Food and Nutrition Service
Forest Service
Economic Analysis Bureau
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Office of the Under-Secretary for Economic Affairs
Federal Energy Regulatory Commission
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Food and Drug Administration
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Substance Abuse and Mental Health Services Administration
Coast Guard
Geological Survey
National Indian Gaming Commission
National Park Service
Drug Enforcement Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Foreign Assets Control Office
Internal Revenue Service
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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Office of Energy Efficiency and Renewable Energy, Department of Energy.
Final rule; correcting amendments.
On January 5, 2017, the U.S. Department of Energy (“DOE”) published a final rule that made two sets of amendments to the test procedure for central air conditioners and heat pumps (“CAC/HPs”): amendments to the existing test procedure required for determining compliance with the current energy conservation standards; and establishment of a new test procedure that would be the basis for making efficiency representations as of the compliance date for any amended energy conservation standards. This document corrects typographical errors, omissions, and incorrect cross-references in the Code of Federal Regulations that resulted from the January 2017 final rule. Neither the errors nor the corrections in this document affect the substance of the rulemaking or any conclusions reached in support of the final rule.
Effective December 2, 2021.
Ms. Catherine Rivest, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 586-7335. Email:
Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 586-9496. Email:
On January 5, 2017, DOE published a final rule regarding the Federal test procedure for central air conditioner and heat pumps. 82 FR 1426 (“January 2017 final rule”). The January 2017 final rule amended the test procedure for central air conditioners and heat pumps at title 10 of the Code of Federal Regulations (“CFR”) part 430 subpart B appendix M (“Appendix M”) and established a new test procedure at 10 CFR part 430 subpart B appendix M1 (“Appendix M1”). 82 FR 1426. Appendix M provides for the measurement of the cooling and heating performance of central air conditioners and heat pumps using the seasonal energy efficiency ratio (“SEER”) metric and heating seasonal performance factor (“HSPF”) metric, respectively. Appendix M1 specifies a revised SEER metric (“SEER2”) and a revised HSPF metric (“HSPF2”). The test procedures as amended and established in the January 2107 final rule for central air conditioners and heat pumps include a number of typographical errors, omissions, and incorrect cross-references, which may result in confusion in executing the test procedures. The errors and corrections are summarized in the Table I.1.
This document identifies and corrects these errors. Neither the errors nor the corrections in this document affect the substance of the rulemaking or any conclusions reached in support of the final rule.
As published, the regulatory text in the January 2017 final rule may result in confusion due to incorrect symbols in the test procedure equations, typographical errors, incorrect cross-references, and missing footnotes. The following sections provide the rationale for each correction. Because this final rule would correct errors in the text and provide additional detail without making substantive changes in the January 2017 final rule, the changes addressed in this document are technical in nature.
The January 2017 Final Rule added provisions for determining represented values for split systems in 10 CFR 429.16(c)(3)(i) but did not make corresponding edits to the cross-references contained within 10 CFR 429.16(a)(1), which describes the additional representations that are allowed for such systems (
In the January 2017 Final Rule, DOE established provisions for represented values required by the Federal Trade Commission—among them the annual operating cost in cooling mode. These sections rely on the calculated quantities for cooling capacity and SEER in order to determine operating costs but contain incorrect cross-references to the sections where these quantities are calculated. This document corrects the cross-references to refer to the correct sections for represented values of cooling capacity and SEER as adopted by the January 2017 Final Rule.
In the January 2017 Final rule, DOE revised the requirement regarding compressor speed for the H1
The January 2017 Final Rule established the HSPF2 metric as measured per the newly created appendix M1. The HSPF2 metric is not defined for appendix M and does not apply in any section of that appendix. Rather, the applicable heating metric for appendix M is Heating Seasonal Performance Factor (“HSPF”). This document replaces two erroneous instances of HSPF2 with HSPF in paragraphs b and c of section 3.6.6 of appendix M.
The January 2017 Final Rule retained testing provisions in appendix M to calculate the electrical power consumption of CAC/HPs when building load is between minimum and maximum capacity in order to satisfy the building cooling demand. For two-stage CAC/HPs, section 4.1.3.2 details the case where the system operates
The January 2017 Final Rule retained provisions in sections 4.2.5.1, 4.2.5.2, and 4.2.5.3 of appendices M and M1 for additional steps to calculate HSPF (or HSPF2 in the case of appendix M1) for heat pumps having heat comfort controllers. These sections each contain a case where outdoor bin temperatures are greater than the maximum supply temperature, T
Section 4.2.5.1 of both appendix M and appendix M1 specify calculating the space heating capacity and electrical power of the heat pump, and to denote these capacities and electrical power by using the subscript “hp” instead of “h”. Case 1 of section 4.2.5.1 of both appendices specifies determining total electrical power consumption E
In sections 4.2.5.1, 4.2.5.2, and 4.2.5.3 of both appendix M and appendix M1, Case 1 of each section covers instances where supply air temperature is greater than or equal to the comfort controller maximum supply temperature (
The January 2017 Final Rule established provisions for testing of triple-capacity northern heat pumps, which utilize a third distinct stage of heating capacity—denoted as “boost” or “booster”—that is higher than both the “high” and “low” stages. Section 4.2.6 of both appendix M and appendix M1 describes additional steps for HSPF calculation for triple-capacity northern heat pumps, referring to boost capacity with the superscript notation “k=3” in all but one instance: In section 4.2.6.c, the boost capacity is erroneously referred using the superscript notation “k=2”. (Elsewhere in the test procedure, the notation “k=2” is used to refer to the “high” stage.) This document corrects that error by updating the superscript to “k=3” to be consistent with the intent established by the January 2017 final rule.
The January 2017 Final rule amended provisions for HSPF calculation of triple-capacity northern heat pumps in section 4.2.6. The title of section 4.2.6.2 describes cases where the heat pump operates at high (k=2) compressor capacity at temperature T
As discussed in paragraph I, the January 2017 Final rule established provisions for HSPF calculation of triple-capacity northern heat pumps in section 4.2.6. Section 4.2.6.3 describes cases where the heat pump operates at the (k=3) compressor capacity (
In the January 2017 Final rule, DOE proposed a definition for “minimum-speed-limiting variable-speed heat pump” to refer to heat pumps that vary the minimum compressor speed when operating in outdoor temperatures that are in the range for which the minimum speed performance factors into the HSPF calculation (
The January 2017 Final Rule established provisions in section 3.1.4.7 of appendix M1 for determining the heating nominal air volume rate to be used in HSPF2 testing. This section omitted a period and erroneously cross-references section 3.14.6 for adjusting airflow—section 3.1.4.6 is the proper cross-reference. This document corrects these errors.
Compressor speeds for variable-speed compressor systems are specified in Table 14 in section 3.6.4 of appendices M and M1. These sections are supposed to include footnotes that specify the “Heating Full” compressor speed at different outdoor temperature test conditions for systems containing a variable-speed compressor. However, at the optional H4
This correction is consistent with the discussion provided in the August 24, 2016 supplemental notice of proposed rulemaking (“SNOPR”), in which DOE stated that the full-speed compressor operation for variable-speed heat pumps could be very different at 5 °F than it is at 17 °F, thus an extrapolation of performance below 5 °F using the [17 °F compressor speed] trend between 17 °F and 5 °F is not appropriate. 81 FR 58164, 58193 (“August 2016 SNOPR”). The regulatory text in the August 2016 SNOPR provided instructional footnotes as to the appropriate “Heating Full” compressor speed for the heating test conditions except for the optional H4
Section 4.1.4.2 of appendix M1 specifies several equations in which variations of the EER metric are used. One of these equations contains the term EER
The title of section 4.1.3.2 of appendix M1 contains extraneous “(” symbols preceding the terms BL(T
Pursuant to the Administrative Procedure Act, 5 U.S.C. 553(b), DOE has determined there is good cause to find that prior notice and opportunity for public comment on the changes contained in this document are impracticable, unnecessary, or contrary to the public interest. Neither the errors nor the corrections in this document affect the substance of the January 2017 Final Rule or any of the conclusions reached in support of the final rule. Providing prior notice and an opportunity for public comment on correcting objective, typographical errors and omissions that do not change the substance of the test procedure serves no useful purpose. As such, this rule is similarly not subject to the 30-day delay in effective date requirement of 5 U.S.C. 553(d) otherwise applicable to rules that make substantive changes.
DOE has also concluded that the determinations made pursuant to the various regulatory review requirements applicable to the January 2017 final rule remain unchanged for this final rule technical correction. These determinations are set forth in the January 2017 final rule. 84 FR 1426, 1463-1468.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Reporting and recordkeeping requirements.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Incorporation by reference, Intergovernmental relations, Small businesses.
This document of the Department of Energy was signed on November 17, 2021, by Kelly Speakes-Backman, Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
For the reasons stated in the preamble, DOE corrects parts 429 and 430 of chapter II, subchapter D, of title 10 of the Code of Federal Regulations by making the following correcting amendments:
42 U.S.C. 6291-6317; 28 U.S.C. 2461 note.
The revision reads as follows:
(a) * * *
(1) * * *
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
The revisions read as follows:
3. * * *
3.6 * * *
3.6.4 * * *
a. * * * For a cooling/heating heat pump, the compressor shall operate for the H1
4. * * *
4.1.3 * * *
4.1.3.2 Unit Alternates Between High (k=2) and Low (k=1) Compressor Capacity to Satisfy the Building Cooling Load at Temperature Tj, Q
4.1.4.2 Unit Operates at an Intermediate Compressor Speed (k=i) In Order To Match the Building Cooling Load at Temperature Q
4.2 * * *
4.2.6 * * *
4.2.6.3 Heat Pump Only Operates at Booster (k=3) Compressor Capacity at Temperature T
The revisions read as follows:
1. * * *
1.2 * * *
3. * * *
3.6 * * *
3.6.4
a. Conduct one maximum temperature test (H0
d. * * *
Farm Credit Administration.
Notification of effective date.
The Farm Credit Administration (FCA) issued a final rule to amend the regulatory capital requirements for Farm Credit System (System or FCS) institutions. The amendments clarified certain provisions in the Tier 1/Tier 2 Capital Framework and codified the guidance provided in an FCA bookletter.
On October 1, 2021, FCA issued a final rule to amend the regulatory capital requirements for System institutions. The amendments clarified provisions in the Tier 1/Tier 2 Capital Framework, codified the guidance provided in FCA Bookletter BL-068, reduced administrative burden, and amended definitions pertaining to qualified financial contracts. In accordance with 12 U.S.C. 2252(c)(1), the final rule provided an effective date of the later to occur of January 1, 2022 or 30 days after the date of rule's publication in the
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
This action corrects typographic errors in the final rule published in the
Effective date 0901 UTC, January 27, 2022. The Director of the Federal Register approves this incorporation by reference action under Title 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
The FAA published a final rule in the
Class D and Class E airspace designations are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order JO 7400.11F dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be subsequently published in FAA Order JO 7400.11.
Accordingly, pursuant to the authority delegated to me, Amendment Class D and Class E Airspace; Ardmore, OK, published in the
Food and Drug Administration, Department of Health and Human Services (HHS).
Final amendment; final order.
The Food and Drug Administration (FDA or we) is classifying the isocapnic ventilation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the isocapnic ventilation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
This order is effective December 2, 2021. The classification was applicable on March 14, 2019.
Todd Courtney, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1216, Silver Spring, MD 20993-0002, 301-796-6371,
Upon request, FDA has classified the isocapnic ventilation device as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On August 18, 2017, Thornhill Research, Inc. submitted a request for De Novo classification of the ClearMate. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in
Therefore, on March 14, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 868.5480.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).
At the time of classification, isocapnic ventilation devices are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 868 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including the following performance characteristics:
(i) Gas concentration accuracy testing for the range of intended concentrations;
(ii) Airway pressure delivery accuracy testing;
(iii) Supplemental O
(iv) Alarm testing; and
(v) Use life testing.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Labeling must include the following:
(i) Instructions for use;
(ii) A precaution that monitoring of capnography is necessary during treatment with non-spontaneously breathing patients; and
(iii) Use life specification.
Food and Drug Administration, Department of Health and Human Services (HHS).
Final amendment; final order.
The Food and Drug Administration (FDA or we) is classifying the esophageal tissue characterization system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the esophageal tissue characterization system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
This order is effective December 2, 2021. The classification was applicable on December 23, 2019.
Pramodh Kariyawasam, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2536, Silver Spring, MD 20993-0002, 301-348-1911,
Upon request, FDA has classified the esophageal tissue characterization system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On December 17, 2018, Diversatek Healthcare Inc. submitted a request for De Novo classification of the Mucosal Integrity Conductivity Test System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on December 23, 2019, FDA issued an order to the requester classifying the device into class II. In this final order,
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) All patient contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.
(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.
(6) Performance data must validate the reprocessing instructions for any reusable components of the device.
(7) Labeling must include:
(i) Specific instructions regarding the proper placement and use of the device;
(ii) Instructions for reprocessing of any reusable components; and
(iii) An expiration date for single use components.
Food and Drug Administration, Department of Health and Human Services (HHS).
Final amendment; final order.
The Food and Drug Administration (FDA or we) is classifying the trunk and limb electrical stimulator to treat headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the trunk and limb electrical stimulator to treat headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and
This order is effective December 2, 2021. The classification was applicable on May 20, 2019.
Erin Keegan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1649, Silver Spring, MD 20993-0002, 240-402-6534,
Upon request, FDA has classified the trunk and limb electrical stimulator to treat headache as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On November 6, 2018, Theranica Bioelectronics Ltd submitted a request for De Novo classification of the Nerivio Migra. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on May 20, 2019, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.5899.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices, Neurological devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:
(i) Characterization of the electrical stimulation, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);
(ii) Characterization of the impedance monitoring system; and
(iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including the typical sensations experienced during treatment;
(ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications;
(iii) A shelf life for the electrodes and reuse information; and
(iv) Instructions on care and cleaning of the device.
Food and Drug Administration, Department of Health and Human Services (HHS).
Final amendment; final order.
The Food and Drug Administration (FDA or we) is classifying the conditioning tool for eating disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the conditioning tool for eating disorders' classification. We are taking this action because we
This order is effective December 2, 2021. The classification was applicable on March 31, 2011.
Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 4110, Silver Spring, MD 20993-0002, 301-796-6476,
Upon request, FDA has classified the conditioning tool for eating disorders as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.
When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
For this device, FDA issued an order on May 24, 2007, finding the Mandometer not substantially equivalent to a predicate not subject to premarket approval. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order.
AB Mando submitted a request for De Novo classification of the Mandometer, dated June 19, 2007. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on March 31, 2011, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 882.5060.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).
At the time of classification, conditioning tools for eating disorders are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Nonclinical performance testing must demonstrate:
(i) Device measurement accuracy and repeatability; and
(ii) Device feedback accuracy.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
(5) Labeling and patient labeling must be provided which includes the following:
(i) Information identifying and explaining how to use the device and its components; and
(ii) Information on how the device operates and the typical course of treatment.
Food and Drug Administration, Department of Health and Human Services (HHS).
Final amendment; final order.
The Food and Drug Administration (FDA or we) is classifying the intraoperative orthopedic strain sensor into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intraoperative orthopedic strain sensor's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
This order is effective December 2, 2021. The classification was applicable on March 28, 2019.
Colin O'Neill, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4458, Silver Spring, MD 20993-0002, 301-796-6428,
Upon request, FDA has classified the intraoperative orthopedic strain sensor as class II (special controls), which we have determined will provide a
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On July 19, 2018, Intellirod Spine, Inc. submitted a request for De Novo classification of the LOADPRO
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on March 28, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 888.3090.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be conducted:
(i) Mechanical testing to evaluate the effect of the device on the mechanical performance of the implant and to characterize the mechanical limits of the components used with the implant; and
(ii) Accuracy and repeatability testing of strain measurements.
(2) Usability testing must evaluate the effect of the device on the performance of the surgical procedure.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance testing must support the sterility and shelf life of the patient-contacting components of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Performance data must validate the reprocessing instructions for reusable components of the device.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
(8) Labeling must include the following:
(i) A shelf life;
(ii) Instructions for use;
(iii) Reprocessing instructions for any reusable components; and
(iv) A statement that the device is not intended to provide diagnostic information or influence clinical decision making.
Coast Guard, DHS.
Notification of enforcement of regulation.
The Coast Guard will enforce the special local regulation for the Charleston Parade of Boats on December 11, 2021. This action is necessary to ensure safety of life on navigable waters of the United States during the Charleston Parade of Boats. During the enforcement period, no person or vessel may enter, transit through, anchor in, or remain within the designated area unless authorized by the Captain of the Port Charleston (COTP) or a designated representative.
The regulations in 33 CFR 100.704, Table 1 to § 100.704, Item No. 10, will be enforced from 4:00 p.m. until 8:30 p.m. on December 11, 2021.
If you have questions about this notice of enforcement, call or email LCDR Chad Ray, Sector Charleston Office of Waterways Management, Coast Guard; telephone (843) 740-3184, email
The Coast Guard will enforce the special local regulation in 33 CFR 100.704, Item No. 10, for the Charleston Parade of Boats from 4:00 p.m. through 8:30 p.m. on December 11, 2021. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Seventh Coast Guard District § 100.704, Item No. 10, specifies the location of the regulated area for the Charleston Parade of Boats, which encompasses a portion of the waterways during the parade transit from Charleston Harbor Anchorage A through Shutes Folly, Bennis Reach, Horse Reach, Hog Island Reach, Town Creek Lower Reach, Ashley River, and finishing at City Marina. During the enforcement period, if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.
In addition to this notice of enforcement in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all navigable waters within a 600-foot radius of a fireworks display on the Columbia River for the City of Richland Christmas Fireworks Display in Richland, WA. This action is necessary to provide for the safety of life on these navigable waters during the fireworks display. Entry of vessels or persons, transiting though, mooring, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Sector Columbia River or a designated representative.
This rule is effective from 7:30 p.m. through 9 p.m. on December 3, 2021, and from 7:30 p.m. through 9 p.m. on December 4, 2021.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LCDR Sean Morrison, Waterways Management Division, Marine Safety Unit Portland, Coast Guard; telephone 503-240-9319, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The City of Richland did not alert the Coast Guard of the fireworks display and the associated safety hazards until November 9, 2021. We must establish this safety zone on December 3, 2021 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Columbia River has determined that potential hazards associated with the fireworks display on December 3, 2021 and December 4, 2021, will be a safety concern for anyone within a 600-foot radius of the fireworks display. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks display is taking place.
This rule establishes a safety zone for the City of Richland Christmas Fireworks Display from 07:30 p.m. through 09 p.m. on December 3, 2021 and from 07:30 p.m. through 09 p.m. on December 4, 2021. The Safety Zone will cover all navigable waters within 600-feet of the pier located on the Columbia River near Howard Amon Park Waterfront on 80 Lee Boulevard, Richland, WA 99352 at approximate location 46°16′29″ N; 119°16′10″ W. W. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the fireworks display is taking place. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of the U.S. Coast Guard Sector Columbia River.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safetly transit around this safety zone which would impact a small designated area on the Columbia River for 1.5 hours during two consecutive evenings, when vessel traffic is normally low. Moreover the rule allows vessels to seek permission to enter the 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 rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this 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 determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only 1.5 hours that will prohibit entry within 600 feet of a fireworks display. It is 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 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
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard is amending 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, Revision No. 01.2.
(a)
(b)
(c)
(2) To seek permission to enter, contact the COTP or the COTP's representative by calling (503) 209-2468 or the Sector Columbia River Command Center on Channel 16 VHF-FM. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary moving safety zone for navigable waters within a 500-yard radius around the ZIM KINGSTON. The safety zone is needed to protect personnel, vessels, and the marine environment from the potential hazards associated with the vessel transit. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Puget Sound.
This rule is effective without actual notice from December 2, 2021 through 9 a.m. on December 6, 2021. For purposes of enforcement, actual notice will be used from 10 a.m. on November 24, 2021 until December 2, 2021.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Peter McAndrew, Sector Puget Sound Waterways Management Division, U.S. Coast Guard; telephone 206-217-6045, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule, as the Coast Guard received initial notification on October 31, 2021 of an anticipated vessel transit from Victoria, BC to Vancouver, BC through US Waters by the ZIM KINGSTON. On or around October 21, 2021, the ZIM KINGSTON lost containers overboard and two containers subsequently caught on fire and may contain toxic flammable gas or other hazardous materials. Immediate action is needed to respond to the potential safety hazards associated with the ZIM KINGSTON's transit. It is impracticable to publish an NPRM for this temporary rule because the safety zone must be established by November 24, 2021 to protect waterway users.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP) Puget Sound has determined that potential hazards associated with the transit of the ZIM KINGSTON will be a safety concern for anyone within a 500-yard radius of the vessel. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during the transit.
This rule establishes a safety zone from 10 a.m. November 24, 2021 through 9 a.m. December 6, 2021. The safety zone will cover all navigable waters within 500 yards of the ZIM KINGSTON. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the vessel is in transit. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the fact that the safety zone created by this rule is limited in size and duration. Vessel traffic would be able to safely transit around this safety zone. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the 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 rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this 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 determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone for navigable waters within a 500-yard radius around the ZIM KINGSTON between 10 a.m. November 24, 2021 through 9 a.m. December 6, 2021. The safety zone is needed to protect personnel, vessels, and the marine environment from the potential hazards associated with the vessel transit. It is categorically excluded from further review under paragraph L[60] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Harbors, Marine Safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) To seek permission to enter, contact the COTP or the COTP's representative by VHF Channel 16. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is issuing this final rule to amend its regulation regarding the process for identifying and paying appropriate payees entitled to retroactive benefits. This amendment is necessary to implement a federal district court order directing the VA to remove certain regulatory text concerning subsequent release of compensation to a payee when the full amount of unpaid benefits has previously been released.
Christopher O. Adeloye, Staff Attorney, Benefits Law Group, Office of General Counsel (022), 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7662. (This is not a toll-free telephone number.)
In 1991, as part of the
On September 17, 2021, the plaintiffs in
On November 10, 2021, the court issued an order (
The Secretary of Veterans Affairs finds that there is good cause under the provisions of 5 U.S.C. 553(b)(B) and (d)(3) to publish this rule without prior opportunity for public comment and with an immediate effective date. The good cause exception allows an agency to forego public notice and comment where it would be “impracticable, unnecessary, or contrary to the public interest.”
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at
The Regulatory Flexibility Act, 5 U.S.C. 601-612, is not applicable to this rulemaking because notice of proposed rulemaking is not required. 5 U.S.C. 601(2), 603(a), 604(a).
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector.
This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The Assistance Listing program numbers and titles for this rule are 64.104 Pension for Non-Service-Connected Disability for Veterans; 64.105 Pension to Veterans Surviving Spouses, and Children; 64.109 Veterans Compensation for Service-Connected Disability; 64.110 Veterans Dependency and Indemnity Compensation for Service-Connected Death.
Pursuant to the Congressional Review Act (5 U.S.C. 801
Administrative practice and procedure, Claims, Disability benefits, Veterans.
Denis McDonough, Secretary of Veterans Affairs, approved this document on November 24, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.
For the reasons set forth in the preamble, 38 CFR part 3 is amended as follows:
38 U.S.C. 501.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision to the Mecklenburg County portion of the North Carolina SIP, hereinafter referred to as the Mecklenburg Local Implementation Plan (LIP). The revision was submitted by the State of North Carolina, through the North Carolina Division of Air Quality (NCDAQ), on behalf of Mecklenburg County Air Quality (MCAQ) via a letter dated April 24, 2020, and was received by EPA on June 19, 2020. The revision updates several Mecklenburg County Air Pollution Control Ordinance (MCAPCO) rules incorporated into the LIP and adds several rules. EPA is approving these changes pursuant to the Clean Air Act (CAA or Act).
This rule is effective January 3, 2022.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2021-0354. All documents in the docket are listed on the
Evan Adams, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9009. Mr. Adams can also be reached via electronic mail at
In a notice of proposed rulemaking (NPRM) published on September 17, 2021 (86 FR 51848), EPA proposed to approve changes to several rules in the Mecklenburg County LIP. The April 24, 2020, submittal includes changes and updates to the following rules to more closely align them with their analog SIP-approved North Carolina regulations.
The September 17, 2021, NPRM provides detail regarding the background and rationale for EPA's action. Comments were due on or before October 18, 2021, and EPA received three comment submittals. Two submittals are from one individual (hereinafter the “Commenter”), are similar in nature, and are addressed below. The third submittal simply thanked EPA. These comments are available in the docket for this action.
The CAA establishes a system of cooperative federalism that sets specific roles for EPA and the states. In this system, EPA provides national leadership and sets national standards for environmental protection such as the National Ambient Air Quality Standards (NAAQS).
While EPA sets the NAAQS, states play a primary role in implementation. Under CAA section 110, states have broad discretion to choose the mix of emission limitations and other control measures, means, or techniques that they will implement (or update) through
EPA agrees that air pollution is detrimental to human health and welfare and appreciates the Commenter's support for this action.
In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of MCAPCO Rule 1.5214—
EPA has made and will continue to make these materials generally available through
EPA is finalizing approval of changes to LIP-approved MCAPCO Rules 1.5212—
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• 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).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 31, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead,
For the reasons stated in the preamble, EPA amends 40 CFR part 52 as follows:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA or Agency) is approving State Implementation Plan (SIP) submissions from Florida, Georgia, North Carolina, and South Carolina, addressing the Clean Air Act (CAA or Act) Good Neighbor interstate transport infrastructure SIP requirements for the 2015 8-hour ozone National Ambient Air Quality Standard (NAAQS or standards). EPA has determined that each state's SIP contains adequate provisions to prohibit emissions that will significantly contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state. This action is being taken in accordance with the CAA.
This rule is effective January 3, 2022.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2019-0156. All documents in the docket are listed on the
Evan Adams of the Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Adams can be reached by telephone at (404) 562-9009, or via electronic mail at
On December 30, 2019, EPA proposed to approve SIP submissions from Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee
Subsequent to the publication of the NPRM on December 30, 2019, two events caused EPA to adjust its analysis of the aforementioned SIP submissions. First, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) issued its ruling in
As a result, EPA issued a supplemental notice of proposed rulemaking (SNPRM) on July 19, 2021, which relied on the new modeling and analysis to supplement EPA's proposed finding in the December 30, 2019 NPRM that emissions from sources in Florida, Georgia, North Carolina, and South Carolina will not significantly contribute to nonattainment or interfere with maintenance of the 2015 8-hour ozone NAAQS in any other state.
The technical rationale for EPA's proposed action is given in the July 19, 2021 SNPRM and in supportive materials contained in the docket for this action. The comment period for the July 19, 2021 SNPRM closed on August 18, 2021, and EPA received no additional comments. However, EPA did receive comments on the original December 30, 2019 NPRM, and relevant responses are provided in section II. EPA is finalizing the approval of this action based on the technical rationale
EPA received four sets of adverse comments and one set of supportive comments on the December 30, 2019, NPRM. The comments were submitted by the Midwest Ozone Group, Sierra Club, New Jersey Department of Environmental Protection, New York State Department of Environmental Conservation, and one anonymous commenter. The full set of comments is provided in the docket for this final rule. This section contains summaries of the comments and EPA's responses.
On May 19, 2020, however, the D.C. Circuit issued the
The December 30, 2019 NPRM proposing approval of the 2015 8-hour ozone Good Neighbor SIPs for Florida, Georgia, North Carolina, and South Carolina on the basis of a 2023 analytic year analysis predates the D.C. Circuit's decisions in
Multiple commenters stated that the approach for identifying nonattainment and maintenance receptors in the original December 30, 2019 NPRM failed to identify all of the potential receptors relevant in a 2021 analytic year. In addition to their objections to EPA's selection of the 2023 analytic year, these commenters argued that measured design values at certain monitoring sites made clear that certain areas would not be able to attain the 2015 8-hour ozone NAAQS by the 2021 Marginal area attainment date. The shift in the July 19, 2021 SNPRM and this final action to a 2021 analytic year partially addresses the concerns raised by these commenters. To the extent commenters are arguing that EPA's method of defining nonattainment and maintenance receptors for Good Neighbor purposes ignores certain areas that may have air quality problems in 2021 based solely on historical measured data, EPA disagrees with these comments. EPA's method of defining these receptors, as described in section II of the SNPRM takes into account both measured data and reasonable projections based on modeling analysis.
Regarding the contention that the CSAPR Update, which covered the 2008 8-hour ozone NAAQS, will not be sufficient to bring areas into attainment of the 2008 or 2015 8-hour ozone NAAQS, this is not relevant to the analysis in support of this action. Whether downwind states may or may not reach attainment of the 2015 8-hour ozone NAAQS with the assistance of the upwind state emissions reductions resulting from the CSAPR Update is not determinative of whether Florida, Georgia, North Carolina, and South Carolina have Good Neighbor obligations for the 2015 8-hour ozone NAAQS pursuant to the CAA. At issue is whether Florida, Georgia, North Carolina, and South Carolina will significantly contribute to downwind nonattainment or interfere with maintenance of the 2015 8-hour ozone NAAQS in any other state. The updated information presented in the SNPRM made clear that they will not, and no party commented on that updated information.
In response to the commenters' contention that EPA should not model using the 0.1 lb/mmBtu emission rate assumption for EGUs because it is not enforceable and some units emit higher than this rate, this concern is addressed by the updates contained in the updated 2023 modeling used to derive EPA's 2021 air quality analysis for this final action. Specifically, as noted in the SNPRM, EPA is relying on updated Integrated Planning Model (IPM) modeling for its EGU projection in the updated analysis for this final action. Additionally, EPA has modeled a range of scenarios reflecting alternative EGU assumptions—each resulting in the same finding made in this action.
Although EPA disagrees with these comments regarding the modeling approach it took at the original proposal with respect to projecting EGU emissions,
EPA projected future 2021 and 2023 baseline EGU emissions using the version 6—January 2020 reference case of the IPM.
The EGU emissions data—both historical and projected—are shown in Table 1, and compared with the CSAPR Update enforceable budget, demonstrate: (1) The reasonableness of EPA's practice of not solely using enforceable levels in deriving projections of actual conditions and contribution at steps 1 and 2 of the interstate-transport framework for ozone, and (2) the robustness of its examination.
In sum, EPA's
Supported by the most recent reported emissions data, EPA concludes that its EGU projections used in the most recent modeling and in the interpolation of that modeling to 2021 are reasonable and conservative. Thus, EPA believes it is reasonable and appropriate to rely on these emissions projections in its air quality analysis for 2021 to approve the 2015 8-hour ozone transport SIP submissions for Florida, Georgia, North Carolina, and South Carolina.
EPA did not finalize the Proposed Repeal of the Glider Rule. EPA announced in the U.S. Office of Management and Budget's Spring 2020 Unified Agenda and Regulatory Plan that “EPA is no longer pursuing this action, and the emission standards and other requirements for heavy-duty glider vehicles, glider engines, and glider kits will remain in place as published in the `Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles Phase 2' final rule on October 26, 2016 (81 FR 73478).”
EPA did not finalize the proposed withdrawal of the CTGs for oil and natural gas sources. On March 9, 2018, for reasons explained in the
EPA and the National Highway Traffic Safety Administration have finalized the revisions to the greenhouse gas (GHG) and CAFE standards for light duty vehicles.
The commenter does not explain how the information they provided regarding health impacts from ambient ozone exposure should influence EPA's action on the Florida, Georgia, North Carolina, and South Carolina Good Neighbor SIP submissions for the 2015 8-hour ozone NAAQS, and EPA considers such comments to be outside of the scope of this action. As stated previously, EPA's evaluation of air quality criteria and impacts to public health and welfare are part of the standard setting process, rather than a step completed through actions on individual SIP submissions that address Good Neighbor interstate transport infrastructure SIP requirements pursuant to CAA section 110(a)(2)(D)(i)(I). EPA's evaluation of individual SIP revisions is limited to determining whether the statutory criteria for implementation and attainment of the NAAQS and other CAA requirements, as applicable, have been satisfied.
EPA is finalizing approval of revisions to the Florida, Georgia, North Carolina, and South Carolina SIPs. EPA finds that emissions from sources in Florida, Georgia, North Carolina, and South Carolina will not significantly contribute to nonattainment or interfere with maintenance of the 2015 8-hour ozone NAAQS in any other state. Thus, EPA is approving the interstate transport portions of the infrastructure SIP submissions from Florida, Georgia, North Carolina, and South Carolina, separately, as meeting CAA section 110(a)(2)(D)(i)(I) requirements for the 2015 8-hour ozone NAAQS.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• Are not significant regulatory actions 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);
• Do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Are 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
• Do 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);
• Do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Are 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
• Do 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, for Florida, Georgia, and North Carolina, the Good Neighbor SIPs are not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
For South Carolina, because this final action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law, this action for the state of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Therefore, this final action will not impose substantial direct costs on Tribal governments or preempt Tribal law. The Catawba Indian Nation Reservation is located within the boundary of York County, South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120 (Settlement Act), “[a]ll state and local environmental laws and regulations apply to the [Catawba Indian Nation and] Reservation and are fully enforceable by all relevant state and local agencies and authorities.” The Catawba Indian Nation also retains authority to impose regulations applying higher environmental standards to the Reservation than those imposed by state law or local governing bodies, in accordance with the Settlement Act.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 31, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 52 as follows:
42 U.S.C. 7401
(e) * * *
(e) * * *
(e) * * *
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve a state implementation plan (SIP) revision submitted by the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), Air Pollution Control Division, on June 23, 2020. The SIP revision includes the 1997 8-hour ozone national ambient air quality standards (NAAQS) Limited Maintenance Plan (LMP) for the Montgomery County, Tennessee portion of the Clarksville-Hopkinsville Area (hereinafter referred to as the “Montgomery County Area” or “Area”). The Clarksville-Hopkinsville Area is comprised of Montgomery County, Tennessee, and Christian County, Kentucky. EPA is approving Tennessee's LMP for the Montgomery County Area because it provides for the maintenance of the 1997 8-hour ozone NAAQS within the Montgomery County Area through the end of the second 10-year portion of the maintenance period. The effect of this action would be to make certain commitments related to maintenance of the 1997 8-hour ozone NAAQS in the Montgomery County Area federally enforceable as part of the Tennessee SIP.
This rule is effective January 3, 2022.
EPA has established a docket for this action under Docket ID No. EPA-R04-OAR-2020-0428. All documents in the docket are listed on the
Sarah LaRocca, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-8994. Ms. LaRocca can also be reached via electronic mail at
In 1979, under section 109 of the Clean Air Act (CAA or Act), EPA established primary and secondary NAAQS for ozone at 0.12 parts per million (ppm), averaged over a 1-hour period.
Following promulgation of a new or revised NAAQS, EPA is required by the CAA to designate areas throughout the nation as attaining or not attaining the NAAQS. On April 15, 2004, EPA designated the Clarksville-Hopkinsville Area, which included Montgomery County, Tennessee, and Christian County, Kentucky, as nonattainment for the 1997 8-hour ozone NAAQS, and the designation became effective on June 15, 2004.
A state may submit a request to redesignate a nonattainment area that is attaining a NAAQS to attainment, and, if the area has met other required criteria described in section 107(d)(3)(E) of the CAA, EPA may approve the
EPA has published long-standing guidance for states on developing maintenance plans.
EPA has interpreted CAA section 175A as permitting the LMP option because section 175A of the Act does not define how areas may demonstrate maintenance, and in EPA's experience implementing the various NAAQS, areas that qualify for an LMP and have approved LMPs have rarely, if ever, experienced subsequent violations of the NAAQS. As noted in the LMP guidance memoranda, states seeking an LMP must still submit the other maintenance plan elements outlined in the Calcagni memo, including: An attainment emissions inventory, provisions for the continued operation of the ambient air quality monitoring network, verification of continued attainment, and a contingency plan in the event of a future violation of the NAAQS. Moreover, a state seeking an LMP must still submit its section 175A maintenance plan as a revision to its SIP, with all attendant notice and comment procedures. While the LMP guidance memoranda were originally written with respect to certain NAAQS,
In a notice of proposed rulemaking (NPRM), published on September 23, 2021 (86 FR 52864), EPA proposed to approve Tennessee's LMP because the State made a showing, consistent with EPA's prior LMP guidance, that the Area's ozone concentrations are well below the 1997 8-hour ozone NAAQS and have been historically stable and that it met the other maintenance plan requirements. The details of Tennessee's submission and the rationale for EPA's action are explained in the NPRM. Comments on the September 23, 2021, NPRM were due on or before October 25, 2021. EPA did not receive any comments on the September 23, 2021, NPRM.
EPA is taking final action to approve the Montgomery County Area LMP for the 1997 8-hour ozone NAAQS, submitted by TDEC on June 23, 2020, as a revision to the Tennessee SIP. EPA is approving the Montgomery County Area LMP because it includes a sufficient update of the various elements of the 1997 8-hour ozone NAAQS Maintenance Plan approved by EPA for the first 10-year portion of the maintenance period (including emissions inventory, assurance of adequate monitoring and verification of continued attainment, and contingency provisions) and retains the relevant provisions of the SIP under sections 110(k) and 175A of the CAA.
EPA also finds that the Montgomery County Area qualifies for the LMP option and that the Montgomery County Area LMP is sufficient to provide for maintenance of the 1997 8-hour ozone NAAQS in the Clarksville-Hopkinsville Area over the second 10-year maintenance period (
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• 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).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 31, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental Protection, Air Pollution Control, Incorporation by Reference, Intergovernmental Relations, Nitrogen Oxides, Ozone, Reporting and Recordkeeping Requirements, Volatile Organic Compounds.
For the reasons stated in the preamble, EPA amends 40 CFR part 52 as follows:
42 U.S.C. 7401
(e) * * *
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Final rule.
On April 4, 2018, the Secretary of Health and Human Services (the Secretary) published in the
This rule is effective January 3, 2022.
Tamara Overby, Acting Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Room 8N146B, Rockville, MD 20857, or by telephone (855) 266-2427. This is a toll-free number.
The National Childhood Vaccine Injury Act of 1986, title III of Public Law 99-660 (42 U.S.C. 300aa-10
To gain entitlement to compensation under this Program, a petitioner must establish that a vaccine-related injury or death has occurred, either by proving that a vaccine actually caused or significantly aggravated an injury (causation-in-fact) or by demonstrating the occurrence of what is referred to as a “Table injury.” That is, a petitioner may show that the vaccine recipient suffered an injury of the type enumerated in the regulations at 42 CFR 100.3—the “Vaccine Injury Table”—corresponding to the vaccination in question and that the onset of such injury took place within the period also specified in the Table. If so, the injury is presumed to have been caused by the vaccination, and the petitioner is entitled to compensation (assuming that other Vaccine Act requirements are satisfied) unless the respondent affirmatively shows that the injury was caused by some factor other than the vaccination (see 42 U.S.C. 300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B), and 300aa-14(a)).
Revisions to the Table are authorized under 42 U.S.C. 300aa-14(c) and (e). Prior to the 21st Century Cures Act (Cures Act) (Pub. L. 114-255), the only vaccines covered under the VICP were those recommended by the CDC for routine administration to children (for example, vaccines that protect against seasonal influenza), are subject to an excise tax by Federal law, and added to the Table by the Secretary. The Table currently includes 17 vaccine categories, with 16 categories for specific vaccines, as well as their corresponding illness, disability, injury, or condition covered, and the requisite time within which the first symptom or manifestation of onset or significant aggravation must begin after the vaccine administration to receive the Table's legal presumption of causation. One category of the Table, “Item XVII,” includes, “Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage.” Two injuries—Shoulder Injury Related to Vaccine Administration (SIRVA) and vasovagal syncope—are listed as associated injuries for this category. Through this general category, new vaccines recommended by the CDC for routine administration to children and subject to an excise tax are covered under the VICP prior to being added to the Table as a separate vaccine category.
The Cures Act amended 42 U.S.C. 300aa-14(e) to expand the types of vaccines covered under the VICP.
As discussed in the NPRM (83 FR 14391), Congress enacted a mechanism for modification of the Table, through the promulgation of regulatory changes by the Secretary after consultation with the Advisory Commission on Childhood Vaccines (ACCV). The Secretary is revising the Table to include new vaccines recommended by the CDC for routine administration in pregnant women in Item XVII of the Table. On September 8, 2017, the Program consulted the ACCV regarding options for adding this new category of vaccines to the Table. The ACCV voted unanimously to amend the existing language in Item XVII of the Table to add “and/or pregnant women” after “children” authorizing coverage under the VICP of any new vaccine recommended by CDC for routine administration in pregnant women (and subject to an excise tax) after the publication of a notice of coverage. The ACCV viewed this option as a simple approach to revising the Table, rather than adding a new general Item XVIII to the Table for vaccines recommended for routine administration in pregnant women. Therefore, following the ACCV's recommendation, the Secretary has amended the existing language in Item XVII of the Table to add “and/or pregnant women” after “children.” This amendment allows any new vaccine recommended by the CDC for routine administration in pregnant women (and subject to an excise tax) to be added to this general category of the Table after the Secretary publishes a notice of coverage. The publication of a notice of coverage reflects the Secretary's approval of CDC's recommendation and the determination that the statutory requirements for coverage under the VICP have been met.
The Secretary also has retained the two injuries currently associated with Item XVII of the Table, SIRVA and vasovagal syncope, as Table injuries for vaccines recommended by the CDC for routine administration in pregnant women. In its 2012 Report, “Adverse Effects of Vaccines: Evidence and Causality,” the Institute of Medicine considered SIRVA and vasovagal syncope as mechanistic injuries resulting from the injection of a vaccine and not from the contents of a particular formulation of a vaccine. Thus, these conditions are listed as Table injuries for any new vaccine recommended by the CDC for routine administration to children (after the imposition of an excise tax and publication by the Secretary of a notice of coverage) to account for any new injected vaccines that potentially may lead to SIRVA or vasovagal syncope. Therefore, the Secretary also has included these injuries on the Table for new vaccines recommended by the CDC for routine administration in pregnant women.
VICP petitions must be filed within the applicable statutes of limitations. With the Table change, the general statutes of limitations applicable to petitions filed with the VICP, set forth in 42 U.S.C. 300aa-16(a), continue to apply. The alternate statute of limitations afforded by 42 U.S.C. 300aa-16(b) does not apply to this Table change. This is because, at present, there are no vaccines added to the Table under the revised general category, since the only vaccines the CDC currently recommends for routine administration in pregnant women are already covered on the Table. In the future, when any new vaccine, not already covered under the VICP, is recommended by the CDC for routine administration in pregnant women, subject to an excise tax, and added to the Table, the alternate statute of limitations afforded by 42 U.S.C. 300aa-16(b) would apply if certain requirements are met.
The NPRM provided a 180-day comment period (April 4, 2018-October 1, 2018), and HRSA received 51 comments during that time, including during a public hearing. There were 48 written comments submitted. The
While the Secretary only sought public comment on how best to implement the statutory amendment to add vaccines recommended by the CDC for routine administration in pregnant women to the Table, many commenters offered comments beyond the scope of the request. Nevertheless, the Secretary carefully considered all 51 comments received in the development of this final rule. Below is a summary of the comments and the Secretary's response to them.
In addition, the Table lists covered vaccines and associated injuries, making it easier for some people to get compensation. The Table lists and explains injuries and/or conditions that are presumed to be caused by vaccines unless another cause is proven. The Table's Qualification and Aids to Interpretation define some of the injuries and/or conditions listed on the Table. The Table also lists periods in which the first symptom of these injuries and/or conditions must occur after receiving the vaccine to receive the Table's presumption of causation. If the first symptom of an injury and/or condition listed on the Table occurs within the listed time, and any associated definition(s) included in the Qualification and Aids to Interpretation are satisfied, it is presumed that the vaccine was the cause of the injury or condition unless another cause is proven.
Moreover, the United States has a long-standing vaccine safety program that closely and constantly monitors the safety of vaccines. A critical part of the vaccine safety program is the CDC's Immunization Safety Office, which identifies possible vaccine side effects and conducts studies to determine whether health problems are caused by vaccines. Information regarding vaccine
Pregnant women are at risk for vaccine-preventable disease-related morbidity and mortality and adverse pregnancy outcomes, including congenital anomalies, spontaneous abortion, preterm birth, and low birth weight. In addition to providing direct maternal benefit, vaccination during pregnancy may provide direct fetal and infant benefit through passive immunity (transplacental transfer of maternal vaccine-induced antibodies).
Existing evidence and data trends indicate that the eradication and reduction of vaccine-preventable diseases through immunization has directly increased life expectancy by reducing mortality. In addition, numerous published and peer-reviewed scientific studies have found that neither vaccines nor vaccine ingredients cause the neurodevelopmental disorders of autism, Attention-Deficit/Hyperactivity Disorder, or speech or language delay.
As explained above, in its 2012 Report, “Adverse Effects of Vaccines: Evidence and Causality,” the Institute of Medicine considered SIRVA and vasovagal syncope as mechanistic injuries resulting from the injection of a vaccine and not from the contents of a particular formulation of a vaccine. Thus, these conditions are listed as Table injuries for any new vaccine recommended by the CDC for routine administration to children or pregnant women (after the imposition of an excise tax and publication by the Secretary of a notice of coverage) to account for any new injected vaccines that potentially may lead to SIRVA or vasovagal syncope. In the future, when specific vaccines recommended for routine administration in pregnant women are added to the Table, the Secretary will review the literature to determine if other injuries should be added to the Table for those new vaccines.
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive, and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities, HHS must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.
The Office of Information and Regulatory Affairs has determined that this rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866.
HHS has determined that no substantial additional administrative and compensation resources are required to implement the requirements in this rule. Compensation will be made in the same manner. As in all other VICP cases, to be found entitled to compensation, petitioners will need to prove by a preponderance of the evidence either that they meet the requirements of the Table or that their injury was caused by the vaccine unless the respondent affirmatively shows that the injury was caused by some factor other than the vaccination. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA), and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.
The National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table Final Rule is “not significant” because no substantial resources are required to implement the requirements in this rule. This rule adds “and/or pregnant women” to the new vaccines category (Item XVII) on the Table. Currently, the only vaccines recommended for routine administration in pregnant women are already on the Table because they are recommended for routine administration to children and have an excise tax imposed on them. Therefore, this final rule does not have a significant impact on a substantial number of small entities. Additionally, this rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. We have determined that the final rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on state, local, and tribal governments and on the private sector such as requiring consultation under the Unfunded Mandates Reform Act of 1995.
The provisions of this final rule do not, on the basis of family well-being, affect the following family elements: Family safety; family stability; marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning; disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.
This final rule is not being treated as a “significant regulatory action” as defined under section 3(f) of Executive Order 12866. As stated above, this final rule will modify the Table based on legal authority.
This final rule will allow any vaccines that in the future are recommended by the CDC for routine administration to pregnant women and subject to an excise tax to be covered under the VICP after the Secretary issues a notice of coverage, without requiring further rulemaking. In addition, this final rule will have the effect of making it easier for future petitioners alleging injuries that meet the criteria in the Vaccine Injury Table to receive the Table's presumption of causation, which relieves them of having to prove that the vaccine actually caused or significantly aggravated their injury.
This final rule has no information collection requirements.
Biologics, Health insurance, Immunization.
Accordingly, 42 CFR part 100 is amended as set forth below:
Secs. 312 and 313 of Public Law 99-660 (42 U.S.C. 300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a); and sec. 13632(a)(3) of Public Law 103-66.
(a) * * *
Federal Communications Commission.
Final action.
This document summarizes the Federal Communications Commission's (Commission) decision in the Second Report and Order in the
The Commission adopted the Standard Questions on September 30, 2021.
Jocelyn Jezierny, International Bureau, Telecommunications and Analysis Division, at (202) 418-0887 or
This is a summary of the Commission's Second Report and Order, FCC 21-104, adopted on September 30, 2021, and released on October 1, 2021. The full text of this document is available on the Commission's website at
As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared a Supplemental Final Regulatory Flexibility Analysis (Supplemental FRFA) of the possible significant impact on small entities of the Standard Questions and procedures addressed in this Second Report and Order.
The Commission will include a copy of this Second Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).
1. In this Second Report and Order, we adopt a set of standardized national security and law enforcement questions (Standard Questions) that certain applicants and petitioners (together, “applicants”) with reportable foreign ownership will be required to answer as part of the Executive Branch review process of their applications and petitions (together, “applications”). In the
2. For over 20 years, the Commission has referred certain applications that have reportable foreign ownership to the Executive Branch agencies for their review.
3. Among other requirements of the Executive Order, for applications referred by the Commission, the Committee has 120 days for initial review, plus an additional 90 days for secondary assessment if the Committee determines that the risk to national security or law enforcement interests cannot be mitigated with standard mitigation measures.
4. In the
5. Under the Commission's rules, the Committee has up to 30 days after the Commission refers an application to send further specifically tailored questions (Tailored Questions) to an applicant in the event that additional information is needed to conduct the national security and law enforcement review of the application. The initial 120-day review time frame begins when the Committee Chair notifies the Commission that it has determined that the responses to the national security and law enforcement questions are complete.
6.
• Attachment A—Standard Questions for an International Section 214 Authorization Application.
• Attachment B—Standard Questions for an Application for Assignment or Transfer of Control of an International Section 214 Authorization.
• Attachment C—Standard Questions for a Submarine Cable Landing License Application.
• Attachment D—Standard Questions for an Application for Assignment or Transfer of Control of a Submarine Cable Landing License.
• Attachment E—Standard Questions for a Section 310(b) Petition for Declaratory Ruling Involving a Broadcast Licensee.
• Attachment F—Standard Questions for a Section 310(b) Petition for Declaratory Ruling Involving a Common Carrier Wireless or Common Carrier Earth Station Licensee.
• Attachment G—Personally Identifiable Information (PII) Supplement.
7. Based on the comments in the record, we adopt the Standard Questions largely as proposed in the
8.
9. We agree that the definition of “Senior Officer” should be modified to be consistent across all the Standard Questions. Specifically, as suggested by NAB, we modify the definition of “Senior Officer” to capture any individual with authority to act on behalf of the entity, not by an individual's title. In the Standard Questions, the definition of “Senior Officer” is modified to include: “any individual that has actual or apparent authority to act on behalf of the Entity. Depending upon the circumstances, such individuals could include the Chief Executive Officer, the President, Chief Financial Officer, Chief Information Officer, Senior Vice President, Chief Technical Officer, or Chief Operating Officer.”
10. We reject MLB's suggestion to eliminate separate definitions for “Remote Access” and “Managed Services.” MLB questions why the terms “Remote Access” and “Managed Services” are defined separately, “even though these features are functionally identical for the underlying information sought by the questions.” MLB suggests condensing definitions in order to “lessen the likelihood of confusion over terms that can be used interchangeably. . . .” The Standard Questions define “Remote Access” as “access from a point that is not physically co-located with the Applicant's network facilities, or that is not at a point within the Applicant's network.” The term “Managed Services” is also referred to as “Enterprise Services” both of which are defined as “the provision of a complete, end-to-end communications solution to customers.” While it is possible that there may be situations in which an applicant's “Managed Services” could include “Remote Access,” we do not view the terms as synonymous. We therefore retain the separate definitions of these two terms. For consistency with the questionnaires, we correct an omission and add the definitions of “Remote Access” and “Managed Services” to Attachment F/Common Carrier Wireless or Earth Station PDR.
11. MLB adds that the terms “Controlling Interest” and “Immediate Owner” are defined but not used in any questions. Contrary to MLB's claim, the term “Controlling Interest” is used in Attachment C/Submarine Cable Application, Question 3.
12. We also recognize that the Standard Questions used inconsistent terms, and correct these inadvertent errors in each set of Standard Questions. For example, we have revised all questionnaires so that they are consistent in the use of the defined terms “Ultimate Owner” and “Ultimate Parent.” In addition, questions in the proposed questionnaires inconsistently asked for information about Corporate Officers, Senior Officers, and Directors, or occasionally just Corporate Officers.
13.
14. MLB, NAB, and USTelecom argue that the Ownership Interest definition is too expansive and requires applicants to submit information for owners that have no influence or control over the applicant, including as insulated interest holders. MLB argues that “[s]ome of the information, including PII, requested from intermediate or non-controlling investors should not be required if the applicant can certify that the intermediate investor is truly passive and has no ability to control or influence the operations of licensee, as is the case with limited partners in a private equity fund.” MLB also believes that “[c]ompiling and reviewing this information is a tedious endeavor that has negligible bearing on the fundamental questions of foreign ownership, control, and influence analyzed by the Committee.” USTelecom urges the Commission to “revise the Standard Questions to apply only to the Commission's standard 10% ownership interest because the 5% threshold would sweep in far too many owners, with little influence per owner, and lead to unnecessary complications, delays and burdens in responding to the standard questions,” and adds that “[l]arge, publicly traded companies may not have the level of visibility into entities owning 5% stakes that would enable them to complete the questions as proposed.” C&B argues for using a 20% ownership threshold or the ability to appoint Board members as the basis for defining Relevant Parties. NAB contends that a publicly traded company should be required to provide only publicly available information about its shareholders. MLB states that the questions should be revised to clarify that PII is sought from only those individuals or entities in the ownership chain with control over the applicant and who participate in “operations or decision-making related to the applicant or the licensee.”
15. The Committee staff, in response, advises that a 5% threshold is appropriate because in some instances a less-than-ten percent foreign ownership interest—or a collection of such interests—may pose a national security or law enforcement risk. The Committee staff adds that when ownership is widely held, five percent can be a significant interest and is consistent with requirements imposed by other agencies such as the Securities and Exchange Commission, which requires disclosure beyond that threshold. The Committee staff states that a group of foreign entities or persons, each owning nine percent and working together, could easily reach a controlling interest in a company without having to disclose any of their interests to the Committee for certain FCC application types.
16. While we recognize that requiring the submission of 5% ownership information to the Committee is a lower threshold for information than the 10% ownership threshold generally set out in our rules, we agree with the Committee staff and reject commenters' requests to modify the submission of 5% or greater ownership information or otherwise change the definition to exclude insulated interests. As indicated by the Committee staff, national security and law enforcement analysis is separate and apart from the foreign ownership analysis the Commission conducts under its statutory authority.
17.
18. We amend Question 1 of the transfer and assignment questionnaires in Attachments B/International Section 214 Assignment or Transfer and D/Submarine Cable Assignment or Transfer. The Committee's national security or law enforcement review is primarily focused on the buyer or new entity obtaining the authorization or license. We therefore remove transferors and assignors (the sellers) from the definition of “Relevant Parties.” Accordingly, the term “Relevant Parties” will only include “the Proposed Authorization Holder(s) of an international section 214 authorization or the Proposed Licensee(s) of a cable landing license, and any individual or entity with an ownership interest in the Proposed Authorization Holder(s) or Proposed Licensee(s).” This change focuses the Standard Questions on the appropriate parties and decreases burdens on the applicants.
19.
20. We concur with MLB that all information submitted in response to the Standard Questions should be treated as business confidential and protected from disclosure and change the instructions accordingly. As proposed, the Standard Questions stated that applicants must “[s]pecifically identify answers or documents for which a claim of privilege or confidentiality is asserted based on the information containing trade secrets or commercial or financial information.” MLB notes that “all of the information submitted by applicants to the Committee should be automatically deemed as business confidential information and properly exempt from disclosure under FOIA and Section 8 of Executive Order 13913.” Based on our experience and understanding of the responses to such questions from the Executive Branch agencies in the past, we agree that most of the information supplied in response to the Standard Questions is business confidential as it is “extremely sensitive and proprietary.” Moreover, no commenter opposed MLB's suggestion. Most importantly, however, the Committee staff—to whom the information will be submitted—agrees that all responses to the Standard Questions submitted to the Committee will be treated as business confidential and the applicant(s) should not have to specifically identify information for such treatment.
21. We decline, however, to take any specific action with regard to MLB's request for “heightened protection” of PII and restrictions on sharing it within Committee agencies. The Privacy Act already requires federal agencies to protect PII
22. Based on comments in the record, we decline to revise and reorganize the Standard Questions with regard to filings involving multiple applicants (joint applicants); however, we clarify and improve the instructions on how applicants can submit joint filings confidentially. USTelecom urges the Commission to make the questionnaires clearer so that questions requiring joint responses can be separated from questions where applicants must respond individually. CTIA asks that the questions be organized so when there are multiple applicants they can clearly see which questions can be answered jointly and which can be separated so sensitive information is not shared. USTelecom requests removal of questions that ask for a list of all government customers and descriptions of services. We recognize that joint applicants have a legitimate interest in preventing the sharing of certain information and identifying which questions an applicant is responsible for answering. Consequently, we will
23. When there are multiple applicants for a single application (such as consortium applicants for a single submarine cable landing license), each applicant should (1) provide a clear statement as to how they have submitted their responses and (2) identify which applicants have filed jointly and which applicants can view each other's business confidential information.
24. We reject commenters' request that applicants generally be allowed to cite to previously filed information in their responses to the Standard Questions rather than resubmit information that was previously filed with the Commission and that remains unchanged. We recognize that allowing applicants to cross-reference to previously filed materials within their responses to questionnaires may ease certain burdens on the applicants. We believe, however, that permitting cross references to previously filed materials may delay Committee staff review of applicants' submissions because Committee staff would then have to locate materials that were previously filed with respect to a different application. Accordingly, we require applicants to provide full and complete responses to the Standard Questions in a complete, self-contained document (or documents). This approach is consistent with Commission staff practice for applications, and it benefits applicants by focusing Committee staff resources on the review of applicants' responses to the Standard Questions. We will, however, allow internal cross-referencing of responses within a single document to streamline the process for applicants. For example, if an applicant provided a response to Question 15, and the applicant's response to Question 27 contains the same information, the applicant may refer back to its earlier response.
25. We also reject NAB's specific request that, for petitioners that have previously been granted a declaratory ruling approving foreign investment, the petitioner be permitted to respond to a streamlined questionnaire that only seeks information on that new investor, rather than having to complete the questionnaire with respect to all Relevant Parties. We decline this request and note that we continue to require petitioners to provide a full and complete Petition for Declaratory Ruling to the Commission, and we similarly require petitioners to submit full and complete responses to the Standard Questions to the Committee. The Committee needs information regarding all owners to conduct its review, including updated information, just as the Commission requires a complete petition with information on all owners, not just the new investors, when reviewing the petition. Consequently, the responses must include the requested information with respect to all Relevant Parties as defined by the Questionnaires.
26.
27.
28. We clarify that “planned relationships” are “current relationships or those reasonably anticipated by negotiations or that are identified under current business plans” and clarify that this includes any situations in which contracts have been signed or where the parties are already in negotiations. We decline to place a time limit on this question, as this question should capture any reasonably anticipated future foreign relationships regardless of the timeframe. We find that this change will clarify for applicants the scope of reportable foreign relationships and will improve and facilitate Committee review of applicants' responses to the Standard Questions.
29.
30.
31. We recognize that the broadcaster questionnaire alone seeks detailed information about relationships with Foreign Parties. Committee staff explain that questions 13-17 in Attachment E/Broadcast Section 310(b) PDR are designed to identify situations in which the applicant may be acting as an agent for a foreign principal and are directly related to Committee concerns under FARA. As recommended by Committee staff, we retain the Foreign Parties information requirement in questions 13-17. However, since the Committee staff do not identify the need for such information in connection with the remaining questions, we conclude the burden of producing Foreign Party information in other questions asked in Attachment E/Broadcast Section 310(b) PDR outweighs the benefit of this information to the Committee. Therefore, we remove the reference to “Foreign Party” in certain questions of Attachment E/Broadcast Section 310(b) PDR.
32. Based on the comments in the record, we modify the Standard Questions to clarify the type of background information applicants should provide. Currently, each set of proposed Standard Questions includes several questions regarding the applicant's background and asks if “the Applicant, any Corporate Officers, Senior Officers, Directors, or any Individual/Entity with an Ownership Interest in the Applicant” have “ever been involved or associated with” a previous application to the Commission or a previous filing with the Committee on Foreign Investment in the United States (CFIUS), or if these individuals or entities have “ever been convicted of any felony” or “been subject to any criminal, administrative, or civil penalties for imposed for violating the regulations of” a number of government agencies.
33. With respect to prior Commission or CFIUS filings, USTelecom is concerned that the phrase “involved or associated with” could include “any level of activity associated with a filing from corporate officer responsibilities to more mechanical involvement with accomplishing a filing, which seems far outside the scope of concern.” To clarify and reduce burdens on the applicants, we amend this language to specify that an “involved” or “associated” Individual or Entity was either the Applicant in a prior Commission or CFIUS filing or listed as an owner in such a prior filing. Modifying the questionnaires accordingly would focus the inquiry to the parties most relevant to any prior Commission or CFIUS filings.
34. We decline USTelecom's recommendation that the Commission provide a two-year time limit for questions concerning previous filings with the Commission or CFIUS, or that the Commission eliminate this question with respect to prior Commission applications. We will not impose any time limit for CFIUS filings as Committee staff state that all information regarding prior CFIUS filings would be relevant to their national security and law enforcement review. We find, however, that we can adopt a ten-year time boundary regarding prior Commission filings, which the Committee indicated would be acceptable. Although we agree that imposing a time limit regarding previous Commission filings is appropriate, we find that USTelecom's proposed two-year limit on such filings is too short and would likely exclude many relevant filings and information. The ten-year time limit will reduce the burdens on the applicant while providing the Committee sufficient relevant information concerning recent Commission filings it requires for its review.
35. We are unpersuaded by USTelecom's argument that the questions regarding criminal, administrative, or civil penalties are “incredibly broad . . . and could be extremely burdensome to even attempt to answer,” particularly taking into consideration the age of some communications companies. We therefore reject USTelecom's recommendation that the Commission set parameters on this question “by limiting the ownership interest threshold by 10% and creating a definitive timeframe of interest, not to exceed two years.” As we explained above, we are not increasing the numerical ownership threshold from 5% or greater to 10% or greater. As to the time frame, we do not believe it would create an undue burden for applicants to report as to such serious actions taken against them or their officers, directors, or attributable owners, as we would expect them to have records of such actions.
36. We modify the Standard Questions in Attachment E/Broadcast Section 310(b) PDR to clarify the set of individuals for whom broadcasters must provide PII, as requested by NAB. Each set of Standard Questions requires applicants to provide PII for several categories of individuals involved in the ownership and management of the applicant as well as non-U.S. individuals with access to the applicant's facilities. This PII will be required to be submitted in a separate attachment, Attachment G. This PII is required so that the Committee can conduct investigations of individuals involved in the ownership and operations of the applicant and those non-U.S. individuals with access to facilities.
37. We agree with NAB that, as proposed, Question 19 is overly inclusive and could be viewed as applying to any non-U.S. employee with access to any facility of the broadcaster, including production facilities located outside of the United States. Additionally, Committee staff has clarified that it is only concerned with facilities outside of the United States that store, process, or provide access to U.S. person data (including data on current, past, and potential customers) or that are used to broadcast into the United States. Based on this, we believe that narrowing the scope of this question is therefore warranted. Accordingly, we clarify that broadcasters must provide the information listed in Question 19 for non-U.S. Individuals with access to (1) all facilities and equipment in the United States, (2) facilities outside the United States that are used to broadcast into the United States, and (3) facilities both inside and outside the United States that store, process, or provide access to U.S. person data (including data on current, past, and potential U.S. customers).
38. We decline USTelecom's request that we change the PII reporting requirements for individuals with access to submarine cable facilities. USTelecom argues that Question 34 in Attachment C—which seeks information on Non-U.S. Individuals' access to submarine cable facilities, equipment, communications content, and customer records, among other things, including PII concerning those Non-U.S. Individuals with such access—“should be confined to the Domestic Communications Infrastructure (except for the NOC), as it has been in practice in past proceedings.” USTelecom also argues that because this question “applies to specific individuals, this will be a constantly changing list given normal personnel activity over time” and “in certain foreign jurisdictions, some of the required information may not be legally obtainable from individuals or may be very difficult to provide to the U.S government given the country's own limitations and privacy laws.” USTelecom urges the Commission to eliminate Question 34 or revise the question to ask generally if non-U.S. individuals will have such access “without any requirement to identify specific individuals.”
39. We reject USTelecom's suggestion. The Committee staff oppose the modification of this question, stating that submarine cables are U.S. critical infrastructure and that applicants should provide PII and other details about non-U.S. individuals with access to either U.S. or foreign facilities (
40. We agree with USTelecom that questions that require the applicant to identify an Individual to be the Licensee's authorized law enforcement point of contact should be limited to the U.S. cable landing party. This is consistent with the Commission's statement in the
41. Based on C&B's request, we will update the list of U.S. critical infrastructure sectors outlined in the Standard Questions to track Presidential Policy Directive 21 (PPD-21). Each set of Standard Questions (excluding Attachment E/Broadcast Section 310(b) PDR) asks if the applicant will serve any sectors of U.S. critical infrastructure and includes a checklist of various sectors. C&B notes that “the listed sectors do not align with the current list of critical infrastructure sectors identified under Presidential Policy Directive 21 (PPD-21).” PPD-21 establishes a national policy on critical infrastructure security and resilience, and identifies 16 critical infrastructure sectors, not all of which overlap with the sectors listed in the proposed Standard Questions' checklist. Upon closer review and consultation with Committee staff, we agree with C&B that the list of critical infrastructure sectors provided in the Standard Questions should be revised to be consistent with PPD-21. Accordingly, we have modified the Standard Questions to reflect the list of sectors contained in PPD-21.
42. We agree with C&B that additional clarity is needed with regards to the meaning of the word “serve” in questions pertaining to serving sectors of U.S. critical infrastructure. C&B
43. We will not modify the list of services in the Reference Question section in Attachments A/International Section 214, B/International Section 214 Assignment or Transfer, and F/Common Carrier Wireless or Earth Station PDR, but will rename this list to clarify the information targeted by this question. Attachments A/International Section 214, B/International Section 214 Assignment or Transfer, and F/Common Carrier Wireless or Earth Station PDR as proposed included an “Applicant Services Portfolio Checklist and Reference Questions” section designed to gather detailed information regarding the types of telecommunication services applicants intend to provide. Applicants indicate with a checkmark the types of services and technologies they intend to offer. C&B contends that some of the named proposed services are not services (such as TDM) or are too generic (such as “video” or “email”). C&B therefore suggests we revise the proposed services checklist “to add specificity and eliminate redundancies, or remove it altogether.” Although we agree with C&B that not all items included on this list are strictly services, we find that the list will be useful to the Committee, which has a specific interest in knowing if the applicant will provide any of the items in the checklist, including certain technologies and types of network infrastructure. To address any confusion as to what the list includes, we will rename the list from “Proposed Services” to “Proposed Services/Technologies/Network Infrastructure.” We do not believe applicants will be unduly burdened in determining how to fill out the checklist, and, as we have discussed, we encourage applicants to explain to the Committee how they interpreted a particular question in providing their response.
44. We do not agree that the “Reference Questions” and Questions 35 in Attachments A/International Section 214 and B/International Section 214 Assignment or Transfer and 38 in Attachment F/Common Carrier Wireless or Earth Station PDR are duplicative, but we provide clarification regarding the information sought by each question. MLB believes that the “Reference Questions” are duplicative of an earlier question that seeks information concerning the manner in which applicants will deliver services to their customers. Specifically, MLB argues that Reference Question 1 in Attachments A/International Section 214 and B/International Section 214 Assignment or Transfer, as proposed, is nearly the same as Question 35 regarding delivery of services. MLB also asserts that the Reference Questions ask for network infrastructure information that would have already been provided in response to Question 32(b) in Section V. MLB advises omitting the Reference Questions altogether, suggesting they are redundant and “needlessly expend the resources of applicants and the Committee.” Although Question 35 and Reference Question 1 appear to be similar, the Committee indicate that they are in fact meant to seek different, albeit related, information. Importantly, Committee staff states that Question 35 is intended to obtain a general description of the services to be provided, whereas the Reference Questions are intended to obtain finer technical detail on the way services are or will be provided with specific reference to each service selected in the services checklist table. Similarly, we find that Question 32(b) is intended to obtain a more general description of the Applicant's network, whereas the Reference Questions are structured to obtain specific technical details, such as equipment models and software update plans. We give deference to the Committee on their need for this information to inform their national security and law enforcement review. Accordingly, we will retain these separate questions but revise Question 35 (now Question 36 in Attachment A/International Section 214) to indicate that this question seeks a general description of the manner in which services will be delivered to customers. To the extent that an applicant believes that its responses to questions are the same, it can cross-reference its responses as directed in the Standard Questions' instructions.
45. We decline to make any changes to questions concerning interconnecting carriers or peering relationships. Questions 33 in Attachment B/International Section 214 Assignment or Transfer, 41 in Attachment C/Submarine Cable Application, and 42 in Attachment D/Submarine Cable Assignment or Transfer ask whether the Proposed Authorization Holder(s) or Applicant(s) “use interconnecting carriers and/or peering relationships,” and ask the Applicants to provide details and list the carriers with whom they have these relationships. USTelecom argues that these questions are “misguided” because “it is unclear as to how this information is useful to the determination of a submarine cable's public interest, nor does it evince a clear understanding of what `interconnecting carriers' do or what `peering relationships' mean in this case.” USTelecom contends that “[t]his is particularly true because [these questions] seek[ ] this information only from the Applicants, not anyone who will purchase the capacity on the system, which for some cables will represent the bulk, if not all, of the traffic carried.” These types of relationships are relevant to the Committee's national security and law enforcement analysis of the application, even if they do not reach everyone who may use the submarine cable. With regard to CTIA's argument that “[r]ather than require a comprehensive, detailed list of peering and interconnection relationships . . . the question should allow sufficient flexibility for parties to determine the level of detail they are able and expected to provide,” we believe that the Standard Questions do provide applicants with flexibility in how they choose to describe peering relationships, and thus do not need to be changed or eliminated.
46. We do not make any changes to the questions related to an applicant's national security and law enforcement obligations. Question 19 in Attachments A/International Section 214 and B/International Section 214 Assignment or Transfer asks whether the applicant, “if required by law, regulation, or license condition,” would report certain named incidents immediately upon discovery. USTelecom asks what the effect of a
47. USTelecom also has concerns with the national security implications of certain questions in the section 214 and submarine cable questionnaires (Attachments A-D). Question 21 in Attachments A/International Section 214 and B/International Section 214 Assignment or Transfer asks if any non-U.S. individuals will have access to any of the applicant's facilities, equipment, customer records, and network control features, among other things, and if so, to provide their identity and certain PII. Question 23 in these questionnaires asks for information about encryption technologies that have been or will be installed in the applicant's network. USTelecom believes that together, Questions 21 and 23 require disclosure of too much network security plan information, and this disclosure could amount to a security risk in and of itself. We find that USTelecom's concern about over-disclosure of network security plans through responses to Questions 21 and 23 is misplaced and we make no changes to these questions. The disclosure in this case is solely to the U.S. government agencies most involved in network security issues and for the purposes of assessing risk to U.S. national security and law enforcement interests. To the extent that an applicant has concerns about co-applicants seeing its responses to Questions 21 and 23, it can mark those responses as sensitive and ask that they not be shared with co-applicants.
48. USTelecom recommends “greater clarity surrounding the security expectations of applicants,” citing Question 33 in Attachment C/Submarine Cable Application, which asks “[w]hat provision will be made to monitor suspicious activity occurring over the paths of the cables,” as an example. USTelecom believes that the details regarding “what an applicant can and cannot monitor from a practical standpoint can vary widely depending on the arrangement and technical architecture of the submarine cable equipment,” and requests that the question be modified to reflect these different arrangements. We understand USTelecom's concern that Question 33 in Attachment C, as written, may not capture the variations in different cable systems' monitoring systems. The Standard Questions must be high-level to a certain extent and applicants may want to consider providing additional details about their monitoring capabilities as part of their response to the Standard Questions to properly frame and explain their responses.
49. We reject NAB's argument that the Commission should eliminate certain questions in Attachment E/Broadcast Section 310(b) PDR, “because they concern issues outside of the scope of the Commission's jurisdiction and are thus not properly the subject of Committee review.” Specifically, NAB raises concerns with Questions 29,
50. By their very nature, Standard Questions that are meant to address a broad range of situations will ask for information that an individual applicant may not find to be specific to its own situation. To the extent that a question is not applicable to an applicant's
51. Along those lines, commenters also ask whether they can consult with Committee staff regarding how to respond to certain questions, as they currently do. The Committee staff have stated a strong preference against negotiating the questions or responses with applicants before the responses are filed with the Committee or prior to Commission referral of an application. For instance, Committee staff state that there could be situations in which an application might not be referred at all. The Committee staff state that applicants should explain in their submissions the scope of their responses and any limitations in their responses. The Committee staff note that they can coordinate with applicants regarding responses after the Commission refers the application or when the Committee sends any Tailored Questions.
52. We also make several revisions to the Standard Questions to correct spelling and grammatical mistakes, to correct formatting issues, and to ensure that questions are standardized across the six questionnaires. These revisions correct unintentional drafting errors and do not change the substance of the Standard Questions beyond what has been discussed in this Second Report and Order. We believe that harmonizing the language across the Standard Questions will ease the application process and facilitate Committee review of applications.
53. With the adoption of Standard Questions in this Second Report and Order, we direct the International Bureau to work with the Media Bureau and the Wireline Competition Bureau to seek approval from the Office of Management and Budget (OMB) for the Standard Questions and the rules adopted in the
54. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), we have prepared this Supplemental Final Regulatory Flexibility Analysis (Supplemental FRFA) of the possible significant economic impact on small entities of the Standard Questions and procedures addressed in this Second Report and Order to supplement the Commission's Initial and Final Regulatory Flexibility Analyses in this proceeding. The Commission previously sought written public comment on the proposals in the
55. This Second Report and Order adopts a set of standardized national security and law enforcement questions (Standard Questions) that certain applicants and petitioners (together, “applicants”) with reportable foreign ownership will be required to answer as part of the Executive Branch review process of their applications and petitions (together, “applications”). To expedite the national security and law enforcement review of such applications, applicants must provide their answers to the Standard Questions directly to the Committee for the Assessment of Foreign Participation in the United States Telecommunications Services Sector (Committee)
56. The
• Attachment A—Standard Questions for an International Section 214
• Attachment B—Standard Questions for an Application for Assignment or Transfer of Control of an International Section 214 Authorization. Standard Questions for an assignment or transfer of control of an international section 214 authorization application filed pursuant to 47 CFR 63.24;
• Attachment C—Standard Questions for a Submarine Cable Landing License Application. Standard Questions for a cable landing license application filed pursuant to 47 CFR 1.767 including a modification of an existing license;
• Attachment D—Standard Questions for an Application for Assignment or Transfer of Control of a Submarine Cable Landing License. Standard Questions for an assignment or transfer of control of a cable landing license application filed pursuant to 47 CFR 1.767;
• Attachment E—Standard Questions for a Section 310(b) Petition for Declaratory Ruling Involving a Broadcast Licensee. Standard Questions for a petition for declaratory ruling for foreign ownership in a broadcast licensee above the benchmarks in section 310(b) of the Communications Act (the Act) filed pursuant to 47 CFR 1.5000-1.5004;
• Attachment F—Standard Questions for a Section 310(b) Petition for Declaratory Ruling Involving a Common Carrier Wireless or Common Carrier Earth Station Licensee. Standard Questions for a petition for declaratory ruling for foreign ownership in a common carrier wireless or common carrier earth station licensee above the benchmarks in section 310(b) of the Act filed pursuant to 47 CFR 1.5000-1.5004; and
• Attachment G—Personally Identifiable Information (PII) Supplement. Each set of Standard Questions references a supplement to assist the Committee in identifying PII.
57. The Commission adopted the Standard Questions largely as proposed in the
• All Attachments: Modify the definition of “Senior Officer” to capture any individual with authority to act on behalf of the entity, rather than referring to specific individuals' titles.
• Attachment A/Question 2 Attachment B/Question 2; Attachment D/Question 3; Attachment E/Question 2; Attachment F/Question 2: For clarity and consistency, modify these questions by adding the term “Controlling Interest.”
• All Attachments: Remove the term “Immediate Owner” from the definitions section as that term is not used in any subsequent questions.
• All Attachments: Correct inadvertent use of inconsistent terms. For example, we have revised all questionnaires so that they are consistent in the use of the defined terms “Ultimate Owner” and “Ultimate Parent.”
• Attachment B/Question 1 and Attachment D/Question 1: Remove transferors and assignors (the sellers) from the definition of “Relevant Parties.”
• All Attachments: Modify the instructions in all questionnaires to provide that all of the submitted information will be protected from disclosure according to the provisions of Executive Order 13913, Section 8, and that applicants will not have to specifically identify information for such treatment.
• All Attachments: Clarify the instructions for multiple applicants for a single application (such as consortium applicants for a single submarine cable landing license).
• All Attachments: Modify the instructions to allow internal cross-referencing of responses within a single questionnaire to streamline the process for applicants. For example, if an applicant provided a response to Question 15, and the applicant's response to Question 27 contains the same information, the applicant may refer back to its earlier response.
• Attachment F/Question 3: Remove language regarding prior relationships from this question as it was unintentionally added to the proposed questionnaire.
• Attachment A/Question 3; Attachment B/Question 3; Attachment C/Question 8; Attachment D/Question 21; Attachment E/Question 3; Attachment F/Question 3: Clarify that “planned relationships” are “current relationships or those reasonably anticipated by negotiations or that are identified under current business plans” and clarify that this includes any situations in which contracts have been signed or where the parties are already in negotiations.
• Attachment A/Question 3; Attachment B/Question 3; Attachment C/Question 8; Attachment D/Question 21; Attachment E/Question 3; Attachment F/Question 3: Clarify that existing or planned relationships/partnerships, and prior relationships/partnerships in the case of broadcast applicants, and funding or service contracts, do not include foreign subscribers to an applicant's retail services. Also clarify that, for the purposes of these questions, these relationships do not include foreign employees who are identified in other questions, such as Senior Officers and Directors, and Non-U.S. Individuals with physical access to certain facilities, records, networks, or electronic interfaces.
• Attachment E: Remove the reference to “Foreign Party” in questions 12, 18-21, 26, 31-34.
• Attachment A/Questions 7, 9; Attachment B/Questions 7, 9; Attachment C/Questions 12, 14; Attachment D/Questions 13, 15; Attachment E/Questions 5, 7; Attachment F/Questions 7, 9: Amend language pertaining to an applicant's involvement or association with prior Commission or Committee on Foreign Investment in the United States (CFIUS) filings to specify that an “involved” or “associated” Individual or Entity was either the applicant in a prior Commission or CFIUS filing or listed as an owner in such a prior filing.
• Attachment A/Question 7; Attachment B/Question 7; Attachment C/Question 12; Attachment D/Question 13; Attachment E/Question 5; Attachment F/Question 7: Adopt a ten-year time boundary regarding prior Commission filings that must be disclosed.
• Attachment E/Question 19: Clarify that broadcasters must provide the information listed in Question 19 for non-U.S. Individuals with access to (1) all facilities and equipment in the United States, (2) facilities outside the United States that are used to broadcast into the United States, and (3) facilities both inside and outside the United States that store, process, or provide access to U.S. person data (including data on current, past, and potential U.S. customers).
• Attachment C/Question 37; Attachment D/Question 39: Clarify that for submarine cable applicants, only the U.S. cable landing party need identify an authorized law enforcement point of contact.
• Attachment A/Question 37; Attachment B/Question 36; Attachment C/Question 45; Attachment D/Question 48; Attachment F/Question 38: Update the list of U.S. critical infrastructure sectors outlined in the Standard Questions to track Presidential Policy Directive 21 (PPD-21).
• Attachment A/Section VI; Attachment B/Section VI; Attachment F/Section VI: Rename the list of services in the Reference Questions section from “Proposed Services” to “Proposed Services/Technologies/Network Infrastructure.”
• Attachment A/Question 36; Attachment B/Question 35; Attachment F/Question 37: Revise questions so as to obtain a general description of the manner in which applicants will deliver services to customers.
• Attachment A/Question 37; Attachment B/Question 36; Attachment C/Question 45; Attachment D/Question 48; Attachment F/Question 38: Revise questions to use phrase “provide services to” and add a statement clarifying that the phrase “provide services to” in these questions includes situations in which the applicant provides service to, has customers in, or participates in the market in sectors of U.S. critical infrastructure.
• All Attachments: Advise applicants that in the event that they find a question to be overly broad or unclear in its applicability, they should explain that in their response.
• All Attachments: Make several revisions to the Standard Questions to correct spelling and grammatical mistakes, to correct formatting issues, and to ensure that questions are standardized across the six questionnaires.
The Standard Questions—with these changes and clarified instructions—will ensure that the Committee has the information it needs to conduct its national security and law enforcement review, while also addressing concerns raised by commenters that certain questions were unclear or overly burdensome.
58. The Commission did not receive comments specifically addressing the rules and policies proposed in the Supplemental IRFA. Nonetheless, in adopting the Standard Questions reflected in this Second Report and Order, the Commission has considered the potential impact of the rules and procedures proposed in the IRFA on small entities in order to reduce the economic impact of the rules and procedures enacted herein on such entities.
59. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rules as a result of those comments.
60. The Chief Counsel did not file any comments in response to the proposed Standard Questions in this proceeding.
61. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by rules. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). Initial and Final Regulatory Flexibility Analyses were incorporated into the
62. This Second Report and Order adopts Standard Questions that would affect reporting, recordkeeping, and other compliance requirements for applicants who file for international section 214 authorizations, submarine cable landing licenses or applications to assign or transfer control of such authorizations, and section 310(b) petitions for declaratory rulings (common carrier wireless, common carrier satellite earth stations, or broadcast). Applicants with reportable foreign ownership will be required to submit responses to standard national security and law enforcement questions and will need to certify in their applications that they have submitted the Standard Questions and will send a copy of their FCC application to the Committee. As noted in the FRFA in connection with the
63. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following alternatives, among others: “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rules for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
64. In this Second Report and Order, the adopted Standard Questions will help improve the timeliness and transparency of the review process, thus lessening the burden of the licensing process on all applicants, including small entities. Requiring applicants to submit responses to the Standard Questions prior to or at the same time that they file their applications at the Commission (rather than after filing the application at the Commission) should facilitate a faster response by the Executive Branch on its national
65. The Commission will send a copy of the Second Report and Order, including this Supplemental FRFA, in a report to be sent to Congress pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996.
66.
67.
68.
69.
Office of Acquisition Policy, General Services Administration (GSA).
Final rule.
The General Services Administration (GSA) is issuing a final rule amending the General Services Administration Acquisition Regulation (GSAR) to conform to changes in the Federal Acquisition Regulation (FAR) that reflect an updated “commercial item” definition pursuant to a section of the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019.
Effective January 3, 2022.
Mr. Stephen Carroll at 817-253-7858 or
This final rule amends the General Services Administration Acquisition Regulation (GSAR) to change instances of “commercial item(s)” with commercial product(s), commercial services(s), or both commercial product(s) and commercial service(s) to match similar actions taken in the Federal Acquisition Regulation (FAR).
FAR Case 2018-018 was published as a final rule at 86 FR 61017 on November 4, 2021, to implement section 836 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 to separate the definition of “commercial item” into the definitions of “commercial product” and “commercial service.”
It is important to note that the amendment to separate “commercial item” with “commercial product” and “commercial service” does not expand or shrink the universe of products or services that the Government may procure using GSAR part 512, nor does it change the terms and conditions vendors must comply with.
This rule does not add any new solicitation provisions or contract clauses. This rule merely replaces the term “commercial item(s)” with “commercial product(s),” “commercial service(s),” “commercial product(s) or commercial service(s),” or “commercial product(s) and commercial service(s)” in the GSAR including in part 552, as appropriate. It does not add any new burdens because the case does not add or change any requirements with which vendors must comply.
Title 40 of the United States Code (U.S.C.) Section 121 authorizes GSA to issue regulations, including the GSAR, to control the relationship between GSA and contractors.
As changed by FAR Case 2018-018, and as required by section 836 of the NDAA for FY 2019, this final rule replaces instances of commercial item(s) with commercial product(s), commercial service(s), or both commercial product(s) and commercial service(s).
This final rule also replaces all instances of “non-commercial” and “noncommercial” with “other than commercial” as it relates to this rule. This is an editorial change and will provide consistent language to the FAR and throughout the GSAR.
Other minor editorial changes are made in this final rule to provide consistent language.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been reviewed and determined by OMB not to be a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.
The Congressional Review Act, 5 U.S.C. 801
The statute that applies to the publication of the GSAR is the Office of Federal Procurement Policy statute (codified at title 41 of the United States Code). Specifically, 41 U.S.C. 1707(a)(1) requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This rule is not required to be published for public comment, because GSA is not issuing a new regulation; rather, this rule is merely an editorial change and will provide consistent language to the FAR (pursuant to section 836 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019) throughout the GSAR. The rule does not expand or shrink the universe of products or services that the Government may procure using GSAR part 512, nor does it change the terms and conditions vendors must comply with.
This rule does not add any new solicitation provisions or contract clauses. This rule merely replaces the term “commercial item(s)” with “commercial product(s),” “commercial service(s),” “commercial product(s) or commercial service(s),” or “commercial product(s) and commercial service(s)” in the GSAR including in part 552, as appropriate. It does not add any new burdens because the case does not add or change any requirements with which vendors must comply.
The Regulatory Flexibility Act (5 U.S.C. 601
The final rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, GSA amends 48 CFR parts 502, 509, 511, 512, 514, 532, 536, 538, and 552 as set forth below:
40 U.S.C. 121(c).
The revisions read as follows:
The revisions read as follows:
The revision reads as follows:
The revisions read as follows:
(a) The Government may make multiple awards for the supplies or services offered in response to this solicitation that meet the commercial product or commercial service definition in FAR clause 52.202-1. * * *
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
The revision reads as follows:
National Indian Gaming Commission, Department of the Interior.
Proposed rule.
The National Indian Gaming Commission proposes to amend agency procedures for calculating the amount of annual fee a gaming operation owes the National Indian Gaming Commission. The proposed amendments will allow a gaming operation to exclude certain promotional credits from the calculation of Assessable Gross Gaming Revenue.
Written comments on this proposed rule must be received on or before January 3, 2022.
You may submit comments by any one of the following methods, however, please note that comments sent by electronic mail are strongly encouraged.
Austin Badger at (202) 632-7003 or by fax (202) 632-7066 (these numbers are not toll free).
The Indian Gaming Regulatory Act (IGRA or Act), Public Law 100-497, 25 U.S.C. 2701
On, June 9, 2021, the National Indian Gaming Commission sent a Notice of Consultation announcing that the Agency intended to consult on a number of topics, including proposed changes to the fee regulations. Prior to consultation, the Commission released proposed discussion drafts of the regulations for review. The proposed amendment to the fee regulations were intended to provide clarity as to whether a tribal gaming operation must include certain promotional credits, commonly referred to as “free play,” as “money wagered” for purposes of calculating assessable gross revenues. The Commission held two virtual consultation sessions in July of 2021 to receive tribal input on the possible changes.
The Commission reviewed all comments received as part of the consultation process. One comment suggested that rather than allowing a tribal gaming operation to decide whether to exclude the promotional credits, it should make the exclusion mandatory. The Commission rejected this comment for purposes of this proposed rulemaking so as to provide maximum flexibility to tribal gaming operations to decide for themselves whether to exclude the credits or not. That being said, the Commission is especially interested in comments as to whether there would be unintended consequences if the Commission were to allow the tribal gaming operation to decide if it will deduct promotional credits.
The rule will not have a significant impact on a substantial number of small entities as defined under the Regulatory Flexibility Act, 5 U.S.C. 601,
The rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. The rule does not have an effect on the economy of $100 million or more. The rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, local government agencies or geographic regions, nor will the proposed rule have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of the enterprises, to compete with foreign based enterprises.
The Commission, as an independent regulatory agency, is exempt from compliance with the Unfunded Mandates Reform Act, 2 U.S.C. 1502(1); 2 U.S.C. 658(1).
In accordance with Executive Order 12630, the Commission has determined that the rule does not have significant takings implications. A takings implication assessment is not required.
In accordance with Executive Order 12988, the Commission has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.
The Commission has determined that the rule does not constitute a major federal action significantly affecting the quality of the human environment and that no detailed statement is required pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321,
The information collection requirements contained in this rule were previously approved by the Office of Management and Budget as required
The National Indian Gaming Commission is committed to fulfilling its tribal consultation obligations—whether directed by statute or administrative action such as Executive Order (E.O.) 13175 (Consultation and Coordination with Indian Tribal Governments)—by adhering to the consultation framework described in its Consultation Policy published July 15, 2013. The NIGC's consultation policy specifies that it will consult with tribes on Commission Action with Tribal Implications, which is defined as: Any Commission regulation, rulemaking, policy, guidance, legislative proposal, or operational activity that may have a substantial direct effect on an Indian tribe on matters including, but not limited to the ability of an Indian tribe to regulate its Indian gaming; an Indian tribe's formal relationship with the Commission; or the consideration of the Commission's trust responsibilities to Indian tribes.
Pursuant to this policy, on June 9, 20201, the National Indian Gaming Commission sent a Notice of Consultation announcing that the Agency intended to consult on a number of topics, including proposed changes to the fee regulations.
Administrative practice and procedure, Gambling, Indian, Indians—lands, Indians—tribal government, Indians—business and finance.
For the reasons discussed in the Preamble, the Commission proposes to revise its regulations at 25 CFR part 514 as follows:
25 U.S.C. 2706, 2710, 2717, 2717a.
(f) The amounts wagered that the gaming operation can demonstrate were issued by the gaming operation as promotional credits may be excluded from the total amount of money wagered.
(g) Unless otherwise provided by regulation, generally accepted accounting principles shall be used.
National Indian Gaming Commission, Department of the Interior.
Notice of proposed rulemaking.
The National Indian Gaming Commission proposes to amend its procedures for processing a request for approval of a management contract under the Indian Gaming Regulatory Act. The proposed amendments make the following changes to the current regulations. The regulations will now require a background investigation of all persons who have 10 percent or more direct or indirect financial interest in a management contract. The regulations will also require a background investigation of all entities with 10 percent or more financial interest in a management contract. The regulations now require a background investigation of any other person or entity with a direct or indirect financial interest in a management contract otherwise designated by the Commission. The regulations authorize the Chair, either by request or unilaterally, to exercise discretion to reduce the scope of the information to be furnished and background investigation to be conducted for certain entities.
Written comments on this proposed rule must be received on or before January 3, 2022.
You may submit comments by any one of the following methods, however, please note that comments sent by electronic mail are strongly encouraged.
Heather McMillan Nakai at (202) 632-7003 or by fax (202) 632-7066 (these numbers are not toll free).
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal.
The Indian Gaming Regulatory Act (IGRA or Act), Public Law 100-497, 25 U.S.C. 2701
On, June 9, 20201, the National Indian Gaming Commission sent a Notice of Consultation announcing that the Agency intended to consult on a number of topics, including proposed changes to the management contract process. Prior to consultation, the Commission released proposed discussion drafts of the regulations for review. The proposed amendment to the management contract regulations were intended to improve the Agency's efficiency in processing management agreements and background investigations, clarify existing regulations, and provide guidance on extending management contracts. The Commission held two virtual
The Commission reviewed all comments and now proposes these changes which it believes will improve the Agency's efficiency in processing background investigations.
The rulemaking will not have a significant impact on a substantial number of small entities as defined under the Regulatory Flexibility Act, 5 U.S.C. 601,
The proposed rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. The rulemaking does not have an effect on the economy of $100 million or more. The proposed rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, local government agencies or geographic regions, nor will the proposed rule have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of the enterprises, to compete with foreign based enterprises.
The Commission, as an independent regulatory agency, is exempt from compliance with the Unfunded Mandates Reform Act, 2 U.S.C. 1502(1); 2 U.S.C. 658(1).
In accordance with Executive Order 12630, the Commission has determined that the proposed rule does not have significant takings implications. A takings implication assessment is not required.
In accordance with Executive Order 12988, the Commission has determined that the proposed rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the order.
The Commission has determined that the rulemaking does not constitute a major federal action significantly affecting the quality of the human environment and that no detailed statement is required pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321,
The information collection requirements contained in this rule were previously approved by the Office of Management and Budget as required by 44 U.S.C. 3501,
The National Indian Gaming Commission is committed to fulfilling its tribal consultation obligations—whether directed by statute or administrative action such as Executive Order (E.O.) 13175 (Consultation and Coordination with Indian Tribal Governments)—by adhering to the consultation framework described in its Consultation Policy published July 15, 2013. The NIGC's consultation policy specifies that it will consult with tribes on Commission Action with Tribal Implications, which is defined as: Any Commission regulation, rulemaking, policy, guidance, legislative proposal, or operational activity that may have a substantial direct effect on an Indian tribe on matters including, but not limited to the ability of an Indian tribe to regulate its Indian gaming; an Indian tribe's formal relationship with the Commission; or the consideration of the Commission's trust responsibilities to Indian tribes.
Pursuant to this policy, on June 9, 20201, the National Indian Gaming Commission sent a Notice of Consultation announcing that the Agency intended to consult on a number of topics, including proposed changes to the management contract process.
Administrative practice and procedure, Gambling, Indians—business and finance, Indian—Indian lands, Indians—tribal government.
For the reasons discussed in the Preamble, the Commission proposes to amend its regulations at 25 CFR part 537 as follows:
25 U.S.C. 81, 2706(b)(10), 2710(d)(9), 2711.
(a) * * *
(3) All persons who have 10 percent or more direct or indirect financial interest in a management contract;
(4) All entities with 10 percent or more financial interest in a management contract; and
(5) Any other person or entity with a direct or indirect financial interest in a management contract otherwise designated by the Commission.
(d) For any of the following entities, or individuals associated with the following entities, the Chair may, upon request or unilaterally, exercise discretion to reduce the scope of the information to be furnished and background investigation to be conducted:
(1) Tribe as defined at 25 CFR 502.13;
(2) Wholly owned tribal entity;
(3) National bank; or
(4) Institutional investor that is federally regulated or is required to undergo a background investigation and licensure by a state or tribe pursuant to a tribal-state compact.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Georgia State Implementation Plan (SIP) submitted by the State of Georgia through the Georgia Environmental Protection Division (GA EPD) on July 2, 2020. EPA is proposing to approve Georgia's certification of existing Nonattainment New Source Review (NNSR) permitting regulations to meet the nonattainment planning
Comments must be received on or before January 3, 2022.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2020-0406 at
Pearlene Williams, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9144. Ms. Williams can also be reached via electronic mail at
The New Source Review (NSR) program is a preconstruction permitting program that requires certain stationary sources of air pollution to obtain permits prior to beginning construction. The NSR permitting program applies to new construction and modification of existing sources. New construction and modifications that emit “regulated NSR pollutants” over certain thresholds are subject to major NSR requirements, while smaller emitting sources and modifications may be subject to minor NSR requirements.
Major NSR permits for sources that are in attainment or unclassifiable areas are referred to as Prevention of Significant Deterioration (PSD) permits. Major NSR permits for sources in nonattainment areas and that emit pollutants above the specified thresholds for which the area is in nonattainment are referred to as NNSR permits.
A new stationary source is subject to major NSR requirements if its potential to emit a regulated NSR pollutant exceeds certain emission thresholds. If it exceeds the applicable threshold, the NSR regulations define it as a “major stationary source.” An existing major stationary source triggers major NSR permitting requirements when it undergoes a “major modification,” which occurs when a source undertakes a physical change or change in method of operation (
On October 1, 2015, EPA promulgated a revised 8-hour NAAQS of 0.070 parts per million (ppm).
On December 6, 2018, EPA issued a final rule entitled “Implementation of the 2015 National Ambient Air Quality Standards for ozone: State Implementation Plan Requirements” (SIP Requirements Rule), which establishes the requirements that state, tribal, and local air quality management agencies must meet as they develop implementation plans for areas where air quality exceeds the 2015 8-hour ozone NAAQS.
Based on the nonattainment designation for the 2015 8-hour ozone standard, Georgia was required to develop a SIP revision addressing the requirements of CAA sections 172(c)(5) and 173 for the Atlanta Area.
Georgia's longstanding SIP-approved NNSR program, established in Rule 391-3-1-.03(8),
On October 16, 2017, this rule was updated to revise NSR permitting regulations to be consistent with federal regulations. EPA approved changes to Rule 391-3-1.03(8),
In a January 16, 2020, rulemaking, EPA approved additional changes to Georgia's NNSR permitting rules in
Additionally, on September 16, 2020, EPA approved clarifying and ministerial changes to permitting regulations at Rule 391-3-1-.03(8),
Lastly, Rule 391-3-1-.03(8)(c) requires emissions offsets for several counties within and surrounding the metropolitan Atlanta Nonattainment Area (including the counties in the current nonattainment area for the 2015 8-hour ozone NAAQS). This rule continues to exceed the required offset ratios for Marginal ozone nonattainment areas in CAA section 182(a)(4).
The current SIP-approved version of Rule 391-3-1-.03(8),
EPA is proposing to approve Georgia's SIP revision addressing the NNSR requirements for the 2015 8-hour ozone NAAQS for the Atlanta Area, submitted on July 2, 2020. EPA has concluded that Georgia's submission fulfills the 40 CFR 51.1314 requirement and meets the requirements of CAA sections 172(c)(5) and 173 and the minimum SIP requirements of 40 CFR 51.165.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• 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).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen Oxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve state implementation plan (SIP) revisions submitted by the State of Georgia through the Georgia Environmental Protection Division (GA EPD) on July 2, 2020, and November 4, 2021. Both submittals address the emissions statements requirements for the 2015 8-hour ozone national ambient air quality standards (NAAQS) for the Atlanta, Georgia 2015 8-hour ozone nonattainment area (hereinafter referred to as the “Atlanta Area”). These requirements apply to all ozone nonattainment areas. The Atlanta Area is comprised of seven counties in and around metropolitan Atlanta (Bartow, Clayton, Cobb, DeKalb, Fulton, Gwinnett, and Henry). This action is being proposed pursuant to the Clean Air Act (CAA or Act).
Comments must be received on or before January 3, 2022.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2020-0401 at
Tiereny Bell, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9088. Ms. Bell can also be reached via electronic mail at
On October 1, 2015, EPA promulgated a revised 8-hour primary and secondary ozone NAAQS, strengthening both from 0.075 parts per million (ppm) to 0.070 ppm (the 2015 8-hour Ozone NAAQS).
Upon promulgation of a new or revised ozone NAAQS, the CAA requires EPA to designate as nonattainment any area that is violating the NAAQS based on the three most recent years of ambient air quality data at the conclusion of the designation process. On April 30, 2018, EPA designated a 7-county area in and around metropolitan Atlanta as a marginal ozone nonattainment area for the 2015 8-hour ozone NAAQS.
Ground level ozone is not emitted directly into the air but is created by chemical reactions between oxides of nitrogen (NO
On July 2, 2020, Georgia submitted a SIP revision to address the emissions statements requirements related to the 2015 8-hour ozone NAAQS for the Atlanta Area.
As discussed above, section 182(a)(3)(B) of the CAA requires states to submit a SIP revision requiring the owner or operator of each NO
In 1996, EPA incorporated Georgia Rule 391-3-1-.02(6)(a)4,
On June 28, 2021, Georgia submitted a draft SIP revision for parallel processing to supplement the July 2, 2020 SIP revision. The June 28, 2021, submittal includes the new draft of Georgia Rule 391-3-1-.02(6)(a)4(iii) and states that the aforementioned change to the rule was presented to the Georgia Department of Natural Resources Board of Directors (DNR Board) for adoption at its September 28, 2021, meeting, along with changes to the rule to reflect only the counties comprising the Atlanta Area. The submittal says that the changes will be submitted to EPA as a SIP revision. The draft June 28, 2021, SIP revision was submitted in final form on November 4, 2021.
As allowed by CAA section 182(a)(3)(B)(ii), Georgia waived the emissions statements requirement for stationary sources emitting less than 25 tpy of NO
Pursuant to CAA Section 182(a)(1), Georgia is required to submit a comprehensive, accurate, current inventory of actual emissions from all sources, as described in CAA section 172(c)(3), in accordance with guidance provided by the Administrator. CAA Section 172(c)(3) states, “Such plan provisions shall include a comprehensive, accurate, current inventory of actual emissions from all sources of the relevant pollutant or pollutants in such area including such periodic revisions as the Administrator may determine necessary to assure that the requirements of this part are met.” Georgia's July 2, 2020, SIP revision includes an emissions inventory submitted pursuant to CAA section 182(a)(1) and states that it was prepared consistent with 83 FR 62998, “Implementation of the 2015 National Ambient Air Quality Standards for Ozone: Nonattainment Area State Implementation Plan Requirements,” and 40 CFR part 51.1315.” Stationary sources emitting less than 25 tpy of NO
The emissions inventory that GA EPD provided in its submission to satisfy the requirements in section 182(a)(1) of the CAA is included in the docket for this rulemaking. EPA has proposed to approve the emissions inventory portion of the July 2, 2020, SIP submission in a separate rulemaking. Given the waiver criteria in section 182(a)(3)(B)(ii), EPA cannot approve the emissions statement portion of the July 2, 2020, SIP submission as proposed herein unless EPA finalizes approval of the emissions inventory portion of the submission in that separate rulemaking.
EPA has preliminarily determined that Georgia's revised emissions statements regulation meets the requirements under CAA section 182(a)(3)(B) and the SIP Requirements Rule for the 2015 8-hour ozone NAAQS. Therefore, a conditional approval of the July 2, 2020, SIP submittal is no longer necessary. Accordingly, EPA is proposing to approve the July 2, 2020, SIP submittal, as updated by the November 4, 2021, SIP submittal.
In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference Rule 391-3-1-.02(6)(a)4(iii), state-effective October 25, 2021. EPA has made and will continue to make these materials generally available through
EPA is proposing to approve the July 2, 2020, SIP revision, as updated by the November 4, 2021, SIP submittal, related to the emissions statements requirements for the 2015 8-hour ozone NAAQS for the Atlanta Area. EPA has preliminarily determined that Georgia's SIP revisions requesting approval meet the requirements of CAA section 182(a)(3)(B).
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• 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).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), 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 the Atlantic humpback dolphin (
Scientific and commercial information pertinent to the petitioned action must be received by January 31, 2022.
You may submit comments on this document, identified by NOAA-NMFS-2021-0110 by the following method:
•
Interested persons may obtain a copy of the petition online at the NMFS website:
Heather Austin, NMFS Office of Protected Resources, (301) 427-8422,
On September 8, 2021, we received a petition from the Animal Welfare Institute, the Center for Biological Diversity, and VIVA Vaquita to list the Atlantic humpback dolphin (
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)). A joint NMFS-U.S. Fish and Wildlife Service (USFWS) (jointly, “the Services”) policy clarifies the agencies' interpretation of the phrase “distinct population segment” for the purposes of listing, delisting, and reclassifying a species under the ESA (61 FR 4722; February 7, 1996). 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: (1) The present or threatened destruction, modification, or curtailment of habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) inadequacy of existing regulatory mechanisms to address identified threats; (5) 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 current population sizes and distributions, both in captivity and the wild, if available; (2) identification of the factors under section 4(a)(1) of the ESA that may affect the species and where these factors are acting upon the species; (3) whether and to what extent any or all of the factors alone or in combination identified in section 4(a)(1) of the ESA may cause the species to be an endangered species or threatened species (
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 (50 CFR 424.14(h)(1)(ii)). 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 (50 CFR 424.14(h)(1)(iii)). 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 petition will generally not be considered to present substantial scientific and commercial information indicating that the petitioned action may be warranted unless the petition provides new information or analysis 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 petitioners' 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 petitioners' assertions. In other words, conclusive information indicating 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 first 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, if we conclude the petition presents substantial scientific or commercial information suggesting that the petitioned entity may constitute a
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, 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. ESA” because NatureServe assessments “have different criteria, evidence requirements, purposes, and taxonomic coverage than official lists of endangered and threatened species”, and therefore these two types of lists should not be expected to “coincide” (
The petition presents information on the taxonomy of the species, including information and references regarding the earliest description of the species primarily on differences in the skull compared to other humpback dolphins known at the time (Kükenthal 1891, Collins 2015, Collins
The Atlantic humpback dolphin is described as an obligate shallow water dolphin and is endemic to the tropical and subtropical eastern Atlantic nearshore waters (<30 m) of western Africa, ranging from Western Sahara to Angola (Collins 2015, Weir and Collins 2015). This species is the only member of the genus that occurs outside of the Indo-Pacific region (Mendez
Migrations and movements are poorly understood largely because tagging work has never been done on this species (Collins
The Atlantic humpback dolphin has specific habitat requirements, which could limit its resilience and ability to escape environmental and anthropogenic stressors (Collins 2015). It occurs exclusively in shallow (<30 m) depths, in warm nearshore waters (average sea surface temperatures ranging from 15.8° to 31.8° Celsius), and in dynamic habitats strongly influenced by tidal patterns (
Data and information regarding life history and reproduction parameters are almost nonexistent for this species. An estimated generation length of 18.4 years is given for the Atlantic humpback dolphin, although a figure closer to 25 years is provided for the Indo-Pacific humpback dolphin (
Abundance data are very limited for
Comprehensive reviews conducted by Collins (2015) and Collins
Because robust abundance estimates for this species are lacking, there are no quantitative assessments of population trends and status. However, the evidence of recent work in some areas and a consensus of expert opinions indicate that most stocks of
In summary, while data on abundance and population trends are largely absent, the information presented in the petition indicates that the species consists of small, fragmented stocks, and may be declining across its range.
The petition asserts that
According to information cited in the petition and readily available in our files, the greatest threat to the Atlantic humpback dolphin is fisheries bycatch. Bycatch of Atlantic humpback dolphins in artisanal gillnets is considered widespread throughout the species' range (Collins 2015, Collins
Work in Conkouati Douli National Park (Republic of the Congo) provides some indication of the potential scale of
Although there is no evidence of any organized, directed fisheries for
The extensive spread of migrant fishermen across western Africa over the past few decades is a related concern, which can augment existing fisheries bycatch issues in areas (or even bring these issues to areas where they did not previously exist) (Collins 2015, Collins
In general, declines in other target fish species may affect the Atlantic humpback dolphin population by increasing artisanal fishing effort and pressure, leading to increased bycatch risk for the species (Collins 2015, Collins
Overall, the information presented in the petition and briefly summarized here regarding the Atlantic humpback dolphin's specific habitat requirements, low estimated abundance, fragmented distribution, and the immediate threat of fisheries bycatch and potential targeted harvest lead us to conclude that listing the species as threatened or endangered may be warranted.
After reviewing the petition, the literature cited in the petition, and other information readily available in our files, we find that listing
To ensure that the status review is based on the best available scientific and commercial data, we are soliciting comments and information from interested parties on the status of the Atlantic humpback dolphin. Specifically, we are soliciting information in the following areas:
(1) Historical and current abundance and population trends of
(2) Historical and current distribution and population structure of
(3) Information on
(4) Historical and current condition of
(5) Information on
(6) Data on
(7) Information and data on common
(8) Historical and current data on
(9) Past, current, and potential threats, including any current or planned activities that may adversely impact
(10) Data on trade of
(11) Management, regulatory, or conservation programs for
We request that all data and information be accompanied by supporting documentation such as maps, bibliographic references, or reprints of pertinent publications. Please send any comments in accordance with the instructions provided in the
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
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes Atlantic bluefish specifications for the 2022 fishing year, and projected specifications for fishing year 2023, as recommended by the Mid-Atlantic Fishery Management Council. This action is necessary to establish allowable harvest levels to prevent overfishing while enabling optimum yield, using the best scientific information available. This rule also informs the public of the proposed fishery specifications and provides an opportunity for comment.
Comments must be received by December 17, 2021.
You may submit comments on this document, identified by NOAA-NMFS-2021-0107, by the following method:
1. Go to
2. Click the “Comment” icon, complete the required fields; and
3. Enter or attach your comments.
The Mid-Atlantic Fishery Management Council prepared a draft environmental assessment (EA) for this action that describes the proposed measures and other considered alternatives. The EA also provides an economic analysis, as well as an analysis of the biological, economic, and social impacts of the proposed measures and other considered alternatives. Copies of the specifications document, including the EA and information on the economic impacts of the proposed measures, are available on request from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. These documents are also accessible via the internet at
Cynthia Ferrio, Fishery Policy Analyst, (978) 281-9180.
The Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission jointly manage the Atlantic Bluefish Fishery Management Plan (FMP). The FMP requires the specification of an acceptable biological catch (ABC), commercial and recreational annual catch limits (ACL), commercial and recreational annual catch targets (ACT), a commercial quota, a recreational harvest limit (RHL), and any other management measures, for up to three years at a time. This action proposes bluefish catch limit specifications for the 2022 fishing year, and projects specifications for 2023, based on Council and Commission recommendations.
These proposed specifications are based on a 2021 assessment update and the recent Amendment 7 to the Bluefish FMP, as well as recommendations from the Council's Scientific and Statistical Committee (SSC) and the Bluefish Monitoring Committee. Amendment 7 was adopted by the Council and Commission in early June 2021, and the final rule published on November 24, 2021, 86 FR 66977. This amendment would implement management measures that affect these proposed specifications, including a rebuilding plan and reallocation of annual quotas between fishery sectors and among states. These proposed specifications were developed based on Amendment 7 measures, and these specifications would implement the first year of the rebuilding plan as well as begin the phasing in of the reallocation of commercial quota to the states in 2022.
There was a 3.65 million-lb (1,656-mt) overage of the fishery ACL caused by recreational catch in 2020. Because the bluefish fishery is overfished, the accountability measure (AM) required by the FMP at 50 CFR 648.163(d)(1) is a pound-for-pound payback of the overage against the soonest possible year's recreational ACT as a single-year adjustment. The 2020 overage AM would therefore be applied to the 2022 specifications under this proposed action. No sector transfer is allowed through these specifications because the stock is still overfished and new sector transfer provisions of Amendment 7 do not allow transfer in this situation. No changes are proposed to recreational management measures because the expected recreational landings under the existing measures are very close to fully achieving the proposed RHL.
This action proposes the Council's recommendations for 2022 and projected 2023 bluefish catch specifications, which are consistent with the SSC and Monitoring Committee recommendations (Table 1). These proposed specifications would increase the fishery ABC by about 55 percent in 2022, and by 21 percent the following year in 2023. The commercial quota and RHL are also proposed to increase by 28 percent and 67 percent in 2022, respectively, and again by 21 percent and 59 percent in 2023.
Table 2 provides the proposed commercial state allocations based on the Council-recommended coastwide commercial quotas for 2022 and 2023, and the phased-in changes to the percent share allocations to the states specified in Amendment 7. No states exceeded their allocated quota in 2020, or are projected to do so in 2021; therefore, no accountability measures for the commercial fishery are required for the 2022 fishing year at this time.
As previously mentioned, no changes to the recreational management measures are proposed in this action, as the expected recreational landings of 13.58 million lb (6,160 mt) under the existing measures are likely to achieve the proposed RHL. All other federal management measures would also remain unchanged under this action.
The projected specifications for 2023 are based on the available data and the second year of the rebuilding plan model. However, there is a research track stock assessment scheduled for bluefish in 2022. The Council will review the projected 2023 specifications in light of any new information, including this assessment, to determine if changes need to be made prior to their implementation. NMFS will publish a notice prior to the 2023 fishing year to confirm these limits as projected or announce any necessary changes.
Pursuant to section 304(b)(1)(A) of the Magnuson Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Atlantic Bluefish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This action is exempt from review under E.O. 12866 because it contains no implementing regulations.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows.
The Council conducted an evaluation of the potential socioeconomic impacts of the proposed measures in conjunction with an EA. There are no proposed regulatory changes in this bluefish action, so none are considered in the evaluation. The proposed specifications would increase bluefish catch limits in both 2022 and 2023 compared to 2021 to allow greater operational flexibility in the fishery, while still adhering to the rebuilding plan implemented by Amendment 7. This action would also incorporate the quota reallocation changes implemented by Amendment 7, allocating 86 percent of the ACL to the recreational sector and 14 percent to the commercial sector, as well as beginning the 7-year phased-in reallocation of commercial quota among the states in 2022.
This action would affect entities that participate in commercial bluefish fishing (those that hold commercial bluefish permits), and those with federal for-hire (party/charter) recreational fishing permits for bluefish. Vessels may hold multiple fishing permits and some entities own multiple vessels and/or permits. According to the Northeast Fisheries Science Center commercial ownership database, 526 affiliate firms landed bluefish during the 2018-2020 period (the most recent and complete data available), with 521 of those commercial entities categorized as small businesses and 5 categorized as large businesses. For the recreational for-hire fishery, 361 for-hire affiliate firms generated revenues from recreational fishing for various species during 2018-2020. All of those business affiliates are categorized as small businesses, but it is not possible to derive the proportion of overall revenues for these for-hire firms resulting from fishing activities for an individual species such as bluefish. Nevertheless, given the popularity of bluefish as a recreational species in the Mid-Atlantic and New England, it is likely that revenues generated from bluefish may be somewhat important for many of these firms at certain times of the year.
Overall, proposed specifications for 2022 and projected specifications for 2023 are expected to provide similar fishing opportunities when compared to the 2021 fishing year. Although these catch limits are increasing, there are no proposed changes to other management measures, such as recreational bag limits, that are likely to change fishing behavior. Entities issued a commercial bluefish permit may experience a slight positive impact related to potentially higher landings throughout the course of the entire year. However, because state allocations are changing, there might be different amounts of quota available regionally compared to past years. Often, fishing behavior and short term landings are based on market conditions, which are not expected to substantially change as a result of these specifications. As such, the proposed action is not expected to have an impact on the way the fishery operates or the revenue of small entities. Overall, analyses indicate that the proposed specifications will not substantially change: Fishing effort, the risk of overfishing, prices/revenues, or fishery behavior. Additionally, this action will not have a significant impact on small entities. As a result, an initial regulatory flexibility analysis is not required and none has been prepared.
This action would not establish any new reporting or record-keeping requirements.
This proposed rule contains no new information collection requirements under the Paperwork Reduction Act of 1995.
16 U.S.C. 1801
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a revision of a currently approved collection (OMB Number 0584-0646) for the 2023 Farm to School Census.
Written comments must be received on or before January 31, 2022.
Comments may be sent to: Amy Rosenthal, Food and Nutrition Service, U.S. Department of Agriculture, 1320 Braddock Place, 5th Floor, Alexandria, VA 22314. Comments may also be via email to Amy Rosenthal at
All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.
Requests for additional information or copies of this information collection should be directed to Amy Rosenthal at
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
The 2023 Farm to School Census (Census) will collect and synthesize data from a national census of SFAs to better understand the characteristics of SFAs participating in farm to school and the scope and details of the activities they engage in (
The primary mode of data collection will be an online survey, distributed to SFA directors. (SFA directors will also have the option to complete the survey over the phone.) The online survey is expected to take 30 minutes to complete. Census questions will be based on prior Farm to School Census instruments, from the iterations conducted in 2019 (the currently approved collection, OMB Number 0584-0646), 2015 (OMB Number 0584-0593), and 2013 (OMB Number 0536-0069). Questions will be removed, added or adjusted based on current research interests and to make the instrument as streamlined as possible.
To construct the contact list for the Census, State Child Nutrition (CN) directors will be sent a list of all SFAs in their State or territory, based on the most recently available FNS data. They will be asked to (1) add or remove any SFAs that have begun or ended participation in the NSLP and (2) provide contact information for the director of each SFA. State CN directors will also be asked to forward a notification email and two email reminders about the Census to SFAs. Directors of State agriculture departments will also be sent one email to notify them of the Census and request their assistance in encouraging SFAs in their State to complete it.
Non-respondents will receive a reminder phone call and up to ten reminder emails. Phone calls, during which SFAs will have the opportunity to complete the Census over the phone, will be conducted by trained interviewers. Staff will also be available for technical and completion assistance via a toll-free phone number.
Forest Service, Agriculture (USDA).
Notice of availability.
In accordance with Section 3(b) of the Wild and Scenic Rivers Act, the Forest Service, U.S. Department of Agriculture, is transmitting the final boundary of Upper White Salmon National Wild and Scenic River to Congress.
Information may be obtained by contacting John Ransom, Regional Land Surveyor, by telephone at 503-808-2420 or via email at
The Upper White Salmon Wild and Scenic River boundary description is available for review on the Gifford Pinchot National Forest website:
Due to COVID-19 health and safety protocols to protect employees and visitors, many Forest Service offices are closed to the public. The Upper White Salmon Wild and Scenic River boundary is available for review at the following offices, if arrangements are made in advance: USDA Forest Service, Yates Building, 14th and Independence Avenues SW, Washington, DC 20024, phone—800-832-1355; Pacific Northwest Regional Office, 1220 SW Third Avenue, Portland, OR 97204, phone—503-808-2468; and Gifford Pinchot National Forest Supervisor's Office, 1501 E Evergreen Blvd., Vancouver, WA 98661, phone—360-891-5000. Please contact the appropriate office prior to arrival.
The Upper White Salmon Wild and Scenic Rivers Act (Pub. L. 109-44) of August 2, 2005 designated Upper White Salmon, Washington as a National Wild and Scenic River, to be administered by the Secretary of Agriculture. As specified by law, the boundary will not be effective until ninety days after Congress receives the transmittal.
Forest Service, Agriculture (USDA).
Notice of availability.
In accordance with section 3(b) of the Wild and Scenic Rivers Act, the Forest Service, U.S. Department of Agriculture, is transmitting the final boundary of Crescent Creek National Wild and Scenic River to Congress and providing notice of availability of the Comprehensive River Management Plan.
Information may be obtained by contacting John Ransom, Regional Land Surveyor, by telephone at 503-808-2420 or via email at
The Crescent Creek Wild and Scenic River boundary description and Comprehensive River Management Plan are available for review on the Deschutes National Forest website:
Due to COVID-19 health and safety protocols to protect employees and visitors, many Forest Service offices are closed to the public. The Crescent Creek Wild and Scenic River boundary and Comprehensive River Management Plan are available for review at the following offices, if arrangements are made in advance: USDA Forest Service, Yates Building, 14th and Independence Avenues SW, Washington, DC 20024, phone—800-832-1355; Pacific Northwest Regional Office, 1220 SW Third Avenue, Portland, OR 97204, phone—503-808-2468; and Deschutes National Forest Supervisor's Office, 63095 Deschutes Market Road, Bend, OR 97701, phone—541-383-5300. Please contact the appropriate office prior to arrival.
The Omnibus Oregon Wild and Scenic Rivers Act of 1988 (Pub. L. 100-557) of October 28, 1988 designated Crescent Creek, Oregon as a National Wild and Scenic River, to be administered by the Secretary of Agriculture. As specified by law, the boundary will not be effective until ninety days after Congress receives the transmittal.
Office of the Under Secretary for Economic Affairs, Department of Commerce.
Request for comments.
The Foundations for Evidence-Based Policymaking Act of 2018 requires Federal agencies to modernize their data management practices to develop and support evidence-based policymaking. The Act requires the Director of the Office of Management and Budget (OMB), or the head of an agency designated by the Director, to establish the Advisory Committee on Data for Evidence Building (Advisory Committee). In a letter dated September 3, 2019, OMB delegated managerial and administrative responsibility for this Federal advisory committee to the Department of Commerce Office of Under Secretary for Economic Affairs (OUSEA). The Advisory Committee is required to deliver publicly available annual reports on its activities and findings to the OMB Director. The Advisory Committee submitted its first-year report on October 29, 2021. This FRN requests comments from the public on the Advisory Committee's first annual report.
Comments must be received by December 31, 2021.
You may submit comments by emailing
Please note the confidentiality of routine communication and responses to this public comment request are treated as public comments and may therefore be made publicly available, notwithstanding the inclusion of the routine notice.
Gianna Marrone, Program Analyst, U.S. Department of Commerce, 4600 Silver Hill Road (BE-64), Suitland, MD 20746; phone (301) 278-9282; email
The Advisory Committee submitted its first-year report to the Director of the Office of Management and Budget on October 29, 2021. The report is also available publicly on the Advisory Committee's website. The report summarizes the Committee's first-year activities and resulting findings, laying out a vision for a National Secure Data Service and the future of data sharing, data linkages, and privacy enhancing techniques across Federal agencies and with state and local governments. The report describes recommended actions that can be taken today to build towards that vision while also articulating the path that the Committee intends to take across the next year to further develop recommendations for implementing the vision.
Over the past 12 months, the Committee has engaged in extensive fact-finding, including examining the recommendations of the Commission on Evidence-Based Policymaking and the implications of their partial implementation through the Evidence Act; leveraging the expertise of its members; hearing from researchers, government leaders, other experts, and the public; conducting virtual site visits to existing data facilities; and beginning to collaboratively synthesize the different perspectives and use cases into a coherent understanding of the current state and future needs for the use of data for evidence building. The Committee members recognize their efforts as a work-in-progress that will continue across the next 12 months.
This request for comments offers researchers, evaluators, contractors, government entities, and other interested parties the opportunity to inform the Committee's second-year plans. This is a general solicitation of comments from the public. The FRN commentors may respond to any section of the report. Please clearly indicate which section(s) of the report you address in your response and provide evidence to support assertions, where practicable.
Bureau of Economic Analysis, U.S. Department of Commerce.
Notice of request for nominations.
The Under Secretary for Economic Affairs requests nominations of individuals to the Federal Economic Statistics Advisory Committee (FESAC). The Under Secretary for Economic Affairs in coordination with the Directors of the Department's statistical agencies, the Bureau of Economic Analysis and the U.S. Census Bureau, as well as the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics will consider nominations received in response to this notice, as well as from other sources. The
Nominations for the FESAC will be accepted on an ongoing basis and will be considered as and when vacancies arise.
Please submit nominations by email to
Gianna Marrone, Committee Management Official, Department of Commerce, Bureau of Economic Analysis, telephone 301-278-9282, email:
The Federal Economic Statistics Advisory Committee (the “Committee”) was established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2). The following provides information about the Committee, membership, and the nomination process.
The Committee advises the Directors of the Department's statistical agencies, the Bureau of Economic Analysis (BEA) and the U.S. Census Bureau, as well as the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics (BLS) on statistical methodology and other technical matters related to the design, collection, tabulation, and analysis of federal economic statistics.
The Committee functions solely as an advisory committee to the senior officials of BEA, the Census Bureau, and BLS (the agencies). Important aspects of the committee's responsibilities include, but are not limited to:
a. Recommending research to address important technical problems arising in federal economic statistics
b. Identifying areas in which better coordination of the agencies' activities would be beneficial;
c. Exploring ways to enhance the agencies' economic indicators to make them timelier, more accurate, and more specific to meeting changing demands and future data needs;
d. Improving the means, methods, and techniques to obtain economic information needed to produce current and future economic indicators; and
e. Coordinating, in its identification of agenda items, with other existing academic advisory committees chartered to provide agency-specific advice, for the purpose of avoiding duplication of effort.
The Committee meets once or twice a year, budget permitting. Additional meetings may be held as deemed necessary by the Under Secretary for Economic Affairs or the Designated Federal Official. All Committee meetings are open to the public in accordance with the Federal Advisory Committee Act.
FESAC will comprise approximately 16 members who serve at the pleasure
Members shall serve as Special Government Employees (SGEs) and shall be subject to ethics rules applicable to SGEs.
A FESAC member term is three years.
Members may serve more than one term as described in the FESAC Charter, available at:
Members of the Committee serve without compensation but may receive reimbursement for Committee-related travel and lodging expenses.
The Committee is currently filling one or more positions on the FESAC.
The Under Secretary of Economic Affairs, in consultation with the agencies will consider nominations of all qualified individuals to ensure that the Committee includes the areas of experience noted above. Individuals may nominate themselves or other individuals, and professional associations and organizations may nominate one or more qualified persons for membership on the Committee. Nominations shall state that the nominee is willing to serve as a member and carry out the duties of the Committee. A nomination package should include the following information for each nominee:
1. A letter of nomination stating the name, affiliation, and contact information for the nominee, the basis for the nomination (
2. a biographical sketch of the nominee;
3. a copy of the nominee's curriculum vitae; and
4. the name, return address, email address, and daytime telephone number at which the nominator can be contacted.
The Committee aims to have a balanced representation among its members, considering such factors as geography, age, sex, race, ethnicity, technical expertise, community involvement, and knowledge of programs and/or activities related to FESAC. Individuals will be selected based on their expertise in or representation of specific areas as needed by FESAC.
All nomination information should be provided in a single, complete package. Interested applicants should send their nomination package to Gianna Marrone, Committee Management Official, at
On July 29, 2021, VIAVI Solutions, Inc. submitted a notification of proposed production activity to the FTZ Board for its facility within FTZ 75, in Chandler, Arizona.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On July 28, 2021, BMW Manufacturing Company, LLC submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 38A, in Spartanburg, South Carolina.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that producers and exporters of certain softwood lumber products (softwood lumber) from Canada received countervailable subsidies during the period of review, January 1, 2019, through December 31, 2019.
Applicable December 2, 2021.
Jonathan Hall-Eastman (Canfor), John Hoffner (JDIL), Kristen Johnson/Samuel Brummitt (Resolute), and Laura Griffith (West Fraser), AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401
Commerce published the preliminary results of this countervailing duty (CVD) administrative review of softwood lumber from Canada on May 27, 2021, and invited interested parties to comment.
The product covered by the
Commerce conducted this CVD administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). The subsidy programs under review, and the issues raised in case and rebuttal briefs submitted by the interested parties, are discussed in the Issues and Decision Memorandum. A list of the issues that the parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice at Appendix I. Based on our analysis of the comments received from the interested parties, we made changes to the subsidy rates calculated for certain respondents. For a discussion of these changes,
Because the rates calculated for the companies selected for individual review are above
For further information on the calculation of the non-selected rate,
In accordance with section 751(a)(1)(A) and of the Act and 19 CFR 351.221(b)(5), we determine that the following total estimated countervailable subsidy rates exist for 2019:
Commerce intends to disclose the calculations performed for these final results of review within five days of the date of publication of this notice in the
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries of subject merchandise covered by this review.
Commerce intends to issue assessment instructions to CBP no earlier than 41 days after the date of publication of the final results of this review in the
In accordance with section 751(a)(2)(C) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown for the companies subject to this review. For all non-reviewed companies, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposits, when imposed, shall remain in effect until further notice.
This notice also serves as a final reminder to parties subject to APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
Commerce is issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4) and 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that producers and/or exporters subject to this administrative review made sales of subject merchandise at less than normal value during the period of review (POR), January 1, 2019, through December 31, 2019.
Applicable December 2, 2021.
Jeff Pedersen (Canfor) or Maisha Cryor (West Fraser), AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration,
Commerce published the
The product covered by this review is softwood lumber from Canada. For a full description of the scope,
All issues raised in the case briefs filed in this administrative review are addressed in the Issues and Decision Memorandum. A list of the topics discussed in the Issues and Decision Memorandum is appended to this notice. The Issues and Decision Memorandum is a public document and is available electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Services System (ACCESS). ACCESS is available to registered users at
Based on our review of the record and comments received from interested parties regarding our
• For Canfor, we corrected a ministerial error where we should have relied on the consolidated customer code but relied on a non-consolidated customer code.
• For Canfor, we updated the market prices for electricity used to value related party transactions involving steam and electricity to be based both on electricity transactions in both Alberta and British Columbia, rather than only in Alberta.
• We reduced the total cost of manufacturing for Canfor by the closure costs of its Vavenby sawmill.
• In calculating Canfor's interest expense, we included the losses on certain derivative investments.
• For West Fraser, we corrected a ministerial error regarding the manner in which we assigned the intended byproduct offset amount to the total cost of manufacturing.
• For West Fraser, we corrected an error with how we calculated the byproduct offset.
• For West Fraser, we made an adjustment to its total cost of manufacturing to account for seed purchases from a joint venture company.
• For West Fraser, we are relying on the alternative grade group product code to ensure a more accurate comparison of comparison market and U.S. market sales.
• For West Fraser, we are determining West Fraser's margin using the mixed method comparison method based upon the percentage of sales that passed the Cohen's
As a result of this administrative review, we are assigning the following weighted-average dumping margins to the manufacturers/exporters listed below for the period of January 1, 2019, through December 31, 2019:
Pursuant to section 751(a)(2)(A) the Act and 19 CFR 351.212(b)(1), Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review.
We intend to calculate importer- (or customer-) specific assessment rates on the basis of the ratio of the total amount of antidumping duties calculated for each importer (or customer's) examined sales and the total entered value of the sales in accordance with 19 CFR 351.212(b)(1). Where an importer- (or customer-) specific rate is zero or
Generally, when calculating margins for non-selected respondents, Commerce looks to section 735(c)(5) of the Act for guidance, which provides instructions for calculating the all-others margin in an investigation. Section 735(c)(5)(A) of the Act provides that when calculating the all-others margin, Commerce will exclude any zero and
In this review, we calculated a weighted-average dumping margin of 17.12 percent for Canfor and 6.06 percent for West Fraser. In accordance with section 735(c)(5)(A) of the Act, Commerce assigned the weighted-average of these two calculated weighted-average dumping margins, 11.59 percent, to the non-selected companies in these final results. The rate calculated for the non-selected companies is calculated based on the simple average of the margins of the two individually examined companies.
Commerce's “reseller policy” will apply to entries of subject merchandise during the POR produced by companies included in these final results of review for which the reviewed companies did
The final results of this administrative review shall be the basis for the assessment of antidumping duties on entries of merchandise under review and for future cash deposits of estimated duties, where applicable. Commerce intends to issue assessment instructions to CBP no earlier than 41 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of these final results, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies under review will be equal to the weighted-average dumping margin listed above in the “Final Results of Review” section; (2) for merchandise exported by producers or exporters not covered in this review but covered in a previously completed segment of this proceeding, the cash deposit rate will continue to be the company-specific rate published in the final results for the most recent period in which that producer or exporter participated; (3) if the exporter is not a firm covered in this review or in any previous segment of this proceeding, but the producer is, then the cash deposit rate will be that established for the producer of the merchandise in these final results of review or in the final results for the most recent period in which that producer participated; and (4) if neither the exporter nor the producer is a firm covered in this review or in any previously completed segment of this proceeding, then the cash deposit rate will be 6.58 percent
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice is the only reminder to parties subject to the administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a violation subject to sanction.
We are issuing and publishing these final results and this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Based on a request from Zhejiang Yuhua Timber Co. Ltd. (Yuhua), A-Timber Flooring Company Limited (A-Timber) and Mullican Flooring Co. (Mullican) (collectively, Yuhua
Applicable December 2, 2021.
Alexis Cherry, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0607.
On December 8, 2011, Commerce published the AD order on MLWF from China.
Multilayered wood flooring is composed of an assembly of two or more layers or plies of wood veneer(s)
The core of multilayered wood flooring may be composed of a range of materials, including but not limited to hardwood or softwood veneer, particleboard, medium-density fiberboard, high density fiberboard (HDF), stone and/or plastic composite, or strips of lumber placed edge-to-edge.
Pursuant to section 751(b) of the Act, Commerce will conduct a CCR upon receipt of a request from an interested party
In the event that Commerce determines an expedited action is warranted, 19 CFR 351.221(c)(3)(ii) permits Commerce to combine the notice of initiation of the review and the preliminary results of review into a single notice. However, we are not combining this notice of initiation with the preliminary results, pursuant to 19 CFR 351.221(c)(3)(ii), because Commerce has determined that it is necessary to issue a questionnaire to Yuhua
Commerce intends to publish in the
This initiation notice is published in accordance with section 751(b)(1) of the Act, 19 CFR 351.216(d), and 19 CFR 351.221(b)(1). Further, interested parties are reminded that the next opportunity to request an administrative review of entries that may be examined in this CCR is December 2021.
National Marine Fisheries Service (NMFS), National Oceanic and
Notice of SEDAR 77 Highly Migratory Species (HMS) Hammerhead Sharks Post Data Workshop Webinar.
The SEDAR 77 assessment of the Atlantic stocks of hammerhead sharks will consist of a stock identification (ID) process, data webinars/workshop, a series of assessment webinars, and a review workshop. See
The SEDAR 77 HMS Hammerhead Sharks Post Data Workshop Webinar has been scheduled for Thursday, January 13, 2022, from 12 p.m. until 3 p.m., ET.
Kathleen Howington, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4371; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.
The items of discussion at the SEDAR 77 HMS Hammerhead Shark Post Data Workshop Webinar are as follows: Discuss any data issues or concerns remaining from the workshop.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the South Atlantic Fishery Management Council office (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of 12-month finding and availability of status review document for the black teatfish (
We, NMFS, have completed a comprehensive status review under the Endangered Species Act (ESA) for the black teatfish (
This finding was made on December 2, 2021.
The
Celeste Stout, NMFS Office of Protected Resources, 301-427-8436.
On May 14, 2020, we received a petition from the Center for Biological Diversity to list black teatfish (
On August 10, 2020, NMFS published a 90-day finding for
We are responsible for determining whether
Section 3 of the ESA defines an endangered species as any species which is in danger of extinction throughout all or a significant portion of its range and a threatened species as one which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range 16 U.S.C. 1532(6), 16 U.S.C. 1532(20). Thus, in the context of the ESA, we interpret an “endangered species” to be one that is presently in danger of extinction. A “threatened species,” on the other hand, is not presently in danger of extinction, but is likely to become so in the foreseeable future (that is, at a later time). In other words, the primary statutory difference between a threatened and endangered species is the timing of when a species is in danger of extinction, either presently (endangered) or not presently but in the foreseeable future (threatened).
When we consider whether a species qualifies as threatened under the ESA, we must consider the meaning of the term “foreseeable future.” Regulations at 50 CFR 424.11(d) state that the foreseeable future extends only so far into the future as we can reasonably determine that both the future threats and the species' responses to those threats are likely. What constitutes the foreseeable future for a particular species depends on case-specific factors such as the the species' life-history characteristics, threat-projection timeframes, and environmental variability. That is, the foreseeability of a species' future status is case specific and depends upon both the foreseeability of threats to the species and foreseeability of the species' response to those threats.
The statute requires us to determine whether any species is endangered or threatened throughout all or a significant portion of its range as a result of any one or a combination of any of the following five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence (16 U.S.C. 1533(a)(1)). We are also required to make listing determinations based solely on the best scientific and commercial data available, after conducting a review of the species' status and after taking into account efforts, if any, being made by any state or foreign nation (or subdivision thereof) to protect the species (16 U.S.C. 1533(b)(1)(A)).
To determine whether
This section provides a summary of key biological information presented in the Status Review Report (NMFS 2021).
Sea cucumbers are characterized by a suboval body arched dorsaly and flattened ventrally, a thick and rigid tegument, a large number of ventral podia arranged tightly and without order, small dorsal papillae, and anal teeth (Purcell
Teatfish are gonochoristic (
Teatfish have slow growth rates, maturing at about 3-7 years, and are thought to live for several decades (Conand
Environmental cues (
The oocytes of most sea cucumber species, which include teatfish, are small (< 200 μm in diameter) and are neutrally buoyant in the water column (Purcell
Few standardized datasets documenting changes in teatfish species densities exist for any range countries. This is due mostly to a lack of detailed historical data on early harvests (Friedman
While data on abundance and population trends for teatfish are lacking, they are even more sparse for
NMFS relied on the best information available to conduct an extinction risk analysis through evaluation of four demographic viability factors and five threats-based listing factors. In determining the extinction risk of a species, it is important to consider both the demographic risks facing the species as well as current and potential threats that may affect the species' status. To this end, a demographic analysis was conducted for
A demographic risk analysis is an assessment of the manifestation of past threats that have contributed to the species' current status and informs the consideration of the biological response of the species to present and future threats. This analysis evaluated the population viability characteristics and
The appropriate time horizon for evaluating whether a species is more likely than not to be at a high level of risk in the “foreseeable future” depends on various case-and species-specific factors. For example, the time horizon may reflect certain life history characteristics (
The “foreseeable future” for this extinction risk analysis was considered to extend out several decades (>30 years). Because of the species' life history traits, with longevity estimated to be several decades, age of sexual maturity ranging from three to seven years, density-dependent reproduction and potentially low rates of recruitment, it would likely take more than a few decades for any recent management actions to be realized and reflected in population abundance. Similarly, the impact of present threats to the species could be realized in the form of noticeable population declines within this timeframe, as demonstrated in the available survey and fisheries data (see Populations and Abundance section in NMFS 2021). As the main potential operative threats to the species are overutilization and the inadequacy of existing regulatory mechanisms, this timeframe would allow for reliable predictions regarding the impact of current levels of fishery-related mortality on the biological status of the species. Additionally, this time frame allows for consideration of the impacts on habitat from climate change while the significance of these effects are still uncertain.
The ability to determine and assess risk factors to a marine species is often limited when quantitative estimates of abundance and life history information are lacking. Therefore, in assessing threats and subsequent extinction risk of a data-limited species such as
Using these concepts, we evaluated extinction risk by assigning a risk level to each of the four demographic viability factors and five threats-based listing factors. The levels are defined as follows:
•
•
•
Aditionally, we provided a confidence rating to the impact of each threat as well as the demographic factors based on the available information. The confidence rating scores were adapted from Lack
• 0 (no confidence) = No information;
• 1 (low confidence) = Very limited information;
• 2 (medium confidence) = Some reliable information available, but reasonable inference and extrapolation required; and
• 3 (high confidence) = Reliable information with little to no extrapolation or inference required.
We also considered the potential interactions among demographic and listing factors. Finally, we examined the levels assigned to each demographic and listing factor along with the uncertainty rating to determine the overall risk of extinction (see
As discussed in the Abundance and Trends section of the Status Review Report, across the range of
Adult density is critical to the species' persistence because the species needs a sufficient density to successfully reproduce (Conand & Muthiga 2007; Purcell
Teatfish generally exhibit low natural mortality rates, low to moderate population growth rates, and variable success of larval survival and recruitment, resulting in generally low productivity (CITES 2019; FAO 2019). While larger individuals may be considered highly fecund, teatfish experience high levels of larval mortality (Uthicke, 2004; FAO 2019). Additionally, successful reproduction is highly dependent on adult density (Conand & Muthiga 2007; Purcell
We could not find any information regarding
In the Status Review Report the risk rating to the species for Abundance, Productivity, and Spatial Distribution/Spatial Connectivity was unknown with a confidence rating of 1 and for Genetic Diversity the rated risk to the species was also unknown with a confidence rating of 0. Thus, we conclude that, while
As described in the Status Review Report (NMFS 2021), the available data do not provide us with an understanding of
The harvest of
We assume that demand for `high value' sea cucumber species, including
Additionally, there is a lack of recent fisheries-dependent data as many of the countries have banned sea cucumber fishing, including Comoros, Egypt, India, Mauritius, Mayotte, Saudi Arabia, Tanzania, and Yemen. However, despite these bans, there is evidence of continued fishing pressure on sea cucumbers through illegal, unregulated, and unreported (IUU) fishing. IUU fishing is common in the range of
Finally, overall and country specific trade data for
Based on the above information, the rated risk to the species assigned in the Status Review Report was moderate with a confidence rating of 2.
The extent to which disease and parasites result in sea cucumber mortality in the wild is largely unknown. The impact of predation as a threat on
The establishment of management strategies for
Another regulatory mechanism that will affect
Appendix II includes species that are not necessarily threatened with extinction, but for which trade must be controlled in order to avoid utilization incompatible with their survival. International trade of Appendix II species is permitted when export permits are granted from the country of origin. In order to issue an export permit, the exporting country must find that the animals were legally obtained and their export will not be detrimental to the survival of the species in the wild (referred to as a “non-detriment finding”).
The extent to which existing regulatory mechanisms are inadequate
While local sea cucumber regulations (
We considered factors including bycatch and effects of climate change on
Guided by the results of the demographic risk and section 4(a)(1) factor analyses above, we analyzed the overall risk of extinction of
Despite much uncertainty due to limited information, it is likely that
Information on the abundance and distribution of teatfish stocks in general does not indicate any wide-spread extirpations or a reduction of range, although declines in densities of teatfish have been reported from time series and snap-shot studies (Kinch
Most of the available data only provide snap-shots of the species (
Although
Furthermore, our ability to make reliable predictions of the impacts of threats and
Given the limitations of the available data, including sparse species-specific information hindering status and trend analyses, significant uncertainty regarding the identification and magnitude of potential threats to the species throughout most of its range, and a lack of demographic data to assess how
Under the ESA, a species may be listed if it is in danger of extinction or likely to become so within the foreseeable future throughout all or a
The Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species”(“SPR Policy,” 79 FR 37578, July 1, 2014), partially guided this assessment. Under the SPR Policy, we must determine whether there is substantial information indicating that (1) any portions may be “significant” and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. The order in which these determinations are made is flexible and typically determined based on the nature of the available information or circumstances for the particular species.
We note that the definition of “significant” in the SPR Policy has been invalidated in two District Court cases that addressed listing decisions made by the USFWS. The SPR Policy set out a biologically-based definition that examined the contributions of the members in the portion to the species as a whole, and established a specific threshold (
Based on our review of the available data, these main threats appear to be largely widespread throughout
Where species-specific information is available, the data show potential negative responses, as evidenced by population declines, in Chagos, Egypt, Madagascar, Mayotte, Saudi Arabia, and Tanzania. However, as stated previously in the extinction risk analysis, where data do indicate species-specific declines there is insufficient data to indicate the species is facing a risk of extinction in those locations. For example, in Chagos the mean density reported for Salomon atoll in 2002 was 83 ind. ha-1 and in 2006 was reported as 10 ind. ha-1. Although this decline to 10 ind. ha-1 could potentially be a cause for concern, in the nearby Seychelles, a mean density of 2.0 ind. ha-1, reported during a 2003-2004 survey, was considered to represent an underexploited
While there are limited data on the locations listed above, demographic data to determine how
Section 4(b)(1) of the ESA requires that NMFS make listing determinations based solely on the best scientific and commercial data available after conducting a review of the status of the species and taking into account those efforts, if any, being made by any state or foreign nation, or political subdivisions thereof, to protect and conserve the species. We have independently reviewed the best available scientific and commercial information, including the petitions, public comments submitted on the 90-day finding (85 FR 48144, August 10, 2020), the Status Review Report (NMFS 2021), and other published and unpublished information. We considered each of the statutory factors to determine whether each contributed significantly to the extinction risk of the species. As previously explained, we could not identify a significant portion of the species's range that is threatened or endangered. Therefore, our determination is based on a synthesis and integration of the foregoing information, factors and considerations, and their effects on the status of the species throughout its entire range.
We have determined the species does not warrant listing at this time. This finding is consistent with the statute's requirement to base our findings on the best scientific and commercial data available. Given the limitations of the available data, including sparse species-specific information hindering status and trend analyses, significant uncertainty regarding the identification and magnitude of potential threats to the species throughout most of its range,
This is a final action, and, therefore, we are not soliciting public comments.
A complete list of the references used in this 12-month finding is available at
In December 2004, the Office of Management and Budget (OMB) issued a Final Information Quality Bulletin for Peer Review establishing minimum peer review standards, a transparent process for public disclosure of peer review planning, and opportunities for public participation. The OMB Bulletin, implemented under the Information Quality Act (Pub. L. 106-554) is intended to enhance the quality and credibility of the Federal Government's scientific information, and applies to influential or highly influential scientific information disseminated on or after June 16, 2005. To satisfy our requirements under the OMB Bulletin, we obtained independent peer review of the Status Review Report. Three independent specialists were selected from the academic and scientific community for this review. All peer reviewer comments were addressed prior to dissemination of the final Status Review Report and publication of this 12-month finding.
The Peer Review Report can be found online at:
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The Pacific Fishery Management Council's (Pacific Council) Ad Hoc Ecosystem Workgroup (EWG) is holding an online meeting, which is open to the public.
The online meeting will be held Friday, December 17, 2021, from 12 p.m. to 2 p.m., Pacific Standard Time, or until business for the day is completed.
This meeting will be held online. Specific meeting information, including directions on how to join the meeting and system requirements will be provided in the meeting announcement on the Pacific Council's website (see
Kit Dahl, Staff Officer, Pacific Council; telephone: (503) 820-2422.
The purpose of this meeting is to discuss the EWG's assignment to compile a list of potential tasks flowing from the results of the Fishery Ecosystem Plan Climate and Communities Initiative. In compiling the list, the EWG will consider the activities identified by the Ad Hoc Climate and Communities Core Team, and other advisory body reports and public comment submitted to the Pacific Council at its September 2021 meeting. The EWG also was asked to prioritize the list of activities and assess the likely workload associated with each. The EWG plans to submit a report with its findings to be included in the advance briefing materials for the March 2022 Pacific Council meeting. Time permitting, the EWG also may discuss other ecosystem-related items scheduled on the March 2022 Pacific Council meeting agenda.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 78 South Atlantic Spanish Mackerel Assessment Webinar 2.
The SEDAR 78 assessment of the South Atlantic Stock of Spanish mackerel will consist of a series of assessment webinars. A SEDAR 78 Assessment Webinar 2 is scheduled for January 5, 2022. See
The SEDAR 78 South Atlantic Spanish Mackerel Assessment Webinar 2 has been scheduled for January 5, 2022, from 1 p.m. until 4 p.m., Eastern. The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the assessment process. Such adjustments may result in the meeting being extended from or completed prior to the time established by this notice.
Kathleen Howington, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone (843) 571-4371; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.
The items of discussion at the SEDAR 78 South Atlantic Spanish Mackerel Assessment Webinar 2 are as follows: Finalize any data issues as needed. Continue discussion on base model configuration and discuss proposed changes to model, sensitivity runs, and projections.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the South Atlantic Fishery Management Council office (see
Corporation for National and Community Service.
Notice of information collection; request for comment.
The Corporation for National and Community Service, operating as AmeriCorps, has submitted a public information collection request (ICR) entitled Childcare Benefit Forms for review and approval in accordance with the Paperwork Reduction Act.
Written comments must be submitted to the individual and office listed in the
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Courtney Russell, at 202-380-7825 or by email to
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of AmeriCorps, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions;
• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and
• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
A 60-day Notice requesting public comment was published in the
Corporation for National and Community Service.
Notice of Information Collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Corporation for National and Community Service, operating as AmeriCorps, is proposing a new information collection.
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1) By mail to: AmeriCorps, Attention Sharron Tendai, 250 E Street SW, Washington, DC 20525.
(2) By hand delivery or by courier to the AmeriCorps mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except federal holidays.
(3) Electronically through
Comments submitted in response to this notice may be made available to the public through
Sharron Tendai, 202-606-3904, or by email at
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. All written comments will be available for public inspection on
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension without change of a currently approved collection.
Interested persons are invited to submit comments on or before January 3, 2022.
Written comments and recommendations for proposed information collection requests should be sent within 30 days of publication of this notice to
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department
Office of Postsecondary Education, Department of Education.
Notice; corrections.
On November 12, 2021, the Department of Education (Department) published in the
Deadline for Transmittal of Applications: January 26, 2022.
Cory Neal, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202-4260. Telephone: (202) 453-6137. 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.
On November 12, 2021, we published in the
In FR Document 2021-24645 appearing on page 62796 of the
On page 62796, in the second column, under the
You may also access documents of the Department published in the
This is a supplemental notice in the above-referenced proceeding of Red Barn Energy, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is December 16, 2021.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
This is a supplemental notice in the above-referenced proceeding of Northern Wind Energy Redevelopment, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is December 16, 2021.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
Federal Energy Regulatory Commission.
Notice of information collection and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC Form 580 (Interrogatory on Fuel and Energy Purchase Practices Pursuant to Section 205 of the Federal Power Act), which will be submitted to the Office of Management and Budget (OMB) for a review of the information collection requirements. The Commission received no comments on the 60-day notice.
Comments on the collection of information are due January 3, 2022.
Send written comments on FERC Form 580 to OMB through
Please submit copies of your comments (identified by Docket No. IC21-39-000) to the Commission as noted below. Electronic filing through
•
• For those unable to file electronically, comments may be filed by USPS mail or by hand (including courier) delivery.
○
○
FERC submissions must be formatted and filed in accordance with submission guidelines at:
Ellen Brown may be reached by email at
Comments are invited
This is a supplemental notice in the above-referenced proceeding of Rock Aetna Power Partners, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is December 16, 2021.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
This is a supplemental notice in the above-referenced proceeding of Indra Power Business DE LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is December 16, 2021.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following Complaints and Compliance filings in EL Dockets:
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:
Environmental Protection Agency.
Notice; request for public comment.
In accordance with the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (“CERCLA”), notice is hereby given by the U.S. Environmental Protection Agency (“EPA”), Region 2, of a proposed settlement agreement (“Agreement”) with Jeco Corporation for the Maywood Chemical Superfund Site (“Site”), Boroughs of Maywood and Lodi, and the Township of Rochelle Park, Bergen County, New Jersey.
Comments must be submitted on or before January 3, 2022.
Comments can be sent via email to Kathryn DeLuca at
Kathryn DeLuca, Attorney, Office of Regional Counsel, U.S. Environmental Protection Agency. Email:
Under the proposed Agreement, Jeco Corporation agrees to reimburse EPA for $125,500 in past and future oversight costs incurred in connection with radiological contamination at the property owned by Jeco Corporation that is part of the Site, located at 149-151 Maywood Avenue, Borough of Maywood and Township of Rochelle Park, Bergen County, New Jersey, designated as Block 124, Lot 30 in the Borough of Maywood and Block 17.02, Lot 1 in the Township of Rochelle Park on the tax map of Bergen County, New Jersey (“Jeco Property”). The Agreement also resolves EPA's Federal lien on the Jeco Property arising under Section 107(l) of CERCLA, 42 U.S.C. 9607(1).
For thirty (30) days following the date of publication of this document, EPA will receive written comments relating to the proposed Agreement. EPA will consider all comments received and may modify or withdraw its consent to the proposed Agreement if comments received disclose facts or considerations that indicate that the proposed Agreement is inappropriate, improper, or inadequate. EPA's response to any comments received will be available for public inspection online and/or at EPA Region 2, 290 Broadway, New York, New York 10007-1866.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Primary Copper Smelters (EPA ICR No. 1850.09, OMB Control No. 2060-0476), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently-approved through November 30, 2021. Public comments were previously requested, via the
Additional comments may be submitted on or before January 3, 2022.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2020-0635, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, 27711; telephone number: (919) 541-0833; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it can
Written comments and recommendations for the proposed information collection should be submitted on or before January 3, 2022.
Comments should be sent to
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
(1) Required internet-based TRS providers to submit certain projected TRS-related cost and demand data to the TRS Fund administrator to be used to calculate the rate; and
(2) directed the TRS Fund administrator to expand its data collection forms accordingly.
In 2003, the Commission released the 2003 Second Improved TRS Order, published at 68 FR 50973, August 25, 2003, which among other things required that TRS providers offer certain local exchange carrier (LEC)-based improved services and features where technologically feasible, including a speed dialing requirement which may entail voluntary recordkeeping for TRS providers to maintain a list of telephone numbers. See also 47 CFR 64.604(a)(3)(vi)(B).
In 2007, the Commission released the Section 225/255 VoIP Report and Order, published at 72 FR 43546, August 6, 2007, extending the disability access requirements that apply to telecommunications service providers and equipment manufacturers under 47 U.S.C. 225, 255 to interconnected voice over internet protocol (VoIP) service providers and equipment manufacturers. As a result, under rules implementing section 225 of the Act, interconnected VoIP service providers are required to publicize information about telecommunications relay services (TRS) and 711 abbreviated dialing access to TRS. See also 47 CFR 64.604(c)(3).
In 2007, the Commission also released the 2007 Cost Recovery Report and Order and Declaratory Ruling, published at 73 FR 3197, January 17, 2008, in which the Commission:
(1) Adopted a new cost recovery methodology for interstate traditional TRS, interstate speech-to-speech service (STS), captioned telephone service (CTS), and Internet Protocol captioned telephone service (IP CTS) based on the
(2) adopted a cost recovery methodology for Internet Protocol (IP) Relay based on a price cap like methodology;
(3) adopted a cost recovery methodology for video relay service (VRS) that adopted tiered rates based on call volume;
(4) clarified the nature and extent that certain categories of costs are compensable from the Fund; and
(5) addressed certain issues concerning the management and oversight of the Fund, including prohibiting financial incentives offered to consumers to make relay calls.
The 2007 TRS Cost Recovery Order requires that state relay administrators and TRS providers submit to the TRS Fund administrator the following information annually, for intrastate traditional TRS, STS, and CTS:
(1) The per-minute compensation rate(s) and other compensation received for the provision of TRS;
(2) whether the rate applies to session minutes or conversation minutes, which are a subset of session minutes;
(3) the number of intrastate session minutes; and
(4) the number of intrastate conversation minutes.
Also, STS providers must file a report annually with the TRS Fund administrator and the Commission on their specific outreach efforts directly attributable to the additional compensation approved by the Commission for STS outreach.
In 2011, to help prevent waste, fraud, and abuse, the Commission adopted three VRS orders to curtail these harmful practices. Each of these orders (collectively, the 2011 VRS Orders) included information collection requirements.
On April 6, 2011, in document FCC 11-54, the Commission released the 2011 Fraud Prevention Order, published at 76 FR 30841, May 27, 2011, which included several measures designed to eliminate the waste, fraud and abuse, while ensuring that VRS remains a viable and a valuable communication tool for Americans who use it on a daily basis.
On July 28, 2011, in document FCC 11-118 the Commission released the VRS Certification Order, published at 76 FR 47469, August 5, 2011, amending its rules for certifying internet-based TRS providers as eligible for payment from the Interstate TRS Fund (Fund) for their provision of internet-based TRS. On October 17, 2011, in document FCC 11-155, the Commission released the Second VRS Certification Order, published at 76 FR 67070, October 31, 2011, addressing three petitions related to the VRS Certification Order by revising the burdens contained in the requirements for the submission of documentation of a provider's VRS equipment and technologies and the submission of documentation regarding sponsorship arrangements.
The following are the final information collection requirements contained in the 2011 VRS Orders:
(1) The Chief Executive Officer (CEO), Chief Financial Officer (CFO), or other senior executive of a TRS provider shall certify, under penalty of perjury, that: (1) Minutes submitted to the Interstate TRS Fund (Fund) administrator for compensation were handled in compliance with the Commission's rules and are not the result of impermissible financial incentives to generate calls, and (2) cost and demand data submitted to the Fund administrator related to the determination of compensation rates are true and correct.
(2) VRS providers shall: (a) Submit to the Commission and the TRS Fund administrator a call center report twice a year and (b) notify the Commission and the TRS Fund administrator at least 30 days prior to any change to their call centers' locations.
(3) VRS providers shall submit detailed call data records (CDRs) and speed of answer compliance data to the Fund administrator.
(4) TRS providers shall use an automated record keeping system to capture the CDRs and shall submit such data electronically in standardized form to the TRS Fund administrator.
(5) Internet-based TRS providers shall retain the CDRs that are used to support payment claims submitted to the Fund administrator for a minimum of five years, in an electronic format.
(6) VRS providers shall: (a) Maintain copies of all third-party contracts or agreements and make them available to the Commission and the TRS Fund administrator upon request; and (b) describe all agreements in connection with marketing and outreach activities in their annual submissions to the TRS Fund administrator.
(7) TRS providers shall provide information about their TRS whistleblower protections to all employees and contractors, in writing.
In 2018, the Commission released the IP CTS Modernization Order, published at 83 FR 30082, June 27, 2018, in which the Commission:
(1) Determined that it would transition the methodology for IP CTS cost recovery from the MARS plan to cost-based rates and adopted interim rates; and
(2) added two cost reporting requirements for IP CTS providers: (i) In annual cost data filings and supplementary information provided to the TRS Fund administrator, IP CTS providers that contract for the supply of services used in the provision of TRS, shall include information about payments under such contracts, classified according to the substantive cost categories specified by the TRS Fund administrator; and (ii) in the course of an audit or otherwise upon demand, IP CTS providers must make available any relevant documentation. 47 CFR 64.604(c)(5)(iii)(D)(1), (6).
In establishing rules requiring wireless providers to disable contraband wireless devices in correctional facilities and adopting a framework to enable designated correctional facility officials (DCFOs) relying on an authorized Contraband Interdiction System (CIS) to submit qualifying requests to wireless providers to disable contraband wireless devices in qualifying correctional facilities, the Commission found that a rules-based process will provide a valuable additional tool for departments of corrections to address contraband wireless device use. The framework includes a two-phase authorization process: (1) CIS applicants will submit applications to the Wireless Telecommunications Bureau (Bureau) describing the legal and technical qualifications of the systems; and (2) CIS applicants will perform on-site testing of approved CISs at individual correctional facilities and file a self-certification with the Commission. After both phases are complete, DCFOs will be authorized to submit qualifying requests to wireless providers to disable contraband devices using approved CISs at each correctional facility. In addition, the Commission adopted rules requiring wireless providers to notify certain types of CIS operators of major technical changes to ensure that CIS effectiveness is maintained. The Commission found that these rules will provide law enforcement with the tools necessary to disable contraband wireless devices, which, in turn, will help combat the serious threats posed by the illegal use of such devices.
The new information collection in 47 CFR 20.23(b)(1) regarding the application to obtain new CIS certification will be used by the Bureau to determine whether to certify a system and ensure that the systems are designed to support operational readiness and minimize the risk of disabling a non-contraband device, and ensure, to the greatest extent possible, that only devices that are in fact contraband will be identified for disabling. Bureau certification will also enable targeted industry review of solutions by allowing interested stakeholders to provide feedback on the application for certification, including the proposed test plan.
The new collections in 47 CFR 20.23(b)(3) include the requirement that the CIS operator must file with the Bureau a self-certification that complies with paragraph (b)(3)(ii) of section 20.23, confirming that the testing at that specific correctional facility is complete and successful, and the CIS operator must serve notice of the testing on all relevant wireless providers prior to testing and provide such wireless providers a reasonable opportunity to participate in the tests. Self-certification will help the Bureau to ensure that qualifying requests identify contraband wireless devices accurately and in accordance with legal requirements. In addition to being used by the Bureau, the self-certification will be relied upon by the DCFO in conjunction with qualifying requests for disabling at a particular correctional facility. The serving of notice to the wireless providers will give them awareness and an opportunity to participate in the process.
The new information collections in 47 CFR 20.23(b)(4) requires that wireless providers objecting to the certification filing submit objections to the Bureau within five business days and serve the DCFO and the CIS operator, which allows all stakeholders to participate in the process and raise objections. Section 20.23(b)(5) requires that CIS operators retest and recertify their systems at least every three years and comply with the same requirements as for initial self-certification. This requirement will enable the Bureau to ensure the ongoing accuracy and reliability of a given CIS at a particular facility. Section 20.23(b)(7) requires that a CIS operator retain records for at least five years and provide them upon request to the Bureau, which will support the Bureau's efforts to identify issues with CIS operations, resolve interference issues, and resolve complaints related to misidentification of contraband devices.
The new collections in 47 CFR 20.23(c)(1)-(2) include the requirement that individuals that seek to be recognized on the Commission's DCFO list must sent a letter to the Contraband Ombudsperson in order for the Commission to approve that person for the qualified DCFO list and provide certainty to wireless providers that disabling requests are made by duly authorized individuals. Qualifying requests that include the required information will be used by wireless carriers to prevent use of contraband devices on their network and on other wireless provider networks.
The new collections 47 CFR 20.23(c)(3)(iii)-(iv) provide that, upon receiving a disabling request from a DCFO, the wireless provider must verify the request, may reject the request and must notify the DCFO whether it is accepting or rejecting the request. This process ensures that a wireless provider responds to a DCFO within a reasonable timeframe—while giving the provider an opportunity to determine if there is an error—and to give the DCFO time to respond quickly if the request has been rejected. The wireless provider may contact the customer of record to notify them of the disabling and involve them in the process.
The new collections in 47 CFR 20.23(c)(4) provide that a wireless provider may reverse a disabled device where it determines that the device was erroneously identified as contraband, and the wireless provider must notify the DCFO of the reversal. The wireless provider may choose to involve the DCFO in the review and reversal process. The DCFO must also provide notice to the Contraband Ombudsperson of the number of erroneously disabled devices. This process ensures the integrity of the contraband device disabling process by giving the wireless provider the opportunity to reverse a disabled device—with the ability to extend review to the DCFO—and by creating safeguards to make sure that the process is efficient and reliable.
The new collections in 47 CFR 20.23(d) regarding notification from CMRS licensees to MAS operators of technical changes to their network are required so that MAS operators are given sufficient time to make necessary adjustments to maintain the effectiveness of their interdiction systems. In order to ensure that issues regarding notification to solutions providers of more frequent, localized wireless provider network changes are appropriately considered, CMRS licensees and MAS operators must negotiate in good faith to reach an agreement for notification for those
Federal Communications Commission.
Notice of a modified system of records.
The Federal Communications Commission (FCC, Commission, or Agency) proposes to modify an existing system of records, FCC-2, Business Contacts and Certifications, 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 modified system of records will become effective on December 2, 2021. Written comments on the routine uses are due by January 3, 2022. The routine uses will become effective on January 3, 2022, unless written comments are received that require a contrary determination.
Send comments to Margaret Drake, at
Margaret Drake, (202) 418-1707, or
FCC-2, BUSINESS CONTACTS AND CERTIFICATIONS.
Unclassified.
Federal Communications Commission (FCC), 45 L Street NE, Washington, DC, 20554; Universal Service Administrative Company, 700 12th Street NW, Suite 900, Washington, DC 20005; or FISMA compliant contractor.
Federal Communications Commission (FCC); Universal Service Administrative Company (USAC); or FISMA compliant contractor.
47 U.S.C. 151, 152, 155, 257, 303; and 5 U.S.C. 602(c) and 609(a)(3).
The FCC and organizations administering programs on behalf of the FCC use this system to collect and maintain points of contact at entities regulated by the FCC and in related industries, as well as contractors, vendors, and those performing collateral duties for the FCC, to ensure compliance with applicable federal laws and FCC rules through certifications of information provided to the Commission.
Individuals and businesses.
Contact information, such as name, username, signature, phone numbers, emails, and addresses, as well as work and educational history.
Information in this system is provided by individuals or businesses who serve as points of contact at FCC contractors, vendors, those providing collateral duties to the FCC, regulated entities, and in related industries or certify data on behalf of an entity.
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. Public Access—Information regarding points of contact at regulated entities and in related industries, as well as certifications made by individuals on behalf of an entity, may be made available for public inspection to comply with FCC regulations that require public disclosure of this information.
2. Third Parties—To third parties, including individuals and businesses in the communications industry, FCC vendors and their contractors, and other federal agencies to administer or support programs on behalf of the FCC.
3. 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.
4. Law Enforcement and Investigation—To disclose pertinent information to the appropriate Federal, State, local, tribal agency, or component of an agency, such as the FCC's Enforcement Bureau, responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, where the FCC becomes aware of an indication of a violation or potential violation of civil or criminal law or regulation.
5. 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.
6. Government-wide Program Management and Oversight—To provide information 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.
7. 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; 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.
8. 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.
9. Non-Federal Personnel—To disclose information to non-federal personnel, including contractors, who have been engaged to assist the FCC in the performance of a contract service, grant, cooperative agreement, or other activity related to this system of records and who need to have access to the records in order to perform their activity.
In each of these cases, the FCC will determine whether disclosure of the records is compatible with the purpose for which the records were collected.
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).
This an electronic system of records that resides on the FCC's network, USAC's network, or on an FCC vendor's network.
Records in this system of records can be retrieved by any category field,
The information in this system is maintained and disposed of in accordance with the National Archives and Records Administration (NARA) General Records Schedule 6.5, Item 020 (DAA-GRS-2017-0002-0002).
The electronic records, files, and data are stored within FCC, USAC, or a vendor's accreditation boundaries and maintained in a database housed in the FCC's, USAC's, or vendor's computer network databases. Access to the electronic files is restricted to authorized employees and contractors; and to IT staff, contractors, and vendors who maintain the IT networks and services. Other employees and contractors may be granted access on a need-to-know basis. The electronic files and records are protected by the FCC, USAC, and third-party privacy safeguards, a comprehensive and dynamic set of IT safety and security protocols and features that are designed to meet all Federal 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 access to and/or 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
None.
86 FR 40838 (July 29, 2021).
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than December 31, 2021.
1.
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than December 13, 2021.
1.
Office on Trafficking in Persons, Administration for Children and Families, Department of Health and Human Services (HHS).
Announcement of meeting and call for public comment on states' efforts to improve the nation's response to the sex trafficking of children and youth.
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on December 9 and 10, 2021. The purpose of the meeting is for the Committee to review state self-assessment survey responses and finalize their January 2022 report. The members of the Committee request comments from the public to inform their ongoing work and January 2022 report. Please submit your comments to
The meeting will be held on December 9 and 10, 2021.
The meeting will be held virtually. Please register for this event online at
Katherine Chon (Designated Federal Officer) at
The formation and operation on behalf of the Committee are governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App. 2), which sets forth standards for the formation and use of federal advisory committees.
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 January 31, 2022.
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 January 31, 2022. 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
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
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 to this collection are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These sponsors represent pharmaceutical, biologic, and medical device firms. Respondents are also clinical investigators who provide financial information to the sponsors of marketing applications.
Table 1 shows information that is the basis of the estimated number of respondents in tables 2 through 4.
FDA estimates the burden of this collection of information as follows:
Under § 54.4(a) (21 CFR 54.4(a)), applicants submitting an application that relies on clinical studies must submit a complete list of clinical investigators who participated in a covered clinical study, and must either certify to the absence of certain financial arrangements with clinical investigators (Form FDA 3454) or, under § 54.4(a)(3), disclose to FDA the nature of those arrangements and the steps taken by the applicant or sponsor to minimize the potential for bias (Form FDA 3455).
FDA estimates that almost all applicants submit a certification statement under § 54.4(a)(1) and (2). Preparation of the statement using Form FDA 3454 should require no more than 1 hour per study. The number of respondents is based on the estimated number of affected applications.
When certification is not possible and disclosure is made using Form FDA 3455, the applicant must describe, under § 54.4(a)(3), the financial arrangements or interests and the steps that were taken to minimize the potential for bias in the affected study. As the applicant would be fully aware of those arrangements and the steps taken to address them, describing them will be straightforward. The Agency estimates that it will take about 5 hours to prepare this narrative. Based on our experience with this collection, FDA estimates that approximately 10 percent of the respondents with affected applications will submit disclosure statements.
Under § 54.6 (21 CFR 54.6), the sponsors of covered studies must maintain complete records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for 2 years after the date of approval of the applications. Sponsors of covered studies maintain many
Under § 54.4(b), clinical investigators supply to the sponsor of a covered study financial information sufficient to allow the sponsor to submit complete and accurate certification or disclosure statements. Clinical investigators are accustomed to supplying such information when applying for research grants. Also, most people know the financial holdings of their immediate family and records of such interests are generally accessible because they are needed for preparing tax records. For these reasons, FDA estimates that the time required for this task may range from 5 to 15 minutes; we used the median, 10 minutes, for the average burden per disclosure (see table 1).
The burden for this information collection request has changed since the last OMB approval. Our estimated burden for the information collection reflects a 298 hour increase. We have adjusted our estimated burden for the information collection to reflect the number of submissions we received in the last few years. Additionally, for products regulated by the Center for Devices and Radiological Health, we now include De Novo requests as a type of application that may rely on clinical studies. For products regulated by the Center for Drug Evaluation and Research, we now include biologics license applications (BLAs) and BLA efficacy supplements that were inadvertently excluded from our last information collection request as a type of application.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of January 3, 2022.
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980,
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of January 3, 2022. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on January 3, 2022 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
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 January 31, 2022.
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 January 31, 2022. 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.
Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360n) is designed to encourage development of new drug or biological products for prevention and treatment of certain tropical diseases affecting millions of people throughout the world and makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease products. Section 524 of the FD&C Act serves to stimulate new drug development for drugs to treat a “tropical disease” (as defined in section 524(a)(3)) by offering additional incentives for obtaining FDA approval for pharmaceutical treatments for these diseases. Under section 524 of the FD&C Act, a sponsor of a “tropical disease product application,” as defined in section 524(a)(4), may be eligible for a voucher that can be used to obtain a priority review for any other application submitted under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 of the Public Health Service Act (PHS Act).
Accordingly, we have developed the guidance for industry entitled “Tropical Disease Priority Review Vouchers” (available at
The guidance also communicates that, under the FDA Reauthorization Act of 2017, section 524 requires attestation by the sponsor of eligibility for a priority review voucher upon submission of the marketing application.
We estimate the burden of this collection of information as follows:
Based on our evaluation of the information collection since last OMB review and approval, the burden estimate decreased based on receipt of fewer vouchers and other information collection activities.
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 January 31, 2022.
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 January 31, 2022. 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
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
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.
Section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) and § 101.93 (21 CFR 101.93) require that, no later than 30 days after the first marketing, we be notified by the manufacturer, packer, or distributor of a dietary supplement that it is marketing a dietary supplement product that bears on its label or in its
Our electronic form (Form FDA 3955) allows respondents to the information collection to electronically submit notifications to FDA via the Food Applications Regulatory Management (FARM) system. Firms that prefer to submit a paper notification in a format of their own choosing will still have the option to do so; however, Form FDA 3955 prompts respondents to include certain elements in their structure/function claim notification (SFCN) described in § 101.93 in a standard electronic format and helps respondents organize their SFCN to include only the information needed for our review of the claim. Note that the SFCN, whether electronic or paper, is used for all claims made pursuant to section 403(r)(6) of the FD&C Act, including nutrient deficiency claims and general well-being claims in addition to structure/function claims. The electronic form, and any optional elements prepared as attachments to the form (
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 no adjustments to our burden estimate. This estimate is based on our experience with this information collection and the number of notifications received in the past 3 years, which has remained constant.
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Request for nominations.
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the National Advisory Council on Migrant Health (NACMH or advisory committee). The NACMH advises, consults with, and makes recommendations to the HHS Secretary concerning the organization, operation, selection, and funding of Migrant Health Centers (MHCs) and other entities under grants and contracts under the Public Health Service (PHS) Act. HRSA is seeking nominations to fill seven positions on the NACMH.
HRSA will receive written nominations for NACMH membership on a continuous basis.
Nomination packages must be submitted in hard copy to the Designated Federal Official (DFO), NACMH, Strategic Initiatives Division, Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, 16N38B, 5600 Fishers Lane, Rockville, Maryland 20857.
All requests for information regarding NACMH nominations should be sent via email to Esther Paul, DFO, NACMH, HRSA at
NACMH was established and authorized under section 217 of the PHS Act (42 U.S.C. 218) to advise, consult with, and make recommendations to the HHS Secretary concerning the organization, operation, selection, and funding of MHCs and other entities under grants and contracts under section 330(g) of the PHS Act (42 U.S.C. 254b(g)). The NACMH meets twice each calendar year, or at the discretion of the DFO in consultation with the Chair.
The HHS Secretary appoints NACMH members with the expertise needed to fulfill the duties of the advisory committee. The membership requirements set-forth under section 217 of the PHS Act (42 U.S.C. 218) require that the NACMH consist of 15 members, at least 12 of whom shall be members of the governing boards of MHCs or other entities assisted under section 330(g) of the PHS Act (42 U.S.C. 254b(g)). Of these 12 board members, at least nine shall be individuals who are MHC patients and familiar with the delivery of health care to MSAWs. The remaining three NACMH members shall be individuals qualified by training and experience in the medical sciences or in the administration of health programs. New members filling a vacancy occurring prior to term expiration may serve only for the remainder of such term. Members may serve after term expiration until their successors take office, but no longer than 120 days. Nominees must reside in the United States, and international travel cannot be funded.
Individuals selected for appointment to the NACMH will be invited to serve for up to 4 years. Members appointed as SGEs receive a stipend and reimbursement for per diem and travel expenses incurred for attending NACMH meetings and/or conducting other business on behalf of the NACMH, as authorized by 5 U.S.C. 5703 for persons employed intermittently in government service.
The following information must be included in the package of materials submitted for each individual nominated for consideration: (1) NACMH nomination form, which can be requested by contacting the DFO at the email provided above; (2) three letters of reference; (3) a statement of prior service on the NACMH; and (4) a current copy of the nominee's curriculum vitae. Nomination packages may be submitted directly by the individual being nominated or by the person/organization recommending the candidate.
HHS endeavors to ensure that NACMH membership is fairly balanced in terms of points of view represented and that individuals from a broad representation of geographic areas, gender, and ethnic and minority groups, as well as individuals with disabilities, are considered for membership. Appointments shall be made without discrimination on the basis of age, ethnicity, gender, sexual orientation, or cultural, religious, or socioeconomic status.
Individuals under consideration for appointment will be required to provide detailed information regarding their financial holdings, consultancies, and research grants or contracts. Disclosure of this information is required in order for HRSA ethics officials to determine whether there is a potential conflict of interest between the SGE's public duties as a member of the NACMH and their private interests, including an appearance of a loss of impartiality as defined by federal laws and regulations, and to identify any required remedial action needed to address the potential conflict.
Substance Abuse and Mental Health Services Administration, HHS.
Notice.
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Anastasia Donovan, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N06B, Rockville, Maryland 20857; 240-276-2600 (voice);
In accordance with Section 9.19 of the Mandatory Guidelines, a notice listing all currently HHS-certified laboratories and IITFs is published in the
If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter.
This notice is also available on the internet at
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and of the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.
The Mandatory Guidelines using Urine were first published in the
The Mandatory Guidelines using Oral Fluid were first published in the
The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71 and allowed urine drug testing only. The Mandatory Guidelines using Urine have since been revised, and new Mandatory Guidelines allowing for oral fluid drug testing have been published. The Mandatory Guidelines require strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on specimens for federal agencies. HHS does not allow IITFs to conduct oral fluid testing.
To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.
Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines using Urine and/
In accordance with the Mandatory Guidelines using Oral Fluid dated October 25, 2019 (84 FR 57554), the following HHS-certified laboratories meet the minimum standards to conduct drug and specimen validity tests on oral fluid specimens:
At this time, there are no laboratories certified to conduct drug and specimen validity tests on oral fluid specimens.
In accordance with the Mandatory Guidelines using Urine dated January 23, 2017 (82 FR 7920), the following HHS-certified IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens:
In accordance with the Mandatory Guidelines using Urine dated January 23, 2017 (82 FR 7920), the following HHS-certified laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens:
* The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS' NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do.
Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (
Advisory Council on Historic Preservation.
Notice of Advisory Council on Historic Preservation quarterly business meeting.
Notice is hereby given that the Advisory Council on Historic Preservation (ACHP) will have its next quarterly meeting on Wednesday, December 15, 2021, starting at 1:30 p.m. EDT.
The quarterly meeting will take place on Wednesday, December 15, 2021 starting at 1:30 p.m. EDT.
Due to continuing COVID-related conditions, the meeting will take place using
Tanya DeVonish, 202-517-0205,
The Advisory Council on Historic Preservation (ACHP) is an independent federal agency that promotes the preservation, enhancement, and sustainable use of our nation's diverse historic resources, and advises the President and the Congress on national historic preservation policy. The goal of the National Historic Preservation Act (NHPA), which established the ACHP in 1966, is to have federal agencies act as responsible stewards of our nation's historic properties when making decisions that may affect them. The ACHP is the only entity with the legal responsibility to encourage federal agencies to factor historic preservation into their decision making. For more information on the ACHP, please visit our website at
The provisional agenda for the upcoming quarterly meeting of the ACHP is the following:
Department of Homeland Security, U.S. Citizenship and Immigration Services
Notice of a re-established matching program.
Pursuant to the Privacy Act of 1974, as amended by the Computer Matching and Privacy Protection Act of 1988 and the Computer Matching and Privacy Protections Amendment of 1990 (Privacy Act), and Office of Management and Budget (OMB) guidance on the conduct of matching programs, notice is hereby given of the re-establishment of a matching program between the Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) and the Massachusetts Department of Unemployment Assistance (MA-DUA). MA-DUA will match against DHS-USCIS data to verify the immigration status of non-U.S. citizens who apply for federal benefits (Benefit Applicants) under Unemployment Compensation (UC) that MA-DUA administers to determine whether Benefit Applicants possess the requisite immigration status to be eligible for the UC benefits it administers.
Please submit comments on the proposal by January 3, 2022. The matching program will be effective on January 3, 2022 unless comments have been received from interested members of the public that require modification and republication of the notice. The matching program will continue for 18 months from the beginning date and may be extended an additional 12 months if the conditions specified in 5 U.S.C. 552a(o)(2)(D) have been met.
You may submit comments, identified by docket number
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•
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To obtain additional information about this matching program and the contents of this Computer Matching Agreement between DHS-USCIS and MA-DUA, please view this Computer Matching Agreement at the following website:
DHS-USCIS provides this notice in accordance with the Privacy Act of 1974 (5 U.S.C. 552a), as amended by the Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503) and the Computer Matching and Privacy Protection Amendments of 1990 (Pub. L. 101-508) (Privacy Act); Office of Management and Budget (OMB) Final Guidance Interpreting the Provisions of Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988, 54 FR 25818 (June 19, 1989); and OMB Circular A-108, 81 FR 94424 (December 23, 2016).
Office of the Secretary, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Anna Guido, Management Analyst, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-5535 (this is not a toll-free number) or email at
Patrice Taylor Department of Housing and Urban Development, 451 7th Street SW, 10218, Washington, DC 20410; telephone 202-402-6104, (this is not a toll-free number). Copies of available documents submitted to OMB may be obtained from Anna Guido.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
U.S. Geological Survey, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act (PRA) of 1995, we, the U.S. Geological Survey (USGS) are proposing a new information collection.
Interested persons are invited to submit comments on or before January 31, 2022.
Send your comments on this information collection request (ICR) by mail to U.S. Geological Survey, Information Collections Officer, 12201 Sunrise Valley Drive, MS 159, Reston, VA 20192 or by email to
To request additional information about this ICR, contact Nicole Herman-Mercer by email at
In accordance with the PRA, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper performance of functions of the USGS; (2) will this information be processed and used in a timely manner; (3) is our estimate of the burden for this ICR accurate; (4) how might the USGS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the USGS minimize the burden of this collection on the respondents, including through the use 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 personally identifiable information (PII) in your comment, you should be aware that your entire comment—including your PII—may be made publicly available at any time. While you can ask us in your comment to withhold your PII from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the PRA (44 U.S.C. 3501
National Park Service, Interior.
Notice.
The National Park Service is soliciting electronic comments on the significance of properties nominated before November 20, 2021, for listing or related actions in the National Register of Historic Places.
Comments should be submitted electronically by December 17, 2021.
Comments are encouraged to be submitted electronically to
Sherry A. Frear, Chief, National Register of Historic Places/National Historic Landmarks Program, 1849 C Street NW, MS 7228, Washington, DC 20240,
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before November 20, 2021. Pursuant to Section 60.13 of 36 CFR part 60, comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
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.
Nominations submitted by State or Tribal Historic Preservation Officers:
Cleveland Apartments, (Historic Resources of Joplin, Missouri MPS), 801-807 West 1st St. and 104 North Jackson Ave., Joplin, MP100007261
A request for removal has been made for the following resource:
Additional documentation has been received for the following resource:
On the basis of the record
The Commission instituted this review on February 1, 2021 (86 FR 7743) and determined on May 7, 2021 that it would conduct a full review (86 FR 27477, May 20, 2021). Notice of the scheduling of the Commission's review and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made this determination pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determination in this review on November 29, 2021. The views of the Commission are contained in USITC Publication 5241 (November 2021), entitled
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission invites comments from the public on whether changed circumstances exist sufficient to warrant the institution of a review pursuant to the Tariff Act of 1930 (the Act) regarding the Commission's affirmative determination in investigation No. 731-TA-1296 (Final). The purpose of the proposed review is to determine whether revocation of the existing antidumping duty order on imports of hot-rolled steel flat products from Turkey is likely to lead to continuation or recurrence of material injury. The Commission further requests comments concerning the degree to which such a proceeding can be conducted in conjunction with the pending five-year review of the antidumping duty order on the same subject merchandise.
December 2, 2021.
Douglas Corkran (202-205-3057), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
On September 10, 2021, the Commission received a request to review its affirmative determination in investigation No. 731-TA-1296 (Final) pursuant to section 751(b) of the Act (19 U.S.C. 1675(b)). The request, filed by Eregli Demir ve Celik Fabrikalari T.A.S. (Erdemir), alleges there have been significant changed circumstances since the issuance of the Commission's 2016 determination. Specifically, Erdemir alleges that Commerce's recalculation of Colakoglu's antidumping duty margin to zero percent and its exclusion from the antidumping duty order as a result of judicial review constitute significantly changed circumstances from those in existence at the time of the original investigation because the facts underlying the Commission's negligibility determination completely changed. According to Erdemir, the exclusion of Colakoglu from the antidumping duty order places this case
The Commission further requests comments concerning the degree to which any changed circumstances proceeding concerning hot-rolled steel flat products from Turkey can be conducted in conjunction with the five-year review of the antidumping duty order on the same subject merchandise that Commerce has initiated and the Commission has instituted on September 1, 2021 (86 FR 49057). If the Commission initiates a changed circumstances review, the review is likely to be conducted on an overlapping basis with the five-year review concerning hot-rolled steel flat products from Turkey. Therefore, commenters are encouraged to address the nature of the respective inquiries, the data and other information necessary for the Commission's evaluation, and procedural considerations for the effective conduct of the reviews.
Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
By order of the Commission.
Drug Enforcement Administration, Department of Justice.
Final order.
This final order establishes the initial 2022 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
The initial 2022 aggregate production quotas and assessment of annual needs are effective December 2, 2021.
Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-2265.
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedule I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of the Drug Enforcement Administration (DEA) pursuant to 28 CFR 0.100.
The 2022 aggregate production quotas (APQ) and assessment of annual needs (AAN) represent those quantities of schedule I and II controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine that may be manufactured in the United States in 2022 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled substances for use in industrial processes.
On October 18, 2021, a notice titled “Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2022” was published in the
Within the public comment period, DEA received 610 comments from DEA registrants, chronic pain patients, pain advocacy associations, professional associations, doctors, nurses, State Attorneys General, and others. The comments included requests for clarification about the data DEA used to determine diversion for the purposes of the APQ for certain schedule II opioids; concerns about potential drug shortages due to further quota reductions; concerns that medical professionals might be impeded from exercising their medical expertise regarding opioid prescriptions; concerns about the quota process; requests for a public hearing; and comments not pertaining to DEA regulated activities.
Congress explicitly directed DEA to establish production quotas for controlled substances in schedule I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine. 21 U.S.C. 826(a). In recognition of FDA's related but distinct role in regulating pharmaceutical products, DEA's regulations require DEA to consider relevant information from FDA before DEA establishes the APQs. As DEA has acknowledged in previous
Additionally, DEA and FDA are required to, and routinely do, coordinate efforts to prevent or alleviate drug shortages pursuant to 21 U.S.C. 826(h). Such efforts may include adjusting the APQ, adjusting individual domestic manufacturers' quotas, FDA approval of additional market competitors, and coordination between the agencies to allow importation of foreign-manufactured drug products that meet FDA approval. For example, in 2020, DEA adjusted its quota to increase the aggregate production quota for drug products containing fentanyl, hydromorphone, morphine, and codeine, and the assessments of annual needs for drug products containing pseudoephedrine and ephedrine. The increased production needs for those substances, which are used to treat patients in intensive care units and those on ventilators, was a result of the COVID-19 public health emergency. These actions were taken based on DEA's consultations with federal partners at the Department of Health and Human Services (HHS), drug manufacturers, drug distributors, and hospital associations. Similarly, in 2018, a domestic shortage of injectable hydromorphone was alleviated through FDA and DEA collaboration to identify other dosage-form manufacturers with injectable hydromorphone products in the market, and to determine whether those other dosage-form manufacturers had the capability to increase their production levels to meet legitimate patient need in a timely manner. When the agencies determined that the domestic manufacturers could not increase production adequately to meet legitimate patient need, DEA and FDA coordinated and used their respective regulatory authorities to allow for the limited importation of injectable hydromorphone into the United States.
However, DEA also considers other relevant factors, as required by regulation, when determining the APQ. 21 U.S.C. 826(a), 21 CFR 1303.11(b). DEA's consideration of all of these relevant factors resulted in the proposed 2022 APQ as published.
FDA provides an important portion of the data that DEA analyzes in developing the annual APQs, but DEA also utilizes other data sources to meet its statutory and regulatory requirements. For instance, DEA utilized information provided by quota applicants and research protocols submitted directly to DEA to derive the estimates of scientific, research, and industrial needs; lawful export requirements; and current reserve stocks. No single data element is adequate to address all of the legal factors.
DEA did receive additional quota applications from DEA-registered manufacturers for 5-MEO-DMT, psilocybin, and MDMA. DEA considered those applications accordingly, as discussed below. DEA has not received quota applications from DEA-registered manufacturers to support the requested changes in the APQ for the other controlled substances mentioned.
DEA received comments that are outside the scope of this order. The comments were general in nature and raised issues of specific medical illnesses, medical treatments, and medication costs. These comments do not impact the analysis involved in establishing the 2022 APQ.
In determining the established 2022 aggregate production quotas and assessment of annual needs, DEA has considered the above comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a). These factors include, but are not limited to, the 2021 manufacturing quotas, current 2021 sales and inventories, anticipated 2022 export requirements, industrial use, additional applications for 2022 quotas, and information on research and product development requirements.
Based on all of the above, the Administrator establishes the 2022 APQ for 5-MEO-DMT, DMT, lisdexamfetamine, MDMA, phenylacetone, psilocybin, and psilocin at higher levels than was proposed.
DEA has determined that the proposed APQs for D-amphetamine (for conversion), dexmethylphenidate (for sale), methadone, methadone intermediate, methylphenidate (for sale), noroxymorphone (for conversion), and remifentanil are sufficient to provide for the 2022 estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these APQ at the same amounts as proposed.
As specified in the proposal, and as required by 21 U.S.C. 826(i), DEA calculated a national diversion estimate for each of the covered controlled substances.
DEA solicited PDMP data through NASCSA from state PDMP Administrators. Based on the data received, DEA considered the number of individuals who received a prescription for a covered controlled substance that met any of the three diversion metrics (“red flags”) mentioned in the October 18, 2021, notice for each of calendar years 2018-20. That number was then compared to the corresponding population for the states responding to DEA's request in order to estimate a percentage of the population issued a prescription meeting one of the red flag metrics. Using this estimated percentage for 2018-20, DEA analyzed trends in the data to predict the estimated percentage of patients who would be expected to meet these diversion metrics for 2022.
DEA also reviewed aggregate sales data for each of the covered controlled substances, which it extracted from IQVIA's National Sales Perspective.
DEA multiplied the forecasted percentage of patients who received a prescription for a covered controlled substance that met any of the three diversion-related metrics for 2022 by the forecasted sales data from IQVIA for 2022 to estimate diversion for each of the covered controlled substances. This data, which remains unchanged, was published in the Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2022, and contributed to the final diversion estimates for covered controlled substances, as set forth in Table 3.
DEA extracted data from its Drug Theft and Loss database and categorized it by basic class. The quantity of active pharmaceutical ingredient (API) in each dosage form was determined, and then the quantity of API of each covered controlled substance was aggregated by metric weight where the data was available. DEA calculated the estimated amount of diversion by multiplying the strength of the API listed for each finished dosage form by the total amount of units reported to estimate the metric weight in grams of the controlled substance being diverted. The estimate of diversion for each of the covered controlled substances, which does not contain any loss reported due to fire, weather, or other disaster, is displayed in Table 2. This data contributed to the final diversion estimates for covered controlled substances, as set forth in Table 3.
DEA's estimate of diversion for the five covered controlled substances was calculated by combining the diversion estimates from the state PDMP data and the supply chain diversion data. DEA reduced the aggregate production quotas for each covered controlled substance by the resulting quantities listed in Table 3.
In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes the 2022 APQ for the following schedule I and II controlled substances and the 2022 AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:
The Administrator also establishes APQ for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Administrator may adjust the 2022 APQ and AAN as needed.
On November 15, 2021, a proposed Stipulation Resolving the General
The proposed Stipulation resolves a proof of claim filed by the United States, on behalf of the Environmental Protection Agency (EPA), against Debtor Exide Technologies, LLC under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) with respect to the Portland Harbor Superfund Site (“Portland Harbor”) in Portland, Oregon; the Wiley's Bridge Lead Site (“Wiley's Bridge”) in Reading, Pennsylvania; the Brown's Battery Breaking Superfund Site (“Brown's Battery”) in Shoemakersville, Berks County, Pennsylvania; and the Reading Battery and Residential Sites (“Reading”) in Reading, Pennsylvania.
The proposed Stipulation provides EPA with an allowed claim of $17,569,392.16 allocated among the following sites: (a) $825,000 for Portland Harbor; $4,273,189.16 for Wiley's Bridge; (c) $471,203 for Brown's Battery; and (d) $12,000,000 for Reading.
The publication of this notice opens a period for public comment on the Stipulation. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division and should refer to
Comments may be submitted either by email or by mail:
During the public comment period, the Stipulation may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $2.00 (25 cents per page reproduction cost) payable to the United States Treasury.
Office of Attorney Recruitment and Management, Justice Management Division, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Justice Management Division, Office of Attorney Recruitment and Management (OARM), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
The Department of Justice encourages public comment and will accept input until January 31, 2022.
If you have additional comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Deana Willis, Assistant Director, Office of Attorney Recruitment and Management, 450 5th Street NW, Suite 10200, Washington, DC 20530;
Written comments and/or suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Office of Attorney Recruitment and Management, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Evaluate whether, and if so, how, the quality, utility, and clarity of the information to be collected can be enhanced; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995 requires federal agencies to publish a notice in the
Submit comments on or before January 31, 2022.
Send all comments via email to
Adrienne Grierson, Deputy Director Office of Financial Program Operations, 202-205-6573,
Section 1102 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, authorized SBA to guarantee loans made by banks or other financial institutions under a temporary program titled the “Paycheck Protection Program” (PPP). These loans were available to eligible small businesses, certain non-profit organizations, veterans' organizations, Tribal business concerns, independent contractors, and self-employed individuals adversely affected by the COVID-19 Emergency. SBA's authority to guarantee PPP loans expired on August 8, 2020. On December 27, 2020, SBA received reauthorization under the Economic Aid Act, Public Law 116-260, to resume guaranteeing PPP loans through March 31, 2021. The Economic Aid Act also allowed certain eligible borrowers that previously received a PPP loan to receive a Second Draw PPP loan and amended certain other PPP statutory provisions. On March 11, 2021, the American Rescue Plan Act, Public Law 117-2, was enacted, amending various PPP statutory provisions. On March 30, 2021, the PPP Extension Act of 2021 was enacted, extending the SBA's PPP program authority through June 30, 2021.
Since the initial approval of this information collection, the information collection has been revised to meet the ever-evolving needs of the PPP program, as necessitated by statutory program amendments, public feedback, or other factors. The information collection is currently approved under the emergency procedures authorized by 5 U.S.C. 3507(j) and 5 CFR 1320.13; this approval is set to expire on January 31, 2022.
Although SBA's PPP program authority has expired, this information collection is still needed for the following reasons: (1) PPP borrowers may apply for forgiveness of their loans up to the date of loan maturity, which may be as late as 2026; (2) SBA may review a PPP loan at any time; and (3) pending litigation may require the collection of information. Therefore, as required by the Paperwork Reduction Act, SBA is publishing this notice as a prerequisite to seeking OMB's approval to use this information collection beyond January 31, 2022. There are no proposed changes to any of the information to be submitted by lenders or borrowers.
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SBA invites the public to submit comments, including specific and detailed suggestions on ways to improve the collection and reduce the burden on respondents. Commenters should also address (i) whether the collection of information is necessary for the agency to properly perform its functions, including whether it has any practical utility; (ii) whether the burden estimates are accurate; (iii) whether there are ways to minimize the information collection burden on those who are required to respond, including through the use of automated techniques or other forms of information technology; and (iv) whether there are ways to enhance the quality, utility, and clarity of the information to be collected.
State Justice Institute.
Notice of meeting.
The SJI Board of Directors will be meeting on Monday, December 6, 2021 at 1:00 p.m. ET. The purpose of this meeting is to consider grant applications for the 1st quarter of FY 2022, and other business.
Jonathan Mattiello, Executive Director, State Justice Institute, 12700 Fair Lakes Circle, Suite 340, Fairfax, VA 22033, 703-660-4979,
Office of the United States Trade Representative (USTR).
Notice.
On October 8, 2021, India joined the United States and 134 other jurisdictions participating in the OECD/G20 Inclusive Framework on Base Erosion and Profit Shifting in reaching a political agreement on a two-pillar solution to address tax challenges arising from the digitalization of the world economy. As part of Pillar 1, all
The additional duties on products of India are terminated as of November 28, 2021.
For questions concerning this notice, please contact Benjamin Allen, Thomas Au, Patrick Childress, or Kate Hadley, Assistant General Counsels at (202) 395-9439, (202) 395-0380, (202) 395-9531, and (202) 395-3911, respectively, Robert Tanner, Director, Services and Investment at (202) 395-6125, or Brendan Lynch, Deputy Assistant U.S. Trade Representative for South and Central Asian Affairs at (202) 395-2851.
This investigation is addressed to India's 2020 “equalisation levy”, which is referred to throughout the investigation as India's DST.
On June 2, 2021, the U.S. Trade Representative determined to take action in the form of additional duties on certain products of India and to immediately suspend those additional duties for up to 180 days. 86 FR 30356 (June 7, 2021).
One-hundred forty-one jurisdictions are engaged in international tax negotiations under the OECD/G20 Inclusive Framework on Base Erosion and Profit Shifting. On October 8, 2021, India joined the United States and 134 other participants in reaching political agreement on a Statement on a Two-Pillar Solution to Address the Tax Challenges Arising from the Digitalisation of the Economy. OECD/G20 Base Erosion and Profit Shifting Project,
The Multilateral Convention (MLC) will require all parties to remove all Digital Services Taxes and other relevant similar measures with respect to all companies, and to commit not to introduce such measures in the future. No newly enacted Digital Services Taxes or other relevant similar measures will be imposed on any company from 8 October 2021 and until the earlier of 31 December 2023 or the coming into force of the MLC. The modality for the removal of existing Digital Services Taxes and other relevant similar measures will be appropriately coordinated.
On November 24, 2021, The Ministry of Finance of the Government of India and Treasury issued statements reflecting a political agreement on a transitional approach to India's DST while implementing Pillar 1.
Section 307 of the Trade Act of 1974, as amended (Trade Act) (19 U.S.C. 2417), provides that “[t]he 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] of this title if . . . such action is being taken under section [301(b)] of this title and is no longer appropriate.” The U.S. Trade Representative has found that the political agreement of India to the OECD/G20 Two-Pillar Solution, which provides for the removal of DSTs upon entry into force of Pillar 1, and the transitional approach agreed to by India provide a satisfactory resolution of the matters covered by the section 301 investigation of India's DST. Accordingly, pursuant to section 307 of the Trade Act, the U.S. Trade Representative has determined that the suspended trade action in this investigation is no longer appropriate and that the action should be terminated.
The U.S. Trade Representative's determination was made in consultation with Treasury and considers the advice of the interagency Section 301 Committee, consultations with representatives of the domestic industry concerned, and public comments and advisory committee advice received during the investigations.
In order to implement the termination of the section 301 action in the investigation of India's DST, subchapter III of chapter 99 of the Harmonized Tariff Schedule of the United States (HTSUS) is modified by the Annex to this notice.
Section 306(a) of the Trade Act (19 U.S.C. 2416(a)) provides that “[t]he Trade Representative shall monitor the implementation of each measure undertaken, or agreement that is entered into, by a foreign country to provide a satisfactory resolution of a matter subject to investigation. . . .” Section 306(b) (19 U.S.C. 2416(b)) provides that “[i]f, on the basis of the monitoring
The U.S. Trade Representative has decided to terminate the additional duties under heading 9903.90.03 of the HTSUS on articles the product of India, as provided for in U.S. notes 24(a) and 24(b) to subchapter III of chapter 99 of the HTSUS. The termination of these additional duties is effective on November 28, 2021.
In accordance with this determination, the U.S. Trade Representative has determined to modify the HTSUS by: (1) Deleting U.S. notes 24(a) and 24(b) to subchapter III of chapter 99 of the HTSUS; and (2) by deleting HTSUS heading 9903.90.03. The modifications of the HTSUS are effective on November 28, 2021. Any provisions of previous notices issued in this investigation that are inconsistent with this notice are superseded to the extent of such inconsistency.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of availability; request for comments.
This notice announces the availability of the proposed aircraft master schedule for the standardized curricula for certain air carriers and operators whose pilots receive training from FAA-certificated training centers. The FAA invites public comment.
The FAA must receive comments on these proposed documents by December 22, 2021.
You may send comments identified by docket number FAA-2021-0910 using any of the following methods:
Joshua Tarkington, Flight Standards, Air Transportation Division, Training and Simulation Group (AFS-280),
The standardized curriculum concept for Title 14 Code of Federal Regulations (14 CFR) part 135 training provided by part 142 training centers is a voluntary approach to training. Additional information about standardized curricula is available in Advisory Circular (AC) 142-1, Standardized Curricula Delivered by Part 142 Training Centers.
The FAA tasked the Aviation Rulemaking Advisory Committee (ARAC) in March 2020, which was further designated to the Training Standardization Working Group (TSWG), with providing advice and recommendations to the ARAC on the most effective ways to achieve standardization (where appropriate) and significant administrative efficiency in check pilot qualification, flight instructor qualification, and part 135 air carrier training curricula delivered by part 142 training centers, known as the Standardized Curriculum Concept. TSWG membership includes representatives from training centers, aircraft manufacturers, operators, and aviation industry organizations.
Standardized curricula will provide a common method for quality training accessible to any certificate holder that obtains approval to use the curriculum in its FAA-approved training program. The Standardized Curriculum Concept aims to provide an efficient means to approve training curricula offered by part 142 training centers while increasing the consistency of training, testing, and checking delivered to part 135 operators. The use of standardized curricula is strictly voluntary and is one means to comply with the applicable regulatory requirements of parts 135 and 142. The standardized curriculum does not modify existing regulatory requirements for pilot training or qualification.
One of the tasks to the ARAC included the following:
• Development of a master schedule that lists the priority of aircraft or series of aircraft for standardized curriculum development.
In order to determine a prioritized list of aircraft for which a standardized curriculum would be appropriate, the working group reviewed training data from centers that represent approximately 80% of air carrier training events. The TSWG chose this methodology to provide a valid sampling of training centers and preferred aircraft training platforms. The group reviewed the aircraft-specific data and ranked the highest density training events to the lowest. This approach ensured the aircraft priority matched industry demand.
The FAA invites public comments on the TSWG proposed Standardized Curricula for Part 135 Delivered by Part 142 Training Centers, Aircraft Master Schedule. The FAA will consider the public comments submitted during this
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of availability; request for comments.
This notice announces the availability of the proposed standardized curricula for instructor and check pilot qualifications for certain air carriers. This curriculum may be delivered by FAA-certificated training centers. The FAA invites public comment.
The FAA must receive comments on these proposed documents by December 22, 2021.
You may send comments identified by docket number FAA-2021-0909 using any of the following methods: Mail: U.S. Department of Transportation (DOT), Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
Joshua Tarkington, Flight Standards, Air Transportation Division, Training and Simulation Group (AFS-280),
The standardized curriculum concept for Title 14 Code of Federal Regulations (14 CFR) part 135 training provided by part 142 training centers is a voluntary approach to training. Additional information about standardized curricula is available in Advisory Circular (AC) 142-1, Standardized Curricula Delivered by Part 142 Training Centers.
The FAA tasked the Aviation Rulemaking Advisory Committee (ARAC) in March 2020, which was further designated to the Training Standardization Working Group (TSWG), with providing advice and recommendations to the ARAC on the most effective ways to achieve standardization (where appropriate) and significant administrative efficiency in check pilot qualification, flight instructor qualification, and part 135 air carrier training curricula delivered by part 142 training centers, known as the Standardized Curriculum Concept. TSWG membership includes representatives from training centers, aircraft manufacturers, operators, and aviation industry organizations.
Standardized curricula will provide a common method for quality training accessible to any certificate holder that obtains approval to use the curriculum in its FAA-approved training program. The Standardized Curriculum Concept aims to provide an efficient means to approve training curricula offered by part 142 training centers while increasing the consistency of training, testing, and checking delivered to part 135 operators. The use of standardized curricula is strictly voluntary and is one means to comply with the applicable regulatory requirements of parts 135 and 142. The standardized curriculum does not modify existing regulatory requirements for pilot training or qualification.
One of the tasks to the ARAC included the following: Development of Instructor and Check Pilot Qualification Curriculum for standardized curriculum.
In response to that task, the TSWG developed a recommended curriculum, the Instructor/Check Pilot Standardized Curriculum, as a means to meet the requirements in part 135 for qualifying instructors and check pilots approved for use at a part 142 training center. This recommended curriculum tracks with the regulatory requirements for qualification as a 14 CFR part 135 instructor or check pilot, and includes the curriculum and subjects necessary to complete:
The FAA invites public comments on the TSWG proposed Standardized Curricula for Part 135 Delivered by Part 142 Training Centers, Instructor/Check Pilot Qualification Curriculum. The FAA will consider the public comments submitted during this comment period in finalizing the Instructor/Check Pilot Qualification Curriculum.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to exempt eight 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 November 19, 2021. The exemptions expire on November 19, 2023.
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 regulatory process. DOT posts these comments, without edit, including any personal information the commenter provides, to
On October 19, 2021, FMCSA published a notice announcing receipt of applications from eight individuals requesting an exemption from vision requirement in 49 CFR 391.41(b)(10) and requested comments from the public (86 FR 57887). The public comment period ended on November 18, 2021, and no comments were 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 no comments in this proceeding.
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 October 19, 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 eight 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, macular scar, prosthesis, 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 three individuals that developed their vision conditions as adults have had them for a range of 11 to 21 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 substantial driving on highways on the interstate system and on other roads built to interstate standards. Moreover, driving in congested urban areas exposes the driver to more pedestrian and vehicular traffic than exists on interstate highways. Faster reaction to traffic and traffic signals is generally required because distances between them are more compact. These conditions tax visual capacity and driver response just as intensely as interstate driving conditions.
The applicants in this notice have driven CMVs with their limited vision in careers ranging for 3 to 68 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
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 eight 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).
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (“OFAC”) is updating the identifying information on its Specially Designated Nationals and Blocked Persons List (“SDN List”) for a person whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism,” as amended by Executive Order 13886 of September 9, 2019, “Modernizing Sanctions to Combat Terrorism”.
See
The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website (
1. On October 26, 2021, OFAC published the following revised information for the following person on OFAC's SDN List whose property and interests in property are blocked pursuant to Executive Order 13224, as amended.
1. ISMAIL, Talib Husayn Ali Jarak (a.k.a. ESMAEL, Taleb H. A. J.), Block 8, Street 20, House No. 33, Jabriya, Kuwait; Street 21, Salem Al Mubarak Avenue, Block 20, Building 13, Salmiya, Kuwait; P.O. Box 3390, Safat 13034, Kuwait City, Kuwait; P.O. Box 126, Safat 13002, Kuwait City, Kuwait; Block 8, Street 103, Building 33, Apartment 33, Jabriya, Kuwait; Mubarak Al Kabir, Darwaza abdul Razak Square, Kuwait City, Kuwait; DOB 30 Apr 1956; POB Kuwait City, Kuwait; nationality Kuwait; Gender Male (individual) [SDGT] (Linked To: HIZBALLAH).
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning the VITA/TCE (Volunteer Income Tax Assistance/Tax Counseling for the Elderly) Volunteer Program.
Written comments should be received on or before January 31, 2022 to be assured of consideration.
Direct all written comments to Paul Adams, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224. Requests for additional information or copies of the form and instructions should be directed to Sara Covington, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or at (737)800-6149 or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.