basis of the LBMA Gold Price PM, as published by the ICE Benchmark Administration Limited (the “IBA”). IBA operates electronic auctions for spot, unallocated loco London gold, providing a market-based platform for buyers and sellers to trade. The auctions are run at 10:30 a.m. and 3:00 p.m. London time for gold. The final auction prices are published to the market as the LBMA Gold Price AM and the LBMA Gold Price PM, respectively. ^{37}
^{37} The LBMA Gold Price is the global benchmark price for unallocated gold delivered in London. According to the IBA, producers, the investment community, banks and central banks, fabricators, jewelers and other consumers as well as market participants from around the globe, transact during the IBA Gold Auctions and use the benchmarks as reference prices. The LBMA Gold Price facilitates spot, monthly averaging, cash-settlement, location swaps, fixed for floating swaps, options and other derivative transactions.
The Administrator will calculate the NAV on each day the Exchange is open for regular trading, at the earlier LBMA Gold Price PM for the day or 12:00 p.m. New York time. If no LBMA Gold Price (AM or PM) is made on a particular evaluation day or if the LBMA Gold Price PM has not been announced by 12:00 p.m. New York time on a particular evaluation day, the next most recent LBMA Gold Price AM or PM will be used in the determination of the NAV, unless the Sponsor determines that such price is inappropriate to use as the basis for such determination.
Once the value of the gold has been determined, the Administrator will subtract all estimated accrued expenses and other liabilities of the Fund from the total value of the gold and any cash of the Fund. The resulting figure is the NAV. The Administrator will determine the NAV per Share by dividing the NAV of the Fund by the number of Shares outstanding as of the close of trading on the Exchange.
With respect to the theoretical possibility that a pricing premium or discount or official deviation in the LBMA gold spot price arises between post-2012 gold and pre-2012 gold, the Fund's valuation of its gold holdings would reflect the appropriate spot price or fair value of such holdings with a view to mitigating the risk of shareholder dilution. For example, the Fund generally values its gold holdings on the basis of the LBMA Gold Price PM, as described above. To the extent that it is determined that the LBMA Gold Price PM no longer reflects an accurate measure of the value of the Fund's gold holdings, or to the extent that the LBMA begins providing two different prices—one for pre-2012 gold and one for post-2012 gold—the Fund would adjust its valuation accordingly. Further, the Fund only holds gold and cash, and transacts in-kind. Each outstanding Share represents a fractional, undivided interest in the gold bullion held by the Fund. The in-kind creation and redemption transactions in creation unit aggregations are based on a specified quantity/number of ounces of gold bullion, which proportionately reflects the amount of gold bullion represented by the Shares outstanding at the time of creation/redemption. ^{38} The Fund also has other levers in the event of theoretical pricing deviations or increased costs with respect to its post-2012 gold holdings, including imposing additional creation and redemption transaction fees on Authorized Participants transacting in the Fund's Shares as appropriate in the Sponsor's discretion. Accordingly, the Fund reserves the right to take appropriate steps to seek to ensure that the Fund and its shareholders are not adversely impacted in such a scenario.
^{38} See supra note 35.

Availability of Information Regarding Gold
Currently, the Consolidated Tape Plan does not provide for dissemination of the spot price of a commodity such as gold over the Consolidated Tape. However, there will be disseminated over the Consolidated Tape the last sale price for the Shares, as is the case for all equity securities traded on the Exchange (including exchange-traded funds). In addition, there is a considerable amount of information about gold and gold markets available on public websites and through professional and subscription services.
Investors may obtain gold pricing information on a 24-hour basis based on the spot price for an ounce of gold from various financial information service providers, such as Reuters and Bloomberg.
Reuters and Bloomberg, for example, provide at no charge on their websites delayed information regarding the spot price of gold and last sale prices of gold futures, as well as information about news and developments in the gold market. Reuters and Bloomberg also offer a professional service to subscribers for a fee that provides information on gold prices directly from market participants. Complete real-time data for gold futures and options prices traded on the COMEX are available by subscription from Reuters and Bloomberg. There are a variety of other public websites providing information on gold, ranging from those specializing in precious metals to sites maintained by major newspapers. In addition, the LBMA Gold Price is publicly available at no charge at www.lbma.org.uk.

Availability of Information
The intraday indicative value (“IIV”) per Share for the Shares will be disseminated by one or more major market data vendors on at least a 15 second delayed basis as required by NYSE Arca Rule 8.201-E(e)(2)(v). The IIV will be calculated based on the amount of gold and cash (if any) held by the Fund and a price of gold derived from updated bids and offers indicative of the spot price of gold, adjusted to reflect estimated price changes based on real time proxy pricing updates. ^{39}
^{39} The IIV on a per Share basis disseminated during the Exchange's Core Trading Session, as defined in NYSE Arca Rule 7.34-E, should not be viewed as a real-time update of the NAV, which is calculated once a day.
The Fund's website ( https://www.franklintempleton.com/investments/options/exchange-traded-funds/products/31714/SINGLCLASS/franklin-responsibly-sourced-gold-etf/FGLD ) will contain the following information, on a per Share basis: (a) The Official Closing Price ^{40} and a calculation of the premium or discount of such Official Closing Price against the Fund's NAV, as of the prior business day, expressed as a percentage of such NAV; (b) a table showing the number of days the Shares of the Fund traded at a premium or discount during the most recently completed calendar year and the most recently completed calendar quarters since that year; (c) a line graph showing the Shares' premiums or discounts for the most recently completed calendar year and the most recently completed calendar quarters since that year; (d) data in chart format displaying the frequency distribution of discounts and premiums of the Official Closing Price against the NAV, within appropriate ranges, for each of the four previous calendar quarters; and (e) the daily holdings of the Fund, before 9:30 a.m. E.T. on each Exchange trading day. The website for the Fund will also provide its prospectus. The NAV of the Fund will be published on each day that the NYSE Arca is open for regular trading and will be posted on the Fund's website. Finally, the Fund's website will be updated once daily to provide the last sale price of the Shares as traded in the U.S. market at the end of regular trading. In addition, information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers.
^{40} The term “Official Closing Price” is defined in NYSE Arca Rule 1.1(ll) as the reference price to determine the closing price in a security for purposes of Rule 7-E Equities Trading, and the procedures for determining the Official Closing Price are set forth in that rule.

Criteria for Initial and Continued Listing
The Fund will be subject to the criteria in NYSE Arca Rule 8.201-E(e) for initial and continued listing of the Shares.
A minimum of 100,000 Shares will be required to be outstanding at the start of trading, which is equivalent to 1,317 fine ounces of gold or approximately $2,500,000 as of February 18, 2022. The Exchange believes that the anticipated minimum number of Shares outstanding at the start of trading is sufficient to provide adequate market liquidity.

Trading Rules
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. Trading in the Shares on the Exchange will occur in accordance with NYSE Arca Rule 7.34-E(a). The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in NYSE Arca Rule 7.6-E Commentary .03, the minimum price variation (“MPV”) for quoting and entry of orders in equity securities traded on the NYSE Arca Marketplace is $0.01, with the exception of securities that are priced less than $1.00, for which the MPV for order entry is $0.0001.
Further, NYSE Arca Rule 8.201-E sets forth certain restrictions on ETP Holders acting as registered Market Makers in the Shares to facilitate surveillance. Under NYSE Arca Rule 8.201-E(g), an ETP Holder acting as a registered Market Maker in the Shares is required to provide the Exchange with information relating to its trading in the underlying gold, any related futures or options on futures, or any other related derivatives. Commentary .04 of NYSE Arca Rule 11.3 requires an ETP Holder acting as a registered Market Maker, and its affiliates, in the Shares to establish, maintain and enforce written policies and procedures reasonably designed to prevent the misuse of any material nonpublic information with respect to such products, any components of the related products, any physical asset or commodity underlying the product, applicable currencies, underlying indexes, related futures or options on futures, and any related derivative instruments (including the Shares).
As a general matter, the Exchange has regulatory jurisdiction over its ETP Holders and their associated persons, which include any person or entity controlling an ETP Holder. To the extent the Exchange may be found to lack jurisdiction over a subsidiary or affiliate of an ETP Holder that does business only in commodities or futures contracts, the Exchange could obtain information regarding the activities of such subsidiary or affiliate through surveillance sharing agreements with regulatory organizations of which such subsidiary or affiliate is a member.
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares. Trading on the Exchange in the Shares may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which conditions in the underlying gold market have caused disruptions and/or lack of trading, or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. In addition, trading in Shares will be subject to trading halts caused by extraordinary market volatility pursuant to the Exchange's “circuit breaker” rule. ^{41} The Exchange will halt trading in the Shares if the NAV of the Fund is not calculated or disseminated daily. The Exchange may halt trading during the day in which an interruption occurs to the dissemination of the IIV, as described above. If the interruption to the dissemination of the IIV persists past the trading day in which it occurs, the Exchange will halt trading no later than the beginning of the trading day following the interruption.
^{41} See NYSE Arca Rule 7.12-E.

Surveillance
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances administered by the Exchange, as well as cross-market surveillances administered by the Financial Industry Regulatory Authority Inc. (“FINRA”), on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws. ^{42} The Exchange represents that these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and federal securities laws applicable to trading on the Exchange.
^{42} FINRA conducts cross-market surveillances on behalf of the Exchange pursuant to a regulatory services agreement. The Exchange is responsible for FINRA's performance under this regulatory services agreement.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares with other markets and other entities that are members of the ISG, and the Exchange or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading in the Shares from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. ^{43}
^{43} For a list of the current members of ISG, see www.isgportal.org.
Also, pursuant to NYSE Arca Rule 8.201-E(g), the Exchange is able to obtain information regarding trading in the Shares and the underlying gold, gold futures contracts, options on gold futures, or any other gold derivatives through ETP Holders acting as registered Market Makers, in connection with such ETP Holders' proprietary or customer trades through ETP Holders which they effect on any relevant market.
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
All statements and representations made in this filing regarding (a) the description of the portfolio or reference assets, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange listing rules specified in this rule filing shall constitute continued listing requirements for listing the Shares of the Fund on the Exchange.
The Trust has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under NYSE Arca Rule 5.5-E(m).

Information Bulletin
Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Information Bulletin will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (including noting that Shares are not individually redeemable); (2) NYSE Arca Rule 9.2-E(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (3) how information regarding the IIV is disseminated; (4) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; (5) the possibility that trading spreads and the premium or discount on the Shares may widen as a result of reduced liquidity of gold trading during the Core and Late Trading Sessions after the close of the major world gold markets; and (6) trading information. For example, the Information Bulletin will advise ETP Holders, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Fund. The Exchange notes that investors purchasing Shares directly from the Fund will receive a prospectus. ETP Holders purchasing Shares from the Fund for resale to investors will deliver a prospectus to such investors.
In addition, the Information Bulletin will reference that the Fund is subject to various fees and expenses as will be described in the Registration Statement. The Information Bulletin will also reference the fact that there is no regulated source of last sale information regarding physical gold, that the Commission has no jurisdiction over the trading of gold as a physical commodity, and that the CFTC has regulatory jurisdiction over the trading of gold futures contracts and options on gold futures contracts.
The Information Bulletin will also discuss any relief, if granted, by the Commission or the staff from any rules under the Act.

2. Statutory Basis
The basis under the Act for this proposed rule change is the requirement under Section 6(b)(5) ^{44} that an exchange have rules that are designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to remove impediments to, and perfect the mechanism of a free and open market and, in general, to protect investors and the public interest.
^{44} 15 U.S.C. 78f(b)(5).
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in NYSE Arca Rule 8.201-E. The Exchange has in place surveillance procedures that are adequate to properly monitor trading in the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. The Exchange may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that there is a considerable amount of gold price and gold market information available on public websites and through professional and subscription services. Investors may obtain on a 24-hour basis gold pricing information based on the spot price for an ounce of gold from various financial information service providers. Current spot prices also are generally available with bid/ask spreads from gold bullion dealers. In addition, the Fund's website will provide pricing information for gold spot prices and the Shares. Market prices for the Shares will be available from a variety of sources including brokerage firms, information websites and other information service providers. The NAV of the Fund will be published on each day that the NYSE Arca is open for regular trading and will be posted on the Fund's website. The IIV relating to the Shares will be widely disseminated by one or more major market data vendors at least every 15 seconds as required by NYSE Arca Rule 8.201-E(e)(2)(v). In addition, the LBMA Gold Price is publicly available at no charge at www.lbma.org.uk. The Fund's website will also provide its prospectus, as well as the two most recent reports to stockholders. In addition, information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement. In addition, as noted above, investors will have ready access to information regarding gold pricing.

B. Self-Regulatory Organization's Statement on Burden on Competition
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes the proposed rule change will enhance competition by accommodating Exchange trading of an additional exchange-traded product relating to physical gold.

C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others
No written comments were solicited or received with respect to the proposed rule change.

III. Discussion and Commission's Findings
After careful review, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange. ^{45} In particular, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with Section 6(b)(5) of the Act, ^{46} which requires, among other things, that the Exchange's rules be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest.
^{45} In approving this proposed rule change, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).
^{46} 15 U.S.C. 78f(b)(5).
The Commission believes that the proposed rule change is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately. The NAV of the Fund will be published on each day that the NYSE Arca is open for regular trading and will be posted on the Fund's website. The IIV relating to the Shares will be widely disseminated by one or more major market data vendors at least every 15 seconds as required by NYSE Arca Rule 8.201-E(e)(2)(v). The IIV will be calculated based on the amount of gold and cash (if any) held by the Fund and a price of gold derived from updated bids and offers indicative of the spot price of gold, adjusted to reflect estimated price changes based on real time proxy pricing updates. Based on the information provided by the Exchange, the Commission believes that there is no separate market for post-2012 gold. All gold held by the Fund will be London Good Delivery bars. The LBMA Gold Price is publicly available at no charge at www.lbma.org.uk.
Additionally, the website for the Fund ^{47} will contain the following information, on a per Share basis: (a) The Official Closing Price and a calculation of the premium or discount of such Official Closing Price against the Fund's NAV, as of the prior business day, expressed as a percentage of such NAV; (b) a table showing the number of days the Shares of the Fund traded at a premium or discount during the most recently completed calendar year and the most recently completed calendar quarters since that year; (c) a line graph showing the Shares' premiums or discounts for the most recently completed calendar year and the most recently completed calendar quarters since that year; (d) data in chart format displaying the frequency distribution of discounts and premiums of the Official Closing Price against the NAV, within appropriate ranges, for each of the four previous calendar quarters; and (e) the daily holdings of the Fund, before 9:30 a.m. E.T. on each Exchange trading day. The website for the Fund will also provide the Fund's prospectus as well as the two most recent reports to shareholders.
^{47} https://www.franklintempleton.com/investments/options/exchange-traded-funds/products/31714/SINGLCLASS/franklin-responsibly-sourced-gold-etf/FGLD.
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. The Fund's website will be updated once daily to provide the last sale price of the Shares as traded in the U.S. market at the end of regular trading. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers. While the Consolidated Tape Plan does not provide for dissemination of the spot price of a commodity such as gold over the Consolidated Tape, the last sale price for the Shares will be disseminated over the Consolidated Tape. In addition, there is a considerable amount of information about gold and gold markets available on public websites and through professional and subscription services. Investors may obtain gold pricing information on a 24-hour basis based on the spot price for an ounce of gold from various financial information service providers. ^{48}
^{48} As the Exchange states, Reuters and Bloomberg, for example, provide at no charge on their websites delayed information regarding the spot price of gold and last sale prices of gold futures, as well as information about news and developments in the gold market. Reuters and Bloomberg also offer a professional service to subscribers for a fee that provides information on gold prices directly from market participants. Complete real-time data for gold futures and options prices traded on the COMEX are available by subscription from Reuters and Bloomberg. There are a variety of other public websites providing information on gold, ranging from those specializing in precious metals to sites maintained by major newspapers.
The Commission also believes that the proposal is reasonably designed to prevent trading when a reasonable degree of transparency cannot be assured. The Exchange represents that it will halt trading in the Shares if the NAV of the Fund is not calculated or disseminated daily. If the IIV is not being disseminated as required, the Exchange may halt trading during the day in which the interruption to the dissemination of the IIV occurs. If the interruption to the dissemination of the IIV persists past the trading day in which it occurs, the Exchange will halt trading no later than the beginning of the trading day following the interruption. With respect to trading halts, the Exchange states that it may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares. Trading on the Exchange in the Shares may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which conditions in the underlying gold market have caused disruptions and/or lack of trading, or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. In addition, trading in Shares will be subject to trading halts caused by extraordinary market volatility pursuant to the Exchange's “circuit breaker” rule.
Additionally, NYSE Arca Rule 8.201-E(g) sets forth certain restrictions on ETP Holders acting as registered Market Makers in the Shares to facilitate surveillance. Under NYSE Arca Rule 8.201-E(g), an ETP Holder acting as a registered Market Maker in the Shares is required to provide the Exchange with information relating to its trading in the underlying gold, related futures or options on futures, or any other related derivatives. Commentary .04 of NYSE Arca Rule 11.3-E requires an ETP Holder acting as a registered Market Maker, and its affiliates, in the Shares to establish, maintain and enforce written policies and procedures reasonably designed to prevent the misuse of any material nonpublic information with respect to such products, any components of the related products, any physical asset or commodity underlying the product, applicable currencies, underlying indexes, related futures or options on futures, and any related derivative instruments (including the Shares). ^{49}
^{49} The Exchange confirms that it has regulatory jurisdiction over its ETP Holders and their associated persons, which include any person or entity controlling an ETP Holder. A subsidiary or affiliate of an ETP Holder that does business only in commodities or futures contracts would not be subject to Exchange jurisdiction, but the Exchange could obtain information regarding the activities of such subsidiary or affiliate through surveillance sharing agreements with regulatory organizations of which such subsidiary or affiliate is a member.
Moreover, the Commission concludes that the proposal is reasonably designed to mitigate the Shares' susceptibility to manipulation and misuse of nonpublic information in trading in the Shares, consistent with Section 6(b)(5) of the Act, ^{50} because the Shares will be subject to the Exchange's and other rules below. Specifically:
^{50} 15 U.S.C. 78f(b)(5).
(1) The Fund will be subject to the criteria in NYSE Arca Rule 8.201-E(e) for initial and continued listing of the Shares.
(2) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. Trading in the Shares on the Exchange will occur in accordance with NYSE Arca Rule 7.34-E(a).
(3) The Exchange deems the Shares to be equity securities, thus rendering trading in the Trust subject to the Exchange's existing rules governing the trading of equity securities.
(4) Trading in the Shares will be subject to the existing trading surveillances administered by the Exchange, as well as cross-market surveillances administered by FINRA on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws. ^{51} The Exchange represents that these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and federal securities laws applicable to trading on the Exchange. These surveillances generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
^{51} FINRA conducts cross-market surveillances on behalf of the Exchange pursuant to a regulatory services agreement. The Exchange is responsible for FINRA's performance under this regulatory services agreement.
(5) The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares with other markets and other entities that are members of the ISG, and the Exchange or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading in the Shares from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.
(6) Pursuant to NYSE Arca Rule 8.201-E(g), the Exchange is able to obtain information regarding trading in the Shares and the underlying gold, gold futures contracts, options on gold futures, or any other gold derivatives, through ETP Holders acting as registered Market Makers, in connection with such ETP Holders' proprietary or customer trades through ETP Holders which they effect on any relevant market.
(7) The Exchange has a general policy prohibiting the distribution of material, non-public information by its employees.
(8) Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Information Bulletin will discuss the following: (a) The procedures for purchases and redemptions of Shares in Creation Units (including noting that Shares are not individually redeemable); (b) NYSE Arca Rule 9.2-E(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (c) how information regarding the IIV is disseminated; (d) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; (e) the possibility that trading spreads and the resulting premium or discount on the Shares may widen as a result of reduced liquidity of gold trading during the Core and Late Trading Sessions after the close of the major world gold markets; and (f) trading information. The Exchange states that investors purchasing Shares directly from the Fund will receive a prospectus. ETP Holders purchasing Shares from the Fund for resale to investors will deliver a prospectus to such investors. In addition, the Information Bulletin will reference that the Fund is subject to various fees and expenses as will be described in the Registration Statement, the fact that there is no regulated source of last sale information regarding physical gold, that the Commission has no jurisdiction over the trading of gold as a physical commodity, and that the CFTC has regulatory jurisdiction over the trading of gold futures contracts and options on gold futures contracts. The Information Bulletin will also discuss any relief, if granted, by the Commission or the staff from any rules under the Act.
(9) A minimum of 100,000 Shares will be required to be outstanding at the start of trading.
In addition, pursuant to Commentary .04 of NYSE Arca Rule 8.201-E, all statements and representations made in this filing regarding (a) the description of the portfolio or reference assets, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange listing rules specified in this rule filing shall constitute continued listing requirements for listing the Shares of the Fund on the Exchange. The issuer must notify the Exchange of any failure by the Fund to comply with the continued listing requirements. Pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor ^{52} for compliance with the continued listing requirements. If the Trust is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under NYSE Arca Rule 5.5-E(m).
^{52} The Commission notes that certain proposals for the listing and trading of exchange-traded products include a representation that the exchange will “surveil” for compliance with the continued listing requirements. See, e.g., Securities Exchange Act Release No. 77499 (April 1, 2016), 81 FR 20428, 20432 (April 7, 2016) (SR-BATS-2016-04). In the context of this representation, it is the Commission's view that “monitor” and “surveil” both mean ongoing oversight of compliance with the continued listing requirements. Therefore, the Commission does not view “monitor” as a more or less stringent obligation than “surveil” with respect to the continued listing requirements.
Accordingly, for the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with Section 6(b)(5) of the Act ^{53} and the rules and regulations thereunder applicable to a national securities exchange.
^{53} 15 U.S.C. 78f(b)(5).

IV. Solicitation of Comments on the Proposed Rule Change, as Modified by Amendment No. 1
Interested persons are invited to submit written views, data, and arguments concerning whether the proposed rule change, as modified by Amendment No. 1, is consistent with the Act. Comments may be submitted by any of the following methods:

Electronic Comments
• Use the Commission's internet comment form ( http://www.sec.gov/rules/sro.shtml ); or
• Send an email to rule-comments@sec.gov. Please include File Number SR-NYSEArca-2021-73 on the subject line.

Paper Comments
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-NYSEArca-2021-73. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website ( http://www.sec.gov/rules/sro.shtml ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-NYSEArca-2021-73 and should be submitted on or before May 16, 2022.

V. Accelerated Approval of the Proposed Rule Change, as Modified by Amendment No. 1
The Commission finds good cause to approve the proposed rule change, as modified by Amendment No. 1, prior to the thirtieth day after the date of publication of notice of the filing of Amendment No. 1 in the Federal Register . As stated above, among other things, Amendment No. 1 to the proposed rule change, among other things, went into greater detail with respect to the operation of the Trust and the Fund, including the assets held by the Fund, the LBMA Responsible Sourcing Programme, the Responsible Gold Guidance, creations and redemptions of the Fund's Shares, determination of net asset value of the Fund's Shares, and availability of information for the Fund's Shares. Amendment No. 1 also made additional and revised representations, including that all gold held by the Fund will be London Good Delivery bars and the information related to the Shares that will be provided on the Fund's website. Finally, Amendment No. 1 provided clarifications and technical edits to the proposed rule change. These changes and additional information in Amendment No. 1 assist the Commission in evaluating the Exchange's proposal and in determining that it is consistent with the Act. The Commission believes that such changes and additional information do not raise unique or novel regulatory issues under the Act. Accordingly, the Commission finds good cause, pursuant to Section 19(b)(2) of the Act, ^{54} to approve the proposed rule change, as modified by Amendment No. 1, on an accelerated basis.
^{54} 15 U.S.C. 78s(b)(2).

VI. Conclusion
It is therefore ordered, pursuant to Section 19(b)(2) of the Act, ^{55} that the proposed rule change (SR-NYSEArca-2021-73), as modified by Amendment No. 1, be, and it hereby is, approved on an accelerated basis.
^{55} Id.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. ^{56}
^{56} 17 CFR 200.30-3(a)(12).
J. Matthew DeLesDernier,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[Release No. 34 94751; File No. SR-CboeBYX-2022-013]
Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Current Pilot Program Related to BYX Rule 11.17, Clearly Erroneous Executions, to the Close of Business on July 20, 2022
April 19, 2022
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”), ^1 and Rule 19b-4 thereunder, ^2 notice is hereby given that on April 18, 2022, Cboe BYX Exchange, Inc. (the “Exchange” or “BYX”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange filed the proposal as a “non-controversial” proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act ^3 and Rule 19b-4(f)(6) thereunder. ^4 The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
^1 15 U.S.C. 78s(b)(1).
^2 17 CFR 240.19b-4.
^3 15 U.S.C. 78s(b)(3)(A)(iii).
^4 17 CFR 240.19b-4(f)(6).

I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change
Cboe BYX Exchange, Inc. (“BYX” or the “Exchange”) is filing with the Securities and Exchange Commission (the “Commission”) a proposed rule change to extend the current pilot program related to BYX Rule 11.17, Clearly Erroneous Executions, to the close of business on July 20, 2022. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website ( http://markets.cboe.com/us/equities/regulation/rule_filings/byx/ ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change
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.

A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

1. Purpose
The purpose of this filing is to extend the effectiveness of the Exchange's current rule applicable to Clearly Erroneous Executions to the close of business on July 20, 2022. Portions of Rule 11.17, explained in further detail below, are currently operating as a pilot program set to expire on April 20, 2022. ^5
^5 See Securities Exchange Act Release No. 93343 (October 15, 2021), 86 FR 58347 (October 21, 2021) (SR-CboeBYX-2021-025).
On September 10, 2010, the Commission approved, on a pilot basis, changes to BYX Rule 11.17 that, among other things: (i) Provided for uniform treatment of clearly erroneous execution reviews in multi-stock events involving twenty or more securities; and (ii) reduced the ability of the Exchange to deviate from the objective standards set forth in the rule. ^6 In 2013, the Exchange adopted a provision designed to address the operation of the Plan. ^7 Finally, in 2014, the Exchange adopted two additional provisions providing that: (i) A series of transactions in a particular security on one or more trading days may be viewed as one event if all such transactions were effected based on the same fundamentally incorrect or grossly misinterpreted issuance information resulting in a severe valuation error for all such transactions; and (ii) in the event of any disruption or malfunction in the operation of the electronic communications and trading facilities of an Exchange, another SRO, or responsible single plan processor in connection with the transmittal or receipt of a trading halt, an Officer, acting on his or her own motion, shall nullify any transaction that occurs after a trading halt has been declared by the primary listing market for a security and before such trading halt has officially ended according to the primary listing market. ^8
^6 See Securities Exchange Act Release No. 63097 (Oct. 13, 2010), 75 FR 64767 (Oct. 20, 2010) (SR-BYX-2010-002).
^7 See Securities Exchange Act Release No. 68798 (Jan. 31, 2013), 78 FR 8628 (Feb. 6, 2013) (SR-BYX-2013-005).
^8 See Securities Exchange Act Release No. 71796 (March 25, 2014), 79 FR 18099 (March 31, 2014) (SR-BYX-2014-003).
On December 26, 2018, the Commission published the proposed Eighteenth Amendment ^9 to the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS under the Act (the “Limit Up-Limit Down Plan” or the “Plan”) ^{10} to allow the Plan to operate on a permanent, rather than pilot, basis. On April 8, 2019, the Exchange amended BYX Rule 11.17 to untie the pilot program's effectiveness from that of the Plan and to extend the pilot's effectiveness to the close of business on October 18, 2019 in order allow the Exchange and other national securities exchanges additional time to consider further amendments, if any, to the clearly erroneous execution rules in light of the proposed Eighteenth Amendment to the Plan. ^{11} On April 17, 2019, the Commission published an approval of the Eighteenth Amendment to allow the Plan to operate on a permanent, rather than pilot, basis. ^{12} On October 21, 2019, the Exchange amended BYX Rule 11.17 to extend the pilot's effectiveness to the close of business on April 20, 2020. ^{13} On March 18, 2020, the Exchange amended BYX Rule 11.17 to extend the pilot's effectiveness to the close of business on October 20, 2020. ^{14} On October 20, 2020, the Exchange amended BYX Rule 11.17 to extend the pilot's effectiveness to the close of business on April 20, 2021. ^{15} On April 14, 2021 the Exchange amended BYX Rule 11.17 to extend the pilot's effectiveness to the close of business on October 20, 2021. ^{16} Finally, on October 15, 2021 the Exchange amended BYX Rule 11.17 to extend the pilot's effectiveness to the close of business on April 20, 2022. ^{17}
^9 See Securities Exchange Act Release No. 84843 (December 18, 2018), 83 FR 66464 (December 26, 2018) (File No. 4-631) (“Eighteenth Amendment”).
^{10} See Securities Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6, 2012) (the “Limit Up-Limit Down Release”).
^{11} See Securities Exchange Act Release No. 85542 (Apr. 8, 2019), 84 FR 15009 (Apr. 12, 2019) (SR-CboeBYX-2019-003).
^{12} See Securities Exchange Act Release No. 85623 (Apr. 11, 2019), 84 FR 16086 (Apr. 17, 2019) (File No. 4-631).
^{13} See Securities Exchange Act Release No. 87364 (Oct. 21, 2019), 84 FR 57528 (Oct. 25, 2019) (SR-CboeBYX-2019-018).
^{14} See Securities Exchange Act Release No. 88496 (March 27, 2020), 85 FR 18600 (April 2, 2020) (SR-CboeBYX-2020-010).
^{15} See Securities Exchange Act Release No. 90230 (October 20, 2020), 85 FR 67802 (Oct. 26, 2020) (SR-CboeBYX-2020-030).
^{16} See Securities Exchange Act Release No. 20578 (April 14, 2021), 86 FR 20578 (April 20, 2021) (SR-CboeBYX-2021-008).
^{17} See supra note 5.
Other self-regulatory organizations (“SROs”), including the Exchange, have worked on a proposed rule change to make the pilot rules permanent. Cboe BZX Exchange, Inc., (“BZX”) filed such a proposed rule change on March 7, 2022. ^{18} The Exchange now proposes to amend BYX Rule 11.17 to extend the pilot's effectiveness an additional three months to the close of business on July 20, 2022 while the Commission considers the BZX proposal. The Exchange understands that the other national securities exchanges and Financial Industry Regulatory Authority (“FINRA”) have filed or plan to file similar proposals to extend their respective clearly erroneous execution pilot programs, the substance of which are identical to BYX Rule 11.17. The Exchange does not propose any additional changes to BYX Rule 11.17. The Exchange believes the benefits to market participants from the more objective clearly erroneous executions rule should continue on a limited three month pilot basis.
^{18} See Securities Exchange Act Release No. 94374 (March 7, 2022), 87 FR 14062 (March 11, 2022) (SR-CboeBZX-2022-017).

2. Statutory Basis
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act. ^{19} Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) ^{20} requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) ^{21} requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
^{19} 15 U.S.C. 78f(b).
^{20} 15 U.S.C. 78f(b)(5).
^{21} Id.
In particular, the Exchange believes that extending the clearly erroneous execution pilot under BYX Rule 11.17 for an additional three months would help assure that the determination of whether a clearly erroneous trade has occurred will be based on clear and objective criteria, and that the resolution of the incident will occur promptly through a transparent process. The proposed rule change would also help assure consistent results in handling erroneous trades across the U.S. equities markets, thus furthering fair and orderly markets, the protection of investors and the public interest. Based on the foregoing, the Exchange believes the amended clearly erroneous executions rule should continue to be in effect on a pilot basis while the Exchange and the other national securities exchanges consider and develop a permanent proposal for clearly erroneous execution reviews.

B. Self-Regulatory Organization's Statement on Burden on Competition
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange understands that FINRA and other national securities exchanges have or will also file similar proposals to extend their respective clearly erroneous execution pilot programs. Thus, the proposed rule change will help to ensure consistency across market centers without implicating any competitive issues.

C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others
Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act ^{22} and Rule 19b-4(f)(6) thereunder. ^{23} Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act ^{24} and subparagraph (f)(6) of Rule 19b-4 thereunder. ^{25}
^{22} 15 U.S.C. 78s(b)(3)(A)(iii).
^{23} 17 CFR 240.19b-4(f)(6).
^{24} 15 U.S.C. 78s(b)(3)(A)(iii).
^{25} 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Commission has waived the five-day prefiling requirement in this case.
A proposed rule change filed under Rule 19b-4(f)(6) ^{26} normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii), ^{27} the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange asked that the Commission waive the 30 day operative delay so that the proposal may become operative immediately upon filing. Waiver of the 30-day operative delay would extend the protections provided by the current pilot program, without any changes, while the Exchange and other self-regulatory organizations consider whether further amendments to these rules are appropriate. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change as operative upon filing. ^{28}
^{26} 17 CFR 240.19b-4(f)(6).
^{27} 17 CFR 240.19b-4(f)(6)(iii).
^{28} For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments
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:

Electronic Comments
• Use the Commission's internet comment form ( http://www.sec.gov/rules/sro.shtml ); or
• Send an email to rule-comments@sec.gov. Please include File Number SR-CboeBYX-2022-013 on the subject line.

Paper Comments
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-CboeBYX-2022-013. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website ( http://www.sec.gov/rules/sro.shtml ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeBYX-2022-013 and should be submitted on or before May 16, 2022.
^{29} 17 CFR 200.30-3(a)(12).
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. ^{29}
J. Matthew DeLesDernier,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[SEC File No. 270-329, OMB Control No. 3235-0371]
Submission for OMB Review; Comment Request
Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736.
Extension:
Rule 15a-6
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501 et seq. ), the Securities and Exchange Commission (“Commission”) has submitted to the Office of Management and Budget (“OMB”) a request for approval of extension of the previously approved collection of information provided for in Rule 15a-6 (17 CFR 240.15a-6) under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq. ).
Rule 15a-6 provides conditional exemptions from the requirement to register as a broker-dealer pursuant to Section 15 of the Securities Exchange Act for foreign broker-dealers that engage in certain specified activities involving U.S. persons. In particular, Rule 15a-6(a)(3) provides an exemption from broker-dealer registration for foreign broker-dealers that solicit and effect transactions with or for U.S. institutional investors or major U.S. institutional investors through a registered broker-dealer, provided that the U.S. broker-dealer, among other things, obtains certain information about, and consents to service of process from, the personnel of the foreign broker-dealer involved in such transactions, and maintains certain records in connection therewith.
These requirements are intended to ensure (a) that the registered broker-dealer will receive notice of the identity of, and has reviewed the background of, foreign personnel who will contact U.S. investors, (b) that the foreign broker-dealer and its personnel effectively may be served with process in the event enforcement action is necessary, and (c) that the Commission has ready access to information concerning these persons and their U.S. securities activities. Commission staff estimates that approximately 2,000 U.S. registered broker-dealers will spend an average of two hours of clerical staff time and one hour of managerial staff time per year obtaining the information required by the rule, resulting in a total aggregate burden of 6,000 hours per year for complying with the rule. Assuming an hourly cost of $72 ^1 for a compliance clerk and $319 ^2 for a compliance manager, the resultant total internal labor cost of compliance for the respondents is $926,000 per year (2,000 entities × ((2 hours/entity × $72/hour) + (1 hour per entity × $319/hour)) = $926,000).
^1 The hourly rate used for a compliance clerk was from SIFMA's Office Salaries in the Securities Industry 2013, modified by Commission staff to account for an 1,800 hour work-year and multiplied by 2.93 to account for bonuses, firm size, employee benefits and overhead.
^2 The hourly rate used for a compliance manager was from SIFMA's Management & Professional Earnings in the Securities Industry 2013, modified by Commission staff to account for an 1,800 hour work-year and multiplied by 5.35 to account for bonuses, firm size, employee benefits and overhead.
In general, the records to be maintained under Rule 15a-6 must be kept for the applicable time periods as set forth in Rule 17a-4 (17 CFR 240.17a-4) under the Exchange Act or, with respect to the consents to service of process, for a period of not less than six years after the applicable person ceases engaging in U.S. securities activities. Reliance on the exemption set forth in Rule 15a-6 is voluntary, but if a foreign broker-dealer elects to rely on such exemption, the collection of information described therein is mandatory. The collection does not involve confidential information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website: www.reginfo.gov. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom, Director/Chief Information Officer, Securities and Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC 20549, or by sending an email to: PRA_Mailbox@sec.gov.
Dated: April 19, 2022.
J. Matthew DeLesDernier,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[Release No. 34-94745; File No. SR-FICC-2022-002]
Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Proposed Rule Change To Revise the MBSD Clearing Rules To Move Certain DRC Items (Mark-to-Market Items, Cash Obligation Items and Accrued Principal and Interest) From the Required Fund Deposit Calculation to Cash Settlement, Revise Certain Thresholds and Parameters in the Intraday Mark-to-Market Charge, Establish a New Intraday VaR Charge and Make Certain Other Clarifications
April 19, 2022.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) ^1 and Rule 19b-4 thereunder, ^2 notice is hereby given that on April 8, 2022, Fixed Income Clearing Corporation (“FICC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II and III below, which Items have been prepared by the clearing agency. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
^1 15 U.S.C. 78s(b)(1).
^2 17 CFR 240.19b-4.

I. Clearing Agency's Statement of the Terms of Substance of the Proposed Rule Change
FICC is proposing to amend the Mortgage-Backed Securities Division (“MBSD”) Clearing Rules (“MBSD Rules”) ^3 to (1)(a) delete the Deterministic Risk Component (“DRC”) from the Required Fund Deposit calculation, (b) move certain items currently in the DRC (Mark-to-Market items, cash obligation items and accrued principal and interest) to Cash Settlement and (c) retain the six days' interest for Fails item currently in the DRC calculation as a separate part of the Required Fund Deposit, (2) revise the definition of Intraday Mark-to Market Charge to reflect the movement of the DRC items to Cash Settlement and to revise certain thresholds and parameters, (3) establish a new intraday VaR Charge and (4) make other clarifying changes in the MBSD Rules, as described in more detail below.
^3 Capitalized terms not otherwise defined herein are defined in the MBSD Rules, as applicable, available at http://www.dtcc.com/legal/rules-and-procedures.
The proposal would also make certain conforming changes to the Methodology and Model Operations Document—MBSD Quantitative Risk Model (the “QRM Methodology”) in order to implement the proposed changes to the MBSD Rules, which changes are attached hereto [sic] as Exhibit 5B, as described in greater detail below. ^4
^4 Because FICC requested confidential treatment, the QRM Methodology was filed separately with the Secretary of the U.S. Securities and Exchange Commission (“Commission”) as part of proposed rule change SR-FICC-2016-007 (the “VaR Filing”). See Securities Exchange Act Release No. 79868 (January 24, 2017), 82 FR 8780 (January 30, 2017) (SR-FICC-2016-007) (“VaR Filing Approval Order”). FICC also filed the VaR Filing proposal as an advance notice pursuant to Section 806(e)(1) of the Payment, Clearing, and Settlement Supervision Act of 2010 (12 U.S.C. 5465(e)(1)) and Rule 19b-4(n)(1)(i) under the Securities Exchange Act of 1934, as amended (“Act”) (17 CFR 240.19b-4(n)(1)(i)), with respect to which the Commission issued a Notice of No Objection. See Securities Exchange Act Release No. 79843 (January 19, 2017), 82 FR 8555 (January 26, 2017) (SR-FICC-2016-801). The QRM Methodology has been amended following the VaR Filing Approval Order. See Securities Exchange Act Release Nos. 85944 (May 24, 2019), 84 FR 25315 (May 31, 2019) (SR-FICC-2019-001), 90182 (October 14, 2020) 85 FR 66630 (October 20, 2020) (SR-FICC-2020-009) and 92303 (June 30, 2021) 86 FR 35854 (July 7, 2021) (SR-FICC-2020-017).

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change
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.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

1. Purpose
As described in greater detail below, FICC is proposing changes to the MBSD Rules that would move mark-to-market components from Clearing Members' Required Fund Deposits to Cash Settlement. While the proposed change would impact, in some cases, the form of Clearing Members' payments with respect to these obligations, a study described in greater detail below indicated that the impact to Clearing Members with debit balances would not be material as compared to their total Clearing Fund obligations.
In connection with this proposed change, the proposal would also make conforming changes to the definition of “Intraday Mark-to-Market Charge” and would clarify the MBSD Rules regarding the thresholds and parameters used in collecting this charge. An impact study based on the hypothetical assumption that MBSD would reduce the thresholds to the proposed floors, as described in greater detail below, indicated the proposal could increase total average Intraday Mark-to-Market Charges collected by FICC by an amount that represented approximately 2.8% of the total average Clearing Fund collected on those days.
Finally, the proposal would provide greater transparency to Clearing Members by introducing a formal Intraday VaR Charge, which FICC currently collects as a special charge in certain market conditions. Again, a study conducted to approximate the impact of this proposed change indicated it could result in an increase in amounts collected by FICC, but that amount represented approximately less than 0.1% of total average Clearing Fund collected on the study dates, as described in greater detail below.
These proposed changes to the MBSD Rules are summarized below and described in greater detail in this filing:
(1) Move Mark-to-Market related charges from the Required Fund Deposit calculation to Cash Settlement. FICC is proposing to move all of the mark-to-market components currently in the DRC (except for six days' interest for Fails) ^5 to Cash Settlement. FICC proposes to accomplish this by deleting the DRC from the Required Fund Deposit calculation and moving certain DRC items (Mark-to-Market items, cash obligation items and accrued principal and interest) to Cash Settlement. One item that FICC currently includes in the DRC calculations is six days' interest for Fails ^6 which will be added directly to the Required Fund Deposit calculation and not moved to Cash Settlement.
^5 A Fail is a Transaction the clearing of which has not occurred or has not been reported to FICC as having occurred on the Contractual Settlement Date, or expiration date, as applicable. See definition of “Fail” in MBSD Rule 1, supra note 3.
^6 In addition to interest that has accrued with respect to a Fails position in Clearing Member's portfolio, FICC also collects an additional six days of interest that has not yet accrued from the seller of any Fail because FICC assumes it could take three days to close out the position if the Clearing Member fails and the pool allocation process could take an additional three days.
While these changes would impact how Clearing Members pay those amounts ( i.e., through Cash Settlement rather than as part of the Required Fund Deposit), these changes would not affect the manner in which these items are calculated or the amounts that Clearing Members are paying with respect to these items. All of the items that are being moved to Cash Settlement would be required to be settled in cash. Therefore, the proposed change would require that Clearing Members satisfy their DRC obligations in cash as part of Cash Settlement, rather than through a mix of cash and Eligible Clearing Fund Securities as is permitted to satisfy Required Fund Deposit obligations.
FICC is proposing these changes in order to more closely align FICC's collections to industry practice, in response to regulatory feedback on its margin methodologies and to ensure the unrealized gains from mark-to-market changes do not leave the Required Fund Deposit insufficient to cover future exposure.
(2) Revise the Intraday Mark-to-Market Charge Definition to reflect movement of Mark-to-Market charges to Cash Settlement and to revise thresholds and parameters. FICC is proposing to modify the definition of “Intraday Mark-to-Market Charge” to reflect the proposed movement of the Mark-to-Market items and related items to Cash Settlement. In addition, FICC is proposing to remove the specific amounts listed for the dollar threshold and the percentage threshold and instead put floors in for the dollar threshold and percentage threshold. FICC is also proposing to remove the backtesting coverage target parameter. As discussed below, FICC currently has the ability to waive such thresholds and parameter under certain circumstances under the MBSD Rules which it does from time to time. However, FICC's current practice is to waive or adjust these thresholds and parameter in volatile market conditions, as permitted by the MBSD Rules. Therefore, these proposed changes to the Intraday Mark-to-Market Charge definition would align the MBSD Rules with FICC's current practice in certain circumstances and provide Clearing Members with greater transparency and certainty regarding the application of this charge outside of those circumstances. While FICC would have the authority to take this charge more frequently under the proposal, subject to the floors to the thresholds, neither the current calculation methodology nor the key components of the Intraday Mark-to-Market Charge would change.
FICC would also remove the provision allowing FICC to collect an Intraday Mark-to-Market Charge under certain circumstances where a Clearing Member meets a certain Surveillance Threshold that is set by a Clearing Member's rating on the Credit Risk Rating Matrix. FICC currently does not apply that provision and does not intend to apply that provision in the future.
FICC believes that the proposed changes to the thresholds and parameters are consistent with its current practices with respect to these thresholds and parameters as provided in the MBSD Rules and would not have a substantial impact on Clearing Members. FICC is transparent with Clearing Members when it sets and waives thresholds and parameters and would continue to notify Clearing Members through publication of Important Notices on its website of the current thresholds and parameters it is using and of any changes to those thresholds and parameters. ^7 FICC would also continue to provide access to reports and calculator tools to allow Clearing Members to determine impacts of certain activity on their Required Fund Deposit amounts. ^8
^7 Important Notices are available at
https://www.dtcc.com/legal/important-notices.
^8 For instance, FICC provides access to the FICC Risk Client Portal which is a Clearing Member accessible website portal that provides Clearing Members the ability, for information purposes, to view and analyze certain risks relating to their portfolio, including calculators to assess the risk and Clearing Fund impact of certain activities. FICC maintains the FICC Client Calculator available on the FICC Risk Client Portal that provides functionality to Clearing Members to enter `what-if' position data and recalculate their VaR charge to determine margin impact pre-trade execution. The FICC Client Calculator allows Clearing Members to see the impact to the VaR Charge if specific transactions are executed, or to anticipate the impact of an increase or decrease to a current clearing position.
FICC is proposing to change the thresholds and remove the backtesting coverage target parameter in order align the MBSD Rules with FICC's current practice and to provide FICC with greater flexibility to adjust the application of the Intraday-Mark-to-Market Charge to better respond to changing market conditions and other factors in connection with its regular reviews of its margining methodologies without having to rely on the waiver provisions. FICC is proposing to remove the provision relating to Surveillance Threshold because it is a provision that FICC does not currently use and does not think is necessary.
(3) Establish a formal Intraday VaR Charge. FICC is proposing to establish a formal Intraday VaR Charge in the MBSD Rules. FICC currently monitors VaR intraday and periodically requires intraday VaR collections in the Required Fund Deposit under certain conditions described below as a special charge. The proposed Intraday VaR Charge would formalize a charge that FICC is currently collecting under its authority to collect a special charge. Similar to the proposed change to Intraday Mark-to-Market Charge parameters and thresholds, this proposed change would align the Rules with FICC's current practice and would provide Clearing Member's with greater transparency regarding this margin charge. However, the proposal would not implement substantive or material changes to the risk this charge is designed to mitigate or to the overall methodology or key components of the calculation of this charge. As discussed below, FICC is proposing to remove the discretion to apply the Intraday VaR Charge under certain circumstances compared to when it implements the special charge. As a result, the introduction of the Intraday VaR Charge would result in more consistent intraday VaR collections when compared to the current practice, on both Securities Industry and Financial Markets Association (“SIFMA”) designated settlement dates and non-SIFMA designated settlement dates.
(4) Make certain clarifying changes. FICC is proposing to make certain clarifying changes to the MBSD Rules. Specifically, FICC would move certain definitions so that they are in alphabetical order, re-letter certain subsections that follow to conform to the deletion of certain subsections and update certain cross-references to improve the readability of the MBSD Rules and to reflect other changes set forth herein. The proposed clarifying changes would not have any substantive effect on the Clearing Members because such changes are clarifications and will not affect the rights or obligations of FICC or the Clearing Members.
FICC would also update the QRM Methodology to reflect the proposed changes to the MBSD Rules.

(i) Background

Required Fund Deposit/VaR Charge
The Required Fund Deposit serves as each Clearing Member's margin. The objective of the Required Fund Deposit is to mitigate potential losses to FICC associated with liquidation of the Clearing Member's portfolio in the event that FICC ceases to act for a Clearing Member (hereinafter referred to as a “default”). Pursuant to the MBSD Rules, each Clearing Member's Required Fund Deposit amount currently consists of the greater of (i) the Minimum Charge or (ii) the sum of the following components: The VaR Charge, the DRC, a special charge (to the extent determined to be appropriate), ^9 and, if applicable, the Backtesting Charge, Holiday Charge, Intraday Mark-to-Market Charge and the Margin Liquidity Adjustment Charge. ^{10} Of these components, the VaR Charge typically comprises the largest portion of a Clearing Member's Required Fund Deposit amount.
^9 In order to mitigate exposure from certain market conditions and other financial and operational capabilities of a Clearing Member, FICC may impose a special charge. For instance, as discussed below, in connection with its intraday VaR monitoring, FICC currently imposes a special charge if a Clearing Member has an intraday VaR increase exceeding 100% and $1 million.
^{10} MBSD Rule 4 Section 2, supra, note 3.
The VaR Charge is calculated using a risk-based margin methodology that is intended to capture the market price risk associated with the securities in a Clearing Member's portfolio. The VaR Charge provides an estimate of the projected liquidation losses at a 99% confidence level. The methodology is designed to project the potential gains or losses that could occur in connection with the liquidation of a defaulting Clearing Member's portfolio, assuming that a portfolio would take three days to hedge or liquidate in normal market conditions. The projected liquidation gains or losses are used to determine the amount of the VaR Charge, which is calculated to cover projected liquidation losses at 99% confidence level. ^{11}
^{11} Unregistered Investment Pool Clearing Members are subject to a VaR Charge with a minimum targeted confidence level assumption of 99.5 percent. See MBSD Rule 4, Section 2(c), supra note 3.
The aggregate of all Clearing Members' Required Fund Deposits constitutes the Clearing Fund of MBSD, which FICC would be able to access in the event a defaulting Clearing Member's own Required Fund Deposit is insufficient to satisfy losses to FICC caused by the liquidation of that Clearing Member's portfolio.

(ii) Proposed Changes

(a) Proposal To Delete the DRC, Move Certain DRC Items (the Mark-to-Market Items, Cash Obligation Items, and the Accrued Principal and Interest) to Cash Settlement and Retain Six Days' Interest for Fails in the Required Fund Deposit Calculation

Mark-to-Market—DRC
MBSD calculates the full suite of components that comprise the Required Fund Deposit ^{12} and imposes the Required Fund Deposit once per day, at the start of the day, based on a Clearing Member's prior end-of-day positions. One of the components of the daily Required Fund Deposit is a start-of-day Mark-to-Market component, ^{13} which is designed to mitigate the risk arising out of the value change between the contract/settlement value of a Clearing Member's open positions and the market value at the end of the prior day. Currently, MBSD's Mark-to-Market items, cash obligation items, and accrued principal and interest are included as the DRC in a Clearing Member's Required Fund Deposit calculation. ^{14} When the DRC is calculated, a debit or credit is added to the Required Fund Deposit amount of each Clearing Member raising the amount or lowering the amount, respectively.
^{12} Section 2 of MBSD Rule 4 set forth each component of the Required Fund Deposit. MBSD Rule 4 Section 2, supra, note 3.
^{13} MBSD Rule 4 Section 2(a), supra, note 3.
^{14} MBSD Rules 4, Section 2(c)(ii), supra note 3. See also definition of “Deterministic Risk Component” in MBSD Rule 1, supra note 3.

Move Mark-to-Market, Cash Obligation Items and Accrued Principal and Interest to Cash Settlement
The DRC is designed to bring a Clearing Member's portfolio of open positions to market value. This charge is calculated as (i) the Mark-to-Market Debit; minus (ii) the Mark-to-Market Credit; plus (iii) a cash obligation item debit; minus (iv) a cash obligation item credit; plus or minus (v) accrued principal and interest. ^{15} FICC also includes another parameter, six days' interest for Fails, in the DRC calculation which is not explicitly referenced in the DRC definition in the MBSD Rules and is discussed in more detail below. FICC is proposing to move the Mark-to-Market items, cash obligation items, and accrued principal and interest from the Required Fund Deposit calculation to the Cash Settlement process in order to more closely align to industry practices regarding the handling of mark-to-market, in response to regulatory feedback on its margin methodologies and to ensure the unrealized gains from mark-to-market changes do not leave the Required Fund Deposit insufficient to cover future exposure. ^{16}
^{15} Definition of “Deterministic Risk Component” in MBSD Rule 1, supra note 3.
^{16} The Basel Committee on Banking Supervision and the Board of the International Organization of Securities Commissions recognized that the exchange of mark-to-market gains/losses “is a prudent risk management tool that limits the build-up of systemic risk”—particularly for longer-dated transactions such as derivatives. See Basel Committee on Banking Supervision & Board of the International Organization of Securities Commissions, Margin Requirements for Non-Centrally Cleared Derivatives, at page 7 (2015), available at https://www.bis.org/bcbs/publ/d317.pdf.
One cash obligation item that would be moved from DRC and the Required Fund Deposit calculation to Cash Settlement is the TBA Transaction Adjustment Payment. The TBA Transaction Adjustment Payment is the difference between the Settlement Price and the System Price at settlement of a TBA Transaction. ^{17} In connection with each TBA Transaction, a Clearing Member pays a TBA Transaction Adjustment Payment at Cash Settlement. ^{18} Currently, the TBA Transaction Adjustment Payment amount is calculated by FICC beginning three days prior to the settlement. The pre-settlement calculated TBA Transaction Adjustment Payment amount is included as a cash obligation item which is a component of the DRC and included in the Required Fund Deposit. The TBA Transaction Adjustment Payment amount is paid by Clearing Members into the Required Fund Deposit each day beginning two days prior to the settlement of the TBA Transaction and every day until Cash Settlement. FICC is proposing to move this cash obligation item to daily Cash Settlement and, as a result, pre-settlement TBA Transaction Adjustment Payment amounts will be paid by Clearing Members beginning two days prior to settlement of the TBA Transaction through Cash Settlement. As a result, the Clearing Member that is receiving the TBA Transaction Adjustment Payment credits prior to settlement of the TBA Transaction will pay the amount of overnight interest on those funds through Cash Settlement which interest amount will then be credited to the Clearing Member that paid the TBA Transaction Adjustment Payment amount. This overnight interest will be added as a Cash Settlement item in the MBSD Rules.
^{17} Definition of “TBA Transaction Adjustment Payment” in MBSD Rule 1, supra note 3.
^{18} MBSD Rule 11, Section 1 and Section 7(a), supra note 3.
In order to move the Mark-to-Market items, cash obligation items, and accrued principal and interest from the DRC to the Cash Settlement process, FICC would change the calculation of Cash Settlement to include amounts for the following: (i) Amounts of pre-settlement TBA Transaction Adjustment Payments, (ii) the return of the pre-settlement TBA Transaction Adjustment Payments, (iii) accrued overnight interest in connection with pre-settlement TBA Transaction Adjustment Payments, (iv) Mark-to-Markets, (v) accrued principal and interest payments required for any Fail, (vi) the return of Mark-to-Market for each Transaction, and principal and interest related payments for each Fail that was collected or paid during the prior Cash Settlement Amount, and (vii) accrued overnight interest in connection with Mark-to-Markets.
As a result of this change, a Clearing Member's Cash Settlement amount would be calculated to include such Clearing Member's pre-settlement TBA Transaction Adjustment Payment items, Mark-to-Market items, cash obligation items, and accrued principal and interest. The Cash Settlement amount would be a cash-only event that is collected or paid (as applicable) by the payment deadlines established by FICC. FICC currently processes MBSD cash settlement debits at 10 a.m. EST daily and cash settlement credits at 2:45 p.m. EST daily. ^{19}
^{19} The schedule of cash settlement for MBSD is posted on its website at http://www.dtcc.com. See MBSD Rule 11, Section 9(f), supra note 3.

Six Days' Interest for Fails
Currently, in addition to interest on Fails that has accrued with respect to any Fails position, the DRC calculation also includes an additional amount equal to six days' interest that has not yet accrued for a sell position of a Fail. This parameter is not in the MBSD Rules. It is reflective of FICC's current practice and it is designed to account for the risk that if a Clearing Member with a net sell position defaults, FICC would make appropriate principal and interest payments on an allocated pool that settles past record date, in addition to the delivery of the related securities to the non-defaulting Clearing Member with the corresponding buy position. FICC collects an additional six days of interest from the seller of any Fail because FICC assumes it could take three days to close out the position and the pool allocation process could take an additional three days.
Although FICC is proposing to move three of the items of the DRC from the Required Fund Deposit calculation to MBSD's Cash Settlement process as discussed above, FICC would continue to include the six days' interest for Fails as a component in the Required Fund Deposit calculation. FICC is proposing to keep the six days' interest for Fails in the Required Fund Deposit calculation because this amount would not have accrued but would continue to mitigate additional interest that may accrue in the event that FICC must close out the position in the event of a Clearing Member default. Therefore, the six days' interest for Fails would remain in the Required Fund Deposit calculation and would be formally added in the MBSD Rules.

(b) Proposal To Revise the Definition of Intraday Mark-to-Market Charge

Intraday Mark-to-Market Charge
Another component of the daily Required Fund Deposit is the Intraday Mark-to-Market Charge. During each trading day, the exposure a Clearing Member's position presents to FICC may change due to the settlement of existing transactions and new trade activities and as the value of the Clearing Member's portfolio changes due to market influences. The DRC is intended to cover FICC's exposure to a Clearing Member that is due to market moves and/or trading and settlement activity by bringing the portfolio of outstanding positions up to the market value at the end of the prior day. However, because the DRC is calculated only once daily using the prior end-of-day positions and prices, it does not mitigate FICC's exposure arising out of intraday changes to a Clearing Member's positions and to the market value of the Clearing Member's portfolio that result in an adverse change to the Clearing Member's Mark-to-Market. FICC manages this intraday risk exposure by observing hourly snapshots of Clearing Members' portfolios from 9:00 a.m. EST to 4:00 p.m. EST and monitoring intraday changes to each Clearing Member's Mark-to-Market. FICC may then collect an Intraday Mark-to-Market Charge from Clearing Members to cover significant risk exposures that warrant the collection of intraday margin pursuant to the MBSD Rules.
FICC currently calculates the Intraday Mark-to-Market Charge by tracking three criteria (each, a “Parameter Break”) for each Clearing Member. ^{20} The Parameter Breaks help FICC determine whether a Clearing Member's Mark-to-Market exposure poses a risk to FICC that is significant enough to warrant an Intraday Mark-to-Market Charge. The objective of the Parameter Breaks is to ensure that FICC is able to limit exposure to intraday Mark-to-Market fluctuations that (a) are of a large dollar amount (the “Dollar Threshold”), (b) exhaust a significant portion of a Clearing Member's VaR Charge (the “Percentage Threshold”) and (c) are experienced by Clearing Members with backtesting deficiencies that bring backtesting results for that Clearing Member below the 99 percent confidence target (the “Coverage Target”), indicating that a Clearing Member's activity was not sufficiently covered by margin. ^{21}
^{20} See definition of “Intraday Mark-to-Market Charge” in MBSD Rule 1, supra note 3. See also Securities Exchange Release No. 80253 (March 15, 2017), 82 FR 14581 (March 21, 2017) (SR-FICC-2017-004) (codifying FICC's practices with respect to the assessment and collection of the intraday Mark-to-Market charge in the MBSD Rules and describing the Intraday Mark-to-Market Charge) (“Intraday Mark-to-Market Charge Filing”).
^{21} Id.
FICC's current practice is to review intraday snapshots of each Clearing Member's portfolios to determine whether the Clearing Member has experienced a change in its Mark-to-Market exposure that warrants FICC assessing an Intraday Mark-to-Market Charge. More specifically, if a Clearing Member's Mark-to-Market exposure breaches all three Parameter Breaks, the Clearing Member will be subject to the Intraday Mark-to-Market Charge and FICC will collect the charge subject to waivers or changes to the amount of the calculated charge, as described below. However, where FICC determines that certain market conditions exist, including but not limited to (i) sudden swings in an equity index in either direction that exceed certain threshold amounts determined by FICC and (ii) moves in U.S. Treasury yields and mortgage-backed security spreads outside of historically observed market moves, FICC does not require that the Coverage Target be breached and FICC may reduce the Dollar Threshold and the Percentage Threshold if FICC determines that such reduction is appropriate in order to accelerate collection of anticipated additional margin from Clearing Members whose portfolios may present relatively greater risks to FICC on an overnight basis. Any such reduction would not cause the Dollar Threshold to be less than $250,000 and the Percentage Threshold to be less than 5 percent. ^{22}
^{22} See Section (b) of the definition of “Intraday Mark-to-Market Charge” in MBSD Rule 1, supra note 3.
Irrespective of market conditions, FICC retains the discretion to impose the Intraday Mark-to-Market Charge on Clearing Members that (i) are approaching but have not yet breached the Percentage Threshold (but are at 20 percent or greater of the daily VaR Charge) and (ii) have a Mark-to-Market exposure that exceeds a certain dollar amount (“Surveillance Threshold”) that is set by FICC per Clearing Member based on the Clearing Member's internal Credit Risk Rating Matrix (“CRRM”) rating and/or the Clearing Member's Watch List status, if the Corporation determines that the size of such Clearing Member's Mark-to-Market change exposes the Corporation to increased risk (“Surveillance Threshold Provision”). ^{23}
^{23} See Section (c) of the definition of “Intraday Mark-to-Market Charge” in MBSD Rule 1, supra note 3.
Although FICC generally collects the Intraday Mark-to-Market Charge under the conditions described above, FICC retains the discretion to waive or alter such Intraday Mark-to-Market Charge in circumstances where it determines that the Mark-to-Market exposure and/or the breaches of the Parameter Breaks do not accurately reflect FICC's risk exposure to the Clearing Member's intraday Mark-to-Market fluctuation ( e.g., Mark-to-Market fluctuation arising from trade error). ^{24} Based on FICC's assessment of the impact of these circumstances and FICC's actual risk exposure to a Clearing Member, FICC may, in its discretion, waive or alter (decrease or increase) an Intraday Mark-to-Market Charge for a Clearing Member. Given the variability of the factors that result in breaches of the Parameter Breaks, FICC believes that it is important to maintain such discretion in order to limit the imposition of the Intraday Mark-to-Market Charge to those Clearing Members with Mark-to-Market exposures that pose a significant level of risk to FICC. The MBSD Rules provide that such Intraday Mark-to-Market Charge as a result of this waiver provision would not reduce a Clearing Member's Required Fund Deposit below the amount reported at the start of day and any increase to the Intraday Mark-to-Market Charge would not cause the Intraday Mark-to-Market Charge to be greater than two times its calculated amount. ^{25}
^{24} See Section (d) of the definition of “Intraday Mark-to-Market Charge” in MBSD Rule 1, supra note 3.
^{25} Id.

Revise the Intraday Mark-to-Market Charge To Reflect Movement of Mark-to-Market Items to Cash Settlement and To Revise Thresholds and Parameters
FICC is proposing to revise the definition of Intraday Mark-to-Market Charge in order to reflect the movement of the Mark-to-Market items to Cash Settlement from the Required Fund Deposit. FICC is also proposing to revise the Dollar Threshold and the Percentage Threshold to remove the specific threshold amounts currently listed and provide a floor amount for each. In addition, FICC is proposing to remove the Coverage Target from the definition.
FICC is proposing each of these changes to provide it with greater flexibility to change the thresholds that apply to the Intraday Mark-to-Market Charge. Although the definition currently provides FICC the ability to (i) change the Dollar Threshold and the Percentage Threshold and not consider the Coverage Target if certain market conditions occur, ^{26} (ii) collect an Intraday Mark-to-Market Charge from a Clearing Member if it has not breached the Percentage Threshold but exceeds a certain dollar threshold based on the Clearing Member's CRRM rating ^{27} and (iii) waive or alter the imposition of the Intraday Mark-to-Market Charge under certain circumstances, ^{28} FICC would like the ability to change the default thresholds that apply from time to time (subject to a floor) rather than rely on the set percentages because it believes that this would allow FICC to more quickly adapt to changing market conditions and more accurately reflects FICC's current application of the Dollar Threshold and Percentage Threshold.
^{26} See Section (b) of the definition of “Intraday Mark-to-Market Charge” in MBSD Rule 1, supra note 3.
^{27} See Section (c) of the definition of “Intraday Mark-to-Market Charge” in MBSD Rule 1, supra note 3.
^{28} See Section (d) of the definition of “Intraday Mark-to-Market Charge” in MBSD Rule 1, supra note 3.
In addition, FICC's current practice is to waive or adjust the Dollar Threshold and parameter in volatile market conditions, as permitted by the MBSD Rules. Therefore, these proposed changes to the Intraday Mark-to-Market Charge definition would align the MBSD Rules with FICC's current practice in certain circumstances and provide Clearing Members with greater transparency and certainty regarding the application of this charge outside of those circumstances. While FICC would have the authority to take this charge more frequently under the proposed changes, subject to the threshold floors, neither the current calculation methodology nor the key components of the Intraday Mark-to-Market Charge would change.
FICC has relied on the waiver provisions in the definition and reduced the thresholds from time to time on a case-by-case basis. FICC believes that removing the set percentages and providing a floor of not less than $1,000,000 for the Dollar Threshold and not less than 10 percent of the daily VaR Charge for the Percentage Threshold, would align the MBSD Rules with FICC's current practice in certain circumstances and give Clearing Members a better understanding of the default thresholds that FICC is using to determine whether to apply the Intraday Mark-to-Market Charge. FICC is transparent with Clearing Members when it sets and waives thresholds and parameters and would continue to notify Clearing Members of the current thresholds and parameters it is using and of any changes to those thresholds and parameters. FICC would also continue to provide reports and tools to allow Clearing Members to determine impacts of certain activity on their Required Fund Deposit amounts.
FICC would notify Clearing Members by important notice of the Dollar Threshold and Percentage Threshold that it would be applying and upon changes to those thresholds. Changes to such parameters and thresholds would be subject to FICC's model risk management governance procedures set forth in the Clearing Agency Model Risk Management Framework which include daily backtesting of model performance, periodic sensitivity analyses of models and annual validation of models (“Model Risk Management Framework”). ^{29} Initially, upon implementation of the proposed changes, FICC would continue to use the same Dollar Threshold ($1,000,000) and the same Percentage Threshold (30%) that it is currently using in determining whether to apply the Intraday Mark-to-Market Charge.
^{29} See Securities Exchange Act Release No. 81485 (August 25, 2017), 82 FR 41433 (August 31, 2017) (SR-DTC-2017-008; SR-FICC-2017-014; SR-NSCC-2017-008); Securities Exchange Act Release No. 84458 (October 19, 2018), 83 FR 53925 (October 25, 2018) (SR-DTC-2018-009; SR-FICC-2018-010; SR-NSCC-2018-009); Securities Exchange Act Release No. 88911 (May 20, 2020), 85 FR 31828 (May 27, 2020) (SR-DTC-2020-008; SR-FICC-2020-004; SR-NSCC-2020-008); Securities Exchange Act Release No. 92380 (July 13, 2021), 86 FR 38140 (July 19, 2021) (SR-FICC-2021-006); Securities Exchange Release No. 94271 (February 17, 2022), 87 FR 10411 (February, 24 2022) (SR-FICC-2022-001).

Remove the Coverage Target
FICC is also proposing to remove the Coverage Target from the definition because it believes that it is not necessary with the other Parameter Breaks. In addition, in volatile market conditions an Intraday Mark-to-Market Charge may be appropriate even if a Clearing Member is meeting the established Coverage Target. This concept is already reflected in Section (b) of the definition of Intraday Mark-to-Market Charge ^{30} which provides FICC the ability to not consider the Coverage Target. FICC has relied on the waiver provisions in the definition and not considered the Coverage Target on a case-by-case basis. FICC believes that removing the Coverage Target would align the MBSD Rules with FICC's current practice and also provide greater transparency into FICC's application of the Intraday Mark-to-Market Charge rather than relying on the waiver provision in Section (b) on a case-by-case basis giving Clearing Members a better understanding of the default thresholds that FICC is using to determine whether to apply the Intraday Mark-to-Market Charge.
^{30} See Section (b) of the definition of “Intraday Mark-to-Market Charge” in MBSD Rule 1, supra note 3.

Remove the Surveillance Threshold Provision
FICC is also proposing to remove the Surveillance Threshold Provision. The Surveillance Thresholds were intended as a tool to aid FICC in identifying Clearing Members whose Mark-to-Market exposures may necessitate the collection of an Intraday Mark-to-Market Charge. ^{31} However, FICC does not currently apply the Surveillance Threshold Provision and does not intend to apply the Surveillance Threshold Provision in the future, Therefore, FICC believes that removing the provision would align the MBSD Rules with FICC's current practice.
^{31} See Intraday Mark-to-Market Charge Filing supra note 20.

(c) Proposal To Introduce the Intraday VaR Charge

Intraday VaR Collections
MBSD observes hourly snapshots from 8:00 a.m. EST to 4:00 p.m. EST of Clearing Members' portfolios to monitor large changes due to SIFMA TBA settlement activity. If a Clearing Member's portfolio has an intraday VaR Charge increase exceeding 100% and $1 million from the start-of-day VaR Charge, FICC may assess a special charge, typically on SIFMA designated settlement dates, and require the Clearing Member to make an intraday payment to the Required Fund Deposit. A Clearing Member may also be subject to an intraday VaR collection via a special charge on any non-SIFMA designated settlement date if the Clearing Member's portfolio has an intraday VaR Charge increase exceeding 100% and $1 million and it is deemed by FICC that the increase in VaR could lead to a backtesting deficiency or push a Clearing Member below 99% backtest coverage.

Establish Intraday VaR Charge
FICC is proposing to amend the MBSD Rules to include a formal Intraday VaR Charge. More specifically, FICC is proposing to utilize its existing intraday monitoring to determine when the difference between a Clearing Member's (1) start of day VaR Charge, collected on that Business Day as part of the Clearing Member's start of day Required Fund Deposit based on that Clearing Member's prior end-of-day positions, and (2) a calculation of the VaR Charge based on that Clearing Member's adjusted intraday positions as of a point intraday between the collection of the start of day Required Fund Deposit and end of day settlement, exceeds a certain percentage or dollar amount. ^{32} FICC has occasionally observed significant intraday changes to market price volatility and significant changes to the size and composition of Clearing Members' portfolios that could cause the amount collected as the VaR Charge at the start of that Business Day to no longer be sufficient to mitigate the volatility risks that such positions present to FICC. Therefore, FICC believes it is appropriate to implement an Intraday VaR Charge that, similar to the current Intraday Mark-to-Market Charge and the intraday VaR collections pursuant to the special charge, may be collected by FICC when certain thresholds are met.
^{32} FICC would continue to monitor intraday volatility in increments throughout the day, and the calculation of the Intraday VaR Charge would be done at those intervals. Similar to the Intraday Mark-to-Market Charge, collections may occur multiple times throughout the day, as determined from time to time by FICC.
The Intraday VaR Charge would be collected when (1) the start of day VaR Charge, collected on that Business Day as part of the Clearing Member's start of day Required Fund Deposit based on that Clearing Member's prior end-of-day positions, and (2) a calculation of the VaR Charge based on that Clearing Member's adjusted intraday positions as of a point intraday between the collection of the start of day Required Fund Deposit and end of day settlement, exceeds a certain percentage threshold and dollar amount. As with the current intraday VaR monitoring and collections through the special charge, the initial percentage threshold and dollar amount to be used by FICC would be 100% and $1 million. FICC could adjust the percentage amount and dollar threshold or other parameters from time to time as appropriate in order to continue to reflect a threshold that mitigates the volatility risks that such positions present to FICC. Changes to the Intraday VaR Charge thresholds would be subject to FICC's model risk management governance procedures set forth in the Model Risk Management Framework. ^{33} FICC would update Clearing Members by important notice if the default thresholds or parameters for the Intraday VaR Charge are changed.
^{33} See supra note 29.
As discussed above, FICC currently may impose a special charge on non-SIFMA designated settlement dates if a Clearing Member's portfolio has an intraday VaR Charge increase exceeding 100% and $1 million and it is deemed by FICC that the increase in VaR could lead to a backtesting deficiency or push a Clearing Member below 99% backtest coverage. FICC would impose the Intraday Var Charge using the same methodology on SIFMA-designated settlement dates and non SIFMA-designated settlement dates. As a result, FICC would begin charging the Intraday VaR Charge on both SIFMA designated settlement dates and non-SIFMA designated settlement dates if the thresholds are crossed regardless of whether the increase in VaR could lead to a backtesting deficiency or push a Clearing Member below 99% backtest coverage.
Portfolio compositions in MBSD can change materially between the day before settlement and the settlement date, when components of the portfolio settle. FICC has implemented an intraday market price risk surveillance process to monitor the change in market price risk associated with settlement risk. The portfolio that is currently margined intraday includes the actual settled positions and the intraday trades/positions that have been transacted, providing FICC with the accurate portfolio to margin and measure whether the Intraday VaR Charge should be applied.

(d) Proposed Clarifying Changes
FICC is proposing to make certain clarifying changes to the MBSD Rules. Specifically, FICC would move certain definitions so that they are in alphabetical order, re-letter certain subsections that follow to conform to the deletion of certain subsections and update certain cross-references to reflect other changes set forth herein. The proposed clarifying changes would not have any substantive effect on the Clearing Members because such changes are clarifications and will not affect the rights or obligations of FICC or the Clearing Members.

(iii) Detailed Description of the Proposed Changes to the MBSD Rules

(a) Proposed Changes to MBSD Rule 1 (Definitions)
FICC is proposing to amend the definition of the term “Aggregated Account” to reflect that the Mark-to-Market requirements would be included in the calculation for the Cash Settlement obligations.
FICC is proposing to delete the term “Deterministic Risk Component” because FICC would eliminate DRC from the Required Fund Deposit calculation as set forth in MBSD Rule 4 and move three items DRC to Cash Settlement, as described above.
FICC is proposing to move the placement of the term “Government Securities Division Funds-Only Settling Bank Member” so that it appears in the correct alphabetical order.
FICC is proposing to move the placement of the term “Government Securities Issuer Clearing Member” so that it appears in the correct alphabetical order.
FICC is proposing to revise the term “Intraday Mark-to-Market Charge” to (i) reflect the movement of the DRC items to Cash Settlement, (ii) revise the Dollar Threshold to be a certain threshold dollar amount as determined by FICC from time to time subject to a $1,000,000 floor, (iii) revise the Percentage Threshold to be a certain threshold percentage as determined by FICC from time to time subject to a 10% floor, (iv) remove the Coverage Target, (v) remove the Surveillance Threshold Provision, as described above and (vi) re-letter and change certain cross-references to reflect the foregoing changes.
FICC is proposing to add the new defined term “Intraday VaR Charge”. This term would be defined as an additional charge that is collected from a Clearing Member if the difference of (i) a Clearing Member's VaR Charge collected pursuant to MBSD Rule 4 and (ii) such Clearing Member's intraday VaR calculations exceeds a certain percentage threshold and dollar amount determined by FICC from time to time based on its regular review of margining methodologies.
FICC is proposing to add the following terms that would be referred to in MBSD Rule 11 which governs the Cash Settlement process in connection with the movement of the cash obligation items and accrued principal and interest of the DRC from the Required Fund Deposit calculation to Cash Settlement:
“Margin Transaction Adjustment Payment Return Interest”—This term would be defined as the overnight interest that accrued on the Margin Transaction Adjustment Payment for each Transaction that was collected or paid during the prior Cash Settlement.
“Margin Transaction Adjustment Payment Return”—This term would be defined as the return of Margin Transaction Adjustment Payment for each Transaction that was collected or paid during the prior Cash Settlement.
“Margin Transaction Adjustment Payment Return Interest”—This term would be defined as the overnight interest that accrued on the Margin Transaction Adjustment Payment for each Transaction that was collected or paid during the prior Cash Settlement.
“Mark Return”—This term would be defined as the return of Mark-to-Market for each Transaction, and principal and interest related payments for each Fail that was collected or paid during the prior Cash Settlement.
“Mark Return Interest”—The term “Mark Return Interest” means the overnight interest that accrued on the Mark Return for each Transaction that was collected or paid during the prior Cash Settlement.
FICC is proposing to amend the term “Mark-to-Market” to change the cross-reference from MBSD Rule 4 to MBSD Rule 11 because the Mark-to-Market calculation would be moved to MBSD Rule 11 in connection with the movement of Mark-to-Market items of the DRC from the Required Fund Deposit calculation to Cash Settlement.
FICC is proposing to delete the terms “Mark-to-Market Credit” and “Mark-to-Market Debit” because those terms are only used in the definition of “Deterministic Risk Component” which FICC is proposing to delete in connection with the movement of DRC items the Required Fund Deposit calculation to Cash Settlement.

(b) Proposed Changes to MBSD Rule 4 (Clearing Fund and Loss Allocation)

Section 2 (Required Fund Deposit Requirements)
FICC is proposing to amend this section as follows: (i) Move the Mark-to-Market calculation of profits and losses (as set forth in subsection (a)) to the Cash Settlement process (set forth in Section 7 of MBSD Rule 11); (ii); re-letter the subsections that follow to conform to the deletion of subsection (a); (iii) update cross-references; (iv) reflect that the definitions of Long Position and Short Position would now also be used in Rule 11 in connection with the movement of the Mark-to-Market calculation to Rule 11; (v) add, with respect to a Clearing Member that is a seller, an amount equal to six days interest for any Fail as a separate item in the Required Fund Deposit; (vi) add the Intraday VaR Charge as a separate line item of the Required Fund Deposit to reflect the introduction of the Intraday VaR Charge and (vii) capitalize “Intraday VaR Charge” in new proposed Section 2(e) to reflect the introduction of the Intraday VaR Charge.

Proposed New Section 3a (Calculation of Intraday VaR Charge and Intraday Mark-to-Market Charge)
FICC is proposing to add this new Section 3a to provide it with the authority to collect an Intraday VaR Charge and the Intraday Mark-to-Market Charge from Clearing Members as discussed above. In connection with this change, FICC would re-letter current Sections 3a (Special Provisions Relating to Deposits of Cash) and 3b (Special Provisions Relating to Deposits of Eligible Clearing Fund Securities) in order to conform to this proposed new Section 3a. The section would provide that pursuant to procedures established by the FICC, FICC would re-calculate intraday, each Business Day, at the times established by FICC for this purpose, the amount of the Intraday VaR Charge and the Intraday Mark-to-Market Charge to each Clearing Member's margin portfolio based upon the open positions in such margin portfolio at a designated time intraday, for purposes of establishing whether a Clearing Member shall be required to make payment of an additional amount to its Required Fund Deposit. Such additional amounts would be deemed part of the Clearing Member's Required Fund Deposit for all purposes under the MBSD Rules.
The section would provide that FICC would establish procedures for collection of an amount calculated in respect of a Clearing Member's Intraday VaR Charge and Intraday Mark-to-Market Charge, including parameters regarding threshold amounts that require payment, and the form and time by which payment is required to be made to FICC. Consistent with the application of the special charge, FICC would also reserve the right to require a Clearing Member or Clearing Members generally to make additional Intraday VaR Charges or Intraday Mark-to-Market Charges if FICC determines it to be necessary to protect itself and its Clearing Members in response to factors such as market conditions or financial or operational capabilities affecting a Clearing Member or Clearing Members generally. The methodology for such additional Intraday Var Charges or Intraday Market Charges would be subject to FICC's model risk management governance procedures set forth in the Model Risk Management Framework. ^{34}
^{34} See supra note 29.

Section 5 (Use of Clearing Fund)
FICC is proposing to replace the reference to “Section 3a” with “Section 3b” in order to reflect the proposed renumbering of Section 3a to 3b described above.

(c) Proposed Changes to MBSD Rule 11 (Cash Settlement)

Proposed New Section 7 (Mark-to-Market—Computation of Profits or Loss)
FICC is proposing to move the Mark-to-Market calculation (as set forth in Section 2(a) of MBSD Rule 4) to proposed new Section 7 of MBSD Rule 11 to reflect the movement of Mark-to-Market to Cash Settlement, as described above. This proposed section would be further amended to state that on each Business Day, profits and/or losses would be computed by FICC and such amounts would be reflected on a Report made available to Clearing Members by FICC. The amount reflected would be either paid by FICC to the Clearing Member or paid by the Clearing Member to FICC.

Section 7 (Computation of Cash Balance for Each Account)
FICC is proposing to re-number this current Section 7 as Section 8a to conform to the proposed changes to move the Mark-to-Market calculation to Section 7 in MBSD Rule 11.
FICC is proposing to amend the Cash Balance calculation to include the positive and negative amounts of any (i) Margin Transaction Adjustment Payment, (ii) Margin Transaction Adjustment Payment Return, (iii) Margin Transaction Adjustment Payment Return Interest, (iv) Mark-to-Market; (v) accrued principal and interest payments required for any Fail, (vi) Mark Return and (vii) Mark Return Interest. FICC is proposing to add these defined terms in connection with the movement of the cash obligation items and accrued principal and interest of the DRC from the Required Fund Deposit calculation to Cash Settlement. In connection with these changes, FICC would re-letter the remainder of the clauses listed in this section.

Section 8 (Netting of Cash Balances for Aggregated Accounts)
FICC is proposing to re-number this current Section 8 as Section 8b to conform to the proposed changes to move the Mark-to-Market calculation to Section 7 in MBSD Rule 11.

(d) Proposed Change to the Section Entitled “Interpretative Guidance With Respect to Watch List Consequences”
FICC is proposing to amend subsection 1 (Additional Clearing Fund Deposits) of Section A (Clearing Fund-Related Consequences) to (i) update the reference to Section 2(a) of Rule 4 to Section 3a of Rule 4 to reflect the new Section 3a; (ii) add a reference to the Intraday VaR Charge; (iii) change references of “Surveillance Thresholds” to “thresholds” to reflect the removal of the Surveillance Threshold Provision and the definition of Surveillance Threshold and to reflect that the Intraday VaR Charge may be subject to certain thresholds that are not “Surveillance Thresholds”; (iv) delete the statement that pursuant to Section 2(f) of MBSD Rule 4, the Corporation may subject a Clearing Member to an intraday VaR Charge if the Clearing Member is on the Watch List because such statement would be redundant following the proposed changes just described and (v) change cross references for subsections 2(c) of MBSD Rule 4 to 2(b) to conform to the proposed renumbering of subsection 2(c) of MBSD Rule 4.

(e) Proposed QRM Methodology Changes
In connection with the proposed changes, FICC would modify the QRM Methodology to reflect the move of the DRC items from the Required Fund Deposit calculation to the MBSD Cash Settlement process and delete the concept of the DRC and to add the six days' interest for any Fail by a seller in the Required Fund Deposit calculation.

(iv) Impact on Clearing Members
FICC conducted an impact study of the proposed changes based on data from July 1, 2020 to June 30, 2021 (“Impact Study”). The results of the Impact Study are described below.

(a) Proposed Movement of DRC Items to Cash Settlement
FICC does not believe that the movement of the DRC items to Cash Settlement would have a substantial economic impact on Clearing Members because the amounts that are currently imposed on Clearing Members for the DRC items and included in their Required Fund Deposit amounts would not change. However, pursuant to this proposed change such amounts would be effectuated as a cash pass-through—meaning that, those Clearing Members that are in a net debit position would be obligated to submit payments that are then used to pay Clearing Members in a net credit position, and the calculated amounts would reflect the difference between the contract value of a trade and the current market value of the security in a Clearing Member's portfolio. The movement would require any debits as a result of such components to be paid in cash through Cash Settlement rather than increasing the Required Fund Deposit amount. Clearing Members currently may pay a portion of the Required Fund Deposit in Eligible Clearing Fund Securities. ^{35} As a result of the proposed change to move the DRC items to Cash Settlement, Clearing Members would be required to fund any debits as a result of such items with cash, rather than through a mix of cash and Eligible Clearing Fund Securities as is permitted to satisfy Required Fund Deposit obligations.
^{35} See MBSD Rule 4, supra note 3.
FICC also believes that while the requirement to fund such adjustments with cash rather than Eligible Clearing Fund Securities may present some operational changes for Clearing Members, it does not believe such changes would have a substantial economic effect on such Clearing Members because the amounts that the Clearing Members are required to pay with respect to the DRC obligations would not change. Clearing Members would be paying the same amounts for the Mark-to-Market components following the movement of such components to Cash Settlement. The only impact on Clearing Members would be that the Clearing Members would be paying such debits as part of Cash Settlement rather than as part of the Required Fund Deposit.
Over the Impact Study period, 49 of the 102 Clearing Members had an overall average DRC debit balance. ^{36} Of those 49 Clearing Members, on average, 26 Clearing Members funded their Required Fund Deposit with only cash. Therefore, based on the Impact Study period data, these 26 Clearing Members would not have had to change the form of their payment whatsoever with respect to the DRC items if the proposed change to move these items to Cash Settlement had been in effect on those dates.
^{36} The data reflected in the impact study reflects only the Clearing Members who had average DRC debits over the study period.
Of the remaining 23 Clearing Members with an average DRC debit balance, taking into consideration the average ratio of cash and Eligible Clearing Fund Securities on deposit in the Required Fund Deposit for such Clearing Members, the amount of the DRC debit balance that had been paid in Eligible Clearing Fund Securities that would need to be paid in cash totaled on average $191 million in the aggregate for all such Clearing Members and approximately $8.3 million for each Clearing Member. These amounts represent approximately 1.4% of the total Clearing Fund collected on those dates and an average of 6.7% of those Clearing Members' Clearing Fund obligations.

(b) Changes To Revise the Intraday Mark-to-Market Charge
FICC believes that the changes to revise the definition of the Intraday Mark-to-Market Charge to remove the specific thresholds and provide a floor for the Dollar Threshold and the Percentage Threshold and to remove the Coverage Target from the definition, as described above, would not have a substantial impact on Clearing Members. As discussed above, the MBSD Rules currently provide the ability to waive or adjust such provisions under certain conditions and FICC believes that providing more flexibility with respect to setting the default thresholds would provide more transparency to the Clearing Members.
The proposal to remove the Coverage Target from the Intraday Mark-to-Market calculation would have resulted in approximately 353 additional Intraday Mark-to-Market Charges over the study period and such additional charges would have resulted in an average aggregate daily increase of total Intraday Mark-to-Market Charges collected by approximately $109,822,538. This amount represents approximately 0.8% of the total average Clearing Fund collected on those dates.
While FICC does not intend to change the Dollar Threshold ($1,000,000) or the Percentage Threshold (30%) that it is currently using upon implementation of the proposed changes, it has conducted an Impact Study of the results of the impact if it were to reduce the Percentage Threshold to the proposed 10% floor. As shown in the Impact Study from the period from July 1, 2020 to June 30, 2021, if FICC were to decrease the percentage threshold to 10% and remove the Coverage Target, the Intraday Mark-to-Market Charge would have resulted in approximately 2,522 additional Intraday Mark-to-Market Charges over that period, and such charges would have result in an average aggregate daily increase of total Intraday Mark-to-Market Charges collected by approximately $376,905,268. This amount represents approximately 2.8% of the total average Clearing Fund collected on those dates.

(c) Introduction of the Intraday VaR Charge
The proposed Intraday VaR Charge would formalize a charge that FICC is currently collecting under its authority to collect a special charge. Similar to the proposed change to Intraday Mark-to-Market Charge parameters and thresholds, this proposed change would align the Rules with FICC's current practice and would provide Clearing Members with greater transparency regarding this margin charge. However, the proposal would not implement substantive or material changes to the risk this charge is designed to mitigate or to the overall methodology or key components of the calculation of this charge.
As discussed above, FICC would begin charging the Intraday VaR Charge on both SIFMA designated settlement dates and non-SIFMA designated settlement dates if the thresholds are crossed regardless of whether the increase in VaR could lead to a backtesting deficiency or push a Clearing Member below 99% backtest coverage. As a result, the introduction of the Intraday VaR Charge would result in more consistent intraday VaR collections when compared to the current practice, on both SIFMA designated settlement dates and non-SIFMA designated settlement dates.
The Impact Study showed the Intraday VaR Charge would have resulted in approximately 126 Intraday VaR Charges collected over the Impact Study period, and such charges would have been an average of $11,663,204, which represents less than 0.1% of the total average Clearing Fund collected on those dates. The Impact Study did not indicate that the introduction of the Intraday VaR would have an impact on any specific Clearing Member type or Clearing Members that held particular portfolios.

(d) Clarifying Changes
The proposed clarifying changes would not have any substantive effect on the Clearing Members because such changes are clarifications and will not affect the rights or obligations of FICC or the Clearing Members.

(v) Implementation Timeframe
FICC would implement the proposed changes no later than 60 Business Days after the approval of the proposed rule change by the Commission and would announce the effective date of the proposed changes by Important Notice posted to its website. As proposed, a legend would be added to MBSD Rule 1, MBSD Rule 4, MBSD Rule 11 and the Interpretive Guidance With Respect to Watchlist Consequences in the MBSD Rules stating that the changes would be effective no later than 60 Business Days after the approval of the proposed rule change by the Commission, that FICC would announce the effective date of the proposed changes by Important Notice posted to its website and that once this proposal is implemented the legend would automatically be removed.

2. Statutory Basis
FICC believes that the proposed changes are consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, FICC believes that the proposed changes are consistent with Section 17A(b)(3)(F) of the Act, ^{37} and Rules 17Ad-22(e)(4)(i), (e)(6)(i) and (e)(6)(iii), each promulgated under the Act, ^{38} for the reasons described below.
^{37} 15 U.S.C. 78q-1(b)(3)(F).
^{38} 17 CFR 240.17Ad-22(e)(4)(i), (e)(6)(i) and (iii).
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of a clearing agency be designed 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. ^{39} FICC believes the proposed changes are designed to assure the safeguarding of securities and funds which are in its custody or control or for which it is responsible because they are designed to enable FICC to better limit its exposure to Clearing Members in the event of a Clearing Member default, as described below. The proposal to move DRC items (Mark-to-Market items, cash obligation items and accrued principal and interest) from the Required Fund Deposit calculation to the MBSD Cash Settlement process would more closely align FICC's mark-to-market process to industry practice and better segregate the unrealized gains or losses associated with a Clearing Member's margin portfolio from the portion of the margin that measures potential future exposure and limit the build-up of systemic risk. Currently, the Required Fund Deposit may be reduced by credits relating to unrealized mark-to-market gains. During the time between the last margin collection and the close out of a Clearing Member's position such gains may reduce without a corresponding increase in the Required Fund Deposit leaving the Required Fund Deposit insufficient to cover the future exposure. Therefore, FICC believes that moving such mark-to-market items to a cash pass-through adjustment is consistent with Section 17A(b)(3)(F) of the Act. ^{40} FICC believes that the changes to revise the definition of the Intraday Mark-to-Market Charge to (i) remove the specific thresholds and provide a floor for the Dollar Threshold and the Percentage Threshold and (ii) remove the Coverage Target from the definition, as described above, is designed to assure the safeguarding of securities and funds which are in its custody or control or for which it is responsible because the removal of the specific thresholds would provide the ability for FICC to adjust the Intraday Mark-to-Market Charge default thresholds more quickly and effectively in response to adverse changes in market conditions, consistent with Section 17A(b)(3)(F) of the Act. ^{41}
^{39} 15 U.S.C. 78q-1(b)(3)(F).
^{40} Id.
^{41} 15 U.S.C. 78q-1(b)(3)(F).
FICC believes the proposed change to implement an Intraday VaR Charge is designed to assure the safeguarding of securities and funds which are in its custody or control or for which it is responsible because it is designed to mitigate changes in volatility that could occur intraday and increase the risks to FICC related to liquidating a Clearing Member's portfolio following that Clearing Member's default. Specifically, the proposed Intraday VaR Charge would allow FICC to collect financial resources to cover its exposures that it may face due to increases in volatility that occur between collections of start-of-day Required Fund Deposits.
The Clearing Fund is a key tool that FICC uses to mitigate potential losses to FICC associated with liquidating a Clearing Member's portfolio in the event of Clearing Member default. The proposed Intraday VaR Charge would formalize a charge that FICC is currently collecting under its authority to collect a special charge. Similar to the proposed change to Intraday Mark-to-Market Charge parameters and thresholds, this proposed change would align the Rules with FICC's current practice and would provide Clearing Member's with greater transparency regarding this margin charge. While the proposed changes are not expected to materially change the overall methodology or key components of the calculation of this charge, the changes would result in more consistency in the application of this charge on SIFMA designated settlement dates and non-SIFMA designated settlement dates. As discussed above, FICC would begin charging the Intraday VaR Charge on both SIFMA designated settlement dates and non-SIFMA designated settlement dates if the thresholds are crossed regardless of whether the increase in VaR could lead to a backtesting deficiency or push a Clearing Member below 99% backtest coverage. As a result, the introduction of the Intraday VaR Charge would result in more consistent intraday VaR collections when compared to the current practice, on both SIFMA designated settlement dates and non-SIFMA designated settlement dates.
Therefore, the proposed change to include an Intraday VaR Charge among the Clearing Fund components, when applicable, would enable FICC to better address any changes to market price volatility or the size of a Clearing Member's portfolio that occur intraday, such that, in the event of Clearing Member default, FICC's operations would not be disrupted, and non-defaulting Members would not be exposed to losses they cannot anticipate or control. In this way, the proposed change to implement the Intraday VaR Charge is designed to assure the safeguarding of securities and funds which are in the custody or control of FICC or for which it is responsible, consistent with Section 17A(b)(3)(F) of the Act. ^{42}
^{42} Id.
Section 17A(b)(3)(F) of the Act also requires, in part, that the rules of a clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions. ^{43} FICC believes that the proposed changes to the Parameter Breaks for the Intraday Mark-to-Market Charge and removal of the Coverage Target and Surveillance Threshold Provision would provide greater transparency and improve Clearing Members' understanding of the application of the Intraday Market-to-Market Charge by providing that the default thresholds could be adjusted, subject to a floor, and providing that the Coverage Target would no longer be a Parameter Break and that the Surveillance Threshold Provision, which is not currently being applied by FICC, would no longer be applicable. FICC also believes that the proposal to introduce the Intraday VaR Charge, which would formalize the intraday VaR charge that FICC is currently collecting under its authority to collect a special charge, would also align the MBSD Rules to FICC's current practices and bring greater transparency to Clearing Members. In addition, FICC believes that the proposal to make certain clarifying changes in the MBSD Rules and the QRM Methodology are consistent with Section 17(A)(b)(3)(F) of the Act because such changes would enhance the clarity and transparency of the MBSD Rules. By enhancing the clarity and transparency of the MBSD Rules, the proposed changes would allow Clearing Members to more efficiently and effectively conduct their business in accordance with the MBSD Rules, which FICC believes would promote the prompt and accurate clearance and settlement of securities transactions, consistent with Section 17A(b)(3)(F) of the Act. ^{44}
^{43} 15 U.S.C. 78q-1(b)(3)(F).
^{44} Id.
Rule 17Ad-22(e)(4)(i) under the Act ^{45} requires a covered clearing agency to establish, implement, maintain and enforce written policies and procedures reasonably designed to effectively identify, measure, monitor, and manage its credit exposures to participants and those exposures arising from its payment, clearing, and settlement processes by maintaining sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence.
^{45} See 17 CFR 240.17Ad-22(e)(4)(i).
FICC believes that the proposed changes to move the DRC items to Cash Settlement are consistent with Rule 17Ad-22(e)(4)(i) under the Act because the changes would help to ensure that FICC maintains sufficient financial resources to cover its credit exposure to each Clearing Member with a high degree of confidence by better segregating the unrealized gains or losses associated with a Clearing Member's margin portfolio from the portion of the margin that measures potential future exposure and by limiting the build-up of systemic risk. By better segregating the unrealized gains or losses from the Required Fund Deposit and moving the mark-to market adjustments to a cash-pass through adjustment, FICC believes that the proposed changes would help ensure that FICC maintains sufficient financial resources by calculating and collecting margin to cover its credit exposure to each Clearing Member with a high degree of confidence, consistent with Rule 17Ad-22(e)(4)(i) under the Act. ^{46}
^{46} Id.
FICC believes the proposed change to add the Intraday VaR Charge would enable it to better identify, measure, monitor, and, through the collection of Clearing Members' Required Fund Deposits, manage its credit exposures to Clearing Members by maintaining sufficient resources to cover those credit exposures fully with a high degree of confidence. Specifically, FICC believes that the proposed Intraday VaR Charge would effectively mitigate the risks related to intraday increases in volatility and would address the increased risks FICC may face related to liquidating a Clearing Member's portfolio following that Clearing Member's default.
The proposed Intraday VaR Charge would formalize a charge that FICC is currently collecting under its authority to collect a special charge. This proposed change would align the Rules with FICC's current practice and would provide Clearing Member's with greater transparency regarding this margin charge. While the proposed changes are not expected to materially change the overall methodology or key components of the calculation of this charge, the changes would result in more consistency in the application of this charge on SIFMA designated settlement dates and non-SIFMA designated settlement dates. As discussed above, FICC would begin charging the Intraday VaR Charge on both SIFMA designated settlement dates and non-SIFMA designated settlement dates if the thresholds are crossed regardless of whether the increase in VaR could lead to a backtesting deficiency or push a Clearing Member below 99% backtest coverage. As a result, the introduction of the Intraday VaR Charge would result in more consistent intraday VaR collections when compared to the current practice, on both SIFMA designated settlement dates and non-SIFMA designated settlement dates.
Therefore, FICC believes the proposal would enhance FICC's ability to effectively identify, measure and monitor its credit exposures and would enhance its ability to maintain sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence, consistent with Rule 17Ad-22(e)(4)(i) under the Act. ^{47}
^{47} Id.
Rule 17Ad-22(e)(6)(i) under the Act requires, in part, that FICC establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, considers, and produces margin levels commensurate with, the risks and particular attributes of each relevant product, portfolio, and market. ^{48}
^{48} 17 CFR 240.17Ad-22(e)(6)(i).
The Required Fund Deposits are made up of risk-based components (as margin) that are calculated and assessed daily to limit FICC's credit exposures to Clearing Members. FICC believes that the proposed changes to move the DRC items to Cash Settlement are consistent with Rule 17Ad-22(e)(6)(i) under the Act because the changes would help to ensure that FICC produces margin levels commensurate with, the risks and particular attributes of each relevant product, portfolio, and market by better segregating the unrealized gains or losses associated with a Clearing Member's margin portfolio from the portion of the margin that measures potential future exposure and by limiting the build-up of systemic risk. By better segregating the unrealized mark-to-market gains that currently reduce Required Fund Deposits, FICC believes that the proposed changes would help ensure that FICC maintains a risk-based margin system that considers, and produces margin levels commensurate with, the risks of portfolios that experience significant mark-to-market volatility on an intraday basis, consistent with Rule 17Ad-22(e)(6)(i) under the Act. ^{49}
^{49} 17 CFR 240.17Ad-22(e)(6)(i).
FICC's proposed change to introduce an Intraday VaR Charge is designed to more effectively address the risks presented by significant intraday changes to market price volatility or a Clearing Member's portfolio. The proposed Intraday VaR Charge would formalize a charge that FICC is currently collecting under its authority to collect a special charge. This proposed change would align the Rules with FICC's current practice and would provide Clearing Member's with greater transparency regarding this margin charge. While the proposed changes are not expected to materially change the overall methodology or key components of the calculation of this charge, the changes would result in more consistency in the application of this charge on SIFMA designated settlement dates and non-SIFMA designated settlement dates. As discussed above, FICC would begin charging the Intraday VaR Charge on both SIFMA designated settlement dates and non-SIFMA designated settlement dates if the thresholds are crossed regardless of whether the increase in VaR could lead to a backtesting deficiency or push a Clearing Member below 99% backtest coverage. As a result, the introduction of the Intraday VaR Charge would result in more consistent intraday VaR collections when compared to the current practice, on both SIFMA designated settlement dates and non-SIFMA designated settlement dates.
FICC believes the addition of the Intraday VaR Charge would enable FICC to assess a more appropriate level of margin that accounts for increases in these volatility risks that may occur intraday. This proposed change is designed to assist FICC in maintaining a risk-based margin system that considers, and produces margin levels commensurate with, the risks of portfolios that experience significant volatility on an intraday basis. Therefore, FICC believes the proposed change is consistent with Rule 17Ad-22(e)(6)(i) under the Act. ^{50}
^{50} Id.
Rule 17Ad-22(e)(6)(iii) under the Act ^{51} requires a covered clearing agency to establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, calculates margin sufficient to cover its potential future exposure to participants in the interval between the last margin collection and the close out of positions following a participant default.
^{51} See 17 CFR 240.17Ad-22(e)(6)(iii).
FICC believes that the proposed changes are consistent with Rule 17Ad-22(e)(6)(iii) under the Act cited above because moving the DRC items to Cash Settlement would better segregate the unrealized gains or losses associated with a Clearing Member's margin portfolio from the portion of the margin that measures potential future exposure and limit the build-up of systemic risk. Currently, the Required Fund Deposit may be reduced by credits relating to unrealized mark-to-market gains. During the time between the last margin collection and the close out of a Clearing Member's position such gains may reduce without a corresponding increase in the Required Fund Deposit leaving the Required Fund Deposit insufficient to cover the future exposure. As such, by segregating the unrealized mark-to-market gains and losses from the Required Fund Deposit FICC believes that the proposed changes are designed to allow FICC to calculate amounts that are sufficient to cover FICC's potential future exposure to Clearing Members in the interval between the last margin collection and the close out of positions following a participant default, consistent with Rule 17Ad-22(e)(6)(iii) under the Act. ^{52}
^{52} Id.

(B) Clearing Agency's Statement on Burden on Competition
FICC does not believe that the proposed rule changes would impose any burden on competition that is not necessary or appropriate in furtherance of the Act. ^{53}
^{53} See 15 U.S.C. 78q-1(b)(3)(I).
FICC believes that the proposal to move the DRC items to Cash Settlement could impose a burden on competition because the proposed change could require a Clearing Member to fund debits relating to such items with cash rather than have the ability to fund all or a portion of such debits with Eligible Clearing Fund Securities. FICC also believes that while the requirement to fund such adjustments with cash rather than Eligible Clearing Fund Securities would present some operational changes for Clearing Members it does not believe such changes would have a substantial economic effect on such Clearing Members or otherwise be a significant burden on competition because the amounts that the Clearing Members are required to pay with respect to the DRC obligations would not change. Clearing Members would be paying the same amounts for the Mark-to-Market components following the movement of such components to Cash Settlement. The only impact on Clearing Members would be that the Clearing Members would be paying such debits as part of Cash Settlement rather than as part of the Required Fund Deposit.
FICC believes that the changes to the Parameter Breaks for the Intraday Mark-to-Market Charge could have an impact on competition. Specifically, the removal of the Coverage Target Parameter Break and setting a floor for the Percentage Threshold that is lower than the current default threshold could result in the Intraday Mark-to-Market Charge being applied more often on Clearing Members. However, FICC has the ability to waive the Coverage Target and lower the Percentage Threshold currently under certain conditions. ^{54} In addition, the use of the Intraday Mark-to-Market Charge would be in direct relation to the specific risks presented by each Clearing Members' portfolio, and each Clearing Member's Required Fund Deposit would continue to be calculated with the same parameters and at the same confidence level for each Clearing Member. Therefore, because the impact of the proposal on a Clearing Member is related to the specific risks presented by that Clearing Member's clearing activity and not on the type or size of a Clearing Member, FICC believes that any burden on competition imposed by the proposed change would be both necessary and appropriate in furtherance of FICC's efforts to mitigate risks and meet the requirements of the Act, as described in this filing and further below.
^{54} FICC exercises its ability to waive the Coverage Target and lower the Percentage Threshold consistently across Clearing Member types based on its model risk management governance procedures set forth in the Clearing Agency Model Risk Management Framework. See supra note 29. For instance, FICC may waive the Coverage Target for all Clearing Members during volatile market conditions if backtesting indicates that such change is necessary to ensure its models are accurately accessing risk.
FICC believes that the proposed change to introduce the Intraday VaR Charge could have an impact on competition. Specifically, FICC believes the proposed change could burden competition because it would result in larger Required Fund Deposit amounts for Clearing Members when the Intraday VaR Charge is applicable and result in a Required Fund Deposit that is greater than the amount calculated pursuant to the current methodology.
The impacts of this proposal on a particular Clearing Member with respect to the Intraday VaR Charge would depend on the size and composition of the Clearing Member's portfolio and the potential market volatility of positions in that portfolio and would not be due to the type of legal entity or size of a Clearing Member. Therefore, Clearing Members that present similar adjusted intraday portfolios, regardless of the type or size of Clearing Member, would have similar impacts on their Required Fund Deposit amounts.
When the Intraday VaR Charge results in a larger Required Fund Deposit, the proposed change could burden competition for Clearing Members that have lower operating margins or higher costs of capital compared to other Clearing Members. However, the increase in Required Fund Deposit would be in direct relation to the specific risks presented by each Clearing Member's adjusted intraday positions, and each Clearing Member's Required Fund Deposit would continue to be calculated with the same parameters and at the same confidence level for each Clearing Member. Therefore, because the impact of the proposal on a Clearing Member is related to the specific risks presented by that Clearing Member's clearing activity and not on the type or size of a Clearing Member, FICC believes that any burden on competition imposed by the proposed change would be both necessary and appropriate in furtherance of FICC's efforts to mitigate risks and meet the requirements of the Act, as described in this filing and further below.
FICC believes the above-described burden on competition that may be created by the proposed changes would be necessary in furtherance of the Act, specifically Section 17A(b)(3)(F) of the Act. ^{55}
^{55} 15 U.S.C. 78q-1(b)(3)(F).
As discussed above, the proposal to move DRC items (Mark-to-Market items, cash obligation items and accrued principal and interest) from the Required Fund Deposit calculation to the MBSD Cash Settlement process would more closely align FICC's mark-to-market process to industry practice and better segregate the unrealized gains or losses associated with a Clearing Member's margin portfolio from the portion of the margin that measures potential future exposure and limit the build-up of systemic risk consistent with Section 17A(b)(3)(F) of the Act. ^{56}
^{56} Id.
As discussed above, FICC believes that the changes to revise the definition of the Intraday Mark-to-Market Charge to remove the specific thresholds and provide a floor for the Dollar Threshold and the Percentage Threshold and to remove the Coverage Target from the definition, as described above, are designed to assure the safeguarding of securities and funds which are in its custody or control or for which it is responsible because they would provide the ability for FICC to adjust the Intraday Mark-to-Market Charge default thresholds more quickly and effectively in response to adverse changes in market conditions consistent with Section 17A(b)(3)(F) of the Act. ^{57} In addition, FICC believes that the proposed changes to the Parameter Breaks for the Intraday Mark-to-Market Charge and removal of the Surveillance Threshold Provision would also align the MBSD Rules to FICC's current practice in certain circumstances and provide greater transparency and improve Clearing Members' understanding of the application of the Intraday Market-to-Market Charge, which is also consistent with Section 17A(b)(3)(F) of the Act, as described above. ^{58}
^{57} Id.
^{58} 15 U.S.C. 78q-1(b)(3)(F).
In addition, as stated above, the proposed Intraday VaR Charge is designed to address the risks of increases in market price volatility or other changes to a Clearing Member's portfolio on an intraday basis that could increase the costs to FICC of liquidating a Member portfolio in the event of the Clearing Member's default. Specifically, the proposed intraday volatility charge would allow FICC to collect sufficient financial resources to cover its exposure that it may face increased costs in liquidating positions that experience intraday volatility that is not captured by the start of day VaR Charge. The proposed Intraday VaR Charge would formalize a charge that FICC is currently collecting under its authority to collect a special charge. As discussed above, the change would align the Rules with FICC's current practice and would provide Clearing Member's with greater transparency regarding this margin charge. While the proposed changes are not expected to materially change the overall methodology or key components of the calculation of this charge, the changes would result in more consistency in the application of this charge on SIFMA designated settlement dates and non-SIFMA designated settlement dates.
Therefore, FICC believes this proposed change is necessary and appropriate in furtherance of the requirements of Section 17A(b)(3)(F) of the Act, which requires that the MBSD Rules be designed to assure the safeguarding of securities and funds that are in FICC's custody or control or which it is responsible. ^{59}
^{59} Id.
FICC believes these proposed changes would also support FICC's compliance with Rules 17Ad-22(e)(4)(i), (e)(6)(i) and (e)(6)(iii) under the Act, ^{60} which require FICC to establish, implement, maintain and enforce written policies and procedures reasonably designed to (x) effectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by maintaining sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence; (y) cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, considers, and produces margin levels commensurate with, the risks and particular attributes of each relevant product, portfolio, and market and (z) cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, calculates margin sufficient to cover its potential future exposure to participants in the interval between the last margin collection and the close out of positions following a participant default.
^{60} 17 CFR 240.17Ad-22(e)(4)(i), (e)(6)(i) and (iii).
As described above, FICC believes that moving the DRC items to Cash Settlement would better address the increased risks FICC may face when intraday mark-to-market adjustments are necessary for a Clearing Member's portfolio. FICC believes that moving such mark-to-market adjustments as cash pass-through adjustments will segregate the unrealized gains or losses associated with a Clearing Member's margin portfolio from the portion of the margin that measures potential future exposure and limit the build-up of systemic risk. Currently, the Required Fund Deposit may be reduced by credits relating to unrealized mark-to-market gains. During the time between the last margin collection and the close out of a Clearing Member's position such gains may reduce without a corresponding increase in the Required Fund Deposit leaving the Required Fund Deposit insufficient to cover the future exposure. Therefore, removing such mark-to-market adjustments from the Required Fund Deposit would better limit FICC's credit exposures to Clearing Members, necessary and appropriate in furtherance of the requirements of Rules 17Ad-22(e)(4)(i), (e)(6)(i) and (e)(6)(iii) under the Act. ^{61}
^{61} Id.
As described above, FICC believes the introduction of the Intraday VaR Charge would allow FICC to employ a risk-based methodology that would address the increased risks FICC may face when intraday volatility changes a Clearing Member's portfolio such that the VaR Charge collected at the start of the day no longer addresses the risks these positions present to FICC. The proposed Intraday VaR Charge would formalize a charge that FICC is currently collecting under its authority to collect a special charge. As discussed above, the change would align the Rules with FICC's current practice and would provide Clearing Member's with greater transparency regarding this margin charge. While the proposed changes are not expected to materially change the overall methodology or key components of the calculation of this charge, the changes would result in more consistency in the application of this charge on SIFMA designated settlement dates and non-SIFMA designated settlement dates. Therefore, the proposed change would better limit FICC's credit exposures to Clearing Members, necessary and appropriate in furtherance of the requirements of Rules 17Ad-22(e)(4)(i) and Rule 17Ad-22(e)(6)(i) under the Act. ^{62}
^{62} 17 CFR 240.17Ad-22(e)(4)(i) and (e)(6)(i).
FICC believes that the above-described burden on competition that could be created by the proposed change would be appropriate in furtherance of the Act because such changes have been appropriately designed to assure the safeguarding of securities and funds which are in the custody or control of FICC or for which it is responsible, as described in detail above. The proposed movement of the DRC items to Cash Settlement and the proposed Intraday VaR Charge would also enable FICC to produce margin levels more commensurate with the risks and particular attributes of each Clearing Member's portfolio.
The proposed changes would do this by segregating the unrealized gains in Clearing Member's portfolios as discussed above with respect to the movement of the DRC items to Cash Settlement and by measuring the change in volatility that impacts Clearing Members' portfolios and could occur intraday with respect to the Intraday VaR Charge. Therefore, because the proposed changes are designed to provide FICC with an appropriate measure of the volatility risks presented by Clearing Members' portfolios, FICC believes the proposal is appropriately designed to meet its risk management goals and its regulatory obligations.
FICC believes it has designed the proposed changes in an appropriate way in order to meet compliance with its obligations under the Act. Specifically, the proposals would improve the risk-based margining methodology that FICC employs to set margin requirements and better limit FICC's credit exposures to its Clearing Members.
Therefore, FICC does not believe that the proposed changes would impose any burden on competition that is not necessary or appropriate in furtherance of the Act. ^{63}
^{63} 15.U.S.C. 78q-1(b)(3)(I).

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others
In an effort to ensure that Clearing Members understand the proposed changes, FICC has invited all Clearing Members to participate in several informational sessions.
In addition, the FICC Product Management, FICC Risk Management and FICC Relationship Management teams have made themselves available to answer individual questions from Clearing Members. One Clearing Member has expressed concern regarding FICC's proposed change to move the Mark-to-Market amount to the Cash Settlement process. This Clearing Member has noted that the proposed change would create a significant burden because the change would require it to fund the mark-to-market differences with cash while under the current MBSD Rules, the amount could be funded with cash or securities. FICC believes that while the requirement to fund such adjustments with cash rather than Eligible Clearing Fund Securities would present some operational changes for Clearing Members it does not believe such changes would have a substantial economic effect on such Clearing Members or otherwise be a significant burden. Clearing Members would be paying the same amounts for the Mark-to-Market components following the movement of such components to Cash Settlement. The only impact on Clearing Members would be that the Clearing Members would be paying such debits as part of Cash Settlement rather than as part of the Required Fund Deposit.
FICC 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, available at https://www.sec.gov/regulatory-actions/how-to-submit-comments . General questions regarding the rule filing process or logistical questions regarding this filing should be directed to the Main Office of the Commission's Division of Trading and Markets at tradingandmarkets@sec.gov or 202-551-5777.

III. Date of Effectiveness of the Proposed Rule Change, and Timing for Commission Action
Within 45 days of the date of publication of this notice in the Federal Register or within such longer period up to 90 days (i) as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the self-regulatory organization consents, the Commission will:
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments
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:

Electronic Comments
• Use the Commission's internet comment form ( http://www.sec.gov/rules/sro.shtml ); or
• Send an email to rule-comments@sec.gov . Please include File Number SR-FICC-2022-002 on the subject line.

Paper Comments
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
All submissions should refer to File Number SR-FICC-2022-002. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website ( http://www.sec.gov/rules/sro.shtml ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of FICC and on DTCC's website ( http://dtcc.com/legal/sec-rule-filings.aspx ). All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-FICC-2022-002 and should be submitted on or before May 16, 2022.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. ^{64}
^{64} 17 CFR 200.30-3(a)(12).
J. Matthew DeLesDernier,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[Release No. 34-94750; File No. SR-CboeEDGX-2022-024]
Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Current Pilot Program Related to EDGX Rule 11.15, Clearly Erroneous Executions, to the Close of Business on July 20, 2022
April 19, 2022.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”), ^1 and Rule 19b-4 thereunder, ^2 notice is hereby given that on April 18, 2022, Cboe EDGX Exchange, Inc. (the “Exchange” or “EDGX”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange filed the proposal as a “non-controversial” proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act ^3 and Rule 19b-4(f)(6) thereunder. ^4 The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
^1 15 U.S.C. 78s(b)(1).
^2 17 CFR 240.19b-4.
^3 15 U.S.C. 78s(b)(3)(A)(iii).
^4 17 CFR 240.19b-4(f)(6).

I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change
Cboe EDGX Exchange, Inc. (“EDGX” or the “Exchange”) is filing with the Securities and Exchange Commission (the “Commission”) a proposed rule change to extend the current pilot program related to EDGX Rule 11.15, Clearly Erroneous Executions, to the close of business on July 20, 2022. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website ( http://markets.cboe.com/us/options/regulation/rule_filings/edgx/ ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change
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.

A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

1. Purpose
The purpose of this filing is to extend the effectiveness of the Exchange's current rule applicable to Clearly Erroneous Executions to the close of business on July 20, 2022. Portions of Rule 11.15, explained in further detail below, are currently operating as a pilot program set to expire on April 20, 2022. ^5
^5 See Securities Exchange Act Release No. 93345 (October 15, 2021), 86 FR 58368 (October 21, 2021) (SR-CboeEDGX-2021-045).
On September 10, 2010, the Commission approved, on a pilot basis, changes to EDGX Rule 11.15 that, among other things: (i) Provided for uniform treatment of clearly erroneous execution reviews in multi-stock events involving twenty or more securities; and (ii) reduced the ability of the Exchange to deviate from the objective standards set forth in the rule. ^6 In 2013, the Exchange adopted a provision designed to address the operation of the Plan. ^7 Finally, in 2014, the Exchange adopted two additional provisions providing that: (i) A series of transactions in a particular security on one or more trading days may be viewed as one event if all such transactions were effected based on the same fundamentally incorrect or grossly misinterpreted issuance information resulting in a severe valuation error for all such transactions; and (ii) in the event of any disruption or malfunction in the operation of the electronic communications and trading facilities of an Exchange, another SRO, or responsible single plan processor in connection with the transmittal or receipt of a trading halt, an Officer, acting on his or her own motion, shall nullify any transaction that occurs after a trading halt has been declared by the primary listing market for a security and before such trading halt has officially ended according to the primary listing market. ^8
^6 See Securities Exchange Act Release No. 62886 (September 10, 2010), 75 FR 56613 (September 16, 2010) (SR-EDGX-2010-03).
^7 See Securities Exchange Act Release No. 68814 (February 1, 2013), 78 FR 9086 (February 7, 2013) (SR-EDGX-2013-06).
^8 See Securities Exchange Act Release No. 72434 (June 19, 2014), 79 FR 36110 (June 25, 2014) (SR-EDGX-2014-12).
On December 26, 2018, the Commission published the proposed Eighteenth Amendment ^9 to the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS under the Act (the “Limit Up-Limit Down Plan” or the “Plan”) ^{10} to allow the Plan to operate on a permanent, rather than pilot, basis. On April 8, 2019, the Exchange amended EDGX Rule 11.15 to untie the pilot program's effectiveness from that of the Plan and to extend the pilot's effectiveness to the close of business on October 18, 2019 in order allow the Exchange and other national securities exchanges additional time to consider further amendments, if any, to the clearly erroneous execution rules in light of the proposed Eighteenth Amendment to the Plan. ^{11} On April 17, 2019, the Commission published an approval of the Eighteenth Amendment to allow the Plan to operate on a permanent, rather than pilot, basis. ^{12} On October 21, 2019, the Exchange amended EDGX Rule 11.15 to extend the pilot's effectiveness to the close of business on April 20, 2020. ^{13} On March 18, 2020, the Exchange amended EDGX Rule 11.15 to extend the pilot's effectiveness to the close of business on October 20, 2020. ^{14} On October 20, 2020, the Exchange amended EDGX Rule 11.15 to extend the pilot's effectiveness to the close of business on April 20, 2021. ^{15} On April 14, 2021 the Exchange amended EDGX Rule 11.15 to extend the pilot's effectiveness to the close of business on October 20, 2021. ^{16} Finally, on October 15, 2021 the Exchange amended EDGX Rule 11.15 to extend the pilot's effectiveness to the close of business on April 20, 2022. ^{17}
^9 See Securities Exchange Act Release No. 84843 (December 18, 2018), 83 FR 66464 (December 26, 2018) (File No. 4-631) (“Eighteenth Amendment”).
^{10} See Securities Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6, 2012) (the “Limit Up-Limit Down Release”).
^{11} See Securities Exchange Act Release No. 87364 (April 10, 2019), 84 FR 15652 (April 16, 2019) (SR-CboeEDGX-2019-018).
^{12} See Securities Exchange Act Release No. 85623 (Apr. 11, 2019), 84 FR 16086 (Apr. 17, 2019) (File No. 4-631).
^{13} See Securities Exchange Act Release No. 87367 (October 21, 2019), 84 FR 57519 (October 25, 2019) (SR-CboeEDGX-2019-062).
^{14} See Securities Exchange Act Release No. 88500 (March 27, 2020), 85 FR 18628 (April 2, 2020) (SR-CboeEDGX-2020-013).
^{15} See Securities Exchange Act Release No. 90233 (October 20, 2020), 85 FR 67787 (October 26, 2020) (SR-CboeEDGX-2020-051).
^{16} See Securities Exchange Act Release No. 91554 (April 14, 2021), 86 FR 20567 (April 20, 2021) (SR-CboeEDGX-2021-019).
^{17} Supra note 5.
Other self-regulatory organizations (“SROs”), including the Exchange, have worked on a proposed rule change to make the pilot rules permanent. Cboe BZX Exchange, Inc., (“BZX”) filed such a proposed rule change on March 7, 2022. ^{18} The Exchange now proposes to amend EDGX Rule 11.15 to extend the pilot's effectiveness an additional three months to the close of business on July 20, 2022 while the Commission considers the BZX proposal. The Exchange understands that the other national securities exchanges and Financial Industry Regulatory Authority (“FINRA”) have filed or plan to file similar proposals to extend their respective clearly erroneous execution pilot programs, the substance of which are identical to EDGX Rule 11.15. The Exchange does not propose any additional changes to EDGX Rule 11.15. The Exchange believes the benefits to market participants from the more objective clearly erroneous executions rule should continue on a limited three month pilot basis.
^{18} See Securities Exchange Act Release No. 94374 (March 7, 2022), 87 FR 14062 (March 11, 2022) (SR-CboeBZX-2022-017).

2. Statutory Basis
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act. ^{19} Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) ^{20} requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) ^{21} requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
^{19} 15 U.S.C. 78f(b).
^{20} 15 U.S.C. 78f(b)(5).
^{21} Id.
In particular, the Exchange believes that extending the clearly erroneous execution pilot under EDGX Rule 11.15 for an additional three months would help assure that the determination of whether a clearly erroneous trade has occurred will be based on clear and objective criteria, and that the resolution of the incident will occur promptly through a transparent process. The proposed rule change would also help assure consistent results in handling erroneous trades across the U.S. equities markets, thus furthering fair and orderly markets, the protection of investors and the public interest. Based on the foregoing, the Exchange believes the amended clearly erroneous executions rule should continue to be in effect on a pilot basis while the Exchange and the other national securities exchanges consider and develop a permanent proposal for clearly erroneous execution reviews.

B. Self-Regulatory Organization's Statement on Burden on Competition
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange understands that FINRA and other national securities exchanges have or will also file similar proposals to extend their respective clearly erroneous execution pilot programs. Thus, the proposed rule change will help to ensure consistency across market centers without implicating any competitive issues.

C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others
Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act ^{22} and Rule 19b-4(f)(6) thereunder. ^{23} Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act ^{24} and subparagraph (f)(6) of Rule 19b-4 thereunder. ^{25}
^{22} 15 U.S.C. 78s(b)(3)(A)(iii).
^{23} 17 CFR 240.19b-4(f)(6).
^{24} 15 U.S.C. 78s(b)(3)(A)(iii).
^{25} 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Commission has waived the five-day prefiling requirement in this case.
A proposed rule change filed under Rule 19b-4(f)(6) ^{26} normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii), ^{27} the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange asked that the Commission waive the 30-day operative delay so that the proposal may become operative immediately upon filing. Waiver of the 30-day operative delay would extend the protections provided by the current pilot program, without any changes, while the Exchange and other self-regulatory organizations consider whether further amendments to these rules are appropriate. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change as operative upon filing. ^{28}
^{26} 17 CFR 240.19b-4(f)(6).
^{27} 17 CFR 240.19b-4(f)(6)(iii).
^{28} For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments
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:

Electronic Comments
• Use the Commission's internet comment form ( http://www.sec.gov/rules/sro.shtml ); or
• Send an email to rule-comments@sec.gov. Please include File Number SR-CboeEDGX-2022-024 on the subject line.

Paper Comments
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-CboeEDGX-2022-024. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website ( http://www.sec.gov/rules/sro.shtml ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeEDGX-2022-024 and should be submitted on or before May 16, 2022.
^{29} 17 CFR 200.30-3(a)(12).
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. ^{29}
J. Matthew DeLesDernier,

Assistant Secretary.
SMALL BUSINESS ADMINISTRATION
[Disaster Declaration #17404 and #17405; Massachusetts Disaster Number MA-00084]
Presidential Declaration of a Major Disaster for Public Assistance Only for the Commonwealth of Massachusetts

AGENCY:
U.S. Small Business Administration.

ACTION:
Notice.

SUMMARY:
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Massachusetts (FEMA-4651-DR), dated 04/18/2022. Incident: Severe Winter Storm and Snowstorm.
Incident Period: 01/28/2022 through 01/29/2022.

DATES:
Issued on 04/18/2022.
Physical Loan Application Deadline Date: 06/17/2022.
Economic Injury (EIDL) Loan Application Deadline Date: 01/18/2023.

ADDRESSES:
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.

FOR FURTHER INFORMATION CONTACT:
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.

SUPPLEMENTARY INFORMATION:
Notice is hereby given that as a result of the President's major disaster declaration on 04/18/2022, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
Primary Counties: Bristol, Norfolk, Plymouth, Suffolk, including the Mashpee Wampanoag Tribe.
The Interest Rates are:
| Percent
For Physical Damage:
Non-Profit Organizations With Credit Available Elsewhere | 1.875
Non-Profit Organizations Without Credit Available Elsewhere | 1.875
For Economic Injury:
Non-Profit Organizations Without Credit Available Elsewhere | 1.875
The number assigned to this disaster for physical damage is 17404 B and for economic injury is 17405 0.
(Catalog of Federal Domestic Assistance Number 59008)
Barbara Carson,

Acting Associate Administrator for Disaster Assistance.
SMALL BUSINESS ADMINISTRATION
[Disaster Declaration #17402 and #17403; South Carolina Disaster Number SC-00078]
Administrative Declaration of a Disaster for the State of South Carolina

AGENCY:
U.S. Small Business Administration.

ACTION:
Notice.

SUMMARY:
This is a notice of an Administrative declaration of a disaster for the State of South Carolina dated 04/19/2022. Incident: Severe Storms and Tornadoes.
Incident Period: 04/05/2022 through 04/06/2022.

DATES:
Issued on 04/19/2022.
Physical Loan Application Deadline Date: 06/20/2022.
Economic Injury (EIDL) Loan Application Deadline Date: 01/19/2023.

ADDRESSES:
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.

FOR FURTHER INFORMATION CONTACT:
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.

SUPPLEMENTARY INFORMATION:
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
Primary Counties: Allendale, Bamberg.
Contiguous Counties:
South Carolina: Barnwell, Colleton, Hampton, Orangeburg.
Georgia: Burke, Screven.
The Interest Rates are:
| Percent
For Physical Damage:
Homeowners with Credit Available Elsewhere | 2.875
Homeowners without Credit Available Elsewhere | 1.438
Businesses with Credit Available Elsewhere | 5.880
Businesses without Credit Available Elsewhere | 2.940
Non-Profit Organizations with Credit Available Elsewhere | 1.875
Non-Profit Organizations without Credit Available Elsewhere | 1.875
For Economic Injury:
Businesses & Small Agricultural Cooperatives without Credit Available Elsewhere | 2.940
Non-Profit Organizations without Credit Available Elsewhere | 1.875
The number assigned to this disaster for physical damage is 17402 C and for economic injury is 17403 0.
The States which received an EIDL Declaration # is Georgia, South Carolina.
(Catalog of Federal Domestic Assistance Number 59008)
Isabella Guzman,

Administrator.
SMALL BUSINESS ADMINISTRATION
Reporting and Recordkeeping Requirements Under OMB Review

AGENCY:
Small Business Administration.

ACTION:
30-Day notice.

SUMMARY:
The Small Business Administration (SBA) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act and OMB procedures, SBA is publishing this notice to allow all interested member of the public an additional 30 days to provide comments on the proposed collection of information.

DATES:
Submit comments on or before May 25, 2022

ADDRESSES:
Written comments and recommendations for this information collection request should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection request by selecting “Small Business Administration”; “Currently Under Review,” then select the “Only Show ICR for Public Comment” checkbox. This information collection can be identified by title and/or OMB Control Number.

FOR FURTHER INFORMATION CONTACT:
You may obtain a copy of the information collection and supporting documents from the Agency Clearance Office at Curtis.Rich@sba.gov; (202) 205-7030, or from www.reginfo.gov/public/do/PRAMain.

SUPPLEMENTARY INFORMATION:
SBA Form 1050, Settlement Sheet is used in SBA's 7(a) Loan Program to collect information from lenders and borrowers regarding the disbursement of loan proceeds. SBA relies on this information during the guaranty purchase review process as a component in determining whether to honor a loan guaranty. The current form includes 1050 Settlement Sheet instructions for the lender. The currently approved form primarily requires the lender and borrower to certify to whether they complied with a series of loan requirements. The current form also requires submission of documentation ( e.g., joint payee or cancelled checks, invoices or paid receipts, and wire transfer records) in support of the certification. SBA has determined that the section for “Authorized Use of Proceeds” does not include in the Settlement Sheet all the categories for” Use of Proceeds” this addition to the 1050 Settlement Sheet would enable the agency to effectively monitor compliance with loan disbursement procedures and will align with the “Use of Proceeds” categories for 7(a) loans. As a result, SBA is proposing to change both the content and format of the Form 1050.
The form will be divided into several sections to clearly identify the information to be submitted. The revised form will continue to collect the same basic identifying information such as loan amount, loan number and lender's name. In addition, the form will continue to require certifications from both the lender and borrower regarding compliance with the disbursement requirements and accuracy of information submitted. In the section for “Authorized Use of Proceeds,” the revised 1050 Settlement Sheet will include “Land Acquisitions with or without improvements”, “Leasehold Improvements to property owned by applicant or owned by others”, “Export Working Capital (EWCP or Export Express)”, “Support Standby Letter of Credit (EWCP or Export Express)”, Refinance Existing (EWCP) or Export LOC (EWCP)”, “Business Acquisition/Change of Ownership”, “Pay off SBA Loan, SID or Other Lender”, ” Pay Notes Payable, SID or Other Lender”, “Pay Accounts Payable.” These changes will allow the lender to document all the sources and uses of funds at the time of loan closing more clearly. This additional information will better allow both lenders and SBA staff to ensure that the necessary information is collected at the time of loan origination.

Solicitation of Public Comments
Comments may be submitted on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
OMB Control: 3245-0200.
Title: Settlement Statement.
Description of Respondents: SBA Lenders and Borrowers.
Estimated Number of Respondents: 52,000.
Estimated Annual Responses: 52,000.
Estimated Annual Hour Burden: 14,112.
Curtis Rich,

Agency Clearance Officer.
SMALL BUSINESS ADMINISTRATION
Delegations of Authority: Delegations of Authority No. 12-G (Revision 1), Amendment 2

AGENCY:
U.S. Small Business Administration.

ACTION:
Notice of amendment to delegations of authority.

SUMMARY:
This document provides the public notice of the second amendment to Delegations of Authority (Delegations), No. 12-G (Revision 1) as first amended by Amendment 1 which delegated authority for lender oversight and enforcement activities by the Administrator of the Small Business Administration (“SBA” or “Agency”) to the Director, Office of Credit Risk Management (D/OCRM), the Lender Oversight Committee (LOC), and the Associate Administrator for Office of Capital Access (AA/OCA). By this second amendment (hereinafter “Amendment”), the Administrator is revising the voting membership of the Agency's LOC to ensure compliance with requirements set forth in statute. This second amendment also updates the provision on the LOC's authority to redelegate certain enforcement actions.

FOR FURTHER INFORMATION CONTACT:
Bethany J. Shana, Office of Credit Risk Management, U.S. Small Business Administration, 409 3rd Street SW, Washington, DC 20416; telephone number: (202) 205-6402; and electronic mail: bethany.shana@sba.gov.

SUPPLEMENTARY INFORMATION:
This document provides the public notice of the second amendment to Delegations of Authority No. 12-G (Revision 1) (79 FR 56842, September 23, 2014) with respect to SBA's lender oversight and enforcement activities. Specifically, this Amendment revises the voting members in the Agency's Lender Oversight Committee (LOC).
Section 48(b) of the Small Business Act (15 U.S.C. 657u(b)) governs LOC membership. This section provides that the LOC consists of at least eight members. Three members of the LOC are to be voting members; two of whom must be career appointees in the Senior Executive Service. ^1 By amendment dated September 26, 2018 (83 FR 48681), SBA designated the following employees as the voting members of the LOC: (i) The Chief Financial Officer, a Senior Executive Service career appointee; (ii) the Associate Administrator for Capital Access, a Senior Executive Service non-career appointee; and (iii) the Associate Administrator for Disaster Assistance, a Senior Executive Service career appointee. The Chief Financial Officer also served as the LOC Chairperson. 83 FR 48681.
^1 The remaining members are to be non-voting members who serve in an advisory capacity on the LOC.
In January of 2022, SBA appointed a non-career member of the Senior Executive Service to the Associate Administrator for Office of Disaster Assistance (AA/ODA) position. Accordingly, SBA is amending the voting membership of the LOC to ensure compliance with the position requirements contained in 15 U.S.C. 657u. Effective with this Amendment, the following SBA employees are designated as the voting members of the LOC: (i) The Chief Financial Officer, a Senior Executive Service career appointee; (ii) the Associate Administrator for OCA, a Senior Executive Service non-career appointee; and (iii) the Deputy Associate Administrator for the Office of Investment and Innovation (DAA/OII), a Senior Executive Service career appointee. The Chief Financial Officer will continue to serve as the LOC Chairperson. Additionally, the LOC non-voting advisory membership will remain the same.
Delegations of Authority No. 12-G (Delegations) also provides for redelegation of the LOC's authority to approve enforcement actions. Specifically, paragraph IV of the Delegations states that the LOC may redelegate to the D/OCRM or a subcommittee the authority to approve, disapprove, or modify certain enforcement actions and lists, by way of example, Agreement, or Memorandum of Understanding (MOU). Subsequent to SBA publishing these examples in 2014, SBA updated 13 CFR 120.1500 on types of formal enforcement actions. Therefore, SBA is replacing Agreement or MOU to cite instead imposition of portfolio guaranty dollar limit, a type of formal enforcement action under 13 CFR 120.1500.
This Amendment replaces sections I.B.6. and IV of the Delegations in its entirety, which cover LOC membership, voting, and redelegations, as set forth below. All other sections of the Delegations are unchanged and continue in effect.
Delegations of Authority No. 12-G (Revision 1) is amended by revising sections I.B.6. and IV to read as follows:
B. To the Lender Oversight Committee:
* * * * *
6. The Lender Oversight Committee will consist of SBA's: (i) Chief Financial Officer (CFO) (Chairperson and voting member); (ii) AA/OCA (voting member); (iii) DAA/OII (voting member); (iv) D/OCRM (non-voting, recommending advisory member); (v) Director, Office of Financial Assistance (non-voting advisory member); (vi) Director, Office of Financial Program Operations (non-voting advisory member); (vii) Associate Administrator, Office of Field Operations (non-voting advisory member); and (viii) General Counsel (non-voting advisory member).
* * * * *
IV. Other than the authority delegated to the Lender Oversight Committee in Paragraph I.B.2.b. (enforcement actions), the authorities delegated herein to the Lender Oversight Committee may not be redelegated. With regard to the authority delegated in Paragraph I.B.2.b., the Lender Oversight Committee may redelegate authority to the D/OCRM or a subcommittee to approve, disapprove, or modify certain enforcement actions ( e.g., imposition of portfolio guaranty dollar limit).
* * * * *
Authority: 5 U.S.C. 302; 5 U.S.C. 552(a)(1)(A); 15 U.S.C. 631 note; 15 U.S.C. 634; 15 U.S.C. 636; 15 U.S.C. 642; 15 U.S.C. 650; 15 U.S.C. 657t and 657u; 15 U.S.C. 697d, 697e, and 697g; 2 CFR. 2700 et. seq ; and 13 CFR. 120.10, 120.802 and Subpart I.
Isabella Casillas Guzman,

Administrator.
DEPARTMENT OF STATE
[Public Notice: 11717]
Determination Under Section 506(a)(1) of the Foreign Assistance Act of 1961 To Provide Military Assistance to Ukraine
Pursuant to the authority vested in me by section 506(a)(1) of the Foreign Assistance Act of 1961 (the “Act”) (22 U.S.C. 2318(a)(1)), and Presidential Delegation of Authority dated April 13, 2022 I hereby determine that an unforeseen emergency exists which requires immediate military assistance to Ukraine. I further determine that the emergency requirement cannot be met under the authority of the Arms Export Control Act or any other provision of law.
I, therefore, pursuant to authority delegated to me by the President, direct the drawdown of up to $800 million in defense articles and services of the Department of Defense, and military education and training, under the authority of section 506(a)(1) of the Act to provide assistance to Ukraine. The Department of State will coordinate implementation of this drawdown.
This determination shall be reported to the Congress and published in the Federal Register .
Dated: April 13, 2022.
Antony J. Blinken,

Secretary of State.
SURFACE TRANSPORTATION BOARD
[Docket No. AB 1315X]
New England Central Railroad, Inc.—Abandonment Exemption—in Franklin County, Vt.
New England Central Railroad, Inc. (NECR), has filed a verified notice of exemption under 49 CFR part 1152 subpart F— Exempt Abandonments to abandon a line of railroad between approximately milepost 0.436 (Railroad Station 23+03) at the south side of Lower Newton Road and milepost 0.60 (Railroad Station 31+68) in St. Albans, Franklin County, Vt. (the Line). There are no stations on the Line. The Line traverses U.S. Postal Service Zip Code 05478.
NECR has certified that: (1) No local traffic has moved over the Line since approximately 2005; (2) because the Line is not a through line, there is no overhead traffic on the Line that would need to be rerouted; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of a complainant within the two-year period; and (4) the requirements at 49 CFR 1105.7(b) and 1105.8(c) (notice of environmental and historic reports), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under Oregon Short Line Railroad—Abandonment Portion Goshen Branch Between Firth & Ammon, in Bingham & Bonneville Counties, Idaho, 360 I.C.C. 91 (1979). To address whether this condition adequately protects affected employees, a petition for partial revocation under 49 U.S.C. 10502(d) must be filed.
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, ^1 this exemption will be effective on May 25, 2022, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues, ^2 formal expressions of intent to file an OFA under 49 CFR 1152.27(c)(2), and interim trail use/rail banking requests under 49 CFR 1152.29 must be filed by May 5, 2022. ^3 Petitions to reopen or requests for public use conditions under 49 CFR 1152.28 must be filed by May 16, 2022.
^1 Persons interested in submitting an OFA must first file a formal expression of intent to file an offer, indicating the type of financial assistance they wish to provide ( i.e., subsidy or purchase) and demonstrating that they are preliminarily financially responsible. See 49 CFR 1152.27(c)(2)(i).
^2 The Board will grant a stay if an informed decision on environmental issues (whether raised by a party or by the Board's Office of Environmental Analysis (OEA) in its independent investigation) cannot be made before the exemption's effective date. See Exemption of Out-of-Serv. Rail Lines, 5 I.C.C.2d 377 (1989). Any request for a stay should be filed as soon as possible so that the Board may take appropriate action before the exemption's effective date.
^3 Filing fees for OFAs and trail use requests can be found at 49 CFR 1002.2(f)(25) and (27), respectively.
All pleadings, referring to Docket No. AB 1315X, 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 NECR's representative, Eric M. Hocky, Clark Hill, PLC, Two Commerce Square, 2001 Market Street, Suite 2620, Philadelphia, PA 19103.
If the verified notice contains false or misleading information, the exemption is void ab initio.
NECR has filed a combined environmental and historic report that addresses the potential effects, if any, of the abandonment on the environment and historic resources. OEA will issue a Draft Environmental Assessment (Draft EA) by April 29, 2022. The Draft EA will be available to interested persons on the Board's website, by writing to OEA, or by calling OEA at (202) 245-0294. Assistance for the hearing impaired is available through the Federal Relay Service at (800) 877-8339. Comments on environmental or historic preservation matters must be filed within 15 days after the Draft EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), NECR shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the Line. If consummation has not been effected by NECR's filing of a notice of consummation by April 25, 2023, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available at www.stb.gov.
Decided: April 20, 2022.
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Brendetta Jones,

Clearance Clerk.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
[Docket No. DOT-OST-2022-0020]
Agency Information Collection Activities: Requests for Comments; Clearance of a New Approval of Information Collection: Airport Concession Disadvantaged Business Enterprise (ACDBE) Program; Correction

AGENCY:
Federal Aviation Administration (FAA), Transportation (DOT).

ACTION:
Notice; correction.

SUMMARY:
The FAA published a Federal Register Notice with a 30-day comment period soliciting comments on the following collection of information was published on March 18, 2022. The collection involves information collected under the Department of Transportation (DOT) Airport Concession Disadvantaged Business Enterprise (ACDBE) Program. The FAA revised the estimated burden to respondents since the publish date of the previous notice, thus resulting in a lower information collection burden to respondents.

FOR FURTHER INFORMATION CONTACT:
Nicholas Giles, by email at: Nicholas.giles@faa.gov; phone: 202-267-0201 Marcus England, by email at: marcus.england@faa.gov; phone: 202-267-0487.

SUPPLEMENTARY INFORMATION:
Correction: In the Federal Register of March 18, 2022, FR Doc. 2022-05760, on page 15486, starting in the second column, the estimated burden is corrected as follows:

3. Monitoring and Compliance Procedures
The FAA estimated the total annual cost burden by multiplying the total annual burden hours (153 hours × 14,256 responses).
Total Annual Burden Hours: 2,181,168 hours.

4. Requirements for Submitting Overall Goal Information to the FAA
The FAA divided the total number of respondents subject to the requirement by three (396/3) to reflect that ACDBE overall goals are submitted on a triennial basis. Thus, approximately 132 respondents are required to report ACDBE overall goal information to the FAA each year.
Respondents: Recipients of FAA grants for Airport Development.
Number of Respondents: 396.
Frequency: Annually.
Number of Responses: 132.
Total Annual Burden Hours: 6,996 hours.

5. Requirements Relating to Shortfalls in Meeting Overall ACDBE Goals
5a. Respondents: CORE 30 Airports—Respondents consisting of CORE 30 airports or other airports designated by the FAA to submit, within 90 days of the end of the fiscal year, an analysis and corrective actions to the FAA for approval.
Number of Respondents: 19.
Frequency: Annually.
Number of Responses: 19.
Total Annual Burden Hours: 399 hours.
5b. Respondents: Non-CORE 30 Airports—Respondents that are not a CORE 30 airport must retain the shortfall analysis in their records for three years and make them available to the FAA, on request, for their review.
Number of Respondents: 120.
Frequency: Annually.
Number of Responses: 120.
Total Annual Burden Hours: 2,520 hours.
OMB Control Number: 2120-NEW.
Title: Airport Concession Disadvantaged Business Enterprise (ACDBE) Program.
Form Numbers: None.
Type of Review: An information collection.
Background: The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on October 25, 2021. The Federal Register Notice with a 30-day comment period soliciting comments on the following collection of information was published on March 18, 2022. This notice corrects the inaccurate burden estimates provided in the previous notice. The Airport Concession Disadvantaged Business Enterprise (ACDBE) Program requires collection of information necessary to ensure that firms competing for airport development concession opportunities are not disadvantaged by unlawful discrimination.
Respondents: Approximately 396 recipients of FAA grants for airport development.
Frequency: There are one-time, annual, and triennial information collection requirements related to this program.
Estimated Average Burden per Response: 43 hours per reporting response, 153 hours per recordkeeping response.
Estimated Total Annual Burden: 2,224,391 hours.
Issued in Washington, DC, on April 20, 2022.
Nicholas Giles,

Equal Opportunity Specialist, Office of Civil Rights, National Airport Civil Rights Policy and Compliance, FAA.
DEPARTMENT OF TRANSPORTATION
Maritime Administration
[Docket No. MARAD-2022-0076]
Deepwater Port License Application: New Fortress Energy Louisiana FLNG LLC

AGENCY:
Maritime Administration, Department of Transportation.

ACTION:
Notice of application.

SUMMARY:
The Maritime Administration (MARAD) and the U.S. Coast Guard (USCG) announce they have received an application from New Fortress Energy Louisiana FLNG LLC (Applicant) for the licensing of a deepwater port and that the application for the New Fortress Energy Louisiana FLNG deepwater port contains information sufficient to commence processing. This notice summarizes the Applicant's plans and the procedures that will be considered during the application review process.

DATES:
The Deepwater Port Act of 1974, as amended, (the Act) requires at least one public hearing on this application to be held in the designated Adjacent Coastal State(s) (ACS) not later than 240 days after publication of this notice and a decision on the application not later than 90 days after the final public hearing(s).

ADDRESSES:
The public docket for the New Fortress Energy Louisiana FLNG deepwater port license application is maintained by the U.S. Department of Transportation, Docket Management Facility, West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
The license application is available for viewing at the Regulations.gov website: https://www.regulations.gov under docket number MARAD-2022-0076.
We encourage you to submit comments electronically through the Federal eRulemaking Portal at https://www.regulations.gov. Alternatively, comments may be mailed to the public docket at the address listed above or faxed to 202-493-2251. Comments that are sent to the docket should include the docket number, which is MARAD-2022-0076.
If you submit your comments electronically, it is not necessary to also submit a hard copy. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted. Anonymous comments will be accepted. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. The Federal Docket Management Facility's telephone number is 202-366-9317 or 202-366-9826, the fax number is 202-493-2251.
If you cannot submit material using https://www.regulations.gov, please contact either Mr. Brian Barton, MARAD, or Ms. Galia Kaplan, as listed in the following FOR FURTHER INFORMATION CONTACT section of this document.

FOR FURTHER INFORMATION CONTACT:
Mr. Brian Barton, Maritime Administration, telephone 202-366-0302, email: Brian.Barton@dot.gov, or Ms. Galia Kaplan, U.S. Coast Guard, telephone: 202-372-1567, email: Galia.Kaplan@uscg.mil. For questions regarding viewing the Docket, call Docket Operations, telephone: 202-366-9826.

SUPPLEMENTARY INFORMATION:

Receipt of Application
On March 31, 2022, MARAD and USCG received an application from the Applicant for all Federal authorizations required for a license to own, construct, and operate a deepwater port for the export of liquified natural gas (LNG) as authorized by the Act, and implemented under 33 Code of Federal Regulations (CFR) Parts 148, 149, and 150. After a coordinated completeness review by MARAD, USCG, and other cooperating Federal agencies, the application is deemed complete and contains information sufficient to initiate processing.

Background
The Act defines a deepwater port as any fixed or floating manmade structure other than a vessel, or any group of such structures, that are located beyond State seaward boundaries and used or intended for use as a port or terminal for the transportation, storage, and further handling of oil or natural gas for transportation to, or from, any State. A deepwater port includes all components and equipment, including pipelines, pumping or compressor stations, service platforms, buoys, mooring lines, and similar facilities that are proposed as part of a deepwater port to the extent they are located seaward of the high-water mark.
The Secretary of Transportation delegated to the Maritime Administrator authorities related to licensing deepwater ports (49 CFR 1.93(h)). Statutory and regulatory requirements for processing applications and licensing appear in 33 U.S.C. 1501 et seq. and 33 CFR part 148. Under delegations from and agreements between the Secretary of Transportation and the Secretary of Homeland Security, applications are jointly processed by MARAD and USCG. Each application is considered on its merits.
In accordance with 33 U.S.C. 1504(f) for all applications, MARAD and the USCG, working in cooperation with other involved Federal agencies and departments, shall comply with the requirements of the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq. ). The U.S. Environmental Protection Agency (EPA), the U.S. Army Corps of Engineers (USACE), the National Oceanic and Atmospheric Administration (NOAA), the Bureau of Ocean Energy Management (BOEM), the Bureau of Safety and Environmental Enforcement (BSEE), and the Pipeline and Hazardous Materials Safety Administration (PHMSA), among others, participate in the processing of deepwater port applications and assist in the NEPA process as described in 40 CFR 1501.6. Each agency may participate in scoping and/or other public meeting(s) and may incorporate the MARAD/USCG environmental impact review for purposes of their jurisdictional permitting processes, to the extent applicable. Comments related to this deepwater port application addressed to the EPA, USACE, or other federal agencies should note the federal docket number, MARAD-2022-0076. Each comment will be incorporated into the Department of Transportation (DOT) docket and considered as the environmental impact analysis is developed to ensure consistency with the NEPA process. All connected actions, permits, approvals, and authorizations will be considered during the processing of the New Fortress Energy Louisiana FLNG deepwater port license application.
MARAD, in issuing this Notice of Application pursuant to 33 U.S.C. 1504(c), must designate as an ACS any coastal state which (A) would be directly connected by pipeline to a deepwater port as proposed in an application, or (B) would be located within 15 nautical miles of any such proposed deepwater port (see 33 U.S.C. 1508(a)(1)). Pursuant to the criteria provided in the Act, Louisiana is the designated ACS for this application. Other states may request from the Maritime Administrator designation as an ACS in accordance with 33 U.S.C. 1508(a)(2).
The Act directs that at least one public hearing take place in each ACS, in this case, Louisiana. Additional public meetings may be conducted to solicit comments for the environmental analysis to include public scoping meetings, or meetings to discuss the Draft and Final Environmental Impact Statement documents prepared in accordance with NEPA.
MARAD, in coordination with the USCG, will publish additional Federal Register notices with information regarding these public meeting(s) and hearing(s) and other procedural milestones, including the NEPA environmental impact review. The Maritime Administrator's decision, and other key documents, will be filed in the public docket for the application at docket number MARAD-2022-0076.
The Act imposes a strict timeline for processing an application. When MARAD and USCG determine that an application is complete ( i.e., contains information sufficient to commence processing), the Act directs that all public hearings on the application be concluded within 240 days from the date the Notice of Application is published.
Within 45 days after the final hearing, the Governor of the ACS, in this case, the Governor of Louisiana, may notify MARAD of their approval, approval with conditions, or disapproval of the application. If such approval, approval with conditions, or disapproval is not provided to the Maritime Administrator by that time, approval shall be conclusively presumed. MARAD may not issue a license without the explicit or presumptive approval of the Governor of the ACS. During this 45-day period, the Governor may also notify MARAD of inconsistencies between the application and State programs relating to environmental protection, land and water use, and coastal zone management. In this case, MARAD may condition the license to make it consistent with such state programs (33 U.S.C. 1508(b)(1)). MARAD will not consider written approvals or disapprovals of the application from the Governor of the ACS until commencement of the 45-day period after the final public hearing for the Final Environmental Impact Statement is completed. The Maritime Administrator must render a decision on the application within 90 days after the final hearing.
Should a favorable record of decision be rendered and a license be issued, MARAD may include specific conditions related to design, construction, operations, environmental permitting, monitoring and mitigations, and financial responsibilities. If a license is issued, USCG, in coordination with other agencies as appropriate, would review and approve the deepwater port's engineering, design, and construction; operations/security procedures; waterways management and regulated navigation areas; maritime safety and security requirements; risk assessment; and compliance with domestic and international laws and regulations for vessels that may call on the port. The deepwater port would be designed, constructed, and operated in accordance with applicable codes and standards.
In addition, the installation of pipelines and other structures may require permits under Section 404 of the Clean Water Act and Section 10 of the Rivers and Harbors Act, which are administered by the USACE.
Permits from the EPA may also be required pursuant to the provisions of the Clean Air Act, as amended, and the Clean Water Act, as amended.

Summary of the Application
The application proposes the ownership, construction, operation, and eventual decommissioning of the New Fortress Energy (“NFE”) Louisiana FLNG deepwater port (“DWP”) terminal approximately 16 nautical miles off the southeast coast of Grand Isle, Louisiana. The project is to source domestic natural gas from multiple supply hubs in the Southeast Louisiana local market, liquify, and export as liquefied natural gas (LNG) up to 2.8 million metric tonnes per annum (MTPA), from a deepwater port located in federal waters off Louisiana.
The project will involve the installation of two nominal 1.4 MTPA liquefaction systems (FLNG1 and FLNG2) installed in the West Delta Outer Continental Shelf Lease Block 38 (“WD-38”) in approximately 30 meters (98 feet) of water. Each system will contain three platforms consisting of natural gas processing, natural gas liquefaction, and utilities and accommodations. FLNG1 will incorporate self-elevating platforms (aka jack-up platforms or rigs), and FLNG2, which will be located adjacent to FLNG1, will utilize fixed platform structures. An additional self-elevating platform will house feed gas compressors. Other than temporary construction staging areas, there are no onshore facilities associated with the Project. Staging for construction, if needed, will utilize existing staging, laydown and warehouse space near Port Fourchon, Port Sulphur, or Venice.
The feed gas supply to the project will be transported to the WD-38 site via the existing Kinetica Energy Express, LLC (“Kinetica”) offshore natural gas pipeline system and two newly constructed, 24-inch pipeline laterals connecting the Kinetica pipeline system to the Project. The Kinetica pipeline has been in continuous natural gas service since it was placed in service. The pipeline pressure is currently operating at 750 pounds per square inch (“psi”) with an onshore Maximum Allowable Operating Pressure (“MAOP”) of 1,000 psi and an offshore MAOP of 1,250 psi.
Both FLNG1 and FLNG2 will be connected to a single Floating LNG Storage Unit (“FSU”) via a flexible, partially submerged, 220-meter cryogenic hose transfer system. The FSU will be positioned approximately 107 meters (350 feet) from the FLNGs. To export the LNG, the FSU will receive one (1) commercially traded LNG carrier (LNGC) at a time, which will have a nominal cargo capacity of approximately 125,000 m3 to 160,000 m3. The LNGCs will berth along the starboard side of the FSU and receive the LNG cargo through a ship-to-ship transfer cargo transfer system. The LNGC will approach the DWP and depart from the DWP using an extension to the established safety fairway, which serves maritime traffic calling at the Louisiana Offshore Oil Port. Approximately 40 LNGCs will call on the Project per year.
For more information please contact either Mr. Brian Barton, MARAD, or Ms. Galia Kaplan, as listed in the FOR FURTHER INFORMATION CONTACT section of this document.

Privacy Act
The electronic form of all comments received into the Federal Docket Management System can be searched by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). The DOT Privacy Act Statement can be viewed in the Federal Register published on April 11, 2000 (Volume 65, Number 70, pages 19477-78) or by visiting www.regulations.gov.
(Authority: 33 U.S.C. 1501, et seq.; 49 CFR 1.93(h))
By Order of the Acting Maritime Administrator.
T. Mitchell Hudson, Jr.,

Secretary, Maritime Administration.
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[Docket No. NHTSA-2022-0007]
Request for Comments on Barriers and Solutions for Submitting Toxicology Data to the Fatality Analysis Reporting System Pursuant to Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities

AGENCY:
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

ACTION:
Request for comments on barriers to and solutions for providing toxicological data on drug-impaired driving investigations of motor vehicle fatalities to the Fatality Analysis Reporting System (FARS) that meet the recommendations described in Recommendations for Toxicological Investigations of Drug-Impaired Driving and Motor Vehicle Fatalities—2021 Update.

SUMMARY:
Section 25025 of the Infrastructure Investment and Jobs Act requires NHTSA to submit a report to Congress that, in accordance with recommendations made in Recommendations for Toxicological Investigations of Drug-Impaired Driving and Motor Vehicle Fatalities—2021 Update, (1) “identifies any barriers the States encounter in submitting alcohol and drug toxicology results to the Fatality Analysis Reporting System;” and (2) “provides recommendations on how to address the barriers identified” pursuant to providing the data described in the above recommendations for toxicological investigations. This notice requests public comments on any barriers that States may encounter that would affect their ability to provide the toxicological data described in the 2021 Update of the Recommendations document to FARS, as well as recommendations to address those barriers identified.

DATES:
The request for comments is effective on April 25, 2022.

ADDRESSES:
You may submit comments identified by DOT Docket ID Number NHTSA-2022-0007 using any of the following methods:
Electronic submissions: Go to https://www.regulations.gov. Follow the on-line instructions for submitting comments.
Mail: Docket Management Facility, M-30, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590.
Hand Delivery: West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
Fax: 1-202-493-2251.
Instructions: Each submission must include the Agency name and the Docket number for this Notice. Note that all comments received will be posted without change to https://www.regulations.gov including any personal information provided.

FOR FURTHER INFORMATION CONTACT:
For more information, contact Dr. Randolph Atkins, Jr., Chief, Behavioral Research Division, NPD-310, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590; Telephone number: (202) 366-5597; Email: randolph.atkins@dot.gov.

SUPPLEMENTARY INFORMATION:

Background
There is a growing concern with drug impaired driving in the United States and around the globe. While alcohol is the drug most often linked to impaired driving and crashes, there are many other drugs that can impair driving ability and contribute to crashes. ^i Other potentially impairing drugs include some over-the-counter (OTC) drugs, some prescription drugs, and most illegal drugs. The use of drugs other than alcohol and in combination with alcohol is widespread. The National Survey on Drug Use and Health (NSDUH) estimated that 53.2 million people in the United States used illegal drugs in 2018, an increase of 2 million people since 2017. The 2018 survey also found that 16.9 million people reported misusing psychotherapeutics in 2018, and 12.6 million people reported driving under the influence of illegal drugs. ^{ii} The 2020 NSDUH found use of illicit drugs in the past year had increased to 59.3 million people or 21.4% of the U.S. population age 12 or older, ^{iii} and an increase of 6.1 million people since 2018.
NHTSA's 2013-2014 National Roadside Survey of Alcohol and Drug Use by Drivers reported that 20.1% of all drivers surveyed on weekend nights tested positive for the presence of some drug, legal and/or illegal, other than alcohol, a statistically significant increase from the 16.3% of drug-positive drivers found in the 2007 survey. ^{iv} NHTSA's study of drug prevalence in road users with serious or fatal injuries admitted to five Level-1 trauma centers or their corresponding Medical Examiner's offices, found that in the months just prior to the current pandemic 50.8% of the drivers in the study had at least one drug in their system (including alcohol) with 17.6% having multiple drugs in their systems. This increased to 64.7% and 25.3%, respectively, during the pandemic in the second quarter of 2020. During this time cannabis presence increased from 20.8% to 32.7% and opioid presence increased from 7.5% to 13.9% in this sample of drivers. ^v Clearly, many drivers on the roads today pose a potential danger to themselves and others because of potentially impairing drugs in their systems.
Prescription and OTC drug use is quite common in America. The National Center for Health Statistics estimated that, from 2015-2018, 48.6% of Americans used at least one prescription medication in the past 30 days, with 24% using three or more prescription medications in the last 30 days and 12.8% using five or more prescription medications in the last 30 days. The most frequently prescribed drugs were analgesics, ^{vi} which is reflected in the current opioid epidemic. Drivers increase the risk of drug-impaired driving because they may not be able to distinguish between prescription drugs that are impairing and those that are not. ^{vii} Furthermore, the simultaneous use of multiple therapeutic drugs or combining therapeutics with alcohol increases the risk of motor vehicle crashes because of the potential for interaction effects. ^{viii}
Another trend fueling concerns about drug-impaired driving is the shift in use, social acceptance, and policies regarding the use of marijuana. Marijuana is defined here as “all substances containing tetrahydrocannabinol.” ^{ix} The terms marijuana and cannabis are used interchangeably in this document. From 2001-2002 to 2012-2013, the use of marijuana doubled from 4.1% to 9.5% of the U.S. adult population, with 30% of these users meeting the criteria for marijuana use disorder. ^x In 2020, 17.9% of Americans 12 years or older reported using cannabis in the past year (approximately 49.6 million people), and an estimated 5.1% of people 12 and older (approximately 14.2 million people) had a cannabis use disorder. ^{xi} Though marijuana is still illegal under federal law, eighteen States and the District of Columbia have now legalized both recreational and medical use of marijuana and seventeen States have legalized the use of medical marijuana. Another thirteen states have legalized marijuana for specific medical conditions. ^{xii} In 2018, Canada legalized the recreational use of marijuana at the national level, and Mexico passed a bill legalizing recreational cannabis in 2021. This trend towards legalization has been accompanied by an increase in the presence of marijuana found in drivers. NHTSA's National Roadside Survey found tetrahydrocannabinol (THC) presence in 12.7% of surveyed drivers in 2013-2014, up from 8.7% in the 2007 survey. In a 2018 study by Washington State, 39.1% of drivers admitted to driving within 3 hours of using marijuana at least once in the previous year, and the biological results from the survey indicated that the presence of marijuana in surveyed drivers had doubled, from approximately 10%, to 20% of all drivers after the state's implementation of retail marijuana sales. ^{xiii} A NHTSA roadside survey in Washington State found similar results, with 7.8% of drivers testing positive for presence of THC prior to the implementation of legal marijuana in the state. NHTSA found significant increases in THC presence in drivers six months (18.4%) and one year (18.9%) after legalization. ^{xiv} While linking the level of marijuana present in biological samples with level of impairment remains challenging, well-established evidence shows that marijuana use detrimentally affects driving-related skills. Marijuana use slows driver reaction time, creates problems with road tracking and maintaining lane position, and decreases cognitive performance and driver attention maintenance. Marijuana use in conjunction with other drugs, such as alcohol, can also have a compounding effect on impairment. ^{xv} The current shifts in policy and marijuana use increase the public health concerns regarding drug-impaired driving.
The lack of adequate data to determine the scope and magnitude of the drug impaired driving problem presents a major challenge in addressing the issue of drug-impaired driving. xi xvi Estimates show that comprehensive societal costs for alcohol-impaired driving were approximately $194 billion in 2010; ^{xvii} however, the data required for conducting similar analyses for the comprehensive societal costs of drug-impaired driving are lacking. The data currently available on drug-impaired driving and motor vehicle crashes have many shortcomings. ^{xviii} These include inconsistent drug testing policies and procedures across jurisdictions, such as considerable variability in who is tested, what drugs are tested for, detection capabilities of the laboratory, and what specimen matrices (blood, oral fluid, urine, etc.) are used.
In 2009, ^{xii} and again in 2017, ^{xi} NHTSA recommended that States provide separate statutes for alcohol- and drug-impaired offenses, to provide incentive for “law enforcement officers to pursue a possible drug-impaired driving charge even when a BAC equal to or above the limit of .08 g/dL has already been established,” but few states currently have such statutes. Many jurisdictions only test for drugs when alcohol levels are below per se limits that indicate a driver, by law, is intoxicated by alcohol, and forego drug testing when alcohol per se limits are met. However, high percentages of specimens in impaired driving cases that were tested only for alcohol are often positive for other drugs, too. ^{xix} Some jurisdictions do not perform any drug testing for motor vehicle crashes. Reporting of the toxicology findings is also inconsistent and often lacks sufficient specificity regarding whether it is reporting a screening test or a confirmation test, and other critical information, such as the drug panels and thresholds of detection used, is often left out. This widespread inconsistency in drug testing and lack of detail in reporting of toxicology on reports of motor vehicle crashes and fatalities creates significant problems for policy makers and traffic safety professionals trying to address the problem of drug-impaired driving.
In many States, the large number of laboratories conducting post-mortem drug testing (typically ordered at the county level by the coroner or medical examiner) often do not look for the same core list of drugs and do not use comparable testing techniques with similar thresholds of detection because there is a lack of standardization regarding the drug panels and detection thresholds used for motor vehicle crashes. This prevents data from different laboratories from being combined to get a clear picture of drug use within the State. Similarly, in many States, individual law enforcement agencies contract with different laboratories which do not screen for the same set of core drugs, nor use comparable testing techniques with similar thresholds of detection. This limits the ability to characterize and monitor/conduct surveillance and better understand the issue of statewide driver drug use. “Currently, the limitations (in the drugged driving data) severely constrain interpretation of the data. Comparisons across labs, States, or years are problematic.” This is reflected at the national level in the FARS data. ^{xx}
A recent expert panel on the impact of marijuana on the driving while intoxicated (DWI) system, which included various experts from divisions in the departments of motor vehicles, law enforcement, and the courts and corrections departments as well as government data systems, reported a serious need for more and better data on drug use by drivers as well as standardized laboratory practices for drug toxicology, including which drugs are tested for, what detection thresholds of the drugs are used, confirmation testing results, and comprehensive reporting on the tests conducted and the matrices used. ^{xxi} Recent reports from the Governors Highway Safety Association (GHSA) have stressed the urgent need for better, more comprehensive toxicology testing and reporting of toxicology test results for motor vehicle crashes. xxii xxiii This need was also emphasized in NHTSA's reports to Congress on marijuana-impaired driving (2017) ^{xi} and drug-impaired driving (2009), ^{xii} and two National Transportation Safety Board (NTSB) reports on impaired driving. xxiv xxv

Recommendations and Request for Comments
The Center for Forensic Science Research & Education (CFSRE) and the National Safety Council Alcohol, Drugs and Impairment Division (NSC-ADID) report, Updates for Recommendations for Drug Testing in DUID & Traffic Fatality Investigations (2016), summarized a survey it conducted of toxicology laboratories from across the country. The survey identified “current practices, capabilities, research needs and gathered information regarding the scope and sensitivity of testing.” ^{xxvi} Subsequently, the Drugs, Technology, Pharmacology and Toxicology Section of the National Safety Council's Alcohol, Drugs and Impairment Division reviewed the survey results and updated their 2013 published recommendations for the toxicology community, ^{xxvii} which were published as “Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities—2017 Update” in the Journal of Analytical Toxicology. ^{xxviii} These recommendations are referenced in Section 25025 of Public Law 117-58. The CFRSE and NSC-ADID conducted a follow-up survey of laboratories in 2020, after which the recommendations were updated and published as “Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities—2021 Update” in the Journal of Analytical Toxicology. ^{xxix} These recommendations address the identified toxicology needs for drug-impaired driving cases. Coupled with comprehensive reporting of the toxicology findings, the widespread use of these toxicology recommendations could greatly enhance understanding of the scope and magnitude of drug-impaired driving and help traffic safety professionals better address this vital public health issue. ^{xxx} The toxicology recommendations in the 2021 Update are available, free of charge, online at: https://pubmed.ncbi.nlm.nih.gov/34086916/.
Given the growing national concern over drug-impaired driving and the clear need for standardized drug-impaired driving toxicological testing and comprehensive reporting on the toxicological results, NHTSA is preparing a Report to Congress on Drug-Impaired Driving Data Collection that identifies the barriers to States in providing the toxicological data to FARS as described in the NSC-ADID document, recommends solutions to overcome those barriers, and describes the steps the Department of Transportation and NHTSA will take to assist States in improving toxicology testing in cases of motor vehicle crashes and reporting of alcohol and drug toxicology results in cases of motor vehicle crashes provided to FARS. Our first step in producing this report is the collection of information from the public on barriers and possible solutions. NHTSA therefore seeks public comment on any barriers that States may have to adopting these recommendations, and any comments on what is needed to overcome these barriers.
As previously noted, the Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities—2021 Update were developed by an expert panel of toxicologists based on the results of a national survey of toxicology laboratories. These voluntary recommendations are for forensic toxicological drug testing and reporting for all drivers, motorcycle and moped operators, bicyclists and pedestrians involved in fatal motor vehicle crashes, and all drivers who are arrested or convicted for impaired operation of motor vehicles, regardless of their tested Blood Alcohol Concentration (BAC) or Breath Alcohol Concentration (BrAC). The recommendations provide standardized lists of drugs, matrices (blood, oral fluid, urine, etc.), and detection threshold levels for testing. The guidelines include two tiers of drugs for testing: Tier 1 drugs (Table II in the document) are drugs that are found throughout the country and that should be tested for in all jurisdictions; Tier 2 drugs (Table III in the document) are less common or predominantly found in specific areas of the country, so they may only need to be routinely tested for in those localities or on a case-by-case basis. NHTSA believes that the voluntary adoption of these toxicology guidelines would greatly improve data collection, and support future initiatives by a wide variety of traffic safety stakeholders using this toxicological data to help reduce drug-impaired driving. It is critical that comprehensive and consistent data on this vital public health issue are available for use in all parts of the impaired-driving system, from law enforcement to adjudication and treatment to public policy.
Drug impaired driving is a growing concern; however, the information currently available on the scope and magnitude of drug impaired driving is unclear. Today, there is great variation across the country regarding which drivers are tested for drug use, what specimens are collected for testing, what drugs are tested for, and what threshold detection levels are used for drug tests. Comprehensive and consistent toxicological data is needed to better inform the public and public policy on this growing public health problem. This testing and data are also essential to increasing the effectiveness of law enforcement and adjudication efforts in drug-impaired driving cases and to making America's roads safer for the driving public.
In support of our efforts to improve the toxicological data provided to FARS and the States, reduce the problem of drug-impaired driving, and “assist States in their efforts to increase public awareness of the dangers of drug-impaired driving,” ^{xxxi} NHTSA hereby requests public comment on the following:
(1) Identification of any barriers or challenges that States currently encounter in submitting alcohol and drug toxicology results to the Fatality Analysis Reporting System (FARS).
(2) Suggestions for overcoming those current barriers and challenges identified to improve the delivery of data to the FARS.
(3) Identification of any barriers or challenges that States may encounter in collecting the toxicology data as described in Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities—2021 Update ( https://pubmed.ncbi.nlm.nih.gov/34086916/ ) and submitting those alcohol and drug toxicology results to the Fatality Analysis Reporting System (FARS).
(4) Suggestions for overcoming those barriers and challenges identified for collecting the toxicological data as described in the Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities—2021 Update to improve the delivery of the data to the FARS.

Notes
^i Couper, F. and Logan, B. 2004. Drugs and Human Performance. DOT HS 809 725. National Highway Traffic Safety Administration. Washington, DC. https://www.wsp.wa.gov/breathtest/docs/webdms/DRE_Forms/Publications/drug/Human_Performance_Drug_Fact_Sheets-NHTSA.pdf.
^{ii} Center for Behavioral Health Statistics and Quality. 2019. Results from the 2018 National Survey on Drug Use and Health. SAMHSA, Rockville, MD. https://www.samhsa.gov/data/report/2018-nsduh-detailed-tables.
^{iii} Substance Abuse and Mental Health Services Administration. (2021). Key substance use and mental health indicators in the United States: Results from the 2020 National Survey on Drug Use and Health (HHS Publication No. PEP21-07-01-003, NSDUH Series H-56). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/.
^{iv} Kelley-Baker, T., Berning, A., Ramirez, A., Lacey, J., Carr, K., Waeher, G., Moore, C. Pell, K., Yao, J., and Compton, R. 2017. 2013-2014 National Roadside Survey of Alcohol and Drug Use by Drivers: Drug Results. DOT HS 812 411. National Highway Traffic Safety Administration. Washington, DC. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/13013-nrs_drug_092917_v6_tag.pdf.
^v Thomas, F.D., Berning, A., Darrah, J., Graham, L., Blomberg, R., Griggs, C., Crandall, M., Schulman, C., Kozar, R., Neavyn, M., Cunningham, K., Ehsani, J., Fell, J., Whitehill, J., Babu, K., Lai, J., and Rayner, M. (2020, October). Drug and alcohol prevalence in seriously and fatally injured road users before and during the COVID-19 public health emergency (Report No. DOT HS 813 018). National Highway Traffic Safety Administration.
^{vi} Centers for Disease Control and Prevention. 2019. National Center for Health Statistics. Therapeutic Drug Use. https://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm.
^{vii} Smith, R., Turturici, M. and Camden, M. 2018. Countermeasures Against Prescription and Over-the-Counter-Impaired Driving. AAA Foundation for Traffic Safety. Washington, DC. http://aaafoundation.org/wp-content/uploads/2018/10/VTTI_Rx_OTC_FinalReport_VTTI-FINAL-complete-9.20.pdf.
^{viii} Alda, A., Pharm, D., and Morse, M. 2008. Multiple Medications and vehicle Crashes: Analysis of Databases. DOT HS 810 858. National Highway Traffic Safety Administration. Washington, DC.
^{ix} Current legislation (Section 25025, Pub. L. 17-58) references the definition of marijuana in the F.A.S.T. Act, Section 4008 (d). https://www.govinfo.gov/content/pkg/PLAW-114publ94/html/PLAW-114publ94.htm.
^x National Institutes of Health. 2015. Prevalence of Marijuana Use Among U.S. Adults Doubles Over Past Decade. https://www.nih.gov/news-events/news-releases/prevalence-marijuana-use-among-us-adults-doubles-over-past-decade.
^{xi} National Institutes of Health. 2022. https://www.drugabuse.gov/publications/research-reports/marijuana/what-scope-marijuana-use-in-united-states.
^{xii} Insurance Institute for Highway Safety. Alcohol and drugs: Marijuana laws. https://www.iihs.org/topics/alcohol-and-drugs.
^{xiii} Grondel, D., Hoff, S., and Doane, D. Marijuana Use, Alcohol Use and Driving in Washington State. 2018.Washington Traffic Safety Commission. http://wtsc.wa.gov/wp-content/uploads/dlm_uploads/2018/05/Marijuana-and-Alcohol-Involvement-in-Fatal-Crashes-in-WA_FINAL.pdf.
^{xiv} Ramirez, A., Berning, A., Carr, K., Schere, M., Lacey, J., Kelley-Baker, T., and Fisher, D. 2016. Marijuana, Other Drugs, and Alcohol Use by Drivers in Washington State. DOT HS 812 299. National Highway Traffic Safety Administration. Washington, DC. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/812299-washingtonstatedrugstudy.pdf.
^{xv} Compton, R. 2017. Marijuana-Impaired Driving: A Report to Congress. DOT HS 812 440. National Highway Traffic Safety Administration. Washington, DC. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/812440-marijuana-impaired-driving-report-to-congress.pdf.
^{xvi} Compton, R., Vegega, M., and Smither, D. 2009. Drug-Impaired Driving: Understanding the Problem and Ways to Reduce It—A Report to Congress. DOT HS 811 268. National Highway Traffic Safety Administration. Washington, DC. https://rosap.ntl.bts.gov/view/dot/1949.
^{xvii} Blincoe, L.J., Miller, T.R., Zaloshnja, E., & Lawrence, B.A. (2015, May). The economic and societal impact of motor vehicle crashes, 2010 (Revised) (Report No. DOT HS 812 013). Washington, DC: National Highway Traffic Safety Administration.
^{xviii} Berning, A. and Smither, D. 2014. Understanding the Limitations of Drug Test Information, Reporting, and Testing Practices in Fatal Crashes. Traffic Safety Facts Research Note DOT HS 812 072. National Highway Traffic Safety Administration. Washington, DC. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/812072-understandlimitsdrugtest-researchnote.pdf.
^{xix} Limoges, J., Tandy, A., and Brown, H. 2009. A Retrospective Study of Drug Prevalence in Alcohol Related Driving Arrests. Presented at the annual meeting of the American Academy of Forensic Sciences.
^{xx} Berning, A., Smith, R.C., Drexler, M., & Wochinger, K. (2022, March). Drug testing and traffic safety: What you need to know (Report No. DOT HS 813 264). National Highway Traffic Safety Administration.
^{xxi} National Highway Traffic Safety Administration, Governors Highway Safety Association, and Volpe National Transportation Systems Center. 2017. Impact of the Legalization and Decriminalization of Marijuana on the DWI System: Highlights from the Expert Panel Meeting. National Highway Traffic Safety Administration. Washington, DC. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/expert_dwi_panel.pdf.
^{xxii} Hedlund, J. 2017. Drug-Impaired Driving: A Guide for the States. Governors Highway Safety Association and Foundation for Advancing Alcohol Responsibility. https://www.ghsa.org/resources/drugged-driving-2017.
^{xxiii} Hedlund, J. 2018. Drug-Impaired Driving: Marijuana and Opioids Raise Critical Issues for States. Governors Highway Safety Association and Foundation for Advancing Alcohol Responsibility. https://www.ghsa.org/resources/DUID18.
^{xxiv} 2013 NTSB Report, Reaching Zero: Actions to Eliminate Alcohol-Impaired Driving ( https://www.ntsb.gov/safety/safety-studies/Documents/SR1301.pdf ).
^{xxv} 2018 NTSB Report, Pickup Truck Centerline Crossover Collision With Medium Size Bus on US Highway 83, Concan, Texas, March 29, 2017 ( https://www.ntsb.gov/investigations/AccidentReports/Reports/HAR1802.pdf ).
^{xxvi} D'Orazio, A., Scott, K., Mohr, A. and Logan, B. 2016. Updates for Recommendations for Drug testing in DUID & Traffic Fatality Investigations. The Center for Forensic Science Research & Education at the Frederic Rieders Family Foundation, 2300 Stratford Avenue, Willow Grove, PA 19090. https://www.forensicscienceeducation.org/wp-content/uploads/2016/04/Full-Survey-Report.pdf.
^{xxvii} Logan, B., Lowrie, K., Turri, J., Yeakel, Limoges, J., Miles, A., Scarneo, C., Kerrigan, S., and Farrell, L. 2013. Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities. Journal of Analytical Toxicology. Volume 37. August 2013, Pages 552-558.
^{xxviii} Logan, B., D'Orazio, A., Mohr, A., Limoges, J., Miles, A., Scarneo, C., Kerrigan, S., Liddicoat, L., Scott, K., and Huestis, M. 2018. Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities—2017 Update. Journal of Analytical Toxicology. Volume 42. Issue 2. March 2018, Pages 63-68. https://academic.oup.com/jat/article/42/2/63/4653729.
^{xxix} D'Orazio, A., Mohr, A., Chan-Hosokawa, A., Harper, C., Huestis, M., Limoges, J., Miles, A., Scarno, C., Kerrigan, S., Liddicoat, L., Scott, K., Logan, B. Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities—2021 Update. Journal of Analytical Toxicology. July, 2021. 45(6):529-536. https://pubmed.ncbi.nlm.nih.gov/34086916/.
^{xxx} Watson, M.W. and Mann, R.E. 2018. Harm reduction and drug-impaired driving: sharing the road?. Drugs: Education Prevention and Policy. 25:2, 105-108. https://doi.org/10.1080/09687637.2017.1344620.
^{xxxi} Fixing America's Surface Transportation Act, Public Law 114-94, 4009 (2015).
Authority: 44 U.S.C. Section 3506(c)(2)(A).
Issued in Washington, DC.
Nanda Narayanan Srinivasan,

Associate Administrator, Research and Program Development.
DEPARTMENT OF THE TREASURY
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Internal Revenue Service Form 7203

AGENCY:
Departmental Offices, U.S. Department of the Treasury.

ACTION:
Notice.

SUMMARY:
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

DATES:
Comments must be received on or before May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Copies of the submissions may be obtained from Molly Stasko by emailing PRA@treasury.gov, calling (202) 622-8922, or viewing the entire information collection request at www.reginfo.gov.

SUPPLEMENTARY INFORMATION:
Title: S Corporation Shareholder Stock and Debt Basis Limitations.
OMB Control Number: 1545-2302.
Type of Review: Extension without change of a currently approved collection.
Description: Internal Revenue Code (IRC) Section 1366 determines the shareholder's tax liability from an S corporation. IRC Section 1367 details the adjustments to basis including the increase and decrease in basis, income items included in basis, the basis of indebtedness, and the basis of inherited stock. Shareholders will use Form 7203 to calculate their stock and debt basis, ensuring the losses and deductions are accurately claimed.
Form Number: IRS Form 7203.
Affected Public: Individuals and Households.
Estimated Number of Respondents: 70,000.
Frequency of Response: On Occasion.
Estimated Total Number of Annual Responses: 70,000.
Estimated Time per Response: 3 hours 46 minutes.
Estimated Total Annual Burden Hours: 257,600.
Authority: 44 U.S.C. 3501 et seq.
Molly Stasko,

Treasury PRA Clearance Officer.
DEPARTMENT OF THE TREASURY
Agency Information Collection Activities; Submission for OMB Review; Community Development Financial Institutions Funds Certificate of Material Events Form

AGENCY:
Departmental Offices, U.S. Department of the Treasury.

ACTION:
Notice.

SUMMARY:
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on this request.

DATES:
Comments must be received on or before May 25, 2022.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:
Copies of the submissions may be obtained from Molly Stasko by emailing PRA@treasury.gov, calling (202) 622-8922, or viewing the entire information collection request at www.reginfo.gov.

SUPPLEMENTARY INFORMATION:
Title: Certification of Material Events Form.
OMB Control Number: 1559-0037.
Type of Review: Revision of a currently approved collection.
Description: This information collection captures information related to specified “material events” that recipients and/or allocatees are required to report per applicable Assistance, Award, Allocation, or Bond Loan Agreement for New Markets Tax Credit Program, CDFI Bond Guarantee Program, Bank Enterprise Award Program, Small Dollar Loan Program, Capital Magnet Fund Program, CDFI Program/Native American CDFI Assistance Program, including Technical Assistance, Financial Assistance, Healthy Food Financing Initiative Financial Assistance, Disability Funds Financial Assistance, Persistent Poverty Counties Financial Assistance, and/or the CDFI Rapid Response Program. The revised form requires recipients and/or allocatees to indicate their material event, explain the event, and describe their organization's response.
Forms: Certificate of Material Events Form.
Affected Public: Businesses or other for-profits; Not-for-profit institutions; State, Local, and Tribal entities.
Estimated Number of Respondents: 200.
Frequency of Response: On Occasion.
Estimated Total Number of Annual Responses: 200.
Estimated Time per Response: 15 minutes.
Estimated Total Annual Burden Hours: 50.
Authority: 44 U.S.C. 3501 et seq.
Molly Stasko,

Treasury PRA Clearance Officer.