Animal and Plant Health Inspection Service
Census Bureau
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
Drug Enforcement Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Bureau of Consumer Financial Protection.
Interpretive rule.
The Bureau of Consumer Financial Protection (Bureau) is issuing this interpretive rule to clarify that, with respect to any aspect of a credit transaction, the prohibition against sex discrimination in the Equal Credit Opportunity Act (ECOA) and Regulation B, which implements ECOA, encompasses sexual orientation discrimination and gender identity discrimination, including discrimination based on actual or perceived nonconformity with sex-based or gender-based stereotypes and discrimination based on an applicant's associations.
This interpretive rule is effective on March 16, 2021.
Pavy Bacon, Senior Counsel, Office of Regulations at 202-435-7700. If you require this document in an alternative electronic format, please contact
The Bureau is responsible for administering and enforcing ECOA
On June 15, 2020, in
In response to Executive Order 13988, “Preventing and Combatting Discrimination on the Basis of Gender Identity or Sexual Orientation”,
Before the issuance of the
The Bureau has previously indicated that legal developments would lead to prohibitions against sex discrimination being interpreted to afford broad protection against discrimination on the bases of sexual orientation and gender identity. In 2016, in response to an inquiry from Services & Advocacy for GLBT Elders (SAGE), the Bureau sent a letter addressing coverage of sex discrimination involving sexual orientation and gender identity under ECOA.
After the Supreme Court issued the
The Bureau interprets the ECOA and Regulation B prohibitions against discrimination on the basis of “sex” to include discrimination based on sexual orientation and/or gender identity. The Bureau's interpretation is consistent with the Court's conclusion in
It is well established that ECOA and Title VII are generally interpreted consistently.
The Bureau believes that even though the term “sex” is not defined in ECOA or Regulation B, the prohibitions against discrimination on the basis of “sex” under ECOA and Regulation B are correctly interpreted to include discrimination based on sexual orientation and/or gender identity. As explained below and consistent with the Court's analysis in the
First, under ECOA and Regulation B, as under Title VII, sexual orientation discrimination and gender identity discrimination necessarily involve consideration of sex. For example, if a creditor declines the loan application of a male applicant on the basis that he is attracted to men, the creditor discriminates against him for traits or actions it tolerates in female applicants; further, this discrimination is motivated, at least partly, by the applicant “failing to fulfill traditional sex stereotypes.”
Second, under ECOA and Regulation B, as under Title VII, sex does not have to be the sole or primary reason for an action to be discriminatory.
Third, ECOA and Regulation B, like Title VII, apply to sex discrimination against individuals, not just to situations where all men or all women are discriminated against categorically.
Last, the Bureau interprets the ECOA and Regulation B prohibition against discrimination on the basis of “sex” to also include discrimination motivated by perceived nonconformity with sex-based or gender-based stereotypes, including those related to gender identity and/or sexual orientation, as well as discrimination based on an applicant's associations. An example of discriminatory sex-based or gender-based stereotyping occurs if a small business lender discourages a small business owner appearing at its office from applying for a business loan and tells the prospective applicant to go home and change because, in the view of the creditor, the small business customer's attire does not accord with the customer's gender.
For these reasons, the ECOA and Regulation B prohibition against discrimination on the basis of “sex” includes discrimination or discouragement based on sexual orientation and/or gender identity, including but not limited to discrimination based on actual or perceived nonconformity with sex-based or gender-based stereotypes and discrimination based on an applicant's associations.
This interpretive rule is issued under the Bureau's authority to interpret the ECOA and Regulation B, including under section 1022(b)(1) of the Dodd-Frank Wall Street Reform and Consumer Protection Act, which authorized guidance as may be necessary or appropriate to enable the Bureau to administer and carry out the purposes and objectives of Federal consumer financial laws.
By operation of the ECOA section 706(e), no provision of ECOA sections 701(a), 704(b), 706(a), or 706(b) imposing any liability applies to any act done or omitted in good faith in conformity with this interpretive rule, notwithstanding that after such act or omission has occurred, the rule is amended, rescinded, or determined by judicial or other authority to be invalid for any reason.
Because this rule is solely interpretive, it is not subject to the 30-day delayed effective date for substantive rules under section 553(d) of the Administrative Procedure Act.
As an interpretive rule, this rule is exempt from the notice-and-comment rulemaking requirements of the Administrative Procedure Act.
Pursuant to the Congressional Review Act,
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
The FAA is superseding Emergency Airworthiness Directive (AD) 2021-05-52 which applied to certain Bell Textron Canada Limited (Bell) Model 505 helicopters. Emergency AD 2021-05-52 required a one-time visual inspection of the pilot collective stick and grip assembly (pilot collective stick), a fluorescent penetrant inspection (FPI) if no crack was found during the visual inspection, and depending on the inspection results, removing the pilot collective stick from service and reporting certain information to Bell. Emergency AD 2021-05-52 also prohibited installing any pilot collective stick on any helicopter unless the inspections had been accomplished. This AD removes the visual inspection of the pilot collective stick, requires repetitive FPIs of the pilot collective stick, and requires revising the existing Rotorcraft Flight Manual (RFM) for your helicopter. This AD retains the reporting requirement
This AD becomes effective March 31, 2021.
The Director of the Federal Register approved the incorporation by reference of certain documents listed in this AD as of March 31, 2021.
The FAA must receive comments on this AD by April 30, 2021.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this final rule, contact Bell Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at
You may examine the AD docket at
Hal Jensen, Aerospace Engineer, Operational Safety Branch, Compliance & Airworthiness Division, FAA National Headquarters, 950 L'Enfant Plaza N SW, Washington, DC 20024; telephone (202) 267-9167; email
On February 22, 2021, the FAA issued Emergency AD 2021-05-52 (Emergency AD 2021-05-52), which was made immediately effective to all known U.S. owners and operators of Bell Model 505 helicopters, serial numbers 65011 and subsequent. Emergency AD 2021-05-52 required, before further flight, removing the pilot collective stick from the jackshaft assembly, cleaning it, and then visually inspecting the complete circumference of certain areas for a crack. If the visual inspection did not reveal a crack, Emergency AD 2021-05-52 required performing an FPI for a crack. Removing from service any cracked pilot collective stick was required before further flight, and if a crack was discovered, reporting certain information to Bell was required within 10 days.
Emergency AD 2021-05-52 was prompted by Canadian Emergency AD CF-2021-05, dated February 21, 2021 (Canadian AD CF-2021-05), issued by Transport Canada, which is the aviation authority for Canada, to correct an unsafe condition for Bell Model 505 helicopters, serial numbers 65011 and subsequent. Transport Canada advised of a report that a pilot collective stick cracked above the cabin floor at the junction with the collective jackshaft. This finding occurred prior to engine start during the pilot pre-flight check of flight controls for travel. The exact cause of the crack was still under investigation, and Transport Canada advised that the unsafe condition, if not addressed, could result in failure of the pilot collective stick and subsequent loss of control of the helicopter.
Accordingly, Canadian AD CF-2021-05 required a one-time visual inspection and as applicable, an FPI of the pilot collective stick to detect cracking. If the pilot collective stick was found to be unserviceable, Canadian AD CF-2021-05 required replacing the collective stick with a serviceable part prior to further flight. Transport Canada advised that a serviceable collective stick is a new collective stick or a collective stick with no crack found during the visual inspection or FPI required by its AD. Transport Canada considered Canadian AD CF-2021-05 an interim action and stated that further AD action may follow.
Since the FAA issued Emergency AD 2021-05-52, Bell has twice revised its service information. The service information was first revised to remove the procedures for a visual inspection and instead specify recurring FPIs, and Transport Canada superseded Canadian AD CF-2021-05 accordingly with Emergency AD CF-2021-05R1, dated February 26, 2021 (Canadian AD CF-2021-05R1). Canadian AD CF-2021-05R1 advised that examination of a pilot collective stick and another cracked pilot collective stick by Bell revealed fatigue cracking. Based on these findings, Bell determined that a visual inspection is not adequate for detecting smaller cracks. Accordingly, Canadian AD CF-2021-05R1 required an initial FPI for cracks before further flight and then at intervals not to exceed 25 hours time-in-service (TIS). Canadian AD CF-2021-05R1 also contained a ferry flight provision that specifies that ferry flights are permitted to a maintenance base to carry out the FPI, provided that the helicopter is flown from the copilot seat only. Transport Canada considered Canadian AD CF-2021-05R1 an interim action and stated that further AD action may follow.
Bell then again revised its service information to specify inserting a temporary revision (TR) into the RFM that prohibits single pilot operations from the right crew seat. Transport Canada again superseded its AD accordingly with Emergency AD CF-2021-05R2, dated March 4, 2021 (Canadian AD CF-2021-05R2). Canadian AD CF-2021-05R2 specifies that subsequent to the issuance of Canadian AD CF-2021-05R1, additional FPI findings showed that cracking of the pilot collective stick could occur at very low flight hours. As a result, Bell published revised service information to introduce TRs to the RFMs to prohibit single pilot operations from the right crew seat. Transport Canada considers Canadian AD CF-2021-05R2 an interim action as well and states that further AD action may follow to mandate further corrective actions to modify the pilot collective stick to prevent cracking and subsequent failure.
These helicopters have been approved by the aviation authority of Canada and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with Canada, Transport Canada, its technical representative, has notified the FAA of the unsafe condition described in its AD. The FAA is issuing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop
The FAA reviewed Bell Alert Service Bulletin 505-21-20, Revision B, dated March 3, 2021 (ASB 505-21-20 Rev B). ASB 505-21-20 Rev B provides instructions for an initial and recurring FPIs for cracks in the pilot collective stick and grip assembly part number M207-20M478-041/-043/-047 on Bell Model 505 helicopters, serial numbers 65011 and subsequent. ASB 505-21-20 Rev B also specifies inserting TRs into the RFMs that prohibit single pilot operations from the right crew seat until further notice. Finally, ASB 505-21-20 Rev B specifies that if the right crew seat pilot collective stick assembly was previously confirmed serviceable following an FPI in accordance with Bell Alert Service Bulletin 505-21-20, Revision A, dated February 26, 2021 (ASB 505-21-20 Rev A), which is not incorporated by reference in this AD, then the 25 flight hour recurring FPI of the right crew seat pilot collective stick assembly is no longer required provided that the helicopter is only operated single pilot in command (PIC) from the left crew seat. If conducting dual pilot operations, ASB 505-21-20 Rev B specifies a 25 flight hour recurring FPI of the right crew seat pilot collective stick assembly.
The FAA also reviewed Bell 505 RFM TR for Pilot Collective (ASB 505-21-20), BHT-505-FM-1, Temporary Revision (TR-6) (BHT-505-FM-1, TR-6) and Bell 505 RFM TR for Pilot Collective (ASB 505-21-20), BHT-505-FM-2, Temporary Revision (TR-1), each dated March 3, 2021. These TRs specify changes to Section 1 of the RFM Limitations Section that the minimum flight crew consists of one pilot that shall operate from the left crew seat and that dual operation is approved provide that the PIC occupies the left crew seat. BHT-505-FM-1, TR-6 also prohibits use of SPLIT-COM mode.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA reviewed Bell ASB 505-21-20, dated February 20, 2021 (ASB 505-21-20) and ASB 505-21-20 Rev A. ASB 505-21-20 specifies a one-time inspection for cracks of the pilot collective stick and grip assembly. ASB 505-21-20 Rev A removes the visual inspection and adds a repetitive FPI.
This AD requires, before further flight, revising Section 1, the Limitations section of the existing RFM for your helicopter to prohibit single pilot operations from the right crew seat, require the pilot in command to occupy the left crew seat for dual pilot operations, and depending on configuration, prohibiting the use of SPLIT-COM mode. This AD also requires, before further flight and thereafter at intervals not to exceed 25 hours TIS, removing the pilot collective stick from the jackshaft assembly, cleaning it as specified in ASB 505-21-20 Rev B, and performing an FPI for a crack as specified in ASB 505-21-20 Rev B. Removing from service any cracked pilot collective stick is required before further flight. In addition, this AD requires, within 10 days after the discovery of any crack, reporting certain information to Bell. This AD also prohibits installing any pilot collective stick and grip assembly on any helicopter unless it has successfully passed the FPI inspection requirements of this AD. Lastly, this AD prohibits relief under any Master Minimum Equipment List or Minimum Equipment List for the Audio Panel when the aircraft is operated with a single pilot.
This AD prohibits relief under any Master Minimum Equipment List or Minimum Equipment List for the Audio Panel when the aircraft is operated with a single pilot, whereas Canadian AD CF-2021-05R2 does not. Canadian AD CF-2021-05R2 requires the repetitive FPI if the aircraft is not flown solely from the left crew seat whereas this AD requires FPI regardless.
The FAA considers this AD to be an interim action and acknowledges that the requirement to revise the existing RFM for your helicopter to require the pilot in command to occupy the left crew seat, and, depending on configuration, prohibit the use of SPLIT-COM mode may impact seat-dependent training for some helicopters operating under Part 135. However, the unsafe condition requires the FAA to mandate these requirements for continued operational safety. The inspection reports that are required by this AD will enable the FAA to obtain better insight into the cause of the cracking, and eventually develop final action to address the unsafe condition. Once final action has been identified, the FAA might consider further rulemaking.
Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551
An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies foregoing notice and comment prior to adoption of this rule because certain requirements must be accomplished before further flight. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).
In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forego notice and comment.
The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Hal Jensen, Aerospace Engineer, Operational Safety Branch, Compliance & Airworthiness Division, FAA National Headquarters, 950 L'Enfant Plaza N SW, Washington, DC 20024; telephone (202) 267-9167; email
The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.
The FAA estimates that this AD affects 88 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.
Removing, cleaning, performing the FPI of the pilot collective stick, and installing a serviceable pilot collective stick takes about 3 work-hours for an estimated cost of $255 per helicopter and $22,440 for the U.S. fleet per inspection cycle. A replacement pilot collective stick costs about $1,979 per helicopter. If required, reporting information takes about 1 work-hour for an estimated cost of $85 per instance.
Revising the existing RFM for your helicopter takes about 0.5 work-hour for an estimated cost of $43 per helicopter.
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 1 hour 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. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866, and
(2) Will not affect intrastate aviation in Alaska.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective March 31, 2021.
This AD replaces Emergency AD 2021-05-52, Project Identifier MCAI-2021-00217-R, dated February 22, 2021.
This AD applies to Bell Textron Canada Limited Model 505 helicopters, serial numbers 65011 and subsequent, certificated in any category.
Joint Aircraft Service Component (JASC) Code: 6710, Main Rotor Control.
This AD was prompted by a report of a cracked pilot collective stick. The FAA is issuing this AD to detect a cracked pilot collective stick which, if not corrected, could result in failure of the pilot collective stick and subsequent loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) Before further flight after the effective date of this AD, revise the Limitations section of the existing Rotorcraft Flight Manual (RFM) for your helicopter by inserting Bell 505 RFM Temporary Revision (TR) for Pilot
(2) Before further flight after the effective date of this AD, and thereafter at intervals not to exceed 25 hours time-in-service:
(i) Remove the pilot collective stick and grip assembly from the jackshaft assembly and clean the areas specified in Figure 2 of Bell Alert Service Bulletin 505-21-20, Revision B, dated March 3, 2021 (ASB 505-21-20 Rev B) with a clean cloth C-516C or equivalent moistened with dry cleaning solvent C-304 or equivalent.
(ii) Perform a fluorescent penetrant inspection (FPI) for a crack by following the Accomplishment Instructions, paragraph 5. (but not paragraphs 5.a. and b.) of ASB 505-21-20 Rev B. Perform this FPI in the areas specified in Figure 2 of ASB 505-21-20 Rev B. If there is a crack, before further flight, remove the pilot collective stick and grip assembly from service.
(3) Within 10 days after the discovery of any crack, report the information specified in paragraph 5.a. of ASB 505-21-20 Rev B to Bell Product Support Engineering at
(4) As of the effective date of this AD, do not install any pilot collective stick and grip assembly on any helicopter unless the actions required by paragraphs (g)(2)(i) and (ii) have been accomplished.
(5) As of the effective date of this AD, relief under any Master Minimum Equipment List or Minimum Equipment List for the Audio Panel is prohibited when the aircraft is operated with a single pilot.
If you performed an FPI of the pilot collective stick and grip assembly before the effective date of this AD using Bell Alert Service Bulletin 505-21-20, dated February 20, 2021, or Bell Alert Service Bulletin 505-21-20, Revision A, dated February 26, 2021, you met the before further flight FPI requirement of paragraph (g)(2) of this AD.
A special flight permit to a maintenance facility may be granted provided that:
(1) There are no passengers on-board,
(2) The helicopter is flown from the copilot seat only, and
(3) The GMA (intercom) is operative.
(1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation office, send it to the attention of the person identified in paragraph (k)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) Hal Jensen, Aerospace Engineer, Operational Safety Branch, Compliance & Airworthiness Division, FAA National Headquarters, 950 L'Enfant Plaza N SW, Washington, DC 20024; telephone (202) 267-9167; email
(2) The subject of this AD is addressed in Transport Canada Emergency AD CF-2021-05R2, dated March 4, 2021. You may view the Transport Canada AD on the internet at
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Bell Alert Service Bulletin 505-21-20, Revision B, dated March 3, 2021.
(ii) Bell 505 Rotorcraft Flight Manual Temporary Revision for Pilot Collective (ASB 505-21-20), BHT-505-FM-1, Temporary Revision (TR-6), dated March 3, 2021.
(iii) Bell 505 Rotorcraft Flight Manual Temporary Revision for Pilot Collective (ASB 505-21-20), BHT-505-FM-2, Temporary Revision (TR-1), dated March 3, 2021.
(3) For service information identified in this AD, contact Bell Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at
(4) You may view this service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email:
Office of the General Counsel, HUD.
Final rule.
This rule provides for 2021 inflation adjustments of civil monetary penalty amounts required by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
Effective April 15, 2021.
Aaron Santa Anna, Associate General Counsel for Legislation and Regulations, Office of the General Counsel, Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20024; telephone number 202-402-5138 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number via TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) (Pub. L. 114-74, Sec. 701), which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410), requires agencies to make annual adjustments to civil monetary penalty (CMP) amounts for inflation “notwithstanding section 553 of title 5, United States Code.” Section 553 refers to the Administrative Procedure Act, which provides for advance notice and public comment during the rulemaking process. However, as explained in Section III below, HUD has determined that advance notice and public comment on this final rule is unnecessary.
This annual adjustment is for 2021. The annual adjustment is based on the percent change between the U.S. Department of Labor's Consumer Price
This final rule makes the required 2021 inflation adjustment of HUD's civil money penalty amounts. Since HUD is not applying these adjustments retroactively, the 2021 increases apply to violations occurring on or after this rule's effective date. HUD provides a table showing how, for each component, the penalties are being adjusted for 2021 pursuant to the 2015 Act. In the first column (“Description”), HUD provides a description of the penalty. In the second column (“Statutory Citation”), HUD provides the United States Code statutory citation providing for the penalty. In the third column (“Regulatory Citation”), HUD provides the Code of Federal Regulations citation under Title 24 for the penalty. In the fourth column (“Previous Amount”), HUD provides the amount of the penalty pursuant to the rule implementing the 2020 adjustment (85 FR 13041, April 06, 2020). In the fifth column (“2021 Adjusted Amount”), HUD lists the penalty after applying the 2021 inflation adjustment.
HUD generally publishes regulations for public comment before issuing a rule for effect, in accordance with its own regulations on rulemaking in 24 CFR part 10. However, part 10 provides for exceptions to the general rule if the agency finds good cause to omit advanced notice and public participation. The good cause requirement is satisfied when prior public procedure is “impractical, unnecessary, or contrary to the public interest” (see 24 CFR 10.1). As discussed, this final rule makes the required 2021 inflation adjustment, which HUD does not have discretion to change. Moreover, the 2015 Act specifies that a delay in the effective date under the Administrative Procedure Act is not required for annual adjustments under the 2015 Act. HUD has determined, therefore, that it is unnecessary to delay the effectiveness of the 2021 inflation adjustments to solicit public comments.
Section 7(o) of the Department of Housing and Urban Development Act (42 U.S.C. 3535(o)) requires that any HUD regulation implementing any provision of the Department of Housing and Urban Development Reform Act of 1989 that authorizes the imposition of a civil money penalty may not become effective until after the expiration of a public comment period of not less than 60 days. This rule does not authorize
Under Executive Order 12866 (Regulatory Planning and Review) (58 FR 51735), a determination must be made whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) (76 FR 3821) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. As discussed above in this preamble, this final rule adjusts existing civil monetary penalties for inflation by a statutorily required amount. HUD determined that this rule was not significant under Executive Order 12866 and Executive Order 13563.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
Executive Order 13132 (entitled “Federalism”) (64 FR 43255) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute, or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This rule will not have federalism implications and would not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.
This final rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern, or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this final rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Administrative practice and procedure, Claims, Fraud, Penalties.
Administrative practice and procedure, Grant programs—housing and community development, Loan programs—housing and community development, Mortgage insurance, Penalties.
Government contracts, Grant programs, Loan programs, Lobbying, Penalties, Reporting and recordkeeping requirements.
Administrative practice and procedure, Aged, Civil rights, Fair housing, Persons with disabilities, Investigations, Mortgages, Penalties, Reporting and recordkeeping requirements.
Administrative practice and procedure, Consumer protection, Intergovernmental relations, Manufactured homes, Reporting and recordkeeping requirements.
Accordingly, for the reasons described in the preamble, HUD amends 24 CFR parts 28, 30, 87, 180, and 3282 to read as follows:
28 U.S.C. 2461 note; 31 U.S.C. 3801-3812; 42 U.S.C. 3535(d).
(a) * * *. (1) A civil penalty of not more than $11,803 may be imposed upon any person who makes, presents, or submits, or causes to be made, presented, or submitted, a claim that the person knows or has reason to know:
(b) * * *. (1) A civil penalty of not more than $11,803 may be imposed upon any person who makes, presents, or submits, or causes to be made, presented, or submitted, a written statement that:
12 U.S.C. 1701q-1, 1703, 1723i, 1735f-14, and 1735f-15; 15 U.S.C. 1717a; 28 U.S.C. 1 note and 2461 note; 42 U.S.C. 1437z-1 and 3535(d).
(b) Maximum penalty. The maximum penalty is $20,731 for each violation.
(b) Maximum penalty. The maximum penalty is $20,731 for each violation.
(c)(1) * * * The maximum penalty is $10,366 for each violation, up to a limit of $2,073,133 for all violations committed during any one-year period. * * *
(c) * * * The maximum penalty is $10,366 for each violation, up to a limit of $2,073,133 for all violations committed during any one-year period. * * *
(c)
(g)
(c)
(c)
(b)
(c)
28 U.S.C. 1 note; 31 U.S.C. 1352; 42 U.S.C. 3535(d).
(a) Any person who makes an expenditure prohibited herein shall be subject to a civil penalty of not less than $20,731 and not more than $207,314 for each such expenditure.
(b) Any person who fails to file or amend the disclosure form (see appendix B of this part) to be filed or amended if required herein, shall be subject to a civil penalty of not less than $20,731 and not more than $207,314 for each such failure.
(e) First offenders under paragraphs (a) or (b) of this section shall be subject to a civil penalty of $20,731, absent aggravating circumstances. Second and subsequent offenses by persons shall be subject to an appropriate civil penalty between $20,731 and $207,314 as determined by the agency head or his or her designee.
28 U.S.C. 1 note; 29 U.S.C. 794; 42 U.S.C. 2000d-1, 3535(d), 3601-3619, 5301-5320, and 6103.
(a) * * *
(1) $21,663, if the respondent has not been adjudged in any administrative hearing or civil action permitted under the Fair Housing Act or any state or local fair housing law, or in any licensing or regulatory proceeding conducted by a federal, state, or local governmental agency, to have committed any prior discriminatory housing practice.
(2) $54,157, if the respondent has been adjudged in any administrative hearing or civil action permitted under the Fair Housing Act, or under any state or local fair housing law, or in any licensing or regulatory proceeding conducted by a federal, state, or local government agency, to have committed one other discriminatory housing practice and the adjudication was made during the 5-year period preceding the date of filing of the charge.
(3) $108,315, if the respondent has been adjudged in any administrative hearings or civil actions permitted under the Fair Housing Act, or under any state or local fair housing law, or in any licensing or regulatory proceeding conducted by a federal, state, or local government agency, to have committed two or more discriminatory housing practices and the adjudications were made during the 7-year period preceding the date of filing of the charge.
15 U.S.C. 2967; 42 U.S.C. 3535(d), 5403, and 5424.
Failure to comply with these regulations may subject the party in question to the civil and criminal penalties provided for in section 611 of the Act, 42 U.S.C. 5410. The maximum amount of penalties imposed under section 611 of the Act shall be $3,011 for each violation, up to a maximum of $3,763,392 for any related series of violations occurring within one year from the date of the first violation.
Office of Special Education and Rehabilitative Services (OSERS), Department of Education.
Final priority and definitions.
The Department of Education (Department) announces a priority and definitions to fund an American Indian Vocational Rehabilitation Training and Technical Assistance Center (AIVRTTAC), Assistance Listing Number 84.250Z. The Department may use the priority and definitions for competitions in fiscal year (FY) 2021 and later years. We take this action to improve employment outcomes and raise expectations for American Indians with disabilities and to fund training and technical assistance (TA) activities to support the American Indian Vocational Rehabilitation Services (AIVRS) projects. We intend the AIVRTTAC to provide training and TA to the AIVRS project personnel, especially vocational rehabilitation (VR) counselors, to improve their capacity to implement innovative and effective VR services and employment strategies and practices to increase the number and quality of employment outcomes for American Indians with disabilities served through the AIVRS program.
Awards will be made to State, local, or Tribal governments, non-profit organizations, or institutions of higher education that have experience in the operation of AIVRS programs.
This priority and definitions are effective April 15, 2021.
Jerry Elliott, U.S. Department of Education, 400 Maryland Avenue SW, Room 5097, Potomac Center Plaza, Washington, DC 20202-2800. Telephone: (202) 245-7335. Email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
29 U.S.C. 741(c).
We published a notice of proposed priorities and definitions (NPP) for this program in the
Except for minor editorial and technical revisions for grammar and clarity, and one substantive change explained in the discussion of the comments that follow, there are no differences between Proposed Priority 1 and the proposed definitions and the final priority and final definitions. We have not included Proposed Priority 2 in the final priorities.
Generally, we do not address technical and other minor changes, or suggested changes the law does not authorize us to make. In addition, we do not address general comments that raise concerns not directly related to the proposed priorities or definitions.
In addition, the Department will revise the proposed priority to encourage but not require an academic path whereby certificate courses taken for academic credit could lead to a degree in vocational rehabilitation or a closely related field. While an academic path leading to a degree is important, the Department does not agree that an academic path should be the only option. AIVRS projects hire staff at different levels in the organization, and certificate course knowledge could be helpful to staff at all levels of the organization. In addition, there may be individuals who bring great cultural or work experience to the AIVRS project but may not be, for various reasons, able to pursue a degree. The knowledge gained through a certificate class would nevertheless be helpful to the employee and benefit the AIVRS consumers the employee serves, even if the class is not taken for academic credit.
The Department also recognizes that the COVID-19 pandemic is not abating, especially in Tribal communities, and that the impact of the pandemic is causing revenue challenges for State and Tribal governments and State and Tribal IHEs, making the provision of matching funds even more difficult.
The proposed matching requirement is not required by statute. Because the Department wishes to invite applications from the broadest range of applicants, and because most of the eligible applicant pool is also economically affected by the COVID-19 pandemic, the Department has determined that the concerns raised by the commenter and the others recognized by the Department outweigh the value that a matching requirement might otherwise generate through greater institutional investment in the grant activity.
This priority funds a five-year cooperative agreement to establish an American Indian Vocational Rehabilitation Training and Technical Assistance Center (AIVRTTAC) to provide four types of training and technical assistance (TA) for the personnel of the American Indian Vocational Rehabilitation Services (AIVRS) projects awarded under section 121(a) of the Rehabilitation Act of 1973, as amended (Act), to the governing bodies of Indian Tribes and consortia of those governing bodies. The four types of training and TA are: (1) Intensive training and TA; (2) targeted training and TA; (3) universal training and TA; and (4) capacity-building for AIVRS project personnel through training modules that build foundational skills for the delivery of VR services to AIVRS project participants. The AIVRTTAC will develop and provide these types of training and TA for AIVRS projects in the following topic areas:
(a) Applicable laws and regulations governing the AIVRS program.
(b) Promising practices for providing VR services to American Indians with disabilities.
(c) The delivery of VR services to American Indians with disabilities, including the determination of eligibility, case management, case record documentation, assessment, development of the individualized plan for employment, and placement into competitive integrated employment.
(d) Knowledge of assistive technology (AT), including the definition of AT, how to evaluate the need for AT and what types of AT are available, use of AT, and access to AT.
(e) Implementing professional development practices to ensure effective project coordination, administration, and management.
(f) Implementing appropriate financial and grant management practices to ensure compliance with OMB's Uniform Guidance (2 CFR part 200) and the Education Department General Administrative Regulations.
(g) Evaluating project performance, including data collection, data analysis, and reporting.
Specific subjects for training and TA in each of these topic areas will be
To be considered for funding under this priority, applicants must conduct the following activities, or a subset of the following activities as determined by the Department, in a culturally appropriate manner:
(a) Maintain and build upon the 12 training modules and the fiscal tool kit developed by the Tribal Vocational Rehabilitation Institute (the Institute) during Federal fiscal years (FFYs) 2015-2021, including maintaining the series of seven training modules that build foundational skills that, when satisfactorily completed, lead to a VR certificate to be awarded by the AIVRTTAC. To satisfy this activity requirement, the grantee—
(i) Must develop both academic and non-academic options for completing courses leading to the VR certificate, the requirements for obtaining a certificate including the specific requirements for academic credit for courses included in the certificate when applicable, and how the certificate may be used by the participants who earn it;
(ii) May offer the series of training modules in a traditional classroom setting, through distance learning, through week-long institutes, at regional trainings throughout the country as an extension of national conferences, and through other delivery methods, as appropriate, to meet the needs of the targeted audience;
(iii) May use grant funds to provide reasonable financial assistance for the cost of tuition, fees, and training materials and to offset costs associated with travel for participants who may be in remote areas of the country;
(iv) Must conduct an assessment before and after providing training for each participant in order to assess strengths and specific areas for improvement, educational attainment, and application of skills, and any issues or challenges to be addressed post-training to ensure improved delivery of VR services to American Indians with disabilities;
(v) Must provide follow-up TA to participants to address any issues or challenges that are identified post-training and to ensure that the training they received is applied effectively in their work setting, and such follow-up may be conducted as part of the provision of targeted training and TA or intensive training and TA as determined by the needs of the specific AIVRS project;
(vi) Must conduct an evaluation to obtain feedback on the training and follow-up TA and to determine whether this training and TA contributed to increased employment outcomes for American Indians with disabilities;
(vii) Are encouraged to develop a path by which courses offered for academic credit lead to a degree in Rehabilitation or a related field; and
(viii) May develop additional training modules as negotiated through the cooperative agreement.
(b) Maintain and build upon the topics and tools the current AIVRRTAC has developed to provide intensive training and TA. To satisfy this activity requirement, the grantee must—
(i) Develop and provide intensive training and TA to a minimum of three AIVRS projects in the first year. For future years, the minimum number of AIVRS projects to receive intensive training and TA will be negotiated through the cooperative agreement;
(ii) Develop and implement training and TA consistent with AIVRS project activities and tailored to the specific needs and challenges of the AIVRS project receiving the intensive training and TA;
(iii) Provide training and TA under an agreement with each AIVRS project receiving intensive training and TA that, at a minimum, details the purpose of the training and TA, intended outcomes, and requirements for the subsequent evaluation of the training and TA; and
(iv) Assess the results of the training and TA 90 days after its completion to ensure that the recipient is able to apply effectively the training and TA, identify any issues or challenges in its implementation, and provide additional training and TA, either virtually or on-site, as needed.
(c) Maintain and build upon the topics and tools the current AIVRTTAC has developed to provide a range of targeted training and TA in the topic areas described in this priority based on needs common to multiple AIVRS projects. The grantee must follow up with the recipients of targeted training and TA it provides to determine the effectiveness of the training and TA;
(d) Maintain and build upon the topics and tools the current AIVRTTAC has developed to provide universal training and TA in the topic areas in this priority;
(e) Provide a minimum of two webinars or video conferences in each of the topic areas in this priority to describe and disseminate up-to-date information, guides, examples, and emerging and promising practices in each area;
(f) Develop new information technology (IT) platforms and systems, or modify existing platforms and systems, as follows:
(i) Develop or modify, and maintain, a state-of-the-art IT platform capable and reliable enough to support webinars, teleconferences, video conferences, and other virtual methods of dissemination of information and TA;
(ii) Develop or modify, and maintain, a state-of-the-art archiving and dissemination system that is open and available to all AIVRS projects and that provides a central location for all AIVRS training and TA products for later use, including course curricula, audiovisual materials, webinars, examples of promising practices related to the topic areas in this priority, the primary areas identified through the annual surveys completed by AIVRS projects, other topics identified by RSA, and other relevant TA products (the possibility of collaborating with the National Clearinghouse of Rehabilitation Training Materials will be considered with the grantee and included in the cooperative agreement, as appropriate);
(iii) Ensure that all products produced by the AIVRTTAC meet government and industry-recognized standards for accessibility; and
(iv) Ensure that all products, resources, and materials developed by the AIVRTTAC are widely disseminated across the AIVRS projects and reflect the AIVRS population and diversity among its communities to the maximum extent possible.
(g) Establish a community of practice (or communities of practice) that will serve as a vehicle for communication, an exchange of information among AIVRS projects, and a forum for sharing the results of training and TA projects that are in progress or have been completed;
(h) Conduct outreach to AIVRS projects so that they are aware of, and can participate in, training and TA activities; and
(i) Conduct an evaluation to determine the quality, relevance, and usefulness of the AIVRTTAC's training and TA, including the impact of the AIVRTTAC's activities on the ability of AIVRS projects to effectively manage their projects and improve the delivery of VR services to American Indians with disabilities.
To be funded under this priority, applicants must meet the project requirements in this priority. RSA encourages innovative approaches to meet these requirements, which are—
(a) Demonstrate in the narrative section of the application under
(1) Use the applicant's knowledge and experience in the operation of AIVRS projects to provide training and TA for these projects;
(2) Address the AIVRS projects' capacity to effectively implement an AIVRS project. To meet this requirement, the applicant must—
(i) Demonstrate knowledge of emerging and promising practices in the topic areas in this priority;
(ii) Demonstrate knowledge of current RSA guidance and Federal initiatives designed to improve the functioning of grant projects in general and grant projects for American Indian Tribes in particular; and
(iii) Present information about the difficulties that AIVRS grantees have encountered in implementing effective AIVRS projects;
(b) Demonstrate in the narrative section of the application under “Quality of Project Design” how the proposed project will—
(1) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—
(i) Measurable intended project outcomes;
(ii) A plan for how the proposed project will achieve its intended outcomes;
(iii) A plan for communicating and coordinating with RSA and key personnel of AIVRS projects; and
(iv) A draft training module or outline for a targeted training and TA presentation or an outline for intensive training and TA activities for one of the topic areas in this priority to demonstrate how participants would be trained in that area. The module or outline is a required attachment in the application and must include, at a minimum, the following:
(A) The goals and objectives of this training module, targeted training and TA activity, or intensive training and TA activities;
(B) A specific list of what participants should know and be able to do as a result of successfully completing the module, targeted training and TA activity, or intensive training and TA activities;
(C) Up-to-date resources, publications, applicable laws and regulations, and other materials that may be used to develop the module, targeted training and TA activity, or intensive training and TA activities;
(D) Exercises that will provide an opportunity for application of the subject matter;
(E) A description of how participant knowledge, skills, and abilities will be measured; and
(F) In the case of an intensive training and TA intervention, how the outcomes and impact of the intensive training and TA intervention will be measured;
(2) Use a logic model to develop project plans and activities that includes, at a minimum, the goals, activities, outputs, and outcomes of the proposed project;
(3) Be based on current research and make use of emerging and promising practices, and evidence-based practices, where available. To meet this requirement the applicant must describe—
(i) The current research on the emerging and promising practices in the topic areas in this priority; and
(ii) How the AIVRTTAC will incorporate current research and promising and evidence-based practices, including research about adult learning principles and implementation science, in the development and delivery of its products and services;
(4) Develop products and provide services that are of high quality and of sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement the applicant must describe—
(i) Its proposed approach to universal training and TA;
(ii) Its proposed approach to targeted training and TA, which must identify—
(A) The intended recipients of the products and services under this approach, including the categories of personnel that would be receiving the training and TA;
(B) Its proposed methods for providing targeted training and TA; and
(C) Its proposed methodology for determining topics for the targeted training and TA;
(iii) Its proposed approach to intensive training and TA, which must identify—
(A) Its proposed approach to identifying recipients for intensive training and TA;
(B) Its proposed methodology for providing intensive training and TA to recipients; and
(C) Its proposed approach to assessing the training and TA needs of recipients, including their ability to respond effectively to the training and TA; and
(iv) Its proposed approach to maintaining and building upon capacity-building modules, which must identify—
(A) Its proposed approach to maintaining the 12 training modules and the fiscal tool kit developed by the Institute in FFYs 2015-2021, including maintaining the series of seven training modules that build foundational skills that, when satisfactorily completed, lead to a VR certificate to be awarded by the grantee; and
(B) Its proposed approach to identifying, developing, and delivering new capacity-building modules; and
(5) Develop products and implement services to maximize the proposed project's efficiency. To address this requirement, the applicant must describe—
(i) How the proposed project will use technology to achieve the intended project outcomes;
(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration; and
(iii) In particular, how the proposed project will coordinate and collaborate with other RSA-funded technical assistance centers to exchange and adapt relevant products and materials to avoid duplication and make effective use of grant funds to better manage the AIVRTTAC project and its available resources to improve service delivery to AIVRS projects;
(c) Demonstrate in the narrative section of the application under “Adequacy of Project Resources” how—
(1) The applicant and any key partners possess adequate resources to carry out the proposed activities; and
(2) The proposed costs are reasonable in relation to the anticipated results and benefits;
(d) Demonstrate in the narrative section of the application under “Quality of Project Personnel” how—
(1) The proposed project will encourage applications for employment from persons who are members of groups that have historically been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate; and
(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to provide training and TA to AIVRS projects in each of the topic areas in this priority and to achieve the project's intended outcomes, including how the proposed project personnel have a high degree of knowledge and understanding of cultural factors that will be sufficient to ensure the delivery of training and TA in a culturally appropriate manner;
(e) Demonstrate in the narrative section of the application under “Quality of the Management Plan” how the proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this
(1) Clearly defined roles and responsibilities for at least two full-time key project personnel designated to the AIVRTTAC through the entire project period and for consultants and subcontractors, as applicable;
(2) Timelines and milestones for accomplishing the project tasks;
(3) Using a personnel loading chart, detailed project activities through the entire project period, key personnel and any consultants or subcontractors that will be allocated to each activity, and the designated level of effort for each of those activities;
(4) How the personnel allocations in the personnel loading chart are appropriate and adequate to achieve the project's intended outcomes, including an assurance that all personnel will communicate with stakeholders and RSA in a timely way;
(5) How the proposed management plan will ensure that the training and TA products developed through this cooperative agreement are complete, accurate, and of high quality; and
(6) How the proposed project will benefit from a diversity of perspectives, including AIVRS projects and consumers, State VR agencies, TA providers, and policy makers, in its development and operation; and
(f) Demonstrate in the narrative section of the application under “Quality of the Evaluation Plan” how the applicant proposes to collect and analyze data on specific and measurable goals, objectives, and intended outcomes of the project, including the effectiveness of the training and TA provided. To address this requirement, the applicant must describe—
(i) Its proposed evaluation methodologies, including instruments, data collection methods, and analyses;
(ii) Its proposed standards or targets for determining effectiveness;
(iii) How it will use the evaluation results to examine the effectiveness of its implementation and its progress toward achieving the intended outcomes; and
(iv) How the methods of evaluation will produce quantitative and qualitative data that demonstrate whether the project and individual training and TA activities achieved their intended outcomes.
When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the
This document does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.
Under Executive Order 12866, OMB must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by OMB. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing this final priority and definitions only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action does not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.
In accordance with these Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities. The costs would include the time and effort in responding to the priority for entities that choose to respond.
In addition, we have considered the potential benefits of this regulatory action and have noted these benefits in the background section of this document. The benefits include continuing to provide both TA and a structured training program focused on the VR process and practices and the unique skills and knowledge necessary to improve employment outcomes for American Indians with disabilities.
The small entities that this regulatory action will affect are public or private nonprofit agencies and organizations, including Indian Tribes and institutions of higher education that may apply. We believe that the costs imposed on an applicant by the priority and definitions will be limited to paperwork burden related to preparing an application and that the benefits of the priority and definitions will outweigh any costs incurred by the applicant. There are very few entities that could provide the type of training and TA required under the final priority. For these reasons the priority and definitions will not impose a burden on a significant number of small entities.
You may also access documents of the Department published in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; correcting amendment.
This action contains corrections to the final rule for the 2021-2022 Biennial Harvest Specifications and Management Measures for groundfish harvested in the U.S. exclusive economic zone off the coasts of Washington, Oregon, and California published on December 11, 2020. This action corrects: the Rockfish Conservation Area (RCA) waypoints for the 100 fathom depth contour, the other flatfish gear restrictions in the RCA, language describing the boundary lines for the depth contours, and the boundaries of the non-groundfish RCA for California halibut, sea cucumber, and ridgeback prawns south of 34°27′ N. lat. These corrections are necessary so the regulations accurately implement the Pacific Fishery Management
This correction is effective March 16, 2021.
Karen Palmigiano at
NMFS published a final rule on December 11, 2020, (85 FR 79880), that implemented the 2021-2022 harvest specifications and management measures for groundfish harvested in the U.S. exclusive economic zone off the coasts of Washington, Oregon, and California. That final rule was effective January 1, 2021. After publication of the final rule, NMFS noted the need for four corrections.
The final rule for the 2021-2022 groundfish harvest specifications and management measures (85 FR 79880; December 11, 2020) inadvertently deleted the final waypoint for the line approximating the 100-fathom depth contour coast-wide at the U.S. and Mexico border. This waypoint, known as point #322, at 32°34.22′ North latitude (N lat.), 117°21.20′ West longitude (W. long.) was part of the regulations in 2020 and the Pacific Fishery Management Council (Council) did not recommend to remove it through the 2021-2022 harvest specifications. This final rule will add point #322 back into the list of waypoints for the 100-fathom line. Without this point identified in the regulations, it is difficult for members of industry to use their plotters to identify the boundaries of the non-trawl RCA. Additionally, the waypoint must be reinstated into the regulations in order for law enforcement to correctly enforce the boundaries of the non-trawl RCA. This correcting amendment would revise the regulations to reinstate the missing waypoint.
In order to make the description of the depth contours off of California consistent with the description used for Oregon and Washington, the final rule noted in section “V. Changes From the Proposed Rule” that the language describing the boundary lines in § 660.360(3)(i)(A)(
The final rule implemented the Council recommendation to remove the gear restrictions for the limited-entry fixed-gear (LEFG) and open-access (OA) fishery targeting stocks in the “Other Flatfish” complex south of 42° N lat. by removing the hook-and-line gear restriction language from the LEFG and OA trip limit tables. However, NMFS inadvertently did not remove the gear restriction from other sections of the regulatory text. Specifically, the requirement to use no more than 12 hooks, Number 2 or smaller, which measure no more than 11 mm (0.44 inches) point to shank and up to two 1-lb (0.45 kg) weights per line should have been removed in all places it appears in the regulatory text and replaced with hook and line gear only. This final rule would remove the gear restriction specifying the type and number of hooks from the regulations so that the regulations are consistent and follow the intent of the action. This correction is needed to reduce confusion and inconsistencies in the regulatory text as to what gears are allowed to be used inside the non-trawl RCA.
The final rule included a typographical error in the description of the boundary lines south of 34°27′ N lat. for the non-groundfish trawl RCA for California halibut, sea cucumber, and ridgeback prawns in Table 3 (South) to Subpart F. Instead of stating the fathom lines of the boundary, the boundaries are stated as 01/01/2021+A108:P133. This final rule will correct the boundary from the 100 fm line to the 150 fm line. This correction is needed to enforce the boundaries of this non-groundfish trawl RCA and also to reduce confusion about the boundaries among members of industry.
All of these corrections are consistent with the Council action for the 2021-2022 groundfish harvest specifications and the public expects the regulations to be written as in the correction. These are minor corrections to correctly implement the Council's intent in their final action taken in June 2020.
NMFS is issuing this rule pursuant to 305(d) of the Magnuson-Stevens Act. In a previous action taken pursuant to section 304(b), the Council designed the Pacific Coast Groundfish Fishery Management Plan (FMP) to authorize NMFS to take this action pursuant to MSA section 305(d). See 50 CFR 660. The NMFS Assistant Administrator has determined that this final rule is consistent with the FMP and other applicable law.
Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator for Fisheries (AA) finds there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be unnecessary and contrary to public interest. Notice and comment are unnecessary and contrary to the public interest because this action corrects inadvertent errors related to the December 11, 2020 final rule (85 FR 79880). Immediate correction of the errors is necessary to prevent confusion among participants in the fishery due to conflicting gear restrictions and lack of waypoints to define boundary lines that could result in issues with enforcement. To effectively correct the errors, the changes in this action must be effective upon publication as the fishery has already begun. Thus, there is not sufficient time for notice and comment. In addition, notice and comment is unnecessary because this notice makes only minor changes to correct inadvertent errors related to the December 11, 2020 final rule (85 FR 79880). These corrections will not affect the results of analyses conducted to support management decisions in the Pacific Coast groundfish fishery. These corrections are consistent with the Council's intent for regulations and the public expects the regulations to be written as in the correction. No change in operating practices in the fishery is required.
For the same reasons stated above, the AA has determined good cause exists to waive the 30-day delay in effectiveness pursuant to 5 U.S.C. 553(d). This notice makes only minor corrections to the final rule which was effective January 1, 2021. Delaying effectiveness of these corrections would result in conflicts in the regulations and confusion among fishery participants. Because prior notice and an opportunity for public comment are not required to be provided for this rule by 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601
This final rule is not significant under Executive Order 12866.
This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
Fisheries, Fishing, and Indian fisheries.
For the reasons set out in the preamble, 50 CFR part 660 is corrected by making the following correcting amendments:
16 U.S.C. 1801
(a) * * *
(322) 32°34.22′ N lat., 117°21.20′ W long.
(d)
(10) * * *
(i) Fishing for “other flatfish” is permitted within the CCAs with hook and line gear only; and provided a valid declaration report as required at § 660.13(d), subpart C, has been filed with NMFS OLE.
(11) * * *
(iv) It is lawful to fish within the nontrawl RCA with limited entry fixed gear using hook and line gear only when trip limits authorize such fishing, and provided a valid declaration report as required at § 660.13(d), subpart C, has been filed with NMFS OLE.
(12)
(13)
(d)
(11) * * *
(i) Fishing for “other flatfish” is allowed within the CCAs with hook and line gear only; and provided a valid declaration report as required at § 660.13(d), has been filed with NMFS OLE.
(12) * * *
(iv) Fishing for “other flatfish” off California (between 42° N lat. south to the U.S./Mexico border) is allowed within the nontrawl RCA with hook and line gear only; and provided a valid declaration report as required at § 660.13(d), has been filed with NMFS OLE.
(14)
(15)
(c) * * *
(3) * * *
(i) * * *
(A) * * *
(
(
Federal Aviation Administration (FAA), DOT.
Notice of proposed special conditions.
This action proposes special conditions for the Boeing Commercial Airplanes (Boeing) Model 737-800 airplane. This airplane, as modified by Haeco Cabin Solutions (Haeco), will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is structure-mounted airbags designed to protect each occupant from serious head injury in the event of an emergency landing. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Send comments on or before April 15, 2021.
Send comments identified by Docket No. FAA-2021-0228 using any of the following methods:
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John Shelden, Human Machine Interface, AIR-626, Technical Innovation Policy Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3214; email
The substance of these special conditions has been subject to the notice and public comment procedure in several prior instances. Additionally, a delay in design approval would significantly affect the applicant's installation of the system on the airplane. Therefore, the FAA is shortening the public comment period to 30 days.
The FAA invites interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
The FAA will consider all comments received by the closing date for comments. The FAA may change these special conditions based on the comments received.
On September 1, 2020, Haeco applied for a supplemental type certificate for structure-mounted airbags in the Boeing Model 737-800 airplane. The Boeing Model 737-800 airplane, which is a derivative of the Boeing Model 737 airplane currently approved under Type Certificate No. A16WE, is a twin-engine, transport-category airplane with seating for 189 passengers and a maximum takeoff weight of 174,200 pounds.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Haeco must show that the Boeing Model 737-800 airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. A16WE or the applicable regulations in effect on the date of application for the
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 737-800 airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The Boeing Model 737-800 airplane will incorporate the following novel or unusual design features:
Airbags mounted to structure to prevent head injury.
Haeco proposes to install structure-mounted airbags instead of inflatable lap belts as a means to protect each occupant from serious injury in the event of an emergency landing, as required by § 25.562(c)(5), on 737-800 airplanes.
Such use of airbags to provide injury protection for the occupant is a novel or unusual feature for this airplane model, and the applicable airworthiness regulations do not contain adequate or appropriate airworthiness standards for these design features. Therefore, special conditions are needed to address requirements particular to installation of airbags in this manner.
Special conditions exist for airbags installed on seat belts, known as inflatable lap belts, which have been installed on transport airplane passenger seats. Structure-mounted airbags, although a novel design, were first introduced on Jetstream Aircraft Limited Model 4100 series airplanes, which resulted in issuance of Special Conditions 25-ANM-127 on May 14, 1997. These special conditions supplemented 14 CFR part 25 and, more specifically, §§ 25.562 and 25.785.
The structure-mounted airbag, similar to the inflatable lap belt, is designed to limit occupant forward excursion in the event of an emergency landing. These airbags will reduce the potential for serious injury, including reducing the head-injury criterion measurement defined in part 25. However, structure-mounted airbags function similarly as automotive airbags, where the airbag deploys from furniture located in front of the passenger, relative to the airplane's direction of flight, forming a barrier between the structure and occupant. Also, unlike the inflatable lap belt, the structure-mounted airbag does not move with the occupant. To account for out-of-position and brace-position occupants, the airbag is designed to conform to the curvature of the exposed structure in the head-strike zone.
Because the airbag system is essentially a single-use device, it could deploy under crash conditions that are not sufficiently so severe as to require the injury protection the airbag system provides. Because an actual crash is frequently composed of a series of impacts before the airplane comes to rest, a larger impact following the initial impact could render the airbag system unavailable. This potential situation does not exist with standard upper-torso restraints, which tend to provide continuous protection regardless of impact severity, or number of impacts, in a crash event. Therefore, the airbag system installation should be such that it provides protection, when it is required, by not expending its protection when it is not required. If the airbag deployment threshold is unnecessarily low, the airbag would need to continue to provide protection when an impact requiring protection occurs.
These proposed special conditions are based upon Special Conditions 25-605-SC for the Boeing Model 787-9 airplanes equipped with B/E Aerospace Super-Diamond model business-class passenger seats and associated furniture. Additionally, the special conditions address protection of the occupant's neck and spine for the structure-mounted airbag deployment. When using the HIC15 head-injury method for airbag impacts (calculated in accordance with 49 CFR 571.208) the neck and spine limits are included as part of the allowance. These additional conditions are based on special conditions issued previously on oblique seats. The proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the Boeing Model 737-800 airplane as modified by Haeco. Should Haeco apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A16WE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only a certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Boeing Model 737-800 airplanes, as modified by Haeco Cabin Solutions:
1. The applicant must demonstrate by test that the structure-mounted airbag will deploy and provide protection under crash conditions where it is necessary to prevent serious injury to a 50th percentile occupant, as specified in § 25.562. The means of protection must provide a consistent approach to energy absorption for a range of occupants, from a two-year-old child to a 95th percentile male. In addition, the following situations should be considered:
• The seat occupant is holding an infant.
• The seat occupant is a child in a child restraint device.
• The seat occupant is a child not using a child restraint device.
• The seat occupant is a pregnant woman.
Compliance with § 25.562(c)(5) is required, except that, if the ATD has no apparent contact with the seat/structure but has contact with an airbag, a head-
If a seat is installed aft of structure (
The seating system must protect the occupant from experiencing serious neck injury. The assessment of neck injury must be conducted with the airbag device activated, unless there is reason to also consider that the neck-injury potential would be higher for impacts below the airbag-device deployment threshold.
(1) The N
(2) In addition, peak F
(3) Rotation of the head about its vertical axis, relative to the torso, is limited to 105 degrees in either direction from forward-facing.
(4) The neck must not impact any surface that would produce concentrated loading on the neck.
Longitudinal tests conducted to measure the injury criteria above must be performed with the FAA Hybrid III ATD, as described in SAE 1999-01-1609, “A Lumbar Spine Modification to the Hybrid III ATD for Aircraft Seat Tests.” The tests must be conducted with an undeformed floor, at the most-critical yaw cases for injury, and with all lateral structural supports (
2. The structure-mounted airbag must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly.
3. The structure-mounted airbag system must not be susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings) likely to be experienced in service.
4. The applicant must demonstrate that an inadvertent deployment that could cause injury to a standing or sitting person is improbable. Inadvertent deployment must not cause injury to anyone who may be positioned close to the structure-mounted airbag (
5. Inadvertent deployment of the structure-mounted airbag during the most critical part of flight will either not cause a hazard to the airplane or is extremely improbable.
6. Deployment of the structure-mounted airbag must not introduce hazards or injury mechanisms to the seated occupant, including occupants in the brace position. Deployment of the structure-mounted airbag must also not result in injuries that could impede rapid exit from the airplane.
7. Effects of the deflection and deformation of the structure to which the airbag is attached must be taken into account when evaluating deployment and location of the inflated airbag. The effect of loads imposed by airbag deployment, or stowed components where applicable, must also be taken into account.
8. The applicant must demonstrate that the structure-mounted airbag, when deployed, does not impair access to the seatbelt- or harness-release means, and must not hinder evacuation. This will include consideration of adjacent seat places and the aisle.
9. The airbag, once deployed, must not adversely affect the emergency-lighting system, and must not block escape-path lighting to the extent that the light(s) no longer meet their intended function.
10. The structure-mounted airbag must not impede occupants' rapid exit from the airplane 10 seconds after its deployment.
11. Where structure-mounted airbag systems are installed in or close to passenger evacuation routes (other than for the passenger seat for which the airbag is installed), possibility of impact on emergency evacuation (
12. The airbag electronic system must be designed to be protected from lightning per § 25.1316(b), and high-intensity radiated fields per § 25.1317(c).
13. The structure-mounted airbag system must not contain or release hazardous quantities of gas or particulate matter into the cabin.
14. The structure-mounted airbag installation must be protected from the effects of fire such that no hazard to occupants will result.
15. The inflatable bag material must meet the 2.5-inches-per-minute horizontal flammability test defined in 14 CFR part 25, appendix F, part I, paragraph (a)(1)(iv).
16. The design of the structure-mounted airbag system must protect the mechanisms and controls from external contamination associated with that which could occur on or around passenger seating.
17. The structure-mounted airbag system must have a means to verify the integrity of the structure-mounted airbag activation system.
18. The applicant must provide installation limitations to ensure installation compatibility between the seat design and opposing monument or structure.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard is proposing to establish a temporary security zone encompassing certain waters of the North Atlantic Ocean. The security zone is necessary to prevent waterside threats
Comments and related material must be received by the Coast Guard on or before April 15, 2021.
You may submit comments identified by docket number USCG-2021-0115 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email LCDR Samuel M. Danus, Waterways Management Division, U.S. Coast Guard; 410-576-2519,
On February 17, 2021, the National Geospatial-Intelligence Agency (NGA) notified the Coast Guard that it will be conducting U.S. Government training and systems testing from 9 a.m. on April 25, 2021, through 10 p.m. on May 8, 2021. The training and testing will take place in two locations offshore of Ocean City, MD. The COTP Maryland-National Capital Region has determined that a security zone is needed for waterborne protection of the public, mitigation of potential terrorist acts, and the enhancing of public and maritime safety and security in order to safeguard life, property, and the environment on or near the navigable waters near Ocean City, MD.
The purpose of this rulemaking is to ensure the security of vessels and government equipment involved in this event by prohibiting vessels from entering the security zone. If a person or vessel has been granted permission to enter the zone, they must not enter waters within 1,000 yards of the on scene Coast Guard vessel or test equipment being used by Coast Guard personnel. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1232).
The COTP is proposing to establish a security zone from 9 a.m. on April 25, 2021, through 10 p.m. on May 8, 2021. The security zone will be enforced from 9 a.m. to 10 p.m. on April 25, 2021, and those same hours on April 26, 2021, April 27, 2021, April 28, 2021, April 29, 2021, April 30, 2021, May 1, 2021, May 2, 2021, May 3, 2021, May 4, 2021, May 5, 2021, May 6, 2021, May 7, 2021 and May 8, 2021. The security zone will cover all waters of the North Atlantic Ocean, from surface to bottom, encompassed by a line connecting the following points beginning at 38°23′56″ N, 074°48′06″ W, thence south to 38°21′40″ N, 074°48′33″ W, thence south to 38°17′54″ N, 074°49′57″ W, thence southwest to 38°15′04″ N, 074°51′44″ W, thence northwest to 38°18′52″ N, 074°54′24″ W, thence north to 38°22′55″ N, 074°52′44″ W, and northeast back to the beginning point. The zone is approximately 9.3 nautical miles in length and 3.6 nautical miles in width. If a person or vessel has been granted permission to enter the zone, they must not enter waters within 1,000 yards of the on scene Coast Guard vessel or test equipment being used by Coast Guard personnel.
The duration of the rule and enforcement of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the Coast Guard vessel and test equipment are being used. All vessels and persons must obtain permission from the COTP Maryland-National Capital Region or his designated representative before entering the security zone. Equipment testing operations may occur anywhere within the security zone during the enforcement periods. Vessels and persons will not be permitted to enter the security zone within 1,000 yards of the Coast Guard vessel or test equipment. While this 1,000 yards area lies within the security zone, its exact location within the security zone may change. The regulatory text we are proposing appears at the end of this document.
We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on location and duration of the security zone. This security zone will be enforced 182 hours over the course of a two week period. Vessels will be able to safely transit around the security zone, which impacts a small area of the North Atlantic Ocean, where vessel traffic is normally low. Additionally, the Coast Guard will make notifications to the maritime community via marine information broadcasts. The Coast Guard will update such notifications as necessary to keep the maritime community informed of the status of the security zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the security zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please call or email the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a security zone lasting only 182 total enforcement hours that will prohibit entry within a small portion of the North Atlantic Ocean. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. Comments we post to
Documents mentioned in this NPRM as being available in the docket, and public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) To seek permission to enter the security zone described in paragraph (a) of this section, contact the COTP or the COTP's representative by telephone at 410-576-2693 or on Marine Band Radio VHF-FM channel 16 (156.8 MHz). The Coast Guard vessel enforcing this section can be contacted on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Those in the security zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(3) A person or vessel operating in the security zone described in paragraph (a)(1) of this section must not enter waters within 1,000 yards of the on scene Coast Guard vessel or test equipment being used by Coast Guard personnel.
(d)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to rescind the federal implementation plan (FIP) that regulates emissions from the Navajo Generating Station (NGS), a coal-fired power plant that was located on the reservation lands of the Navajo Nation near Page, Arizona. NGS permanently ceased operations on November 18, 2019, and the Clean Air Act (CAA or “Act”) operating permit for this facility has expired.
Any comments on this proposal must arrive by April 15, 2021.
Submit your comments, identified by Docket ID number EPA-R09-OAR-2021-0018, at
Anita Lee, EPA Region IX, (415) 972-3958,
Throughout this document, “we,” “us,” and “our” refer to the EPA.
In this action, the EPA is proposing to rescind the FIP for NGS that we promulgated on October 3, 1991 (“1991 FIP”), March 5, 2010 (“2010 FIP”), and August 8, 2014 (“2014 FIP”).
NGS was a coal-fired power plant that ceased operation in 2019, located on the reservation lands of the Navajo Nation, just east of Page, Arizona, and approximately 135 miles north of Flagstaff. NGS was co-owned by several entities and operated by Salt River Project Agricultural Improvement and Power District (“SRP”).
The area around NGS is designated attainment, unclassifiable/attainment, or unclassifiable for all criteria pollutants under the Act.
When the CAA was amended in 1990, Congress included a new provision, section 301(d), granting the EPA authority to treat tribes in the same manner as states where appropriate.
In the preambles to the proposed and final 1998 TAR, the EPA generally discussed the legal basis in the CAA that authorizes the EPA to regulate sources of air pollution in Indian country.
On December 2, 1980, EPA issued regulations addressing visibility impairment that is traceable or “reasonably attributable” to a single source or small group of sources.
In 1989, based on a report submitted by the National Park Service, the EPA proposed to find that a portion of the visibility impairment in Grand Canyon National Park was reasonably attributable to NGS.
On September 8, 1999, the EPA proposed a source-specific FIP for NGS.
The EPA published a new proposed rule to promulgate federally enforceable numerical emissions limitations for PM and SO
On August 8, 2014, the EPA promulgated a final rule that established emissions limitations for NO
In 2017, due to the changing economics of the energy industry, the owners of NGS voted to permanently close the facility at the end of 2019.
On December 18, 2020, the Navajo Nation EPA notified SRP that effective December 1, 2020, expiration of the title V permit terminated the ability of NGS to be operated.
In its rescission request, SRP stated that since ceasing operations all equipment permitted to operate under the title V permit, which includes all equipment subject to the NGS FIP, are non-operational and in the process of being removed. In addition, electrical and mechanical equipment had been removed, preventing the combustion of fuel and equipment operation and eliminating sources of air pollutant emissions from the permitted equipment. The Kayenta Mine, which supplied coal to NGS, has permanently closed, and the dedicated rail line linking the mine to NGS has been dismantled. In addition, the three 775-foot stacks at NGS have been demolished.
Because NGS has permanently ceased operation and all equipment subject to the NGS FIP is no longer operational, and because the facility no longer holds a valid CAA title V permit to operate, the EPA is proposing to rescind the FIP for NGS at 40 CFR 52.145(d) and 40 CFR 49.5513.
The provisions of the 1991 FIP at 40 CFR 52.145(d) applied to the fossil fuel-fired steam-generating units designated as Units 1, 2, and 3, and NGS and addressed emissions limitations for SO
Under 110(l) of the CAA, the EPA shall not approve a revision of an implementation plan if the revision would interfere with any applicable requirements concerning attainment, reasonable further progress, or any other applicable requirement of the CAA. Although this provision does not apply directly to the EPA's revision or rescission of a FIP, we have nonetheless considered whether rescission of the NGS FIP would interfere with any CAA requirements.
The 1991 FIP established emissions limitations for SO
The provisions of the 2010 FIP at 40 CFR 49.5513(a) through (i) apply to Units 1, 2, and 3, equipment associated with coal and ash handling, and the two auxiliary steam boilers at NGS, and established emissions limitations and associated continuous monitoring, testing and reporting requirements for SO
Because NGS has permanently ceased operation, the air pollutants regulated under the 2010 FIP are no longer emitted from the facility, and the facility no longer operates the coal handling and storage equipment or the fly ash handling and storage equipment. Therefore, the provisions of the 2010 FIP that regulate emissions of air pollutants from NGS are no longer necessary to satisfy any CAA requirements related to regional haze and visibility protection. In addition, the area surrounding NGS is designated attainment, unclassifiable/attainment, or unclassifiable for all NAAQS, therefore, the provisions of the 2010 FIP are not needed to satisfy requirements concerning attainment or reasonable further progress. The ambient monitors at the Glen Canyon Dam are operated by SRP and are not relied upon by any state, local or tribal agency to satisfy the minimum monitoring requirements in 40 CFR part 58. Furthermore, data from the monitors are not reported to the EPA's Air Quality System. For these reasons, we propose to determine that the 2010 FIP, including the provisions
The provision of the 2014 FIP at 40 CFR 49.5513(j) were promulgated to satisfy the BART requirements of the CAA and the Regional Haze Rule and established emissions limitations for NO
As described above, the EPA is proposing the rescind the NGS FIP from 40 CFR 52.145(d) and 40 CFR 49.5513. The EPA solicits comments on this proposed FIP rescission and will accept comments until April 15, 2021.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget for review. This proposed rule applies to only one facility and is therefore not a rulemaking of general applicability.
This action does not impose an information collection burden under the PRA because this action does not contain any information collection activities.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications, as specified in Executive Order 13175. The Navajo Generating Station is located on the reservation lands of the Navajo Nation, and the EPA recognizes there is significant community and tribal interest in this facility. The facility has already permanently ceased operations and this action simply proposes to rescind previously promulgated requirements applicable to this shuttered facility. In addition, the Navajo Nation EPA has already determined that NGS no longer has the right to operate. This proposed action to rescind the NGS FIP will not have substantial direct effects on any Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes. Thus, Executive Order 13175 does not apply to this action. However, on January 7, 2021, we invited the Navajo Nation to consult on this proposed action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. The facility has already permanently ceased operations and this action simply proposes to rescind previously promulgated requirements applicable to this shuttered facility. Therefore, the EPA considers this proposed action to rescind the NGS FIP to have no impacts to human health and the environment, and to have no potential disproportionately high and adverse effects on minority, low-income, or indigenous populations.
Administrative practice and procedure, Air pollution control, Environmental protection, Incorporation by reference, Indians, Intergovernmental relations, Reporting and recordkeeping requirements.
Air pollution control, Environmental protection, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements, Visibility.
For the reasons stated in the preamble, the Environmental Protection Agency proposes to amend chapter I, title 40, of the Code of Federal Regulations as follows:
42 U.S.C. 7401,
42 U.S.C. 7401,
Environmental Protection Agency (EPA).
Proposed rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is proposing to approve a revision to the Texas State Implementation Plan (SIP) that pertains to the Texas Diesel Emissions Reduction Incentive Program, submitted on August 13, 2020.
Written comments must be received on or before April 15, 2021.
Submit your comments, identified by Docket No. EPA-R06-OAR-2020-0713, at
Carl Young, EPA Region 6 Office, Infrastructure and Ozone Section, 214-665-6645,
Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.
Section 110 of the CAA requires states to develop and submit to the EPA a SIP to ensure that state air quality meets National Ambient Air Quality Standards (NAAQS). These ambient standards currently address six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. The EPA approved SIP regulations and control strategies are federally enforceable.
An Economic Incentive Program (EIP) is a program that uses market-based strategies to reduce emissions of air pollutants.
In 2019 the Texas Legislature revised the eligibility requirements for DERIP. As a result, the Texas Commission on Environmental Quality (TCEQ) revised the DERIP regulations found in Title 30, Chapter 114 (Control of Air Pollution from Motor Vehicles) of the Texas Administrative Code (30 TAC 114). The revisions were adopted on June 10, 2020 and submitted to the EPA as a SIP revision on August 13, 2020. Specifically, the TCEQ revisions: (1) Changed the minimum required usage for grant-funded vehicles and equipment in the eligible area from 75% to 55% (30 TAC 114.622), and (2) removed Victoria County from the list of counties eligible for DERIP grants (30 TAC 114.629). A copy of the SIP revision submitted to EPA is available in the electronic docket for this action.
We approved DERIP regulations into the Texas SIP in 2005 (70 FR 48647, August 19, 2005). More recently, we approved updates to DERIP regulations in 2018 (83 FR 50018, October 4, 2018). This SIP revision further updates DERIP regulations. The effect of this update is to: (1) Allow more diesel vehicles and equipment in nonattainment areas or
Section 110(l) of the CAA requires that EPA shall not approve a SIP revision if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in Section 171 of the CAA) or any other applicable requirements of the CAA. DERIP is a voluntary incentive program for reducing emissions and is not a requirement of the Act. The inclusion of DERIP in the SIP, therefore, is discretionary and as such, revisions can be made as long as they do not contribute to nonattainment or interfere with maintenance. Reductions from the TERP program were part of the emission reductions in SIP revisions relied upon to provide for attainment of (1) the 1997 ozone standard in the Dallas-Fort Worth area (70 FR 15592, March 28, 2005) and (2) the 1-hour ozone standard in the Houston-Galveston-Brazoria area (71 FR 52670, September 6, 2006). The reductions relied upon in these plans have long been achieved through grants and rebates that have already been issued and none of the subsequent ozone attainment plans submitted by the State have relied upon reductions from the TERP or DERIP programs. However, the State could use DERIP as a tool in future SIP revisions to obtain needed emission reductions.
As noted above, revisions to 30 TAC 114.622 changed the amount of time equipment needs to operate in the affected counties. This change will provide for an increase in the pool of vehicles and equipment eligible for this program and potentially generate more emission reductions through future state grants. Some of these reductions, however, will likely be outside of designated nonattainment areas. As Texas is not relying on emission reductions from future DERIP grants, it is not necessary for the reductions to occur exactly in an affected nonattainment area.
As stated previously, DERIP and TERP are not mandated by the Clean Air Act. The implementation of these programs is discretionary. The Texas legislature originally adopted the programs to apply in nonattainment areas and other affected areas deemed near-nonattainment areas. None of the reductions that will be achieved by these programs going forward are being relied upon in any plan for any affected area in Texas. The Texas legislature decided that it no longer should implement the program in Victoria County which is meeting all current NAAQS. Not providing grants to reduce emissions from diesel equipment will not cause emissions to increase in Victoria county. Instead emissions in the county will not be impacted by this SIP revision. Therefore, approval of the revision to 30 TAC 114.629 will not contribute to nonattainment or interfere with maintenance in Victoria County. As more diesel equipment become eligible, the concentration of the DERIP program in nonattainment areas will likely result in additional emission reductions. As additional grants are issued to reduce emissions from diesel equipment, the air quality will benefit, which will assist in maintenance and attainment of the NAAQS. Therefore, the proposed approval of the SIP revision is consistent with the CAA section 110(1). Also, because the program is discretionary, it will not interfere with any applicable requirement for attainment and reasonable further progress, or any other applicable requirement of the CAA. Because the revised program will continue to achieve additional reductions not relied upon by any plan for attainment or maintenance, the revisions will not contribute to nonattainment or interfere with maintenance.
We are proposing to approve the revisions to 30 TAC 114.622 and 114.629 adopted on June 10, 2020 and submitted on August 13, 2020.
In this action, we are proposing to include in a final rule regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are proposing to incorporate by reference revisions to the Texas regulations as described in the Proposed Action section above. We have made, and will continue to make, these documents generally available electronically through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
In accordance with the January 21, 2021, Executive Order entitled “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis” and other Biden-Harris Administration Executive orders and other direction, the Environmental Protection Agency (EPA) is requesting additional public comments on five final rules recently issued under the Toxic Substances Control Act (TSCA). On January 6, 2021, EPA issued final rules to address its obligations under TSCA for five persistent, bioaccumulative, and toxic (PBT) chemicals that EPA determined met the criteria for expedited action under TSCA. These chemicals are 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (CASRN 732-26-3); decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5); phenol, isopropylated phosphate (3:1) (PIP (3:1)) (CASRN 68937-41-7); pentachlorothiophenol (PCTP) (CASRN 133-49-3); and hexachlorobutadiene (HCBD) (CASRN 87-68-3). PBT chemicals are of particular concern in the Agency's efforts to protect human health and the environment because they are toxic and remain in the environment for long periods of time and can build up or accumulate in the body. As a first step in its efforts to immediately review these rules to determine whether they are consistent with the Administration policy to limit exposure to dangerous chemicals (and to determine whether and how these rules should be revised), EPA invites public comment on the final rules, including whether there are further exposure reductions that could be achieved, including exposure reductions for potentially exposed or susceptible subpopulations and the environment; implementation issues associated with these final rules; and whether to consider additional or alternative measures or approaches. In particular, EPA is seeking comment on specifics of recently raised issues regarding the compliance date for the prohibition on the processing and distribution of PIP (3:1) for use in articles, and PIP (3:1)-containing articles.
Comments must be received on or before May 17, 2021.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0202, through the Federal eRulemaking Portal at
Please note that due to the public health emergency the EPA Docket Center (EPA/DC) and Reading Room were closed to public visitors on March 31, 2020. Our EPA/DC staff will continue to provide customer service via email, phone, and webform. For further information on EPA/DC services, docket contact information and the current status of the EPA/DC and Reading Room, please visit
This document is directed to the public in general and may be of interest to persons who currently or may manufacture (including import), process, distribute, use, and/or dispose of the five PBT chemicals: 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (CASRN 732-26-3); decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5); phenol, isopropylated phosphate (3:1) (PIP (3:1)) (CASRN 68937-41-7); pentachlorothiophenol (PCTP) (CASRN 133-49-3); and hexachlorobutadiene (HCBD) (CASRN 87-68-3). The action may also be of interest to persons who currently or may manufacture (including import), process, distribute, use, and/or dispose of products and articles containing these PBT chemicals. Non-governmental organizations in the environmental and public health sectors, state and local government agencies, and members of the public may also be interested in this action. Since other entities may also be interested, EPA has not attempted to describe all the specific entities that may be affected by this action.
EPA issued the final rules under TSCA section 6(h), 15 U.S.C. 2601
EPA is inviting public comment on the provisions of the final rules. The Agency is broadly re-examining TSCA section 6(h) requirements and other provisions of amended TSCA, including determining how the new Executive orders and other direction provided by the Biden-Harris Administration (Refs. 9-13) will be addressed, as well as new information received from stakeholders. As part of this process, EPA will review and consider revising the final PBT rules with an eye towards reducing exposure to the extent practicable, environmental justice, scientific integrity, and EPA's mission of protecting human health and the environment, taking into consideration information received while the rules were under development as well as any new information submitted since the rules were finalized and information received in response to this document. EPA is also aware of and plans to consider revisions in response to implementation issues that have been raised by a range of stakeholders. In particular, EPA is seeking comment on newly-raised issues associated with the March 8, 2021, compliance date in the PIP (3:1) rule for certain regulated articles.
1.
2.
This unit provides a summary of the five TSCA section 6(h) final rules that published in the
Uses of 2,4,6-TTBP may be grouped into four general categories: (1) Domestic manufacture and use as an intermediate/reactant in processing at chemical facilities; (2) use in formulations and mixtures for fuel treatment in refineries and fuel facilities; (3) use in formulations intended for the maintenance or repair of motor vehicles and machinery at small commercial operations and for retail sale, and (4) use in formulations and mixtures for liquid lubricant and grease additives/antioxidants additives. 2,4,6-TTBP is toxic to aquatic plants, aquatic invertebrates, and fish. Surveyed animal data indicate the potential for liver and developmental effects. The final rule for 2,4,6-TTBP (Ref. 4) prohibits the distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP at concentrations above 0.3% by weight in any container with a volume of less than 35 gallons in order to minimize the use of 2,4,6-TTBP as a fuel additive or fuel injector cleaner by consumers and small commercial operations (
DecaBDE (Ref. 5) is used as an additive flame retardant in plastic enclosures for televisions, computers, audio and video equipment, textiles and upholstered articles, wire and cables for communication and electronic equipment, and other applications. DecaBDE is also used as a flame retardant for multiple applications for aerospace and automotive vehicles, including replacement parts for aircraft and cars. DecaBDE is toxic to aquatic invertebrates, fish, and terrestrial invertebrates. Data indicate the potential for developmental, neurological, and immunological effects, general developmental toxicity, liver effects, and carcinogenicity. The final rule for decaBDE (Ref. 5) prohibits the manufacture (including import) and processing of decaBDE, and products and articles containing decaBDE, as of March 8, 2021. Distribution in commerce of products and articles to which decaBDE has been added is prohibited as of January 6, 2022. Different compliance dates or exclusions include:
• Manufacture, processing, and distribution in commerce for use in curtains in the hospitality industry after July 6, 2022;
• Processing and distribution in commerce for use in wire and cable insulation in nuclear power generation facilities after January 6, 2023;
• Manufacture, processing, and distribution in commerce for use in parts for new aerospace vehicles after January 8, 2024;
• Manufacture, processing, and distribution in commerce for use in replacement parts for aerospace vehicles until the end of the vehicles' service lives;
• Manufacture, processing, and distribution in commerce for use in replacement parts for motor vehicles until the end of the vehicles' service lives or 2036, whichever is earlier;
• Distribution in commerce of plastic shipping pallets manufactured prior to the publication of the final rule that contain decaBDE until the end of the pallets service lives; and
• Processing and distribution in commerce for recycling of plastic that contained decaBDE before the plastic was recycled, and the articles and products made from such recycled plastic so long as no new decaBDE is added during the recycling or production process.
PIP (3:1) (Ref. 6) is used as a plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive in hydraulic fluid, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants, and plastic articles. PIP (3:1) is toxic to aquatic plants, aquatic invertebrates, sediment invertebrates and fish. Data indicate the potential for reproductive and developmental effects, neurological effects and effects on systemic organs,
• Use in photographic printing articles after January 1, 2022;
• Use in aviation hydraulic fluid in hydraulic systems and use in specialty hydraulic fluids for military applications;
• Use in lubricants and greases;
• Use in new and replacement parts for the aerospace and automotive industries;
• Use as an intermediate in the manufacture of cyanoacrylate glue;
• Use in specialized engine air filters for locomotive and marine applications;
• Use in sealants and adhesives after January 6, 2025; and
• Recycling of plastic that contained PIP (3:1) before the plastic was recycled, and the articles and products made from such recycled plastic, so long as no new PIP (3:1) is added during the recycling or production process.
In addition, the final rule requires manufacturers, processors, and distributors of PIP (3:1) and products containing PIP (3:1) to notify their customers of these restrictions. Finally, the rule prohibits releases to water from the remaining manufacturing, processing, and distribution in commerce activities, and requires commercial users of PIP (3:1) and PIP (3:1)-containing products to follow existing regulations and best practices to prevent releases to water during use.
PCTP was used in rubber manufacturing as a peptizer, or a chemical that makes rubber more amenable to processing. Although it is likely that PCTP is no longer used as a peptizer, it can be found as an impurity in the zinc salt of PCTP (zinc PCTP) (CASRN 117-97-5) after zinc PCTP manufacturing. PCTP is toxic to protozoa, fish, terrestrial plants, and birds. Data for analogous chemicals (pentachloronitrobenzene and hexachlorobenzene) indicate the potential for liver and reproductive effects. However, no animal or human hazard data has been identified. The final rule for PCTP (Ref. 7) prohibits all manufacturing (including import) and processing of PCTP, and products or articles containing PCTP, unless PCTP concentrations are at or below 1% by weight. A prohibition on the distribution in commerce of PCTP or PCTP-containing products or articles, unless PCTP concentrations are at or below 1% by weight, will take effect on January 6, 2022.
HCBD is a halogenated aliphatic hydrocarbon that is produced as an unintentional byproduct during the manufacture of chlorinated hydrocarbons, particularly perchloroethylene, trichloroethylene, and carbon tetrachloride, and is subsequently burned as a waste fuel. HCBD is toxic to aquatic invertebrates, fish, and birds, and has been identified as a possible human carcinogen. Data indicate the potential for renal, reproductive, and developmental effects. The final rule for HCBD (Ref. 8) prohibits the manufacture (including import), processing, and distribution in commerce of HCBD and HCBD-containing products or articles, except for the unintentional production of HCBD as a byproduct during the production of chlorinated solvents, and the processing and distribution in commerce of HCBD for burning as a waste fuel.
During the comment period, the public may submit comments and information relevant to any aspect of the final PBT rules. The public is encouraged to provide comments and information relating to EPA's statutory obligations under TSCA section 6(h) and the extent to which there are further exposure reductions that could be achieved, including exposure reductions for potentially exposed or susceptible subpopulations and the environment. EPA is particularly interested in information relating to the impacts of the final rules on human health, including potentially exposed or susceptible subpopulations, and the environment. EPA is also requesting comment on implementation issues associated with these final rules. EPA specifically invites public comment on additional measures or approaches that EPA could take in addition to the provisions in the final rules.
In particular, EPA is seeking comment on newly-raised issues associated with the March 8, 2021 compliance date in the PIP (3:1) rule for certain regulated articles. Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature. Stakeholders note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging. They assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles. It was clearly not EPA's intent during the development of the rule to have such a broad disruptive impact. Nonetheless, compliance deadlines for the PBT rules must be in place “as soon as practicable” and provide reasonable transition periods, pursuant to the requirements of TSCA section 6(d)(1). Thus, for EPA to amend the existing deadline, the Agency needs additional information regarding the impact of the deadline. EPA specifically asks commenters to specify the articles that need the alternative deadline; the basis for the alternative deadline, taking into consideration the reasons supporting alternative deadlines in the final rule already issued, such as the January 1, 2022, date for photographic printing articles and the January 6, 2025, date for adhesives and sealants, with supporting documentation; and the additional time needed for specific articles to clear channels of trade. EPA plans to address the compliance deadline in the PIP (3:1) rule as part of the broader re-examination of these rules and will take into account comments received during this comment period when deciding upon future action involving this matter. In the meantime, the Agency will exercise its enforcement discretion to not pursue enforcement actions for violations of the prohibitions on the processing and distribution of PIP (3:1) for use in articles, or articles containing PIP (3:1) for up to 180 days, while this review and agency action to address this matter are pending.
15 U.S.C. 2601
Federal Communications Commission.
Proposed rule; correction.
The Federal Communications Commission published a document in the
Andrew Manley,
In the
Federal Communications Commission, Office of the Secretary, 45 L Street NE, Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve counsel for petitioner as follows: Joan Stewart, Esq., Wiley Rein LLP, 1776 K Street NW, Washington, DC 20006.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Announcement of availability of fishery management plan amendment; request for comments.
NMFS announces that the Pacific Fishery Management Council has submitted Amendment 18 to the Coastal Pelagic Species Fishery Management Plan for review by the Secretary of Commerce. Amendment 18 would implement a rebuilding plan for the northern subpopulation of Pacific sardine, which NMFS declared overfished in June 2019. NMFS will consider public comments in deciding whether to approve, disapprove, or partially approve Amendment 18.
Comments on Amendment 18 must be received by May 17, 2021. Comments on the associated Environmental Assessment must be received by April 15, 2021.
You may submit comments on this document, identified by NOAA-NMFS-0008-2021, by the following electronic methods:
• The Pacific Fishery Management Council and NMFS prepared a draft excerpt of the Coastal Pelagic Species Fishery Management Plan as amended through Amendment 18, with notations showing how Amendment 18 would change the Fishery Management Plan, if approved. This draft can be viewed via the Federal eRulemaking Portal:
• The Pacific Fishery Management Council and NMFS prepared a draft Environmental Assessment for this action pursuant to the National Environmental Policy Act. This draft can be viewed on NMFS' website at
Lynn Massey, Sustainable Fisheries Division, NMFS, (562) 436-2462,
The coastal pelagic species (CPS) fishery in the U.S. exclusive economic zone off the West Coast is managed under the CPS Fishery Management Plan (FMP). The Pacific Fishery Management Council (Council) developed the CPS FMP pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801
The Magnuson-Stevens Act requires each regional fishery management council to submit any amendment to an FMP to NMFS for review and approval, disapproval, or partial approval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an amendment to an FMP, publish notification in the
NMFS declared the northern subpopulation of Pacific sardine (hereafter, Pacific sardine) overfished in June 2019. This determination was based on the results of an April 2019 stock assessment, which indicated that the biomass of Pacific sardine had dropped below the overfished threshold of 50,000 metric tons (mt) defined in the CPS FMP. NMFS notified the Council about the overfished declaration on July 9, 2019. The Magnuson-Stevens Act requires that NMFS and the Council prepare a rebuilding plan within 2 years of NMFS' overfished notification to the Council that specifies a rebuilding timeframe (
In September 2020, the Council recommended a rebuilding plan strategy to NMFS that would maintain the existing management framework for the Pacific sardine fishery. Under the rebuilding plan, the harvest control rules and other FMP provisions currently in place for Pacific sardine would be maintained. This includes the harvest guideline control rule, which requires that the primary directed fishery for Pacific sardine be closed when the biomass is at or below 150,000 mt and restrictions on incidental landings of Pacific sardine in other CPS fisheries, including an automatic reduction in allowable incidental landings when the biomass is below 50,000 mt. The rebuilding plan would also maintain the Council's annual harvest specifications process for Pacific sardine, such that an overfishing limit and acceptable biological catch are calculated annually based on an estimate of that year's biomass from annual stock assessments and their respective control rules in the FMP (that have been approved by the Scientific and Statistical Committee to prevent overfishing). In addition to the harvest control rules prescribed by the CPS FMP, the rebuilding plan would allow the Council to maintain their ability to annually adjust the incidental harvest percentages or other accountability measures for the various sectors based on new information from the previous year or changes in fishery dynamics, if necessary. Although this framework would maintain the current management strategy, this management strategy already severely restricts fishing and will continue to do so until the stock is rebuilt.
Current fishing mortality is not considered to be the primary constraining factor or rebuilding Pacific sardine. The primary directed fishery for Pacific sardine has been closed since 2015 when the stock's biomass dropped below the 150,000 mt threshold in the CPS FMP for allowing a primary directed fishery. This closure of the primary directed fishery, which took place 4 years prior to the stock dropping, drastically reduced catch of Pacific sardine and has kept harvest at very low levels since that time. As such, the contribution of this rebuilding plan to stock recovery would be additional to measures already in place via the CPS FMP and Council process that limit fishing mortality of Pacific sardine.
As described above, the Magnuson-Stevens Act specifies that the time period for rebuilding a fishery generally should not exceed 10 years unless the biology of the stock or environmental conditions dictate otherwise, as is the case for Pacific sardine. Pacific sardines are known for wide swings in population abundance, and studies show the species has long experienced boom-bust cycles even in the absence of fishing. Periods of low recruitment success driven by prevailing oceanographic conditions can lead to low population abundance over extended periods of time. Because environmental conditions represent the primary constraint on rebuilding Pacific sardine, the projected time for rebuilding, is 14 years (
Amendment 18 would expand Section 4.5 of the CPS FMP to include the proposed rebuilding plan for Pacific sardine. There are no implementing regulations associated with Amendment 18, therefore NMFS will not promulgate proposed and final rules to implement this amendment.
Public comments on Amendment 18 must be received by May 17, 2021. Public comments on the associated EA for Amendment 18 must be received by May 17, 2021. All comments received by the end of the comment period on Amendment 18 will be considered in the Secretary's decision to approve, disapprove, or partially approve this amendment. To be considered in this decision, comments must be received by close of business on the last day of the comment period; that does not mean postmarked or otherwise transmitted by that date. NMFS will respond to any substantive comments received by the end of the comment period on Amendment 18 in a subsequent
16 U.S.C. 1801
Office of the Chief Economist, U.S. Department of Agriculture.
Request for public comment.
On January 27, 2021, President Biden issued an Executive Order on Tackling the Climate Crisis at Home and Abroad. This Executive Order laid out a series of actions for Federal Agencies to take regarding climate change mitigation and resilience, including directing the Secretary of Agriculture to collect stakeholder input on a climate-smart agriculture and forestry strategy. As part of this process, the U.S. Department of Agriculture (USDA) is seeking input from the public to ensure that relevant information is considered. USDA is interested in your comments in response to the topics, categories and questions shown in the
Interested persons are invited to submit comments on or before 11:59 p.m. Eastern Time April 29, 2021.
Comments may be submitted online via the Federal eRulemaking Portal. Go to
William Hohenstein, Director, USDA Office of Energy and Environmental Policy, Phone: 202-720-0450; Email:
Through the Executive Order on Tackling the Climate Crisis at Home and Abroad, the U.S. Department of Agriculture (USDA) is being asked to seek public input regarding USDA's climate strategy. Part II Section 216(b) of this Executive Order directs the Secretary of Agriculture to, “collect input from Tribes, farmers, ranchers, forest owners, conservation groups, firefighters, and other stakeholders on how to best use Department of Agriculture programs, funding and financing capacities, and other authorities, and how to encourage the voluntary adoption of climate-smart agricultural and forestry practices that decrease wildfire risk fueled by climate change and result in additional, measurable, and verifiable carbon reductions and sequestration and that source sustainable bioproducts and fuels.” This public input will be considered as USDA prepares recommendations to expand climate-smart agriculture and forestry practices and systems. The feedback requested through this Executive Order is far-reaching; it encompasses the best use of USDA programs, funding and financing capabilities, authorities, and encouragement of voluntary conservation adoption.
USDA currently requests public comment on:
A. How should USDA utilize programs, funding and financing capacities, and other authorities, to encourage the voluntary adoption of climate-smart agricultural and forestry practices on working farms, ranches, and forest lands?
1. How can USDA leverage
2. What
B. How can partners and stakeholders, including State, local and Tribal governments and the private sector, work with USDA in advancing climate-smart agricultural and forestry practices?
C. How can USDA help support emerging markets for carbon and greenhouse gases where agriculture and forestry can supply carbon benefits?
D. What data, tools, and research are needed for USDA to effectively carry out climate-smart agriculture and forestry strategies?
E. How can USDA encourage the voluntary adoption of climate-smart agricultural and forestry practices in an efficient way, where the benefits accrue to producers?
A. How should USDA utilize programs, funding and financing capacities, and other authorities to encourage greater use of biofuels for transportation, sustainable bioproducts (including wood products), and renewable energy?
B. How can incorporating climate-smart agriculture and forestry into biofuel and bioproducts feedstock production systems support rural economies and green jobs?
C. How can USDA support adoption and production of other renewable energy technologies in rural America, such as renewable natural gas from livestock, biomass power, solar, and wind?
A. How should USDA utilize programs, funding and financing capacities, and other authorities to decrease wildfire risk fueled by climate change?
B. How can the various USDA agencies work more cohesively across programs to advance climate-smart forestry practices and reduce the risk of wildfire on all lands?
C. What additional data, tools and research are needed for USDA to effectively reduce wildfire risk and manage Federal lands for carbon?
D. What role should partners and stakeholders play, including State, local and Tribal governments, related to addressing wildfires?
A. How can USDA ensure that programs, funding and financing capacities, and other authorities used to advance climate-smart agriculture and forestry practices are available to all landowners, producers, and communities?
B. How can USDA provide technical assistance, outreach, and other assistance necessary to ensure that all
C. How can USDA ensure that programs, funding and financing capabilities, and other authorities related to climate-smart agriculture and forestry practices are implemented equitably?
Please provide information including citations and/or contact details for the correspondent when submitting comments to
Animal and Plant Health Inspection Service, USDA.
New information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request approval of a new information collection associated with the National Animal Health Monitoring System's On-Farm Monitoring of Antimicrobial Use and Resistance in U.S. Broiler Production Study.
We will consider all comments that we receive on or before May 17, 2021.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on the NAHMS On-Farm Monitoring of Antimicrobial Use and Resistance in U.S. Broiler Production Study, contact Mr. Bill Kelley, Assistant Director, Program Coordination and Implementation, Center for Epidemiology and Animal Health, VS, 2150 Centre Avenue, Building B, Fort Collins, CO 80524; (970) 494-7270. For information on the information collection process, contact Mr. Joseph Moxey, APHIS Information Collection Coordinator, at (301) 851-2483;
In connection with this mission, APHIS operates the National Animal Health Monitoring System (NAHMS), which collects on a national basis, statistically valid and scientifically sound data on the prevalence and economic importance of livestock, poultry, and aquaculture disease risk factors. APHIS is the only agency responsible for collecting data on livestock, poultry, and aquaculture health. NAHMS' studies have evolved into a collaborative industry and Government initiative to help determine the most effective means of preventing and controlling diseases of livestock, poultry, and aquaculture. Participation in any NAHMS study is voluntary, and all data are confidential.
APHIS plans to conduct the On-Farm Monitoring of Antimicrobial Use and Resistance in U.S. Broiler Production Study as part of an ongoing series of NAHMS studies on the U.S. livestock, poultry, and aquaculture populations. This study will support the following objectives: (1) Measure and track trends in antimicrobial use (AMU) and antimicrobial resistance (AMR) in broiler complexes within participating companies over time; (2) Evaluate the relationship between AMU patterns and AMR measured in select bacterial species collected; and (3) Quantify antimicrobial resistance genes in the litter of sampled broiler farms and examine the relationship between these quantities and antimicrobial use patterns.
This study is an information collection conducted by APHIS through a cooperative agreement with the University of Minnesota. The university completed previous work for APHIS under a different cooperative agreement in which APHIS received reports and completed analyses but not farm-level data. APHIS now seeks access to farm-level data that is presented in a manner in which the farms are not identified.
This study will monitor U.S. broiler operations for AMU, AMR, animal health and production practices, and the relationship between AMU, AMR, animal health, production practices, and changes over time. We will collect annual informed consent forms from producers, quarterly survey data, and litter samples from the same poultry complexes, and examine AMR in bacteria such as
APHIS and the University of Minnesota will analyze and organize the information into one or more descriptive reports and scientific manuscripts, and for important or special topics, APHIS will develop and disseminate targeted information sheets to producers, stakeholders, academicians, veterinarians, and any other interested parties. This information benefits the poultry industry by supplying scientific estimates of AMU and stewardship by poultry producers and evaluation of the influence of these and other management practices on AMR.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Census Bureau, Commerce.
Notice of information collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment on the reinstatement, without change, of Form BC-170, U.S. Census Employment Application and Form BC-171, Additional Applicant Information, prior to the submission of the information collection request (ICR) to OMB for approval.
To ensure consideration, comments regarding this proposed information collection must be received on or before May 17, 2021.
Interested persons are invited to submit written comments by email to Michael DeFrank, Chief, Management Services Branch at
Please reference Form BC-170, U.S. Census Employment Application and Form BC-171, Additional Applicant Information in the subject line of your comments. You may also submit comments, identified by Docket Number USBC-2021-0006, to the Federal e-Rulemaking Portal:
Requests for additional information or specific questions related to collection activities should be directed to Michael A. DeFrank, Chief, Management Services Branch. Mr. DeFrank can be reached by telephone on 301-763-2864 or by email at
The U.S. Census Bureau is requesting to continue to use Form BC-170, U.S. Census Employment Application and Form BC-171, Additional Applicant Information. There are no changes requested to these forms at this time.
The Census Bureau uses these forms to collect applicant information. Selecting officials use Form BC-170 as part of the recruitment, assessment, and selection process for potential field employees. The form was used for the Decennial Census and will continue to be used for Current/Permanent Surveys, upcoming Special Censuses as well as Decennial Census tests. Applicants applying for Current/Permanent Survey positions will submit a paper version of these forms at no cost to the applicant. An online version of these forms will be used for Special Censuses and Decennial Census tests.
In 2018, Form BC-171, Additional Applicant Information replaced Equal Employment Opportunity Commission (EEOC) common use from 3046-0046, Demographic Information on Applicants for Federal Employment to collect voluntary applicant data and is not used in the selection process.
The Census Bureau intends for applicants to access, complete, and submit both the BC-170 and BC-171 to human resources staff via an online applicant system for census jobs. The Census Bureau will continue to use a paper version of the BC-170 and BC-171 forms for applicants to complete and submit to the Regional Office for the Field Representative, Field Supervisor, and temporary clerical positions until an online version is available for this group of applicants. Lastly, the online version, paper forms and the online PDF format forms will be available in Spanish for Puerto Rico.
All interested applicants submit the forms as described above.
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include, or summarize, each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Zoetis Services, LLC (Zoetis) submitted a notification of proposed production activity to the FTZ Board for its facility in Lincoln, Nebraska. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on March 2, 2021.
The Zoetis facility is located within Subzone 59E. The facility is used for the production of pharmaceuticals for the animal pharmaceutical industry. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status material and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Zoetis from customs duty payments on the foreign-status components used in export production. On its domestic sales, for the foreign-status material noted below, Zoetis would be able to choose the duty rates during customs entry procedures that applies to Simparica® (Sarolaner) chewable tablets (duty-free). Zoetis would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The material sourced from abroad is sarolaner spray dried dispersion (duty rate 6.5%).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to:
A copy of the notification will be available for public inspection in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Christopher Wedderburn at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable March 16, 2021.
Joshua Tucker at (202) 482-2044 or Adam Simons at (202) 482-6172, AD/CVD Operations Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On February 1, 2021, the Department of Commerce (Commerce) initiated a countervailing duty (CVD) investigation of imports of pentafluoroethane (R-125) from the People's Republic of China (China).
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a CVD investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation if: (A) The petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily
On March 2, 2021, the petitioner
In accordance with 19 CFR 351.205(e), the petitioner has stated the reasons for requesting a postponement of the preliminary determination, and Commerce finds no compelling reason to deny the request. Therefore, in accordance with section 703(c)(1)(A) of the Act, Commerce is postponing the deadline for the preliminary determination to no later than 130 days after the date on which this investigation was initiated,
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Notice; correction.
The Department of Commerce (Commerce) published a notice in the
Samantha Kinney, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2285.
In the
This correction to the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
90-Day petition finding, request for information, and initiation of status review.
We, NMFS, announce a 90-day finding on a petition to list Southern Oregon and Northern California Coastal (SONCC) spring-run Chinook salmon (
Scientific and commercial information pertinent to the petitioned action must be received by May 17, 2021.
You may submit data and information relevant to our review of the status of Southern Oregon and Northern California Coastal spring-run Chinook salmon, identified by NOAA-NMFS-2020-0079, by either of the following methods:
•
•
Electronic copies of the petition and other materials are available from the NMFS website at
Gary Rule, NMFS West Coast Region, at
On May 4, 2020, the Secretary of Commerce received a petition from Richard K. Nawa (hereafter, the Petitioner) to identify SONCC spring-run Chinook salmon as a separate ESU and list the ESU as threatened or endangered under the ESA. Previously, in 1999, we identified the SONCC Chinook salmon ESU as including both spring-run and fall-run Chinook salmon and determined that the ESU did not warrant listing as threatened or endangered under the ESA (64 FR 50394; September 16, 1999). The Petitioner is requesting that SONCC spring-run Chinook salmon be considered as a separate ESU and listed as threatened or endangered. The Petitioner asserts that new research into the genomic basis for premature migration in salmonids demonstrates that significant genetic differences underlie the spring- and fall-run life history types, and that the unique evolutionary lineage of spring-run Chinook salmon warrants their listing as a separate ESU. The Petitioner also requests the designation of critical habitat for SONCC spring-run Chinook salmon concurrent with ESA listing. The petition includes an overview of new research into the genomic basis for premature migration in salmonids, as well as general biological information about SONCC spring-run Chinook salmon including their distribution and range, life history characteristics, habitat requirements, as well as basin-level population status and trends and factors contributing to the populations' status. Copies of the petition are available as described above (see
Section 4(b)(3)(A) of the ESA of 1973, as amended (16 U.S.C. 1531
Under the ESA, a listing determination may address a species, which is defined to also include subspecies and, for any vertebrate species, any distinct population segment (DPS) that interbreeds when mature (16 U.S.C. 1532(16)). In 1991, we issued the Policy on Applying the Definition of Species Under the Endangered Species Act to Pacific Salmon (ESU Policy; 56 FR 58612; November 20, 1991), which explains that Pacific salmon populations will be considered a DPS, and hence a “species” under the ESA, if it represents an “evolutionarily significant unit” of the biological species. The two criteria for delineating an ESU are: (1) It is substantially reproductively isolated from other conspecific populations, and (2) it represents an important component in the evolutionary legacy of the species. The ESU Policy was used to define the SONCC Chinook salmon ESU in 1999 (64 FR 50394; September 16, 1999), and we use it exclusively for defining distinct population segments of Pacific salmon. A joint NMFS-U.S. Fish and Wildlife Service (USFWS) (jointly, “the Services”) policy clarifies the Services' interpretation of the phrase “distinct population segment” for the purposes of listing, delisting, and reclassifying a species under the ESA (DPS Policy; 61 FR 4722; February 7, 1996). In announcing this policy, the Services indicated that the ESU Policy for Pacific salmon was consistent with the DPS Policy and that NMFS would continue to use the ESU Policy for Pacific salmon.
A species, subspecies, or DPS is “endangered” if it is in danger of extinction throughout all or a significant portion of its range, and “threatened” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range (ESA sections 3(6) and 3(20), respectively, 16 U.S.C. 1532(6) and (20)). Pursuant to the ESA and our implementing regulations, we determine whether species are threatened or endangered based on any one or a combination of the following five section 4(a)(1) factors: The present or threatened destruction, modification, or curtailment of habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; inadequacy of existing regulatory mechanisms to address identified threats; or any other natural or manmade factors affecting the species' existence (16 U.S.C. 1533(a)(1), 50 CFR 424.11(c)).
ESA-implementing regulations issued jointly by NMFS and USFWS (50 CFR 424.14(h)(1)(i)) define “substantial scientific or commercial information” in the context of reviewing a petition to list, delist, or reclassify a species as “credible scientific or commercial information in support of the petition's claims such that a reasonable person conducting an impartial scientific review would conclude that the action proposed in the petition may be warranted.” Conclusions drawn in the petition without the support of credible scientific or commercial information will not be considered “substantial information.” In reaching the initial (90-day) finding on the petition, we will consider the information described in sections 50 CFR 424.14(c), (d), and (g) (if applicable).
Our determination as to whether the petition provides substantial scientific or commercial information indicating that the petitioned action may be warranted will depend in part on the degree to which the petition includes the following types of information: (1) Information on current population status and trends and estimates of
If the petitioner provides supplemental information before the initial finding is made and states that it is part of the petition, the new information, along with the previously submitted information, is treated as a new petition that supersedes the original petition, and the statutory timeframes will begin when such supplemental information is received.
We may also consider information readily available at the time the determination is made. We are not required to consider any supporting materials cited by the petitioner if the petitioner does not provide electronic or hard copies, to the extent permitted by U.S. copyright law, or appropriate excerpts or quotations from those materials (
The “substantial scientific or commercial information” standard must be applied in light of any prior reviews or findings we have made on the listing status of the species that is the subject of the petition. Where we have already conducted a finding on, or review of, the listing status of that species (whether in response to a petition or on our own initiative), we will evaluate any petition received thereafter seeking to list, delist, or reclassify that species to determine whether a reasonable person conducting an impartial scientific review would conclude that the action proposed in the petition may be warranted despite the previous review or finding. Where the prior review resulted in a final agency action—such as a final listing determination, 90-day not-substantial finding, or 12-month not-warranted finding—a petitioned action will generally not be considered to present substantial scientific and commercial information indicating that the action may be warranted unless the petition provides new information or analyses not previously considered.
At the 90-day finding stage, we do not conduct additional research, and we do not solicit information from parties outside the agency to help us in evaluating the petition. We will accept the petitioner's sources and characterizations of the information presented if they appear to be based on accepted scientific principles, unless we have specific information in our files that indicates the petition's information is incorrect, unreliable, obsolete, or otherwise irrelevant to the requested action. Information that is susceptible to more than one interpretation or that is contradicted by other available information will not be dismissed at the 90-day finding stage, so long as it is reliable and a reasonable person conducting an impartial scientific review would conclude it supports the petitioner's assertions. In other words, conclusive information indicating that the species may meet the ESA's requirements for listing is not required to make a positive 90-day finding. We will not conclude that a lack of specific information alone necessitates a negative 90-day finding if a reasonable person conducting an impartial scientific review would conclude that the unknown information itself suggests the species may be at risk of extinction presently or within the foreseeable future.
To make a 90-day finding on a petition to list a species, we evaluate whether the petition presents substantial scientific or commercial information indicating the subject species may be either threatened or endangered, as defined by the ESA. First, we evaluate whether the information presented in the petition, in light of the information readily available in our files, indicates that the petitioned entity constitutes a “species” eligible for listing under the ESA. Next, we evaluate whether the information indicates that the species faces an extinction risk such that listing, delisting, or reclassification may be warranted; this may be indicated in information expressly discussing the species' status and trends, or in information describing impacts and threats to the species. We evaluate any information on specific demographic factors pertinent to evaluating extinction risk for the species (
Information presented on impacts or threats should be specific to the species and should reasonably suggest that one or more of these factors may be operative threats that act or have acted on the species to the point that it may warrant protection under the ESA. Broad statements about generalized threats to the species, or identification of factors that could negatively impact a species, alone, do not constitute substantial information indicating that listing may be warranted. We look for information indicating that not only is the particular species exposed to a factor, but that the species may be responding in a negative fashion; then we assess the potential significance of that negative response.
Many petitions identify risk classifications made by nongovernmental organizations, such as the International Union on the Conservation of Nature (IUCN), the American Fisheries Society, or NatureServe, as evidence of extinction risk for a species. Risk classifications by such organizations or made under other Federal or state statutes may be informative, but such classification alone may not provide the rationale for a positive 90-day finding under the ESA. For example, as explained by NatureServe, their assessments of a species' conservation status do “not constitute a recommendation by NatureServe for listing under the U.S. Endangered Species Act” because NatureServe assessments “have different criteria, evidence requirements, purposes and taxonomic coverage than government lists of endangered and threatened species, and therefore these two types of lists should not be expected to coincide” (
On September 16, 1999, following completion of a status review of west coast Chinook salmon (
The petition contains information and assertions in support of designating and listing the spring-run component of the SONCC Chinook salmon ESU as threatened or endangered under the ESA. As discussed above, based on biological, genetic, and ecological information compiled and reviewed as part of the previous status review of Chinook salmon (
The Petitioner asserts that spring-run Chinook salmon in the SONCC Chinook salmon ESU have been sufficiently isolated from fall-run Chinook salmon for evolutionarily important differences to have arisen and been maintained. The Petitioner presents new genetic evidence to suggest the SONCC spring-run Chinook salmon populations may qualify as a separate ESU from the fall-run populations. The Petitioner asserts that findings from recently published articles on the evolutionary basis of premature migration in Pacific salmon (Prince
The Petitioner also asserts that the Chinook salmon spring-run life history represents an important component of the evolutionary legacy of the species. In support of this assertion, the Petitioner describes specific ecological and evolutionary benefits of the life history variation provided by spring-run stocks within the SONCC Chinook salmon ESU. The Petitioner describes how spring-run Chinook salmon tend to spawn higher up in the watershed than fall-run and how this adds to the spatial distribution of the species. The Petitioner notes that the presence of spring-run Chinook salmon in the headwaters could protect SONCC Chinook salmon from large mortality events due to disease outbreaks, interspecific competition for food and habitat, warm temperatures and low flow regimes due to climate change, and temporal unfavorable conditions in the marine environment. The Petitioner asserts that diversity in run timing contributes to the resiliency and stability of salmon populations.
At the 90-day finding stage, we also consider information readily available in our files. We are currently processing another petition that cites the same scientific research in support of a request to identify and list a new coastal spring-run Chinook salmon ESU. On September 24, 2019, the Secretary of Commerce received a petition from the Native Fish Society, Center for Biological Diversity, and Umpqua Watersheds to identify Oregon Coast spring-run Chinook salmon as a separate ESU and list the ESU as threatened or endangered under the ESA. In the Oregon Coast spring-run Chinook salmon petition, the petitioners similarly asserted that findings from recently published articles on the evolutionary basis of premature migration in Pacific salmon (Prince
We have reviewed the new genetic information and the information presented by the Petitioner about the evolutionary legacy of spring-run Chinook salmon in the SONCC ESU. Based on information provided by the Petitioner, as well as information readily available in our files, we find that a reasonable person would conclude that SONCC spring-run Chinook salmon may qualify as an ESU pursuant to our ESU Policy.
The Petitioner asserts that spring-run Chinook salmon populations in the SONCC ESU have suffered significant declines in numbers from historical abundance. The Petitioner cited findings by Nicholas and Hankin (1989) that all spring-run Chinook salmon populations on the Oregon coast are smaller than fall-run populations and are depressed from historical population sizes. The Petitioner presents data from the Oregon Department of Fish and Wildlife (ODFW) that indicate a 25-year decline in abundance of spring-run Chinook salmon on the Rogue River (1981-2006) (ODFW 2019). During a 10-year period (1970-1979) that spans the
The Petitioner notes that following ODFW's adoption of the Rogue Spring Chinook Conservation Plan in 2007, the average annual abundance of natural-origin adult spring-run Chinook salmon increased from 7,596 to 9,663 in 2017. The Petitioner asserts that this increase of spring-run Chinook salmon in the Rogue River was likely a result of the removal of the Gold Hill, Savage Rapids, and Gold Ray dams, which allowed heterozygous and homozygous fall-run Chinook salmon to ascend upriver rapidly and spawn with homozygous spring-run Chinook. In the Final Rogue Spring Chinook Salmon Conservation Plan Comprehensive Assessment and Update, ODFW found that while the status of spring-run Chinook salmon improved over the past decade the ten year average is below the desired threshold of 15,000 naturally produced adult spring-run Chinook salmon returning to the Rogue River annually (ODFW, 2019). The Petitioner also calls attention to the Cole M. Rivers Hatchery and Genetic Management Plan that reports the smolt to adult return rate of Cole M. Rivers Hatchery spring-run Chinook salmon in the Rogue River has been below 1 percent since 2002 (ODFW, 2016). The Petitioner asserts that the smolt to adult return rate for natural fish is also likely low.
The Petitioner further asserts that the abundance of spring-run Chinook salmon in the Rogue River may actually be lower than reported. Hess
The Petitioner also calls attention to a declining trend in abundance of adult spring-run Chinook salmon in the Smith River. The Petitioner cites data from snorkel surveys of spring-run Chinook salmon in the South Fork, Middle Fork, and North Fork of the Smith River from 1982 to 2018 (Hanson, 2018). Hanson (2018) found that the number of adult spring-run Chinook salmon counted per mile (density) has been declining since survey counts peaked in 1996 at a density of 2.5 salmon per mile. Hanson (2018) reported that adult spring-run Chinook salmon densities have remained at less than 0.3 salmon per mile since 2007 (Hanson, 2018). The Petitioner asserts that this decline in spring-run Chinook salmon indicates that the population within the Smith River is threatened with extinction.
Based on information provided by the Petitioner, as well as information readily available in our files, we find that a reasonable person would conclude current demographic risks indicate that SONCC spring-run Chinook salmon populations may be at risk of extinction and thus warrant further investigation.
The Petitioner asserts that all five ESA section 4(a)(1) factors contribute to the need to list the SONCC spring-run Chinook salmon as a threatened or endangered ESU. Each of these factors is discussed in further detail below.
The Petitioner asserts that SONCC spring-run Chinook salmon face numerous threats to suitable habitat, including impacts from dams, logging practices, road building, and mining operations. The Army Corps of Engineers completed construction of William Jess Dam/Lost Creek Reservoir on the upper Rogue River in 1977. The Petitioner cites the Rogue Spring Chinook Salmon Conservation Plan Comprehensive Assessment and Update (ODFW, 2019) in support of their assertion that artificially enhanced summer stream flows from Lost Creek Reservoir are adversely affecting spring-run Chinook salmon. ODFW (2019) found that enhanced summer stream flows allow fall-run Chinook salmon to spawn upstream in habitat that historically was utilized primarily by spring-run Chinook salmon.
The Petitioner asserts that artificially augmented high flows in August and September in the Rogue River may reduce egg to fry survival of spring-run Chinook salmon. If spring-run Chinook salmon spawn during high river flows in September, redds may be dewatered and embryos desiccated when releases from the Lost Creek Reservoir decrease during the reservoir fill season, which begins in January (ODFW, 2019). ODFW (2019) states that egg to fry survival has likely decreased as a result of redds being dewatered.
The Petitioner also asserts that other anthropogenic disturbances have degraded spring-run Chinook salmon spawning habitat in the Rogue and Smith Rivers. Specifically, the Petitioner asserts that increased fine sediments due to logging, road building, and mining have adversely affected spawning habitat which is supported by similar conclusions in NMFS' 1997 final rule listing the SONCC coho salmon ESU under the ESA (62 FR 24588; May 6, 1997), describing habitat that is co-extensive with the range of SONCC spring-run Chinook salmon.
NMFS' most recent SONCC coho salmon status review (NMFS, 2016) evaluated the status of habitat threats over an area that includes the range of SONCC spring-run Chinook salmon and concluded that degraded habitat conditions in this area continue to be of concern, particularly with regard to insufficient instream flow, unsuitable water temperatures, and insufficient rearing habitat due to a lack of floodplain and channel structure. While restoration and regulatory actions have been made to improve freshwater and estuary habitat conditions in the SONCC coho salmon ESU, habitat concerns remain throughout the range of the ESU particularly in regards to water quality, water quantity, and rearing habitat.
Based on information provided by the Petitioner, as well as information readily available in our files, we find that a reasonable person would conclude that habitat destruction and curtailment of their range may pose a threat to the continued existence of SONCC spring-run Chinook salmon.
The Petitioner asserts that harvest of SONCC spring-run Chinook salmon for commercial and recreational fisheries in the ocean and freshwater may be a threat. The Petitioner notes that the fisheries off the coast of Oregon and California are not managed to minimize impacts on SONCC spring-run Chinook. The Petitioner notes that the Rogue
The Petitioner additionally summarizes the freshwater angling regulations put in place in 2008 to protect spring-run Chinook salmon from direct harvest in the Rogue River. The Petitioner does not provide an explanation for why freshwater angling regulations may be inadequate. ODFW (2019) states that from January through May, anglers may only keep adipose fin-clipped hatchery spring-run Chinook Salmon on the Rogue River. Wild harvest opens at various sections of the Rogue River after the early-run fish have passed. ODFW also states that the fishery does not open to wild harvest upstream of Dodge Bridge, where early-run fish occupy deep pools during the spring and summer. ODFW (2019) found that following implementation of the freshwater angling regulations, there were immediate reductions in freshwater harvest and increased spawner escapement (2008-2011). As a result, adult returns of naturally produced spring-run Chinook salmon began to improve in 2012. The Petitioner notes that while the estimated harvest rates of natural spring-run Chinook salmon are low, spring-run Chinook salmon are not meeting the escapement goal and homozygous spring-run Chinook salmon are likely declining.
Based on information provided by the Petitioner, as well as information readily available in our files, we find that there is inadequate information for a reasonable person to determine if overutilization poses a threat to the continued existence of SONCC spring-run Chinook salmon.
The Petitioner asserts that disease poses a risk to naturally produced spring-run Chinook in the Rogue River. ODFW (2019) found that under certain conditions disease, primarily caused by the bacterium
The Petitioner also asserts that hatchery produced coho salmon and steelhead prey upon natural origin spring-run Chinook salmon fry. Surveys conducted during 1979-81 indicated that both of these species prey upon the fry of spring-run Chinook salmon (ODFW, 2007). The Petitioner cites estimations made by Evenson
Based on information provided by the Petitioner, as well as information readily available in our files, we find that there is inadequate information for a reasonable person to determine if disease or predation pose a threat to the continued existence of SONCC spring-run Chinook salmon.
The Petitioner asserts that existing federal and state regulatory mechanisms are not sufficient to protect and recover SONCC spring-run Chinook salmon and their habitat. The Petitioner states that the Oregon Native Fish Conservation Policy, The Rogue Spring Chinook Salmon Conservation Plan, and the Coles M. Rivers Hatchery and Genetic Management Plan do not provide safeguards to stabilize or reverse increases in Chinook salmon heterozygous for run timing. The Petitioner asserts that insufficient measures have been taken to prevent the interbreeding between naturally produced spring-run Chinook salmon and hatchery produced spring-run Chinook salmon from the Cole M. Rivers Hatchery. The Petitioner further asserts that the Rogue Fall Chinook Conservation Plan (ODFW, 2007) does not adequately address the risks of interbreeding with spring-run fish as a result of artificially augmented summer flows (ODFW, 2013).
The Petitioner notes that spring-run Chinook salmon on the Rogue River are not listed as threatened or endangered under the Oregon state Endangered Species Act. The Petitioner asserts that while the Rogue Spring Chinook Species Management Unit/SONCC ESU is on the Oregon Sensitive Species List, the designation does not provide regulatory protection for SONCC Chinook salmon.
Consistent with the petition received to list an ESU of Oregon Coast spring-run Chinook salmon under the ESA, the Petitioner here asserts that the Oregon Forest Practices Act and Forest Practice Rules do not provide adequate habitat protections for spring-run Chinook salmon. For reasons previously described in the 90-day finding for that petition (85 FR 20476; April 13, 2020) the petitioner asserts that it is unlikely that the Oregon Forest Practices Act adequately protects the habitat of spring-run Chinook salmon in the Rogue River.
NMFS' most recent SONCC coho salmon status review (NMFS 2016) evaluated the inadequacy of existing regulatory mechanisms over an area in large part co-extensive with the range of SONCC spring-run Chinook salmon and concluded that the Oregon Forest Practices Act does not provide adequate protection for SONCC coho salmon. NMFS (2016) noted that particular areas of concern include: (1) Whether the widths of riparian management areas (RMAs) are sufficient to fully protect riparian functions and stream habitats; (2) whether operations allowed within RMAs will degrade stream habitats; (3) operations on high-risk landslide sites; and (4) watershed-scale effects. NMFS (2016) similarly expressed concerns
Based on information provided by the Petitioner, as well as information readily available in our files, we find that a reasonable person would conclude that the inadequacy of existing regulatory mechanisms may pose a threat to the continued existence of SONCC spring-run Chinook salmon.
The Petitioner asserts that the Cole M. Rivers Hatchery threatens the future viability of spring-run Chinook salmon in the Rogue River. The Petitioner asserts that operation of the Cole M. Rivers Hatchery poses a risk to natural origin spring-run Chinook salmon due to multiple factors including competition, predation, disease, and interbreeding. The Petitioner asserts that the release of an average of 1.6 million spring-run Chinook salmon annually from the Cole M. Rivers Hatchery results in increased competition between naturally produced spring-run Chinook salmon and the more abundant artificially produced salmonids. As previously mentioned the Petitioner asserts that hatchery produced coho salmon and steelhead prey upon natural origin spring-run Chinook salmon fry. The Petitioner further notes that the hatchery is a known source of disease in Chinook salmon. Amandi
The Petitioner also asserts that ongoing threats of poor ocean conditions and climate change are likely to threaten the continued existence of SONCC spring-run Chinook salmon. As described in NMFS' Oregon Coast Chinook salmon status reviews (NMFS, 2011; Stout
Based on information provided by the Petitioner, as well as information readily available in our files, we find that a reasonable person would conclude that hatcheries and climate change may pose threats to the continued existence of SONCC spring-run Chinook salmon.
After reviewing the information contained in the petition, as well as information readily available in our files, we conclude the petition presents substantial scientific information indicating that the petitioned action to delineate the SONCC spring-run Chinook salmon ESU and list it as threatened or endangered under the ESA may be warranted. Therefore, in accordance with section 4(b)(3)(A) of the ESA and NMFS' implementing regulations (50 CFR 424.14(h)(2)), we will commence a status review to determine whether the spring-run populations of SONCC Chinook salmon constitute an ESU, and, if so, whether that SONCC spring-run Chinook salmon ESU is in danger of extinction throughout all or a significant portion of its range, or likely to become so within the foreseeable future throughout all or a significant portion of its range. After the conclusion of the status review, we will make a finding as to whether listing the SONCC spring-run Chinook salmon ESU as endangered or threatened is warranted as required by section 4(b)(3)(B) of the ESA.
To ensure that our status review is informed by the best available scientific and commercial data, we are opening a 60-day public comment period to solicit information on spring-run Chinook salmon in the SONCC Chinook salmon ESU. We request information from the public, concerned governmental agencies, Native American tribes, the scientific community, agricultural and forestry groups, conservation groups, fishing groups, industry, or any other interested parties concerning the current and/or historical status of spring-run Chinook salmon in the SONCC Chinook salmon ESU. Specifically, we request information regarding: (1) Species abundance; (2) species productivity; (3) species distribution or population spatial structure; (4) patterns of phenotypic, genotypic, and life history diversity; (5) habitat conditions and associated limiting factors and threats; (6) ongoing or planned efforts to protect and restore the species and their habitats; (7) information on the adequacy of existing regulatory mechanisms, whether protections are being implemented, and whether they are proving effective in conserving the species; (8) data concerning the status and trends of identified limiting factors or threats; (9) information on targeted harvest (commercial and recreational) and bycatch of the species; (10) other new information, data, or corrections including, but not limited to, taxonomic or nomenclatural changes; and (11) information concerning the impacts of environmental variability and climate change on survival, recruitment, distribution, and/or extinction risk.
We request that all information be accompanied by: (1) Supporting documentation such as maps, bibliographic references, or reprints of pertinent publications; and (2) the submitter's name, address, and any association, institution, or business that the person represents.
A complete list of all references cited herein is available upon request (See
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting applications for fiscal year (FY) 2021 for American Indian Vocational Rehabilitation Training and Technical Assistance Center (AIVRTTAC)—Assistance Listing Number 84.250Z—to provide training and technical assistance (TA) to governing bodies of Indian Tribes that have received an American Indian Vocational Rehabilitation Services (AIVRS) grant.
For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the
Jerry Elliott, U.S. Department of Education, 400 Maryland Avenue SW, Room 5097, Potomac Center Plaza, Washington, DC 20202-2800. Telephone: (202) 245-7335. Email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
This priority is:
This priority funds a five-year cooperative agreement to establish an American Indian Vocational Rehabilitation Training and Technical Assistance Center (AIVRTTAC) to provide four types of training and technical assistance (TA) for the personnel of the American Indian Vocational Rehabilitation Services (AIVRS) projects awarded under section 121(a) of the Rehabilitation Act of 1973, as amended (Act), to the governing bodies of Indian Tribes and consortia of those governing bodies. The four types of training and TA are: (1) Intensive training and TA; (2) targeted training and TA; (3) universal training and TA; and (4) capacity-building for AIVRS project personnel through training modules that build foundational skills for the delivery of vocational rehabilitation (VR) services to AIVRS project participants. The AIVRTTAC will develop and provide these types of training and TA for AIVRS projects in the following topic areas:
(a) Applicable laws and regulations governing the AIVRS program.
(b) Promising practices for providing VR services to American Indians with disabilities.
(c) The delivery of VR services to American Indians with disabilities, including the determination of eligibility, case management, case record documentation, assessment, development of the individualized plan for employment, and placement into competitive integrated employment.
(d) Knowledge of assistive technology (AT), including the definition of AT, how to evaluate the need for AT and what types of AT are available, use of AT, and access to AT.
(e) Implementing professional development practices to ensure effective project coordination, administration, and management.
(f) Implementing appropriate financial and grant management practices to ensure compliance with OMB's Uniform Guidance (2 CFR part 200) and the Education Department General Administrative Regulations.
(g) Evaluating project performance, including data collection, data analysis, and reporting.
Specific subjects for training and TA in each of these topic areas will be identified on an annual basis and in coordination with RSA.
To be considered for funding under this priority, applicants must conduct the following activities, or a subset of the following activities as determined by the Department, in a culturally appropriate manner:
(a) Maintain and build upon the 12 training modules and the fiscal tool kit developed by the Tribal Vocational Rehabilitation Institute (the Institute) during Federal fiscal years (FFYs) 2015-2021, including maintaining the series of seven training modules that build foundational skills that, when satisfactorily completed, lead to a VR certificate to be awarded by the AIVRTTAC. To satisfy this activity requirement, the grantee—
(i) Must develop both academic and non-academic options for completing courses leading to the VR certificate, the requirements for obtaining a certificate including the specific requirements for academic credit for courses included in the certificate when applicable, and how the certificate may be used by the participants who earn it;
(ii) May offer the series of training modules in a traditional classroom setting, through distance learning, through week-long institutes, at regional trainings throughout the country as an extension of national conferences, and through other delivery methods, as appropriate, to meet the needs of the targeted audience;
(iii) May use grant funds to provide reasonable financial assistance for the cost of tuition, fees, and training materials and to offset costs associated with travel for participants who may be in remote areas of the country;
(iv) Must conduct an assessment before and after providing training for each participant in order to assess strengths and specific areas for improvement, educational attainment and application of skills, and any issues
(v) Must provide follow-up TA to participants to address any issues or challenges that are identified post-training and to ensure that the training they received is applied effectively in their work setting, and such follow-up may be conducted as part of the provision of targeted training and TA or intensive training and TA as determined by the needs of the specific AIVRS project;
(vi) Must conduct an evaluation to obtain feedback on the training and follow-up TA and to determine whether this training and TA contributed to increased employment outcomes for American Indians with disabilities;
(vii) Are encouraged to develop a path by which courses offered for academic credit lead to a degree in Rehabilitation or a related field; and
(viii) May develop additional training modules as negotiated through the cooperative agreement.
(b) Maintain and build upon the topics and tools the current AIVRRTAC has developed to provide intensive training and TA. To satisfy this activity requirement, the grantee must—
(i) Develop and provide intensive training and TA to a minimum of three AIVRS projects in the first year. For future years, the minimum number of AIVRS projects to receive intensive training and TA will be negotiated through the cooperative agreement;
(ii) Develop and implement training and TA consistent with AIVRS project activities and tailored to the specific needs and challenges of the AIVRS project receiving the intensive training and TA;
(iii) Provide training and TA under an agreement with each AIVRS project receiving intensive training and TA that, at a minimum, details the purpose of the training and TA, intended outcomes, and requirements for the subsequent evaluation of the training and TA; and
(iv) Assess the results of the training and TA 90 days after its completion to ensure that the recipient is able to apply effectively the training and TA, identify any issues or challenges in its implementation, and provide additional training and TA, either virtually or on-site, as needed.
(c) Maintain and build upon the topics and tools the current AIVRTTAC has developed to provide a range of targeted training and TA in the topic areas described in this priority based on needs common to multiple AIVRS projects. The grantee must follow up with the recipients of targeted training and TA it provides to determine the effectiveness of the training and TA;
(d) Maintain and build upon the topics and tools the current AIVRTTAC has developed to provide universal training and TA in the topic areas in this priority;
(e) Provide a minimum of two webinars or video conferences in each of the topic areas in this priority to describe and disseminate up-to-date information, guides, examples, and emerging and promising practices in each area;
(f) Develop new information technology (IT) platforms and systems, or modify existing platforms and systems, as follows:
(i) Develop or modify, and maintain, a state-of-the-art IT platform capable and reliable enough to support webinars, teleconferences, video conferences, and other virtual methods of dissemination of information and TA;
(ii) Develop or modify, and maintain, a state-of-the-art archiving and dissemination system that is open and available to all AIVRS projects and that provides a central location for all AIVRS training and TA products for later use, including course curricula, audiovisual materials, webinars, examples of promising practices related to the topic areas in this priority, the primary areas identified through the annual surveys completed by AIVRS projects, other topics identified by RSA, and other relevant TA products (the possibility of collaborating with the National Clearinghouse of Rehabilitation Training Materials will be considered with the grantee and included in the cooperative agreement, as appropriate);
(iii) Ensure that all products produced by the AIVRTTAC meet government and industry-recognized standards for accessibility; and
(iv) Ensure that all products, resources, and materials developed by the AIVRTTAC are widely disseminated across the AIVRS projects and reflect the AIVRS population and diversity among its communities to the maximum extent possible.
(g) Establish a community of practice (or communities of practice) that will serve as a vehicle for communication, an exchange of information among AIVRS projects, and a forum for sharing the results of training and TA projects that are in progress or have been completed;
(h) Conduct outreach to AIVRS projects so that they are aware of, and can participate in, training and TA activities; and
(i) Conduct an evaluation to determine the quality, relevance, and usefulness of the AIVRTTAC's training and TA, including the impact of the AIVRTTAC's activities on the ability of AIVRS projects to effectively manage their projects and improve the delivery of VR services to American Indians with disabilities.
To be funded under this priority, applicants must meet the project requirements in this priority. RSA encourages innovative approaches to meet these requirements, which are—
(a) Demonstrate in the narrative section of the application under “Significance of the Proposed Project” how the proposed project will—
(1) Use the applicant's knowledge and experience in the operation of AIVRS projects to provide training and TA for these projects;
(2) Address the AIVRS projects' capacity to effectively implement an AIVRS project. To meet this requirement, the applicant must—
(i) Demonstrate knowledge of emerging and promising practices in the topic areas in this priority;
(ii) Demonstrate knowledge of current RSA guidance and Federal initiatives designed to improve the functioning of grant projects in general and grant projects for American Indian Tribes in particular; and
(iii) Present information about the difficulties that AIVRS grantees have encountered in implementing effective AIVRS projects;
(b) Demonstrate in the narrative section of the application under “Quality of Project Design” how the proposed project will—
(1) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—
(i) Measurable intended project outcomes;
(ii) A plan for how the proposed project will achieve its intended outcomes;
(iii) A plan for communicating and coordinating with RSA and key personnel of AIVRS projects; and
(iv) A draft training module or outline for a targeted training and TA presentation or an outline for intensive training and TA activities for one of the topic areas in this priority to demonstrate how participants would be trained in that area. The module or outline is a required attachment in the application and must include, at a minimum, the following:
(A) The goals and objectives of this training module, targeted training and TA activity, or intensive training and TA activities;
(B) A specific list of what participants should know and be able to do as a
(C) Up-to-date resources, publications, applicable laws and regulations, and other materials that may be used to develop the module, targeted training and TA activity, or intensive training and TA activities;
(D) Exercises that will provide an opportunity for application of the subject matter;
(E) A description of how participant knowledge, skills, and abilities will be measured; and
(F) In the case of an intensive training and TA intervention, how the outcomes and impact of the intensive training and TA intervention will be measured;
(2) Use a logic model to develop project plans and activities that includes, at a minimum, the goals, activities, outputs, and outcomes of the proposed project;
(3) Be based on current research and make use of emerging and promising practices, and evidence-based practices, where available. To meet this requirement the applicant must describe—
(i) The current research on the emerging and promising practices in the topic areas in this priority; and
(ii) How the AIVRTTAC will incorporate current research and promising and evidence-based practices, including research about adult learning principles and implementation science, in the development and delivery of its products and services;
(4) Develop products and provide services that are of high quality and of sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement the applicant must describe—
(i) Its proposed approach to universal training and TA;
(ii) Its proposed approach to targeted training and TA, which must identify—
(A) The intended recipients of the products and services under this approach, including the categories of personnel that would be receiving the training and TA;
(B) Its proposed methods for providing targeted training and TA; and
(C) Its proposed methodology for determining topics for the targeted training and TA;
(iii) Its proposed approach to intensive training and TA, which must identify—
(A) Its proposed approach to identifying recipients for intensive training and TA;
(B) Its proposed methodology for providing intensive training and TA to recipients; and
(C) Its proposed approach to assessing the training and TA needs of recipients, including their ability to respond effectively to the training and TA; and
(iv) Its proposed approach to maintaining and building upon capacity-building modules, which must identify—
(A) Its proposed approach to maintaining the 12 training modules and the fiscal tool kit developed by the Institute in FFYs 2015-2021, including maintaining the series of seven training modules that build foundational skills that, when satisfactorily completed, lead to a VR certificate to be awarded by the grantee; and
(B) Its proposed approach to identifying, developing, and delivering new capacity-building modules; and
(5) Develop products and implement services to maximize the proposed project's efficiency. To address this requirement, the applicant must describe—
(i) How the proposed project will use technology to achieve the intended project outcomes;
(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration; and
(iii) In particular, how the proposed project will coordinate and collaborate with other RSA-funded technical assistance centers to exchange and adapt relevant products and materials to avoid duplication and make effective use of grant funds to better manage the AIVRTTAC project and its available resources to improve service delivery to AIVRS projects;
(c) Demonstrate in the narrative section of the application under “Adequacy of Project Resources” how—
(1) The applicant and any key partners possess adequate resources to carry out the proposed activities; and
(2) The proposed costs are reasonable in relation to the anticipated results and benefits;
(d) Demonstrate in the narrative section of the application under “Quality of Project Personnel” how—
(1) The proposed project will encourage applications for employment from persons who are members of groups that have historically been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate; and
(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to provide training and TA to AIVRS projects in each of the topic areas in this priority and to achieve the project's intended outcomes, including how the proposed project personnel have a high degree of knowledge and understanding of cultural factors that will be sufficient to ensure the delivery of training and TA in a culturally appropriate manner;
(e) Demonstrate in the narrative section of the application under “Quality of the Management Plan” how the proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—
(1) Clearly defined roles and responsibilities for at least two full-time key project personnel designated to the AIVRTTAC through the entire project period and for consultants and subcontractors, as applicable;
(2) Timelines and milestones for accomplishing the project tasks;
(3) Using a personnel loading chart, detailed project activities through the entire project period, key personnel and any consultants or subcontractors that will be allocated to each activity, and the designated level of effort for each of those activities;
(4) How the personnel allocations in the personnel loading chart are appropriate and adequate to achieve the project's intended outcomes, including an assurance that all personnel will communicate with stakeholders and RSA in a timely way;
(5) How the proposed management plan will ensure that the training and TA products developed through this cooperative agreement are complete, accurate, and of high quality; and
(6) How the proposed project will benefit from a diversity of perspectives, including AIVRS projects and consumers, State VR agencies, TA providers, and policy makers, in its development and operation; and
(f) Demonstrate in the narrative section of the application under “Quality of the Evaluation Plan” how the applicant proposes to collect and analyze data on specific and measurable goals, objectives, and intended outcomes of the project, including the effectiveness of the training and TA provided. To address this requirement, the applicant must describe—
(i) Its proposed evaluation methodologies, including instruments, data collection methods, and analyses;
(ii) Its proposed standards or targets for determining effectiveness;
(iii) How it will use the evaluation results to examine the effectiveness of its implementation and its progress toward achieving the intended outcomes; and
(iv) How the methods of evaluation will produce quantitative and qualitative data that demonstrate whether the project and individual training and TA activities achieved their intended outcomes.
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The Secretary considers the need for and significance of the proposed project. In determining the need for and significance of the proposed project, the Secretary considers the following factors:
(1) The magnitude of the need for the services to be provided or the activities to be carried out by the proposed project.
(2) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses.
(3) The potential contribution of the proposed project to increased knowledge or understanding of rehabilitation problems, issues, or effective strategies.
(4) The extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the needs of the target population.
(b)
The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers the following factors:
(1) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable.
(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs.
(3) The extent to which the proposed project will establish linkages with other appropriate agencies and organizations providing services to the target population.
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The Secretary considers the quality of the services to be provided by the proposed project. In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
In addition, the Secretary considers the following factors:
(1) The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services.
(2) The likely impact of the services to be provided by the proposed project on the intended recipients of those services.
(3) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.
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In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
In addition, the Secretary considers the qualifications, including relevant training and experience, of key project personnel.
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The Secretary considers the adequacy of resources for the proposed project. In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:
(1) The adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization or the lead applicant organization.
(2) The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project.
(3) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits.
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The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:
(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.
(2) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project.
(3) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.
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The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers the following factors:
(1) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project.
(2) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible.
(3) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.
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In addition, in making a competitive grant award, the Secretary requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
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Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
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(a) Selecting recipients most likely to be successful in delivering results based on the program objectives through an objective process of evaluating Federal award applications (2 CFR 200.205);
(b) Prohibiting the purchase of certain telecommunication and video surveillance services or equipment in alignment with section 889 of the National Defense Authorization Act of 2019 (Pub. L. 115—232) (2 CFR 200.216);
(c) Providing a preference, to the extent permitted by law, to maximize use of goods, products, and materials produced in the United States (2 CFR 200.322); and
(d) Terminating agreements in whole or in part to the greatest extent authorized by law if an award no longer effectuates the program goals or agency priorities (2 CFR 200.340).
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If your application is not evaluated or not selected for funding, we notify you.
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We reference the regulations outlining the terms and conditions of an award in the
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(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
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For the purposes of GPRA and Department reporting under 34 CFR 75.110, we have established the following performance measures for this program:
(a) Of all AIVRS project staff, the number and percentage of AIVRS project staff that complete at least on personnel preparation class offered by the AIVRTTAC.
(b) Of all AIVRS projects, the number and percentage of AIVRS projects that have at least one staff member that has completed at least one personnel preparation class offered by the AIVRTTAC.
(c) Of all AIVRS project staff, the number and percentage of AIVRS project staff that receive a certificate based on classes offered by the AIVRTTAC.
(d) Of AIVRS projects that received intensive training and technical assistance, the number and percentage of AIVRS projects that completed all activities in the intensive TA agreement.
(e) Of AIVRS projects that received intensive training and technical assistance, the number and percentage of AIVRS projects that show an increase in consumers achieving an employment outcome compared to the prior year.
(f) Of AIVRS projects that received intensive training and technical assistance, the number and percentage of AIVRS projects that show an increase in consumers receiving services under an IPE compared to the prior year.
Applicable short-term and long-term indicators and targets will be specified in the AIVRTTAC cooperative agreement.
Annual project progress toward meeting project goals must be posted on the project website.
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In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
You may also access documents of the Department published in the
U.S. Election Assistance Commission.
Notice.
The EAC is implementing a new official agency seal for use on all agency internal and external correspondence, communications, media, materials, and methods of identification.
The new agency seal is effective on March 15, 2021.
Kristen Muthig, Telephone: (202) 897-9285, Email:
In 2021, the U.S. Election Assistance Commission (EAC) underwent the process to rebrand and develop a new seal for the agency to better reflect the mission and work of the EAC. Since the agency was established by the Help America Vote Act of 2002 (HAVA), the EAC used a variation of the Great Seal of the United States for its logo.
As the new seal was developed, the following considerations were made and elements incorporated:
• The seal reflects the EAC's testing and certification of voting machines by showing a circuit board.
• The circuit board diodes incorporate the word “VOTE” in Braille reflecting the importance of accessibility for voters with disabilities and EAC's role in ensuring all Americans can vote privately and independently.
• The flag reflects democracy, the EAC as a federal agency, and voters' rights.
• The three stars in the flag represent the three main functions of the EAC: Clearinghouse, Testing and Certification, Research.
• The ballot box reflects the various options of voting and the EAC's mission to assist with election administration best practices.
Permission is required for the replication or use of this seal. The seal is effective on March 15, 2021. The EAC believes that delaying the effective date is unnecessary as this is a notice regarding agency organization, procedure, and practice and there are no changes to public access to the agency or agency services provided to the public. Additionally, the public will benefit immediately from recognition of the new official logo of the EAC on official documents and materials.
On November 6, 2020, Kinet, Inc., filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a conventional hydropower project located in Jessamine, Garrard, and Madison Counties, Kentucky. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed Kentucky River Lock and Dam No. 8 Hydroelectric Project would consist of the following: (1) An existing 309-foot-long, 31-foot-high, timber crib dam with concrete overlay connected to a 384-foot-long, and 52-foot-wide abandoned navigation lock, which are owned by the Kentucky River Authority; (2) a reservoir with a surface area of 499 acres and a storage capacity of 8,700 acre-feet; (3) six, proposed, 32-foot-long, 9-foot-diameter penstocks connected to six generating units with a combined capacity of 3.7 megawatts, within the existing lock; (4) a proposed powerhouse/control room adjacent to the lock; (5) a 30-foot-long by 75-foot-wide tailrace; and (6) a 675-foot-long, 12.47 kilo-Volt transmission line. The proposed project would have an estimated annual generation of 21,002 megawatt-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's website at
On December 3, 2020, Kinet, Inc., filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a conventional hydropower project located in Anderson, Woodford, and Mercer Counties, Kentucky. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed Kentucky River Lock and Dam No. 5 Hydroelectric Project would consist of the following: (1) An existing 594-foot-long, 36-foot-high, timber crib dam with concrete overlay connected to a 390-foot-long, and 38-foot-wide abandoned navigation lock, which are owned by the Kentucky River Authority; (2) a reservoir with a surface area of 448 acres and a storage capacity of 7,500 acre-feet; (3) five, proposed, 32-foot-long, 9-foot-diameter penstocks connected to five generating units with a combined capacity of 2.4 megawatts, within the existing lock; (4) a proposed powerhouse/control room adjacent to the lock; (5) a 30-foot-long by 63-foot-wide tailrace; and (6) a 175-foot-long, 12.47 kilo-Volt transmission line. The proposed project would have an estimated annual generation of 16,243 megawatt-hours.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's website at
Take notice that BM Energy Park LLC, permittee for the proposed Banner Mountain Pumped Storage Hydro Project, has requested that its preliminary permit be terminated. The permit was issued on May 8, 2018 and would have expired on April 30, 2021.
The preliminary permit for Project No. 14863 will remain in effect until the close of business, April 9, 2021. But, if the Commission is closed on this day, then the permit remains in effect until the close of business on the next day in which the Commission is open.
The following notice of meeting is published pursuant to section 3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:
Federal Energy Regulatory Commission.
March 18, 2021, 10:00 a.m.
Open to the public via audio Webcast only. Join FERC online to listen live at
Open.
Agenda. *
Kimberly D. Bose, Secretary, Telephone (202) 502-8400.
For a recorded message listing items struck from or added to the meeting, call (202) 502-8627.
This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed on line at the Commission's website at
The public is invited to listen to the meeting live at
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
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The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. The application is not ready for environmental analysis at this time.
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The project is operated in a run-of-river mode and discharges a minimum flow of 35 cubic feet per second (cfs) or inflow to the reservoir, whichever is less, into the project's bypassed reach for the protection and enhancement of aquatic resources.
As part of the license application, Sandy Hollow Hydro filed a settlement agreement entered into between itself, the U.S. Fish and Wildlife Service, and the New York State Department of Environmental Conservation. As part of the settlement agreement, Sandy Hollow Hydro proposes to: (1) Continue to operate the project in a run-of-river mode; (2) provide a year-round minimum flow in the bypassed reach of 35 cfs, or inflow, whichever is less; (3) continue the existing stream flow and water level monitoring; (4) maintain the existing trash rack on turbine unit 3 with 1-inch clear spacing and, within 5 years of any license issued for the project, install trash racks with either 1-inch clear spacing or the equivalent (
o. In addition to publishing the full text of this notice in the
You may also register online at
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q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that during the month of February 2021, the status of the above-captioned entities as Exempt Wholesale Generators became effective by operation of the Commission's regulations. 18 CFR 366.7(a) (2020).
On December 3, 2020, Kinet, Inc., filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a conventional hydropower project located in Jessamine, Woodford, and Mercer Counties, Kentucky. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed Kentucky River Lock and Dam No. 6 Hydroelectric Project would consist of the following: (1) An existing 465-foot-long, 34-foot-high, timber crib dam with concrete overlay connected to a 280-foot-long, and 45-foot-wide abandoned navigation lock, which are owned by the Kentucky River
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's website at
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following public utility holding company filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Federal Communications Commission.
Notice of a new matching program.
In accordance with the Privacy Act of 1974, as amended (“Privacy Act”), this document announces the modification of a computer matching program the Federal Communications Commission (“FCC” or “Commission” or “Agency”) and the Universal Service Administrative Company (USAC) will conduct with the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS) (“Agency”). The purpose of this matching program is to verify the eligibility of applicants to and subscribers of Lifeline (existing purpose) and the new Emergency Broadband Benefit Program, both of which are administered by USAC under the direction of the FCC. More information about these programs is provided in the
Written comments are due on or before April 15, 2021. This computer matching program will commence on April 15, 2021, and will conclude 18 months after the effective date.
Send comments to Margaret Drake, FCC, 45 L Street NE, Washington, DC 20554, or to
Margaret Drake at 202-418-1707 or
The Lifeline program provides support for discounted broadband and voice services to low-income consumers. Lifeline is administered by the Universal Service Administrative Company (USAC) under FCC direction. Consumers qualify for Lifeline through proof of income or participation in a qualifying program, such as Medicaid, the Supplemental Nutritional Assistance Program (SNAP), Federal Public Housing Assistance, Supplemental Security Income (SSI), Veterans and Survivors Pension Benefit, or various Tribal-specific Federal assistance programs.
The Emergency Broadband Benefit Program (EBBP) was established by Congress in the Consolidated Appropriations Act of 2021, Public Law 116-260, 134 Stat. 1182. EBBP is a program that will help low-income Americans obtain discounted broadband service and one-time co-pay for a connected device (laptop, desktop computer or tablet). This program was created specifically to assist American families' access to broadband, which has proven to be essential for work, school, and healthcare during the public health emergency that exists as a result of COVID-19. A household may qualify for the EBBP benefit under various criteria, including an individual qualifying for the FCC's Lifeline program.
In a Report and Order adopted on March 31, 2016 (81 FR 33026 (May 24, 2016)), the Commission ordered USAC to create a National Lifeline Eligibility Verifier (“National Verifier”), including the National Lifeline Eligibility Database (LED), that would match data about Lifeline applicants and subscribers with other data sources to verify the eligibility of an applicant or subscriber. The Commission found that the National Verifier would reduce compliance costs for Lifeline service providers, improve service for Lifeline subscribers, and reduce waste, fraud, and abuse in the program.
The Consolidated Appropriations Act of 2021 directs the FCC to leverage the National Verifier to verify applicants' eligibility for EBBP. The purpose of this matching program is to verify the eligibility of EBBP applicants and subscribers by determining whether they receive Medicaid or Supplemental Nutrition Assistance Program (SNAP) benefits administered by the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. Under FCC rules, consumers receiving these benefits qualify for Lifeline discounts and also for EBBP benefits.
U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services.
The authority for the FCC's EBBP is Consolidated Appropriations Act of 2021, Public Law 116-260, 134 Stat. 1182; 47 CFR part 54, subpart P. The authority for the FCC's Lifeline program is 47 U.S.C. 254; 47 CFR part 54, subpart E; Lifeline and Link Up Reform and Modernization,
In the 2016 Lifeline Modernization Order, the FCC required USAC to develop and operate the National Verifier to improve efficiency and reduce waste, fraud, and abuse in the Lifeline program. The stated purpose of the National Verifier is “to increase the integrity and improve the performance of the Lifeline program for the benefit of a variety of Lifeline participants, including Lifeline providers, subscribers, states, community-based organizations, USAC, and the Commission.” 31 FCC Rcd 3962, 4006, para. 126. To help determine whether Lifeline applicants and subscribers are eligible for Lifeline benefits, the Order contemplates that the USAC-operated LED will communicate with information systems and databases operated by other Federal and State agencies. Id. at 4011-2, paras. 135-7. The Consolidated Appropriations Act of 2021 directs the FCC to leverage the National Verifier to verify applicants' eligibility for EBBP.
The purpose of this modified matching agreement is to verify the eligibility of applicants and subscribers to Lifeline (existing purpose), as well as to the new EBBP and to other Federal programs that use qualification for Lifeline as an eligibility criterion. This new agreement would replace the existing agreement with CMS, which permits matching only for the Lifeline program by checking an applicant's/subscriber's participation in Medicaid. Under FCC rules, consumers receiving these benefits qualify for Lifeline discounts and also for EBBP benefits.
The categories of individuals whose information is involved in the matching program include, but are not limited to, those individuals who have applied for Lifeline and/or EBBP benefits; are currently receiving Lifeline and/or EBBP benefits; are individuals who enable another individual in their household to qualify for Lifeline and/or EBBP benefits; are minors whose status qualifies a parent or guardian for Lifeline and/or EBBP benefits; or are individuals who have received Lifeline and/or EBBP benefits.
The categories of records involved in the matching program include, but are not limited to, the last four digits of the applicant's Social Security Number, date of birth, state of residence, first name, and last name. The National Verifier will transfer these data elements to the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services which will respond either “yes” or “no” that the individual is enrolled in a qualifying assistance program: U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, Medicaid.
The records shared as part of this matching program reside in the Lifeline system of records, FCC/WCB-1,
The records shared as part of this matching program reside in the EBBP system of records, FCC/WCB-3, Emergency Broadband Benefit Program, which was published in the
Federal Communications Commission.
Notice of a modified system of records.
The Federal Communications Commission (FCC, Commission, or Agency) has modified an existing system of records, FCC/WTB-7, Licensing and Related Support Services (formerly FCC/WTB-7, Remedy Action Request System (RARS)), subject to the Privacy Act of 1974, as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the
This action will become effective on March 16, 2021. Written comments on the system's routine uses are due by April 15, 2021. The routine uses in this action will become effective on April 15, 2021, unless written comments are received that require a contrary determination.
Send comments to Privacy Team, Office of General Counsel, Federal Communications Commission (FCC), 45 L Street NE, Washington, DC 20554 or
Margaret Drake, Privacy Team, Office of General Counsel, Federal Communications Commission, 45 L Street NE, Washington, DC 20554, 202-418-1707, or
The Wireless Telecommunications Bureau (WTB) uses the information in FCC/WTB-7 to record and process requests for assistance from individuals or groups in connection with FCC systems, research tools, electronic databases, licenses, authorizations, and registrations.
This notice serves to modify FCC/WTB-7 to reflect various necessary changes and updates, which include clarification of the purpose of the system, format changes required by OMB Circular A-108 since its previous publication, the revision of five Routine Uses, and the addition of two new Routine Uses. The substantive changes and modification to the previously published version of FCC/WTB-7 (formerly FCC/WTB-7, Remedy Action Request System (RARS)) system of records include:
1. Changing the name of the system of records to FCC/WTB-7, Licensing and Related Support Services.
2. Updating the Security Classification to follow OMB and FCC guidance.
3. Clarifying the Purpose for the system.
4. Updating and/or revising language in six Routine Uses: (1) Third Parties, (2) Adjudication and Litigation, (3) Law Enforcement and Investigation, (4) Congressional Inquiries, (5) Government-wide Program Management and Oversight, and (6) Breach Notification, the changes to this routine required by OMB Memorandum M-17-12.
6. Adding two new Routine Uses: (7) Assistance to Federal Agencies and Entities, to allow the FCC to provide assistance to other Federal agencies in their data breach situations, as required by OMB Memorandum M-17-12; and (8) For Non-Federal Personnel, to allow contractors performing or working on a contract for the Federal Government access to information in this system.
7. Adding two new sections: Reporting to a Consumer Reporting Agency, to address valid and overdue debts owed by individuals to the FCC under the Debt Collection Act, as recommended by OMB; and a History section referencing the previous publication of this SORN in the
The system of records is also updated to reflect various administrative changes related to the policy and practices for storage and retrieval of the information; administrative, technical, and physical safeguards; and updated notification, records access, and procedures to contest records.
FCC/WTB-7, LICENSING AND RELATED SUPPORT SERVICES.
Unclassified.
Wireless Telecommunications Bureau (WTB), Federal Communications Commission (FCC), Washington, DC 20554.
Wireless Telecommunications Bureau (WTB), Federal Communications Commission (FCC), Washington, DC 20554.
47 U.S.C. 151, 154, 208, 258, 301, 303, 309(e), and 312.
The FCC staff uses the records in this system to process requests for assistance from individuals or groups in connection with FCC systems, research tools, electronic databases, licenses, authorizations, and registrations.
The categories of individuals in the system include individuals who request assistance in connection with FCC systems, research tools, electronic databases, licenses, authorizations, and registrations.
The categories of records in the system include:
1. Requests for assistance by the requester's first name, last name, telephone number and extension, international telephone number and extension, email address(es), computer operating system, web browser, FCC Registration Number (FRN), and personal security question and answer.
2. Records verifying identity information by the individual's first name, last name, contact telephone number, FRN, and personal security question and answer.
Information in this system is provided by users who request assistance in connection with FCC systems, research tools, electronic databases, licenses, authorizations, and registrations.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed to authorized entities, as is determined to be relevant and necessary, outside the FCC as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows.
1. Third Parties—To third parties, including Federal, state, local, or tribal agencies, or entities that may be subject to the Communications Act of 1934, as amended, to resolve requests for assistance.
2. Adjudication and Litigation—To disclose to the Department of Justice (DOJ), or to other administrative or adjudicative bodies before which the FCC is authorized to appear, when: (a) The FCC or any component thereof; or (b) any employee of the FCC in his or her official capacity; or (c) any employee of the FCC in his or her individual capacity where the DOJ or the FCC have agreed to represent the employee; or (d) the United States is a party to litigation or has an interest in such litigation, and the use of such records by the DOJ or the FCC is deemed by the FCC to be relevant and necessary to the litigation.
3. Law Enforcement and Investigation—To disclose pertinent information to the appropriate Federal, State, local, or tribal agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, when the FCC becomes aware of an indication of a violation or potential violation of civil or criminal law or regulation.
4. Congressional Inquiries—To provide information to a Congressional office from the record of an individual in response to an inquiry from that Congressional office made at the written request of that individual.
5. Government-wide Program Management and Oversight—To provide information to the National Archives and Records Administration (NARA) for the use in its records management inspections; to the Department of Justice (DOJ) to obtain that department's advice regarding disclosure obligations under the Freedom of Information Act; or to the Office of Management and Budget (OMB) to obtain that office's advice regarding obligations under the Privacy Act.
6. Breach Notification—To appropriate agencies, entities, and persons when: (a) The Commission suspects or has confirmed that there has been a breach of PII maintained in the system of records; (b) the Commission has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Commission (including its information system, programs, and operations), the Federal Government, or national security; and, (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Commission's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
7. Assistance to Federal Agencies and Entities—To another Federal agency or Federal entity, when the Commission determines that information from this system is reasonably necessary to assist the recipient agency or entity in: (a) Responding to a suspected or confirmed breach or (b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, program, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
8. Non-Federal Personnel—To disclose information to third parties, including contractors, performing or working on a contract in connection with resolving requests for assistance and/or IT services for the Federal Government, who may require access to this system of records.
In addition to the routine uses cited above, the Commission may share information from this system of records with a consumer reporting agency regarding an individual who has not paid a valid and overdue debt owed to the Commission, following the procedures set out in the Debt Collection Act, 31 U.S.C. 3711(e).
Information in the information system consists of electronic data, files, and records, which are housed in the FCC's computer network databases. Any paper documents that WTB receives are scanned into the electronic database upon receipt, and then the paper documents are destroyed.
The electronic data, files, and records may be retrieved by searching electronically using a variety of parameters including the requester's name, entity name, telephone number, licensee, applicant or unlicensed individual, call sign, file number, problem type, FRN, email address, and/or subject matter.
The information in the system is maintained according to General Records Schedules 5.8 and 6.5. The electronic records, files, and data are destroyed physically (electronic storage media) or by electronic erasure. Paper documents are destroyed by shredding after they are scanned into the information system's electronic databases.
The records in the FCC's computer network are protected by the FCC privacy safeguards, a comprehensive and dynamic set of IT safety and security protocols and features that are designed to meet all Federal IT privacy standards, including those required by the Federal Information Security Modernization Act of 2014 (FISMA), the Office of Management and Budget (OMB), and the National Institute of Standards and Technology (NIST).
Individuals wishing to request access to and/or amendment of records about themselves should follow the Notification Procedure below.
Individuals wishing to request an amendment of records about themselves should follow the Notification Procedure below.
Individuals wishing to determine whether this system of records contains information about themselves may do so by writing to the Privacy Team, Office of General Counsel, Federal Communications Commission, Washington, DC 20554,
Individuals requesting access must also comply with the FCC's Privacy Act regulations regarding verification of identity to gain access to the records (47 CFR part 0, subpart E).
None.
The FCC last gave full notice of this system of records, FCC/WTB-7, Licensing and Related Support Services (formerly: FCC/WTB-7, Remedy Action Request System (RARS)), by publication in the
Federal Communications Commission.
Notice of a new matching program.
In accordance with the Privacy Act of 1974, as amended (“Privacy Act”), this document announces the modification of a computer matching program the Federal Communications Commission (“FCC” or “Commission” or “Agency”) and the Universal Service Administrative Company (USAC) will conduct with the Indiana Family and Social Services Administration Division of Family Resources (FSSA/DFR) (“Agency”). The purpose of this matching program is to verify the eligibility of applicants to and subscribers of Lifeline (existing purpose) and the new Emergency Broadband Benefit Program, both of which are administered by USAC under the direction of the FCC. More information about these programs is provided in the
Written comments are due on or before April 15, 2021. This computer matching program will commence on April 15, 2021, and will conclude 18 months after the effective date.
Send comments to Margaret Drake, FCC, 45 L Street NE, Washington, DC 20554, or to
Margaret Drake at 202-418-1707 or
The Lifeline program provides support for discounted broadband and voice services to low-income consumers. Lifeline is administered by the Universal Service Administrative Company (USAC) under FCC direction. Consumers qualify for Lifeline through proof of income or participation in a qualifying program, such as Medicaid, the Supplemental Nutritional Assistance Program (SNAP), Federal Public Housing Assistance, Supplemental Security Income (SSI), Veterans and Survivors Pension Benefit, or various Tribal-specific Federal assistance programs.
The Emergency Broadband Benefit Program (EBBP) was established by Congress in the Consolidated Appropriations Act of 2021, Public Law 116-260, 134 Stat. 1182. EBBP is a program that will help low-income Americans obtain discounted broadband service and one-time co-pay for a connected device (laptop, desktop computer or tablet). This program was created specifically to assist American families' access to broadband, which has proven to be essential for work, school, and healthcare during the public health emergency that exists as a result of COVID-19. A household may qualify for the EBBP benefit under various criteria, including an individual qualifying for the FCC's Lifeline program.
In a Report and Order adopted on March 31, 2016 (81 FR 33026 (May 24, 2016)), the Commission ordered USAC to create a National Lifeline Eligibility Verifier (“National Verifier”), including the National Lifeline Eligibility Database (LED), that would match data about Lifeline applicants and subscribers with other data sources to verify the eligibility of an applicant or subscriber. The Commission found that the National Verifier would reduce compliance costs for Lifeline service providers, improve service for Lifeline subscribers, and reduce waste, fraud, and abuse in the program.
The Consolidated Appropriations Act of 2021 directs the FCC to leverage the National Verifier to verify applicants' eligibility for EBBP. The purpose of this matching program is to verify the eligibility of EBBP applicants and subscribers by determining whether they receive Medicaid or Supplemental Nutrition Assistance Program (SNAP) benefits administered by the Indiana Family and Social Services Administration Division of Family Resources. Under FCC rules, consumers receiving these benefits qualify for Lifeline discounts and also for EBBP benefits.
Indiana Family and Social Services Administration Division of Family Resources.
The authority for the FCC's EBBP is Consolidated Appropriations Act of 2021, Public Law 116-260, 134 Stat. 1182; 47 CFR part 54, subpart P. The authority for the FCC's Lifeline program is 47 U.S.C. 254; 47 CFR part 54, subpart E; Lifeline and Link Up Reform and Modernization,
In the 2016 Lifeline Modernization Order, the FCC required USAC to develop and operate the National Verifier to improve efficiency and reduce waste, fraud, and abuse in the Lifeline program. The stated purpose of the National Verifier is “to increase the integrity and improve the performance of the Lifeline program for the benefit of a variety of Lifeline participants, including Lifeline providers, subscribers, states, community-based organizations, USAC, and the Commission.” 31 FCC Rcd 3962, 4006, para. 126. To help determine whether Lifeline applicants and subscribers are eligible for Lifeline benefits, the Order contemplates that the USAC-operated LED will communicate with information systems and databases operated by other Federal and State agencies. Id. at 4011-2, paras. 135-7. The Consolidated Appropriations Act of 2021 directs the FCC to leverage the National Verifier to verify applicants' eligibility for EBBP.
The purpose of this modified matching agreement is to verify the eligibility of applicants and subscribers to Lifeline (existing purpose), as well as to the new EBBP and to other Federal programs that use qualification for Lifeline as an eligibility criterion. This new agreement would replace the existing agreement with Indiana, which permits matching only for the Lifeline program by checking an applicant's/subscriber's participation in SNAP and Medicaid. Under FCC rules, consumers receiving these benefits qualify for Lifeline discounts and also for EBBP benefits.
The categories of individuals whose information is involved in the matching program include, but are not limited to, those individuals who have applied for Lifeline and/or EBBP benefits; are currently receiving Lifeline and/or EBBP benefits; are individuals who enable another individual in their household to qualify for Lifeline and/or EBBP benefits; are minors whose status qualifies a parent or guardian for Lifeline and/or EBBP benefits; or are individuals who have received Lifeline and/or EBBP benefits.
The categories of records involved in the matching program include, but are not limited to, the last four digits of the applicant's Social Security Number,
The records shared as part of this matching program reside in the Lifeline system of records, FCC/WCB-1, Lifeline, which was published in the
The records shared as part of this matching program reside in the EBBP system of records, FCC/WCB-3, Emergency Broadband Benefit Program, which was published in the
Office of Family Assistance, Administration for Children and Families, HHS.
Request for public comment.
The Office of Family Assistance (OFA), Administration for Children and Families, is requesting a 3-year extension of the form ACF-4125: Annual Report on Children in Foster Homes and Children in Families Receiving Payment in Excess of the Poverty Income Level from a State Program Funded Under Part A of Title IV of the Social Security Act (OMB #0970-0004, expiration 3/21/2021). There are no changes requested to the form.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Pub. L. 107-110 Sec: 1124(c)(4) and Pub. L. 104-193 Sec: 110(j).
Children's Bureau, Administration on Children, Youth and Families, HHS.
Request for Public Comment.
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Program Instruction (PI) for the Community-Based Family Resource and Support Grants or the Community-Based Child Abuse Prevention (CBCAP) program (OMB No.: 0970-0155, expiration 3/31/2021), which outlines information collection requirements pursuant to receiving a grant award. There are no changes requested to the information collection process.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The CAPTA Reauthorization Act of 2010; Title II of the CAPTA, Pub. L. 115-271 (42 U.S.C. 5116
Office of Community Services, Administration for Children and Families, HHS.
Request for Public Comment.
The Administration for Children and Families (ACF) is requesting a revision to the Social Services Block Grant (SSBG) Post-Expenditure Report, Pre-Expenditure Report, and Intended Use Plan (OMB #0970-0234, previously titled, “Social Services Block Grant (SSBG) Post-Expenditure Report”). ACF is proposing to expand the information collection to include the collection of states' Intended Use Plans and retitle the information collection to clarify the role of the Pre-Expenditure Report.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
42 U.S.C. 1397 through 1397e.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) 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
Submit either electronic or written comments on the collection of information by May 17, 2021.
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 May 17, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
Under the PRA (44 U.S.C. 3501-3521), Federal
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.
From 1998 to 2008, the FDA's National Retail Food Team conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors most commonly reported to the Centers for Disease Control and Prevention as contributing factors to foodborne illness outbreaks at the retail level. Specifically, data was collected by FDA Specialists in retail and foodservice establishments at 5-year intervals (1998, 2003, and 2008) in order to observe and document trends in the occurrence of the following foodborne illness risk factors:
• Food from Unsafe Sources,
• Poor Personal Hygiene,
• Inadequate Cooking,
• Improper Holding/Time and Temperature, and
• Contaminated Equipment/Cross-Contamination.
FDA developed reports summarizing the findings for each of the three data collection periods, released in 2000, 2004, and 2009 (Refs. 1 to 3). Data from all three data collection periods were analyzed to detect trends in improvement or regression over time and to determine whether progress had been made toward the goal of reducing the occurrence of foodborne illness risk factors in selected retail and foodservice facility types (Ref. 4).
Using this 10-year survey as a foundation, in 2013-2014, FDA initiated a new study in full-service and fast-food restaurants. This study will span 10 years with data collections completed in 2013-2014 and 2017-2018, and an additional collection planned for 2021-2022. Three data collections are necessary to trend the data. Data collected in 2013-2014 is published, and data from 2017-2018 is currently being evaluated for trends and significance.
The results of this 10-year study period will be used to:
• Develop retail food safety initiatives, policies, and targeted intervention strategies focused on controlling foodborne illness risk factors;
• Provide technical assistance to State, local, tribal, and territorial regulatory professionals;
• Identify FDA retail work plan priorities; and
• Inform FDA resource allocation to enhance retail food safety nationwide.
The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). Responsibility for carrying out the provisions of the PHS Act relative to food protection was transferred to the Commissioner of Food and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
The objectives of this study are to:
• Identify the least and most often occurring foodborne illness risk factors and food safety behaviors/practices in restaurants within the United States;
• Determine the extent to which Food Safety Management Systems and the presence of a Certified Food Protection Manager impact the occurrence of foodborne illness risk factors and food safety behaviors/practices; and
• Determine whether the occurrence of foodborne illness risk factors food safety behaviors/practices in delis differs based on an establishment's risk categorization and status as a single-unit or multiple-unit operation (
The methodology to be used for this information collection is described as follows. To obtain a sufficient number of observations to conduct statistically significant analysis, FDA will conduct approximately 400 data collections in each facility type. This sample size has been calculated to provide for sufficient observations to be 95 percent confident that the compliance percentage is within 5 percent of the true compliance percentage.
A geographical information system database containing a listing of businesses throughout the United States provides the establishment inventory for the data collections. FDA samples establishments from the inventory based on the descriptions in table 1. FDA does not intend to sample operations that handle only prepackaged food items or conduct low-risk food preparation activities. The “FDA Food Code” contains a grouping of establishments by risk, based on the type of food preparation that is normally conducted within the operation (Ref. 5). The intent
FDA has approximately 25 Retail Food Specialists (Specialists) who serve as the data collectors for the 10-year study. The Specialists are geographically dispersed throughout the United States and possess technical expertise in retail food safety and a solid understanding of the operations within each of the facility types to be surveyed. The Specialists are also standardized by FDA's Center for Food Safety and Applied Nutrition personnel in the application and interpretation of the FDA Food Code (Ref. 5).
Sampling zones have been established that are equal to the 175-mile radius around a Specialist's home location. The sample is selected randomly from among all eligible establishments located within these sampling zones. The Specialists are generally located in major metropolitan areas (
1. It provides a cross-section of urban and rural areas from which to sample the eligible establishments.
2. It represents a mix of small, medium, and large regulatory entities having jurisdiction over the eligible establishments.
3. It reduces overnight travel and, therefore, reduces travel costs incurred by the Agency to collect data.
The sample for each data collection period is evenly distributed among Specialists. Given that participation in the study by industry is voluntary and the status of any given randomly selected establishment is subject to change, substitute establishments have been selected for each Specialist for cases where the restaurant facility is misclassified, closed, or otherwise unavailable, unable, or unwilling to participate.
Prior to conducting the data collection, Specialists contact the State or local jurisdiction that has regulatory responsibility for conducting retail food inspections for the selected establishment. The Specialist verifies with the jurisdiction that the facility has been properly classified for the purposes of the study and is still in operation. The Specialist ascertains whether the selected facility is under legal notice from the State or local regulatory authority. If the selected facility is under legal notice, the Specialist will not conduct a data collection, and a substitute establishment will be used. An invitation is extended to the State or local regulatory authority to accompany the Specialist on the data collection visit.
A standard form is used by the Specialists during each data collection. The form is divided into three sections: Section 1—“Establishment Information”; Section 2—“Regulatory Authority Information”; and Section 3—“Foodborne Illness Risk Factor and Food Safety Management System Assessment.” The information in Section 1 “Establishment Information” of the form is obtained during an interview with the establishment owner or person in charge by the Specialist and includes a standard set of questions.
The information in Section 2 “Regulatory Authority Information” is obtained during an interview with the program director of the State or local jurisdiction that has regulatory responsibility for conducting inspections for the selected establishment.
Section 3 includes three parts: Part A for tabulating the Specialists' observations of the food employees' behaviors and practices in limiting contamination, proliferation, and survival of food safety hazards; Part B for assessing the food safety management system being implemented by the facility; and Part C for assessing the frequency and extent of food employee handwashing. The information in Part A is collected from the Specialists' direct observations of food employee behaviors and practices. Infrequent, nonstandard questions may be asked by the Specialists if clarification is needed on the food safety procedure or practice being observed. The information in Part B is collected by making direct observations and asking follow-up questions of facility management to obtain information on the extent to which the food establishment has developed and implemented food safety management systems. The information in Part C is collected by making direct observations of food employee handwashing. No questions are asked in the completion of Section 3, Part C of the form.
FDA collects the following information associated with the establishment's identity: Establishment name, street address, city, State, ZIP Code, county, industry segment, and facility type. The establishment-identifying information is collected to ensure the data collections are not duplicative. Other information related to the nature of the operation, such as seating capacity and number of employees per shift, is also collected. Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study.
FDA has collaborated with the Food Protection and Defense Institute to develop a web-based platform in FoodSHIELD to collect, store, and analyze data for the Retail Risk Factor Study. This platform is accessible to State, local, territorial, and tribal regulatory jurisdictions to collect data relevant to their own risk factor studies. For the 2015-2016 data collection, FDA piloted the use of hand-held technology for capturing the data onsite during the data collection visits. The tablets that were made available for the data collections were part of a broader Agency initiative focused on internal uses of hand-held technology. The tablets provided for the data collection presented several technical and logistical challenges and increased the time burden associated with the data collection as compared to the manual entry of data collections. For these reasons, FDA will not be further evaluating hand-held technology in subsequent data collections during the 10-year study period.
When a data collector is assigned a specific establishment, he or she conducts the data collection and enters the information into the web-based data platform. The interface will support the manual entering of data, as well as the ability to directly enter information in the database via a web browser.
The burden for the 2021-2022 data collection is as follows. For each data collection, the respondents will include: (1) The person in charge of the selected facility (whether it be a fast-food or full-service restaurant); and (2) the program director (or designated individual) of the respective regulatory authority. In order to provide the sufficient number of observations needed to conduct a statistically significant analysis of the data, FDA has determined that 400 data collections will be required in each of the two restaurant facility types. Therefore, the total number of responses will be 1,600 (400 data collections × 2 facility types × 2 respondents per data collection).
The burden associated with the completion of Sections 1 and 3 of the form is specific to the persons in charge of the selected facilities. The burden includes the time it will take the person in charge to accompany the data collector during the site visit and answer the data collector's questions. The burden related to the completion of Section 2 of the form is specific to the program directors (or designated
To calculate the estimate of the hours per response, FDA will use the average data collection duration for the same facility types during the 2015-2016 data collection. FDA estimates that it will take the persons in charge of full-service restaurants and fast-food restaurants 104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectively, to accompany the data collectors while they complete Sections 1 and 3 of the form. In comparison, for the 2017-2018 data collection, the burden estimate was 106 minutes (1.76 hours) in full-service restaurants and 73 minutes (1.21 hours) in fast-food restaurants. FDA estimates that it will take the program director (or designated individual) of the respective regulatory authority 30 minutes (0.5 hours) to answer the questions related to Section 2 of the form. This burden estimate is unchanged from the last data collection. Hence, the total burden estimate for a data collection in a full-service restaurant, including both the program director's and the person in charge's responses, is 134 minutes (104 + 30) (2.23 hours). The total burden estimate for a data collection in a fast-food restaurant, including both the program director's and the person in charge's responses, is 112 minutes (82 + 30) (1.86 hours).
Based on the number of entry refusals from the 2017-2018 data collection, we estimate a refusal rate of 2 percent for the data collections within restaurant facility types. The estimate of the time per non-respondent is 5 minutes (0.08 hours) for the person in charge to listen to the purpose of the visit and provide a verbal refusal of entry.
FDA estimates the burden of this collection of information as follows:
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
The following references are on display in the Dockets Management Staff (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) 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
Submit either electronic or written comments on the collection of information by May 17, 2021.
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 May 17, 2021. The
Submit electronic comments in the following way:
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• 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”).
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• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
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
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.
This information collection supports FDA regulations setting forth criteria and definitions applicable to human food and to animal food, as established under the FDA Food Safety and Modernization Act (FSMA) (Pub. L.
The regulations include recordkeeping necessary to demonstrate compliance with the requirements; however, respondents that meet the definition of a “qualified facility,” under 21 CFR 117.3 and 507.3, are subject to reporting. To be subject to the modified requirements set forth in part 117, subpart D and part 507, subpart D for human food and animal food, respectively, respondents must attest to their status. To assist respondents in this regard, we have developed Forms FDA 3942a (Quality Facility Attestation: Human Food) and 3942b (Quality Facility Attestation: Animal Food), available for downloading from our website at:
Section 418(l)(2)(B)(ii) of the FD&C Act (21 U.S.C. 350g(l)(2)(B)(ii)) directs us to issue guidance on documentation required to determine status as a qualified facility. Accordingly, we issued a guidance for industry entitled “Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,” also available for downloading from our website at:
We estimate the burden of this collection of information as follows:
Based on a review of the information collection since our last request for OMB approval, we have made slight adjustments to reflect a decrease in third-party disclosure burden associated with animal foods. In this submission we provide a cumulative estimate for related disclosure activities that we had previously accounted for separately.
Food and Drug Administration, HHS.
Notice.
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 (PRA).
Submit written comments (including recommendations) on the collection of information by April 15, 2021.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
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: (1) Advertising features, including content and format; (2) target populations; and (3) 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 our research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first two 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 is improved by utilizing 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 homepage, which can be found at:
During the prescription drug approval process, sponsors propose proprietary names for their products. These names undergo a proprietary name review that involves the Office of Drug Safety, the relevant medical office, and OPDP. OPDP reviews names to assess for alignment with the FD&C Act, which, among other things, provides that labeling can misbrand a product if false or misleading representations are made (see 21 U.S.C. 321(n), 352(a)). A proprietary name, which appears in labeling, could result in such misbranding if it is false or misleading. OPDP focuses its review on identifying names that overstate the efficacy or safety of the drug, suggest drug indications that are not accurate, suggest superiority without substantiation, or are of a fanciful nature that misleadingly implies unique effectiveness or composition. This research will focus on the effect on consumers' and/or healthcare providers' perceptions of a drug product of names that overstate the efficacy of the drug product. An overstatement of efficacy can occur, for example, in terms of level of efficacy, in which the degree of relief is overstated, or in terms of the type of effect, in which case there is a mismatch with the indication of the drug. The drug products that are studied will be fictitious, and whether the names overstate the drug products' efficacy will be determined with regard to the products' fictitious degree of efficacy.
The proposed study is designed to provide systematic, empirical evidence to answer two research questions:
•
•
The ideas generated in the Prescription Drug User Fee Amendments pilot project proprietary name review concept paper of 2008
To our knowledge, this study is the first to provide a systemic investigation of a variety of proprietary prescription drug names.
In the
(Comment 1) Two comments recommended that the study should exclude consumers who work in the healthcare, marketing, or branding industries; primary care providers that spend less than 50 percent of their time on patient care; and the Department of Health and Human Services employees.
(Response 1) We agree and currently have those exclusions included in the screener.
(Comment 2) Two comments recommended the screener should include additional inclusion/exclusion criteria, such as number of years in practice and in what size facility they work (HCPs), and whether consumers have any of five diagnoses and how many HCPs they see (consumers).
(Response 2) We plan to include most of the screening criteria and demographic data mentioned, including years in practice (HCPs); amount of time treating patients (HCPs); size of facility (HCPs); age (consumers); and diagnosis with one of the two illnesses which the hypothetical drugs in this study are indicated to treat—GERD and high cholesterol (consumers). Some of the other suggested questions for the screener are beyond the scope of this study. For this study, we have chosen to focus on primary care providers, as drugs for these two specific medical conditions are prescribed by primary care providers and should thus be salient for them. Additionally, we will ask relevant background questions of all participants, both HCPs and consumers, to determine age, sex, and race, as well as familiarity with the target conditions.
(Comment 3) One comment recommended that the complexity of the target names should be equivalent across indications.
(Response 3) We have attempted to make these as similar as possible, including having them reviewed by a linguist and checking the number of syllables across conditions.
(Comment 4) Three comments recommend better clarity around what the definitions of “typical” and “standard” and “extreme” and “neutral” mean when describing the fictitious drug name and how these categories were identified and validated.
(Response 4) The list of names was developed by our multimedia and creative services team who are well-versed in the practice of proprietary name development. The list was reviewed by the study team and also by a consultant with a Ph.D. in linguistics, who helped to screen for any overlap between categories.
In July 2019, we conducted a pretest of 120 healthcare providers and 121 consumers to establish the categories for these names. We combined results of four measures to determine the most extreme and most neutral amongst a list of names. These measures included ability to identify the medical condition for which the drug is indicated; perceived benefit and perceived balance of benefit and risk; and, finally, a ranking of most obvious benefit. Names with the lowest joint rank across the four measures were considered most extreme and those with highest were considered most neutral. The results were consistent between HCPs and consumers.
(Comment 5) One comment recommended excluding “extreme, explicitly suggestive” proprietary names that FDA would never permit or names that suggest the drug indication. The comment suggested instead that FDA use data that could assist the Agency in determining impressions produced by permissible proprietary names and names that would marginally fail FDA's misbranding review.
(Response 5) The purpose of including “extreme” names in this study is not to have data on names that do not mimic real-world conditions, but to have something against which to compare the target names, which are similar to the kind of names that would be submitted to FDA for approval. Our findings may suggest that “extreme” and target names are very different and that target names are similar to more neutral names in their effects on perceptions.
(Comment 6) One comment inquired if FDA will be providing sound files with the intended pronunciation of each of the test names.
(Response 6) In consideration of this comment, and after hearing from our cognitive interview participants, we will introduce sound files at the beginning of the survey.
(Comment 7) One comment expressed concerns about how the selection of target names will represent the current landscape—that is, it questioned how FDA will generalize these study results across therapeutic areas not tested if only representing one or two therapeutic areas.
(Response 7) We recognize that our study is making use of only two therapeutic areas. As one research study, it cannot examine all possible therapeutic areas. Although our two divergent medical conditions will not provide us with unlimited information, they will provide limited generalizability and provide important information that may help inform the proprietary name review process.
(Comment 8) Two comments were concerned that the questionnaire would take longer than the estimated 20 minutes.
(Response 8) See our response to Comment 4 concerning the pretest that we conducted in July 2019. In the pretest, we successfully tested a total of 16 names across two indications in this time frame. During cognitive testing, we
(Comment 9) Five comments recommended that we add “none of the above,” “no impression,” “no opinion” or “do not know” response options to some questions.
(Response 9) The rationale usually given for including “don't know”/“no opinion”/“none” options is to allow participants who cannot form a relevant judgment (
(Comment 10) Seven comments suggested adding more open-ended responses to explain why respondents answered questions in certain ways.
(Response 10) As noted by two comments the survey may be longer than an average of 20 minutes, which will cause us to remove questions after cognitive testing. Unfortunately, it is impractical to include many open-ended questions in this particular research because of time constraints. Qualitative research on this topic may be a good idea for a future study.
(Comment 11) One comment recommended checks to ensure that respondents are not being careless in their responses (
(Response 11) We intend to check for inattentive respondents by testing for straight-lining and examining the distribution of time to complete the study for outliers. Participants who complete the study plus or minus three standard deviations from the sample mean will be excluded from the main analysis. We agree with the recommendation to include speed traps/attention checks in the questionnaire and will add one to the study.
(Comment 12) Three comments requested access to the screener or study target names.
(Response 12) We have described the purpose of the study, the design, the population of interest, and have provided the questionnaire to numerous individuals upon request. Our full stimuli are under development during the PRA process. We do not make draft stimuli public during this time because of concerns that this may contaminate our participant pool and compromise the research. We strive to publish the results of our research in peer-reviewed journals and all stimuli will be available at that time.
(Comment 13) One comment recommended a specific approach for addressing the issue of broadening the indication that included an unaided “fit to category” question and an open-ended “does the brand name tell you anything about the product?” OR “what does this name mean to you?”—type question for each name.
(Response 13) The approach described in this comment is one method to approach the issue of broadening the indication and may be useful for future research. However, in the current study we aim to collect information about multiple names, which precludes open-ended questions for each name in a single participant session. Moreover, our initial examination is focused on overstatement of efficacy. Broadening of the indication is another topic that researchers could pursue.
(Comment 14) One comment mentioned that we had no particular items on the issue of unique composition and suggested adding an open-ended question regarding general associations to determine whether a particular ingredient or dosage formulation is implied by a proprietary name.
(Response 14) Our current research is focused on the issue of overstatement of efficacy in proposed proprietary drug names. Future research could examine issues related to composition and dosage formulation, but that is beyond the scope of the current research.
(Comment 15) One comment suggested FDA should conduct two survey pretests: One to assess whether the survey answers the research questions, and one that allows respondents to complete the survey under the supervision of a moderator, who is able to converse with respondents and gather feedback on how participants interpret the questions. Further, the comment suggests FDA should consider conducting qualitative followup interviews with survey respondents to gain deeper insight into how the sample proprietary names affected their impressions of safety, efficacy and indication.
(Response 15) We have accomplished the goals recommended in this comment by conducting cognitive interviewing. During these cognitive interviews, participants were encouraged to think aloud as they reviewed and answered the survey with prompts from a trained moderator. These interviews enabled us to capture deeper, more qualitative responses from a small nonrepresentative sample of individuals in order to improve the questionnaire.
(Comment 16) One comment suggested FDA consider the inverse approach of our design by setting up the research to examine how, if at all, names that do suggest the drug's indication increase the chance for proper usage, reduce the potential for medication errors, do not mislead HCPs or patients regarding non-approved use of the drug, and increase the chance that if a patient does ask an HCP about a certain medication then that medication would be one approved to treat a condition with which the patient has been diagnosed.
(Response 16) The purpose of the current study is to provide evidence about whether certain types of names influence consumers' perceptions, as well as benefit and risk perceptions so that FDA reviewers may better assess names during premarket review. Other effects of names are beyond the scope of the current study but may be considered in future research.
(Comment 17) One comment suggested the ability of HCPs who prescribe drug products to determine whether a proprietary name overstates the efficacy of that product
(Response 17) The purpose of the current study is to determine whether a proprietary name itself could play a role in influencing consumer and HCP perceptions of drug risks or benefits by suggesting the medical condition for which the drug is indicated or by suggesting an overstatement of the efficacy of the drug. Including the package insert would confound any potential results of this study, as it would not be possible to tease apart
(Comment 18) One comment suggested that the proposed primary research question, which is designed to determine how, if at all, a proprietary name that suggests the medical condition for which it is indicated affects perceptions of the drug, does not determine whether a name overstates the efficacy of the product.
(Response 18) We agree that whether a name suggests the medical condition for which a drug is indicated is a separate question from whether the name overstates the drug's efficacy. However, we aim, in part, to investigate how individuals perceive the efficacy of products when the names do suggest the medical condition they are indicated to treat. The purpose of this study is to compare names that: (1) With varying degrees of specificity, may suggest the medical condition for which a drug is indicated, with or without varied promises of effect (target names); (2) we know through pretesting overstate the efficacy (extreme names); and (3) we know to be neutral through pretesting. Perceptions of consumers and HCPs are important to consider when reviewing proprietary names and thus, important to test empirically.
(Comment 19) One comment suggested that research is not necessary because names should be evaluated by those who have medical and regulatory experience.
(Response 19) We agree that people who are knowledgeable about the relevant fields should make decisions about proprietary names based on the best information in their fields. Determining how names are processed and understood by consumers and HCPs is important information to be considered in the review of these names. Therefore, this research is being conducted to increase the body of evidence upon which experts can rely when assessing proposed proprietary names for misbranding concerns.
(Comment 20) Three comments mentioned the study sample size. One comment stated that the reason for selecting approximately 1000 respondents was not provided, and it suggested that the size of such a study on a proposed drug product would not be reasonable or cost effective for the pharmaceutical industry. One comment recommended that an appropriate sample size be used, and another comment remarked that the sample size seemed appropriate.
(Response 20) The sample size was selected based on power analysis. We have set statistical power for the main study to test five proposed names against both the neutral control name and the extreme control name, using a 7 × 7 Latin squares design. With a Bonferroni correction for up to 10 pairwise comparisons, the study is powered to detect conventionally small effects (
This is a large-scale study examining multiple names, whose purpose differs from that of one pharmaceutical company assessing their chosen names.
(Comment 21) One comment concurred that an automated online survey would be the most efficient means to conduct the research.
(Response 21) Thank you for this comment.
(Comment 22) One comment asked that we clarify what specific statistical tests will be performed to determine whether a particular target name has an improper (biasing) impact on perceptions of drug efficacy and/or safety—and (possibly) on other perceptions.
(Response 22) To compare names based on the categorical name recognition and perceived indication questions, we will apply nonparametric tests of dependent proportions. First, we plan to conduct Cochran's
To test for evidence of mean differences by drug name on interval-level outcomes (
See information about the study's statistical power assumptions above.
(Comment 23) One comment asked for clarity regarding what decision rule or norm/standard will be used to conclude that there is or is not improper suggestiveness.
(Response 23) There is an important distinction between investigating the effect of a prescription drug name on perceptions and establishing that the name is improperly suggestive. This study is focused on the effect on perceptions of: (1) Names that suggest the medical condition for which a drug is indicated with varying degrees of explicitness and (2) names that suggest an overstatement of the efficacy of the drug with varying degrees of explicitness. Determining whether what a prescription drug name suggests or the name's degree of suggestiveness is “improper,” or could contribute to misbranding the drug or to other violation(s) of the FD&C Act and Agency regulations, falls beyond the scope of the current project.
(Comment 24) One comment suggested clarifying the purpose and intended use of the data and further suggests that regardless of the purpose of the proposed information collection, in addressing use of the survey data, FDA should account for the First Amendment protection provided to proprietary names.
(Response 24) As stated in the 60-day notice, the purpose of this study is to expand the body of knowledge by answering questions about whether names alone impact consumer and provider perceptions of a drug. This information will help inform the proprietary name review process. FDA's review of proprietary names is conducted to help ensure that proposed proprietary names do not contribute to misbranding a drug or to other violation(s) of the FD&C Act and Agency regulations, particularly when that proprietary name appears in labeling (see,
(Comment 25) One comment suggested Q1 should have a timer element (
(Response 25) In addition to counterbalancing the sets of names, we will institute a time limit for each viewing.
(Comment 26) Another comment suggested that for Q1, we use names that were found unacceptable due to promotional reasons for foils.
(Response 26) The purpose of Q1 is to determine how well participants recall the names they viewed. The foils are used to help determine whether participants are merely checking off the complete list of names or marking ones they truly saw on the previous screen. Thus, we do not believe using actual names as foils would add value.
(Comment 27) One comment mentioned that Q3-Q7 introduce an aided portion of the survey (by grouping names into two specific medical conditions and identifying those names with each medical condition to the respondents) and suggested that, without seeing the product profile, “it will be difficult to get responsible data on efficacy perceptions of the respondents.” Another comment suggested that Q3 should ask a more specific question, perhaps on unique effectiveness or overstatement of efficacy.
(Response 27) Our research questions focus on whether the names alone result in perceptions of risk or efficacy, thus, Q3-Q7 are directly relevant to the research questions. Regarding Q3, we do not want to lead participants into answers or confuse them by asking them about regulatory terms with which they are unfamiliar. We will delete Q7.
(Comment 28) Regarding Q2, one comment suggested caution in terms of handling responses in which respondents presented with a particular target name (
(Response 28) The target names are representative of the types of names that are frequently submitted to FDA for review. They may include information about the medical condition for which the drug is indicated, or both the medical condition and efficacy. We do not presuppose that a name's effect on perceptions of drug effectiveness are dependent on recognition of the medical condition for which the drug is indicated, though we will consider this mediation effect as we refine the analysis plan for this project.
(Comment 29) One comment suggested that Q4 does not seem relevant since serious side effects of the drug would normally be evaluated in the context of the clinical studies or post-marketing studies and would be presented in the package insert labeling.
(Response 29) The question is whether the name alone influences perception of risk and benefit; thus, Q4 is directly relevant to answering those questions.
(Comment 30) Three comments suggested deleting Q5. For example, one comment discussed that perceived balance of risks and benefits is usually communicated in advertising by utilizing the approved labeling in presenting fair balance and, thus, a proprietary name would not normally present risks and benefits. The comment stated that names that do present benefits within the name without context to its risk would not be considered misleading since the approved labeling would represent balance of risks and benefits.
(Response 30) Our research questions focus on whether the proprietary name alone affects consumer and HCP perceptions of risk or efficacy of the drug. Q5 helps to answer those research questions by asking participants to opine on whether the proprietary name alone indicates to them that the benefits of a product outweigh the risks. Our research will not answer the question whether a given name is misleading or whether labeling or advertising incorporating the name would violate the FD&C Act and its implementing regulations.
(Comment 31) One comment suggested that measuring attitudes toward each name (Q6) does not seem to add anything toward measuring the efficacy claims of a name and another comment recommends changing semantic differential endpoints for this item.
(Response 31) Measuring attitudes adds to our knowledge of how individuals interpret particular drug names. The semantic differential endpoints used in the original attitude question, as well as the proposed replacements, are among those recommended by prominent attitude theorists (Ref. 2). We have used these items in several studies without any issues, including studies measuring consumer and physician attitudes toward prescription drugs. Nevertheless, we will replace the negative-positive item with an item using worthless-valuable as endpoints.
(Comment 32) Five comments suggested reducing or eliminating Q7, which questions participants about their attitudes toward the drug names.
(Response 32) As noted in Response 17, in the interest of reducing time burden for participants, we will delete this question.
(Comment 33) Two comments questioned the utility of or recommended deleting Q8.
(Response 33) We agree and will delete this item.
(Comment 34) Two comments suggested that Q9 and two comments suggested that Q10 and Q11 are not applicable to the objectives of this survey.
(Response 34) Similarity, typicality, and familiarity could reasonably influence perceptions of drug names independently of the experimental manipulation. These measures are being included in this study as potential covariates.
(Comment 35) One comment suggested that Q11 is confusing, as respondents are asked to rate if they “have heard of each of the following drug names before,” after being previously told in the questionnaire introduction that the drugs “have been recently developed” and before being informed in the debriefing that the names are fictitious. Moreover, some respondents could interpret the present question as meaning “Were the following names mentioned in this survey?” which is presumably not the intent of the question.
(Response 35) We agree that this item as written was confusing, and this was confirmed by cognitive testing. Thus, we will alter the question to clarify that we are interested in whether respondents had heard the drug name prior to the study. This question will be used as a covariate in the study design.
FDA estimates the burden of this collection of information as follows:
The following references are on display with the Dockets Management Staff, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, 240-402-7500 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these are not available electronically at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 17, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the medical device HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM. HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease (
FDA has determined that the applicable regulatory review period for HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM is 4,676 days. Of this time, 3,661 days occurred during the testing phase of the regulatory review period, while 1,015 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,825 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 19 new drug applications (NDAs) 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.
Approval is withdrawn as of April 15, 2021.
Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137,
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 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.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 15, 2021. 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
Food and Drug Administration, HHS.
Notice.
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
Submit either electronic or written comments on the collection of information by May 17, 2021.
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 May 17, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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
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.
This information collection supports Agency regulations. Under section 351 of the Public Health Service Act (42 U.S.C. 262), FDA has the responsibility to issue regulations that prescribe standards designed to ensure the safety, purity, and potency of biological products and to ensure that the biologics licenses for such products are only issued when a product meets the prescribed standards. Under § 610.2 (21 CFR 610.2), the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research may at any time require manufacturers of licensed biological products to submit to FDA samples of any lot, along with the protocols showing the results of applicable tests, prior to distributing the lot of the product. In addition to § 610.2, there are other regulations that require the submission of samples and protocols for specific licensed biological products: §§ 660.6, 660.36, and 660.46 (21 CFR 660.6, 660.36, and 660.46).
Section 660.6(a) provides requirements for the frequency of submission of samples from each lot of Antibody to Hepatitis B Surface Antigen product, and § 660.6(b) provides the requirements for the submission of a protocol containing specific information along with each required sample. For § 660.6 products subject to official release by CBER, one sample from each filling of each lot is required to be submitted along with a protocol consisting of a summary of the history of manufacture of the product, including all results of each test for which test results are requested by CBER. After official release is no longer required, one sample along with a protocol is required to be submitted at 90-day intervals. In addition, samples, which must be accompanied by a protocol, may at any time be required to be submitted to CBER if continued evaluation is deemed necessary.
Section 660.36(a) requires, after each routine establishment inspection by FDA, the submission of samples from a lot of final Reagent Red Blood Cell product along with a protocol containing specific information. Section 660.36(a)(2) requires that a protocol contain information, including, but not limited to, manufacturing records, certain test records, and identity test results. Section 660.36(b) requires a copy of the antigenic constitution matrix specifying the antigens present or absent to be submitted to the CBER Director at the time of initial distribution of each lot.
Section 660.46(a) contains requirements as to the frequency of submission of samples from each lot of Hepatitis B Surface Antigen product, and § 660.46(b) contains the requirements as to the submission of a protocol containing specific information along with each required sample. For § 660.46 products subject to official release by CBER, one sample from each filling of each lot is required to be submitted along with a protocol consisting of a summary of the history or manufacture of the product, including all results of each test for which test results are requested by CBER. After notification of official release is received, one sample along with a protocol is required to be submitted at 90-day intervals. In addition, samples, which must be accompanied by a protocol, may at any time be required to be submitted to CBER if continued evaluation is deemed necessary.
Samples and protocols are required by FDA to help ensure the safety, purity, or potency of the product because of the potential lot-to-lot variability of a product produced from living organisms. In cases of certain biological products (
The following burden estimate is for the protocols required to be submitted with each sample. The collection of samples is not a collection of information under 5 CFR 1320.3(h)(2). Respondents to the collection of information under § 610.2 are manufacturers of licensed biological products. Respondents to the collection of information under §§ 660.6(b), 660.36(a)(2) and (b), and 660.46(b) are manufacturers of the specific products referenced previously in this document. The estimated number of respondents for each regulation is based on the annual number of manufacturers that submitted samples and protocols for biological products, including submissions for lot release, surveillance, licensing, or export. Based on information obtained from FDA's database system, approximately 75 manufacturers submitted samples and protocols in fiscal year (FY) 2020 under the regulations cited previously in this document. FDA estimates that approximately 72 manufacturers submitted protocols under § 610.2, and 3 manufacturers submitted protocols under the regulation (§ 660.6) for the other specific product. FDA received no submissions under §§ 660.36 or 660.46; however, FDA is using the estimate of one protocol submission under each regulation in the event that protocols are submitted in the future.
The estimated total annual responses are based on FDA's final actions completed in FY 2020 for the various submission requirements of samples and protocols for the licensed biological products. The average burden per response is based on information provided by industry. The burden estimates provided by industry ranged from 1 hour to 5.5 hours. Under § 610.2, the hours per response are based on the average of these estimates and rounded to 3 hours. Under the remaining regulations, the average burden per response is based on the higher end of the estimate (rounded to 5 or 6 hours) because more information is generally required to be submitted in the other protocols than under § 610.2.
FDA estimates the burden of this information collection as follows:
Our estimated burden for the information collection reflects an overall decrease of 1,463 hours and a corresponding decrease of 491 responses. We attribute this adjustment to a decrease in the number of submissions we received over the last few years.
Food and Drug Administration, HHS.
Notice; reopening of comment period.
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled “Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments” that appeared in the
FDA is reopening the comment period for the notice published on June 1, 2020 (85 FR 33169). Submit either electronic or written comments by April 15, 2021.
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 April 15, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Nicole Park, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7764.
In the
On January 5, 2021, the President signed into law the Orange Book Transparency Act of 2020 (Pub. L. 116-290). Section 2(e) of the Orange Book Transparency Act of 2020 requires the Agency to solicit public comment regarding the types of patent information that should be included on, or removed from, the Orange Book and to transmit to Congress a summary of such comments and actions the Agency is considering taking, if any, in response to such public comment by January 5, 2022.
In accordance with section 2(e) of the Orange Book Transparency Act of 2020, FDA is reopening the comment period for the public docket for 30 days, until April 15, 2021, to allow interested persons time to submit any additional comments regarding the types of patent information that should be included on, or removed from, the Orange Book. The Agency believes that an additional 30 days will allow adequate time for interested persons to submit comments.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that NIPRIDE RTU (sodium nitroprusside), 10 milligrams (mg)/50 milliliters (mL) (0.2 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sodium nitroprusside, 10 mg/50 mL (0.2 mg/mL), if all other legal and regulatory requirements are met.
Michael Bernstein, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6240, Silver Spring, MD 20993-0002, 301-796-3478,
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), is the subject of NDA 209387, held by Exela Pharma Sciences, LLC, and initially approved on March 8, 2017. NIPRIDE RTU is indicated for immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises; induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding; and treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance, and mean arterial blood pressure.
NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), is currently listed in the “Discontinued Drug Product List” section of the Orange Book.
Cardinal Health Regulatory Sciences submitted a citizen petition dated July 15, 2020 (Docket No. FDA-2020-P-1678), under 21 CFR 10.30, requesting that the Agency determine whether NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other
Accordingly, the Agency will continue to list NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to NIPRIDE RTU (sodium nitroprusside), 10 mg/50 mL (0.2 mg/mL), may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA 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
Submit either electronic or written comments on the collection of information by May 17, 2021.
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 May 17, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
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
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.
Some countries may require manufacturers of FDA-regulated products to provide certificates for products they wish to export to that country. Accordingly, firms exporting products from the United States often ask FDA to provide such a “certificate.” In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States, or that they meet specific U.S. requirements. In some cases, review of an FDA export certificate may be required as part of the process to register or import a product into another country. An export certificate generally indicates that the particular product is marketed in the United States or otherwise eligible for export and that the particular manufacturer has no unresolved enforcement actions pending before, or taken by, FDA.
FDA's Center for Food Safety and Applied Nutrition (CFSAN) issues export certificates for human food and cosmetic products. Interested persons may request a certificate electronically via the CFSAN Export Certification Application and Tracking System (CFSAN eCATS) or Certificate Application Process (CAP), components of the FDA Industry Systems, or by contacting CFSAN for assistance. Health certificates are the exception and are requested via email. To facilitate the application process, we have eliminated paper-based forms. For food products, respondents are able to identify facilities using their Food Facility Registration, an FDA Establishment Identifier number, or a Data Universal Numbering System number. The system uses these identifiers to locate and autopopulate name and address information, eliminating the need for users to manually enter this information and reducing the time to complete the application. For some applications, respondents can also upload product information via a spreadsheet, which reduces the time needed to enter product information, particularly for applications that include multiple products.
All information is entered using electronic Forms FDA 3613d, 3613e, and 3613k and used to evaluate certificate requests. The eCATS Module is Form 3613k, where 3613e is the Certificate of Free Sale (
While burden associated with information collection activities for export certificates issued for other FDA-regulated products is approved under OMB control number 0910-0498, this collection specifically supports export certificates issued by CFSAN. Also, because we have eliminated paper-based forms, respondents who require assistance with completing export certificate applications online may contact CFSAN directly by email (
We estimate the burden of this collection of information as follows:
Based on a review of the information collection since our last OMB approval, we have reduced our burden estimate. The burden estimate has been lowered due to a reduced number of respondents. We base our estimates on our experience with certificate applications received in the past 3 fiscal years.
Food and Drug Administration, HHS.
Notice of availability; reopening of the comment period.
The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled “Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability” that appeared in the
FDA is reopening the comment period for the notice published on December 9, 2020 (85 FR 79187). Submit either electronic or written comments on the draft guidance by June 14, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building,
Danielle Harris, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4461, Silver Spring, MD 20993-0002, 301-796-4590; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
In the
The Agency has received a request for an extension of the comment period for the draft guidance to ensure that the Agency considers additional comments on the draft guidance before it begins work on the final version of the guidance. FDA has considered the request and is reopening the comment period until June 14, 2021. The Agency believes that an additional 90 days will allow adequate time for interested persons to submit comments.
Persons with access to the internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for OCS LUNG SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Anyone with knowledge that any of the dates as published (in the
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 May 17, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and continues until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the medical device OCS LUNG SYSTEM. OCS LUNG SYSTEM is a portable organ perfusion, ventilation, and monitoring medical device indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double-lung transplantation. Subsequent to this approval, the USPTO received a patent term restoration application for OCS LUNG SYSTEM (U.S. Patent No. 6,100,082) from TransMedics, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated June 21, 2019, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of OCS LUNG SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for OCS LUNG SYSTEM is 2,341 days. Of this time, 1,672 days occurred during the testing phase of the regulatory review period, while 669 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,687 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled “Potential Medication Error Risks with Investigational Drug Container Labels.” This public meeting is being convened and supported by a partnership between the Reagan-Udall Foundation and FDA. The purpose of the public meeting is to solicit input from stakeholders (
The public meeting will be held virtually and broadcast via webcast on May 18, 2021, from 1 p.m. to 4 p.m. (Eastern Time), and May 19, 2021, from 10 a.m. to 1 p.m. (Eastern Time). Submit either electronic or written comments on this public meeting by June 18, 2021. See the
Please note that due to the impact of the COVID-19 pandemic, all meeting participants will be joining this public meeting via an online teleconferencing platform.
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 18, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Jo Wyeth, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4326, Silver Spring, MD 20993, 301-796-1985,
The purpose of the public meeting announced in this notice is to solicit input from stakeholders (
For the purpose of this meeting, an investigational drug means a drug or
The incidence and scope (
Best practice guidelines, such as those released by the American Society of Health System Pharmacists, have recommended specific content and format for investigational drug container labels (Ref. 7). In 2018, the Institute for Safe Medication Practices (ISMP) published two reports on medication error risks with investigational drugs (Refs. 8 and 9). The first report (published in April 2018) explored reported risks with investigational drug nomenclature, labeling, and packaging, which included unlabeled containers and look-alike product identifiers, confusing or missing information (
FDA reviewed additional reports of medication error concerns related to unlabeled or poorly labeled investigational drug container labels (Refs. 10 to 13). The design of container labels can impact the ability of healthcare providers to readily locate and understand critical information for product use (Ref. 14), which in turn may threaten the integrity of clinical investigations and impact the safety and protection of subjects who participate in these investigations.
During the public meeting, speakers and participants will cover a range of issues related to medication errors and investigational drugs. Discussion topics related to the format and content of information on investigational drug container labels include: (1) The prevalence and types of medication errors attributed to container labels; (2) the impact of such errors on clinical investigations; (3) information that should always be on the container label, and how that information should be presented to facilitate safe use; (4) entities responsible for labeling containers; (5) existing processes for reporting and analyzing medication errors and complaints related to container labels; and (6) global regulatory convergence and differences for the information on container labels.
If you need special accommodations due to a disability, please contact Jo Wyeth (see
Registered participants will be sent technical system requirements in advance of the event. It is recommended that you review these technical system requirements before joining the streaming web conference of the public meeting.
FDA has verified the website addresses in this document, as of the date this document publishes in the
The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857; (301) 443-6593, or visit our website at:
The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10
A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the
Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:
1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and
2. Any allegation in a petition that the petitioner either:
a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or
b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.
In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the United States Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, Maryland 20857. The Court's caption (Petitioner's Name v. Secretary of HHS) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
Comments on this ICR should be received no later than April 15, 2021.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at
Partner surveys to be conducted by HRSA might include, for example, mail, electronic, and/or telephone surveys of grantees to determine satisfaction with grant processes or technical assistance provided by a contractor, or in-class or virtual evaluation forms completed by providers who receive training from HRSA grantees to measure satisfaction with the training experience. Results of these surveys will be used to plan and redirect resources and efforts as needed to improve services and processes.
Focus groups may also be used to gain partner input that will inform the design of mail, electronic and/or telephone surveys. Focus groups, in-class evaluation forms, mail surveys, electronic surveys, and telephone surveys are expected to be the preferred data collection methods for this information collection.
A generic approval allows HRSA to conduct a limited number of partner surveys without a full-scale OMB review of each survey. If this generic information collection request receives continued approval, information on each individual partner survey will not be published in the
A 60-day notice published in the
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice of amendment.
The Acting Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.
This amendment to the Declaration is effective as of March 11, 2021.
L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; 202-260-0365,
The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.
The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, section 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act.
On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, and January 21, 2021.
On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, August 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary's Declaration and authorizations issued by the Department's Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration's liability protections; made explicit that there are substantive Federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID-19 pandemic among Federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full. (85 FR 79190, December 9, 2020). On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 9516, February 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, February 22, 2021).
The Acting Secretary now amends section V of the Declaration to revise subsection (f) to clarify that observers should be experienced in administering intramuscular injections; delete subsection (g), change the prior subsection (h) to subsection (g) and add a new subsection (h) to add additional categories of qualified persons covered under the PREP Act, and thus authorizes: (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph:
1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;
2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is
3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;
Subject to the following requirements:
i. The vaccine must be authorized, approved, or licensed by the FDA;
ii. Vaccination must be ordered and administered according to ACIP's COVID-19 vaccine recommendation(s);
iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention COVID-19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;
iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID-19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;
v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation;
vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and
vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID- 19 vaccine(s).
Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. “Qualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).
By this amendment to the Declaration, the Acting Secretary identifies an additional categories of persons who are qualified persons under section 247d-6d(i)(8)(B): licensed healthcare professionals who may not ordinarily prescribe, dispense or administer vaccines, additional healthcare providers with recently expired licenses, and students in a healthcare profession training program, subject to appropriate training, supervision, and other specified requirements. The Acting Secretary anticipates that significantly more vaccines will be available to the public in the spring and summer of 2021, and wants to ensure that states have the greatest flexibility in mobilizing the workforce they will need to engage in the largest vaccination effort in our Nation's history. This amendment thus expands the pool of vaccinators to individuals who have or can obtain training and the capability to administer vaccines even if prescribing, dispensing and administering vaccines is not within the scope of their license or usual responsibilities, allowing States, Territories, local areas and Tribes to use these individuals in their vaccination programs.
The Acting Secretary has determined that there is an urgent need to expand the pool of available COVID-19 vaccinators in order to respond effectively to the pandemic. As vaccine supply is made more widely available over the coming months, health care system capacity and the vaccination workforce are likely to become increasingly strained throughout the Nation.
As qualified persons, these healthcare professionals and students in healthcare profession training programs will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit the healthcare professionals and students in healthcare profession training programs who are a “qualified person” from prescribing, dispensing, or administering COVID-19 vaccines or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are
The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID-19 as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID-19 vaccination program.
Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.
Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (December 9, 2020).
1. Covered Persons, section V, delete in full and replace with:
Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. “Order” as used herein and in guidance issued by the Office of the Assistant Secretary for Health
(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration;
(b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act;
(c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act;
(d) A State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy),
i. The vaccine must be authorized, approved, or licensed by the FDA;
ii. In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP's COVID-19 vaccine recommendation(s);
iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP's standard immunization schedule;
iv. The licensed pharmacist must have completed the immunization training that the licensing State requires for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;
v. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines;
vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation;
vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;
viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;
ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and
x. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.
(f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID-19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: (i) Documentation of completion of the Centers for Disease Control and Prevention COVID-19 (CDC) Vaccine Training Modules
(g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met: the executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the
(h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph:
1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;
2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General;
3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering vaccines as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID-19 vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the COVID-19 vaccine covered countermeasure is administered;
Subject to the following requirements:
i. The vaccine must be authorized, approved, or licensed by the FDA;
ii. Vaccination must be ordered and administered according to ACIP's COVID-19 vaccine recommendation(s);
iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention COVID-19 Vaccine Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;
iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID-19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;
v. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation;
vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and
vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10
2. Effective Time Period, section XII, delete in full and replace with:
Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October l, 2024.
Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October l, 2024.
Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as
Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect, or (b) October l, 2024, whichever occurs first.
Liability protections for Qualified Persons under section V(f) of the declaration begin on February 2, 2021, and last through October 1, 2024.
Liability protections for Qualified Persons under section V(g) of the declaration begin on February 16, 2021, and last through October 1, 2024.
Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021 and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024.
42 U.S.C. 247d-6d.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Dental and Craniofacial Research.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until May 17, 2021.
All submissions received must include the OMB Control Number 1615-0046 in the body of the letter, the agency name and Docket ID USCIS-2006-0062. Submit comments via the Federal eRulemaking Portal website at
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, telephone number (240) 721-3000 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
You may access the information collection instrument with instructions or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
(7)
U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
Comments are encouraged and will be accepted until April 15, 2021.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be submitted via the Federal eRulemaking Portal website at
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, Telephone number (240) 271-3000 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
The information collection notice was previously published in the
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
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(7)
Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice.
This notice establishes Renewal Funding Inflation Factors (RFIFs) to adjust Fiscal Year (FY) 2021 renewal funding for the Housing Choice Voucher (HCV) Program of each public housing agency (PHA), as required by the Consolidated Appropriations Act, 2021. The notice apportions the expected percent change in national Per Unit Cost (PUC) for the HCV program, 5.80 percent, to each PHA based on the change in Fair Market Rents (FMRs) for their operating area to produce the FY 2021 RFIFs. HUD's FY 2021 methodology is the same as that which was used in FY 2020.
Miguel A. Fontanez, Director, Housing Voucher Financial Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, telephone number 202-402-4212; or Adam Bibler, Program Parameters and Research Division, Office of Policy Development and Research, telephone number 202-402-6057, for technical information regarding the development of the schedules for specific areas or the methods used for calculating the inflation factors. Their mailing address is: Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410. Hearing- or speech-impaired persons may contact the Federal Relay Service at 800-877-8339 (TTY). (Other than the “800” TTY number, the above-listed telephone numbers are not toll free.)
Division L, Title II of the Consolidated Appropriations Act, 2021 requires that the HUD Secretary, for the calendar year 2021 funding cycle, provide renewal funding for each public housing agency (PHA) based on validated voucher management system (VMS) leasing and cost data for the prior calendar year and by applying an inflation factor as established by the Secretary, by notice published in the
RFIFs are used to adjust the allocation of Housing Choice Voucher (HCV) program funds to PHAs for local changes in rents, utility costs, and tenant incomes. To calculate the RFIFs, HUD first forecasts a national inflation factor, which is the annual change in the national average Per Unit Cost (PUC). HUD then calculates individual area inflation factors, which are based on the annual changes in the two-bedroom Fair Market Rent (FMR) for each area. Finally, HUD adjusts the individual area inflation factors to be consistent with the national inflation factor.
HUD's forecast of the national average PUC is based on forecasts of gross rent and tenant income. Each forecast is produced using historical and forecasted macroeconomic data as independent variables, where the forecasts are consistent with the Economic Assumptions of the Administration's FY 2022 Budget. The forecast of gross rent is itself based on forecasts of the Consumer Price Index (CPI) Rent of Primary Residence Index and the CPI Fuels and Utilities Index. Forecasted values of these series are applied to the FY 2021 national average two-bedroom FMR to produce a CY 2021 value. A “notional” PUC is calculated as the difference between gross rent value and 30 percent of tenant income (the standard for tenant rent contribution in the voucher program). The change between the forecasted CY 2021 notional PUC and the CY 2020 notional PUC is the expected national change in PUC, or 5.80 percent. HUD uses a notional PUC as opposed to the actual PUC to project costs that are consistent with PHAs leasing the same number and quality of units. For more information on HUD's forecast methodology, see 82 FR 26710.
The inflation factor for an individual geographic area is based on the annualized change in the area's FMR between FY 2020 and FY 2021. These changes in FMRs are then scaled such that the voucher-weighted average of all individual area inflation factors is equal to the national inflation factor,
HUD subsequently applies the calculated individual area inflation factors to eligible renewal funding for each PHA based on VMS leasing and cost data for the prior calendar year.
As explained above, inflation factors based on area FMR changes are produced for all FMR areas and applied to eligible renewal funding for each PHA. The tables showing the RFIFs, available electronically from the HUD data information page, list the inflation factors for each FMR area on a state-by-state basis. The inflation factors use the same OMB metropolitan area definitions, as revised by HUD, that are used in the FY 2021 FMRs. PHAs should refer to the Area Definitions Table on the following web page to make certain that they are referencing the correct inflation factors:
This notice involves a statutorily required establishment of a rate or cost determination which does not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Drug Enforcement Administration, Justice.
Notice of application; correction.
The Drug Enforcement Administration (DEA) published a document in the
In the
Drug Enforcement Administration, Justice.
Notice of application.
Purisys, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 15, 2021. Such persons may also file a written request for a hearing on the application on or before April 15, 2021.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
In accordance with 21 CFR 1301.34(a), this is notice that on February 17, 2021, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia 30601, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import drug code 8501, Phenylacetone and drug code 9670, Poppy Straw Concentrate to bulk manufacture other controlled substances for distribution to its customers. The company plans to import impurities of buprenorphine that have been determined by DEA to be captured under drug code 9333, Thebaine. In reference to drug codes 73760, Marihuana and 7370, Tetrahydrocannabinols the company plans to import a Synthetic Cannabidiol and a Synthetic Tetrahydrocannabinol. No other activity for these drug codes is authorized for this registration. Placement of these drug codes on the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-
10:00 a.m., Thursday, March 18, 2021.
Due to the COVID-19 Pandemic, the meeting will be open to the public via live webcast only. Visit the agency's homepage (
This meeting will be open to the public.
1. NCUA Rules and Regulations, Central Liquidity Facility.
2. NCUA Rules and Regulations, Asset Thresholds Pertaining to Large Credit Unions.
3. Board Briefing, NCUA Guaranteed Note and Asset Management Estates Programs.
Melane Conyers-Ausbrooks, Secretary of the Board, Telephone: 703-518-6304.
9:30 a.m., Tuesday, April 6, 2021.
Virtual.
The one item may be viewed by the public through webcast only.
Candi Bing at (202) 590-8384 or by email at
This meeting will take place virtually. The public may view it through a live or archived webcast by accessing a link under “Webcast of Events” on the NTSB home page at
There may be changes to this event due to the evolving situation concerning the novel coronavirus (COVID-19). Schedule updates, including weather-related cancellations, are also available at
The National Transportation Safety Board is holding this meeting under the Government in the Sunshine Act, 5 U.S.C. 552(b).
Nuclear Regulatory Commission.
Exemptions; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued exemptions in response to a request to reduce the required level of primary offsite liability insurance from $450 million to $100 million and to eliminate the requirement to carry secondary financial protection for Three Mile Island Nuclear Station, Unit 1 and to reduce the required level of primary offsite liability insurance in the event of an extraordinary nuclear occurrence from $200 million to $100 million for Three Mile Island Nuclear Station, Unit 2.
The exemptions were issued on March 9, 2021.
Please refer to Docket ID NRC-2021-0069 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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Theodore Smith, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6721, email:
The text of the exemptions is attached.
For the Nuclear Regulatory Commission.
By letter dated June 20, 2017 (Agencywide Documents Access and Management System [ADAMS] Accession No. Main Library [ML] ML17171A151), Exelon Generation Company, LLC (Exelon) certified to the U.S. Nuclear Regulatory Commission (NRC, the Commission) that it planned to permanently cease power operations at Three Mile Island Nuclear Station, Unit 1 (TMI-1) on or about September 30, 2019. On September 20, 2019, Exelon permanently ceased power operations at TMI-1. By letter dated September 26, 2019 (ADAMS Accession No. ML19269E480), Exelon certified to the NRC that the fuel was permanently removed from the TMI-1 reactor vessel and placed in the spent fuel pool (SFP) as of September 26, 2019. Accordingly,
Three Mile Island Nuclear Station, Unit 2 (TMI-2) was a 2,770 megawatts thermal pressurized light-water reactor supplied by Babcock & Wilcox that was issued an operating license on February 8, 1978 and began commercial operations on December 30, 1978. On March 28, 1979, TMI-2 experienced an accident that resulted in severe damage to the reactor core. Subsequently, approximately 99 percent of the fuel and damaged core material was removed from the TMI-2 reactor vessel and associated systems and shipped to the U.S. Department of Energy Idaho National Laboratory. After the completion of accident recovery operations, TMI-2 was placed in a Post-Defueling Monitored Storage (PDMS) state on September 14, 1993, with a possession only license that authorizes the possession of byproduct and special nuclear materials but not the operation of the reactor.
Following the TMI-2 accident, in 1982, the NRC granted an exemption from the requirements of 10 CFR 140.11(a)(4) for TMI-1 and TMI-2 (ML19141A211). The exemption allowed the licensees to provide two endorsements to meet the financial protection requirements of subsection 170 of the Atomic Energy Act of 1954, as amended. The first endorsement, Endorsement No. 43, restored the limits of liability to the amounts listed in other endorsements upon an “extraordinary nuclear occurrence” (ENO) being declared by the NRC arising out of the ownership, operation, maintenance, or use of TMI-1 and/or TMI-2. The second endorsement, Endorsement No. 44, increased the TMI-1 liability limit to the NRC limit in effect at the time for any bodily injury or property damages caused by a nuclear energy hazard, but increased the TMI-2 liability limit only in the event the NRC declared an ENO on or after May 1, 1979. Subsequently, in 1994, the NRC granted TMI-2 an exemption from participation in secondary financial protection (ADAMS Accession No. 9408050260 [Legacy Library]). The exemptions herein do not impact the exemptions already in place.
By letter dated January 3, 2020 (ADAMS Accession No. ML20003E096), Exelon requested an exemption from 10 CFR 140.11(a)(4) to reduce the required level of primary offsite liability insurance from $450 million to $100 million and to eliminate the requirement to carry secondary financial protection for TMI-1 and TMI-2 Solutions, LLC (TMI-2 Solutions)
The regulation at 10 CFR 140.11(a)(4) requires each licensee to have and maintain primary financial protection in an amount of $450 million. In addition, the licensee is required to participate in an industry retrospective rating plan (secondary financial protection) that commits each licensee to pay into an insurance pool to be used for damages that may exceed primary insurance coverage. Participation in the industry retrospective rating plan will subject the licensee to deferred premium charges up to a maximum total deferred premium of $131,056,000 with respect to any nuclear incident at any operating nuclear power plant and up to a maximum annual deferred premium of $20,496,000 per incident.
Many of the accident scenarios postulated in the updated safety analysis reports for operating power reactors involve failures or malfunctions of systems, which could affect the fuel in the reactor core and, in the most severe postulated accidents, would involve the release of large quantities of fission products. With the permanent cessation of power operations at TMI-1 and the permanent removal of the fuel from the reactor vessel, and the PDMS state of TMI-2 with no fuel assemblies in the TMI-2 reactor or the TMI-2 SFP, many accidents are no longer possible. Similarly, the associated risk of offsite liability damages that would require insurance or indemnification is commensurately lower for such plants. Therefore, Exelon requested an exemption from 10 CFR 140.11(a)(4) to permit a reduction in primary offsite liability insurance and to withdraw from participation in the industry retrospective rating plan for TMI-1. Additionally, TMI-2 Solutions requested an exemption from 10 CFR 140.11(a)(4) to permit a reduction in primary offsite liability insurance to $100 million in the event of an ENO for TMI-2.
Pursuant to 10 CFR 140.8, “Specific exemptions,” the Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in 10 CFR part 140 when the exemptions are authorized by law and are otherwise in the public interest. The NRC staff has reviewed the licensees' request for exemptions from 10 CFR 140.11(a)(4) and has concluded that the requested exemptions are authorized by law and are otherwise in the public interest.
The Price Anderson Act of 1957 (PAA) requires that nuclear power reactor licensees have insurance to compensate the public for damages arising from a nuclear incident. Specifically, the PAA requires licensees of facilities with a “rated capacity of 100,000 electrical kilowatts or more” to maintain the maximum amount of primary offsite liability insurance commercially available (currently $450 million) and a specified amount of secondary insurance coverage (currently up to $131,056,000 per reactor). In the event of an accident causing offsite damages in excess of $450 million, each licensee would be assessed a prorated share of the excess damages, up to $131,056,000 per reactor, for a total of approximately $13 billion per nuclear incident. The NRC's regulations at 10 CFR 140.11(a)(4) implement these PAA insurance requirements and set forth the amount of primary and secondary insurance each power reactor licensee must have.
As noted above, the PAA requirements with respect to primary and secondary insurance and the implementing regulations at 10 CFR 140.11(a)(4) apply to licensees of facilities with a “rated capacity of 100,000 electrical kilowatts or more.” In accordance with 10 CFR 50.82(a)(2), the license for a power reactor no longer authorizes operation of the reactor or emplacement or retention of fuel into the reactor vessel upon the docketing of the certifications for permanent cessation of operations and permanent removal of fuel from the reactor vessel, or when a final legally effective order to permanently cease operations has come into effect. Therefore, the reactor cannot be used to generate power.
Accordingly, a reactor that is undergoing decommissioning has no “rated capacity.” Thus, the NRC may take the reactor licensee out of the category of reactor licensees that are required to maintain the maximum available insurance and to participate in
The financial protection limits of 10 CFR 140.11(a)(4) were established to require a licensee to maintain sufficient insurance, as specified under the PAA, to satisfy liability claims by members of the public for personal injury, property damage, and the legal cost associated with lawsuits as the result of a nuclear accident at an operating reactor with a rated capacity of 100,000 kilowatts electric or greater. Thus, the insurance levels established by this regulation, as required by the PAA, were associated with the risks and potential consequences of an accident at an operating reactor with a rated capacity of 100,000 kilowatts electric or greater.
The legal and associated technical basis for granting exemptions from 10 CFR part 140 is set forth in SECY-93-127, “Financial Protection Required of Licensees of Large Nuclear Power Plants During Decommissioning,” dated May 10, 1993 (ADAMS Accession No. ML12257A628). The legal analysis underlying SECY-93-127 concluded that, upon a technical finding that lesser potential hazards exist after permanent cessation of power operations (and the reactor having no “rated capacity”), the Commission has the discretion under the PAA to reduce the amount of insurance required of a licensee undergoing decommissioning.
As a technical matter, the fact that a reactor has permanently ceased power operations is not itself determinative as to whether a licensee may cease providing the offsite liability coverage required by the PAA and 10 CFR 140.11(a)(4). In light of the presence of freshly discharged irradiated fuel in the SFP at a recently shut down reactor, the potential for an offsite radiological release from a zirconium fire with consequences comparable in some respects to an operating reactor accident remains. That risk is very low at the time of reactor shut down because of design provisions that prevent a significant reduction in coolant inventory in the SFP under normal and accident conditions and becomes no longer credible once the continual reduction in decay heat provides ample time to restore coolant inventory and permits air-cooling in a drained SFP. After that time, the probability of a large offsite radiological release from a zirconium fire is negligible for permanently shut down reactors, but the SFP is still operational and an inventory of radioactive materials still exists onsite. Therefore, an evaluation of the potential for offsite damage is necessary to determine the appropriate level of offsite insurance post shut down, in accordance with the Commission's discretionary authority under the PAA to establish an appropriate level of required financial protection for such permanently shut down facilities.
The NRC staff has conducted an evaluation and concluded that, aside from the handling, storage, and transportation of spent fuel and radioactive materials for a permanently shut down and defueled reactor, no reasonably conceivable potential accident exists that could cause significant offsite damage. During normal power reactor operations, the forced flow of water through the reactor coolant system (RCS) removes heat generated by the reactor. The RCS transfers this heat away from the reactor core by converting reactor feedwater to steam, which then flows to the main turbine generator to produce electricity. Most of the accident scenarios postulated for operating power reactors involve failures or malfunctions of systems that could affect the fuel in the reactor core, which in the most severe postulated accidents would involve the release of large quantities of fission products. With the permanent cessation of reactor operations at the TMI site and the permanent removal of the fuel from the reactor core, such accidents are no longer possible. The reactor, RCS, and supporting systems no longer operate and have no function related to the storage of the irradiated fuel. Therefore, postulated accidents involving failure or malfunction of the reactor, RCS, or supporting systems are no longer applicable.
During reactor decommissioning, the principal radiological risks are associated with the storage of spent fuel onsite. On a case-by-case basis, licensees undergoing decommissioning have been granted permission to reduce the required amount of primary offsite liability insurance coverage from $450 million to $100 million and to withdraw from the secondary insurance pool. One of the technical criteria for granting the exemption is that the possibility of a design-basis event that could cause significant offsite damage has been eliminated.
In its exemption request, Exelon described both design-basis and beyond-design-basis events involving irradiated fuel stored in the TMI-1 SFP. Exelon stated, and the NRC staff agrees, that while spent fuel remains in the SFP, the only postulated design-basis accident that would remain applicable to TMI-1 in the permanently defueled condition that could contribute a significant dose is a fuel handling accident (FHA) in the Reactor Building, where the SFP is located. For completeness, the NRC staff also evaluated the applicability of other design-basis accidents documented in the TMI-1 Updated Final Safety Analysis Report (UFSAR) (ADAMS Package Accession No. ML18117A343) to ensure that these accidents would not have consequences that could potentially exceed the 10 CFR 50.67 dose limits and Regulatory Guide 1.183, “Alternative Radiological Source Terms for Evaluating Design Basis Accidents at Nuclear Power Reactors,” dose acceptance criteria or approach the U.S. Environmental Protection Agency (EPA) early phase protective action guides (PAGs).
In the TMI-1 UFSAR, the licensee has determined that 365 days after shut down, the FHA doses would decrease to a level that would not warrant protective actions under the EPA early phase PAG framework, notwithstanding meeting the dose limit requirements under 10 CFR 50.67 and dose acceptance criteria under Regulatory Guide 1.183. The NRC staff notes that the doses from an FHA are dominated by the isotope Iodine-131. TMI-1 permanently ceased power operations on September 20, 2019. With 488 days of decay, the thyroid dose from an FHA would be negligible and the only isotope remaining in significant amounts, among those postulated to be released in a design-basis FHA, would be Krypton-85. Since Krypton-85 primarily decays by beta emission, the calculated skin dose from an FHA analysis would make an insignificant contribution to the total effective dose equivalent, which is the parameter of interest in the determination of the EPA early phase PAGs for sheltering or evacuation. The NRC staff concludes that the dose consequence from an FHA for the permanently shut down TMI-1 would not approach the EPA early phase PAGs. Therefore, any offsite consequence from a design-basis radiological release is highly unlikely and, thus, a significant amount of offsite liability insurance coverage is not required.
The only beyond design-basis event that has the potential to lead to a significant radiological release at a permanently shut down and defueled reactor is a zirconium fire. The zirconium fire scenario is a postulated, but highly unlikely, accident scenario that involves the loss of water inventory from the SFP resulting in a significant heat up of the spent fuel and culminating in substantial zirconium cladding oxidation and fuel damage. The probability of a zirconium fire scenario is related to the decay heat of the irradiated fuel stored in the SFP. Therefore, the risks from a zirconium
In the analysis provided in Attachment 2, “Three Mile Island Nuclear Station Zirconium Fire Analysis for Drained Spent Fuel Pool (Calculation C-1101-202-E410-476, Revision 1),” to the letter dated July 1, 2019 (ADAMS Accession No. ML19182A104), the licensee compared the conditions for the hottest fuel assembly stored in the SFP to a criterion proposed in SECY-99-168, “Improving Decommissioning Regulations for Nuclear Power Plants,” dated June 30, 1999 (ADAMS Accession No. ML12265A598), applicable to offsite emergency response for the unit in the decommissioning process. This criterion considers the time for the hottest assembly to heat up from 30 degrees Celsius (°C) to 900 °C adiabatically. If the heat up time is greater than 10 hours, then offsite emergency preplanning involving the plant is not necessary. Based on the limiting fuel assembly for decay heat and adiabatic heat up analysis presented in Attachment 2, at 488 days (approximately 16 months) after permanent cessation of power operations, the time for the hottest fuel assembly to reach 900 °C is 10 hours after the assemblies have been uncovered. As stated in NUREG-1738, “Technical Study of Spent Fuel Pool Accident Risk at Decommissioning Nuclear Power Plants,” dated February 2001 (ADAMS Accession No. ML010430066), 900 °C is an acceptable temperature to use for assessing onset of fission product release under transient conditions to establish the critical decay time for determining the availability of 10 hours for deployment of mitigation equipment and, if necessary, for offsite agencies to take appropriate action to protect the health and safety of the public if fuel and cladding oxidation occurs in air.
The NRC staff reviewed the calculation to verify that important physical properties of materials were within acceptable ranges and the results were accurate. The NRC staff determined that physical properties were appropriate and completed independent confirmatory calculations that produced similar results. Therefore, the NRC staff found that after 488 days of decay, at least 10 hours would be available before a significant offsite release could begin. The NRC staff concluded that the adiabatic heat up calculation provided an acceptable method for determining the minimum time available for deployment of mitigation equipment and, if necessary, implementing measures under a comprehensive general emergency plan.
In this regard, one technical criterion for relieving decommissioning reactor licensees from the insurance obligations applicable to an operating reactor is a finding that the heat generated by the SFP has decayed to the point where the possibility of a zirconium fire is highly unlikely. This was addressed in SECY-93-127, where the NRC staff concluded that there was a low likelihood and reduced short-term public health consequences of a zirconium fire once a decommissioning plant's spent fuel has sufficiently decayed. In its Staff Requirements Memorandum, “Financial Protection Required of Licensees of Large Nuclear Power Plants during Decommissioning,” dated July 13, 1993 (ADAMS Accession No. ML003760936), the Commission approved a policy that authorized, through the exemption process, withdrawal from participation in the secondary insurance layer and a reduction in commercial liability insurance coverage to $100 million when a licensee is able to demonstrate that the spent fuel could be air-cooled if the SFP was drained of water.
The NRC staff has used this technical criterion to grant similar exemptions to other decommissioning reactors (
Additional discussions of other decommissioning reactor licensees that have received exemptions to reduce their primary insurance level to $100 million are provided in SECY-96-256, “Changes to the Financial Protection Requirements for Permanently Shutdown Nuclear Power Reactors, 10 CFR 50.54(w) and 10 CFR 140.11,” dated December 17, 1996 (ADAMS Accession No. ML15062A483). These prior exemptions were based on the licensee demonstrating that the SFP could be air-cooled consistent with the technical criterion discussed above.
The NRC staff has evaluated the issue of zirconium fires in SFPs and presented an independent evaluation of an SFP subject to a severe earthquake in NUREG-2161, “Consequence Study of a Beyond-Design-Basis Earthquake Affecting the Spent Fuel Pool for a U.S. Mark l Boiling Water Reactor,” dated September 2014 (ADAMS Accession No. ML14255A365). This evaluation concluded that, for a representative boiling-water reactor, fuel in a dispersed high-density configuration would be adequately cooled by natural circulation air flow within several months after discharge from a reactor if the pool was drained of water.
In its exemption request, Exelon compared TMI-1 fuel storage parameters with those used in NRC generic evaluations of fuel cooling included in NUREG/CR-6451, “A Safety and Regulatory Assessment of Generic BWR [Boiling-Water Reactor] and PWR [Pressurized-Water Reactor] Permanently Shut down Nuclear Power Plants,” dated August 1997 (ADAMS Accession No. ML082260098). The analysis described in NUREG/CR-6451 determined that natural air circulation would adequately cool fuel that has decayed for 17 months after operation in a typical PWR, which is a slightly longer decay time than the zirconium fire period of 488 days on which the TMI-1 exemption request is based. In order to evaluate if the TMI-1 decay period was conservative, Exelon examined the decay heat at TMI-1 and determined that the average fuel assembly decay heat for the most recently offloaded TMI-1 spent fuel at 488 days after shut down will be approximately 3 percent less than the decay heat for the average fuel assembly at 519 days for the representative PWR plant in NUREG/CR-6451.
A comparison of the parameters for the fuel assembly power, power density, and hydraulic resistance of the 15x15 fuel assemblies at TMI-1 indicated that these parameters are less than those of the 17x17 fuel assemblies modeled in NUREG/CR-6451. Therefore, the NUREG/CR-6451 fuel assembly model is conservative for TMI-1. The SFP rack configuration was also evaluated and found to be conservative for TMI-1. The configuration/hydraulic resistance of the TMI-1 downcomers and plenum underneath the SFP storage racks is bounded by that modeled in NUREG/CR-6451. Additionally, the hydraulic resistance of the SFP rack loaded cells is less than that of the SFP rack configuration modeled in NUREG/CR-6451. The bottom orifices on all TMI-1 SFP racks are equal to or larger than those modeled in NUREG/CR-6451, which also makes the estimates for TMI-1 more conservative.
As a result of the comparison, Exelon concluded that the TMI-1 SFP conditions are bounded by the NUGREG/CR-6451 benchmark and that the TMI-1 spent fuel would be air-coolable at 488 days after permanent shut down. Therefore, at 16 months after permanent shut down, the NRC staff has reasonable assurance that fuel stored in the TMI-1 SFP would be adequately air-cooled in the unlikely event the SFP completely drained.
In SECY-00-0145, “Integrated Rulemaking Plan for Nuclear Power Plant Decommissioning,” dated June 28, 2000, and SECY-01-0100, “Policy Issues Related to Safeguards, Insurance, and Emergency Preparedness Regulations at Decommissioning Nuclear Power Plants Storing Fuel in Spent Fuel Pools,” dated June 4, 2001 (ADAMS Accession Nos. ML003721626 and ML011450420, respectively), the NRC staff discussed additional information concerning SFP zirconium fire risks at decommissioning reactors and associated implications for offsite insurance. Analyzing when the spent fuel stored in the SFP is capable of adequate air-cooling is one measure that demonstrates when the probability of a zirconium fire would be exceedingly low.
In addition, the licensee performed adiabatic heat up analyses to determine a dose rate curve at the Exclusion Area Boundary (EAB) and Control Room. Although the analysis described above demonstrated that a significant release of radioactive material from the spent fuel in the absence of water cooling is not possible after 488 days following permanent cessation of power operations, the potential exists for radiation exposure to an offsite individual in the event that shielding of the fuel is lost. The site-specific offsite and Control Room radiological impacts of a postulated complete loss of SFP water were assessed in TMI-1 Technical Evaluation 623073, “TMI Spent Fuel Pool Draindown Shine Dose Rate Evaluation, Revision 0.” With a decay of 365 days from shut down, the dose rate at the EAB would be 4.04 × 10
The licensee's adiabatic heat up analyses demonstrate that 16 months after the permanent cessation of operations, there would be at least 10 hours to take mitigative actions in response to events that could lead to a zirconium fire. In addition, the TMI-1 SFP conditions were determined to be bounded by the analysis of the NUREG/CR-6451 benchmark demonstrating that the SFP would be air-coolable at 488 days after permanent cessation of operations.
In its exemption request, Exelon furnished the following information: “Because of the length of time it would take for the adiabatic heat up to occur, there is ample time to respond (≥10 hours) to any drain down event that might cause such an occurrence by restoring [SFP] cooling or makeup or providing [SFP] spray. As a result, the likelihood that such a scenario would progress to a zirconium fire is not deemed credible.”
In the NRC staff's evaluation contained in SECY-20-0041, “Request by Exelon Generation Company, LLC for Exemptions from Certain Emergency Planning Requirements for the Three Mile Island Nuclear Station,” dated May 5, 2020 (ADAMS Accession No. ML19311C763), the NRC staff assessed the Exelon accident analyses associated with the radiological risks from a zirconium fire at a permanently shut down and defueled TMI site. For the highly unlikely beyond design-basis accident scenario where the SFP coolant inventory is lost in such a manner that all methods of heat removal from the spent fuel are no longer available, the NRC staff found that there will be a minimum of 10 hours from the initiation of the accident until the cladding reaches a temperature where offsite radiological release might occur. The NRC staff finds that 10 hours is sufficient time to support deployment of mitigation equipment, consistent with plant conditions, to prevent the zirconium cladding from reaching a point of rapid oxidation.
The NRC staff has determined that the licensee's proposed reduction in primary offsite liability coverage to a level of $100 million and the licensee's proposed withdrawal from participation in the secondary insurance pool for offsite financial protection are consistent with the policy established in SECY-93-127 and subsequent insurance considerations resulting from zirconium fire risks, as discussed in SECY-00-0145 and SECY-01-0100. The NRC has previously determined in SECY-00-0145 that the minimum offsite financial protection requirement may be reduced to $100 million and that secondary insurance is not required once it is determined that the spent fuel in the SFP is no longer thermal-hydraulically capable of sustaining a zirconium fire based on a plant-specific analysis. In addition, the NRC staff notes that similar exemptions from these insurance requirements have been granted to other permanently shut down and defueled power reactors upon satisfactory demonstration that zirconium fire risk from the irradiated fuel stored in the SFP is of negligible concern.
As provided in SECY-93-127, the NRC staff included in its recommendations that using the standards set forth in SECY-93-127, primary financial protection could be reduced to $100 million for nuclear power plants that have had the requisite spent fuel cooling period. However, as specifically mentioned in SECY-93-127 (Note 5), for TMI-2 “primary financial protection covering the site will remain at $200 million [the full required regulatory value at the time of the issuance of SECY-93-127] because there is at least one other operating reactor on [the] site.” Since TMI-1 is no longer authorized to operate, there is no longer at least one other operating reactor on the TMI site. Therefore, TMI-2 Solutions requested a corresponding exemption from 10 CFR 140.11(a)(4) for TMI-2 to permanently reduce the required level of primary offsite liability insurance for ENOs from $200 million to $100 million. As discussed above, TMI-2 is maintained in a PDMS state with a possession only license that authorizes the possession of byproduct and special nuclear materials but not the operation of the reactor.
The NRC staff evaluated the applicability of a waste gas tank rupture as documented in the TMI-1 UFSAR, and the applicability of any unanticipated releases as documented in the Unanticipated Events Analysis in the TMI-2 Post-Defueling Monitored Storage Safety Analysis Report (ADAMS Package Accession No. ML17236A295), to ensure that these accidents would not have consequences that could potentially exceed the 10 CFR 50.67 dose limits and Regulatory Guide 1.183 dose acceptance criteria or approach the EPA early phase PAGs. Exelon stated that the bounding event for TMI-2 is a fire in the Reactor Building with the Reactor Building Purge System in operation. The NRC staff reviewed the assumptions, inputs, and methods used by Exelon to assess the radiological impacts of the requested exemption. The NRC staff concludes that Exelon has demonstrated that the dose consequences for postulated accidents at the permanently defueled TMI facility would not have consequences that could potentially exceed the applicable dose limits in 10 CFR 100.11, “Determination of exclusion area, low population zone, and population center distance,” and 10 CFR 50.67, and the dose acceptance criteria in Regulatory Guide 1.183. The analysis demonstrates
The most significant accident sequence for a permanently defueled and shut down reactor involves the complete loss of water from the spent fuel pool. As the NRC previously recognized when issuing an exemption for TMI-2 from the requirement to participate in secondary financial protection, this accident scenario is not credible or reasonably conceivable at TMI-2 since the spent fuel pool is drained and no spent fuel is stored in the pool. Since TMI-2 is being maintained in a PDMS state with the reactor defueled and no fuel in the TMI-2 SFP, TMI-2 meets the criterion established in SECY-93-127 for relief from the requirements to maintain primary offsite liability insurance for ENOs at a level above $100 million. As discussed previously, TMI-2 has already received an exemption from participation in the secondary retrospective insurance pool. Because the criteria presented in SECY-93-127 for removal from the secondary financial protection requirement are identical to those for reducing the primary offsite liability insurance, there is precedent for allowing the reduction of offsite liability insurance for TMI (as a site), once TMI-1 has met the criteria in SECY-93-127. In addition, the NRC staff notes that similar exemptions from these insurance requirements have been granted to other permanently shut down and defueled power reactors, upon satisfactory demonstration that zirconium fire risk from the irradiated fuel stored in the SFP is of negligible concern.
The PAA and its implementing regulations in 10 CFR 140.11(a)(4) require licensees of nuclear reactors that have a rated capacity of 100,000 kilowatts electric or more to have and maintain $450 million in primary financial protection and to participate in a secondary retrospective insurance pool. In accordance with 10 CFR 140.8, the Commission may grant exemptions from the regulations in 10 CFR part 140 as the Commission determines are authorized by law. The legal and associated technical basis for granting exemptions from 10 CFR part 140 are set forth in SECY-93-127. The legal analysis underlying SECY-93-127 concluded that, upon a technical finding that lesser potential hazards exist after permanent cessation of operations, the Commission has the discretion under the PAA to reduce the amount of insurance required of a licensee undergoing decommissioning.
Based on its review of the exemption requests, the NRC staff concludes that the technical criteria for relieving Exelon and TMI-2 Solutions from their existing primary and/or secondary insurance obligations have been met. As explained above, the NRC staff found that no reasonably conceivable design-basis accident exists that could cause an offsite release greater than the EPA PAGs and, therefore, that any offsite consequence from a design-basis radiological release is highly unlikely and the need for a significant amount of offsite liability insurance coverage is unwarranted. Additionally, the NRC staff determined that, after 16 months decay, the fuel stored in the TMI-1 SFP will be capable of being adequately cooled by air in the highly unlikely event of pool drainage. Moreover, in the highly unlikely beyond design-basis accident scenario where the SFP coolant inventory is lost in such a manner that all methods of heat removal from the spent fuel are no longer available, the NRC staff has determined that at least 10 hours would be available and is sufficient time to support deployment of mitigation equipment, consistent with plant conditions, to prevent the zirconium cladding from reaching a point of rapid oxidation. Thus, the NRC staff concludes that the fuel stored in the TMI-1 SFP will have decayed sufficiently by the requested effective date for the exemptions of 16 months after permanent cessation of power operations to support a reduction in the required insurance consistent with SECY-00-0145. Moreover, since the criteria presented in SECY-93-127 for removal from the secondary financial protection requirement are identical to those for reducing the primary offsite liability insurance, there is precedent for allowing the reduction of offsite liability insurance for TMI (as a site), once TMI-1 has met the criteria in SECY-93-127.
The NRC staff has determined that granting the licensees' proposed exemptions will not result in a violation of the Atomic Energy Act of 1954, Section 170, or other laws, as amended, which require licensees to maintain adequate financial protection. Accordingly, consistent with the legal standard presented in SECY-93-127, under which decommissioning reactor licensees may be relieved of the requirements to carry the maximum amount of insurance available and to participate in the secondary retrospective premium pool where there is sufficient technical justification, the NRC staff concludes that the requested exemptions are authorized by law.
The financial protection limits of 10 CFR 140.11 were established to require licensees to maintain sufficient offsite liability insurance to ensure adequate funding for offsite liability claims following an accident at an operating reactor. However, the regulation does not consider the reduced potential for and consequence of nuclear incidents at permanently shut down and decommissioning reactors.
The basis provided in SECY-93-127, SECY-00-0145, and SECY-01-0100 allows licensees of decommissioning plants to reduce their primary offsite liability insurance and to withdraw from participation in the retrospective rating pool for deferred premium charges. As discussed in these documents, once the zirconium fire concern is determined to be negligible, possible accident scenario risks at permanently shut down and defueled reactors are greatly reduced when compared to the risks at operating reactors and the associated potential for offsite financial liabilities from an accident are commensurately less. The licensee analyzed and the NRC staff confirmed that the risks of accidents that could result in an offsite radiological risk are minimal, thereby justifying the proposed reductions in offsite primary liability insurance and withdrawal from participation in the secondary retrospective rating pool for deferred premium charges.
Additionally, participation in the secondary retrospective rating pool could potentially have adverse consequences on the safe and timely completion of decommissioning. If a nuclear incident sufficient to trigger the secondary insurance layer occurred at another nuclear power plant, the licensee could incur financial liability of up to $131,056,000. However, because TMI is permanently shut down, it cannot produce revenue from electricity generation sales to cover such a liability. Therefore, such liability if subsequently incurred could significantly affect the ability of the facility to conduct and complete timely radiological decontamination and decommissioning activities. In addition, as SECY-93-127 concluded, the shared financial risk exposure to the licensee is greatly disproportionate to the
Therefore, the NRC staff has concluded that the requested exemptions from 10 CFR 140.11(a)(4) at the requested effective date of 16 months after the permanent cessation of power operations, are in the public interest.
The NRC's approval of an exemption from insurance or indemnity requirements belongs to a category of actions that the Commission, by rule or regulation, has declared to be a categorical exclusion after first finding that the category of actions does not individually or cumulatively have a significant effect on the human environment. Specifically, the exemption is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement in accordance with 10 CFR 51.22(c)(25).
Under 10 CFR 51.22(c)(25), granting of an exemption from the requirements of any regulation of Chapter I to 10 CFR is a categorical exclusion provided that: (i) There is no significant hazards consideration; (ii) there is no significant change in the types or significant increase in the amounts of any effluents that may be released offsite; (iii) there is no significant increase in individual or cumulative public or occupational radiation exposure; (iv) there is no significant construction impact; (v) there is no significant increase in the potential for or consequences from radiological accidents; and (vi) the requirements from which an exemption is sought involve surety, insurance, or indemnity requirements.
As the Director, Division of Decommissioning, Uranium Recovery, and Waste Programs, Office of Nuclear Material Safety and Safeguards, I have determined that approval of the exemption request involves no significant hazards consideration, as defined in 10 CFR 50.92, because reducing a licensee's offsite liability requirements at TMI does not: (1) Involve a significant increase in the probability or consequences of an accident previously evaluated; (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. The exempted financial protection regulation is unrelated to the operation of TMI or site activities. Accordingly, there is no significant change in the types or significant increase in the amounts of any effluents that may be released offsite and no significant increase in individual or cumulative public or occupational radiation exposure. The exempted regulation is not associated with construction so there is no significant construction impact. The exempted regulation does not concern the source term (
Therefore, pursuant to 10 CFR 51.22(b) and 51.22(c)(25), no environmental impact statement or environmental assessment need be prepared in connection with the approval of this exemption request.
Accordingly, the Commission has determined that, pursuant to 10 CFR 140.8, the requested exemptions are authorized by law and are otherwise in the public interest. Therefore, the Commission hereby grants Exelon and TMI-2 Solutions exemptions from the requirements of 10 CFR 140.11(a)(4) for the TMI site. TMI-1 permanently ceased power operations on September 20, 2019. The exemptions from 10 CFR 140.11(a)(4) permit TMI-1 to reduce the required level of primary financial protection from $450 million to $100 million and to withdraw from participation in the secondary layer of financial protection 16 months after the permanent cessation of power operations. Further, the exemptions permit TMI-2 relief from the requirements to maintain primary offsite liability insurance for ENOs at a level above $100 million.
The exemptions are effective as of 16 months after permanent cessation of power operations.
For the Nuclear Regulatory Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The principal purpose of the proposed amendments is for ICE Clear Europe to (i) modify its Futures and Options Risk Policy (the “F&O Risk Policy”) and Futures and Options Risk Procedures (the “F&O Risk Procedures” or the “Procedures”) to update certain aspects of the F&O initial margin methodology, including with respect to the capital to margin ratio, use of delivery margin, calculation of net liquidating value and certain buffers, and (ii) retire its Futures and Options Concentration Charge Policy (“F&O Concentration Charge Policy”) once such proposed amendment are made, as such policy would be made redundant as a result of the proposed amendments.
In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
ICE Clear Europe is proposing to revise the F&O Policy to remove the description of the capital to margin ratio as a basis for requesting additional initial margin or a reduction in positions to reduce the required initial margin level.
ICE Clear Europe is also proposing to amend its F&O Procedures to (i) update certain processes, escalations and controls with respect to the review of the IRM margin rate parameters, (ii) update the existing descriptions of review and testing processes for additional margin calculation methodologies, (iii) add a description of the Clearing House's use of delivery margin, net liquidating value, intraday buffers, overnight buffers, and ad hoc buffers as margin calculation methodologies and (iv) make various other drafting clarifications and improvements. These proposed amendments would result in the retiring of ICE Clear Europe's F&O Concentration Charge Policy as the F&O Risk Policy and F&O Risk Procedures (as amended) would render such Future and Options Concentration Charge Policy redundant.
The Policy would be revised to remove section 2.2.6, which describes the capital to margin ratio, from the additional margin requirements discussion. The description is being removed as the ratio is not in itself necessarily the basis of additional margin requirements and is addressed in other existing ICE Clear Europe policies and procedures. This amendment does not reflect a change in Clearing House practice or margin methodology. Certain minor non-substantive typographical updates would also be made to the Policy.
Amendments to the Procedures would update the standard parameters for daily calculation of the calibrated IM rate (the so-called “Autopilot” or “AP” rate) to reference inter-contract volatility spreads. The amendments would update and clarify certain processes for the routine periodic review of the production margin rate (which is the actual rate used in the margin calculation generating CMs' Core IM requirements, and is typically based on the Autopilot rate). Specifically, the amendments would clarify that details of proposed parameters and margin impact along with justification for any manual overrides from the Autopilot rate would need to be approved by the CRO and the President of ICEU or their deputies. The amendments would provide that the CRD can inform exchange staff (instead of sales staff) at its discretion for information about the margin update. The amendments would also remove a process for the CRD to receive feedback on proposed parameters by sales staff or management, which the Clearing House views as unnecessary in light of the procedures for senior management approval.
Furthermore, the amendments would provide that upon review and approval of specific Senior Management Team members, the CRD would promote the rates into the risk system. The CRD would refresh the Product Report to perform a check on the rates to go live. One such check would be to ensure no cross-asset class inter-commodity spread (ICS) parameters are larger than 80%. Any correction to the promoted rates would be made at such point. The summary table of the review and promotion process for IRM margin rate parameters would be updated to reflect the Clearing House's current practices with respect to the testing and frequency of testing for such IRM margin rate parameters. Specifically, daily checks flagging any difference between production rate and AP rate using a threshold of 20% where AP is larger than production would be used. Additionally, monthly checks would flag any difference between production rate and AP rate for material parameters using a threshold of 20% relative difference where AP is larger than production scanning rate, and 20% absolute difference where production is larger than AP ICS rate.
The amendments would clarify that exceptions driving an ad hoc review and parameter recalibration would be subject to notification to the Risk Oversight Department (“ROD”) in addition to Senior CRD (director or above) decision. This clarification would be made throughout the Procedures with respect to parameter review and recalibration.
This section would be amended to correctly reference relevant model documentation. The summary of the review process would be updated to add that ad hoc reviews would be triggered by large deviations in the daily sensitivity report.
Amendments to the section of the Procedures relating to concentration charges would update the testing frequency for product review and group mapping requirements from at least annually to monthly for a subset of products, and otherwise quarterly.
With respect to the Stress Margin or Stress Loss Charge (“SLC”) additional Initial Margin calculation methodology, the Procedures would update the testing and frequency with respect to the SLC process from no specific test to provide for Daily Cover 1 and Cover 2 tests where the largest uncollateralized stress loss of a single member and pair of members, respectively, is determined. Any SLC top up would be called from the member. Furthermore, with respect to the SLC process for stress scenarios and proxy mapping, the amendments would update the frequency of review to provide that PCA EVT scenarios (
The amendments would update the description of F&O guarantee fund (GF) requirements to clarify that GF size corresponds to the maximum of the largest cover 2 loss over the last month or the average cover two losses over the last three months plus one standard deviation. This change conforms to current practice and does not reflect a change in methodology.
Regarding the Clearing House's Wrong-Way Risk (WWR) Requirements, the amendments would update the testing/frequency of the WWR process to add that index weights would be reviewed quarterly.
With respect to the EMIR add-on calculation methodology, the testing frequency would be updated to provide for monthly backtesting on benchmark products using a one-day margin period of risk and a daily check for benchmark products using a two-day margin period of risk. Ad hoc review would be dependent on test results, margin behavior during high volatility periods, and market expert feedback, rather than being only applicable for H and F accounts.
The updates to the procedures would add a new section addressing “Delivery Margins”, which would add a description of the Clearing House's existing use of delivery margins to mitigate any payment or delivery risks during the delivery timeline of physically delivered products. Such delivery margins include: (i) Delivery margin, which is designed to cover any price movement on the product in delivery, (ii) buyer security, which is the notional value of the prompt portion of the contract in delivery, (iii) seller security, which is the additional charge on the seller to cover the situation where the seller is unable to deliver agreed product, and (iv) contingent variation margin, collected against difference between spot price and end of day settlement price between the last trading day and collection of buyer's security. The amended Procedures would also include a summary table that describes details of the delivery margin, buyer/seller security, and contingent variation margin.
The amendments to the Procedures would also add a new section describing the Clearing House's existing practices regarding net liquidating value of certain “equity-style” margined F&O options. For such options, the option premium must be paid/received at inception of the trade and the daily option value held as a credit or debit against the margin account for the remainder of the open position. The level of NLV credit/debit would be recalculated each day according to the option settlement price and any top up would be called the following day. A summary table of the details of the NLV determination would be included.
The updates to the Procedures would add a new section regarding “Intraday and Overnight Buffer”, which would summarize the existing ability of Clearing Members to post an additional buffer each day to offset intraday margin shortfall. The provisions would reference existing descriptions of intraday and overnight buffers in the Procedures. A summary table of the intraday and overnight buffers would also be included.
Finally, the updates to the Procedures would add a new section describing “Ad-Hoc Buffer”, which would state that Clearing Members may be requested to post additional buffers for various risks not otherwise covered in the Procedures. Such requirements would be set by the Risk Senior Management and the Credit Risk team. A summary table of the ad-hoc buffer would be included. The amendments are intended to describe more clearly an existing authority of the Clearing House.
The amendments would define previously undefined terms such as “CRO” (Chief Risk Officer). Various typographical and similar corrections would also be made throughout the Procedures.
ICE Clear Europe believes that the proposed amendments to the F&O Risk Policy and the F&O Risk Procedures are consistent with the requirements of Section 17A of the Act
The proposed changes to the F&O Procedures and F&O Policy are designed to strengthen ICE Clear Europe's tools to manage the risk of losses resulting from defaulting Clearing Members' portfolios. The amendments would update and clarify the processes, controls and escalations with respect to the testing and reviewing Clearing Members' Initial Margin requirements and related parameters. The amendments would also more clearly describe certain types of additional margin and calculation methodologies, and clarify the procedures for the testing and review thereof. Through better managing risks in default scenarios and promoting market stability, the proposed amendments would promote the stability of the Clearing House and the prompt and accurate clearance and settlement of cleared contracts. The enhanced risk management is therefore also generally consistent with the protection of investors and the public interest in the safe operation of the Clearing House. (ICE Clear Europe would not expect the amendments to affect the safeguarding of securities and funds in ICE Clear Europe's custody or control or for which it is responsible.) Accordingly, the amendments satisfy the requirements of Section 17A(b)(3)(F).
The amendments are also consistent with relevant provisions of Rule 17Ad-22. Rule 17Ad-22(e)(3)(i)
Rule 17Ad-22(e)(6)(i)
Rule 17Ad-22(e)(6)(vi)(A) and (B)
Rule 17Ad-22(e)(4)(v)
Rule 17Ad-22(e)(2)
ICE Clear Europe does not believe the proposed amendments would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purposes of the Act. The amendments are being adopted to update and clarify the F&O Risk Policy and the F&O Risk Procedures and will apply to all F&O Clearing Members. The proposed amendments are not expected to materially change F&O Guaranty Fund Contributions or margin requirements for F&O Clearing Members. ICE Clear Europe does not believe the amendments would affect the costs of clearing, the ability to market participants to access clearing, or the market for clearing services generally. Therefore, ICE Clear Europe does not believe the proposed rule change imposes any burden on competition that is inappropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed amendments have not been solicited or received by ICE Clear Europe. ICE Clear Europe will notify the Commission of any written comments received with respect to the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2021-007
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's Pricing Schedule at Options 7, Section 3 (Regular Order Fees and Rebates), as described further below.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend the Exchange's Pricing Schedule at Options 7, Section 3 (Regular Order Fees and Rebates) to: (i) Decrease the Priority Customer
The Exchange initially filed the proposed pricing changes on March 1, 2021 (SR-ISE-2021-02). On March 2, 2021, the Exchange withdrew that filing and submitted this filing.
Today, Priority Customers are charged a taker fee of $0.41 per contract for regular orders in Select Symbols. The Exchange now proposes to decrease this fee to $0.37 per contract for Priority Customers.
Today, all Non-Priority Customers are charged a maker fee of $0.11 per contract for regular orders in Select Symbols. The Exchange now proposes to increase this fee to $0.18 per contract for all Non-Priority Customers.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposed changes to its Pricing Schedule are reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for options securities transaction services that constrain its pricing determinations in that market. The fact that this market is competitive has long been recognized by the courts. In
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Numerous indicia demonstrate the competitive nature of this market. For example, clear substitutes to the Exchange exist in the market for options security transaction services. The Exchange is only one of sixteen options exchanges to which market participants may direct their order flow. Within this environment, market participants can freely and often do shift their order flow among the Exchange and competing venues in response to changes in their respective pricing schedules. As such, the proposal represents a reasonable attempt by the Exchange to increase its liquidity and market share relative to its competitors.
The Exchange believes that the proposed decrease for the Priority Customer taker fee in Select Symbols is reasonable, equitable, and not unfairly discriminatory. As discussed above, this fee will decrease from $0.41 to $0.37 per contract for Priority Customers. The Exchange seeks to incentivize Priority Customer participation, in particular, Priority Customer activity to remove liquidity in Select Symbols, with the proposed change. As amended, Priority Customers will continue to be charged the lowest taker fee in Select Symbols.
The Exchange believes that the proposed increase for the Non-Priority Customer maker fees in Select Symbols is reasonable, equitable, and not unfairly discriminatory. As discussed above, this fee will increase from $0.11 to $0.18 per contract for all Non-Priority Customers. While the maker fee is increasing for Non-Priority Customers, the proposed increase is intended to offset the cost of decreasing the Priority Customer taker fee proposed above. Furthermore, the Exchange notes that the proposed maker fees remain lower than maker fees at another options exchange.
The Exchange believes that the proposed maker fees in Select Symbols is equitable and not fairly discriminatory because they will be increased uniformly for all Non-Priority Customers. Priority Customers will continue to be assessed no maker fees in Select Symbols under this proposal. For the same reasons discussed above for the proposed Priority Customer taker fees, the Exchange believes that it is equitable and not unfairly discriminatory to continue offering a lower rate to Priority Customers compared to other market participants.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In terms of intra-market competition, the Exchange does not believe that its proposal will place any category of market participant at a competitive disadvantage. The proposed Select Symbol taker fee will be decreased for Priority Customers, who will continue to be charged at a lower rate than all other market participants for removing liquidity on the Exchange. The proposed Select Symbol maker fee will be increased uniformly for all Non-Priority Customers, while Priority Customers will continue to be assessed no fee for adding liquidity on the Exchange. As discussed above, the Exchange has historically charged lower rates to Priority Customers compared to other market participants. The Exchange believes that this incentivizes increased Priority Customer order flow, which enhances liquidity on the Exchange for the benefit of all market participants by providing more trading opportunities, which in turn attracts Market Makers and other market participants who may interact with this order flow.
In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other options exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited. For example, while the Exchange is increasing the maker fees for Non-Priority Customers in Select Symbols under this proposal, the Exchange does not believe this will cause an undue burden on inter-market competition as the proposed fees remain lower than similar fees charged by other options exchanges such as Phlx.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 609 (17 CFR 230.609) under the Securities Act of 1933 (15 U.S.C. 77a
The Commission estimates that, on average, approximately one respondent submits a Form 2-E filing each year. The Commission further estimates that this information collection imposes an annual burden of four hours and imposes an annual external cost burden of zero.
The collection of information under Form 2-E is mandatory. The information provided by the form will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view the background documentation for this information collection at the following website,
On December 1, 2020, The Nasdaq Stock Market LLC (“Nasdaq” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On December 1, 2020, the Exchange also filed with the Commission, pursuant to Section 19(b)(1) of the Act
The Commission is publishing this notice and order to solicit comments on the proposed rule changes, as modified by Amendments No. 1, from interested persons and to institute proceedings pursuant to Section 19(b)(2)(B) of the Act
The Exchange proposes to adopt new Rule 5605(f)(2), which would require each Nasdaq-listed company (other than a Foreign Issuer, Smaller Reporting Company, or Company with a Smaller Board, as discussed below) to have, or explain why it does not have, at least two members of its board of directors who are Diverse,
The Exchange proposes to define a Foreign Issuer under proposed Rule 5605(f)(1) as: (a) A Foreign Private Issuer (as defined in Rule 5005(a)(19));
The Exchange proposes to define a Smaller Reporting Company as set forth in Rule 12b-2 under the Act.
Proposed Rule 5605(f)(2)(D) would require each company with a board of directors of five or fewer members (“Company with a Smaller Board”) to have, or explain why it does not have, at least one member of its board of directors who is Diverse.
If a company elects to satisfy the requirements of proposed Rule 5605(f)(2) by disclosing why it does not meet the applicable diversity objectives of proposed Rule 5605(f)(2), proposed Rule 5605(f)(3) would require the company to: (i) Specify the requirements of proposed Rule 5605(f)(2) that are applicable (
Proposed Rule 5605(f)(5) would specify the phase-in period for any
As proposed, any newly-listed company on the Nasdaq Global Select Market (“NGS”) or Nasdaq Global Market (“NGM”) would be permitted to satisfy the requirement of proposed Rule 5605(f)(2) to have, or explain why it does not have: (i) At least one Diverse director by the later of (a) one year from the date of listing or (b) the date the company files its proxy statement or information statement (or, if the company does not file a proxy, its Form 10-K or 20-F) for the company's first annual meeting of shareholders subsequent to the company's listing; and (ii) at least two Diverse directors by the later of (a) two years from the date of listing or (b) the date the company files its proxy statement or information statement (or, if the company does not file a proxy, its Form 10-K or 20-F) for the company's second annual meeting of shareholders subsequent to the company's listing.
Proposed Rule 5605(f)(5)(C) would provide that any company that ceases to be a Foreign Issuer, Smaller Reporting Company, or Exempt Company would be permitted to satisfy the requirements of proposed Rule 5605(f) by the later of: (i) One year from the date that the company no longer qualifies as a Foreign Issuer, Smaller Reporting Company, or Exempt Company; or (ii) the date the company files its proxy statement or information statement (or, if the company does not file a proxy, its Form 10-K or 20-F) for the company's first annual meeting of shareholders subsequent to such event.
Proposed Rule 5605(f)(6)(A) would provide that if a company (i) does not meet the applicable diversity objectives under proposed Rule 5605(f)(2) and fails to provide the disclosure required by proposed Rule 5605(f)(3), or (ii) fails to hold an annual meeting of shareholders during the applicable periods in proposed Rule 5605(f)(5) or (7) and therefore fails to meet, or explain why it does not meet, the diversity objectives of proposed Rule 5605(f)(2), the Exchange's Listing Qualifications Department would promptly notify the company and inform it that it has until the later of its next annual shareholders meeting or 180 days from the event that caused the deficiency to cure the deficiency.
Moreover, proposed Rule 5605(f)(6)(B) would provide that a company that has satisfied the diversity objectives of proposed Rule 5605(f)(2) within the timeframes set forth in proposed Rule 5605(f)(7), but later ceases to meet the diversity objectives of proposed Rule 5605(f)(2) due to a vacancy on its board of directors, would have until the later of (i) one year from the date of vacancy or (ii) the date the company files its proxy statement or its information statement (or, if the company does not file a proxy, its Form 10-K or 20-F) in the calendar year following the year of the date of vacancy, to satisfy proposed Rule 5605(f)(2) or (3). As proposed, in lieu of providing the disclosure required by proposed Rule 5605(f)(3), a company relying on this rule may publicly disclose that it is relying on the grace period provided by proposed Rule 5605(f)(6)(B).
Proposed Rule 5605(f)(7) would specify the transition period for the implementation of the requirements of proposed Rule 5605(f). As proposed, each company listed on the Exchange (including a Company with a Smaller Board) would be required to have, or explain why it does not have, at least one Diverse director by the later of: (i) Two calendar years after the approval date of the proposal (“First Effective Date”); or (ii) the date the company files its proxy statement or information statement (or, if the company does not file a proxy, its Form 10-K or 20-F) for the company's annual shareholders meeting during the calendar year of the First Effective Date.
Proposed Rule 5605(f)(4) would exempt the following types of companies from the requirements of proposed Rule 5605(f) (“Exempt Companies”): (1) Acquisition companies; (2) asset-backed issuers and other passive issuers (as set forth in Rule 5615(a)(1)); (3) cooperatives (as set forth in Rule 5615(a)(2)); (4) limited partnerships (as set forth in Rule 5615(a)(4)); (5) management investment companies (as set forth in Rule 5615(a)(5)); (6) issuers of non-voting preferred securities, debt securities, and derivative securities (as set forth in Rule 5615(a)(6)) that do not have equity securities listed on the Exchange; and (7) issuers of securities listed under the Rule 5700 series.
The Exchange states that it has published FAQs on its Listing Center to provide guidance to companies on the application of the proposed rules in the Board Diversity Proposal, and represents that it will establish a dedicated mailbox for companies and their counsel to email additional questions to the Exchange regarding the application of such proposed rules.
The Exchange proposes to adopt new Rule 5606, which would require each Nasdaq-listed company (other than Exempt Companies
Specifically, pursuant to proposed Rule 5606(a), each Nasdaq-listed company would be required to annually disclose its board-level diversity data a substantially similar format
In the proposed Board Diversity Matrix, a company would be required to provide the total number of directors on its board and the company (other than a Foreign Issuer) would include the following information in accordance with the instructions accompanying the Board Diversity Matrix: (1) The number of directors based on gender identity (female, male, or non-binary
A company that qualifies as a Foreign Issuer under proposed Rule 5605(f)(1) may elect to use an alternative Board Diversity Matrix format.
Proposed Rule 5606(b) would require each company to provide the disclosure required under proposed Rule 5606 in the same manner as, and concurrently with, the disclosure required by proposed Rule 5605(f)(3).
Proposed Rule 5606(d) would permit a company newly listing on the Exchange that was not previously subject to a substantially similar requirement of another national securities exchange (including through an initial public offering, direct listing, transfer from another exchange or the over-the-counter market, in connection with a spin-off or carve-out from a company listed on the Exchange or another exchange, or through a merger with an acquisition company) to satisfy the requirement of proposed Rule 5606 within one year of listing on the Exchange.
Pursuant to Rule 5606(e), proposed Rule 5606 would become operative one year after a Commission approval of the proposal. A company would be required to be in compliance with proposed Rule 5606 by the later of: (i) One calendar year from the approval date (“Effective Date”); or (ii) the date the company files its proxy statement or its information statement for its annual meeting of shareholders (or, if the company does not file a proxy or information statement, the date it files its Form 10-K or 20-F) during the calendar year of the Effective Date.
The Exchange proposes to amend Rule 5810(c)(2)(A)(iv) to include a deficiency from the standards of proposed Rule 5606 as a deficiency for which a company may submit a plan of compliance for Exchange staff review. Accordingly, if a company fails to adhere to proposed Rule 5606, the Exchange would notify the company that it is not in compliance with a listing standard and allow the company 45 calendar days to submit a plan to regain compliance and, upon review of such plan, the Exchange may provide the company with up to 180 days to regain compliance.
In order to help advance diversity on company boards and to help companies prepare for and, if approved, comply with proposed Rules 5605(f) and 5606, the Exchange proposes to provide certain Nasdaq-listed companies with one-year of complimentary access for two users to a board recruiting solution, which would provide access to a network of board-ready Diverse candidates, allowing companies to identify and evaluate Diverse board candidates.
The Exchange proposes to offer this service to any “Eligible Company,” which would be defined to mean a listed company (except as described below) that represents to the Exchange that it does not have: (i) At least one director who self-identifies as Female; and (ii) at least one director who self-identifies as one or more of the following: Black or African American, Hispanic or Latinx, Asian, Native American or Alaska Native, Native Hawaiian or Pacific Islander, or Two or More Races or Ethnicities, or who self-identifies as lesbian, gay, bisexual, transgender, or as a member of the queer community.
As proposed, until December 1, 2022, any Eligible Company that requests access to this service through the Nasdaq Listing Center will receive complimentary access for one year from the initiation of the service.
In support of the Board Diversity Proposal, the Exchange states that it has reviewed dozens of empirical studies and found that an extensive body of empirical research demonstrates that diverse boards are positively associated with improved corporate governance and company performance.
The Exchange also states that there is substantial evidence that board diversity promotes investor protection, including by enhancing the quality of a company's financial reporting, internal controls, public disclosures, and management oversight.
The Exchange states that, while some companies have made progress in diversifying their boardrooms,
Moreover, the Exchange states that current reporting of board diversity data is not provided in a consistent manner or on a sufficiently widespread basis and, as such, investors are not able to readily compare board diversity statistics across companies.
The Exchange states that it is well positioned to establish practices that would assist in carrying out its mandate to protect investors and remove impediments from the market through the Board Diversity Proposal.
The Exchange believes that the disclosure-based framework of proposed Rule 5605(f) may influence corporate conduct if a company chooses to meet the proposed diversity objectives,
The Exchange believes that the disclosures required by proposed Rule 5606 and the accompanying format requirements would protect investors by eliminating data collection inaccuracies, decreasing investors' costs, and enhancing investors' ability to utilize the information disclosed.
In support of the Board Recruiting Service Proposal, the Exchange argues that offering a board recruiting solution would assist and encourage listed companies to increase diverse representation on their boards, which the Exchange believes could result in improved corporate governance, strengthening of market integrity, and improved investor confidence.
The Exchange further argues that it is reasonable and not unfairly discriminatory to offer the board recruiting solution only to Eligible Companies because the Exchange believes these companies have the greatest need to identify Diverse board candidates, particularly if these companies elect to meet the diversity objectives in the Board Diversity Proposal, if approved, rather than disclosing why they have not met the objectives.
The Commission has received comment letters that support the proposals, comment letters that suggest changes to the proposals, and comment letters that oppose the proposals.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
The Commission is instituting proceedings to allow for additional analysis of, and input from commenters with respect to, the consistency of the proposals, as modified by Amendments
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposals. In particular, the Commission invites the written views of interested persons concerning whether the proposals, as modified by Amendments No. 1, are consistent with Sections 6(b)(4),
Interested persons are invited to submit written data, views, and arguments regarding whether the proposals, as modified by Amendments No. 1, should be approved or disapproved by April 6, 2021. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by April 20, 2021. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 11a-2 (17 CFR 270.11a-2) under the Investment Company Act of 1940 (15 U.S.C. 80a-1
There are currently 676 registrants governed by Rule 11a-2. The Commission includes the estimated burden of complying with the information collection required by Rule
The estimate of average burden hours is made solely for the purposes of the PRA, and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules or forms. With regard to Rule 11a-2, the Commission includes the estimate of burden hours in the total number of burden hours estimated for completing the relevant registration statements and reported on the separate PRA submissions for those statements (see the separate PRA submissions for Form N-3, Form N-4 and Form N-6).
The information collection requirements imposed by Rule 11a-2 are mandatory. Responses to the collection of information will not be kept confidential. 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 control number.
The public may view background documentation for this information collection at the following website:
2:00 p.m. on Thursday, March 18, 2021.
The meeting will be held via remote means and/or at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
The subject matter of the closed meeting will consist of the following topics:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to examinations and enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting agenda items that may consist of adjudicatory, examination, litigation, or regulatory matters.
For further information; please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to update its Fees Schedule in connection with the Exchange's plans to list and trade options on the Mini-RUT Index (“MRUT” or “Mini-RUT”). The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of
The Exchange proposes to amend its Fees Schedule in connection with its plans to list and trade MRUT options, effective March 1, 2021.
MRUT options are options on the Mini-RUT Index, the value of which is 1/10th the value of the Russell 2000 (“RUT”) Index. The Russell 2000 Index measures the performance of small-cap segment of the U.S. equity universe. It is a subset of the Russell 3000 Index and includes approximately 2,000 U.S.-based securities based on a combination of their market cap and current index membership. The Russell 2000 Index is constructed to provide a comprehensive and unbiased small-cap barometer and is completely reconstituted annually to ensure larger stocks do not distort the performance and characteristics of the true small-cap opportunity set. The Russell 2000 Index is a commonly used benchmark for mutual funds that identify themselves as “small-cap,” and much like the S&P 500 Index (“SPX”), is used to benchmark large capitalization stocks. The Exchange understands that investors often use Russell 2000 Index-related products to diversify their portfolios and benefit from market trends. RUT options currently offer these benefits to investors but may be expensive given their larger notional value and are therefore primarily used by institutional market participants. By contrast, MRUT options are reduced-value options (1/10th) compared to RUT options that will offer individual investors lower cost options to obtain the potential benefits of options on the Russell 2000 Index.
The Exchange believes that investors will benefit from the availability of Mini-RUT option contracts by making options overlying the higher-valued RUT Index more readily available as an investing tool and at more affordable prices for investors. The Exchange also believes that the investor-base for MRUT options are likely to be the same investor-base for Mini-SPX options (“XSP”), which are also proprietary, reduced-value options on a broad-based index (SPX), as they are both designed to provide low-cost means to hedge investors' portfolios in connection with higher-value broad-based indexes (
First, the Exchange proposes to adopt certain standard transaction fees in connection with MRUT options in a manner that closely aligns the fees assessed for MRUT options with that of the fees assessed for RUT options. As described above, MRUT options and RUT options track the same underlying index, yet MRUT options are 1/10th the size of standard RUT options contracts. As such, the proposed rule change adopts certain fees for MRUT options in the Rate Table for All Products Excluding Underlying Symbol A
• Adopts fee code CQ, appended to all Customer (capacity “C”) orders in MRUT options and assesses a fee of $0.02 per contract. This proposed fee is approximately 1/10th of the fees assessed for Customer orders in RUT options ($0.18).
• Adopts fee code FM, appended to all Clearing Trading Permit Holder (“TPHs”) (capacity “F”) and for Non-TPH Affiliate of a Clearing TPH (capacity “L”) (collectively, “Firms”) orders in MRUT options and assesses a fee of $0.02 per contract. The proposed fee is approximately 1/10th of the fees assessed for Firm orders in RUT options ($0.26);
• Adopts fee code MM, which is appended to all Market-Maker (capacity “M”) orders in MRUT options and assesses a fee of $0.03 per contract. The proposed fee is approximately 1/10th of the fees assessed for Market-Maker orders in RUT options ($0.30); and
• Adopts fee code BM, appended to all Broker-Dealer (capacity “B”), Joint Back-Office (capacity “J”), Non-TPH Market-Maker (capacity “N”), and Professional (capacity “U”) (collectively, “Non-Customers”) orders in MRUT options and assesses a fee of $0.04 per contract. The proposed fee is approximately 1/10th of the difference between the two rates assessed for Non-Customer orders in RUT options ($0.25 for manual and AIM transactions and $0.65 for non-AIM electronic transactions).
The Exchange also proposes to waive the proposed MRUT transaction fees for Firms and Market-Makers through August 31, 2021. Specifically, proposed footnote 32 (appended to MRUT options for Market-Maker and Firm transaction fees in the Rate Table—All Products Excluding Underlying Symbol List A) provides that transaction fees for orders executed in MRUT options with a capacity code of “F”, “L”, or “M” will be waived through August 31, 2021. The proposed waiver is intended to encourage liquidity in a newly listed and traded product on the Exchange.
In addition to the above transaction fees, the proposed rule change also adopts certain surcharges to MRUT transactions within the Rate Table—All Products Excluding Underlying Symbol List A. The proposed rule change applies an Index License Surcharge Fee of $0.02 to all Firm, Market-Maker and Non-Customer transactions in MRUT options. Currently, the Index License Surcharge Fee assesses a $0.10 charge for transactions in DJX, MXEA and MXEF options. The proposed lower Index License Surcharge rate for MRUT options is intended to promote and encourage trading of MRUT options once listed. The Exchange notes that this is similar to lower (or waived) Index License fees for other options classes in order to similarly continue to promote their trading and growth.
The proposed rule change adds MRUT options to the list of options, which currently includes XSP, for which the FLEX Surcharge Fee of $0.10 (capped at $250 per trade) applies to electronic FLEX orders executed by all capacity codes.
The proposed rule change excludes MRUT volume from the Liquidity Provider Sliding Scale, which offers credits on Market-Maker orders where a Market-Maker achieves certain volume thresholds based on total national Market-Maker volume in all underlying symbols, excluding Underlying Symbol List A and XSP, during the calendar month. Specifically, the proposed rule change updates the Liquidity Provider Sliding Scale table to provide that volume thresholds are based on total national Market-Maker volume in all underlying symbols excluding Underlying Symbol List A, MRUT and XSP during the calendar month, and that it applies in all underlying symbols excluding Underlying Symbol List A, MRUT and XSP. The proposed rule change also updates footnote 10 (appended to the Liquidity Provider Sliding Scale) to provide that the Liquidity Provider Sliding Scale applies to Liquidity Provider (Cboe Options Market-Maker, DPM and LMM) transaction fees in all products except (1) Underlying Symbol List A (34), MRUT and XSP,
The proposed rule change updates the Volume Incentive Program (“VIP”) table to exclude MRUT volume from the VIP, which currently offers a per contract credit for certain percentage threshold levels of monthly Customer and Non-Customer volume in all underlying symbols, excluding Underlying Symbol List A, Sector Indexes, DJX, MXEA, MXEF and XSP. The proposed rule change also amends footnote 36 (appended to the VIP table) to reflect the proposed exclusion of MRUT from the VIP by providing (in relevant part) that: The Exchange shall credit each Trading Permit Holder the per contract amount resulting from each public customer (“C” capacity code) order transmitted by that Trading Permit Holder which is executed electronically on the Exchange in all underlying symbols excluding Underlying Symbol List A, Sector Indexes, DJX, MRUT, MXEA, MXEF, XSP, QCC trades, public customer to public customer electronic complex order executions, and executions related to contracts that are routed to one or more exchanges in connection with the Options Order Protection and Locked/Crossed Market Plan referenced in Rule 5.67, provided the Trading Permit Holder meets certain percentage thresholds in a month as described in the Volume Incentive Program (VIP) table; the percentage thresholds are calculated based on the percentage of national customer volume in all underlying symbols excluding Underlying Symbol List A, Sector Indexes, MRUT, MXEA, MXEF, DJX and XSP entered and executed over the course of the month; and in the event of a Cboe Options System outage or other interruption of electronic trading on Cboe Options, the Exchange will adjust the national customer volume in all underlying symbols excluding Underlying Symbol List A, Sector Indexes, MRUT, MXEA, MXEF, DJX and XSP for the entire trading day.
The proposed rule change excludes MRUT from the list of products eligible to receive Break-Up Credits in orders executed in AIM, SAM, FLEX AIM, and FLEX SAM, by amending the Break-Up Credits table to exclude MRUT along with the products currently excluded—Underlying Symbol List A, Sector Indexes, DJX, MXEA, MXEF and XSP.
The Exchange also proposes to exclude Firm transactions in MRUT from the Clearing TPH Fee Cap. Specifically, it amends footnote 22 (appended to the Clearing TPH Fee Cap table) to provide that all non-facilitation business executed in AIM or open outcry, or as a QCC or FLEX transaction, transaction fees for Clearing TPH Proprietary and/or their Non-TPH Affiliates in all products except MRUT, XSP, Sector Indexes and Underlying Symbol List A (which includes SPX), in the aggregate, are capped at $55,000 per month per Clearing TPH. It additionally updates footnote 11 (which is also appended to the Clearing TPH Fee Cap table) to provide that the Clearing TPH Fee Cap in all products except MRUT, XSP, Underlying Symbol List A and Sector Indexes (the “Fee Cap”),
The Exchange proposes to exclude MRUT from eligibility for the Order Router Subsidy (“ORS”) and Complex Order Router Subsidy (“CORS”) Programs, in which Participating TPHs
The Exchange notes that excluding MRUT transactions from the above-described programs is consistent with the manner in which XSP transactions are also excluded each of these programs today.
Additionally, the Exchange proposes to exclude MRUT from the Marketing Fee Program by updating the Marketing Fee table to provide that the marketing fee will be assessed on transactions of Market-Makers (including DPMs and LMMs), resulting from customer orders at the per contract rate provided above on all classes of equity options, options on ETFs, options on ETNs and index options, except that the marketing fee shall not apply to Sector Indexes, DJX, MXEA, MXEF or Underlying Symbol List A. The Exchange notes that, in this way, MRUT will be treated as most of the Exchange's other exclusively listed products that are currently excluded from the Marketing Fee Program. The Exchange does believe that it is necessary at the point of newly listing and trading for MRUT options to be eligible for the Marketing Fee Program and may determine in the future to submit a fee filing to add MRUT to the Marketing Fee Program if the Exchange believes it would potentially generate more customer order flow in MRUT.
Finally, the Exchange proposes to adopt a financial program for LMMs appointed in MRUT options. As proposed, the MRUT LMM Incentive Program provides that if the appointed LMM in MRUT provides continuous electronic quotes during Regular Trading Hours that meet or exceed the proposed heightened quoting standards (below) in at least 99% of the series 90% of the time in a given month, the LMM will receive a payment for that month in the amount of $20,000 (or pro-rated amount if an appointment begins after the first trading day of the month or ends prior to the last trading day of the month).
Meeting or exceeding the heightened quoting standards in MRUT, as proposed, to receive the proposed compensation payment is optional for an MRUT LMM. The Exchange may consider other exceptions to this quoting standard based on demonstrated legal or regulatory requirements or other mitigating circumstances. In calculating whether an LMM met the heightened quoting standard each month, the Exchange will exclude from the calculation in that month the business day in which the LMM missed meeting or exceeding the heightened quoting standard in the highest number of series. In addition to the above rebate, if the appointed LMM meets or exceeds the above heightened quoting standards in a given month and provides an average daily volume (“ADV”) in MRUT that meets or exceeds 25,000 contracts in a given month, the LMM will receive the Monthly ADV Payment amount that corresponds to the level of ADV in MRUT provided for that month per the MRUT Volume Incentive Pool program below:
The heightened requirements and MRUT Volume Incentive Pool offered by the MRUT LMM Incentive Program are designed to incentivize LMMs to provide significant liquidity in MRUT options during the trading day upon their listing and trading on the Exchange, which, in turn, would provide greater trading opportunities, added market transparency and enhanced price discovery for all market participants in MRUT.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange believes that the proposed amendments to the Fees Schedule in connection with standard transaction rates and surcharges for MRUT transactions are reasonable, equitable and not unfairly discriminatory. Specifically, the Exchange believes that it is reasonable to assess fees for Customer, Market-Maker, Firm, and Non-Customer orders in MRUT that reflect approximately 1/10th of the transactions fees assessed for corresponding orders in RUT because of the relation between MRUT options and RUT options, wherein MRUT options overlie an index 1/10th the value of the index that underlies RUT options. Additionally, the Exchange believes it is reasonable to waive the transaction fees for Market-Maker and Firm orders in MRUT options through August 31, 2021 because the waiver is designed to encourage order flow from these market participants in a newly listed and traded options class on the Exchange. The Exchange recognizes that Market-Makers and Firms each provide important and distinct sources of liquidity to the Exchange and increased liquidity provides more trading opportunities, in turn, signaling additional corresponding increase in order flow from other market participants, and, as a result, contributing towards a robust, well-balanced market ecosystem. The Exchange also believes that it is reasonable to assess a lower Index License fee on transactions in MRUT because MRUT is a new product and the Exchange wishes to promote and encourage trading of MRUT once listed. The Exchange notes that, similar to assessing a lower Index License fee, the Index License fees for certain options in other classes are waived in order to continue to promote their trading and growth.
The Exchange believes the proposed standard transaction rates and surcharges (or exclusions) are equitable and not unfairly discriminatory because they will apply automatically and uniformly to all Customer, Firm, Market-Maker and/or Non-Customer, orders, as applicable, in MRUT options. The Exchange also believes that it is equitable and not unfairly discriminatory to waive the transaction fees (through August 31, 2021) for Market-Maker and Firm orders in MRUT because, as stated above, the Exchange recognizes that these market participants can provide key and distinct sources of liquidity, which is particularly important for a newly listed and traded options class on the Exchange. An increase in general market-making activity facilitates tighter spreads, which tend to signal additional corresponding increase in order flow from other market participants, ultimately incentivizing more overall order flow and improving liquidity levels and price transparency on the Exchange to the benefit of all market participants. Similarly, the Exchange also recognizes that Firms can be an important source of liquidity when they facilitate their own customers' trading activity, thus, adding transparency and promoting price discovery to the benefit of all market participants. The Exchange notes too that Market-Makers and Firms take on a number of obligations that other market participants do not have. For example, unlike other market participants, Market-Makers take on quoting obligations and other market making requirements and Firms must have higher capital requirements, clear trades for other market participants, and must be members of OCC.
The Exchange believes that the proposed updates to the Fees Schedule in connection with the application of certain fees programs to transactions in MRUT options are reasonable, equitable and not unfairly discriminatory. Particularly, the Exchange believes it is reasonable to exclude transactions in MRUT options from the Liquidity Provider Sliding Scale, the VIP, the Break-Up Credits table, the Clearing TPH Fee cap, and the ORS/CORS programs in the same manner in which transactions in XSP options are currently excluded from the same programs today as the Exchange believes it is appropriate to update these fees programs in a manner that similarly situates transactions in MRUT with transactions in XSP, as both mini-index options are designed to offer investors lower cost options to obtain the potential benefits of options on a broad-based index options and are intended for the same investor base. Additionally, the Exchange believes that excluding MRUT from the Marketing Fee Program is reasonable most of the Exchange's other proprietary products are currently excluded from the Marketing Fee Program. The Exchange does believe that it is necessary at the point of newly listing and trading for MRUT transactions to be eligible for the Marketing Fee Program and may determine in the future to submit a fee filing to add MRUT to the Marketing Fee Program if the Exchange believes it would potentially generate more customer order flow in MRUT options.
The Exchange believes that excluding MRUT transactions from certain fees programs is equitable and not unfairly discriminatory because the programs will equally not apply to, or exclude in the same manner, all market participants' orders in MRUT options. The Exchange notes that the proposed rule change does not alter any of the existing program rates or volume calculations, but instead, merely proposes not to include transactions in MRUT in those programs and volume calculations in the same way that transactions in XSP options are not currently included, or, regarding the Marketing Fee Program, in the same way transactions in most of the Exchange's other exclusively listed products are not currently included.
The Exchange believes the proposed MRUT LMM Incentive Program is reasonable, equitable and not unfairly discriminatory. Particularly, the proposed MRUT LMM Incentive Program is a reasonable financial incentive program because the proposed heightened quoting standards and rebate amount for meeting the heightened quoting standards in MRUT series are reasonably designed to incentivize an appointed LMM to meet the proposed heightened quoting standards during RTH for MRUT, thereby providing liquid and active markets, which facilitates tighter spreads, increased trading opportunities, and overall
Finally, the Exchange believes it is equitable and not unfairly discriminatory to offer the financial incentive to MRUT LMMs pursuant to the proposed MRUT LMM Incentive Program, because it will benefit all market participants trading MRUT during RTH by encouraging the LMMs to satisfy the heightened quoting standard, which incentivizes continuous increased liquidity and thereby may provide more trading opportunities and tighter spreads. Indeed, the Exchange notes that its LMMs serve a crucial role in providing quotes and the opportunity for market participants to trade MRUT, which can lead to increased volume, providing for robust markets. The Exchange ultimately wishes to sufficiently incentivize LMMs to provide liquid and active markets in the newly listed and traded MRUT options during the trading day to encourage liquidity, thereby protecting investors and the public interest. The Exchange also notes that an LMM may have added costs each month that it needs to undertake in order to satisfy that heightened quoting standard (
The Exchange believes the proposed amendments to its Fee Schedule will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed MRUT transactions fee and surcharge amounts for each separate type of market participant will be assessed automatically and uniformly to all such market participants,
The Exchange does not believe that the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the propose fees assessed and rebates offered apply to a product exclusively listed on the Exchange.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any written comments from members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change would revise the Clearing Agency Investment Policy (“Investment Policy”) of The Depository Trust Company (“DTC”) and its affiliates, National Securities Clearing Corporation (“NSCC”) and Fixed Income Clearing Corporation (“FICC,” and together with DTC and NSCC, the “Clearing Agencies”) in order to (1) enhance the methodology for determining investment limits for investments in bank deposits, and (2) clarify the description of certain investable funds of the Government Securities Division of FICC (“GSD”), as described in greater detail below.
In its filing with the Commission, the clearing agency included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Clearing Agencies are proposing to revise the Investment Policy, which was adopted for each clearing agency in December 2016
The Investment Policy governs the management, custody and investment of cash deposited to the respective NSCC and FICC Clearing Funds, and the DTC Participants Fund,
The Investment Policy identifies the guiding principles for investments and defines the roles and responsibilities of DTCC staff in administering the Investment Policy pursuant to those principles. The Investment Policy is co-owned by DTCC's Treasury group (“Treasury”)
The Investment Policy also identifies sources of funds that may be invested, and the permitted investments of those funds, including the authority required to make such investments and the parameters of, and limitations on, each type of investment. Allowable investments include bank deposits, reverse repurchase agreements, direct obligations of the U.S. government, money market mutual funds, high-grade corporate debt, and hedge transactions. Finally, the Investment Policy defines the approval authority required to exceed established investment limits.
The Investment Policy is reviewed and approved by the Boards annually. In connection with a recent annual review of the Investment Policy, the Clearing Agencies have decided to propose revisions to the Investment Policy in order to (1) enhance the methodology for determining investment limits for investments in bank deposits, and (2) clarify the description of certain investable funds of GSD, as described in greater detail below.
Section 6.2.1 of the Investment Policy sets forth the investment limits applicable to bank deposit investments. Currently, bank deposit investment limits are determined based on the bank counterparty's external credit rating. For example, investments in a bank deposits with a bank counterparty with an external credit rating of AAA or Aaa are limited to no more than $750 million, and an investment with a bank counterparty with an external credit rating of BBB+ or Baa1 are limited to no more than $100 million.
The Clearing Agencies are proposing to enhance the methodology for setting investment limits and investment caps on bank deposits with a particular counterparty by including a consideration of the size of the bank counterparty, measured as the total shareholders' equity capital, in this calculation. Under the proposed methodology, an investment limit for a bank deposit counterparty would continue to be based on the counterparty's credit rating, but would be the lower of (1) a percentage of its total shareholders' equity capital, and (2) the applicable dollar value that is currently in Section 6.2.1 of the Investment Policy. For example, investments in a bank deposits with a bank counterparty with an external credit rating of AAA or Aaa and total shareholders' equity capital of $9 billion would be limited to no more than $750 million, however, investments with a bank counterparty with the same external credit rating and total shareholders' equity capital of $2 billion would be limited to no more than $300 million.
The proposed approach would permit the Clearing Agencies to take into account the size of a counterparty in setting investment limits rather than apply the same investment limits to each counterparty with the same credit rating without regard to the entity's size. The proposal is designed to mitigate the Clearing Agencies' risk exposure to smaller bank counterparties.
The Clearing Agencies are also proposing to amend Section 5 of the Investment Policy to revise the description of investable funds of GSD, which are currently described as “GSD Forward Margin.” The proposed changes would refer to these funds as “GSD Forward Mark Adjustment Payment,” which is the term used in the GSD Rules to refer to these funds.
The Clearing Agencies believe that the proposed rule changes are consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, the Clearing Agencies believe that the proposed modifications to the Investment Policy are consistent with Section 17A(b)(3)(F) of the Act
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of each of the Clearing Agencies be designed to assure the safeguarding of securities and funds that are in the custody or control of each of the Clearing Agencies or for which they are responsible.
Additionally, the proposed change to align the description of investable funds of GSD with the description of these funds in the GSD Rules would clarify the funds that are subject to the Policy and, thereby, improve the effectiveness of the Investment Policy and allow the Investment Policy to continue to be administered in alignment with the
Rule 17Ad-22(e)(16) under the Act requires the Clearing Agencies to establish, implement, maintain and enforce written policies and procedures reasonably designed to safeguard the Clearing Agencies' own and their participants' assets, minimize the risk of loss and delay in access to these assets, and invest such assets in instruments with minimal credit, market, and liquidity risks.
For the reasons stated above, the Clearing Agencies believe that the proposed revisions would both strengthen the risk management objectives of the Investment Policy and improve the clarity of the Policy and, therefore, make the Investment Policy more effective in governing the management, custody, and investment of funds of and held by the Clearing Agencies. In this way, the proposed changes would better allow the Clearing Agencies to maintain this document in a way that is designed to meet the requirements of Rule 17Ad-22(e)(16). Therefore, the Clearing Agencies believe the proposed revisions would be consistent with the requirements of Rule 17Ad-22(e)(16) under the Act.
Each of the Clearing Agencies believes that none of the proposed revisions to the Investment Policy would have any impact, or impose any burden, on competition. The Investment Policy applies equally to allowable investments of Clearing Fund and Participants Fund deposits, as applicable, of each member of the Clearing Agencies, and establishes a uniform policy at the Clearing Agencies. The proposed changes to the Investment Policy would not affect any changes on the fundamental purpose or operation of this document and, as such, would also not have any impact, or impose any burden, on competition.
The Clearing Agencies have not solicited or received any written comments relating to this proposal. The Clearing Agencies will notify the Commission of any written comments received by the Clearing Agencies.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 498 (17 CFR 230.498) under the Securities Act of 1933 (15 U.S.C. 77a
The purpose of rule 498 is to enable a fund to provide investors with a Summary Prospectus containing key information necessary to evaluate an investment in the fund. Unlike many other federal information collections, which are primarily for the use and benefit of the collecting agency, this information collection is primarily for the use and benefit of investors. The information filed with the Commission also permits the verification of compliance with securities law requirements and assures the public availability and dissemination of the information.
Based on an analysis of fund filings, the Commission estimates that approximately 10,536 funds are using a Summary Prospectus. The Commission estimates that the annual hourly burden per fund associated with the compilation of the information required on the cover page or the beginning of the Summary Prospectus is 0.5 hours, and estimates that the annual hourly burden per fund to comply with the website posting requirement is approximately 1 hour, requiring a total of 1.5 hours per fund per year.
Estimates of the average burden hours are made solely for the purposes of the Paperwork Reduction Act and are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules and forms. Under rule 498, use of the Summary Prospectus is voluntary, but the rule's requirements regarding provision of the statutory prospectus upon investor request are mandatory for funds that elect to send or give a Summary Prospectus in reliance upon rule 498. The information provided under rule 498 will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change would revise the Clearing Agency Investment Policy (“Investment Policy”) of Fixed Income Clearing Corporation (“FICC”) and its affiliates, The Depository Trust Company (“DTC”) and National Securities Clearing Corporation (“NSCC,” and, together with DTC and FICC, the “Clearing Agencies”) in order to (1) enhance the methodology for determining investment limits for investments in bank deposits, and (2) clarify the description of certain investable funds of the Government Securities Division of FICC (“GSD”), as described in greater detail below.
In its filing with the Commission, the clearing agency included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Clearing Agencies are proposing to revise the Investment Policy, which was adopted for each clearing agency in December 2016
The Investment Policy governs the management, custody and investment of cash deposited to the respective NSCC and FICC Clearing Funds, and the DTC Participants Fund,
The Investment Policy identifies the guiding principles for investments and defines the roles and responsibilities of DTCC staff in administering the Investment Policy pursuant to those principles. The Investment Policy is co-owned by DTCC's Treasury group (“Treasury”)
The Investment Policy also identifies sources of funds that may be invested, and the permitted investments of those funds, including the authority required to make such investments and the parameters of, and limitations on, each type of investment. Allowable investments include bank deposits, reverse repurchase agreements, direct obligations of the U.S. government, money market mutual funds, high-grade corporate debt, and hedge transactions. Finally, the Investment Policy defines the approval authority required to exceed established investment limits.
The Investment Policy is reviewed and approved by the Boards annually. In connection with a recent annual review of the Investment Policy, the Clearing Agencies have decided to propose revisions to the Investment Policy in order to (1) enhance the methodology for determining investment limits for investments in bank deposits, and (2) clarify the description of certain investable funds of GSD, as described in greater detail below.
Section 6.2.1 of the Investment Policy sets forth the investment limits applicable to bank deposit investments. Currently, bank deposit investment limits are determined based on the bank counterparty's external credit rating. For example, investments in a bank deposits with a bank counterparty with an external credit rating of AAA or Aaa are limited to no more than $750 million, and an investment with a bank counterparty with an external credit rating of BBB+ or Baa1 are limited to no more than $100 million.
The Clearing Agencies are proposing to enhance the methodology for setting investment limits and investment caps on bank deposits with a particular counterparty by including a consideration of the size of the bank counterparty, measured as the total shareholders' equity capital, in this calculation. Under the proposed methodology, an investment limit for a bank deposit counterparty would continue to be based on the counterparty's credit rating, but would be the lower of (1) a percentage of its total shareholders' equity capital, and (2) the applicable dollar value that is currently in Section 6.2.1 of the Investment Policy. For example, investments in a bank deposits with a bank counterparty with an external credit rating of AAA or Aaa and total shareholders' equity capital of $9 billion would be limited to no more than $750 million, however, investments with a bank counterparty with the same external credit rating and total shareholders' equity capital of $2 billion would be limited to no more than $300 million.
The proposed approach would permit the Clearing Agencies to take into account the size of a counterparty in setting investment limits rather than apply the same investment limits to each counterparty with the same credit rating without regard to the entity's size. The proposal is designed to mitigate the Clearing Agencies' risk exposure to smaller bank counterparties.
The Clearing Agencies are also proposing to amend Section 5 of the Investment Policy to revise the description of investable funds of GSD, which are currently described as “GSD Forward Margin.” The proposed changes would refer to these funds as “GSD Forward Mark Adjustment Payment,” which is the term used in the GSD Rules to refer to these funds.
The Clearing Agencies believe that the proposed rule changes are consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, the Clearing Agencies believe that the proposed modifications to the Investment Policy are consistent with Section 17A(b)(3)(F) of the Act
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of each
Additionally, the proposed change to align the description of investable funds of GSD with the description of these funds in the GSD Rules would clarify the funds that are subject to the Policy and, thereby, improve the effectiveness of the Investment Policy and allow the Investment Policy to continue to be administered in alignment with the investment guidelines and governance procedures set forth therein. Given that such guidelines and governance procedures are designed to safeguard funds that are in the custody or control of the Clearing Agencies or for which they are responsible, the Clearing Agencies believe the proposed changes are consistent with the requirements of Section 17A(b)(3)(F) of the Act.
Rule 17Ad-22(e)(16) under the Act requires the Clearing Agencies to establish, implement, maintain and enforce written policies and procedures reasonably designed to safeguard the Clearing Agencies' own and their participants' assets, minimize the risk of loss and delay in access to these assets, and invest such assets in instruments with minimal credit, market, and liquidity risks.
For the reasons stated above, the Clearing Agencies believe that the proposed revisions would both strengthen the risk management objectives of the Investment Policy and improve the clarity of the Policy and, therefore, make the Investment Policy more effective in governing the management, custody, and investment of funds of and held by the Clearing Agencies. In this way, the proposed changes would better allow the Clearing Agencies to maintain this document in a way that is designed to meet the requirements of Rule 17Ad-22(e)(16). Therefore, the Clearing Agencies believe the proposed revisions would be consistent with the requirements of Rule 17Ad-22(e)(16) under the Act.
Each of the Clearing Agencies believes that none of the proposed revisions to the Investment Policy would have any impact, or impose any burden, on competition. The Investment Policy applies equally to allowable investments of Clearing Fund and Participants Fund deposits, as applicable, of each member of the Clearing Agencies, and establishes a uniform policy at the Clearing Agencies. The proposed changes to the Investment Policy would not affect any changes on the fundamental purpose or operation of this document and, as such, would also not have any impact, or impose any burden, on competition.
The Clearing Agencies have not solicited or received any written comments relating to this proposal. The Clearing Agencies will notify the Commission of any written comments received by the Clearing Agencies.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change would revise the Clearing Agency Investment Policy (“Investment Policy”) of National Securities Clearing Corporation (“NSCC”) and its affiliates, The Depository Trust Company (“DTC”) and Fixed Income Clearing Corporation (“FICC,” and together with DTC and NSCC, the “Clearing Agencies”) in order to (1) enhance the methodology for determining investment limits for investments in bank deposits, and (2) clarify the description of certain investable funds of the Government Securities Division of FICC (“GSD”), as described in greater detail below.
In its filing with the Commission, the clearing agency included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Clearing Agencies are proposing to revise the Investment Policy, which was adopted for each clearing agency in December 2016
The Investment Policy governs the management, custody and investment of cash deposited to the respective NSCC and FICC Clearing Funds, and the DTC Participants Fund,
The Investment Policy identifies the guiding principles for investments and defines the roles and responsibilities of DTCC staff in administering the Investment Policy pursuant to those principles. The Investment Policy is co-owned by DTCC's Treasury group (“Treasury”)
The Investment Policy also identifies sources of funds that may be invested, and the permitted investments of those funds, including the authority required to make such investments and the parameters of, and limitations on, each type of investment. Allowable investments include bank deposits, reverse repurchase agreements, direct obligations of the U.S. government, money market mutual funds, high-grade corporate debt, and hedge transactions. Finally, the Investment Policy defines the approval authority required to exceed established investment limits.
The Investment Policy is reviewed and approved by the Boards annually. In connection with a recent annual review of the Investment Policy, the Clearing Agencies have decided to propose revisions to the Investment Policy in order to (1) enhance the methodology for determining investment limits for investments in bank deposits, and (2) clarify the description of certain investable funds of GSD, as described in greater detail below.
Section 6.2.1 of the Investment Policy sets forth the investment limits applicable to bank deposit investments. Currently, bank deposit investment limits are determined based on the bank counterparty's external credit rating. For example, investments in a bank deposits with a bank counterparty with an external credit rating of AAA or Aaa are limited to no more than $750 million, and an investment with a bank counterparty with an external credit rating of BBB+ or Baa1 are limited to no more than $100 million.
The Clearing Agencies are proposing to enhance the methodology for setting investment limits and investment caps on bank deposits with a particular counterparty by including a consideration of the size of the bank counterparty, measured as the total shareholders' equity capital, in this calculation. Under the proposed methodology, an investment limit for a bank deposit counterparty would continue to be based on the counterparty's credit rating, but would be the lower of (1) a percentage of its total shareholders' equity capital, and (2) the applicable dollar value that is currently in Section 6.2.1 of the Investment Policy. For example, investments in a bank deposits with a bank counterparty with an external credit rating of AAA or Aaa and total shareholders' equity capital of $9 billion would be limited to no more than $750 million, however, investments with a bank counterparty with the same external credit rating and total shareholders' equity capital of $2 billion would be limited to no more than $300 million.
The proposed approach would permit the Clearing Agencies to take into account the size of a counterparty in setting investment limits rather than apply the same investment limits to each counterparty with the same credit rating without regard to the entity's size. The proposal is designed to mitigate the Clearing Agencies' risk exposure to smaller bank counterparties.
The Clearing Agencies are also proposing to amend Section 5 of the Investment Policy to revise the description of investable funds of GSD, which are currently described as “GSD Forward Margin.” The proposed changes would refer to these funds as “GSD Forward Mark Adjustment Payment,” which is the term used in the GSD Rules to refer to these funds.
The Clearing Agencies believe that the proposed rule changes are consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, the Clearing Agencies believe that the proposed modifications to the Investment Policy are consistent with Section 17A(b)(3)(F) of the Act
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of each of the Clearing Agencies be designed to assure the safeguarding of securities and funds that are in the custody or control of each of the Clearing Agencies or for which they are responsible.
Additionally, the proposed change to align the description of investable funds of GSD with the description of these funds in the GSD Rules would clarify the funds that are subject to the Policy and, thereby, improve the effectiveness of the Investment Policy and allow the Investment Policy to continue to be administered in alignment with the investment guidelines and governance procedures set forth therein. Given that such guidelines and governance procedures are designed to safeguard funds that are in the custody or control of the Clearing Agencies or for which they are responsible, the Clearing Agencies believe the proposed changes are consistent with the requirements of Section 17A(b)(3)(F) of the Act.
Rule 17Ad-22(e)(16) under the Act requires the Clearing Agencies to establish, implement, maintain and enforce written policies and procedures reasonably designed to safeguard the Clearing Agencies' own and their participants' assets, minimize the risk of loss and delay in access to these assets, and invest such assets in instruments with minimal credit, market, and liquidity risks.
For the reasons stated above, the Clearing Agencies believe that the proposed revisions would both strengthen the risk management objectives of the Investment Policy and improve the clarity of the Policy and, therefore, make the Investment Policy more effective in governing the management, custody, and investment of funds of and held by the Clearing Agencies. In this way, the proposed changes would better allow the Clearing Agencies to maintain this document in a way that is designed to meet the requirements of Rule 17Ad-22(e)(16). Therefore, the Clearing Agencies believe the proposed revisions would be consistent with the requirements of Rule 17Ad-22(e)(16) under the Act.
Each of the Clearing Agencies believes that none of the proposed revisions to the Investment Policy would have any
The Clearing Agencies have not solicited or received any written comments relating to this proposal. The Clearing Agencies will notify the Commission of any written comments received by the Clearing Agencies.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On September 3, 2020, The Nasdaq Stock Market LLC (“Nasdaq” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend listing rules applicable to companies whose business plan is to complete one or more business combinations (the “Original Proposal”). The Exchange is filing this proposal (“Amendment No. 1”) to amend the Original Proposal. Amendment No. 1 supersedes the
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.
Nasdaq is filing this amendment to SR-NASDAQ-2020-062, which was published for comment by the Commission on September 16, 2020.
In 2009, Nasdaq adopted additional listing requirements for a company whose business plan is to complete an initial public offering and engage in a merger or acquisition with one or more unidentified companies within a specific period of time (“Acquisition Companies”).
Under the existing rules, “following each business combination” with an Acquisition Company, the resulting company must satisfy all initial listing requirements. The rule does not provide a timetable for the company to demonstrate that it satisfies those requirements, however. Accordingly, Nasdaq proposes to modify the rule to specify if the Acquisition Company demonstrates that it will satisfy all requirements except the applicable round lot shareholder requirement, then the company will receive 15 calendar days following the closing to demonstrate that it satisfied the applicable round lot shareholder requirement immediately following the transaction's closing.
Ordinarily, in determining compliance with the round lot shareholder requirement at the time of a business combination, Nasdaq will review a company's public disclosures and information provided by the company about the transaction. For example, the merger agreement may result in the Acquisition Company issuing a round lot of shares to more than 300 holders of the target of the business combination at closing. If public information is not available that enables Nasdaq to determine compliance, Nasdaq will typically request that the company provide additional information such as registered shareholder lists from the company's transfer agent, data from Cede & Co. about shares held in street name, or data from broker-dealers and from third parties that distribute information such as proxy materials for the broker-dealers.
However, Nasdaq has observed that in some cases it can be difficult for a company to obtain evidence demonstrating the number of shareholders that it has or will have following a business combination. As noted above, shareholders of an Acquisition Company may redeem or tender their shares until just before the time of the business combination, and the company may not know how many shareholders will choose to redeem until very close to the consummation of the business combination. In cases where the number of round lot shareholders is close to the applicable requirement, this could affect the ability for Nasdaq to determine compliance before the business combination closes. Accordingly, for a company that has demonstrated that it will satisfy all initial listing requirements except for the round lot shareholder requirement before consummating the business combination, Nasdaq will allow the company 15 calendar days after the closing of the business combination, if necessary, to demonstrate that it also complied with the round lot requirement at the time of the business combination. To be clear, the company must still demonstrate that it satisfied the round lot shareholder requirement immediately following the business combination; the proposal is merely giving the company 15 calendars days to provide evidence that it did.
Providing Acquisition Companies with an additional 15 days to demonstrate compliance with the round lot rule as of the date of the business combination will result in the continuation of the listing of companies that have completed a business combination but not yet demonstrated that they satisfied all initial listing requirements. For this reason, the Exchange proposes that each Acquisition Company that has not demonstrated compliance with the applicable round lot shareholder requirement on the date of the business combination's closing will be required to issue a press release or file a Form 8-K, if required, prior to closing of the business combination, stating that the company is relying upon the additional 15 calendar days available under Nasdaq rules to demonstrate
Nasdaq believes that this proposal balances the burden placed on the Acquisition Company to obtain accurate shareholder information for the new entity and the need to ensure that a company that does not satisfy the initial listing requirements following a business combination enters the delisting process promptly. If the company does not evidence compliance within the proposed time period, Nasdaq staff would issue a delisting determination, which the company could appeal to an independent Hearings Panel as described in the 5800 Series of the Nasdaq Rules. Nasdaq also believes that the disclosure requirement will help provide transparency to investors about the status of the company during this time.
Finally, Nasdaq proposes a non-substantive change to eliminate a duplicate paragraph in paragraphs (d) and (e) of IM-5101-2 and to add a new paragraph designation.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The proposed rule would specify the time when an Acquisition Company must demonstrate compliance with the initial listing standards following the completion of a business combination, thereby enhancing investor protection. Specifically, it would require an Acquisition Company to provide evidence
The proposed rule change is also consistent with Section 6(b)(7) of the Act in that it provides a fair procedure for the prohibition or limitation by the Exchange of any person with respect to access to services offered. The proposed rule change accounts for the particular difficulties encountered by Acquisition Companies when attempting to determine their total number of shareholders due to the ability of shareholders to redeem their shares. Acquisition Companies will still be required to demonstrate compliance with all initial listing standards immediately following the business combination, which is the initial listing of the combined company. This is no different from the requirements imposed on other newly listing companies.
The non-substantive changes to eliminate a duplicate paragraph in paragraphs (d) and (e) of IM-5101-2 and to add a new paragraph designation will improve the rule's readability and thereby remove an impediment to a free and open market and a national market system and help to better protect investors, which Nasdaq believes is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule would clarify that a company listing in connection with a merger with an Acquisition Company must provide evidence before completing the business combination that it will satisfy all requirements for initial listing, although a reasonable accommodation would be made to allow the company to demonstrate compliance with the round lot shareholder requirement before issuing a delisting letter if that is the only requirement that the company cannot demonstrate compliance with before completing the business combination. This change is not expected to have any impact on competition.
On December 21, 2020, the Commission issued an Order Instituting Proceedings
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including 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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 19, 2021, Long-Term Stock Exchange, Inc. (“LTSE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend Rule 14.501(d)(2)(A)(iii) to specify the process under LTSE Rule Series 14.500 for enforcing compliance with LTSE Rule 14.425, which requires listed Companies
Currently, LTSE states that it enforces the provisions of LTSE Rule 14.425 through a number of rules in the LTSE Rulebook.
Finally, LTSE Rule 14.501 sets forth the provisions regarding the Exchange's process for notifying Companies regarding different types of deficiencies and their corresponding consequences.
The Exchange proposes to amend LTSE Rule 14.501(d)(2)(A)(iii) to specify that deficiencies relating to LTSE Rule 14.425 would be included among those for which a Company may submit a Plan of Compliance for staff review.
Under LTSE Rule 14.501(d)(2)(C), a Company has 45 calendar days to submit a plan to regain compliance.
According to the Exchange, the process for reviewing such a Plan of Compliance is set forth in LTSE Rule 14.501(d)(2)(B) and would be unchanged by this proposal.
The Exchange asserts that providing an opportunity for remediation to Companies that face a deficiency with respect to LTSE Rule 14.425 will allow Companies to formulate effective Policies tailored to Company-specific needs.
The Commission has carefully reviewed the proposed rule change and finds that it is consistent with the requirements of Section 6 of the Act.
The Commission notes that the proposed rule change will bring the Exchange's handling of deficiencies in a Company's compliance with LTSE Rule 14.425 into alignment with its handling of deficiencies in a Company's compliance with other LTSE Rules pertaining to corporate governance,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Office of the United States Trade Representative (USTR).
Notice.
The U.S. Trade Representative has determined to modify the action being taken in the investigation by suspending the additional tariffs on goods of the European Union for a period of four months. The suspension is in accord with a joint U.S.-EU statement that promotes a resolution of the large civil aircraft dispute.
As of 12:01 a.m. eastern standard time on March 11, 2021, the additional duties on products of the European Union covered by the action taken in this investigation are suspended for a period of four months.
For questions about the investigation or this notice, contact Associate General Counsel Megan Grimball, at (202) 395-5725, or Director for Europe Michael Rogers, at (202) 395-3320.
For background on the proceedings in this investigation, please see prior notices, including: Notice of initiation, 84 FR 15028 (April 12, 2019); notice of determination and action, 84 FR 54245 (October 9, 2019); and notices concerning revisions or modifications of action, 85 FR 10204 (February 21, 2020), 85 FR 50866 (August 18, 2020), 86 FR 674 (January 6, 2021), 86 FR 9420 (February 12, 2021), and FR Doc. 2021-05035 (March 11, 2021).
Section 307(a) of the Trade Act of 1974, as amended, (Trade Act) provides that the U.S. Trade Representative may modify or terminate any action subject to the specific direction, if any, of the President with respect to such action, that is being taken under section 301 if any of the conditions described in section 301(a)(2) exist. Section 301(a)(2)(B)(iv) of the Trade Act provides that the U.S. Trade Representative is not required to take action under section 301(a)(1) “in extraordinary cases, where the taking of action . . . would have an adverse impact on the United States economy substantially out of proportion to the benefits of such action, taking into account the impact of not taking such action on the credibility of [actions taken under section 301].”
On March 5, 2021, the United States and the European Union issued a Joint Statement promoting a resolution of the large civil aircraft dispute:
The European Union and the United States today agreed on the mutual suspension for four months of the tariffs related to the World Trade Organization (WTO) Aircraft disputes. The suspension will cover all tariffs both on aircraft as well as on non-aircraft products, and will become effective as soon as the internal procedures on both sides are completed.
This will allow the EU and the US to ease the burden on their industries and workers and focus efforts towards resolving these long running disputes at the WTO.
The EU and the US are committed to reach a comprehensive and durable negotiated solution to the Aircraft disputes. Key elements of a negotiated solution will include disciplines on future support in this sector, outstanding support measures, monitoring and enforcement, and addressing the trade distortive practices of and challenges posed by new entrants to the sector from non-market economies, such as China.
These steps signal the determination of both sides to embark on a fresh start in the relationship.
Promoting a successful resolution of the dispute by suspending the additional duties provides benefits to the U.S. economy that outweigh any adverse impacts on the U.S. economy, and the suspension maintains the credibility of the section 301 action. Accordingly, the U.S. Trade Representative has determined, in accordance with sections 307(a) and 301(a)(2)(B)(iv) of the Trade Act, to modify the action by suspending the additional duties on products of the European Union for four months. The decision to modify the action takes into account the public comments received in response to prior notices issued in the investigation as well as the advice of the interagency Section 301 Committee.
To give effect to the U.S. Trade Representative's determination, as specified in the Annex to this notice, the additional duties imposed by subheadings 9903.89.05, 9903.89.07, 9903.89.10, 9903.89.13, 9903.89.16, 9903.89.19, 9903.89.22, 9903.89.25, 9903.89.28, 9903.89.31, 9903.89.34, 9903.89.37, 9903.89.40, 9903.89.43, 9903.89.46, 9903.89.52, 9903.89.55, 9903.89.57, 9903.89.59, 9903.89.61, and 9903.89.63, and as provided by their associated subchapter notes, will not apply to products of Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden, that are entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern standard time on March 11, 2021, and before 12:01 a.m. eastern daylight time on July 11, 2021.
Any product of Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus,
Any product of Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden covered by subparagraph 2 of the Annex to this notice, that is admitted into a U.S. foreign trade zone on or after 12:01 a.m. eastern standard time on March 11, 2021, and before 12:01 a.m. eastern daylight time on July 11, 2021, may be admitted in any status, as applicable, as defined in 19 CFR 146, Subpart D.
The U.S. Trade Representative will continue to consider the action taken in this investigation.
Effective with respect to articles the product of Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden that are entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern standard time on March 11, 2021, and entered for consumption, or withdrawn from warehouse for consumption, before 12:01 a.m. eastern daylight time on July 11, 2021:
1. Note 21(a) to subchapter III of chapter 99 of the Harmonized Tariff Schedule of the United States is modified by deleting “Except as provided in note 21(u) of this subdivision,” and by inserting “Except as provided in notes 21(u) and 21(v) of this subdivision,” in lieu thereof.
2. Note 21 to subchapter III of chapter 99 of the Harmonized Tariff Schedule of the United States is modified by inserting in alphabetical order:
“(v) The U.S. Trade Representative has determined that additional duties imposed by subheadings 9903.89.05, 9903.89.07, 9903.89.10, 9903.89.13, 9903.89.16, 9903.89.19, 9903.89.22, 9903.89.25, 9903.89.28, 9903.89.31, 9903.89.34, 9903.89.37, 9903.89.40, 9903.89.43, 9903.89.46, 9903.89.52, 9903.89.55, 9903.89.57, 9903.89.59, 9903.89.61, and 9903.89.63 and as provided by their associated subchapter notes, shall not apply to articles the product of Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden that are entered on or after 12:01 a.m. eastern standard time on March 11, 2021 and before 12:01 a.m. eastern daylight time on July 11, 2021.”
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before April 5, 2021.
Send comments identified by docket number FAA-2021-0079 using any of the following methods:
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Nia Daniels, (202) 267-7626, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request approval from the Office of Management and Budget (OMB) to renew a currently approved information collection. The FAA collects information from U.S. and foreign air carriers holding a slot at Ronald Reagan Washington National Airport (DCA), John F. Kennedy International Airport (JFK), and LaGuardia Airport (LGA); operating scheduled flights at Newark Liberty International Airport (EWR), Los Angeles International Airport (LAX), O'Hare International Airport (ORD), and San Francisco International Airport (SFO); and conducting unscheduled operations at DCA and LGA. The information collected is necessary to support the advance management of air traffic demand by the FAA Slot Administration in an effort to reduce potential delays. The FAA proposes renaming this information collection to “FAA Runway Slot Administration and Schedule Analysis” to more accurately reflect the collection of information related to multiple airports subject to different FAA regulatory and voluntary processes under this program.
Written comments should be submitted by May 17, 2021.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; telephone: (800) 647-5527, or (202) 366-9826. You must identify FAA Docket Number FAA-2021-0067 at the beginning of your comments. You may also submit comments through the internet at
Matthew Gonabe, FAA Slot Administration, by email at:
At DCA, U.S. and foreign air carriers, including commuter operators, must notify the FAA of: (1) Written consent and requests for confirmation of slot transfers; (2) slots required to be returned and slots voluntarily returned; (3) requests to be included in a lottery for the permanent allocation of available slots; (4) reports on usage of slots on a bi-monthly basis; and (5) requests for slots in low-demand hours or other temporary allocations. Operators must obtain a reservation from the FAA prior to conducting an unscheduled operation. At LGA, U.S. and foreign air carriers must notify the FAA of: (1) Written consent and requests for confirmation of slot transfers; (2) slots required to be returned and slots voluntarily returned; (3) requests to be included in a lottery for the permanent allocation of available slots; and (4) reports usage of slots on a bi-monthly basis. Carriers must also request and obtain a reservation from the FAA prior to conducting an unscheduled operation. At JFK, U.S. and foreign air carriers must notify the FAA of: (1) Written consent and requests for confirmation of slot transfers; (2) requests for seasonal allocation of historic and additional available slots; (3) reports on usage of slots on a seasonal basis; (4) the return of slots; and (5) changes to allocated slots. At EWR, LAX, ORD, and SFO, all carriers are asked to notify the FAA of their intended operating schedules during designated hours on a semiannual basis (for each winter and summer scheduling season) based on the IATA WASG Calendar of Coordination Activities and provide updates throughout the year when there are significant schedule changes.
The FAA estimates that all information from carriers is submitted electronically from data stored in carrier scheduling databases. Requests for unscheduled flight reservations are submitted electronically via the internet. The FAA also proposes to re-name the collection to “FAA Runway Slot Administration and Schedule Analysis” to more accurately reflect the collection of information related to multiple airports subject to different FAA regulatory and voluntary processes.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before March 22, 2021.
Send comments identified by docket number FAA-2020-0307 using any of the following methods:
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Nia Daniels, (202) 267-9677, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for exemption; request for comments.
FMCSA announces that FirstGroup plc (FirstGroup) has applied for an exemption on behalf of three of its subsidiaries, First Student, Inc., First Transit, Inc., and First Mile Square, which employ commercial driver's license (CDL) holders subject to drug and alcohol testing. FirstGroup requests an exemption from the requirement that an employer must conduct a full query of FMCSA's Drug and Alcohol Clearinghouse (Clearinghouse) before employing a CDL holder to perform safety-sensitive functions. Under the requested exemption, in lieu of a full query, FirstGroup would conduct a limited pre-employment query of the Clearinghouse. If the limited query indicated that information about the driver existed in the Clearinghouse, FirstGroup would then conduct a full query of the Clearinghouse, with the driver-applicant providing consent in the Clearinghouse as required. In addition, FirstGroup would conduct a second limited query within 30 to 35 days of the initial limited query and conduct multiple limited queries on all its CDL drivers each year thereafter.
Comments must be received on or before April 15, 2021.
You may submit comments identified by Federal Docket Management System Number FMCSA-2020-0224 by any of the following methods:
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Each submission must include the Agency name and the docket number for this notice (FMCSA-2020-0224). Note that DOT posts all comments received without change to
Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; (202) 366-2722;
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2020-0224), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved absent the exemption (49 U.S.C 31315(b)(1)). The decision of the Agency must be published in the
Under 49 CFR 382.701(a)(2) employers of CDL holders must not employ a driver subject to the testing requirements of 49 CFR part 382 without first conducting a pre-employment full query of the Clearinghouse. A full query allows the employer to see any information that exists about a driver in the Clearinghouse. An employer must obtain the driver's specific consent, provided electronically through the Clearinghouse, prior to the release of detailed information provided in response to the full query.
A limited query is permitted to satisfy the annual query requirement in 49 CFR 382.701(b)(1), which pertains to currently employed drivers. The limited query, conducted after obtaining the driver's general consent, will tell the employer whether information about the individual driver exists in the Clearinghouse but will not release that information to the employer. General consent is obtained and retained outside the Clearinghouse and may be in written or electronic form. If the response to a limited query indicates there is information about the driver in the Clearinghouse, the employer must conduct a full query, after obtaining the driver's specific consent, within 24 hours, as required by 49 CFR 382.701(b)(3).
FirstGroup requests an exemption from the rule prohibiting an employer from employing a driver subject to drug and alcohol testing requirements to perform safety-sensitive functions without first conducting a full query of the Clearinghouse. Under the requested exemption, FirstGroup would, in lieu of a full query, conduct a limited pre-employment query of the Clearinghouse before one of its members employed a driver. If the limited query indicated that information about the driver exists in the Clearinghouse, FirstGroup would then conduct a full query of the Clearinghouse, with the driver applicant providing consent in the Clearinghouse as required. In addition, FirstGroup would conduct a second limited query within 30 to 35 days of the initial query, would conduct quarterly limited queries on all its CDL drivers for the first year of the exemption, and for years 2 through 5, would conduct semi-annual limited queries on all its CDL drivers.
FirstGroup believes the requirements of 49 CFR 382.701(a)(2) is hindering its ability to hire at the speed and level needed to keep pace with the demands of the contracted school and transit transportation industry. FirstGroup also believes the exemption is needed since the delays and administrative costs related to conducting a full query during FirstGroup's driver hiring process is resulting in hundreds of thousands of dollars of increased costs.
A copy of FirstGroup's exemption application is included in the docket referenced above.
In accordance with 49 U.S.C. 31315(b), FMCSA requests public comment from all interested persons on FirstGroup's application for an exemption from § 382.701(a)(2). All comments received before the close of business on the comment closing date indicated at the beginning of this notice will be considered and will be available for examination in the docket at the location listed under the
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to renew exemptions for 66 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates provided below.
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
To view comments go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
On January 7, 2021, FMCSA published a notice announcing its decision to renew exemptions for 66 individuals from the vision requirement in 49 CFR 391.41(b)(10) to operate a CMV in interstate commerce and requested comments from the public (86 FR 697). The public comment period ended on February 5, 2021, and one comment was received.
FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would achieve a level of safety equivalent to, or greater than, the level that would be achieved by complying with the current regulation § 391.41(b)(10).
The physical qualification standard for drivers regarding vision found in § 391.41(b)(10) states that a person is physically qualified to drive a CMV if that person has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of a least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing red, green, and amber.
FMCSA received one comment in this proceeding and it was unrelated to the scope of this notice.
Based on its evaluation of the 66 renewal exemption applications and comments received, FMCSA confirms its decision to exempt the following drivers from the vision requirement in § 391.41(b)(10).
In accordance with 49 U.S.C. 31136(e) and 31315(b), the following groups of drivers received renewed exemptions in the month of February and are discussed below. As of February 5, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 63 individuals have satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (65 FR 20245; 65 FR 33406; 65 FR 57230; 65 FR 57234; 67 FR 10471; 67 FR 19798; 67 FR 46016; 67 FR 57266; 67 FR 57627; 69 FR 19611; 69 FR 51346; 69 FR 52741; 69 FR 53493; 69 FR 62742; 69 FR 64806; 70 FR 2705; 70 FR 48797; 70 FR 61493; 71 FR 26602; 71 FR 32183; 71 FR 41310; 71 FR 50970; 71 FR 53489; 71 FR 62147; 71 FR 62148; 71 FR 63379; 72 FR 1050; 72 FR 1051; 72 FR 1056; 72 FR 64273; 73 FR 6242; 73 FR 6244; 73 FR 15567; 73 FR 16950; 73 FR 16952; 73 FR 27015; 73 FR 27018; 73 FR 35197; 73 FR 35198; 73 FR 36955; 73 FR 38498; 73 FR 38499; 73 FR 48273; 73 FR 48275; 73 FR 51336; 73 FR 51689; 73 FR 61922; ; 73 FR 61925; 73 FR 61925; 73 FR 63047; 73 FR 74565; 73 FR 75803; 73 FR 75807; 73 FR 76439; 73 FR 78421; 73 FR 78423; 74 FR 6209; 74 FR 62632; 75 FR 9477; 75 FR 19674; 75 FR 22179; 75 FR 36778; 75 FR 36779; 75 FR 39725; 75 FR 44051; 75 FR 47883; 75 FR 50799; 75 FR 52062; 75 FR 54958; ; 75 FR 59327; 75 FR 59327; 75 FR 61833; 75 FR 63257; 75 FR 64396; 75 FR 69737; 75 FR 70078; 75 FR 72863; 75 FR 77591; 75 FR 77942; 75 FR 77949; 75 FR 79079; 75 FR 79083; 75 FR 79084; 76 FR 1499; 76 FR 2190; 76 FR 4413; 76 FR 5425; 76 FR 70215; 77 FR 13689; 77 FR 20879; 77 FR 23797; 77 FR 31427; 77 FR 36338; 77 FR 38384; 77 FR 41879; 77 FR 46153; 77 FR 48590; 77 FR 52381; 77 FR 52389; 77 FR 52391; 77 FR 56261; 77 FR 60008; 77 FR 60010; 77 FR 64582; 77 FR 64583; 77 FR 64583; 77 FR 64841; 77 FR 65933; 77 FR 68200; 77 FR 68202; 77 FR 71671; 77 FR 74273; 77 FR 74730; 77 FR 74733; 77 FR 74734; 77 FR 75496; 77 FR 76166; 78 FR 797; 78 FR 63302; 78 FR 64280; 78 FR 67454; 78 FR 77780; 79 FR 4803; 79 FR 10606; 79 FR 10609; 79 FR 14331; 79 FR 22003; 79 FR 23797; 79 FR 35212; 79 FR 35218; 79 FR 35220; 79 FR 37843; 79 FR 38659; 79 FR 38661; 79 FR 41735; 79 FR 45868; 79 FR 46153; 79 FR 47175; 79 FR 51643; 79 FR 53514; 79 FR 56097; 79 FR 56099; 79 FR 56104; 79 FR 56117; 79 FR 58856; 79 FR 59348; 79 FR 59357; 79 FR 64001; 79 FR 65759; 79 FR 65760; 79 FR 70928; 79 FR 72754; 79 FR 72756; 79 FR 73397; 79 FR 73686; 79 FR 73687; 79 FR 73689; 79 FR 74169; 80 FR 3305; 80 FR 9304; 80 FR 63869; 80 FR 80443; 81 FR 20435; 81 FR 28138; 81 FR 39320; 81 FR 45214; 81 FR 66720; 81 FR 66726; 81 FR 70248; 81 FR 70251; 81 FR 70253; 81 FR 71173; 81 FR 72664; 81 FR 80161; 81 FR 81230; 81 FR 90046; 81 FR 90050; 81 FR 91239; 81 FR 94013; 81 FR 96165; 81 FR 96178; 81 FR 96180; 81 FR 96191; 81 FR 96196; 82 FR 13048; 83 FR 3861; 83 FR 6925; 83 FR 18633; 83 FR 28325; 83 FR 28342; 83 FR 34661; 83 FR 53724; 83 FR 56140; 83 FR 56902; 84 FR 2309; 84 FR 2311; 84 FR 2314):
The drivers were included in docket numbers FMCSA-2000-7006; FMCSA-2000-7165; FMCSA-2001-11426; FMCSA-2002-12294; FMCSA-2004-18885; FMCSA-2004-18885; FMCSA-2004-19477; FMCSA-2005-21711; FMCSA-2006-24783; FMCSA-2006-26066; FMCSA-2007-0071; FMCSA-2008-0021; FMCSA-2008-0106; FMCSA-2008-0174; FMCSA-2008-0266; FMCSA-2008-0292; FMCSA-2008-0340; FMCSA-2010-0161; FMCSA-2010-0187; FMCSA-2010-0201; FMCSA-2010-0287; FMCSA-2010-0354; FMCSA-2010-0385; FMCSA-2012-0039; FMCSA-2012-0161; FMCSA-2012-0215; FMCSA-2012-0216; FMCSA-2012-0279; FMCSA-2013-0168; FMCSA-2013-0170; FMCSA-2014-0002; FMCSA-2014-0006; FMCSA-2014-0007; FMCSA-2014-0010; FMCSA-2014-0011; FMCSA-2014-0296; FMCSA-2014-0299; FMCSA-2016-0028; FMCSA-2016-0030; FMCSA-2016-0207; FMCSA-2016-0208; FMCSA-2016-0209; FMCSA-2016-0210; FMCSA-2018-0010; FMCSA-2018-0207. Their exemptions were applicable as of February 5, 2021, and will expire on February 5, 2023.
As of February 18, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315, the following two individuals have satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (80 FR 2473; 80 FR 18693; 82 FR 13048; 84 FR 2314):
The drivers were included in docket number FMCSA-2014-0030. Their exemptions were applicable as of February 18, 2021, and will expire on February 18, 2023.
As of February 25, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315, the following individual has satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (69 FR 64806; 70 FR 2705; 72 FR 1056; 73 FR 76439; 75 FR 79084; 77 FR 75496; 80 FR 3723; 82 FR 13048; 84 FR 2314):
The driver was included in docket number FMCSA-2004-19477. The exemption was applicable as of February 25, 2021, and will expire on February 25, 2023.
In accordance with 49 U.S.C. 31315(b), each exemption will be valid
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to exempt seven individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. They are unable to meet the vision requirement in one eye for various reasons. The exemptions enable these individuals to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
The exemptions were applicable on February 5, 2021. The exemptions expire on February 5, 2023.
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
To view comments, as well as any documents mentioned in this notice as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
On January 7, 2021, FMCSA published a notice announcing receipt of applications from seven individuals requesting an exemption from vision requirement in 49 CFR 391.41(b)(10) and requested comments from the public (86 FR 695). The public comment period ended on February 5, 2021, and one comment was received.
FMCSA has evaluated the eligibility of these applicants and determined that granting the exemptions to these individuals would achieve a level of safety equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(10).
The physical qualification standard for drivers regarding vision found in § 391.41(b)(10) states that a person is physically qualified to drive a CMV if that person has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of a least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing red, green, and amber.
FMCSA received one comment in this proceeding. Tracy Ibinger submitted a comment stating that the Minnesota Department of Public Safety has no objections to the decision to grant an exemption to Burl V. Ingebretsen.
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statute also allows the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The Agency's decision regarding these exemption applications is based on medical reports about the applicants' vision, as well as their driving records and experience driving with the vision deficiency. The qualifications, experience, and medical condition of each applicant were stated and discussed in detail in the January 7, 2021,
FMCSA recognizes that some drivers do not meet the vision requirement but have adapted their driving to accommodate their limitation and demonstrated their ability to drive safely. The seven exemption applicants listed in this notice are in this category. They are unable to meet the vision requirement in one eye for various reasons, including amblyopia, corneal scarring, ectopia lentis, optic nerve hypoplasia, and retinal detachment. In most cases, their eye conditions did not develop recently. Five of the applicants were either born with their vision impairments or have had them since childhood. The two individuals that developed their vision conditions as adults have had them for a range of 3 to 4 years. Although each applicant has one eye that does not meet the vision requirement in § 391.41(b)(10), each has at least 20/40 corrected vision in the other eye, and, in a doctor's opinion, has sufficient vision to perform all the tasks necessary to operate a CMV.
Doctors' opinions are supported by the applicants' possession of a valid license to operate a CMV. By meeting State licensing requirements, the applicants demonstrated their ability to operate a CMV with their limited vision in intrastate commerce, even though their vision disqualified them from driving in interstate commerce. We believe that the applicants' intrastate driving experience and history provide an adequate basis for predicting their ability to drive safely in interstate commerce. Intrastate driving, like interstate operations, involves
The applicants in this notice have driven CMVs with their limited vision in careers ranging for 3 to 92 years. In the past 3 years, no drivers were involved in crashes, and no drivers were convicted of moving violations in CMVs. All the applicants achieved a record of safety while driving with their vision impairment that demonstrates the likelihood that they have adapted their driving skills to accommodate their condition. As the applicants' ample driving histories with their vision deficiencies are good predictors of future performance, FMCSA concludes their ability to drive safely can be projected into the future.
Consequently, FMCSA finds that in each case exempting these applicants from the vision requirement in § 391.41(b)(10) is likely to achieve a level of safety equal to that existing without the exemption.
The terms and conditions of the exemption are provided to the applicants in the exemption document and includes the following: (1) Each driver must be physically examined every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the standard in § 391.41(b)(10) and (b) by a certified medical examiner (ME) who attests that the individual is otherwise physically qualified under § 391.41; (2) each driver must provide a copy of the ophthalmologist's or optometrist's report to the ME at the time of the annual medical examination; and (3) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy in his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the seven exemption applications, FMCSA exempts the following drivers from the vision requirement, § 391.41(b)(10), subject to the requirements cited above:
In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that on February 22, 2021, the Port Authority Trans-Hudson Corporation (PATH) petitioned the Federal Railroad Administration (FRA) for an extension of a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 229, Railroad Locomotive Safety Standards. FRA assigned the petition Docket Number FRA-2008-0135.
Specifically, PATH requests continued relief from 49 CFR 229.123,
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by April 30, 2021 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that on February 16, 2021, the Walkersville Southern Railroad (WSRR) petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 215, Freight Car Safety Standards, and part 224, Reflectorization. FRA assigned the petition Docket Number FRA-2021-0028
Specifically, WSRR seeks a special approval pursuant to 49 CFR 215.203,
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by April 30, 2021 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable. Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that on January 1, 2021, The Everett Railroad Company (EV) petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 230, Steam Locomotive Inspection and Maintenance Standards. FRA assigned the petition Docket Number FRA-2021-0008.
Specifically, EV requests relief from 49 CFR 230.16(a),
EV 11 is currently stored inside a shop building, and EV does not anticipate operating the locomotive until May 2021 or later.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received by April 30, 2021 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable. Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App.2, that virtual meetings of the Advisory Committee on Homeless Veterans will be held April 6-7, 2021 from 12:00 p.m. to 4:00 p.m. (Eastern Standard Time). The virtual meetings are open to the public.
The purpose of the Committee is to provide the Secretary of Veterans Affairs with an on-going assessment of the effectiveness of the policies, organizational structures, and services of VA in assisting Veterans at-risk and experiencing homelessness. The Committee shall assemble, and review information related to the needs of homeless Veterans and provide advice on the most appropriate means of providing assistance to that subset of the Veteran population. The Committee will make recommendations to the Secretary of Veterans Affairs regarding such activities.
The agenda will include briefings from officials at VA and other Federal, state, and local agencies regarding services for homeless Veterans.
No time will be allocated at this virtual meeting for receiving oral presentations from the public. Interested parties should provide written comments on issues affecting homeless Veterans for review by the Committee to Mr. Adam M. Ruege at
Members of the public who wish to virtually attend should contact Leisa Davis (