Agricultural Marketing Service
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Air Force Department
Army Department
Energy Information Administration
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Land Management Bureau
Antitrust Division
Drug Enforcement Administration
Employee Benefits Security Administration
Employment and Training Administration
Veterans Employment and Training Service
Copyright Royalty Board
National Endowment for the Humanities
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Federal Transit Administration
Maritime Administration
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.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Consumer Financial Protection Bureau.
Final rule; official interpretation.
The Consumer Financial Protection Bureau (CFPB) is amending the official commentary that interprets the requirements of the CFPB's Regulation C (Home Mortgage Disclosure) to reflect the asset-size exemption threshold for banks, savings associations, and credit unions based on the annual percentage change in the average of the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Based on the 4.1 percent increase in the average of the CPI-W for the 12-month period ending in November 2023, the exemption threshold is adjusted to $56 million from $54 million. Therefore, banks, savings associations, and credit unions with assets of $56 million or less as of December 31, 2023, are exempt from collecting data in 2024.
This rule is effective on January 1, 2024.
Anna Boadwee and Adrien Fernandez, Attorney-Advisors, Office of Regulations, at (202) 435-7700. If you require this document in an alternative electronic format, please contact
The CFPB is amending Regulation C, which implements the Home Mortgage Disclosure Act of 1975 (HMDA) asset thresholds, to establish the asset-sized exemption threshold for depository financial institution for 2024. The asset threshold will be $56 million for 2024.
HMDA requires most mortgage lenders located in metropolitan areas to collect data about their housing-related lending activity.
Prior to 1997, HMDA exempted certain depository institutions as defined in HMDA (
The definition of “financial institution” in § 1003.2(g) provides that the CFPB will adjust the asset threshold based on the year-to-year change in the average of the CPI-W, not seasonally adjusted, for each 12-month period ending in November, rounded to the nearest $1 million. For 2023, the threshold was $54 million. During the 12-month period ending in November 2023, the average of the CPI-W increased by 4.1 percent. As a result, the exemption threshold is increased to $56 million for 2024. Thus, banks, savings associations, and credit unions with assets of $56 million or less as of December 31, 2023, are exempt from collecting data in 2024. An institution's exemption from collecting data in 2024 does not affect its responsibility to report data it was required to collect in 2023.
Under the Administrative Procedure Act (APA), notice and opportunity for public comment are not required if the CFPB finds that notice and opportunity for public comment are impracticable, unnecessary, or contrary to the public interest.
Section 553(d) of the APA generally requires publication of a final rule not less than 30 days before its effective date, except in the case of (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule.
The Regulatory Flexibility Act (RFA) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
In accordance with the Paperwork Reduction Act of 1995,
Pursuant to the Congressional Review Act, the CFPB will submit a report containing this rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to the rule taking effect.
Banks, banking, Credit unions, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations.
For the reasons set forth above, the CFPB amends Regulation C, 12 CFR part 1003, as set forth below:
12 U.S.C. 2803, 2804, 2805, 5512, 5581.
1.
2.
i. Two institutions that are not covered merge. The surviving or newly formed institution meets all of the requirements necessary to be a covered institution. No data collection is required for the calendar year of the merger (even though the merger creates an institution that meets all of the requirements necessary to be a covered institution). When a branch office of an institution that is not covered is acquired by another institution that is not covered, and the acquisition results in a covered institution, no data collection is required for the calendar year of the acquisition.
ii. A covered institution and an institution that is not covered merge. The covered institution is the surviving institution, or a new covered institution is formed. For the calendar year of the merger, data collection is required for covered loans and applications handled in the offices of the merged institution that was previously covered and is optional for covered loans and applications handled in offices of the merged institution that was previously not covered. When a covered institution acquires a branch office of an institution that is not covered, data collection is optional for covered loans and applications handled by the acquired branch office for the calendar year of the acquisition.
iii. A covered institution and an institution that is not covered merge. The institution that is not covered is the surviving institution, or a new institution that is not covered is formed. For the calendar year of the merger, data collection is required for covered loans and applications handled in offices of the previously covered institution that took place prior to the merger. After the merger date, data collection is optional for covered loans and applications handled in the offices of the institution that was previously covered. When an institution remains not covered after acquiring a branch office of a covered institution, data collection is required for transactions of the acquired branch office that take place prior to the acquisition. Data collection by the acquired branch office is optional for transactions taking place in the remainder of the calendar year after the acquisition.
iv. Two covered institutions merge. The surviving or newly formed institution is a covered institution. Data collection is required for the entire calendar year of the merger. The surviving or newly formed institution files either a consolidated submission or separate submissions for that calendar year. When a covered institution acquires a branch office of a covered institution, data collection is required for the entire calendar year of the merger. Data for the acquired branch office may be submitted by either institution.
Consumer Financial Protection Bureau.
Final rule; official interpretation.
The Consumer Financial Protection Bureau (CFPB) is amending the official commentary to its Regulation Z in order to make annual adjustments to the asset-size thresholds exempting certain creditors from the requirement to establish an escrow account for a higher-priced mortgage loan (HPML). These changes reflect updates to the exemption from the escrow requirement in the Truth in Lending Act (TILA) for creditors that, together with their affiliates that regularly extended covered transactions secured by first liens, had total assets of less than $2 billion (adjusted annually for inflation). They also reflect updates to the exemption the CFPB added, by implementing section 108 of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA), for certain insured depository institutions and insured credit unions with assets of $10 billion or less (adjusted annually for inflation). These amendments are based on the annual percentage change in the average of the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Based on the 4.1 percent increase in the average of the CPI-W for the 12-month period ending in November 2023, the exemption threshold for creditors and their affiliates that regularly extended covered transactions secured by first liens is adjusted to $2.640 billion from $2.537 billion and the exemption threshold for certain insured depository institutions and insured credit unions with assets of $10 billion or less is adjusted to $11.835 billion from $11.374 billion.
This rule is effective on January 1, 2024.
Anna Boadwee and Adrien Fernandez, Attorney-Advisors, Office of Regulations, at (202) 435-7700. If you require this document in an alternative electronic format, please contact
Section 129D of TILA generally requires creditors to establish escrow accounts for certain first-lien higher-priced mortgage loan transactions. However, TILA section 129D also permits the CFPB to exempt creditors from this higher-priced mortgage loan escrow requirement if they meet certain requirements, including any asset-size threshold that the CFPB may establish.
In the 2013 Escrows Final Rule,
During the 12-month period ending in November 2023, the average of the CPI-W increased by 4.1 percent. As a result, the exemption threshold is increased to $2.640 billion for 2024.
In the 2018 Economic Growth, Regulatory Relief, and Consumer
During the 12-month period ending in November 2023, the average of the CPI-W increased by 4.1 percent. As a result, the exemption threshold is increased to $11.835 billion for 2024.
Under the Administrative Procedure Act (APA), notice and opportunity for public comment are not required if the CFPB finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). Pursuant to this final rule, comment 35(b)(2)(iii)-1 in Regulation Z is amended to update the exemption threshold in § 1026.35(b)(2)(iii) and comment 35(b)(2)(vi)(A)-1 in Regulation Z is amended to update the exemption threshold in § 1026.35(b)(2)(vi). The amendments in this final rule are technical and merely apply the formulae previously established in Regulation Z for determining any adjustments to the exemption thresholds. For these reasons, the CFPB has determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary. Therefore, the amendments are adopted in final form.
Section 553(d) of the APA generally requires publication of a final rule not less than 30 days before its effective date, except (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule. 5 U.S.C. 553(d). At a minimum, the CFPB has determined the amendments fall under the third exception to section 553(d). The CFPB finds that there is good cause to make the amendments effective on January 1, 2024. The amendment in this final rule is technical and non-discretionary, and it merely applies the method previously established in the agency's regulations for automatic adjustments to the threshold.
The Regulatory Flexibility Act (RFA) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
In accordance with the Paperwork Reduction Act of 1995,
Pursuant to the Congressional Review Act (5 U.S.C. 801
Advertising, Banks, banking, Consumer protection, Credit, Credit unions, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations, Truth-in-lending.
For the reasons set forth above, the CFPB amends Regulation Z, 12 CFR part 1026, as set forth below:
12 U.S.C. 2601, 2603-2605, 2607, 2609, 2617, 3353, 5511, 5512, 5532, 5581; 15 U.S.C. 1601
1.
i. During the preceding calendar year, or during either of the two preceding calendar years if the application for the
A. In general, whether the rural-or-underserved test is satisfied depends on the creditor's activity during the preceding calendar year. However, if the application for the loan in question was received before April 1 of the current calendar year, the creditor may instead meet the rural-or-underserved test based on its activity during the next-to-last calendar year. This provides creditors with a grace period if their activity meets the rural-or-underserved test (in § 1026.35(b)(2)(iii)(A)) in one calendar year but fails to meet it in the next calendar year.
B. A creditor meets the rural-or-underserved test for any higher-priced mortgage loan consummated during a calendar year if it extended a first-lien covered transaction in the preceding calendar year secured by a property located in a rural-or-underserved area. If the creditor does not meet the rural-or-underserved test in the preceding calendar year, the creditor meets this condition for a higher-priced mortgage loan consummated during the current calendar year only if the application for the loan was received before April 1 of the current calendar year and the creditor extended a first-lien covered transaction during the next-to-last calendar year that is secured by a property located in a rural or underserved area. The following examples are illustrative:
ii. The creditor and its affiliates together extended no more than 2,000 covered transactions, as defined in § 1026.43(b)(1), secured by first liens, that were sold, assigned, or otherwise transferred by the creditor or its affiliates to another person, or that were subject at the time of consummation to a commitment to be acquired by another person, during the preceding calendar year or during either of the two preceding calendar years if the application for the loan was received before April 1 of the current calendar year. For purposes of § 1026.35(b)(2)(iii)(B), a transfer of a first-lien covered transaction to “another person” includes a transfer by a creditor to its affiliate.
A. In general, whether this condition is satisfied depends on the creditor's activity during the preceding calendar year. However, if the application for the loan in question is received before April 1 of the current calendar year, the creditor may instead meet this condition based on activity during the next-to-last calendar year. This provides creditors with a grace period if their activity falls at or below the threshold in one calendar year but exceeds it in the next calendar year.
B. For example, assume that in 2015 a creditor and its affiliates together extended 1,500 loans that were sold, assigned, or otherwise transferred by the creditor or its affiliates to another person, or that were subject at the time of consummation to a commitment to be acquired by another person, and 2,500 such loans in 2016. Because the 2016 transaction activity exceeds the threshold but the 2015 transaction activity does not, the creditor satisfies this condition for exemption for a higher-priced mortgage loan consummated during 2017 if the creditor received the application for the loan before April 1, 2017, but does not satisfy this condition for a higher-priced mortgage loan consummated during 2017 if the application for the loan was received on or after April 1, 2017.
C. For purposes of § 1026.35(b)(2)(iii)(B), extensions of first-lien covered transactions, during the applicable time period, by all of a creditor's affiliates, as “affiliate” is defined in § 1026.32(b)(5), are counted toward the threshold in this section. “Affiliate” is defined in § 1026.32(b)(5) as “any company that controls, is controlled by, or is under common control with another company, as set forth in the Bank Holding Company Act of 1956 (12 U.S.C. 1841
iii. As of the end of the preceding calendar year, or as of the end of either of the two preceding calendar years if the application for the loan was received before April 1 of the current calendar year, the creditor and its affiliates that regularly extended covered transactions secured by first liens, together, had total assets that are less than the applicable annual asset threshold.
A. For purposes of § 1026.35(b)(2)(iii)(C), in addition to the creditor's assets, only the assets of a creditor's “affiliate” (as defined by § 1026.32(b)(5)) that regularly extended covered transactions (as defined by § 1026.43(b)(1)) secured by first liens, are counted toward the applicable annual asset threshold.
B. Only the assets of a creditor's affiliate that regularly extended first-lien covered transactions during the applicable period are included in calculating the creditor's assets. The meaning of “regularly extended” is based on the number of times a person extends consumer credit for purposes of the definition of “creditor” in § 1026.2(a)(17). Because covered transactions are “transactions secured by a dwelling,” consistent with § 1026.2(a)(17)(v), an affiliate regularly extended covered transactions if it extended more than five covered transactions in a calendar year. Also consistent with § 1026.2(a)(17)(v), because a covered transaction may be a
C. If multiple creditors share ownership of a company that regularly extended first-lien covered transactions, the assets of the company count toward the asset limit for a co-owner creditor if the company is an “affiliate,” as defined in § 1026.32(b)(5), of the co-owner creditor. Assuming the company is not an affiliate of the co-owner creditor by virtue of any other aspect of the definition (such as by the company and co-owner creditor being under common control), the company's assets are included toward the asset limit of the co-owner creditor only if the company is controlled by the co-owner creditor, “as set forth in the Bank Holding Company Act.” If the co-owner creditor and the company are affiliates (by virtue of any aspect of the definition), the co-owner creditor counts all of the company's assets toward the asset limit, regardless of the co-owner creditor's ownership share. Further, because the co-owner and the company are mutual affiliates the company also would count all of the co-owner's assets towards its own asset limit.
D. A creditor satisfies the criterion in § 1026.35(b)(2)(iii)(C) for purposes of any higher-priced mortgage loan consummated during 2016, for example, if the creditor (together with its affiliates that regularly extended first-lien covered transactions) had total assets of less than the applicable asset threshold on December 31, 2015. A creditor that (together with its affiliates that regularly extended first-lien covered transactions) did not meet the applicable asset threshold on December 31, 2015, satisfies this criterion for a higher-priced mortgage loan consummated during 2016 if the application for the loan was received before April 1, 2016, and the creditor (together with its affiliates that regularly extended first-lien covered transactions) had total assets of less than the applicable asset threshold on December 31, 2014.
E. Under § 1026.35(b)(2)(iii)(C), the $2,000,000,000 asset threshold adjusts automatically each year based on the year-to-year change in the average of the Consumer Price Index for Urban Wage Earners and Clerical Workers, not seasonally adjusted, for each 12-month period ending in November, with rounding to the nearest million dollars. The Bureau will publish notice of the asset threshold each year by amending this comment. For calendar year 2024, the asset threshold is $2,640,000,000. A creditor that together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2023 has total assets of less than $2,640,000,000 on December 31, 2023, satisfies this criterion for purposes of any loan consummated in 2024 and for purposes of any loan consummated in 2025 for which the application was received before April 1, 2025. For historical purposes:
9. For calendar year 2021, the asset threshold was $2,230,000,000. A creditor that together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2020 had total assets of less than $2,230,000,000 on December 31, 2020, satisfied this criterion for purposes of any loan consummated in 2021 and for purposes of any loan consummated in 2022 for which the application was received before April 1, 2022.
10. For calendar year 2022, the asset threshold was $2,336,000,000. A creditor that together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2021 had total assets of less than $2,336,000,000 on December 31, 2021, satisfied this criterion for purposes of any loan consummated in 2022 and for purposes of any loan consummated in 2023 for which the application was received before April 1, 2023.
11. For calendar year 2023, the asset threshold was $2,537,000,000. A creditor that together with the assets of its affiliates that regularly extended first-lien covered transactions during calendar year 2022 had total assets of less than $2,537,000,000 on December 31, 2022, satisfied this criterion for purposes of any loan consummated in 2023 and for purposes of any loan consummated in 2024 for which the application was received before April 1, 2024.
iv. The creditor and its affiliates do not maintain an escrow account for any mortgage transaction being serviced by the creditor or its affiliate at the time the transaction is consummated, except as provided in § 1026.35(b)(2)(iii)(D)(
1. The asset threshold in § 1026.35(b)(2)(vi)(A) will adjust automatically each year, based on the year-to-year change in the average of the Consumer Price Index for Urban Wage Earners and Clerical Workers, not seasonally adjusted, for each 12-month period ending in November, with rounding to the nearest million dollars. Unlike the asset threshold in § 1026.35(b)(2)(iii) and the other thresholds in § 1026.35(b)(2)(vi), affiliates are not considered in calculating compliance with this threshold. The Bureau will publish notice of the asset threshold each year by amending this comment. For calendar year 2024, the asset threshold is $11,835,000,000. A creditor that is an insured depository institution or insured credit union that during calendar year 2023 had assets of $11,835,000,000 or less on December 31, 2023, satisfies this criterion for purposes of any loan consummated in 2024 and for purposes of any loan secured by a first lien on a principal dwelling of a consumer consummated in 2025 for which the application was received before April 1, 2025. For historical purposes:
Federal Aviation Administration (FAA), DOT.
Final rule; correction; withdrawal.
This action withdraws the final rule correction published in the
As of date 0901 UTC, December 21, 2023, the final rule correction published December 6, 2023 (88 FR 84695), is withdrawn.
Steven Roff, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a final rule in the
Subsequently, the FAA published a final rule correction in the
Airspace, Prohibited areas, Restricted areas.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
This rule is effective January 22, 2024.
For access to the docket to read background documents or comments received, go to
Lauren Milner, Office of Clinical Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5514,
This final rule implements the statutory changes made to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Cures Act to allow for a waiver or alteration of informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The rule will permit an IRB to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain minimal risk clinical investigations.
The final rule amends FDA's regulations to allow IRBs responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations. For an IRB to approve a waiver or alteration of informed consent requirements for minimal risk clinical investigations, the rule requires an IRB to find and document five criteria that are consistent with the revised rule entitled “Federal Policy for the Protection of Human Subjects” (the revised Common Rule (January 19, 2017)). FDA believes the amendment provides appropriate safeguards to protect the rights, safety, and welfare of the human subjects participating in such clinical investigations. We are also making conforming amendments to FDA's regulations.
Sections 505(i)(4) and 520(g)(3) of the FD&C Act, as amended by the Cures Act, in conjunction with FDA's general rulemaking authority in section 701(a) of the FD&C Act, serve as FDA's principal legal authority for this rule. In addition, the Cures Act directs the Secretary of the Department of Health and Human Services (HHS) to “harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations,” to the extent practicable and consistent with other statutory provisions.
This rule will help enable the conduct of certain minimal risk clinical investigations for which the requirement to obtain informed consent is waived or for which certain elements of informed consent are waived or altered.
We expect costs in the form of affected IRBs, as well as investigators and sponsors of clinical investigations, reading and learning the rule. We also expect costs in the form of drafting new
We expect that there will be cost savings to IRBs from harmonization of FDA's informed consent regulations with the provision for waiver or alteration of informed consent for certain minimal risk research in the Common Rule. The estimated net present value of the cost savings of the rule are approximately $1.7 million, with a lower bound of approximately $0.9 million and an upper bound of approximately $3.5 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated cost savings of the rule are approximately $1.4 million, with a lower bound of approximately $0.7 million and an upper bound of approximately $2.8 million. The estimated annualized cost savings of the rule are approximately $0.2 million, with a lower bound of approximately $0.1 million and an upper bound of approximately $0.4 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated annualized costs savings of the rule are approximately $0.2 million, with a lower bound of approximately $0.1 million and an upper bound of approximately $0.4 million.
We also expect benefits in the form of healthcare advances from minimal risk clinical investigations that would not be performed without a waiver or alteration of informed consent. We cannot quantify all benefits that might arise from such studies because of the lack of relevant data available regarding the focus of these types of studies that will support regulatory submissions to FDA.
In the
On December 13, 2016, the Cures Act (Pub. L. 114-255) was signed into law. Section 3024 of the Cures Act amended sections 505(i)(4) and 520(g)(3) of the FD&C Act (21 U.S.C. 355(i)(4) and 360j(g)(3)) to provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. This rule implements the statutory change by allowing an additional exception from the general requirements of informed consent for certain FDA-regulated clinical investigations.
In addition, section 3023 of the Cures Act directs the Secretary of the Department of Health and Human Services (HHS) to “harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations,” to the extent practicable and consistent with other statutory provisions. This rule harmonizes
On July 25, 2017, FDA issued a guidance document entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects” (IRB Waiver or Alteration of Informed Consent Guidance) (82 FR 34535). This guidance informs sponsors, investigators, and IRBs that FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, the guidance informs sponsors, investigators, and IRBs that FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance. FDA intends to withdraw the guidance after the regulations in this rule become effective.
FDA is issuing this final rule to permit an IRB waiver or alteration of informed consent in limited circumstances, consistent with the Cures Act. We believe that this rule will both safeguard the rights, safety, and welfare of human subjects and enable minimal risk clinical investigations that may facilitate medical advances and promote public health. In addition, because some clinical research is subject to FDA and other federal requirements under the Common Rule, harmonization of this waiver provision should also provide clarity for and reduce burden on the research community.
We received fewer than 50 comment letters to the proposed rule from academia, IRBs, public advocacy groups, industry, trade organizations, public health organizations, individuals, and other organizations. FDA received comments on topics that included the following: (1) general support or opposition to the rule; (2) definitions and descriptions of the criteria listed in the rule; (3) adopting the fifth criterion from the revised Common Rule; (4) secondary research involving biospecimens; (5) examples of clinical investigations that might meet the proposed waiver criteria; (6) requests for specific and/or additional guidance on the rule; (7) the expedited review list and IRB continuing review; (8) cost savings of the proposed rule; and (9) the proposed effective date of the rule.
In this rulemaking, FDA is finalizing its proposal to add new § 50.22, “Exception from informed consent requirements for minimal risk clinical investigations” to part 50 and make three conforming amendments to §§ 50.20, 312.60, and 812.2 (21 CFR 50.20, 312.60, and 812.2) of our current regulations to reflect the exception from informed consent for certain minimal risk clinical investigations. In addition, based on comments received on the proposed rule, FDA is adding the criterion at § 50.22(c), which addresses clinical investigations involving identifiable private information or identifiable biospecimens. As described below, FDA changed the order of the criteria in § 50.22 to match the order of the revised Common Rule's requirements for general waiver or alteration of consent (45 CFR 46.116(f)(3)). FDA also made minor organizational and editorial changes to § 50.22 to increase clarity and consistency with the regulatory text of the revised Common Rule.
• FDA made a minor editorial change to the introductory text to § 50.22 for clarity. Specifically, we revised the text “or that waives” to read “or may waive.” The regulation permits the IRB responsible for the review, approval, and continuing review of the clinical investigation to approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent in § 50.25(a) and (b) of FDA's current regulations, or to waive the requirement to obtain informed consent, provided that the IRB finds and documents five criteria under § 50.22(a) through (e).
• In § 50.22(a), FDA finalizes the criterion as proposed that the clinical investigation involves no more than minimal risk to the subjects.
• In § 50.22(b), FDA adopts the criterion that was proposed at § 50.22(c) and adds the word “requested” for clarity and to harmonize with the text of the revised Common Rule at 45 CFR 46.116(f)(3)(ii) (
• Based on comments received on the proposed rule (see section V.D. of this final rule), FDA is finalizing this rule with the additional criterion at § 50.22(c) that states that if the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format.
• In § 50.22(d), FDA adopts the criterion that was proposed at § 50.22(b) that states that the waiver or alteration will not adversely affect the rights and welfare of the subjects.
• In § 50.22(e), FDA adopts the criterion that was proposed at § 50.22(d) and adds “or legally authorized representatives” to the criterion (
• Three conforming amendments to §§ 50.20, 312.60, and 812.2 of our current regulations are finalized as proposed. FDA received no public comments on these three proposed conforming amendments. The introductory clause of § 50.20, General requirements for informed consent, is revised to include reference to § 50.22 as one of the limited exceptions to the general requirements for informed consent. The second sentence in § 312.60, General responsibilities of investigators, is revised to reference part 50 generally rather than list each specific exception to the informed consent requirements in part 50. This simplifies the regulatory text and makes it clear that the investigator is responsible for obtaining the informed consent of each human subject to whom the drug is administered in accordance with part 50, which includes § 50.22. Similarly, in part 812, Investigational Device Exemptions (IDEs), § 812.2(b)(1)(iii) is revised to make clear that the investigator must obtain informed consent in accordance with part 50, which includes § 50.22. In
Title III, section 3024 of the Cures Act amended sections 505(i)(4) and 520(g)(3) of the FD&C Act to provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. This statutory amendment was signed into law and became effective on December 13, 2016. These regulations reflect these statutory changes to the FD&C Act, including appropriate human subject protection safeguards. Thus, sections 505(i)(4) and 520(g)(3) of the FD&C Act, as amended by section 3024 of the Cures Act, in conjunction with FDA's general rulemaking authority in section 701(a) of the FD&C Act (21 U.S.C. 371(a)), serve as our principal legal authority for this rule. In addition, Title III, section 3023 of the Cures Act provides that the Secretary of Health and Human Services shall “harmonize differences between HHS Human Subject Regulations and FDA Human Subject Regulations” to the extent practicable and consistent with other statutory provisions.
We received fewer than 50 comment letters on the proposed rule by the close of the comment period. We received comments from academia, IRBs, public advocacy groups, industry, trade organizations, public health organizations, individuals, and other organizations.
We describe and respond to the comments below. Comment summaries are numbered, with similar comments grouped together under the same number. In some cases, different issues discussed in the same comment letter were designated as distinct comments for purposes of our responses. The number assigned to each comment summary or comment topic is purely for organizational purposes and does not signify the comment's value or importance, or the order in which comments were received.
FDA proposed to amend its regulations to allow the IRB responsible for the review, approval, and continuing review of FDA-regulated clinical investigations to approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b), or that waives the requirement to obtain informed consent, provided that the IRB finds and documents that four criteria are met. FDA also solicited public comment on the inclusion of a fifth criterion and asked for comment on the types of FDA-regulated minimal risk clinical investigations for which sponsors would anticipate requesting a waiver or alteration of informed consent from the IRB.
(Comment 1) A majority of general comments favor the Agency's efforts to harmonize FDA's human subject protection regulations with the revised Common Rule. These comments generally support the proposed rule because it would reduce administrative burdens on IRBs and researchers, reduce research costs, facilitate valuable research, or address public health concerns without compromising subjects' rights, safety, or welfare.
Several comments express support for harmonization with the revised Common Rule's provision for waiver or alteration of informed consent to reduce burdens related to conducting certain types of research, including some cluster randomized or pragmatic trials, and enabling learning health systems, in which clinicians continually learn from data collected at the point of care. One comment indicates that such research has the potential to contribute in important ways to the evidence base regarding drug and device efficacy, while another suggests that finalizing the proposal would result in more and better data regarding the risks and benefits of drugs and devices in real-world settings. An additional comment argues that a waiver of informed consent may be necessary and ethically justifiable for certain types of clinical investigations that are critical for medical advancement, patient care, and safety.
Other comments support the proposal because certain minimal risk investigations are difficult or impossible to carry out if consent is required, such as certain secondary research involving biospecimens that may lead to important medical advances toward personalized medicine; research involving retrospective records reviews; and research involving no more than minimal risk to subjects that would not qualify for an exception from informed consent under § 50.24 of FDA's current regulations because participation would not hold out a prospect of direct benefit to the subjects. The comments point out that current FDA regulations permit waivers from the requirement to obtain informed consent only under limited circumstances.
(Response 1) FDA agrees that this rule will facilitate investigators' ability to conduct certain minimal risk clinical investigations that could lead to healthcare advances through development of products to diagnose or treat diseases or other conditions, without compromising subjects' rights, safety, or welfare. To the extent that the studies described in the comments would constitute FDA-regulated clinical investigations that could not be carried out under our current regulations, we agree that this final rule may help enable such research and that a waiver of informed consent is ethically justifiable for certain types of investigations.
In addition, FDA expects that this final rule will reduce administrative burdens on IRBs and researchers and reduce research costs. For example, harmonization with the revised Common Rule's general provision for waiver or alteration of informed consent will allow IRBs that review minimal risk clinical research subject to both FDA's regulations and the revised Common Rule to use the same criteria for reviewing a request for a waiver or alteration of informed consent for a clinical investigation. This should minimize the need for separate processes for review of such requests.
(Comment 2) Of the comments that oppose the proposed rule, two oppose it because they assert that waiving consent conflicts with existing ethical and international standards, such as the Belmont Report, the Nuremberg Code, the Declaration of Helsinki, and the International Covenant on Civil and Political Rights (ICCPR). Two other comments suggest that FDA withdraw the proposal because the underlying law and revised Common Rule are defective and “against the spirit” of human subject protection.
(Response 2) FDA disagrees with the comments opposing the rule. We believe that the rule upholds the principles underlying existing ethical standards, while accounting for advances in the conduct of FDA-regulated clinical investigations. It is also consistent with the obligations of the ICCPR and the U.S.' reservations, declarations, and understandings to the Covenant (see,
Additionally, the ethical principles identified in many of the national and international guidelines for research conduct, such as the three ethical principles described in the Belmont Report (respect for persons, beneficence, and justice), should be considered and weighed within the context of a particular clinical investigation, as the consideration of each principle depends on multiple factors associated with the investigation, such as research methodologies or participant populations. This rule permits a waiver or alteration of consent only in limited circumstances where the risks posed to subjects by the research are very low. We believe that with the protections in place under this rule (including the requirement for an IRB to find and document that the waiver or alteration will not adversely affect the rights and welfare of subjects), the balance between respect for persons and beneficence should come out in favor of facilitating research that satisfies the criteria in § 50.22 by permitting waiver or alteration of informed consent requirements to advance the public health. Additionally, although informed consent is a critical element of FDA's regulations that reflects the principle of respect for persons through the exercise of autonomy, we believe that the criteria provided in this rule also reflect the principle of respect for persons. For example, in a minimal risk clinical investigation for which an IRB waives consent, ensuring that the rights and welfare of subjects are not adversely affected by the waiver demonstrates respect for persons, as does providing additional pertinent information about the investigation to subjects whenever appropriate (Ref. 2).
Finally, FDA declines to withdraw the proposed rule in response to the comments that disagree with section 3024 of the Cures Act and the revised Common Rule. The Common Rule's provisions for waiver or alteration of informed consent for minimal risk research have been in effect for over 30 years and have provided appropriate safeguards to protect the rights and welfare of human subjects. As noted above, FDA believes that this rule provides an important mechanism for conducting clinical investigations that will both appropriately safeguard human subjects and potentially lead to medical advances that serve the public health.
(Comment 3) Some comments suggest that conducting research without informed consent would violate the U.S. Constitution or weaken constitutionally guaranteed rights. One comment argues that “invasive procedures, interventions or intrusions” into a person's “body, cognition, or otherwise” without consent is a violation or a potential violation of the Fourth, Fifth, Eighth, and Fourteenth Amendments. A second comment asserts that waiving consent for research involving physical interventions would violate the Fourth and Fifth Amendments and requested clarification that Constitutional rights are among the rights at issue when considering whether the proposed criteria for waiver of consent are satisfied. Another comment indicates that a waiver of informed consent would constitute an unwanted bodily invasion and that individuals have a constitutional right to privacy that protects them against such invasions. Other comments make general statements questioning the constitutionality of a waiver of informed consent.
(Response 3) We disagree with comments suggesting that the rule is unconstitutional. With respect to the comments that make only a general assertion that the rule may violate the Constitution or weaken constitutional rights, the lack of additional detail regarding the grounds for this assertion makes it impossible to provide a further substantive response. One comment cites a Federal district court case,
Of those comments that identify particular constitutional Amendments or rights, none provides specific facts or a legal basis for their claims that the rule would violate those provisions or rights. We are thus unable to provide a specific response to those comments. However, we note that the rule does not require an IRB to waive or alter informed consent, nor does it require any entity, including a government entity, to conduct or support any research. Therefore, to the extent that conducting a particular clinical investigation with a waiver or alteration of informed consent could be viewed as interfering with a constitutional right, this rule does not require an IRB to grant such a waiver or alteration or require that the research be conducted. In addition, we are clarifying, as requested by one comment, that constitutional rights are among the rights that may be appropriate for an IRB to consider when determining if the criterion in § 50.22(d) of the final rule (which requires the IRB to find that “[t]he waiver or alteration will not adversely affect the rights and welfare of the subjects”) is satisfied.
Finally, we note that some of the comments that question the constitutionality of the rule appear to be concerned about potential waivers of informed consent for research involving “invasive procedures.” It is important to emphasize that the provision for a waiver or alteration of informed consent being finalized in this rule is available only for clinical investigations that involve no more than minimal risk to the subjects and meet the other criteria in § 50.22. In general, we do not believe that a study involving an invasive procedure being used for research
(Comment 4) A few comments oppose the proposal because it would not restrict or prohibit waiver of consent for classified research, citing President Clinton's Memorandum of 1997 regarding classified research (“Clinton Memorandum,” Ref. 3).
(Response 4) We do not believe it is necessary to address classified research in this rulemaking. As noted in some of these comments, the Clinton Memorandum is directed to Agencies that may conduct or support classified research subject to the 1991 Common Rule. FDA's informed consent regulations apply to all clinical investigations, as defined in § 50.3(c) (21 CFR 50.3(c)), involving FDA-regulated articles. FDA does not regulate research on the basis that it is federally conducted or supported. To the extent a Federal Agency conducts or supports classified research and prohibits waiver of informed consent for such research, FDA's new waiver provision at § 50.22 does not require any IRB to waive informed consent and thus would not conflict with the prohibition.
(Comment 5) Several comments argue that waivers of informed consent weaken human subject protections and would allow IRBs to retreat from their human subject protection responsibilities. These comments also express concern that the proposal might decrease public trust in both research and healthcare providers. One comment states that no third parties, including IRBs, should be allowed to make decisions for study subjects as to what constitutes “minimal risk.”
(Response 5) We do not agree that providing a waiver or alteration of informed consent under the limited circumstances described in the rule would allow IRBs to retreat from their human subject protection responsibilities or that such waivers or alterations will decrease public trust in research and healthcare providers. IRBs have been making similar waiver and alteration decisions for research subject to the Common Rule since its issuance in 1991, and the comments do not provide evidence that such decisions have decreased overall public trust in either research or healthcare providers. As noted above, this rule provides appropriate safeguards to protect the rights, safety, and welfare of human subjects when consent is waived and thus waivers granted in accordance with § 50.22 should not weaken public trust.
We also disagree with the comment stating that IRBs should not be allowed to make decisions as to what research constitutes “minimal risk.” IRBs have considerable experience making “minimal risk” determinations under FDA regulations (see response to Comment 10). For example, IRBs have been making minimal risk determinations for decades to decide whether expedited review procedures may be used for certain categories of research (see § 56.110(b)(1) (21 CFR 56.110(b)(1)); 63 FR 60353, November 9, 1998) and when reviewing clinical investigations involving children as subjects (see part 50, subpart D). In light of this experience, we believe that IRBs are generally well-positioned to determine what constitutes “minimal risk” to subjects when considering the details of a particular clinical investigation.
(Comment 6) Several comments criticize the proposal as too vague and subjective. These comments recommend adding definitions or providing further description of the criteria in § 50.22. They also recommend clarifying or providing examples of research for which a waiver or alteration would be allowed under the proposal in order to reduce the potential for inconsistency and variability in IRBs' decision making.
(Response 6) We do not agree with the comments stating that this rule is too vague and subjective. The five criteria in § 50.22 for a waiver or alteration of informed consent for minimal risk clinical investigations are harmonized with the revised Common Rule's criteria in 45 CFR 46.116(f)(3). We note that four of these criteria have been included in the Common Rule and have been successfully applied since the Common Rule was originally issued in 1991. The revised Common Rule added a fifth criterion (45 CFR 46.116(f)(3)(iii)), which corresponds to § 50.22(c) in this rule. That fifth criterion was modeled on a comparable criterion in the HIPAA Privacy Rule, which requires, as a condition of waiver of the requirement to obtain an individual's authorization, that the research could not practicably be conducted without access to and use of protected health information (PHI) (see 82 FR 7149 at 7224).
In response to the comments recommending additional definitions or criteria descriptions, we note that throughout this document (for example, see FDA responses to comments 10, 12, 13, and 16) we address comments requesting the addition of specific definitions or further clarification for each of the criteria described in § 50.22. FDA intends to issue further guidance to assist IRBs in applying these criteria to clinical investigations with additional information on the types of clinical investigations that may qualify for a waiver or alteration of consent under § 50.22.
(Comment 7) Some comments address implementation-related aspects of the proposed waiver or alteration provision. One comment, noting that subjects may already be giving consent to undergo non-research related patient care, questions why it would not also be appropriate to obtain their consent for research-related interventions at the same time. Another comment questions how a person reviewing hospital records would know a subject agreed to be in the study if consent had been waived.
(Response 7) With respect to the comment that questions why consent would need to be waived if informed consent to participate in research could be obtained at the same time that non-research related consent for patient care was being obtained, FDA notes that that the investigation would need to be impracticable to perform without a waiver in order to qualify for a waiver under this final rule. As stated in the preamble to the proposed rule, if scientifically sound research can practicably be carried out using only consenting subjects, we believe it should be carried out without involving nonconsenting subjects (83 FR 57378 at 57382). Waivers or alterations of informed consent under § 50.22 are intended for situations where it is impracticable to carry out the clinical investigation, as designed, without the waiver or alteration. There may be certain cases in which getting consent from a subset of individuals in the target study population may be possible, but the study may still be considered impracticable without a waiver because of obstacles
With respect to the comment that questions how a person reviewing hospital records would know a subject agreed to be in the study if consent had been waived, any person reviewing the data for purposes of the study would be themselves an investigator or otherwise involved in the investigation, and should therefore be aware that an IRB had approved the study, found the criteria under § 50.22 were met, and granted a waiver of the requirement to obtain informed consent. This would provide that person with assurance that the subject's rights, safety, and welfare are protected. Additionally, in the event of concerns about including a particular subject or group of subjects in a clinical investigation for which informed consent has been waived in accordance with § 50.22, the investigator or member of the study team could consult appropriate parties, such as the sponsor or the IRB, to address those concerns.
(Comment 8) Two comments suggest additional requirements for studies in which consent is waived. One comment cites a research paper that assesses the legitimacy of waivers of consent for research, which the authors posit is “predicated on the reasonable belief that potential subjects would agree if they were asked and capable of consent.” The paper includes a literature review and qualitative assessment of studies examining participation and refusal rates in human subjects research (Ref. 4). From this review, the authors conclude that there is reason to believe that many potential participants would not want to be enrolled in a study for which informed consent is waived, if asked. The paper concludes that waivers of informed consent should be rare, and that IRBs and researchers must find out if a study is acceptable to the target population and in the community where the proposed research takes place. The comment states that “waivers of informed consent may be granted for a population based on general characteristics of the population that make getting consent from everyone impracticable, with express acknowledgement that securing consent from some members of the population may be quite feasible and practicable, and in those cases consent must be secured.” The comment notes that this approach is modeled on the exception from informed consent in FDA's emergency research regulations at § 50.24, and states that § 50.24 is legally and ethically superior to the waiver provision in the proposed rule. Finally, the comment recommends that an additional requirement be added to the proposed regulations requiring that consent should be secured from individuals or their LARs “when practicable.”
A second comment suggests that, for any research for which the requirement to obtain informed consent would be waived under the provision in the proposed rule, FDA require the drafting of an “as if” consent form in language geared toward the subject's viewpoint before the research begins. This comment argues a precedent for this approach under § 50.24(a)(6). It also asserts that this exercise would prevent practitioners from being deprived of a description of research interventions and would describe the intervention in language geared toward the viewpoint of the human subject, which may enhance human subject protections and promote an atmosphere of appropriate respect and empathy for non-consenting human subjects.
(Response 8) With regard to the points outlined in the cited research paper, we agree that the acceptability of the research to potential participants is an important consideration for an IRB when determining whether to grant a waiver or alteration of informed consent under the final rule. FDA stated in the preamble of the proposed rule that, to make the finding that the waiver or alteration will not adversely affect the rights and welfare of the subjects, IRBs may consider, for example, whether the subject population in general would be likely to object to a waiver or alteration being granted for the research in question (83 FR 57378 at 57381 to 57382). However, individual decisions to participate in research often depend on different factors, such as the recruitment method used (Ref. 5) and health literacy (Ref. 6). Additionally, an individual's trust (or distrust) in their healthcare provider and/or in the institution conducting the research may also contribute to their willingness to participate (Ref. 7). Requiring IRBs to determine and researchers to establish that an “appropriate majority” of the target study population would choose to participate before granting a waiver of consent, as the article suggests, would involve accounting for the individualized factors underlying such decisions. This would be unduly burdensome and could create significant limitations or delays for minimal risk investigations that § 50.22 is intended to facilitate. Given the complexities and unknowns surrounding individual reasons for participation or refusal to participate in minimal risk research, we believe that this rule strikes an appropriate balance between enabling important research to proceed while safeguarding the rights, safety, and welfare of subjects such that consent (or elements of consent) can be appropriately waived.
FDA declines to adopt the commenter's suggestion to include in the final rule a requirement to obtain consent from individual potential subjects or their LARs “when practicable.” FDA's provision for exceptions from informed consent for emergency research requires, among other things, an investigator commitment to attempt to contact an LAR for each subject within the therapeutic window and, if feasible, to ask the LAR for consent within that window (§ 52.24(a)(5)). However, we disagree with the commenter's conclusion that because of this requirement, § 50.24 is “superior” to the requirements for a waiver under § 50.22. Each of these provisions was developed to address significantly different types of clinical investigations. The criteria listed in § 50.24 are intended for research involving a study population with no capacity to consent, in a setting where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each subject's legally authorized representative. Specifically, for research to qualify to be conducted under § 50.24 certain conditions, including the following, must be satisfied: the subject is in a life-threatening situation; available treatments are unproven or unsatisfactory; participation in the research holds out the prospect of direct benefit to the subject; obtaining informed consent from the subject is not feasible because the subject cannot provide consent due to their medical condition; and the intervention must be administered before consent can be obtained from the subject's LAR. In contrast, the criteria for waiver or alteration of consent in § 50.22 are intended for research in which the risk to participants is minimal and are not focused on research where subjects are in a life-threatening situation. We, therefore, conclude that revising § 50.22 in this final rule to include a requirement similar to that found in § 50.24(a)(5) is not appropriate for the minimal risk research that would otherwise qualify for a waiver or alteration of informed consent under this final rule. In addition, the comment's suggestion that FDA require informed consent to be obtained from individual subjects or their LARs “when practicable” could cause confusion, given that the criterion at § 50.22(b) requires an IRB to find that the research could not practicably be carried out
We also decline the suggestion to require the drafting of an “as if” informed consent form (
(Comment 9) Two comments suggest tracking the cumulative effects of minimal risk studies on subjects who have participated in more than one such study and suggest establishing a centralized registry containing the names of all human subjects who are involved in research or clinical investigations, the names of the sponsor and researcher, whether the research is classified, and whether informed consent was waived or altered.
(Response 9) We decline to adopt the suggested requirement that all participants in minimal risk studies be tracked and the suggestion to establish a centralized registry of participants in clinical investigations because, among other issues (
FDA proposed that, to permit a waiver or alteration of the informed consent requirements, the IRB must find and document that the following four criteria are met: (1) the clinical investigation involves no more than minimal risk to the subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the clinical investigation could not practicably be carried out without the waiver or alteration; and, (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.
The proposed rule included, as the first criterion, that the clinical investigation involves no more than minimal risk to the subjects. “Minimal risk” is defined in § 50.3(k) to mean that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
(Comment 10) Fewer than half of the comments reference proposed § 50.22(a) or mention the minimal risk criterion. The majority of these comments support an IRB's ability to approve informed consent procedures that do not include or that alter some of the elements of informed consent, or to waive consent entirely, for minimal risk research. Some of these comments support the ability to waive or alter informed consent requirements for specific types of research they identify as minimal risk, including research involving clinical record reviews or secondary use of biospecimens, and certain cluster randomized trials. One comment expresses trust in IRBs' abilities to know when informed consent is required.
Conversely, some comments oppose or express reservations about allowing waiver or alteration of consent for minimal risk studies, suggesting that the term “minimal risk” is vague, ambiguous, or subjective, or express other confusion about its meaning. One comment indicates concern that the vagueness of the term “minimal risk” would precipitate misuse of the rule. Other comments suggest that the rule clarify the meaning of specific terms in the definition of minimal risk (
Several comments assert that IRBs should not be entrusted to make minimal risk determinations. A few comments suggest that determinations of risk are subjective and that only the individual subject can make a meaningful decision about degrees of risk and whether a particular risk in a study is actually minimal. Some comments express concern that IRBs might inappropriately grant waivers for clinical investigations that are greater than minimal risk, or that they may fail to appreciate both the nature and risks of procedures in the research studies that are submitted to them for review. Other comments caution that IRB members may have conflicts of interest that could affect their interpretation of the term. To support their concerns and opposition, these comments cite past instances in which researchers had
Other comments suggest that additional oversight or clarification regarding IRB processes is needed with regard to granting waivers of informed consent and the determination of minimal risk. One comment urges that, if waivers are allowed, the Agency revise the proposal to address the following: clarify the process to determine whether to grant and approve waivers of informed consent, require ongoing review of waivers to determine whether IRBs are properly defining the studies as minimal risk, immediately terminate any research in which medical interventions are withheld or are too aggressive, and provide a “whistleblower form” for individuals involved in a research study to anonymously submit a complaint about that study to HHS. Another comment requests that FDA provide details about the practical application of the proposal, that is, how an IRB's process of determining whether to grant waivers of informed consent might work to remove the risk of variability in when and how such waivers are granted.
Some comments express concern that studies involving records or data are often labeled as minimal risk, even though IRBs struggle to make determinations about the magnitude of the risks posed by such studies and whether the risks are indeed minimal. One of these comments notes that the ability to link various sources of personal data may create additional risks for study subjects. One comment indicates concern that, in research involving real-world data (RWD) or review of health records that is categorized as “minimal risk,” hacking or inadvertent sharing could put the subjects' information at risk or cause subjects to be at risk for losing healthcare coverage.
(Response 10) FDA is not revising the definition of minimal risk in this rule. Retaining the current definition of minimal risk will avoid confusion in the research community and maintain harmonization with the revised Common Rule. The Common Rule and FDA regulations have shared the same definition of minimal risk since 1991,
In response to comments suggesting that IRB members might have conflicts of interest that could affect their interpretation of the term “minimal risk,” we note that IRBs are subject to the requirements under § 56.107 (21 CFR 56.107), including the requirements prohibiting participation in IRB review by a member with a conflict of interest, except to provide information requested by the IRB, under § 56.107(e).
With respect to the comment that recommends revising the rule to clarify the process of an IRB waiver determination and require ongoing review for waivers to determine the adequacy of IRBs' interpretation of “minimal risk,” we note that IRBs are required to prepare and follow written procedures for conducting reviews of FDA-regulated clinical investigations (see 21 CFR 56.108(a) and 56.115(a)(6)). These written procedures should include an IRB's processes for reviewing requests to waive or alter informed consent and documenting that the criteria in § 50.22 are satisfied. We also note that FDA inspects IRBs to determine whether they are reviewing and approving research in accordance with FDA regulations and with the IRBs' written procedures. We do not believe it is necessary to prescribe a particular process or procedure that IRBs must follow when making and documenting a waiver or alteration decision for a research study, or that such a process would result in more consistent decision making. FDA regulations provide for flexibility in terms of the specific contents of IRB written procedures, which gives IRBs the ability to establish procedures best suited to their own operations. Written procedures, including the processes IRBs follow for making certain determinations, may vary among institutions and IRBs because of differences in the way organizations are structured, the type of research studies reviewed by the IRB, institutional policy or administrative practices, the number of IRBs at the institution, affiliation with an institution, or local and State laws and regulations (Ref. 8).
FDA also declines the commenter's suggestion to add to the rule a requirement that research be terminated that withholds or provides for aggressive medical intervention. Although the comment does not elaborate on the meaning of an “aggressive” medical intervention, it does not appear that the types of research studies the comment describes would qualify for a waiver or alteration under § 50.22. In addition, if changes are proposed to a study for which a waiver or alteration has been granted under § 50.22, and those changes include the addition of an investigational intervention or other protocol amendment that involves more than minimal risk to subjects, then the study, with the change, would no longer qualify for the waiver or alteration.
Regarding the comment suggesting that hacking or inadvertent sharing of health information can create risks for subjects, such as losing healthcare coverage, we note that § 56.111(a)(7) (21 CFR 56.111(a)(7)) of FDA's regulations requires IRBs to determine that, where appropriate, adequate provisions to protect subjects' privacy and maintain the confidentiality of data are in place in order to approve FDA-regulated research. This would include research for which the IRB grants a waiver or alteration of consent under § 50.22.
As previously noted, FDA plans to publish guidance to assist IRBs in applying the criteria for waiver or alteration of informed consent requirements in § 50.22 to FDA-regulated clinical investigations. In that guidance, we intend to include additional information on the types of research activities that may involve no
(Comment 11) One comment, focused on device studies, warns about the potential for confusion and inconsistent interpretation across IRBs when applying the concept of “minimal risk” to studies of “non-significant risk” devices.
(Response 11) FDA addressed the difference between “non-significant risk” and “minimal risk” in a 2006 guidance for IRBs, clinical investigators, and sponsors entitled “Significant Risk and Nonsignificant Risk Medical Device Studies” (SR/NSR Guidance; Ref. 9). In the SR/NSR Guidance, FDA explains that “non-significant risk” and “minimal risk” determinations are distinct and involve different considerations. IRBs that review device investigations have experience applying FDA's regulations at parts 50, 56, and 812, and the SR/NSR Guidance has been in place for many years as a resource. As a result, IRBs should be aware that “non-significant risk” and “minimal risk” are different concepts that serve different regulatory purposes. Given this experience, we do not believe that IRBs will encounter difficulty applying the concept of “minimal risk” in § 50.22 to clinical investigations involving “non-significant risk” devices.
The proposed rule included, as the second criterion, that the waiver or alteration will not adversely affect the rights and welfare of the subjects.
(Comment 12) Several comments mention the effects of the proposed rule on subjects' rights and welfare. Some comments oppose the idea of a waiver of consent, stating that the absence or omission of informed consent affects the rights of subjects. Two comments assert that a waiver of informed consent would be unethical and in violation of subjects' trust because subjects would be prevented from knowing who is seeing or using their records, and the waiver would take away the subjects' choice and ability to specify how their data will be used. An additional comment mirrors this concern and notes the importance of protecting personal data.
Two comments object to waiving consent on the grounds that doing so would deny subjects necessary information about the research (
(Response 12) FDA does not agree with the comments suggesting that allowing for a waiver of informed consent for minimal risk clinical investigations in the circumstances described in § 50.22, including the criterion in proposed § 50.22(b), adversely affects the rights of subjects or is unethical or in violation of subjects' trust. We note that provisions relating to safeguarding the rights and welfare of subjects in clinical investigations have been included in FDA's regulations for decades. Section 56.107(a) of our regulations on IRB membership requires that each IRB be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. We believe that an IRB responsible for the review, approval, and continuing review of a minimal risk clinical investigation that meets these membership requirements is capable of finding and documenting, as appropriate, that the waiver or alteration will not adversely affect the rights and welfare of subjects participating in the research. Additionally, we note that to approve a clinical investigation, including a clinical investigation for which informed consent is waived or altered under this rule, an IRB must find that, where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (§ 56.111(a)(7)).
We believe that the safeguards in § 50.22 also help to alleviate the comments' concerns regarding subjects' access to information about the research, as we anticipate that IRBs will consider if any study information falling within the elements listed in § 50.25(a) or (b) should be provided to subjects. If so, the IRB may conclude, for example, that an alteration of certain informed consent elements is appropriate rather than a waiver, or that it is appropriate for the subjects or their LARs to be provided with additional pertinent information after participation (see § 50.22(e) in this rule).
In response to the comments objecting to the waiver provision as unethical or adversely affecting subjects' rights, we also point to our response to comment 2 for discussion regarding the ethical principles associated with clinical research (
Finally, FDA declines to include a definition of “welfare” or “welfare of the subjects” in the final rule. We note that the language of “rights and welfare of human subjects” has a long history of inclusion in both FDA regulations for human subject protections and the Common Rule. This and similar language are also used in other well-established guidelines on human subject research (Refs. 10 and 11). Given this history, FDA believes that IRBs are accustomed to applying the term “welfare” to different types of research, including minimal risk research.
FDA notes that there are resources available to IRBs and the research community more broadly when considering human subject welfare in minimal risk research. For example, the Secretary's Advisory Committee on Human Research Protections (SACHRP), through its Subcommittee on Subpart A, developed several recommendations regarding the interpretation of the Common Rule criteria for a waiver or alteration of informed consent, including the criterion regarding the “rights and welfare” of subjects (Ref. 2).
The proposed rule included, as the third criterion, that the clinical investigation could not practicably be carried out without the waiver or
(Comment 13) Several comments on the proposal make reference to proposed § 50.22(c) or commented on the term “practicably” in this criterion. Several of the comments ask for clarification or additional guidance about the meaning of the term “practicably” in the proposed criterion.
One comment asserts that there is wide variation in the way IRBs interpret the practicability standard. The comment continues that some IRBs interpret impracticable to mean that the research is impossible to do with consent, while other IRBs might accept investigator resistance to obtaining informed consent as meeting the impracticability threshold. This comment also recommends that practicability determinations be made in the context of understanding the value or importance of the research, and that “impracticable” should be understood to mean that the burdens of getting consent are too high, given the benefit, or value, promised by the research. This comment is one of two recommending that FDA revise its interpretation of “practicable” to align with recommendations made by SACHRP in 2008 related to waiver of informed consent and interpretation of minimal risk under the Common Rule (Ref. 2).
Another comment seeks reassurance that one of the objectives of § 50.22 is to provide IRBs with the latitude to allow a sponsor to have access to and utilize data and/or biospecimens that have already been collected without having to obtain informed consent. The comment encourages the inclusion of examples of minimal risk investigations to help IRBs understand that they have the flexibility to make real-world assessments of whether the research would be rendered impracticable because of the unavailability of subjects to give new individual consent.
A final comment asks that FDA clarify the meaning of the phrase “unduly delayed” in its description of the term “practicable.” This comment states that more effort should be put into finding an alternative to conducting research without subjects' consent.
(Response 13) With respect to the interpretation of the term “practicably,” we reiterate that the emphasis is on situations where it is impracticable—not necessarily impossible—to carry out the clinical investigation, as designed, without the waiver or alteration. Practicability should be assessed on a case-by-case basis considering the unique factors associated with the clinical investigation, such as its aims, its population(s), and the impact on its scientific validity if informed consent were required (
If an IRB finds that a clinical investigation can be practicably carried out using only consenting subjects, then FDA believes it should be carried out without involving nonconsenting subjects. However, we agree that, under this final rule, an IRB can approve a clinical investigation falling within the scope of part 50 in which investigators will have access to and utilize data and/or biospecimens that have already been collected without having to obtain informed consent, provided the IRB finds and documents that the criteria under § 50.22 are met.
In addition, we agree that IRBs may find under § 50.22(b) (§ 50.22(c) in the proposed rule) that a clinical investigation could not practicably be carried out without a waiver or alteration of informed consent based on the unavailability of certain subjects in an investigation to give consent for a new investigation (
As some comments point out, SACHRP made recommendations in 2008 related to waivers of informed consent and the interpretation of minimal risk under the Common Rule, including the Common Rule waiver criterion that corresponds to § 50.22(b). In its recommendations, SACHRP emphasized that the criterion “states that the research could not practicably be carried out without the waiver or alteration. Put another way, it would not be practicable to perform the research (as it has been defined in the protocol by its specific aims and objectives) if consent was required” (Ref. 2). SACHRP also offered the following concepts to help an IRB determine whether the research could not be practicably carried out without the waiver or alteration of consent: (1) the scientific validity of the research would be compromised if consent were required; (2) ethical concerns would be raised if consent were required; (3) there is a scientifically and ethically justifiable rationale why the research could not be conducted with a population from whom consent can be obtained; and (4) practicability should not be determined solely by considerations of convenience, cost, or speed.
Although SACHRP's recommendations regarding the “practicably” waiver criterion were developed for research that is regulated under the Common Rule, they are consistent with FDA's interpretation of the corresponding waiver criterion in this rule (
In addition, as stated in the preamble to the proposed rule, FDA interprets the term “practicably” in § 50.22(b) to mean, for example, that the research is not unduly delayed by restricting it to consenting subjects (83 FR 57378 at 57382). The phrase “unduly delayed” refers to more than just considerations of speed. By “unduly delayed,” we mean a delay in the initiation of a clinical investigation that is so lengthy as to raise ethical or scientific concerns given the benefit, or value, potentially gained by the research (
We note that it would be inappropriate for an IRB to find that a clinical investigation could not practicably be carried out without a waiver or alteration of informed consent based solely on a clinical investigator being resistant to obtaining informed consent. We do not consider investigator resistance to obtaining informed consent to be a scientifically or ethically valid reason for finding under § 50.22(b) that a clinical investigation could not practicably be carried out without a requested waiver or alteration of informed consent.
As the fourth criterion, FDA proposed that, whenever appropriate, the subjects will be provided with additional pertinent information after participation.
(Comment 14) FDA received a few comments about proposed § 50.22(d). Two comments cite a lack of clarity about the phrase “whenever appropriate” and one asks “when and why” it would not be appropriate to provide a subject with pertinent information after the research has ended. One comment recommends that definitions for § 50.22(d) be included, without providing further specificity on the definitions to be included.
(Response 14) For this criterion, the phrase “whenever appropriate” means that, when evaluating whether this criterion is met, the reviewing IRB considers factors relevant to the specific clinical investigation and population of the study under review to determine whether an investigator should provide information to the subjects of the minimal risk clinical investigation or to their LARs after participation (Ref. 2). One example where providing additional pertinent information after participation may be appropriate is in the case where some aspects of the study are not fully disclosed upfront because full disclosure may interfere with the purpose of the study (
FDA declines the recommendation that definitions in § 50.22(d) be included, as we do not have additional information from the commenter regarding what specific definitions should be described. As noted in our responses to comments 6 and 10, we believe that IRBs are equipped to consider the criteria outlined in the rule, as IRBs have experience applying the criteria in the corresponding Common Rule provision for waiver or alteration of informed consent. IRBs also have resources available to draw upon when considering a waiver or alteration of informed consent for minimal risk research (Ref. 2).
In the proposed rule, FDA explained that the revised Common Rule retained the same four criteria for IRB waiver or alteration of informed consent as were included in the 1991 version of the Common Rule, but added a fifth criterion,
(Comment 15) Several comments support including the fifth criterion in the final rule because it would harmonize FDA's criteria in § 50.22 for a waiver or alteration of informed consent for minimal risk clinical investigations with the revised Common Rule's criteria in 45 CFR 46.116(f)(3) and would support the continued protection of human subjects by addressing identifiable private information and biospecimens. Some comments also note that adopting the fifth criterion is consistent with the goal of reducing administrative burden. One comment expresses the concern that less than complete harmonization would do nothing to reduce the time and effort spent training staff and developing multiple sets of forms and processes for review of research under different standards.
Some comments maintain that inclusion of the fifth criterion is helpful because research involving biospecimens is an area of confusion and controversy and including the fifth criterion provides clarification of FDA's policy. One comment asserts that omission of the fifth criterion would contribute to the mistaken belief that FDA's regulations do not permit a waiver or alteration of informed consent for minimal risk research involving identifiable biospecimens.
Two comments request FDA's rationale for not promulgating the fifth criterion if the criterion is not adopted in the final rule. Another comment recommends that FDA revise the definition of human subject at § 50.3(g) to clarify the applicability of part 50 to private information and biospecimens. This comment also recommends that, given that “identifiability is more fluid than the term implies, and technology is rapidly changing how data can be identified,” FDA adopt a provision, similar to the revised Common Rule at 45 CFR 46.102(e)(7), requiring the Agency to periodically reevaluate the meaning of “identifiable” and what technologies or techniques generate identifiable information or specimens.
(Response 15) FDA is adopting the fifth criterion in this final rule. To match the structure of the revised Common Rule's general waiver provision (
In adopting the fifth criterion, we are harmonizing the waiver criteria set forth in § 50.22 with those set forth in the revised Common Rule's general waiver provision (45 CFR 46.116(f)(3)). As discussed in our response to comment 1, we expect that this harmonization will reduce administrative burdens on IRBs and researchers and reduce research costs. We also agree with comments noting that inclusion of the fifth criterion in the codified text will help avoid confusion regarding the applicability of § 50.22 to minimal risk clinical investigations involving the use of private information or biospecimens in an identifiable format. The fifth criterion makes it clear that § 50.22 applies to minimal risk clinical investigations involving the use of
We decline the recommendation to revise the definition of “human subject” in § 50.3(g), as changes to the definition of “human subject” could have unintended effects on other sections in part 50 beyond the scope of this rule. We also decline to adopt a provision that would require FDA to periodically reexamine the definitions of “identifiable private information” or “identifiable biospecimen.” We note that definitions of “identifiable private information” and “identifiable biospecimen” are included in FDA's proposed rule to amend part 50, Protection of Human Subjects, and part 56, Institutional Review Boards (87 FR 58733, September 28, 2022). Additionally, the revised Common Rule includes provisions at 45 CFR 46.102(e)(7)(i) and 46.102(e)(7)(ii) that require Federal departments and Agencies implementing the revised Common Rule, regularly and upon consultation with appropriate experts, to (i) reexamine the meaning of “identifiable private information” and “identifiable biospecimen”
(Comment 16) A few comments oppose adopting the fifth criterion. Two comments observe that FDA did not propose to establish a regulatory definition for “identifiable.” These comments assert that the definitions of the terms “identifiable private information” and “identifiable biospecimen” in the revised Common Rule must be periodically reevaluated under 45 CFR 46.102(e)(7) and may change in the future, which could impact research involving identifiable biospecimens and identifiable private information in unknown ways. In addition, these comments maintain that the fifth criterion could lead to unintended negative consequences, such as investigators being reluctant to retain identifiers needed for quality control purposes and for the verification of data that may be required for FDA submissions, applications, and approvals. The comments also express concern that IRBs may be reluctant to grant waivers for research with identifiable biospecimens and data. Additional comments contend that the fifth criterion is unnecessary because it does not provide additional human subject protections beyond those provided by the other criteria in proposed § 50.22, or because certain types of research (
(Response 16) FDA declines to add a definition for “identifiable” in this rule. As noted in our response to comment 15, we include definitions of “identifiable private information” and “identifiable biospecimen” as part of our proposed rule to amend part 50, Protection of Human Subjects, and part 56, Institutional Review Boards. In that rule, the proposed definitions of “identifiable private information” and “identifiable biospecimen” harmonize with the revised Common Rule's definitions of these terms (45 CFR 46.102(e)(5) and (6)).
With respect to the revised Common Rule definitions for “identifiable private information” and “identifiable biospecimen,” we acknowledge that the meaning of these terms must be periodically reexamined pursuant to 45 CFR 46.102(e)(7) and that they may be interpreted differently by the Common Rule departments and Agencies in the future. However, we believe the commenters' concerns regarding the potential impact on FDA-regulated research of such periodic reexaminations can be addressed through FDA's involvement in the consultation process described in the revised Common Rule, as discussed in the response to comment 15. Additionally, these comments do not provide a basis for us to conclude that adoption of the fifth criterion will have unintended negative consequences for investigator retention of identifiers. We fully expect clinical investigators to retain the identifiers for private information and biospecimens when it is necessary to do so for quality control purposes. A failure to preserve the identifiers could compromise the integrity of an investigation's results. We do not believe clinical investigators will risk compromising an investigation to avoid triggering the fifth criterion in any research involving private information or biospecimens. Nor are we aware of evidence that IRBs will be reluctant to waive or alter informed consent for clinical investigations involving private information or biospecimens in an identifiable format when the waiver criteria are met, or that IRBs are more reluctant to waive informed consent for research involving identifiable private information or biospecimens since the fifth criterion has been adopted in the revised Common Rule. FDA expects IRBs to evaluate carefully each request and grant a waiver or alteration of informed consent only when adequately justified.
We disagree with the contention that the fifth criterion is unnecessary because it does not provide additional human subject protections beyond what the other criteria provide. The fifth criterion respects subjects' interests in protecting the confidentiality of their information and biospecimens by embodying the principle that nonidentifiable private information and nonidentifiable biospecimens should be used whenever possible in clinical investigations for which informed consent is not obtained.
In response to the comment suggesting that the fifth criterion is unnecessary because “biospecimen research” does not involve a human subject and thus does not meet the definition of “clinical investigation,” we disagree. The comment points to FDA's definition of “human subject” in § 50.3(g) (“
We also do not agree that informed consent should never be waived for clinical investigations involving private information or biospecimens in an identifiable format. Such research plays an important role in the discovery and development of innovative medical products, and it may not be practicable to perform the research if investigators are required to obtain informed consent from the individuals associated with the private information or biospecimens. Without the possibility of a waiver of informed consent, scientific progress in many therapeutic areas could be slowed. We believe that the criteria for obtaining a waiver or alteration of informed consent in § 50.22 (including, for example, that “[t]he waiver or alteration will not adversely affect the rights and welfare of the subjects”), in conjunction with the requirement in § 56.111(a)(7) that requires IRBs, in order to approve research, to determine that “[w]here appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data,” adequately protect the privacy of individuals while not unduly inhibiting research that could benefit the public health.
A few public comments address the applicability of § 50.22 to secondary research involving previously collected human biospecimens.
(Comment 17) One comment points out that FDA has an existing policy, the “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” (Leftover Specimen Guidance; Ref. 12), that addresses the use, without informed consent, of nonidentifiable leftover human specimens in certain in vitro diagnostic (IVD) device investigations. This comment recommends incorporating key elements of section IV of the Leftover Specimen Guidance into § 50.22(a) to clarify when IRBs may waive informed consent for IVD device investigations that use nonidentifiable leftover human specimens. The comment specifically proposes adding a new paragraph to § 50.22(a) that would identify IVD device investigations meeting these key elements as examples of clinical investigations that involve no more than minimal risk to subjects.
(Response 17) We decline the commenter's suggestion to add a new paragraph to § 50.22(a) that would include key elements of section IV of the Leftover Specimen Guidance as examples of clinical investigations that involve no more than minimal risk to the subjects because such a change would create unnecessary differences between the revised Common Rule's general waiver provision (
We believe that most IVD device investigations falling within the scope of the policy described in section IV of the Leftover Specimen Guidance will satisfy the criteria at § 50.22. However, to the extent that there are IVD device investigations that fall within the scope of the Leftover Specimen Guidance but do not satisfy the waiver criteria in § 50.22, FDA is retaining the Leftover Specimen Guidance at this time to help avoid potential disruption to IVD device investigations as IRBs gain experience implementing the new waiver provision in § 50.22 for FDA-regulated clinical investigations.
(Comment 18) Two comments support the proposal, noting that it would facilitate research on residual biospecimens (
(Response 18) FDA agrees that clinical investigations involving the use, without informed consent, of previously collected biospecimens and related clinical data can play an important role in the development of new medical products, provided that the rights, safety, and welfare of the subjects from whom the data and/or biospecimens were obtained are adequately protected. For example, leftover biospecimens are frequently used in feasibility studies and studies to characterize the performance of new IVD devices. In addition, banked leftover biospecimens can be a source for unique and possibly rare specimens in sufficient quantity to permit the rapid completion of IVD device investigations that would be very difficult to conduct in a reasonable timeframe without these specimens. This rule addresses the minimal risk secondary research use of biospecimens that are individually identifiable by permitting IRBs to waive or alter informed consent for a clinical investigation involving the use of such specimens if they find and document that the waiver criteria in § 50.22 have been satisfied.
In the proposed rule, FDA solicited additional public input on the types of FDA-regulated clinical investigations for which sponsors would anticipate requesting a waiver or alteration of informed consent from the IRB. Several respondents provide examples of the types of studies for which sponsors would anticipate requesting a waiver or alteration of informed consent.
(Comment 19) Several comments provide the example of secondary research on biospecimens,
One comment provides the hypothetical example of an investigator who wants to use archived prostate cancer biospecimens and clinical data for a study of a new molecular marker of response to treatment for which the investigator anticipates submitting an application to FDA. The comment includes the caveat that the investigator could use the archived biospecimens with 10 years of clinical data but for the ability to obtain informed consent from patients. The comment concludes that, while this kind of research would offer tremendous potential to advance medical care, it would not be possible under the existing FDA regulations. The comment cites this study as an example of the type of study that would be appropriate for a waiver of informed consent under the proposed rule.
Several comments suggest that studies including RWD would exemplify of the type of studies that would benefit from the proposed regulations. One comment describes several examples of minimal risk research including RWD, such as: (1) minimal risk studies that involve previously collected biospecimens and/or data from prior studies, with the safeguard that subjects' personal data must remain protected from public disclosure; retrospective or prospective use of de-identified subject data collected in registries (
One comment provides an example of “minimal risk emergency research” that does not hold out the prospect of direct benefit to the subjects as a type of study where requesting a waiver or alteration of informed consent would be anticipated. The comment suggests that sponsors may want to study FDA-approved products where the use of the product is no more than minimal risk. As an example, this comment cites a clinical investigation for a new indication for an approved diagnostic device utilizing ultrasound for the diagnosis of lower extremity venous thromboses being studied for the detection of cerebral thromboses in an acute, pre-hospital setting,
Finally, several comments request that FDA provide specific examples of the types of clinical investigations intended to be covered by the rule, while one comment argues that instances in which informed consent is difficult or impossible to obtain in minimal risk clinical investigations would be rare and that many common examples used to illustrate minimal risk research are unlikely to qualify as clinical investigations.
(Response 19) FDA appreciates the efforts of those commenters responding to our request for examples of FDA-regulated clinical investigations for which sponsors would anticipate requesting a waiver or alteration of informed consent from the IRB. To the extent that the studies described in the comments would be considered FDA-regulated clinical investigations, we agree that some of the examples appear to be of the type for which we would anticipate sponsors might request a waiver or alteration of informed consent (
(Comment 20) Several comments generally support the proposed rule, but ask FDA to place additional restrictions on, or limit the types of studies eligible for, such a waiver or alteration. Some comments suggest that the Agency place limitations on waivers or alterations of informed consent, such as limiting the duration of the research to 1 year or less or limiting the number of occurrences in which a waiver of consent can be used for any individual to one. Some of these comments also recommend precluding waivers or alterations of consent for a variety of research activities, including research involving interventions or invasive procedures, behavior modifications, the introduction of energy into the human body, and data collection from an individual's body or behavior in a private space. Two comments suggest that a notice be published in the
Other comments oppose permitting a waiver of informed consent for certain types of research, such as studies involving RWD and those being conducted in learning healthcare systems, use of specimens without consent, or studies in certain research populations, such as children or adults of diminished capacity.
A final comment states that waivers or alterations of informed consent should never be permitted for interventions on human subjects.
(Response 20) FDA does not agree with the comments suggesting that we limit the duration or number of studies that may be eligible for a waiver or
We also do not agree with the comments stating that individual or public notice should be required for every minimal risk clinical investigation conducted with a waiver of informed consent. While FDA regulations provide for community consultation and public disclosure in the context of the exception from informed consent requirements for emergency research (see § 50.24), FDA does not believe minimal risk research that is reviewed by an IRB and found to meet the criteria in § 50.22 necessitates these additional protections. However, under § 50.22(e), IRBs may find that additional pertinent information must be provided to subjects or their LARs after participation for the clinical investigation to qualify for a waiver or alteration of informed consent under § 50.22.
With regard to excluding children and adults with diminished capacity from the types of studies that may be conducted under § 50.22, we believe it is appropriate for studies with child subjects to qualify for a waiver or alteration under § 50.22 when the IRB finds and documents that the criteria in § 50.22 are satisfied. In addition to the requirements of § 50.22, other requirements in FDA's regulations are intended to ensure that the rights and welfare of child subjects are adequately protected. For example, to approve a clinical investigation involving children as subjects, the IRB must determine that the clinical investigation meets the requirements of part 50, subpart D, Additional Safeguards for Children in Clinical Investigations (see 21 CFR 50.50 and 56.109(h)). Similarly, FDA regulations at § 56.111(b) require that additional safeguards be included in studies to protect the rights and welfare of subjects likely to be vulnerable to coercion or undue influence. Further, § 56.111(a)(3) requires IRBs to make an assessment that the selection of subjects for any clinical investigation is equitable, including that the IRB “should be particularly cognizant of the special problems of research involving vulnerable populations.”
FDA believes that IRBs can appropriately determine whether the criteria in § 50.22 are satisfied for research involving vulnerable populations, including children and adults with diminished capacity. FDA encourages IRBs to carefully consider the anticipated risks of the investigation as they might specifically affect vulnerable populations included in the proposed research when making findings regarding the “minimal risk” criterion in § 50.22(a).
Finally, we do not agree that a waiver or alteration of informed consent should never be allowed for interventions on human subjects as part of a minimal risk clinical investigation. We note that the definition of minimal risk included in FDA's regulations at § 50.3(k) is identical to the definition of minimal risk found in the revised Common Rule at 46 CFR 46.102(j). The current definition of minimal risk in both FDA regulations and in the revised Common Rule states that minimal risk means “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or
Several comments specifically request that FDA issue guidance on topics related to the proposed rule.
(Comment 21) A few comments request clarification and guidance to ensure that IRBs apply the criteria in § 50.22 appropriately and consistently. As noted above, several commenters request additional guidance to clarify the terms “minimal risk” and “practicability.” Others specifically ask for guidance on the applicability of a waiver for studies comparing the effectiveness of FDA-approved products to help IRBs understand and apply the criteria consistently.
One comment requests that detailed guidance on the types of clinical investigations that would and would not qualify for the waiver of informed consent be issued simultaneously with the final rule. This comment expresses the concern that clinical investigators will inappropriately seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk to subjects after FDA finalizes the proposed rule. The comment cites studies that, according to the comment, were inappropriately characterized as minimal risk by researchers and states that researchers have often mischaracterized the nature of their studies involving human subjects and minimized the risks of the procedures involved in the research in an effort to avoid the requirements for obtaining and documenting the informed consent of the human subjects.
One comment requests guidance on the relationship and interplay between the new waiver criterion (
(Response 21) Throughout this document we provide clarification of specific terms and phrases that are used in this rule. As discussed in section V.C, many of the terms used in § 50.22 have longstanding definitions in both the Common Rule and FDA's regulations (
FDA believes that the structure of § 50.22, requiring IRBs to find and document that applicable criteria are met, provides appropriate safeguards to protect the rights, safety, and welfare of human subjects. We note that § 50.22 requires that the IRB responsible for the review, approval, and continuing review of a minimal risk clinical investigation
(Comment 22) One comment requests that FDA provide clarification or advisory text for sponsors, investigators, and IRBs to carefully consider the specific data elements to be collected as part of research to determine the applicability of the HIPAA Privacy Rule requirements.
(Response 22) FDA agrees that the protection of human subjects' privacy when participating in clinical investigations is important, including when the investigation uses data collected as part of clinical care. We note that the criteria for IRB approval of research in our current regulations at § 56.111(a)(7) require that, to approve research, IRBs determine that “[w]here appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.” This provision requires IRBs to review clinical investigations to ensure that appropriate privacy safeguards are in place to protect human subjects involved in FDA-regulated clinical investigations.
Applicability of the HIPAA Privacy Rule to clinical investigations covered by § 50.22 is outside the scope of this rulemaking. However, we note that the standards laid out in both the HIPAA Privacy Rule and the Common Rule have coexisted for many years. Accordingly, FDA believes that IRBs have experience considering both rules when reviewing minimal risk research. By harmonizing the waiver criteria set forth in § 50.22 with those set forth in the revised Common Rule's general waiver provision, we are promoting consistency in the application of such requirements across Common Rule Agencies and minimizing burden to IRBs tasked with applying the criteria described in this rule to FDA-regulated research.
(Comment 23) Some comments question the interpretation of “minimal risk” in the proposed rule in relation to the list of categories of research that may be reviewed by the IRB through an expedited review procedure (“expedited review list,” Ref. 14). One comment disagrees with categories of research included on the expedited review list. Another comment notes that, while the expedited review list categories could provide some benchmarks for the types of research that are minimal risk, these applications are limited and there may be research that qualifies as “minimal risk,” that would not qualify for the expedited review procedure.
Similarly, some comments express concern that the proposed rule did not address how FDA intends to harmonize with the revised Common Rule with respect to expedited review procedures and IRB continuing review. A few comments cite SACHRP's recommendations on the expedited review list (Ref. 15) and note concern about FDA and HHS adopting them. These comments assert that if FDA and HHS adopt the SACHRP recommendations and FDA harmonizes with changes made in the revised Common Rule regarding expedited review (
(Response 23) FDA agrees with the comments to the extent they emphasize the importance of ensuring that waivers or alterations of informed consent under this rule are granted only for research that presents no more than minimal risk to the subjects. However, we do not agree that it is necessary to address how FDA intends to harmonize with the revised Common Rule's expedited and continuing review requirements as part of this rulemaking, which finalizes our proposal to permit an IRB to approve an informed consent procedure that waives or alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk investigations. FDA issued a separate proposed rule to amend its regulations at parts 50 and 56, including with respect to expedited and continuing review (87 FR 58733), and will consider all timely comments received as part of that rulemaking, including those related to expedited review and/or continuing review. We address below the more specific concerns raised by the comments in relation to expedited or continuing review.
Some of the comments appear concerned that any changes to the FDA expedited review requirements intended to harmonize with the revised Common Rule could be perceived by the research community as broadening what qualifies as minimal risk or discourage determinations that a study presents more than minimal risk. As an initial matter, the revised Common Rule did not modify the current definition of “minimal risk” that is found in HHS regulations (45 CFR 46.102(j)), so FDA regulations (§ 50.3(k)) remain consistent with the definition of “minimal risk” provided in the revised Common Rule. In addition, under FDA's regulations at § 56.110(b)(1), for research to qualify for expedited review, a determination must be made by an IRB that the proposed research involves no more than minimal risk to human subjects. In other words, under current FDA regulations, the categories of activities appearing on the expedited review list are not presumed to be minimal risk. FDA's proposed rule to amend parts 50 and 56 (87 FR 58733) does not propose to change this. In addition, the revised Common Rule did not modify the 1998 expedited review list (63 FR 60364), so HHS and FDA (63 FR 60353) maintain identical lists of categories of research activities that may be reviewed by an IRB through the expedited review procedure. As described in the revised Common Rule, an IRB may use the expedited review procedure to review studies that involve activities appearing on the expedited review list, unless the IRB reviewer determines that the studies involve more than minimal risk (see 45 CFR 46.110(b)(1)(i)). However, OHRP has clarified that, until a new expedited review list is finalized, the entire 1998 HHS expedited review list, including the “Applicability” section, remains in
As noted in comments, the revised Common Rule provision at 45 CFR 46.109(f)(1)(i) eliminates the requirement for an IRB to conduct continuing review of research that is eligible for expedited review in accordance with 45 CFR 46.110, unless the IRB determines otherwise. FDA's IRB continuing review requirements are not being revised in this rule. As explained above, FDA is engaged in separate rulemaking to amend parts 50 and 56 to harmonize with the revised Common Rule in accordance with section 3023 of the Cures Act. As part of that effort, FDA proposed changes to eliminate the requirement for an IRB to conduct continuing review of research, unless an IRB determines otherwise, that has progressed to the point that it involves only data analysis, including analysis of identifiable private information or identifiable biospecimens, and/or accessing followup clinical data from procedures that subjects would undergo as part of clinical care. However, FDA's proposed rule to amend parts 50 and 56 (87 FR 58733) does not propose to eliminate continuing review of all research eligible for expedited review, unless the IRB determines otherwise, for the reasons described in the preamble to that proposed rule. FDA will take into account the comments urging that minimal risk studies for which an IRB waives informed consent remain subject to IRB continuing review as part of finalizing any changes to continuing review requirements in that separate rulemaking.
As HHS evaluates and amends, as appropriate, its current expedited review list as required under 45 CFR 46.110(a), FDA intends to participate in the process and will update our own expedited review list, as appropriate, and will consider if any related changes to our regulations are necessary.
(Comment 24) Some comments describe support for the rule because it will reduce administrative burden and result in cost savings. Other comments express the view that the proposed cost savings of the rule are low and may not outweigh the negative impact of waiving informed consent for certain minimal risk studies. One comment states that, although the potential benefits cannot be fully quantified, the analysis should focus on some of the drawbacks of this rule.
(Response 24) As discussed in section VII, FDA believes that this rule will reduce administrative burden and that any costs incurred are outweighed by non-quantifiable benefits in the form of healthcare advances resulting from research performed using a waiver or alteration of informed consent, as well as a reduction in burden for the research community arising from the harmonization of FDA's informed consent regulations with the revised Common Rule's provision for waiver or alteration of informed consent for certain minimal risk research.
However, as part of developing a response to this comment, we reanalyzed the proposed rule to consider potential additional costs associated with the rulemaking. Based on that review, we determined that there are some one-time costs associated with reading and implementing the rule, which we anticipate to be small because the final rule is harmonized with Common Rule provisions with which the clinical research community is already familiar. We also determined that there are some annual costs associated with drafting and reviewing requests for a waiver or alteration of consent. In this final rule, we include a revised analysis of cost and cost savings in the Economic Analysis of Impacts (section VII). We also determined that some of these costs are associated with collections of information subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA). For further information, see section IX.
(Comment 25) We proposed that any final rule issued based on the proposed rule would become effective 30 days after its date of publication in the
(Response 25) In response to this comment, we note that the rule will apply to IRB review at any stage of an FDA-regulated clinical investigation conducted on or after the effective date, including initial IRB approval or review of any changes to a previously approved clinical investigation.
This rule is effective 30 days after the date of its publication in the
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 14094, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866 Section 3(f)(1) (as amended by Executive Order 14094) if they “have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” OIRA has determined that this final rule is not a significant regulatory action under Executive Order 12866 Section 3(f)(1).
A rule is “major” under the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act if it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in the Congressional Review Act (5 U.S.C. 804(2)). OIRA has determined that this
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule is unlikely to impose a substantial burden on the affected small entities, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated impacts, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $177 million, using the most current (2022) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
We expect costs in the form of affected IRBs, as well as investigators and sponsors of clinical investigations, reading and learning the rule. We also expect costs in the form of drafting new waiver or alteration requests, and additional recordkeeping burdens associated with reviewing and documenting IRB decisions on waiver or alteration requests. The net present value of the estimated costs of the rule are approximately $10.1 million, with a lower bound of approximately $8.1 million and an upper bound of approximately $14.0 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated costs of the rule are approximately $9.1 million, with a lower bound of approximately $7.5 million and an upper bound of approximately $12.4 million. The estimated annualized costs of the rule are approximately $1.2 million, with a lower bound of approximately $0.9 million and an upper bound of approximately $1.6 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated annualized costs of the rule are approximately $1.3 million, with a lower bound of approximately $1.1 million and an upper bound of approximately $1.8 million.
We also expect that there will be cost savings to IRBs because the time burdens of reviewing waiver or alterations requests would be reduced from harmonization of FDA's informed consent regulations with the provision for waiver or alteration of informed consent for certain minimal risk research in the Common Rule. The estimated net present value of the cost savings of the rule are approximately $1.7 million, with a lower bound of approximately $0.9 million and an upper bound of approximately $3.5 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated cost savings of the rule are approximately $1.4 million, with a lower bound of approximately $0.7 million and an upper bound of approximately $2.8 million. The estimated annualized cost savings of the rule are approximately $0.2 million, with a lower bound of approximately $0.1 million and an upper bound of approximately $0.4 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated annualized costs savings of the rule are approximately $0.2 million, with a lower bound of approximately $0.1 million and an upper bound of approximately $0.4 million.
We expect benefits in the form of healthcare advances from minimal risk clinical investigations for which the requirements for informed consent are waived or altered under the final rule and that otherwise would not be conducted. We cannot quantify all benefits that might arise from such studies because of the lack of relevant data available regarding the focus of these types of studies that will support regulatory submissions to the Agency. The costs and cost savings of the rule are summarized in table 1.
We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Docket No. FDA-2018-N-2727) and at
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
In the proposed rule, FDA stated, “This proposed rule refers to previously approved collections of information found in FDA regulations. . . . Therefore, FDA tentatively concludes the requirements in this document are not subject to additional review by OMB.” In developing the final rule, FDA determined that there are information collections contained in the rule that are subject to review by OMB under the PRA (44 U.S.C. 3501-3521). Specifically, the final rule adds § 50.22 to part 50 to allow IRBs responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations, provided the IRB finds and documents the criteria set forth in § 50.22(a)-(e). The information collections associated with part 50 have been approved in accordance with the PRA under OMB control number 0910-0130, but the additional provision at § 50.22 will modify this information collection. We estimate the rulemaking will result in an annual burden increase of 1,102 responses and 1,102 hours from recordkeeping and disclosure activity relating to the revised regulations in 21 CFR part 50.
With this exception, we conclude that the other provisions of this rule do not require substantive revisions to information collections already approved under the PRA. Provisions in part 312 (21 CFR part 312) of FDA's regulations set forth procedures for the conduct of clinical investigations of drugs and provide for the protection of human subjects involved in such investigations. Existing regulations at § 312.60 describe the general responsibilities of investigators with regard to study conduct, including ensuring the rights, safety, and welfare of human subjects. As part of these responsibilities, the current regulations require that investigators obtain informed consent, except as provided in exceptions from general requirements (§ 50.23) and exception from informed consent requirements for emergency research (§ 50.24). This final rule, as noted above, adds an additional exception to include waiver or alteration of informed consent for minimal risk clinical investigations under § 50.22. Therefore, FDA made a conforming revision to § 312.60 to cross-reference part 50 generally, rather than list each specific exception to the informed consent requirements, for simplicity and for accuracy of the cross-references in the regulatory text. FDA does not expect changes to the collections of information approved under OMB control number 0910-0014 as a result of this final rule. In addition, FDA's existing regulations at § 812.2 describe abbreviated requirements for IDEs, which require that investigators obtain and document informed consent under part 50, unless documentation is waived under IRB regulations at § 56.109(c). This final rule amends § 812.2(b)(1)(iii) to clarify that the investigator must obtain informed consent in accordance with part 50, which includes the new provision for waiver or alteration in § 50.22. The final rule also simplifies the regulatory text at § 812.2(b)(1)(iii) by removing the cross-reference to waiver of documentation of informed consent under § 56.109(c). The relevant section of the regulations in part 50 (
Before the effective date of this final rule, FDA will publish a notice in the
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.
The following references are on display at the Dockets Management Staff (see
Human research subjects, Prisoners, Reporting and recordkeeping requirements, Safety.
Drugs, Exports, Imports, Investigations, Labeling, Medical research, Reporting and recordkeeping requirements, Safety.
Health records, Medical devices, Medical research, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 50, 312, and 812 are amended as follows:
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262.
Except as provided in §§ 50.22, 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. * * *
The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b), or may waive the requirement to obtain informed consent, provided the IRB finds and documents the following:
(a) The clinical investigation involves no more than minimal risk to the subjects;
(b) The clinical investigation could not practicably be carried out without the requested waiver or alteration;
(c) If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format;
(d) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
(e) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. An
21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.
(b) * * *
(1) * * *
(iii) Ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator's care, informed consent in accordance with part 50 of this chapter.
Coast Guard, DHS.
Final rule.
The rule makes non-substantive changes to Coast Guard regulations in association with a change in the Coast Guard's internal organization. The purpose of this rule is to reflect that U.S. Coast Guard Sector Sault Sainte Marie has been renamed U.S. Coast Guard Sector Northern Great Lakes. This rule will have no substantive effect on the regulated public.
This rule is effective without actual notice December 21, 2023. For the purposes of enforcement, actual notice will be used from December 1, 2023, until December 21, 2023.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email Chief Warrant Officer Charles Palmer, U.S. Coast Guard; telephone 906-253-2462, email
For the last several years, the Coast Guard has sought to better align the names of its assets to correspond to the area of responsibility which they serve. Review of the missions and engagements within the northern Great Lakes region highlighted that “Sector Sault Sainte Marie” alone did not adequately capture the breadth and range of Coast Guard operations and relationships throughout the region. The Coast Guard has approved the name change to U.S. Coast Guard Sector Northern Great Lakes to acknowledge the long-standing commitment to all communities of the region and to reaffirm the multi-mission support that the Coast Guard provides to ensure safety at sea and enhanced maritime governance. The geographic boundaries of Sector Northern Great Lakes are not changing, and its office is not moving from Sault Sainte Marie, MI.
We did not publish a notice of proposed rulemaking (NPRM) before this final rule. The Coast Guard finds that this rule is exempt from notice and comment rulemaking requirements under 5 U.S.C. 553(b)(A) because the changes it makes are conforming amendments involving agency organization. The Coast Guard also finds good cause exists under 5 U.S.C. 553(b)(B) for not publishing an NPRM because the changes will have no substantive effect on the public and notice and comment are therefore unnecessary. For the same reasons, the Coast Guard finds good cause exists under 5 U.S.C. 553(d)(3) to make the rule effective fewer than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 14 U.S.C. 504(a)(2), as delegated at 33 CFR 1.05-1(h), to issue regulations necessary to implement technical, organizational, and conforming amendments and corrections to rules, regulations, and notices.
On November 06, 2023, the Coast Guard issued Operating Facility Change Order (OFCO) No. 037-23 which changed the official unit name of U.S. Coast Guard Sector Sault Sainte Marie to U.S. Coast Guard Sector Northern Great Lakes. The previous name of Sector Sault Sainte Marie is described and reflected in regulations, which also contain contact details and other references to Sector Sault Sainte Marie. These conforming amendments update those regulations so that they contain current information.
Under 14 U.S.C. 504(a)(2), the Commandant of the Coast Guard has the authority to establish and prescribe the purpose of Coast Guard Shore establishments. This authority has been delegated to the Chief of the Coast Guard's Office of Regulations and Administrative Law under 33 CFR 1.05-1(h).
OFCO No. 037-23, issued November 06, 2023, changed the official unit name of U.S. Coast Guard Sector Sault Sainte Marie to U.S. Coast Guard Sector Northern Great Lakes. The November 2023 OFCO did not change the area of responsibility (AOR). The AOR of U.S. Coast Guard Sector Northern Great Lakes is identical to that of what was U.S. Coast Guard Sector Sault Sainte Marie. All authorities and responsibilities previously assigned to Commander, U.S. Coast Guard Sector Sault Sainte Marie have been assigned to Commander, U.S. Coast Guard Sector Northern Great Lakes. Additionally, all authorities that were vested in the Commander, U.S. Coast Guard Sector Sault Sainte Marie as it pertains to the COTP, the OCMI, the Federal On Scene Coordinator, the Federal Maritime Security Coordinator, and the Search and Rescue Coordinator, have been assigned to Commander, U.S. Coast Guard Sector Northern Great Lakes. This rule does not change any sector, OCMI, or COTP zone boundary lines, nor does
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.
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 section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the finding that the name change will have no substantive effect on the public.
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.
For the reasons stated in section V.A. above, this rule will not have a significant economic impact on any member of the public, including “small entities.”
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 consists only of an organizational amendment. It is categorically excluded from further review under paragraph L3 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1, Implementation of the National Environmental Policy Act.
Organization and functions (Government agencies).
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
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 parts 3, 100, and 165 as follows:
14 U.S.C. 501, 504; Pub. L. 107-296, 116 Stat. 2135; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
46 U.S.C. 70041; 33 CFR 1.05-1.
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
Coast Guard, DHS.
Temporary interim rule and request for comments
The Coast Guard is temporarily modifying the operating schedule that governs the draw of the Zuckerman Brothers (McDonald Island) bridge, mile 2.3, across Turner Cut, near Stockton, CA. This action is necessary to allow the bridge owner, Reclamation District 2030 (RD2030), to complete design plans and conduct repairs to the bridge to bring it back to its normal operating status.
This temporary interim rule is effective from December 21, 2023 through 5 p.m. on September 30, 2024.
Comments and related material must reach the Coast Guard on or before January 22, 2024.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this temporary interim rule, call or email Carl Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email
The Coast Guard is issuing this temporary interim 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), 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. This bridge is secured closed and will be secured closed until design plans are finalized, coordination of construction schedule can be made with landowners and PG&E, contractor hired, and repairs completed.
On June 21, 2023, RD2030 notified the Coast Guard that the Zuckerman Brothers (McDonald Island) retractable span bridge should not open for the passage of vessels. The cause was the gradual movement which squeezed the abutments towards the center movable steel section. The span cannot be opened without the risk of it being stuck in the open-to-navigation position. The Zuckerman Brothers (McDonald Island) bridge is the only road in and out of McDonald Island, which includes farms and a PG&E station and wells. The Coast Guard granted a Notice of Temporary Deviation (NOTD) from the operating schedule of the bridge, allowing the span to be secured in the closed position until repairs can be made. The NOTD will expire at 7 a.m. on December 18, 2023. The design, coordination of work with affected parties, and repair is delayed. The retractable span will not be operational at the expiration of the NOTD. The Coast Guard received the report of these delays on November 17, 2023. Therefore, there is insufficient time to provide a reasonable comment period and then consider those comments before issuing the modification.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective in less than 30 days after publication in the
We are soliciting comments on this rulemaking. If the Coast Guard determines that changes to the temporary interim rule are necessary, we will publish a temporary final rule or other appropriate document.
The Coast Guard is issuing this temporary interim rule under authority in 33 U.S.C. 499. The Coast Guard is modifying the operating schedule that governs the Zuckerman Brothers (McDonald Island) bridge, mile 2.3, across Turner Cut, near Stockton, CA. The Zuckerman Brothers (McDonald Island) bridge has a vertical clearance, in the closed position, of 16 feet at mean high water and unlimited vertical clearance when opened.
The existing drawbridge regulation, 33 CFR 117.5, states that the draw of the Zuckerman Brothers (McDonald Island) bridge must open for vessels if a signal is given to do so. RD2030, the bridge owner, has requested this modification as additional time is required to complete bridge repairs.
Drawtender logs from January 2022 through June 2023 indicate the span opened on average, 2 times in January; 1 time in February; 1 time in March; 3 times in April; 11 times in May; 8 times in June; 18 times in July; 6 times in August; 7 times in September; 4 times in October; 2 times in November; and 3 times in December. No complaints have been received from mariners since the
The Coast Guard is issuing this rule, which permits a temporary deviation from the operating schedule that governs the Zuckerman Brothers (McDonald Island) bridge, mile 2.3, across Turner Cut, near Stockton, CA. This rule allows the bridge to be secured in the closed-to-navigation position through 5 p.m. on September 30, 2024.
RD2030 hired an engineering firm as part of the design, planning and repairs of the bridge. RD2030 and the engineers are working to finalize the plans for the repairs. RD2030 is also coordinating construction time windows with landowners on McDonald Island. PG&E is currently conducting major well rehabilitation on the island and have limited windows where their access to McDonald Island across the bridge can be interrupted. These elements contributed to the delay in the repairs to the retractable span. Currently, the retractable span is secured closed until repairs are complete. The anticipated completion of the repairs is September 30, 2024.
We developed this temporary interim 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.
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, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, it has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the fact that little or no commercial or recreational vessel traffic will be impacted by this rule. Furthermore, the retractable span of the bridge, as of date of the publication of this rule, should not be operated for fear of becoming non-operational in the partially open position until repairs can be made.
The Regulatory Flexibility Act of 1980 (RFA), 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 bridge may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no 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 Management Directive 023-01, Rev.1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series) which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has 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 promulgates the operating regulations or procedures for drawbridges and is categorically excluded from further review, under paragraph L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.
Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this rule.
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
The draw of the Zuckerman Brothers (McDonald Island) bridge, mile 2.3, near Stockton need not open for the passage of vessels.
Copyright Royalty Board (CRB), Library of Congress.
Final rule; correction.
On November 30, 2023, the Copyright Royalty Judges amended regulations governing royalty rates that commercial and noncommercial noninteractive webcasters pay for eligible transmissions pursuant to the statutory licenses for the public performance of and for the making of ephemeral reproductions of sound recordings. That document contained an incorrect reference to a rate. This document corrects that reference.
Anita Brown, (202) 707-7658,
On November 30, 2023, at 88 FR 83508, the Copyright Royalty Judges published a rule that contained an incorrect reference to a rate in the
In the
1. On page 85309, in the first column, in the fourth paragraph, correct “$0.20025” to read “$0.0025”.
Copyright Royalty Board, Library of Congress.
Correcting amendments; cost of living adjustment.
On December 12, 2023, the Copyright Royalty Judges amended regulations governing royalty rates for making and distributing physical phonorecords and Permanent Downloads of nondramatic musical works pursuant to statutory license. That document inadvertently omitted figures related to calculation of the adjusted rates and listed an incorrect per-minute rate.
Anita Brown, Program Specialist, (202) 707-7658,
This document provides an amplification of the information in the
Section 115 of the Copyright Act, title 17 of the United States Code, creates a statutory license for making and distributing phonorecords of nondramatic musical works. On December 16, 2022, the Copyright Royalty Judges (Judges) adopted final regulations governing the rates and terms of copyright royalty payments under that license for the license period 2024-2027 for making and distributing phonorecords of nondramatic musical works.
Pursuant to those regulations, at least 25 days before January 1 of each year, the Judges shall publish in the
The adjustment in the royalty fee shall be based on a calculation of the percentage increase in the Consumer Price Index for All Urban Consumers (CPI-U) published in November 2022 (298.012)
The adjusted rates for 2024 are 12.4 cents for the per-work rate and 2.38 cents for the per-minute rate.
Details of the required calculations were inadvertently omitted from the document published in the
Copyright, Phonorecords, Recordings.
In consideration of the foregoing, the Judges correct part 385 of title 37 of the Code of Federal Regulations by making the following correcting amendment:
17 U.S.C. 115, 801(b)(1), 804(b)(4).
(a) * * *
(1)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve a revision to the San Diego County Air Pollution Control District (SDCAPCD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of oxides of nitrogen (NO
This rule is effective January 22, 2024.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2023-0157. All documents in the docket are listed on the
Alina Batool, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105; by phone at (415) 972-3345 or by email at
Throughout this document, “we,” “us,” and “our” refer to the EPA.
On July 26, 2023 (88 FR 48150), the EPA proposed to approve the following rule into the California SIP.
We proposed to approve this rule because we determined that it complies with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.
The EPA's proposed action provided a 30-day public comment period. During this period, we received one comment that was supportive of the proposed action.
No comments were submitted that change our assessment of the rule as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule into the California SIP.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Rule 69.2.1, “Small Boilers, Process Heaters, Steam Generators, and Large Water Heaters,” revised on July 8, 2020, which regulates NO
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to
• 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 14094 (88 FR 21879, April 11, 2023);
• 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 subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
The State did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.
This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 20, 2024. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, the Environmental Protection Agency amends part 52, chapter I, title 40 of the Code of Federal Regulations as follows:
42 U.S.C. 7401
(c) * * *
(557) The following rules were submitted on September 21, 2020, by the Governor's designee as an attachment to a letter dated September 18, 2020.
(i) * * *
(B) * * *
(2) Rule 69.2.1, “Small Boilers, Process Heaters, Steam Generators, and Large Water Heaters,” revised on July 8, 2020.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing a revision to the Great Basin Unified Air Pollution Control District's (GBUAPCD or “District”) portion of the California State Implementation Plan (SIP). This revision governs the District's issuance of permits for stationary sources, and focuses on the preconstruction review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA or “the Act”).
This rule is effective January 22, 2024.
The EPA has established a docket for this action under Docket No. EPA-R09-OAR-2022-0925. All
Nidia Trejo, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105; by phone: (415) 972-3968, or by email at
Throughout this document, the terms “we,” “us,” and “our” refer to the EPA.
On August 28, 2023,
For areas designated nonattainment for one or more National Ambient Air Quality Standards (NAAQS), the applicable SIP must include preconstruction review and permitting requirements for new or modified major stationary sources of such nonattainment pollutant(s) under part D of title I of the Act, commonly referred to as Nonattainment New Source Review (NNSR). The rule listed in Table 1 contains the GBUAPCD's NNSR permit program applicable to new and modified major sources located in the District. Our proposed action contains more information on the rule and our evaluation.
The EPA's proposed action provided a 30-day public comment period. During this period, we received one comment, which was supportive of our proposal.
We received one comment that was supportive of our proposed action and did not change our findings regarding Rule 222. We continue to find that Rule 222 satisfies the relevant requirements for a CAA NNSR program for PM
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is incorporating by reference Great Basin Unified Air Pollution Control District's Rule 222 as described in Section I of this preamble. Rule 222 governs the District's issuance of permits for stationary sources, and focuses on the preconstruction review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA or “the Act”). The EPA has made, and will continue to make, these materials available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
• 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 subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it proposes to approve a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, the SIP is not approved to apply on any Indian reservation land
Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
The District did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goals of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.
This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 20, 2024. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate Matter, Reporting and recordkeeping requirements.
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(607) The following regulations were submitted on July 5, 2022, by the Governor's designee.
(ii)
(ii) Rule 222, “New Source Review Requirements for New and Modified Major Sources in Nonattainment Areas,” adopted on January 6, 2022.
(
(B) [Reserved]
(ii) [Reserved]
(d) * * *
(13) Great Basin Unified Air Pollution Control District.
Federal Communications Commission.
Final rule; announcement of effective and compliance dates.
In this document, the Federal Communications Commission (FCC or Commission) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with certain rules adopted in the Commission's documents
Michael Scott, Disability Rights Office, Consumer and Governmental Affairs Bureau, at (202) 418-1264, or email:
This document announces that, on December 5, 2023, and December 13, 2023, OMB approved, for a period of three years, the information collection requirements contained in the Commission's Report and Order, FCC 22-51, published at 87 FR 57645, September 21, 2022, and
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on December 5, 2023, and December 13, 2023, for the information collection requirements contained in the Commission's documents FCC 22-51 and FCC 22-76.
Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Numbers are 3060-1053 and 3060-1089.
The foregoing notification is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
On August 1, 2003, the Commission released
On July 19, 2005, the Commission released
On January 11, 2007, the Commission released
On August 26, 2013, the Commission issued
On June 8, 2018, the Commission issued
On February 15, 2019, the Commission issued
On June 30, 2022, the Commission issued
On September 30, 2022, the Commission released
Not-for-profit institutions; State, Local or Tribal Government.
The telecommunications relay service (TRS) program enables access to the nation's telephone network by persons with hearing and speech disabilities. In 1991, as required by the Americans with Disabilities Act and codified at 47 U.S.C. 225, the Commission adopted rules governing the telecommunications relay services (TRS) program and procedures for each state TRS program to apply for initial Commission certification and renewal of Commission certification of each state program.
Between 2008 and 2011, to integrate internet-based TRS into the North American Numbering plan and facilitate interoperability, universal calling, and 911 emergency services, the Commission adopted rules in three separate orders related to the telephone numbering system and enhanced 911 (E911) services for users of two forms of internet-based TRS: Video Relay Service (VRS) and Internet Protocol Relay service (IP Relay).
The rules adopted in these three orders have information collection requirements that include requiring VRS and IP Relay providers to: register each user who selects the provider as his or her default provider, including obtaining a self-certification from each user; verify the accuracy of each user's registration information; provision and maintain their registered users' routing information to the TRS Numbering Directory; place their users' Registered Location and certain callback information in Automatic Location Information (ALI) databases across the country and provide a means for their users to update their Registered Locations; include advisories on their websites and in any promotional materials addressing numbering and E911 services for VRS or IP Relay; verify in the TRS Numbering Directory whether each dial-around user is registered with another provider; and if they provide equipment to a consumer, make available to other VRS providers enough information about that equipment to enable another VRS provider selected as the consumer's default provider to perform all of the functions of a default provider.
On July 28, 2011, the Commission released
On June 10, 2013, the Commission made permanent the interim rules adopted in the
The
In the
On March 23, 2017, the Commission released
On May 15, 2019, the Commission released
On August 2, 2019, the Commission released
Fixed internet-based TRS devices must provide automated dispatchable location. For non-fixed devices, when dispatchable location is not technically feasible, internet-based TRS providers may fall back to Registered Location or provide alternative location information. As a last resort, internet-based providers may route calls to Emergency Relay Calling Centers after making a good faith effort to obtain location data from all available alternative location sources. Dispatchable location means a location delivered to the PSAP with a 911 call that consists of the validated street address of the calling party, plus additional information such as suite, apartment, or similar information necessary to adequately identify the location of the calling party. Automated dispatchable location means automatic generation of dispatchable location. Alternative location information is location information (which may be coordinate-based) sufficient to identify the caller's civic address and approximate in-building location, including floor level, in large buildings.
On January 31, 2020, the Commission released
On June 30, 2022, the Commission released
On September 30, 2022, the Commission released
Federal Communications Commission.
Final rule; correction.
The Federal Communications Commission (Commission) is correcting a final rule that appeared in the
For further information, contact Melissa Kirkel at
The Commission is correcting a final rule that appeared in the
Accordingly, in FR Rule Doc. No. 2023-26605 appearing on page 84406 in the issue of Tuesday, December 5, 2023, make the following correction:
(i)
Department of Transportation.
Final rule.
This final rule amends the Transportation Acquisition Regulation (TAR) to provide needed editorial changes. DOT is publishing a technical amendment to make a minor administrative correction to a TAR clause citation.
This rule is effective on December 21, 2023.
Ms. LaWanda Morton-Chunn, Procurement Analyst, Acquisition Policy, Oversight & Business Strategies (M-61), Office of the Senior Procurement Executive (OSPE), Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, (202) 366-2267. This is not a toll-free telephone number.
The purpose of this rule is to make a minor administrative correction to the clause at 1252.239-92, Information and Communication Technology Accessibility Notice, paragraph (b). This revision corrects an erroneous reference to a separate TAR clause.
TAR part 1252, 1252.239-92, Information and Communication Technology Accessibility Notice, paragraph (b), is revised to correct a typographical error to a reference to another TAR clause. The reference in paragraph (b) to the clause at 1252.239-81, Information and Communication Technology Accessibility, is revised to reference the clause at 1252.239-93, Information and Communication Technology Accessibility. The clause at 1252.239-81 is titled Cloud Identification and Authentication (Organizational Users) Multi-Factor Authentication, which is not the correct reference. The clause at 1252.239-93 is titled Information and Communication Technology Accessibility. The clause at 1252.239-93 is the clause that paragraph (b) of 1252.239-92 intended to reference.
This rule makes administrative changes that do not require prior notice and an opportunity for comment or a delayed effective date, consistent with 41 U.S.C. 1707, 48 CFR 1.301, and 48 CFR 1.501-3.
The statutes at 41 U.S.C. 1707(a) specifies a required comment period for procurement policies, regulations, procedures and forms. Specifically, a procurement policy, regulation, procedure, or form may not take effect until 60 days after it is published for public comment if it relates to the expenditure of funds and either (i) has a significant effect beyond the internal operating procedures of the agency issuing the action; or (ii) has a significant cost or administrative impact on contractors or offerors. An exception can be made if there are compelling circumstances for an earlier effective date. The statutes at 41 U.S.C. 1707(b) also requires agencies to publish proposed procurement regulations in the
The Department has determined that publication of this rule for notice and comment is not required pursuant to these authorities. The correction of the erroneous cross reference is an administrative change that will not have a significant effect on any party. The correction will not impose a significant cost, or have a significant administrative impact, on contractors or offerors. This final rule merely updates 1252.239-92 to reference the correct TAR clause.
The Office of Management and Budget (OMB) has determined that this rule is not a significant regulatory action under Executive Order 12866. Therefore, OMB did not review the final rule.
The Secretary hereby certifies that this final rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). The factual basis for this certification follows. This rulemaking does not change DOT's policy regarding small businesses, does not have an economic impact on individual businesses, and does not impose any increased or decreased costs on small business entities. Instead, it is merely an administrative correction to an erroneous cross reference. Therefore, pursuant to 5 U.S.C. 605(b), a regulatory flexibility analysis is not required.
This final rule does not contain any information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This rule has not been designated by the Office of Information and Regulatory Affairs as a major rule pursuant to the Congressional Review Act (5 U.S.C. 801
Government procurement, Reporting and recordkeeping requirements.
Signed under authority provided by 5 U.S.C. 301; 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304; 1.501-3, and 49 CFR 1.38 in Washington, DC, on December 14, 2023.
For the reasons set out in the preamble, DOT amends 48 CFR part 1252 as set forth below.
5 U.S.C. 301; 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Final rule.
NMFS issues this final rule “Approach Regulations for Humpback Whales in Waters Surrounding the Islands of Hawaii under the Marine Mammal Protection Act” under the Marine Mammal Protection Act (MMPA). This rule prohibits the “take” of humpback whales (
This rule is effective January 22, 2024.
Public comments and other supporting materials are available at
Elena Duke, NMFS, Pacific Islands Regional Office,
Protections for humpback whales in Hawaii were initially promulgated under the ESA, after NMFS determined that guidelines published in 1979 as a “Notice of Interpretation of `Taking by Harassment' in Regard to Humpback Whales in the Hawaiian Islands Area” (44 FR 1113; January 4, 1979) proved ineffective in protecting humpback whales in Hawaii from tour vessel operators approaching closer than the recommended viewing guidelines. The ESA rule that protected humpback whales in Hawaii was published on November 23, 1987 as an interim final rule (52 FR 44912), and then was finalized on January 19, 1995 (60 FR 3775). That rule made it unlawful to operate an aircraft within 1,000 feet (ft), approach by any means within 100 yards (yds), cause a vessel or another object to approach within 100 yds, or disrupt the normal behavior or prior activity of a humpback whale by any other act or omission. Regulations regarding the implementation of the ESA were then reorganized on March 23, 1999, with the section containing the approach regulations for humpback whales in Hawaii, changed from 50 CFR 222.31 to 50 CFR 224.103 (64 FR 14052).
NMFS published a final ESA listing rule on September 8, 2016 (81 FR 62259) that revised the species-wide
However, NMFS determined that, although unpermitted take is prohibited by the MMPA for humpback whales or any marine mammals in any location, specific regulations were warranted to address approach and human interactions that result in the take of humpback whales in Hawaii. These specific regulations were warranted because: (1) humpback whales are charismatic and sought out by local community members and tourists; (2) commercial and recreational whale watchers and other tour operators are expected to pursue humpback whales for close encounters absent any protections; (3) increasing numbers of both humpback whales and humans using Hawaiian waters raises the likelihood of human-whale interactions; and (4) approaching whales during the breeding, calving, and nursing season is likely to cause a disturbance that could adversely affect reproduction and development of individuals.
Therefore, an interim final rule was published on September 8, 2016, to ensure that there was no lapse in protection for humpback whales in Hawaii once the final ESA listing rule became effective on October 11, 2016. The interim final rule prohibited operating an aircraft within 1,000 ft (304.8 meters (m)) of a humpback whale, approaching within 100 yds (91.4 m) of a humpback whale by any means, causing a vessel, person or another object to approach within 100 yds (91.4 m) of a humpback whale, or approaching a humpback whale by interception (
This final rule serves to clarify the interim final rule by amending regulatory language in paragraphs (a)(5) and (b) of 50 CFR 216.19. The changes to 50 CFR 216.19 include a punctuation correction in paragraph (a)(5), a word change in paragraph (b)(3), and further clarification of exception 1, described in paragraph (b)(1). This final rule also amends the regulatory language in 50 CFR 216.19(b)(4) to clarify the scope of NMFS-permitted or authorized activities that may fall under that exemption. The exemption under 50 CFR 216.19(b)(4) in the interim final rule reads “vessels or persons authorized under permit or authorization issued by NMFS to conduct scientific research or response efforts that may result in taking of humpback whales.” However, the exemption as worded in the interim rule leaves out other potentially permitted or authorized activities. The intent of the rule was not to preclude the issuance of permits or authorizations for purposes of scientific research, enhancement, educational or commercial photography, or during emergency response of stranded or entangled marine mammals, or persons authorized to incidentally take humpback whales consistent with the requirements of the MMPA. Therefore, NMFS is amending 50 CFR 216.19(b)(4) to read, “Activities authorized through a permit or authorization issued by the National Marine Fisheries Service to take humpback whales.”
Under the MMPA, the regulations apply to all humpback whales found in the action area, as described below.
The action area for this rule is limited to the waters within 200 nmi (370.4 km) from the shore of the islands of Hawaii. The islands of Hawaii consist of the entire Hawaiian Archipelago, including the main Hawaiian Islands (Hawai'i, Maui, Kaho'olawe, Lāna'i, Moloka'i, O'ahu, Kaua'i, and Ni'ihau) and the Northwestern Hawaiian Islands.
The regulations apply to all forms of approach in water and air. Forms of approaching humpback whales include, but are not limited to, operating a manned or unmanned motorized, non-motorized, self-propelled, human-powered, or submersible vessel; operating a manned aircraft; operating an unmanned aircraft system (UAS) or drone; and swimming at the water surface or underwater (
The regulations prohibit people from operating aircraft within 1,000 ft (304.8 m) or approaching by any means within 100 yds (91.4 m) of humpback whales within the action area described above (see
The following specific categories are exempt from the regulations:
(1) Federal, State, or local government vessels, aircraft, personnel, and assets, when necessary, in the course of performing official duties;
(2) Vessel operations necessary to avoid an imminent and serious threat to a person, vessel, or the environment;
(3) Vessels restricted in their ability to maneuver that, because of this restriction, are not able to comply with approach restrictions; or
(4) Activities authorized through a permit or authorization issued by the National Marine Fisheries Service to take humpback whales.
NMFS solicited public comments on the interim final rule and received 10 comments. Several comments contained similar recommendations and/or questions and are consolidated. In response to comments, NMFS concurred with comments of support and clarified why NMFS is taking this action specific to humpback whales and not all cetaceans. NMFS provided rationale for not including regulations on speed, approach angle, and engine operating procedures in this rule making. NMFS
Regarding exceptions or exemptions to this rule, for exceptions to apply, a person must be a Federal, State, or local government official operating in the course of their official duties; avoiding an imminent and serious threat to a person, vessel, or the environment; authorized under permit or other authorization issued by NMFS; or operating a vessel restricted in its ability to maneuver. Additional details regarding exceptions to these regulations are provided in the final rule below in (b) Exceptions. Any person claiming the benefit of any exemption, exception, or permit has the burden of proving that the exemption or exception is applicable. Enforcement officials will consider and collect, as part of the normal investigative process, all available evidence, including evidence tending to support a party's claim to be exempt from the rule.
Regarding intent, the MMPA is a strict liability statute, meaning the intention of a party violating a regulation issued under the MMPA is not relevant for purposes of liability. Nonetheless, the Agency does consider the individual circumstances of each violation in deciding on an appropriate enforcement response and assessing any penalties. Under the Agency's penalty policy, available to the public at
Specifically, regarding the acquisition of up-close footage of whales, the regulations include exceptions to the 100-yd approach regulations for humpback whales in Hawaii, including an exception for vessels or persons authorized under permit or authorization issued by NMFS to take humpback whales for purposes of scientific research, enhancement educational or commercial photography, or during emergency response of stranded or entangled marine mammals; or persons authorized to incidentally take humpback whales.
NMFS prepared an EA pursuant to NEPA (42 U.S.C. 4321,
This final rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866.
The purpose of the Paperwork Reduction Act is to minimize the paperwork burden for individuals, small businesses, educational and nonprofit institutions, and other persons resulting from the collection of information by or for the Federal government. The final rule includes no new collection of information, so further analysis is not required.
NMFS determined that the interim final rule would be implemented in a manner consistent, to the maximum extent practicable, with the enforceable policies of the approved coastal zone management program of the State of Hawaii. The State of Hawaii's Coastal Zone Management Program (the responsible State agency under section 307(c)(1) of the Federal Coastal Zone Management Act (CZMA) of 1972) provided a letter, dated May 13, 2016, concurring with NMFS's federal consistency determination. Because the interim final rule is substantively the same as this final rule, no updated CZMA documentation is necessary.
E.O. 13132 requires agencies to take into account any federalism impacts of regulations under development. It includes specific directives for consultation in situations in which a regulation will preempt State law or impose substantial direct compliance costs on State and local governments (unless required by statute). Neither of those circumstances applies to this final rule; therefore, this action does not have federalism implications as that term is defined in E.O. 13132.
Pursuant to section 515 of Public Law 106-554 (the Information Quality Act), this information product has undergone a pre-dissemination review by NMFS. The signed Pre-dissemination Review and Documentation Form is on file with the NMFS Pacific Islands Regional Office (see
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Administrative practice and procedure, Marine mammals.
For the reasons set out in the preamble, NMFS amends 50 CFR part 216 as follows:
16 U.S.C. 1361,
(a) * * *
(5) Disrupt the normal behavior or prior activity of a whale by any other act or omission. A disruption of normal behavior may be manifested by, among other actions on the part of the whale, a rapid change in direction or speed; escape tactics such as prolonged diving, underwater course changes, underwater exhalation, or evasive swimming patterns; interruptions of breeding, nursing, or resting activities; attempts by a whale to shield a calf from a vessel or human observer by tail swishing or by other protective movements; or the abandonment of a previously frequented area.
(b)
(1) Federal, State, or local government vessels, personnel, and assets, when necessary, in the course of performing official duties;
(2) Vessel operations necessary to avoid an imminent and serious threat to a person, vessel, or the environment;
(3) Vessels restricted in their ability to maneuver that, because of this restriction, are not able to comply with approach restrictions; or
(4) Activities authorized through a permit or authorization issued by the National Marine Fisheries Service to take humpback whales.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS announces 2024 specifications for the summer flounder, scup, and black sea bass fisheries, and projected 2025 specifications for summer flounder and scup. The implementing regulations for the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan require us to publish specifications for the upcoming fishing year for each of these species and to respond to public comments received during the public comment period. This action is intended to inform the public of the specifications for the start of the 2024 fishing year for summer flounder, scup, and black sea bass. A Supplemental Information Report (SIR) was prepared for the 2024 black sea bass specifications. An Environmental Assessment (EA) was prepared for the 2024 and projected 2025 summer flounder and scup specifications.
This rule is effective January 1, 2024.
Copies of the SIR and EA 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. The SIR and EA are also accessible via the internet at
Emily Keiley, Fishery Policy Analyst, (978) 281-9116, or
The Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) cooperatively manage the summer flounder, scup, and black sea bass fisheries. The Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) outlines the Council's process for establishing specifications. The FMP requires NMFS to set an acceptable biological catch (ABC), annual catch limit (ACL), annual catch targets (ACT), commercial quotas, recreational harvest limits (RHL), and other management measures, for 1 to 3 years at a time. This action establishes the 2024 ABCs, as well as the recreational and commercial ACLs, ACTs, commercial quotas, and RHLs for all three species, consistent with the recommendations made by the Commission's Summer Flounder, Scup, and Black Sea Bass Board (Board) and the Council at their joint August 2023 meeting. This action also sets projected 2025 ABCs and corresponding specifications for summer flounder and scup.
This action approves the Council- and Board-recommended 2024 and projected 2025 summer flounder specifications as shown in table 1. The recommendations are based on the averaged 2024-2025 ABCs recommended by the Council's Science and Statistical Committee (SSC). This approach allows for constant catch and landings limits across both years. The ABCs are based on the overfishing limit (OFL) and the Council's risk policy, resulting in a 32- to 38-percent probability of overfishing. For summer flounder, this results in a 42-percent decrease in the recommended 2024 and 2025 ABC relative to the 2023 ABC. The 2024-2025 commercial quota represents a 42-percent decrease compared to the 2023 quota, and an approximately 30-percent reduction compared to 2022 reported landings. The 2024-2025 RHL is a 40-percent decrease compared to the 2023 RHL.
The final state summer flounder commercial quotas take into account any overages that occurred during the 2022 fishing year and the current fishing year, through October 31, 2023, as described at 50 CFR 648.103(b)(2). The final 2024 state-by-state summer flounder commercial quotas are provided in table 2.
This action makes no changes to the current commercial management measures, including the minimum fish size (14-inch (36-centimeter (cm)) total length), gear requirements, and possession limits. Changes to 2024 recreational management measures (bag limits, size limits, and seasons) will be considered through a separate action.
This action approves the Council- and Board-recommended 2024 black sea bass specifications as shown in table 3. No updated stock assessment information is available for black sea bass this year; therefore, the SSC decided to set the 2024 ABC equal to the 2023 ABC. The Council and Board made no changes to the ACLs or ACTs compared to 2023. They approved a 2024 commercial quota of 6 million lb (2,721 mt) (25-percent increase from 2023) and a 2024 RHL of 6.27 million lb (2,845 mt) (5-percent decrease from 2023). While these values are based on the same methodology used to set the 2023 measures, updated dead-discard projections for each sector led to a change in the quota and RHL. An updated management track stock assessment is anticipated to be available in 2024 for setting future specifications.
This action implements no changes to the 2024 commercial management measures for black sea bass, including the commercial minimum fish size (11-inch (27.94-cm) total length) and gear requirements.
On August 2, 2023, NMFS partially approved Amendment 23 to the Summer Flounder, Scup, and Black Sea Bass FMP. The approved measures change the Federal coastwide commercial in-season accountability measure such that the commercial fishery will now close when the quota plus an additional buffer of up to 5-percent is projected to be landed. The intent of this buffer is to minimize negative economic impacts when the coastwide quota is reached before all states have fully harvested their allocations due to overages in individual states. Each year, through the specification process, the Council and Board will recommend a buffer from 0- to 5-percent. For 2024, the Council and Board have recommended a 5-percent commercial in-season closure buffer. The final rule implementing Amendment 23 has not been published, so the buffer cannot be implemented through this action. Implementation of the 5-percent buffer recommended for 2024 will be considered through the Amendment 23 final rule.
This action approves the Council- and Board-recommended 2024 scup specifications as shown in table 4. The SSC-recommended 2024-2025 ABCs are based on the OFL and the Council's risk policy for a stock above 1.5 times the biomass target, with an associated 49-percent probability of overfishing. To ensure that the probability of overfishing remained below 50-percent in each year, the SSC recommended annually varying ABCs for 2024 and 2025. This results in a 2024 ABC that is 49-percent higher than the 2023 ABC; and a projected 2025 ABC that is 35-percent higher than the 2023 ABC. The scup commercial quota for 2024 is 52-percent higher than the 2023 commercial quota. The 2024 RHL is 43-percent higher than the 2023 RHL.
The commercial scup quota is divided into three commercial fishery quota periods, as outlined in table 5.
The current quota period possession limits are not changed by this action and are outlined in table 6.
The Winter I scup commercial possession limit will drop to 1,000 lb (454 kg) when 80-percent of that period's allocation is landed. If the Winter I quota is not fully harvested, the remaining quota is transferred to Winter II. The Winter II possession limit may be adjusted (in association with a transfer of unused Winter I quota to the Winter II period) via notification in the
This action makes no changes to the 2024 commercial management measures for scup, including the minimum fish size (9-inch (22.9-cm) total length), gear requirements, and quota period possession limits.
Through this action, we are removing the January 1-April 30 Federal recreational scup closure. Because of the timing of the recreational management measures discussions and rulemaking, it would not be possible to remove this closure prior to the January 1, 2024, start date of the closure outside of this rulemaking. At the December 2023 meeting, the Council and Board approved a 10-percent reduction in recreational scup harvest in 2024 and 2025. State waters measures, in addition to the 40-fish possession limit and 10-inch minimum size in Federal waters, will be developed to achieve the full reduction required. The Federal closure will not be needed to achieve the required reduction. Additionally, preliminary data on recreational scup harvest indicate that 2023 harvest is trending lower than 2022. Estimated scup harvest in waves 1 to 4 is 9.46 million lb (4,291 mt), which is 31-percent lower than scup harvest during the same time period in 2022. For these reasons, we have determined that the January 1-April 30 Federal recreational fishery closure can be removed through this action.
We received two comments on the proposed rule (88 FR 80263, November 17, 2023). One comment was not applicable to the proposed measures.
Table 4 in the proposed rule has been updated as several of the values were incorrect. The corrected numbers are shown in table 4 of this rule.
Pursuant to section 304(b)(3) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the NMFS Assistant Administrator has determined that this final rule is consistent with the Summer Flounder, Scup, and Black Sea Bass FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.
The Assistant Administrator for Fisheries finds that the need to implement these measures in a timely manner constitutes good cause, under the authority contained in 5 U.S.C. 553(d)(3), to waive the 30-day delay in effective date of this action. This action implements 2024 specifications for the summer flounder, scup, and black sea bass fisheries. These specifications should be effective by the start of the fishing year on January 1, 2024, and must be published on or before December 31, 2023.
This rule is being issued at the earliest possible date. Preparation of the final rule is dependent on the analysis of commercial summer flounder landings for the prior fishing year (2022) and the current fishing year through October 31, 2023, to determine whether any overages have occurred and adjustments are needed to the final state quotas. This process is codified in the summer flounder regulations and, therefore, cannot be performed earlier. A proposed rule was published on November 17, 2023, with a public comment period through December 2, 2023. This final rule is being published as soon as possible. Annual publication of the summer flounder quotas prior to the start of the fishing year, by December 31, is required by Court Order in
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
16 U.S.C. 1801
Fisheries, Fishing, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, NMFS amends 50 CFR part 648 as follows:
16 U.S.C. 1801
Fishermen and vessels that are not eligible for a scup moratorium permit under § 648.4(a)(6), may possess scup from January 1 through December 31, subject to the possession limit specified in § 648.128(a). The recreational fishing season may be adjusted pursuant to the procedures in § 648.122. Should the recreational fishing season be modified, non-federally permitted scup vessels abiding by state regulations may transit with scup harvested from state waters on board through the Block Island Sound Transit Area following the provisions outlined in § 648.131.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2022-08-12, which applies to all The Boeing Company Model 757 airplanes. AD 2022-08-12 requires repetitive inspections for skin cracking and shim migration at the upper link drag fittings, diagonal brace cracking, and fastener looseness; and applicable on-condition actions. Since the FAA issued AD 2022-08-12, it was determined that certain drag fittings may be made of alternate materials, which could result in reduced structural integrity of the engine strut, and that additional inspections and revised compliance times are needed. This proposed AD would retain the requirements of AD 2022-08-12 with revised compliance times for certain actions and would add inspections for existing repairs and applicable on-condition actions. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by February 5, 2024.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; website
• You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available at
Wayne Ha, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone 562-627-5238; email
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Wayne Ha, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone 562-627-5238; email
The FAA issued AD 2022-08-12, Amendment 39-22015 (87 FR 26964, May 6, 2022) (AD 2022-08-12), for all The Boeing Company Model 757 airplanes. AD 2022-08-12 was prompted by reports of bolt rotation in the engine drag fitting joint and fastener heads and cracks found in the skin of the fastener holes, and the need to reduce the compliance time for certain groups. AD 2022-08-12 requires repetitive inspections for skin cracking and shim migration at the upper link drag fittings, diagonal brace cracking, and fastener looseness; and applicable on-condition actions. The FAA issued AD 2022-08-12 to address cracking in the wing upper skin and forward drag fittings, which could lead to a compromised upper link and reduced structural integrity of the engine strut, and possible separation of a strut and engine from the airplane during flight.
Since the FAA issued AD 2022-08-12, it was determined that drag fittings made of alternate materials have possibly been installed on some configurations, which could result in reduced structural integrity of the engine strut. The FAA has determined that additional inspections and revised compliance times are needed to maintain structural integrity.
The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
The FAA reviewed Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023. This service information specifies procedures for a general visual inspection or records check of the wing upper skin at the drag fitting attachment holes for any existing repair; repetitive general visual and detailed inspections for loose fasteners, skin cracking, and shim migration at the upper link drag fittings, and for cracking in the diagonal brace and diagonal brace fittings; repetitive open-hole high frequency eddy current (HFEC) inspections for cracking of the fastener holes and loose bolt holes; and applicable on-condition actions. On-condition actions include performing an ultrasonic inspection for cracks at any repaired upper wing skin location; installing the upper link and upper link pins; replacing drag fittings; installing bolts, washers, and nuts; performing a torque check of fasteners on the affected shims; trimming affected shims and applying chemical conversion coating on the shims, fillet seal, and drag fittings; and repairing cracks, migrated shims, mistorqued bolts, and loose fasteners.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in
Although this proposed AD does not explicitly restate the requirements of AD 2022-08-12, this proposed AD would retain all of the requirements of AD 2022-08-12. Those requirements are referenced in the service information identified previously, which, in turn, is referenced in paragraph (g) of this proposed AD.
This proposed AD would require accomplishing the actions specified in the service information already described except for any differences identified as exceptions in the regulatory text of this proposed AD. For information on the procedures and compliance times, see this service information at
The FAA estimates that this AD, if adopted as proposed, would affect 496 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA has received no definitive data on which to base the cost estimates for the on-condition actions specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by February 5, 2024.
This AD replaces AD 2022-08-12, Amendment 39-22015 (87 FR 26964, May 6, 2022) (AD 2022-08-12).
This AD applies to all The Boeing Company Model 757-200, 200PF, -200CB, and -300 series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by reports of bolt rotation in the engine drag fitting joint and fastener heads and cracks found in the skin of the fastener holes, a determination that certain drag fittings may be made of alternate materials, which could result in reduced structural integrity of the engine strut, and a determination that additional inspections and revised compliance times are needed. The FAA is issuing this AD to address cracking in the wing upper skin and forward drag fittings, which could lead to a compromised upper link and reduced structural integrity of the engine strut, and possible separation of a strut and engine from the airplane during flight.
Comply with this AD within the compliance times specified, unless already done.
Except as specified by paragraph (h) of this AD: At the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023.
(1) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, use the phrase “the Original Issue date of Requirements Bulletin 757-57A0073 RB,” this AD requires using “September 10, 2018 (the effective date of AD 2018-16-05, Amendment 39-19345 (83 FR 38250, August 6, 2018))” (AD 2018-16-05).
(2) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, use the phrase “the Revision 1 date of Requirements Bulletin 757-57A0073 RB,” this AD requires using “January 14, 2021 (the effective date of AD 2020-21-17, Amendment 39-21290 (85 FR 79418, December 10, 2020))” (AD 2020-21-17).
(3) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, use the phrase “the Revision 2 date of Requirements Bulletin 757-57A0073 RB,” this AD requires using “June 10, 2022 (the effective date of AD 2022-08-12).”
(4) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, use the phrase “the Revision 3 date of Requirements Bulletin 757-57A0073 RB,” this AD requires using the effective date of this AD.
(5) Where Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, specifies contacting Boeing for repair instructions or for alternative inspections: This AD requires doing the repair, or doing the alternative inspections and applicable on-condition actions using a method approved in accordance with the procedures specified in paragraph (j) of this AD.
(1) This paragraph provides credit for the actions specified in paragraph (g) of this AD, except for the open-hole high frequency eddy current inspections at fastener locations 11-18, if those actions were performed before January 14, 2021 (the effective date of AD 2020-21-17) using Boeing Alert Requirements Bulletin 757-57A0073 RB, dated July 14, 2017.
(2) This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before June 10, 2022 (the effective date of AD 2022-08-12) using Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 1, dated August 1, 2019.
(3) This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 2, dated March 1, 2021.
(1) The Manager, AIR-520, Continued Operational Safety Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (k)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, AIR-520, Continued Operational Safety Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) AMOCs approved for AD 2022-08-12 are approved as AMOCs for the corresponding provisions of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, that are required by paragraph (g) of this AD, except for AMOCs approved for locations at the wing skin and drag fittings at the upper link drag fittings (fasteners 1-18).
(5) AMOCs approved for AD 2020-21-17 are approved as AMOCs for the corresponding provisions of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, that are required by paragraph (g) of this AD, except for AMOCs approved for locations at the wing skin and drag fittings at the upper link drag fittings (fasteners 1-18).
(6) AMOCs approved for AD 2018-16-05 are approved as AMOCs for the corresponding provisions of Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023, that are required by paragraph (g) of this AD, except for AMOCs approved for locations at the wing skin and drag fittings at the upper link drag fittings (fasteners 1-18).
(1) For more information about this AD, contact Wayne Ha, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone 562-627-5238; email
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (l)(3) and (4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Alert Requirements Bulletin 757-57A0073 RB, Revision 3, dated May 5, 2023.
(ii) [Reserved]
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; website
(4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Leonardo S.p.a Model AW169 helicopters. This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. This proposed AD would require revising the airworthiness limitations section (ALS) of the existing helicopter maintenance manual or instructions for continued airworthiness (ICA) for your helicopter and the existing approved maintenance or inspection program for your helicopter, as applicable, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by February 5, 2024.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For EASA material that is proposed for incorporation by reference in this NPRM, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
• You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110. The EASA material is also available at
Sungmo Cho, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone (781) 238-7241; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Sungmo Cho, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone (781) 238-7241; email:
EASA, which is the Technical Agent for the Member States of the European Union, issued a series of ADs with the most recent being EASA AD 2023-0160, dated August 16, 2023 (EASA AD 2023-0160), to correct an unsafe condition for Leonardo S.p.A. Model AW169 helicopters.
This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is proposing this AD to address fatigue cracking, damage, and corrosion in principal structural elements.
You may examine the EASA AD in the AD docket at
EASA AD 2023-0160 requires replacing components before exceeding their life limits and accomplishing maintenance tasks within thresholds
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA also reviewed AW169 Air vehicle maintenance planning information, 69-A-AMPI-00-P, Chapter 04, ALS, Issue 21, dated July 7, 2023. This service information specifies airworthiness limitations, tasks, and associated thresholds and intervals for various parts, and specifies new or more restrictive airworthiness limitations for certain components installed on the tail rotor system.
These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of the same type design.
This proposed AD would require accomplishing the actions specified in EASA AD 2023-0160, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD and except as discussed under “Differences Between this Proposed AD and the EASA AD.”
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2023-0160 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2023-0160 through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2023-0160 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2023-0160. Service information referenced in EASA AD 2023-0160 for compliance will be available at
EASA AD 2023-0160 requires replacing certain components before exceeding applicable life limits, accomplishing certain maintenance tasks within thresholds and intervals as specified in the ALS, as defined within, and depending on the results, accomplishing corrective action within the compliance time specified in that ALS. EASA AD 2023-0160 also requires revising the approved AMP to incorporate the limitations, tasks, and associated thresholds and intervals described in that ALS within 12 months after its effective date. Whereas, this proposed AD would require revising existing documents and programs within 30 days to incorporate the limitations, tasks, and associated thresholds and intervals described in that ALS, and clarifies that if an incorporated limitation or threshold therein is reached before 30 days after the effective date of the final rule of this proposed AD, you still have up to 30 days after the effective date of the final rule of this proposed AD to accomplish the corresponding task.
The FAA estimates that this AD, if adopted as proposed, would affect 10 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.
Revising the ALS of the existing helicopter maintenance manual or ICA for your helicopter and the existing approved maintenance or inspection program for your helicopter, as applicable, would take about 2 work-hours for an estimated cost of $170 per helicopter and $1,700 for the U.S. fleet.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by February 5, 2024.
None.
This AD applies to Leonardo S.p.a. Model AW169 helicopters, certificated in any category.
Joint Aircraft Service Component (JASC) Code: 6400, Tail rotor system.
This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address fatigue cracking, damage, and corrosion in principle structural elements. The unsafe condition, if not addressed, could result in failure of a part and loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2023-0160, dated August 16, 2023 (EASA AD 2023-0160).
(1) Where EASA AD 2023-0160 refers to its effective date, this AD requires using the effective date of this AD.
(2) This AD does not adopt the requirements specified in paragraphs (1), (2), (4), and (5) of EASA AD 2023-0160.
(3) Where paragraph (3) of EASA AD 2023-0160 specifies “Within 12 months after the effective date of this AD, revise the approved AMP,” this AD requires replacing those words with “Within 30 days after the effective date of this AD, revise the airworthiness limitations section of your existing helicopter maintenance manual or instructions for continued airworthiness and your existing approved maintenance or inspection program, as applicable.”
(4) The initial compliance time for doing the tasks specified in paragraph (3) of EASA AD 2023-0160 is on or before the applicable “limitations” and “associated thresholds” as incorporated by the requirements of paragraph (3) of EASA AD 2023-0160, or within 30 days after the effective date of this AD, whichever occurs later.
(5) This AD does not adopt the Remarks paragraph of EASA AD 2023-0160.
No alternative actions and associated thresholds and intervals, including life limits, are allowed for compliance with paragraph (g) of this AD unless they are approved as specified in the provisions of the “Ref. Publications” section of EASA AD 2023-0160.
Special flight permits are prohibited.
(1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (l) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Sungmo Cho, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone (781) 238-7241; email:
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) European Union Aviation Safety Agency (EASA) AD 2023-0160, dated August 16, 2023.
(ii) [Reserved]
(3) For EASA AD 2023-0160, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(4) You may view this service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Leonardo S.p.a Model AW189 helicopters. This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. This proposed AD would require revising the airworthiness limitations section (ALS) of the existing helicopter maintenance manual or instructions for continued airworthiness (ICA) for your helicopter and the existing approved maintenance or inspection program for your helicopter, as applicable, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by February 5, 2024.
You may send comments, using the procedures found in 14 CFR
•
•
•
•
• For EASA material identified in this NPRM, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
• You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110. The EASA material is also available at
Sungmo Cho, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone (781) 238-7241; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Sungmo Cho, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone (781) 238-7241; email:
EASA, which is the Technical Agent for the Member States of the European Union, has issued a series of ADs with the most recent being EASA AD 2023-0161, dated August 16, 2023 (EASA AD 2023-0161), to correct an unsafe condition on Leonardo S.p.A. Model AW189 helicopters.
This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is proposing this AD to address fatigue cracking, damage, and corrosion in principal structural elements.
You may examine the EASA AD in the AD docket at regulations.gov under Docket No. FAA-2023-2245.
EASA AD 2023-0161 requires replacing components before exceeding their life limits and accomplishing maintenance tasks within thresholds and intervals specified in the applicable ALS as defined in EASA AD 2023-0161. Depending on the results of the maintenance tasks, EASA AD 2023-0161 requires accomplishing corrective action(s) or contacting Leonardo [Leonardo S.p.a.] for approved instructions and accomplishing those instructions. EASA AD 2023-0161 also requires revising the Aircraft Maintenance Programme (AMP) by incorporating the limitations, tasks, and associated thresholds and intervals described in the specified ALS as applicable to the helicopter model and configuration. Revising the AMP constitutes terminating action for the requirement to record accomplishment of the actions of replacing components before exceeding their life limits and accomplishing maintenance tasks within the thresholds and intervals specified in the applicable ALS as required by EASA AD 2023-0161 for demonstration of AD compliance on a continued basis.
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA also reviewed Leonardo AW189 document 89-A-AMPI-00-P, Air Vehicle Maintenance Planning Information, Chapter 4, Airworthiness Limitations, Issue 25, dated July 5, 2023, for helicopters equipped with General Electric CT7-2E1 engines. This service information specifies procedures for airworthiness limitations, tasks, and associated thresholds and intervals for various parts; including a new or more restrictive airworthiness limitation for a certain component installed in the main rotor gearbox.
These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all
This proposed AD would require accomplishing the actions specified in EASA AD 2023-0161, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD and except as discussed under “Differences Between this Proposed AD and the EASA AD.”
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2023-0161 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2023-0161 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2023-0161 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2023-0161. Service information referenced in EASA AD 2023-0161 for compliance will be available at regulations.gov under Docket No. FAA-2023-2245 after the FAA final rule is published.
EASA AD 2023-0161 requires replacing certain components before exceeding applicable life limits, accomplishing certain maintenance tasks within thresholds and intervals as specified in the ALS, as defined within, and depending on the results, accomplishing corrective action within the compliance time specified in that ALS. EASA AD 2023-0161 also requires revising the approved AMP to incorporate the limitations, tasks, and associated thresholds and intervals described in that ALS within 12 months after its effective date. Whereas, this proposed AD would require revising existing documents and programs within 30 days to incorporate the limitations, tasks, and associated thresholds and intervals described in that ALS, and clarifies that if an incorporated limitation or threshold therein is reached before 30 days after the effective date of the final rule of this proposed AD, you still have up to 30 days after the effective date of the final rule of this proposed AD to accomplish the corresponding task.
Additionally, EASA AD 2023-0161 requires using 89-E-AMPI-00-P Air Vehicle Maintenance Planning Information, Chapter 04, ALS Issue 09, dated July 5, 2023, for revising the ALS. This service information is applicable for helicopters equipped with SAFRAN ANETO-1K engines. This proposed AD would not allow this service information because that engine has not been FAA type-certificated for Model AW189 helicopters.
The FAA estimates that this AD, if adopted as proposed, would affect 4 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.
Revising the ALS of the existing helicopter maintenance manual or instructions for ICA for your helicopter and the existing approved maintenance or inspection program for your helicopter, as applicable, would take about 2 work-hours for an estimated cost of $170 per helicopter and $680 for the U.S. fleet.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by February 5, 2024.
None.
This AD applies to all Leonardo S.p.a. Model AW189 helicopters, certificated in any category.
Joint Aircraft Service Component (JASC) Code: 6320, Main rotor gearbox.
This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address fatigue cracking, damage, and corrosion in principle structural elements. The unsafe condition, if not addressed, could result in failure of a part and loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2023-0161, dated August 16, 2023 (EASA AD 2023-0161).
(1) Where EASA AD 2023-0161 defines “the ALS” as “Leonardo AW189 document 89-A-AMPI-00-P (Air Vehicle Maintenance Planning Information), Chapter 04, Airworthiness Limitations Section (ALS) Issue 025, applicable for helicopters equipped with General Electric (GE) CT7-2E1 engines; or document 89-E-AMPI-00-P (Air Vehicle Maintenance Planning Information), Chapter 04, ALS Issue 09, applicable for helicopters equipped with SAFRAN ANETO-1K engines.;” for this AD, replace that definition with “Leonardo AW189 document 89-A-AMPI-00-P, Air Vehicle Maintenance Planning Information, Chapter 4, Airworthiness Limitations, Issue 25, dated July 5, 2023 (for helicopters equipped with General Electric CT7-2E1 engines).”
(2) Where EASA AD 2023-0161 refers to its effective date, this AD requires using the effective date of this AD.
(3) This AD does not adopt the requirements specified in paragraphs (1), (2), (4), and (5) of EASA AD 2023-0161.
(4) Where paragraph (3) of EASA AD 2023-0161 specifies “Within 12 months after the effective date of this AD, revise the approved AMP,” this AD requires replacing those words with “Within 30 days after the effective date of this AD, revise the airworthiness limitations section of your existing helicopter maintenance manual or instructions for continued airworthiness and your existing approved maintenance or inspection program, as applicable.”
(5) The initial compliance time for doing the tasks specified in paragraph (3) of EASA AD 2023-0161 is on or before the applicable “limitations” and “associated thresholds” as incorporated by the requirements of paragraph (3) of EASA AD 2023-0161, or within 30 days after the effective date of this AD, whichever occurs later.
(6) This AD does not adopt the “Remarks” section of EASA AD 2023-0161.
No alternative actions and associated thresholds and intervals, including life limits, are allowed for compliance with paragraph (g) of this AD unless they are approved as specified in the provisions of the “Ref. Publications” section of EASA AD 2023-0161.
Special flight permits are prohibited.
(1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (l) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Sungmo Cho, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone (781) 238-7241; email:
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) European Union Aviation Safety Agency (EASA) AD 2023-0161, dated August 16, 2023.
(ii) [Reserved]
(3) For EASA AD 2023-0161, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(4) You may view this service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend the Class E airspace at Ebensburg, PA. The FAA is proposing this action as the result of an airspace review conducted due to the decommissioning of the Revloc very high frequency omnidirectional range (VOR) as part of the VOR Minimum Operating Network (MON) Program. This action will bring the airspace into compliance with FAA orders to support instrument flight rule (IFR) operations.
Comments must be received on or before February 5, 2024.
Send comments identified by FAA Docket No. FAA-2023-2431 and Airspace Docket No. 23-AEA-26 using any of the following methods:
*
*
*
*
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend the Class E airspace extending upward from 700 feet above the surface at Ebensburg Airport, Ebensburg, PA, to support IFR operations at this airport.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it received on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or dely. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Class E airspace is published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published subsequently in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
The FAA is proposing to amend 14 CFR part 71 by amending the Class E airspace extending upward from 700 feet above the surface to within an 8.1-mile (increased from a 6.4-mile) radius of Ebensburg Airport, Ebensburg, PA; adding an extension within 4 miles each side of the 237° bearing from the airport extending from the 8.1-mile radius to 11.3 miles west of the airport; removing the exclusion area as it is no longer required; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.
This FAA is proposing this action as the result of an airspace review conducted due to the decommissioning of the Revloc VOR as part of the VOR MON Program, to bring the airspace into compliance with current FAA orders, and to support IFR operations at this airport.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 8.1-mile radius of Ebensburg Airport; and within 4 miles each side of the 237° bearing from the airport extending from the 8.1-mile radius to 11.3 miles west of the airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to revoke Colored Federal airway Amber 15 (A-15) within United States (U.S.) airspace due to the pending decommissioning of the Nabesna, Sumner Strait, Haines, and Nichols Nondirectional Radio Beacons (NDB) in Alaska. Additionally, this action proposes to amend Alaskan Very High Frequency Omnidirectional Range (VOR) Federal Airway V-428 due to the pending decommissioning of the Haines NDB.
Comments must be received on or before February 5, 2024.
Send comments identified by FAA Docket No. FAA-2023-2363 and Airspace Docket No. 22-AAL-33 using any of the following methods:
*
*
*
*
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Steven Roff, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System (NAS).
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific segment of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Colored Federal airways are published in paragraph 6009 and Alaskan VOR Federal airways are published in paragraph 6010 of FAA
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L. 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.
In support of NextGen, this proposal is part of an ongoing, large, and comprehensive T-route modernization project in the state of Alaska. The project mission statement states: “To modernize Alaska's Air Traffic Service route structure using satellite-based navigation development of new T-routes and optimization of existing T-routes will enhance safety, increase efficiency and access, and will provide en route continuity that is not subject to the restrictions associated with ground-based airway navigation.” As part of this project, the FAA evaluated the existing Colored Airway structure for: (a) direct replacement (
The aviation industry/users have indicated a desire for the FAA to transition the Alaskan en route navigation structure away from dependency on NDBs and move to develop and improve the United States Area Navigation (RNAV) route structure.
Colored Federal airway A-15 extends between the Ethelda, British Columbia (BC), Canada, NDB and the Delta Junction, AK, NDB, excluding the airspace within Canada.
The decommissioning of the Nichols, Sumner Strait, and Haines NDBs in Alaska would render the segment of A-15 within U.S. airspace between the United Sates/Canadian border south of the Nichols NDB and the United States/Canadian border north of Haines NDB unusable. Mitigations to the loss of this segment are a combination of conventional airways and RNAV routes. Alternatives to the segment of A-15 between the United Sates/Canadian border and the Nichols NDB are nearby V-317 and V-309. Alternative routing between the Nichols NDB and the United States/Canadian border north of the Haines NDB, are V-317, T-266, and T-481. T-266 was developed for routing from the Nichols NDB to the Haines NDB and T-481 was developed for routing from Haines to the United States/Canadian border. T-266 and T-481 were developed to provide alternate routing in this area that avoids mountainous terrain and its associated weather by following the water channels along the Lynn Canal and Stephens Passage. This routing adds some mileage to the route but avoids the higher minimum enroute altitudes (MEA) and the dangers associated with overflying the mountain terrain.
The decommissioning of the Nabesna, AK, NDB, would render the northern segment of A-15 within U.S. airspace between the United States/Canadian border and the Delta Junction NDB unusable. The loss of this segment is mitigated by the existence of V-444, T-232, and T-372.
Alaskan VOR Federal Airway V-428 extends between the Biorka Island, AK, Very High Frequency Omnidirectional Range/Tactical Air Navigation (VORTAC) and Whitehorse, Yukon Territory (YT), Canada, VOR/distance measuring equipment (VOR/DME), excluding the airspace within Canada. With the decommissioning of the Haines NDB, a segment of V-428 would become unusable. The FAA is proposing to revoke the segment of V-428 between the Sisters Island, AK, VORTAC and Whitehorse, YT, Canada, VOR/DME within United States airspace. The loss of this airway is mitigated by an existing RNAV route, T-481, between the Sisters Island VORTAC and the Haines NDB, and T-266 between the Haines NDB and the United States/Canadian border.
The FAA is proposing an amendment to 14 CFR part 71 to revoke Colored Federal airway A-15 in its entirety and amend Alaskan VOR Federal Airway V-428 due to the pending decommissioning of supporting Navigational Aids (NAVAID).
Colored Federal airway A-15 extends between the Ethelda, BC, Canada, NDB and the Delta Junction, AK, NDB, excluding the airspace within Canada. The FAA proposes to revoke Colored Federal airway A-15 in its entirety.
Alaskan VOR Federal Airway V-428 extends between the Biorka Island, AK, VORTAC and the Whitehorse, YT, Canada, VOR/DME, excluding the airspace within Canada. The FAA is proposing to revoke the segment of V-428 within U.S. airspace between the Sisters Island, AK, VORTAC and Whitehorse, YT, Canada, VOR/DME. As amended, V-428 would extend between the Biorka Island VORTAC and the Sisters Island VORTAC.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From Biorka Island, AK; to Sisters Island, AK.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to revoke Colored Federal airway Amber 1 (A-1) in Alaska due to the pending decommissioning of the navigational aids (NAVAID) that support the airway.
Comments must be received on or before February 5, 2024.
Send comments identified by FAA Docket No. FAA-2023-2346 and Airspace Docket No. 22-AAL-31 using any of the following methods:
*
*
*
*
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Steven Roff, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System (NAS).
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Colored Federal airways are published in paragraph 6009 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L. 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.
In support of NextGen, this proposal is part of an ongoing, large, and comprehensive T-route modernization project in the state of Alaska. The project mission statement states: “To modernize Alaska's Air Traffic Service route structure using satellite-based navigation development of new T-routes and optimization of existing T-routes will enhance safety, increase efficiency and access, and will provide en route continuity that is not subject to the restrictions associated with ground-based airway navigation.” As part of this project, the FAA evaluated the existing Colored Airway structure for: (a) direct replacement (
The aviation industry/users have indicated a desire for the FAA to transition the Alaskan en route navigation structure away from dependency on Nondirectional Radio Beacons (NDB) and move to develop and improve the United States Area Navigation (RNAV) route structure.
Colored Federal airway A-1 extends between the Abbotsford, British Columbia (BC), Canada and Orca Bay, AK, NDBs; and between the Takotna River, AK, and Fort Davis, AK, NDBs, excluding the airspace within Canada. The Orca Bay, Ocean Cape, Sitka, Takotna River, North River, and Fort Davis NDBs are scheduled for decommissioning. The FAA is proposing to revoke Colored Federal airway A-1 in its entirety due to its supporting NAVAIDs being decommissioned.
The loss of the segment extending between the Abbotsford and Orca Bay NDBs is mitigated by Area Navigation (RNAV) route T-269 and Alaskan Very High Frequency Omnidirectional Range (VOR) Federal Airways V-319 and V-440.
The loss of the segment of extending between the Takotna River and Fort Davis NDBs is mitigated by Alaskan VOR Federal Airway V-440.
The FAA is proposing an amendment to 14 CFR part 71 to revoke Colored Federal airway A-1 in Alaska due to the pending decommissioning of its supporting NAVAIDs.
Colored Federal airway A-1 extends between the Abbotsford, BC, Canada and Orca Bay, AK, NDBs and between the Takotna River, AK, and Fort Davis, AK, NDBs, excluding the airspace within Canada. The FAA proposes to revoke Colored Federal airway A-1 in its entirety.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend the Class E airspace at Mankato, MN. The FAA is proposing this action as the result of an airspace review conducted due to the decommissioning of the Mankato very high frequency omnidirectional range (VOR) as part of the VOR Minimum Operating Network (MON) Program. The name of an airport would also be updated to coincide with the FAA's aeronautical database. This action will bring the airspace into compliance with FAA orders to support instrument flight rule (IFR) operations.
Comments must be received on or before February 5, 2024.
Send comments identified by FAA Docket No. FAA-2023-2432 and Airspace Docket No. 23-AGL-39 using any of the following methods:
*
*
*
*
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend the Class E surface airspace and the Class E airspace extending upward from 700 feet above the surface at Mankato Regional Airport, Mankato, MN, to support IFR operations at this airport.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it received on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or dely. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Class E airspace is published in paragraphs 6002 and 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published subsequently in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
The FAA is proposing to amend 14 CFR part 71 by:
Modifying the Class E surface airspace at Mankato Regional Airport, Mankato, MN, by removing the Mankato VOR/DME and associated extensions from the airspace legal description; and replacing the outdated terms “Notice to Airmen” and “Airport Facility/Directory” with “Notice to Air Missions” and “Chart Supplement”;
And modifying the Class E airspace extending upward from 700 feet above the surface to within a 6.7-mile (decreased from a 7-mile) radius of Mankato Regional Airport; removing the extensions to the northeast and north of the airport from the airspace legal description as they are no longer needed; adding an extension 1.9 miles each side of the 155° bearing from the Mankato RGNL: RWY 33-LOC extending from the 6.7-mile radius to 11.1 miles southeast of the airport; adding an extension 2 miles each side of the 227° bearing from the Mankato Regional Airport extending from the 6.7-mile radius to 11 miles southwest of the airport; and updating the name of Mayo Clinic Health System-Mankato (previously Immanuel-St. Joseph's Hospital) to coincide with the FAA's aeronautical database.
The FAA is proposing this action as the result of an airspace review conducted due to the decommissioning of the Mankato VOR as part of the VOR
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Within a 4.2-mile radius of Mankato Regional Airport. This Class E airspace is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective dates and times will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from 700 feet above the surface within a 6.7-mile radius of Mankato Regional Airport; and within 1.9 miles each side of the 155° bearing from the Mankato RGNL: RWY 33-LOC extending from the 6.77-mile radius to 11.1 miles southeast of Mankato Regional Airport; and within 2 miles each side of the 227° bearing from the Mankato Regional Airport extending from the 6.7-mile radius to 11 miles southwest of the Mankato Regional Airport; and within a 6-mile radius of the point in space serving Mayo Clinic Health Systems-Mankato.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Very High Frequency Omnidirectional Range (VOR) Federal Airway V-220 and revoke VOR Federal Airways V-79 and V-380. The FAA is proposing this action due to the planned decommissioning of the VOR portion of the Hastings, NE (HSI), VOR/Distance Measuring Equipment (VOR/DME) navigational aid (NAVAID). The Hastings VOR is being decommissioned in support of the FAA's VOR Minimum Operational Network (MON) program.
Comments must be received on or before February 5, 2024.
Send comments identified by FAA Docket No. FAA-2023-2466 and Airspace Docket No. 23-ACE-6 using any of the following methods:
*
*
*
*
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Colby Abbott, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs,
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see
VOR Federal Airways are published in paragraph 6010(a) of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
The FAA is planning to decommission the VOR portion of the Hastings, NE, VOR/DME in September 2024. The Hastings VOR is one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the Final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the
Although the VOR portion of the Hastings VOR/DME is planned for decommissioning, the co-located DME portion of the NAVAID is being retained to support current and future NextGen PBN flight procedure requirements.
The VOR Federal Airways affected by the planned decommissioning of the Hastings VOR are V-79, V-220, and V-380. With the planned decommissioning of the Hastings VOR, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected airways. As such, proposed modifications to V-220 would result in the airway segments supported by the Hastings VOR being removed and to V-79 and V-380 would result in the airways being revoked.
To address the proposed amendment and revocation actions to the affected airways, instrument flight rules (IFR) traffic could use adjacent VOR Federal Airways V-6, V-8, or V-38, or request radar vectors from air traffic control (ATC) to fly around or through the affected area. Additionally, pilots with Area Navigation (RNAV) equipped aircraft could also navigate using RNAV routes T-286, T-413, and T-468, or navigate point-to-point using the existing fixes that would remain in place to support continued operations though the affected area. Visual flight rules pilots who elect to navigate via the affected VOR Federal Airways could also take advantage of the adjacent airways or routes, or the ATC services listed previously.
The FAA is proposing an amendment to 14 CFR part 71 to amend VOR Federal Airway V-220 and revoke VOR Federal Airways V-79 and V-380 due to the planned decommissioning of the VOR portion of the Hastings, NE, VOR/DME. The proposed airway actions are described below.
The NAVAID radials listed in the V-220 description in the proposed regulatory text of this NPRM are unchanged and stated in degrees True north.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From Grand Junction, CO; INT Grand Junction 075° and Rifle, CO, 163° radials; Rifle; Meeker, CO; Hayden, CO; Kremmling, CO; INT Kremmling 081° and Gill, CO, 234° radials; Gill; Akron, CO; INT Akron 094° and McCook, NE, 264° radials; McCook; INT McCook 072° and Kearney, NE, 237° radials; to Kearney.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish restricted area R-4601 in the vicinity of Townsend, MT. The new restricted area would provide the Montana Army National Guard (MTARNG) and the 40th Helicopter Squadron with the ability to conduct aerial gunnery training.
Comments must be received on or before February 5, 2024.
Send comments identified by FAA Docket No. FAA-2023-2371 and Airspace Docket No. 22-ANM-42 using any of the following methods:
*
*
*
*
Steven Roff, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish restricted area airspace over the MTARNG Limestone Hills Training Area near Townsend, MT.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see
The MTARNG submitted a proposal to the FAA to establish a new restricted area, R-4601, over the Limestone Hills Training Area (LHTA) near Townsend, MT, to support aerial gunnery training requirements. Currently, the LHTA consists of multiple surface-to-surface live-fire weapons ranges that are contained within a Controlled Firing Area (CFA); however aerial gunnery live-fire is not authorized within a CFA. Hazardous activities, such as aerial gunnery, are required to be contained within a restricted area. Restricted areas are designated pursuant to 14 CFR part 73 rulemaking procedures to contain activities that may present a hazard to nonparticipating aircraft.
The proposed restricted area would provide a training capability to the MTARNG in preparation for combat deployments and also the 40th Helicopter Squadron located at Malmstrom Air Force Base (AFB) in support of security operations.
The United States Air Force's Global Strike Command (AFGSC) is tasked to provide armed helicopters in support of Malmstrom AFB missile field security operations. These helicopter units require an aerial gunnery range within one flight duty period (FDP) of their permanent bases to effectively and efficiently qualify and remain proficient in aerial gunnery operations. The LHTA is the only existing facility within one FDP with the possibility to support this training requirement. LHTA is located approximately 75 nautical miles from Malmstrom AFB.
The MTARNG aviation rotary wing assets would utilize the proposed restricted area to conduct day and night aerial gunnery training on an annual basis at a minimum, to increase and maintain their operational readiness. The MTARNG aviation units would schedule the proposed restricted area for approximately 40 training events (20 days, 20 nights) per year with each training event lasting over a six-hour period of time.
The 40th Helicopter Squadron is tasked with ensuring strategic security for Malmstrom AFB by providing flexible, rapid-response helicopter airlift and security support to the 341st Missile Wing. The 40th Helicopter Squadron would schedule the proposed restricted area for approximately 60 aerial training events (30 days, 30 nights) per year with each training event lasting over a four-to-six-hour period of time.
The use of the proposed restricted area could vary due to weather, unit requirements, or scheduling conflicts.
The FAA is proposing an amendment to 14 CFR part 73 to establish R-4601 over the Limestone Hills Training Area in the vicinity of Townsend, MT. This action would be used to contain hazardous aerial gunnery activities. The proposed restricted area is described below.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Prohibited areas, Restricted areas.
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 73 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Employment and Training Administration, Department of Labor.
Request for information.
The Department of Labor's (Department or DOL) Employment and Training Administration (ETA) is considering revisions to Schedule A of the permanent labor certification process to include occupations in Science, Technology, Engineering and Mathematics (STEM) and other non-STEM occupations and invites employers and other interested parties to comment on this Request for Information (RFI). ETA's Office of Foreign Labor Certification developed this RFI and is publishing it for comment so that the public may provide input, including data, statistical metrics or models, studies, and other relevant information, on how the Department may establish a reliable, objective, and transparent methodology for revising Schedule A to include STEM and other non-STEM occupations that are experiencing labor shortages, consistent with requirements of the Immigration and Nationality Act (INA). The Department wants to ensure that it is striking an appropriate balance between the need to provide U.S. workers notice of available permanent job opportunities and the opportunity to apply for those job opportunities, and, where insufficient U.S. workers are available to satisfy an employer's need for permanent labor, the need to provide employers access to foreign labor through effective administration of the permanent labor certification program. Information received from the public will help inform decisions regarding whether or how to improve Schedule A and ensure that its purpose in responding to national labor shortages is more effectively met.
Submit written comments on or before February 20, 2024.
You may submit written comments electronically by the following method:
•
•
For further information, contact Brian Pasternak, Administrator, Office of Foreign Labor Certification, Employment and Training Administration, Department of Labor, 200 Constitution Avenue NW, N-5311, Washington, DC 20210; Telephone (202) 513-7350 (this is not a toll-free number). For persons with a hearing or speech disability who need assistance to use the telephone system, please dial 711 to access telecommunications relay services.
Section 212(a)(5)(A) of the INA, 8 U.S.C. 1182(a)(5)(A), deems inadmissible certain foreign nationals who seek to enter the United States for purposes of employment, unless the Secretary of Labor first certifies that: (1) there are insufficient U.S. workers at the place where the foreign worker would be employed who are able, willing, qualified and available for the job the foreign worker seeks; and (2) employment of the foreign worker would not adversely affect the wages and working conditions of U.S. workers in similar jobs.
In an effort to address the workforce needs of employers at a time when the U.S. economy was rapidly expanding, the Department first established a mechanism in the mid-1960s by regulation for pre-certifying job vacancies of occupations for which U.S. workers were in short supply nationwide, which became known as Schedule A of the permanent labor certification program.
Schedule A was proposed in 1965 by the Secretary of Labor via rulemaking modifying then 29 CFR 60.2: “Certification and noncertification schedules. (a) Determination. To reduce the delay in processing an alien's request for visa, the determination has been made by the Secretary of Labor pursuant to section 212(a)(14) that: (1) For the categories of employment described in Schedule A and in the geographic areas therein set forth, there are not sufficient workers who are able, willing, qualified, and available for employment in such categories, and the employment of aliens in such categories and in such areas will not adversely affect the wages and working conditions of workers in the United States similarly employed.”
In part because Schedule A has not been comprehensively examined or modified in approximately three decades, and in part because Schedule A by definition allows employers to bypass filing an application for a labor certification, the Department does not have comprehensive data on how employers utilize Schedule A and the types of work performed thereunder.
In order to help gather evidence about how to determine whether to expand or alter Schedule A, the Department is seeking information from the public that will help inform this decision. In this RFI, the Department provides an overview of key research, data, and trends related to STEM occupations. We also welcome comments from the public on non-STEM occupations, including those that may be related to but not traditionally considered STEM occupations as well as those that are outside of the STEM arena but nonetheless may also face labor shortages.
Anecdotal evidence and industry research suggest that economic and labor market conditions have changed for certain industries and occupations that rely on foreign workers and various visa programs, especially in the area of STEM occupations, including occupations in the field of artificial intelligence (AI).
While ETA is familiar with the BLS's Occupational Employment Wage Statistics (OEWS) data and Employment Projections data,
Over the last decade, the federal government has taken steps toward diversifying the pipeline of STEM talent in the United States, primarily supporting STEM education opportunities for historically underrepresented groups in these fields.
The Department notes that various articles and studies have been written and conducted outlining reasons why there has been a STEM shortage in the United States including: a lack of interest in STEM occupations, a STEM branding problem with younger generations, and employers' lack of access to foreign talent.
Executive Order 13806, published in 2017, directs the Secretary of Defense to conduct a government-wide risk analysis of manufacturing and the defense industrial base and propose recommendations to improve economic and national security.
Subsequently, a non-profit organization, produced an analysis of data from the Census Bureau stating that foreign-born STEM workers have made important contributions to the U.S. economy in terms of productivity and innovation.
At the same time that the U.S. has shown greater reliance on foreign workers and foreign-born U.S.-educated workers, the U.S. is undergoing significant demographic changes indicating that the U.S. faces many challenges in supplying its own domestic STEM workforce. In 2017, a scientific journal determined that the U.S. had seen significant demographic trends with an aging STEM workforce that saw a decline in scientists ages 35 to 53 and a rise in scientists older than 53 between 1993 and 2010.
According to BLS data of job openings, hires, separations, and total employment in the United States, employment growth is projected to slow
These trends are also more pronounced for certain demographics. For example, additional analysis finds women are underrepresented in STEM careers and are being hindered in STEM by social barriers, like gender stereotypes and lack of representation, and discouragement.
Furthermore, there remain significant racial disparities in the technical workforce among women.
Not only is the United States facing headwinds in developing enough U.S.-born students pursuing STEM careers to replace those entering retirement, but broader market trends also suggest that the need for STEM workers will increase in future years. The growth rate of employment in STEM fields is projected to expand significantly—specifically, by 10.8 percent through 2032, compared to 2.8 percent for all occupations.
However, the NSB, in its analysis of the U.S. STEM labor force, argued that new scientific and technological advancements and discoveries, such as quantum technologies, space exploration, and medical vaccines, are “rapidly changing the world of work and, as a result, continue to challenge the traditional framework used to define the STEM labor force in the United States.”
In evaluating the utility of expanding Schedule A to include STEM occupations, the Department invites the public to provide input on the appropriate data sources and methods for determining whether labor shortages exist, whether Schedule A should be used to alleviate any labor shortages in STEM occupations should it be determined from these data sources and methods that such shortages exist, and if so, how the Department could establish a reliable, objective, and transparent methodology for identifying STEM occupations that are experiencing labor shortages. Additionally, the Department invites the public to provide input on whether to limit examination of STEM only to those OEWS occupations used in most of the recent BLS publications,
The Department invites general comments and suggestions concerning:
(A) whether any STEM occupations should be added to Schedule A, and why; and
(B) defining and determining which occupations should be considered as falling under the umbrella of STEM, and why.
The Department is also specifically seeking input on the questions listed below.
Accordingly, the Department invites the public to answer one or more of the following questions in their submissions:
1. Besides the OEWS, ACS, and CPS, what other appropriate sources of data are available that can be used to determine or forecast potential labor shortages for STEM occupations by occupation and geographic area?
2. What methods are available that can be used alone, or in conjunction with other methods, to measure presence and severity of labor shortages for STEM occupations by occupation and geographic area?
3. How could the Department establish a reliable, objective, and transparent methodology for identifying STEM occupations with significant shortages of workers that should be added to Schedule A?
4. Should the STEM occupations potentially added to Schedule A be limited to those OEWS occupations used in most of the recent BLS publications, or should the STEM occupations be expanded to include additional occupations that cover STW occupations?
5. Beyond the parameters discussed for STW occupations, should the Department expand Schedule A to include other non-STEM occupations? If so, what should the Department consider to establish a reliable, objective, and transparent methodology for identifying non-STEM occupations with a significant shortage of workers that should be added to or removed from Schedule A?
Department of Veterans Affairs.
Proposed rule.
The Department of Veterans Affairs (VA) is issuing this proposed rule to address its process for reviewing, determining, and allocating reasonable fees for claim representation, and to address the effect on direct payment of the termination of an agent's or attorney's VA accreditation.
Comments must be received on or before February 20, 2024.
Comments must be submitted through
Jonathan Taylor, Office of General Counsel (022D), 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7699. (This is not a toll-free telephone number.)
Congress has authorized VA to prescribe reasonable restrictions on the amount of fees that agents or attorneys may charge claimants for services on VA benefits claims. 38 U.S.C. 5904(a)(5). In addition, VA has the authority to review a fee agreement between an agent or attorney and a claimant and order a reduction in the fee if VA finds that fee is excessive or unreasonable. 38 U.S.C. 5904(c)(3)(A). VA also has the discretion to directly pay the fee of an agent or attorney from a claimant's past-due benefits if the claimant and the agent or attorney have entered into a fee agreement that requests direct payment and meets statutory and regulatory criteria, including the requirement that the fee not exceed 20 percent of the past-due benefits awarded to the claimant. 38 U.S.C. 5904(d). VA may issue all necessary or appropriate rules and regulations to carry out these authorities. 38 U.S.C. 501(a).
Based on these authorities, VA's Office of the General Counsel (OGC), which acts as the agency of original jurisdiction for reviewing fee agreements, currently performs a “fee reasonableness” review in two circumstances: (1) when the claimant or VA has questioned the reasonableness of the fee set forth in the agreement, and (2) when multiple agents or attorneys provided representation. OGC provides review in the latter circumstance in order to decide the amount to be directed to each agent or attorney for purposes of direct payment, since the “total fee payable” in direct payment cases is limited to 20 percent of the past-due benefits awarded.
Over the past decade, however, there has been a steady increase in cases involving multiple agents or attorneys, as well as requests for OGC review. For example, in fiscal year 2020, OGC received approximately 150 fee reasonableness requests or referrals; in fiscal year 2023, OGC received almost 700. OGC has limited resources to issue determinations on reasonable fees in all those cases. This has led to increased inventory for all fee matters, which has delayed attorneys, agents, and claimants from promptly receiving their earned fees or benefits. To best ensure timely resolution of fee matters for all parties, VA believes it is appropriate to establish reasonable default allocation rules for fee matters and to focus OGC's resources on those cases where a party has expressed an affirmative desire for an OGC determination based on the unique circumstances of the particular case. Moreover, there are many fee matters that can be worked out between the parties, without OGC involvement, and VA wishes to encourage such resolutions. Overall, these default rules will allow attorneys, agents, and claimants (as further explained below) to receive their fees and benefits faster.
Under current practice, after issuing a decision awarding past-due benefits, if a direct-pay fee agreement has been filed, the agency of original jurisdiction (typically the Veterans Benefits Administration) issues a fee notice containing a determination on agent or attorney fee eligibility. 38 CFR 14.636(c)(4). Under this proposed rule, the fee notice would provide one of two default fee allocations depending on the posture of the case. In cases where there is a “continuous agent or attorney”—an agent or attorney who provided representation that continued through the date of the decision awarding benefits—who meets the requirements for fee eligibility and direct payment enumerated in other paragraphs of § 14.636, the default would be allocation of the fee to that continuous agent or attorney. Otherwise, the default would be an equal split of the fee based on the number of agents or attorneys who meet the requirements for fee eligibility and direct payment plus the claimant.
The fee notice would note that any party (
As to the reason for proposing these specific default fee allocations, where a continuous agent or attorney meets the requirements for fee eligibility and direct payment, the default of allocating the fee to that agent or attorney is logical because that agent or attorney's fee is presumed reasonable under 38 CFR 14.636(f)(1). That agent or attorney—who was the representative of record
Furthermore, where all agents or attorneys were discharged prior to the date of the decision awarding benefits, the default of a split of the fee is logical because the presumption of 38 CFR 14.636(f)(1) does not apply to such agents and attorneys, and all agents or attorneys are generally in the same position vis-à-vis the fee: they are only entitled to a fee based on quantum meruit, 38 CFR 14.636(f)(2);
This data reflects the practical reality that, when a claimant secures a favorable decision (sometimes months, often years) after agent or attorney discharge, it may be the claimant (or a Veterans Service Organization) that bears more responsibility for the benefits awarded, and the former agents or attorneys that bear less. It is reasonable for a default—which is merely a baseline that has no effect once a party requests OGC review—to reflect that reality, particularly given the general law on quantum meruit, which suggests that a default should be structured in a way that places the burden on discharged agents or attorneys to file with OGC if they believe their contributions warrant the full potential fee, not on the claimant to file with OGC if they believe otherwise.
These changes would be incorporated into § 14.636(i), the current paragraph addressing OGC's review of fee agreements. Proposed paragraph (i)(1) would address fee allocation notices and the default fee allocations therein. Proposed paragraph (i)(2) would address the release of allocated fees and finality at the expiration of the 60-day period for requesting OGC review. Proposed paragraph (i)(3) would address the process for requesting that OGC initiate a reasonableness review. Proposed paragraph (i)(4) would address the opportunity to submit argument and evidence during OGC's review. Proposed paragraph (i)(5) would provide the standards for OGC's decision. Proposed paragraph (i)(6) would note the right to appeal OGC's decision to the Board of Veterans' Appeals.
To be clear, the default fee allocations of this proposed rule do not relieve attorneys or agents of their ethical obligation not to accept an unreasonable fee.
Related to that ethical issue, VA is proposing to update § 14.636(h) to address the effect on direct payment of the termination of an agent or attorney's VA accreditation. Post-termination, VA has no internal enforcement mechanism against these individuals for violating VA's standards of conduct, including the aforementioned standard that prohibits receipt of a fee that is clearly unreasonable; it would therefore complicate the ethical safeguards underpinning this proposed rule if agents or attorneys who have lost accreditation are included. Moreover, as a practical matter, it has been difficult to contact and directly pay agents or attorneys who have had their VA accreditation terminated, because they are no longer responsible for maintaining updated contact information with VA.
VA has the discretion to decline direct payment in certain circumstances notwithstanding the submission of a direct-pay fee agreement.
Lastly, VA is proposing additional, minor revisions to § 14.636. First, VA would remove § 14.636(c)(4), since the agency of original jurisdiction's fee eligibility notice under that paragraph would now be termed a fee allocation notice under proposed § 14.636(i)(1). Second, VA would revise § 14.636(e) to use the term “agent or attorney” in lieu of “representative,” because only agents and attorneys (not all representatives) can charge a fee. Also in that paragraph, VA would reiterate that fees set forth in a fee agreement, charged, or received for services must be reasonable, consistent with VA's standards of conduct discussed above, and note that fee reasonableness for one agent or attorney can be affected by the fee entitlement of another agent or attorney. Third, while filing fee agreements within 30 days of their execution would remain a regulatory requirement, § 14.636(g)(3) would explicitly note VA's discretion to accept fee agreements filed thereafter upon a showing of sufficient cause. Fourth, VA would simplify § 14.636(k), since the “modernized review system” of the Veterans' Appeals Improvement and Modernization Act, Public Law 115-55 (2017), governs all decisions on new fee matters. Fifth, VA is proposing new or revised captions for paragraphs (e), (j), and (k) that more accurately convey the subject-matter of each paragraph.
Executive Orders (E.O.) 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). E.O. 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 (Modernizing Regulatory Review) supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review established in Executive Orders 12866 and 13563. The Office of Information and Regulatory Affairs has determined that this rulemaking is a significant regulatory action under E.O. 12866, as amended by Executive Order 14094. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at
The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). The basis for this certification is the fact that the proposed rule would merely institute reasonable default rules for fee allocation and provide that agents and attorneys who have lost their VA accreditation collect any earned fees without VA assistance. These changes would not result in any loss of fees to which an agent or attorney is reasonably entitled, because, as noted above, any party dissatisfied with the default allocation in a given case can request OGC's determination on reasonable fees in the case. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.
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 proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.
This proposed rule includes provisions associated with a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521) that require approval by the Office of Management and Budget (OMB). The collection of information was previously approved by OMB and assigned the control number of 2900-0605 but expired in March 2022. Accordingly, under 44 U.S.C. 3507(d), VA has submitted a copy of this rulemaking action to OMB for review and reinstatement with change.
OMB assigns control numbers to collection of information it approves. VA 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. If OMB does not approve the collection of information as requested, VA will immediately remove the provisions containing the collection of information or take such other action as is directed by OMB.
Comments on the collection of information associated with this rulemaking should be submitted through
OMB is required to make a decision concerning the collection of information contained in this rulemaking between 30 and 60 days after publication of this rulemaking in the
The Department considers comments by the public on a collection of information in—
• Evaluating whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility;
• Evaluating the accuracy of the Department's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Enhancing the quality, usefulness, and clarity of the information to be collected; and
• Minimizing 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,
The collection of information associated with this rulemaking is
•
(1) Applicants seeking accreditation as claims agents or attorneys to represent benefits claimants before VA must file VA Form 21a with OGC. The information requested in VA Form 21a includes basic identifying information, as well as certain information concerning training and experience, military service, and employment.
(2) If accredited agents and attorneys wish to maintain accreditation, they must file recertifications with OGC that they have completed Continuing Legal Education (CLE) requirements and are in good standing with other courts, bars, and Federal and State agencies.
(3) Accredited agents and attorneys must file with VA any agreement for the payment of fees charged for representing claimants before VA. 38 U.S.C. 5904(c)(2); 38 CFR 14.636(g).
(4) Claimants, accredited agents, or accredited attorneys may request an OGC determination on a reasonable fee allocation in a given case. If they do, OGC will solicit (optional) responses from the other parties in the case. 38 U.S.C. 5904(c)(3); 38 CFR 14.636(i).
•
(1) The information in the VA Form 21a is used by OGC to determine the applicant's eligibility for accreditation as a claims agent or attorney. More specifically, it is used to evaluate qualifications, ensure against conflicts of interest, and to establish that statutory and regulatory eligibility requirements,
(2) The information in recertifications is used by OGC to monitor whether accredited attorneys and agents continue to have appropriate character and reputation and whether they remain fit to prepare, present, and prosecute VA benefit claims.
(3) The information in a fee agreement is used by the Veterans Benefits Administration (VBA) to associate the fee agreement with the claimant's claims file, to potentially determine the attorney or agent's fee eligibility, and to potentially process direct payment of a fee from the claimant's past-due benefits. It is used by OGC to monitor whether the agreement is in compliance with laws governing paid representation, and to potentially review fee reasonableness.
(4) The information in a request for OGC fee review, or a response to such request, is used by OGC to determine the agents' or attorneys' contribution to and responsibility for the ultimate outcome of the claimant's claim, so that a determination on reasonable fees can be rendered.
•
•
(1) For VA Form 21a applications, 2,280.
(2) For recertifications, 4,860.
(3) For fee agreements, 27,250 (750 first time filers and 26,500 repeat filers).
(4) For requests for OGC fee review, 305 (203 initial requests and 102 party responses).
•
•
(1) For VA Form 21a applications, 45 minutes.
(2) For recertifications, 10 minutes.
(3) For fee agreements, 11 minutes (1 hour for first time filers and 10 minutes for repeat filers).
(4) For requests for OGC fee review, 2 hours (for both initial requests and party responses).
•
(1) For VA Form 21a applications, 1,710 hours.
(2) For recertifications, 810 hours.
(3) For fee agreements, 5,167 hours (750 hours for first time filers and 4,417 hours for repeat filers).
(4) For requests for OGC fee review, 610 hours (406 hours for initial requests and 204 hours for responses).
•
(1) For VA Form 21a applications, $74,767.
(2) For recertifications, $63,779.
(3) For fee agreements, $406,850.
(4) For requests for OGC fee review, $43,133.
* To estimate the total information collection burden cost, VA used the Bureau of Labor Statistics (BLS) average hourly wage information available at
Administrative practice and procedure, Claims, Courts, Foreign relations, Government employees, Lawyers, Legal services, Organization and functions (Government agencies), Reporting and recordkeeping requirements, Surety bonds, Trusts and trustees, Veterans.
Denis McDonough, Secretary of Veterans Affairs, signed and approved this document on December 12, 2023, 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 stated in the preamble, the Department of Veterans Affairs proposes to amend 38 CFR part 14 as set forth below:
5 U.S.C. 301; 28 U.S.C. 2671-2680; 38 U.S.C. 501(a), 512, 515, 5502, 5901-5905; 28 CFR part 14, appendix to part 14, unless otherwise noted.
The revisions read as follows:
(e)
(1) The extent and type of services the agent or attorney performed;
(2) The complexity of the case;
(3) The level of skill and competence required of the agent or attorney in giving the services;
(4) The amount of time the agent or attorney spent on the case;
(5) The results the agent or attorney achieved, including the amount of any benefits recovered;
(6) The level of review to which the claim was taken and the level of the review at which the agent or attorney was retained;
(7) Rates charged by other agents or attorneys for similar services;
(8) Whether, and to what extent, the payment of fees is contingent upon the results achieved;
(9) If applicable, the reasons why an agent or attorney was discharged or withdrew from representation before the date of the decision awarding benefits; and
(10) If applicable, the fee entitlement of another agent or attorney in the case.
(g) * * *
(3) A copy of a direct-pay fee agreement, as defined in paragraph (g)(2) of this section, must be filed with the agency of original jurisdiction within 30 days of its execution. A copy of any fee agreement that is not a direct-pay fee agreement must be filed with the Office of the General Counsel within 30 days of its execution by mailing the copy to the following address: Office of the General Counsel (022D), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420. Only fee agreements that do not provide for the direct payment of fees, documents related to review of fees under paragraph (i) of this section, and documents related to review of expenses under § 14.637, may be filed with the Office of the General Counsel. All documents relating to the adjudication of a claim for VA benefits, including any correspondence, evidence, or argument, must be filed with the agency of original jurisdiction, Board of Veterans' Appeals, or other VA office as appropriate. VA may accept fee agreements that were not filed within 30 days of execution upon a showing of sufficient cause.
(h) * * *
(1) * * *
(ii) The amount of the fee is contingent on whether or not the claim is resolved in a manner favorable to the claimant or appellant,
(iii) The agent or attorney is accredited (
(iv) The award of past-due benefits results in a cash payment to a claimant or an appellant from which the fee may be deducted. (An award of past-due benefits will not always result in a cash payment to a claimant or an appellant. For example, no cash payment will be made to military retirees unless there is a corresponding waiver of retirement pay. (See 38 U.S.C. 5304(a) and 38 CFR 3.750))
(i)
(1) When one or more direct-pay fee agreements has been filed in accordance with paragraph (g) of this section and a decision awards past-due benefits in a case, the agency of original jurisdiction that issued the decision shall issue to the parties a fee allocation notice. The fee allocation notice shall decide whether the agents or attorneys who filed direct-pay fee agreements in the case are eligible for direct payment, and shall provide one of two default fee allocations:
(i) In cases where a continuous agent or attorney is eligible for direct payment, the default shall be allocation of the fee to the continuous agent or attorney.
(ii) In cases where paragraph (i)(1)(i) of this section does not apply, the default shall be an equal split of the fee based on the number of agents or attorneys who are eligible for direct payment plus the claimant or appellant.
(2) A party that disagrees with the default fee allocation in a given case may file a request for Office of the General Counsel fee review, as provided in paragraph (i)(3) of this section. A party that disagrees with a direct payment eligibility determination may only appeal to the Board of Veterans' Appeals. Absent a timely filed request for Office of the General Counsel fee review or a timely filed appeal to the Board of Veterans' Appeals, the default fee allocation described in paragraphs (i)(1)(i) and (ii) of this section is final and VA may release the fee.
(3) A request for Office of the General Counsel fee review under this paragraph (i) must be filed electronically in accordance with the instructions on the Office of the General Counsel's website, or at the following address: Office of the General Counsel (022D), 810 Vermont Avenue NW, Washington, DC 20420. The request must include the names of the veteran and all parties, the applicable VA file number, and the date of the decision awarding benefits. The request must set forth the requestor's proposal as to reasonable fee allocation, and the reasons therefor, and must be accompanied by all argument and evidence the requestor desires to submit.
(4) Upon the receipt of a timely filed request under paragraph (i)(3) of this section, or upon his or her own initiative, the Deputy Chief Counsel with subject-matter jurisdiction will initiate the Office of the General Counsel's motion for a fee review by sending notice to the parties. Not later than 30 days from the date of the motion, any party may file a response, with all argument and evidence the party desires to submit, electronically in accordance with the instructions on the Office of the General Counsel's website, or at the following address: Office of the General Counsel (022D), 810 Vermont Avenue NW, Washington, DC 20420. Such responses must be served on all other parties. The Deputy Chief Counsel with subject-matter jurisdiction may, for a reasonable period upon a showing of sufficient cause, extend the time for any party's response.
(5) The General Counsel or his or her designee shall render the Office of the General Counsel's decision on the matter. The decision will be premised on the reasonableness factors of paragraph (e) of this section, the standards of paragraph (f) of this section, the limitation on direct payment of paragraph (h)(1)(i) of this section, the claims file, the parties' submissions, and all relevant factors. The decision may address the issue of fee eligibility if no other agency of original jurisdiction has made a determination on that issue.
(6) The Office of the General Counsel's decision is a final adjudicative action that may only be appealed to the Board of Veterans' Appeals. Unless a party files a Notice of Disagreement with the Office of the General Counsel's decision, the parties must allocate any excess payment in accordance with the decision not later than the expiration of the time within which the Office of the General Counsel's decision may be appealed to the Board of Veterans' Appeals.
(j)
(k)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve, as a revision of the Nevada state implementation plan (SIP), the State's second 10-year plan for maintaining the 1997 8-hour ozone standard in Clark County (“Clark County Second Maintenance Plan” or “Plan”). The Clark County Second Maintenance Plan includes, among other elements, a base year emissions inventory, a maintenance demonstration, contingency provisions, and motor vehicle emissions budgets for use in transportation conformity determinations to ensure the continued maintenance of the 1997 National Ambient Air Quality Standards for ozone (“1997 ozone NAAQS” or “1997 8-hour ozone standard”). With this proposed rulemaking, the EPA is initiating the adequacy process for the 2017, 2023, and 2033 motor vehicle emissions budgets. The EPA is proposing these actions because the SIP revision meets the applicable statutory and regulatory requirements for such plans and motor vehicle emissions budgets.
Comments must be received on or before January 22, 2024.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2022-0955, at
Andrew Ledezma, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 972-3985 or by email at
Throughout this document, “we,” “us,” and “our” refer to the EPA.
Under Clean Air Act (CAA or “the Act”) section 110(k)(3), the EPA is proposing to approve two submittals from the Nevada Division of Environmental Protection (NDEP) as a revision to the Nevada SIP: the Clark County Second Maintenance Plan dated December 21, 2021, and a supplement to the Clark County Second Maintenance Plan (“Contingency Measure Revision”) dated August 16, 2023. In this action, we refer to the Clark County Second Maintenance Plan and the Contingency Measure Revision collectively as the “Clark County Second Maintenance Plan submittal.”
The EPA is proposing to find that the maintenance demonstration, showing how the area will continue to attain the 1997 8-hour ozone NAAQS for 10 additional years beyond the approval the State's first 10-year plan for maintaining the 1997 8-hour ozone standard in Clark County (“Clark County First Maintenance Plan” or “first maintenance plan”) (
Sections 108 and 109 of the CAA govern the establishment, review, and revision, as appropriate, of the NAAQS to protect public health and welfare. The CAA requires the EPA to periodically review the air quality criteria, the science upon which the standards are based, and the standards themselves. Ground-level ozone is one of the criteria pollutants regulated under the NAAQS.
Ground-level ozone is generally not emitted directly by sources. Rather, directly emitted oxides of nitrogen (NO
Scientific evidence indicates that adverse public health effects occur following exposure to ozone, particularly in children and adults with lung disease. Breathing air containing ozone can reduce lung function and inflame airways, which can increase respiratory symptoms and aggravate asthma or other lung diseases.
In 1997, the EPA revised the NAAQS for ozone, setting it at 0.08 parts per million (ppm) averaged over an 8-hour time frame.
In 2004, the EPA designated areas of the country with respect to the 1997 8-hour ozone NAAQS.
In
On May 14, 2012, in response to the Court's vacatur of the provision of the Phase 1 rule for the 1997 8-hour ozone standard that placed certain nonattainment areas, including Clark County solely under subpart 1, the EPA classified Clark County as a marginal ozone nonattainment area under subpart 2 of the CAA.
On March 29, 2011, the EPA determined that the Clark County 8-hour ozone nonattainment area had attained the 1997 8-hour ozone NAAQS, based on complete, quality-assured, and certified ambient air monitoring data that showed the area monitored attainment of the 1997 8-hour ozone NAAQS for the 2007-2009 monitoring period.
On April 11, 2011, NDEP submitted the Clark County First Maintenance Plan and requested that the EPA redesignate the Clark County 8-hour ozone nonattainment area to attainment for the 1997 8-hour ozone standard. On January 8, 2013, the EPA approved the Clark County First Maintenance Plan, and redesignated the area from nonattainment to attainment of the 1997 8-hour ozone NAAQS.
On October 31, 2018, NDEP submitted a
On September 30, 2020, NDEP submitted an additional
On January 24, 2022, NDEP submitted the Clark County Second Maintenance Plan showing how the area will continue to attain the 1997 8-hour ozone national ambient air quality standard (NAAQS) for 10 additional years beyond the approval the State's first 10-year plan.
Lastly, on August 16, 2023, NDEP submitted the Contingency Measure Revision, which revised the contingency measure section of the Clark County Second Maintenance Plan. In this action, we are proposing action on the
CAA section 110(a)(1) and (2) and section 110(1) require states to provide reasonable notice and public hearing prior to adoption of SIP revisions. In this action, we are proposing action on NDEP's January 24, 2022, submittal of the Clark County Ozone Second Maintenance Plan, and NDEP's August 16, 2023, submittal of the Contingency Measure Revision as a revision to the Nevada SIP, collectively referred to as the Clark County Second Maintenance Plan submittal.
Following a 30-day public comment period, the Clark County Second Maintenance Plan was adopted by the Clark County Board of Commissioners, submitted to NDEP, and submitted to the EPA. Appendix B of the Clark County Second Maintenance Plan documents the public review process followed by Clark County in adopting the plan prior to transmittal to NDEP for subsequent submittal to the EPA as a revision to the Nevada SIP. The documentation in appendix B provides evidence that reasonable notice of a public hearing was provided to the public and that a public hearing was conducted prior to adoption. Specifically, notice of the availability of, and opening of a 30-day comment period on, the draft Clark County Second Maintenance Plan was published on October 14, 2021, on the Clark County Department of Environment and Sustainability (DES) website, the DES official Facebook page, and the DES official Twitter. No comments were submitted.
On December 7, 2021, the Clark County Board of Commissioners set a public hearing for December 21, 2021, to consider and approve the Clark County Second Maintenance Plan. The announcement of the public hearing was subsequently published on the County's web page. On December 21, 2021, the Clark County Board of Commissioners adopted the Clark County Second Maintenance Plan at the close of the public hearing. Following adoption, Clark County DES forwarded the plan to NDEP, the Governor of Nevada's designee for SIP matters, and NDEP then submitted the plan as a revision to the Nevada SIP to the EPA for approval on January 24, 2022.
Appendix A of the Contingency Measure Revision documents the board approval process followed by Clark County in adopting the plan prior to transmittal to NDEP for subsequent submittal to the EPA as a revision to the Nevada SIP. On July 18, 2023, the Clark County Board of Commissioners put the Contingency Measure Revision up for public notice and adopted the Contingency Measure Revision at the close of the public hearing. Following adoption, Clark County DES forwarded the plan to NDEP and NDEP then submitted the plan, as a revision to the Nevada SIP, to the EPA for approval on August 16, 2023.
Based on the documentation contained in appendix B of the Plan and appendix A of the Contingency Measure Revision, we find that the Clark County Second Maintenance Plan submittal satisfies the procedural requirements of section 110(l) of the Act.
Section 175A of the CAA provides the general framework for a maintenance plan. The initial 10-year maintenance plan must provide for maintenance of the NAAQS for at least 10 years after redesignation, including any additional control measures necessary to ensure such maintenance. In addition, maintenance plans are to contain contingency provisions necessary to ensure the prompt correction of a violation of the NAAQS that occurs after redesignation. The contingency measures must include, at a minimum, a requirement that the state will implement all control measures contained in the nonattainment SIP prior to redesignation. Beyond these provisions, section 175A of the CAA does not define the content of a second 10-year maintenance plan.
The primary guidance on maintenance plans and redesignation requests is a September 4, 1992, memorandum from John Calcagni, titled “Procedures for Processing Requests to Redesignate Areas to Attainment” (Calcagni Memo).
CAA section 175A(b) requires states to submit an additional SIP revision (Second 10-Year Maintenance Plan) to maintain the NAAQS for an additional 10 years after the expiration of the 10-year period covered by the initial maintenance plan approved in connection with the redesignation of the area from nonattainment to attainment. The revision is submitted eight years after the original redesignation request and maintenance plan have been approved. The deadline to submit Clark County's Second Maintenance Plan was January 8, 2021. On January 24, 2022, NDEP submitted the Clark County Second Maintenance Plan, to meet the requirement for the subsequent maintenance plan under CAA section 175A(b). The Clark County Second Maintenance Plan is intended to provide for continued maintenance of the 1997 ozone NAAQS for the 10-year period following the end of the first 10-year period,
Section 175A of the CAA sets forth the elements of a maintenance plan. We interpret this section of the Act to require, in general, the following core elements: attainment inventory, maintenance demonstration, monitoring network, verification of continued attainment, and contingency plan.
Continued ambient monitoring of an area is generally required over the maintenance period. Clark County DES currently operates ozone monitors at thirteen sites within the Clark County 8-hour ozone maintenance area.
In the Clark County Second Maintenance Plan,
For maintenance plans, a state should develop a comprehensive and accurate inventory of actual emissions for an attainment year which identifies the level of emissions in the area which is sufficient to maintain the NAAQS. The inventory should be developed consistent with the EPA's most recent guidance. For ozone, the inventory should be based on typical ozone season day emissions of NO
In the Clark County First Maintenance Plan, Clark County DES used 2008 for the attainment year inventory, because 2008 was one of the years in the 2007-2009 three-year period when the area first attained the 1997 ozone NAAQS.
Table 1 presents the VOC and NO
The data shown in Table 1 in this document is based on the 2017 National Emissions Inventory (NEI).
Point sources are stationary sources that have a potential to emit (PTE) greater than 100 tons per year of NO
Nonpoint sources include emissions from equipment, operations and activities that are numerous and in total have significant emissions. Clark County DES included emissions from minor sources, residential combustion, agricultural burning, industrial solvents and graphic arts, and degreasing operations. Clark County DES used several methods to estimate area source activity levels and emissions, including applying local activity levels, apportioning national or statewide activity levels to the local level, applying per capita emission factors considering county-specific populations and using specific method abstracts detailed within the submittal.
Non-road emissions sources include equipment that either move under their own power or can be moved from site to site.
The on-road emissions sector includes emissions from engines used primarily to propel equipment on highways and other roads, including passenger vehicles, motorcycles, and heavy-duty diesel trucks. Clark County DES used MOVES3, EPA's MOVES3 emissions factors, fleet data from Department of Motor Vehicles (DMV) registration data, Coordinated Research council (CRC) vehicle speed data, the Regional Transportation Commission (RTC) of Southern Nevada's transportation demand modeling results, vehicle classification data from the June 2018 Clark County Vehicle Classification Study,
Biogenic emissions are from vegetation and soil, and include crops, lawn grass, and forests. Clark County DES used the Biogenic Emissions Inventory System version 3.61 (BEIS3.61) embedded in the SMOKE 4.7 model for the month of July to generate average ozone season day emissions for Clark County.
The airport sector includes emissions from aircraft from commercial and federal aviation sources. Clark County DES relied on airport-specific emissions inventory information provided by the Clark County Department of Aviation (CCDOA) for the five commercial airports located within the nonattainment area.
Locomotives include emissions from railroad and high-speed passenger train emissions. Locomotive emissions were estimated by Clark County DES based on local activity data collected for the Clark County First Maintenance Plan and predicted emissions from high-speed passenger train service.
ERCs refer to allowances earned through voluntary pollutant emissions reductions such as equipment shutdowns or voluntarily installed controls. Clark County adopted New Source Review (NSR) rule, Section 12.7.5—Emission Reduction credits into the SIP,
The EPA has reviewed the emissions inventory submitted by Clark County and proposes to conclude that the plan's inventory is based on reasonable assumptions and methodologies, and that the inventory is comprehensive, current, accurate, and consistent with applicable CAA provisions and the Calcagni Memo. Therefore, we are proposing that the inventory is acceptable for use in demonstrating maintenance of the 1997 ozone NAAQS.
CAA section 175A(a) requires that the maintenance plan “provide for the maintenance of the national primary ambient air quality standard for such air pollutant in the area concerned for at least 10 years after the redesignation.” Generally, a state may demonstrate maintenance of the ozone NAAQS by either showing that future emissions of a pollutant or its precursors will not exceed the level of the attainment inventory or by modeling to show that the future mix of sources and emissions rates will not cause a violation of the NAAQS.
Clark County used the 2017 national emissions inventory (NEI) data as the baseline to develop growth factors for point, nonpoint, and locomotive sources. Clark County DES used the EPA 2016 v.1 modeling platform emissions data to develop per-year growth adjustment factors for point, nonpoint, federal aviation, and locomotives. Clark County DES used local activity data to develop commercial airport growth factors and conducted MOVES3 modeling to project on-road and non-road emissions. The derived growth adjustment factors were used to extrapolate emissions to account for a 16-year (2017 through 2033) spread. The 2033 growth factors were multiplied by the 2017 actual emissions to produce the 2033 projected point source and various other stationary source emissions; including Residential Wood Combustion,
In addition to accounting for areawide growth trends, Clark County DES added emissions from specific projects that are expected to become operational during the second maintenance period,
Table 1 compares the VOC and NO
In addition, historical monitoring data presented in the plan shows a gradual downward trend in ozone design values during 2008-2020. The 1997 NAAQS level of 80 ppb was achieved in 2009, and the 2020 value of 74 ppb is well below the NAAQS.
NDEP and the Clark County Board of County Commissioners have the legal authority to implement and enforce the requirements of the Clark County Second Maintenance Plan. This includes the authority to adopt, implement and enforce any emissions control contingency measures determined to be necessary to correct ozone NAAQS violations. To verify continued attainment, Clark County DES commits in the Clark County Second Maintenance Plan to the continued operation of an ozone monitoring network that meets the EPA ambient air quality surveillance requirements.
Secondly, the transportation conformity process represents another means by which to verify continued attainment of the 1997 8-hour ozone NAAQS in the Clark County 8-hour ozone area given the relative importance of motor vehicle emissions to the overall emissions inventories of ozone precursors.
Lastly, while not cited in the plan, NDEP and Clark County DES must inventory emissions sources and report to the EPA on a periodic basis under 40 CFR part 51, subpart A (“Air Emissions Reporting Requirements”). These emissions inventory updates will provide a third means with which to track emissions in the area relative to those projected in the maintenance plan and thereby verify continued attainment of the NAAQS. These methods are sufficient for the purpose of verifying continued attainment.
Section 175A(d) of the Act requires that maintenance plans include contingency provisions, as the EPA deems necessary, to promptly correct any violations of the NAAQS that occur after redesignation of the area. Such provisions must include a requirement that the State will implement all measures with respect to the control of the air pollutant concerned which were contained in the SIP for the area before redesignation of the area as an attainment area.
Under section 175A(d), contingency measures identified in the contingency plan do not have to be fully adopted at the time of redesignation. However, the contingency plan is an enforceable part of the SIP and should ensure that the contingency measures are adopted expeditiously once they are triggered by a specified event. The maintenance plan should clearly identify the measures to be adopted, a schedule and procedure for adoption and implementation, and a specific timeline for action by the State. As a necessary part of the plan, the State should also identify specific indicators or triggers, which will be used to determine when the contingency measures need to be implemented.
As required by section 175A of the CAA, Clark County DES has adopted a contingency plan to address possible future ozone air quality problems.
Potential contingency measures listed in the maintenance plan are those emissions controls or other measures that Clark County, the Nevada State Board of Agriculture, and/or the Nevada State Environmental Commission may choose to adopt and implement in response to the contingency trigger. The contingency measures plan in the Contingency Measure Revision lists the following potential contingency measures that will be considered for adoption and implementation by the applicable State or County agency, but the Plan indicates that the list is not to be considered exclusive:
• Reid vapor pressure reduction (
• Inspection/maintenance program changes and additions (
• Consumer and commercial products (Clark County would be responsible for adoption and implementation);
• Architectural surface coatings (Clark County would be responsible for adoption and implementation);
• Lawn and garden equipment use (Clark County would be responsible for adoption and implementation); and
• Establish/enhance trip reduction programs (Clark County and the RTC would be responsible for adoption and implementation).
Upon our review of the plan, we find that the contingency provisions of the Contingency Measure Revision clearly identify specific contingency measures, contain tracking and triggering mechanisms to determine when contingency measures are needed, contain a description of the process of recommending and implementing contingency measures, and contain specific timelines for action. Thus, we conclude that the contingency provisions of the Contingency Measure Revision are adequate to ensure prompt correction of a violation and therefore comply with section 175A(d) of the Act.
Section 176(c) of the CAA requires federal actions in nonattainment and
Actions involving Federal Highway Administration (FHWA) or Federal Transit Administration (FTA) funding or approval are subject to the EPA's transportation conformity rule, codified at 40 CFR part 93, subpart A. Under this rule, RTCs in nonattainment and maintenance areas coordinate with state and local air quality and transportation agencies, the EPA, FHWA, and FTA to demonstrate that an area's regional transportation plans and transportation improvement programs conform to the applicable SIP. This demonstration is typically done by showing that estimated emissions from existing and planned highway and transit systems are less than or equal to the motor vehicle emissions budgets (“budgets”) contained in submitted or approved control strategy SIPs and maintenance plans.
These control strategy SIPs and maintenance plans typically set budgets for criteria pollutants and/or their precursors to address pollution from cars and trucks. Budgets are generally established for specific years and specific pollutants or precursors. Maintenance plan submittals should identify budgets for transportation-related VOC and NO
For budgets in a maintenance plan to be approvable, they must meet, at a minimum, the EPA's adequacy criteria.
Clark County's Second Maintenance Plan contains VOC and NO
The EPA proposes to approve 2017, 2023, and 2033 budgets in the Clark County Second Maintenance Plan for transportation conformity purposes in the final rulemaking on Clark County's ozone redesignation request. If the EPA approves the budgets in the final rulemaking action, the new budgets must be used in future transportation conformity determinations for Clark County for the 2015 ozone standard. The new budgets, if approved in the final rulemaking, will be effective on the date of the EPA's final rulemaking in the
The MVEBs are the on-road mobile source VOC and NO
We evaluated the budgets against our adequacy criteria in 40 CFR 93.118(e)(4) and (5) as part of our review of the budget's approvability and expect to complete the adequacy review of the budgets concurrent with our final action on the Clark County's Second Maintenance Plan. The EPA is not required under its transportation conformity rule to find budgets adequate prior to proposing approval of them. In this notice, the EPA is announcing that the adequacy process for these budgets begins, and the public has 30 days to comment on their adequacy, per the transportation conformity rule at 40 CFR 93.118(f)(2)(i) and (ii).
Clark County DES developed the budgets for 2023 and 2033 using on-road motor vehicle emission estimates made using the EPA's MOVES3 model, fleet data from DMV registration data, CRC vehicle speed data, NDOT HPMS data, travel demand modeling from the Regional Transportation Commission and vehicle classification data from the June 2018 Clark County On-road Vehicle Classification Study.
As documented in the separate memorandum
The EPA performed a screening-level analysis using the EPA's environmental justice (EJ) screening and mapping tool (“EJSCREEN”). Our screening-level analysis included multiple environmental and demographic indicators, including the EJSCREEN “Demographic Index,” which is the average of an area's percentage of minority and low-income populations. The Demographic Index of Clark County is at the 68th percentile, compared to the United States as a whole.
This action addresses a plan for continued maintenance of the 1997 ozone NAAQS for Clark County. Approval of this plan does not impose any additional regulatory requirements on sources beyond those imposed by state law. As discussed in this document, Nevada has demonstrated that the Clark County is attaining the 1997 ozone NAAQS and the Clark County Second Maintenance Plan provides for the maintenance of the NAAQS for the reminder of the maintenance period. We expect that this action will generally be neutral or contribute to reduced environmental and health impacts on all populations in Clark County, including people of color and low-income populations. At a minimum, this action would not worsen any existing air quality and is expected to ensure the area is meeting requirements to maintain air quality standards. Further, there is no information in the record indicating that this action is expected to have disproportionately high or adverse human health or environmental effects on a particular group of people.
Under CAA section 110(k)(3), and for the reasons set forth in this document, the EPA is proposing to approve the Clark County Second Maintenance Plan submitted by NDEP on January 24, 2022, as a revision to the Nevada SIP.
We are soliciting comments on these proposed actions. We will accept comments from the public for 30 days following publication of this proposal in the
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Will not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994), as discussed in section VI of this proposal.
In addition, there are no areas of Indian country within the planning area, and the state plan for which the EPA is proposing approval does not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the Clark County Second Maintenance Plan does not apply, and therefore, this proposed action does not have tribal implications and would not, if approved, impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Particulate matter, Sulfur dioxide, 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 a State Implementation Plan (SIP) revision submitted by the State of Georgia, through the Georgia Environmental Protection Division (EPD) via a letter dated October 20, 2022. The revision seeks to change Georgia's Rules for Air Quality Control in the SIP by removing the 1971 annual and 24-hour ambient air quality primary standard for sulfur dioxide (SO
Comments must be received on or before January 22, 2024.
Submit your comments, identified by Docket ID No. at EPA-R04-OAR-2023-0232 at
Josue Ortiz Borrero, 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) 562-8085. Mr. Ortiz Borrero can also be reached via electronic mail at
On June 2, 2010, EPA revised the primary SO
When EPA revised the SO
After EPA promulgates a new or revised NAAQS, the agency is required to designate all areas of the country as either “nonattainment,” “attainment,” or “unclassifiable” for that NAAQS pursuant to section 107(d) of the CAA. The CAA requires EPA to complete the initial designations process within two years of promulgating a new or revised standard or June 2012 for the 1-hour SO
Subsequently, lawsuits were filed against EPA alleging that the Agency had failed to perform a nondiscretionary duty under the CAA by not designating all portions of the country by June 3, 2013.
Georgia's October 22, 2022, submittal proposes to revise Rule 391-3-1-.02(4), “Ambient Air Standards”, at subparagraphs (b)1 and (b)2 of paragraph (b), “Sulfur Dioxide” to remove the 1971 annual and 24-hour ambient air quality primary SO
As described above, EPA designated all counties in Georgia as attainment/unclassifiable through the three rounds of designations for the 2010 1-hour primary NAAQS, with the final Round 4 designations effective on April 30, 2021. Thus, these 1971 standards no longer applied anywhere in Georgia effective on April 30, 2022. Moreover, with no SO
In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, and as explained in sections I and II of this preamble, EPA is proposing to incorporate by reference Georgia Rule 391-3-1-.02(4), “Ambient Air Standards,” paragraph (b), “Sulfur Dioxide,” State effective September 19, 2022, to remove subparagraphs (b)1 and (b)2 and renumber the remaining provisions accordingly. EPA has made and will continue to make these materials generally available through
EPA is proposing to approve Georgia's October 20, 2022, SIP submittal, which would remove the 1971 annual and 24-hour primary SO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
• 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 subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
Georgia EPD did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this proposed action. Consideration of EJ is not required as part of this proposed action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
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 Department of Natural Resources (GA DNR), Environmental Protection Division (EPD), on June 8, 2022, and on June 6, 2023. Georgia's June 8, 2022, SIP revision (hereinafter referred to as Georgia's 2022 I/M SIP revision) removes obsolete references and provisions; updates the State's inspection and maintenance (I/M) requirements; updates terminology, in part to reflect advances in test and vehicle technology; and makes other minor changes. The June 6, 2023, SIP revision (hereinafter referred to as Georgia's 2023 I/M SIP revision) removes outdated terminology; updates with new terminology; removes one requirement; and makes other minor changes to Georgia's enhanced I/M program. EPA is proposing to approve these changes pursuant to the Clean Air Act (CAA or Act).
Comments must be received on or before January 22, 2024.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2022-0630 at
Weston Freund, 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) 562-8773. Mr. Freund can also be reached via electronic mail at
Below provides the background for EPA's proposed actions on Georgia's 2022 and 2023 I/M SIP revisions that were submitted to EPA by GA DNR on June 8, 2022, and on June 6, 2023, respectively.
The CAA requires areas that are designated as moderate, serious, severe, or extreme ozone nonattainment areas to establish motor vehicle I/M programs to ensure regular monitoring of gasoline fueled motor vehicle emissions.
In 1991, EPA classified a 13-county area in and around the Atlanta, Georgia, metropolitan area as a serious ozone nonattainment area for the 1979 1-hour ozone national ambient air quality standards (NAAQS or standard), triggering the requirement for the State to establish an enhanced I/M program for the area.
On July 18, 1997 (62 FR 38856), EPA established an 8-hour ozone NAAQS and subsequently designated areas. On April 30, 2004 (69 FR 23858), EPA designated a 20-county area in and around metropolitan Atlanta as a marginal ozone nonattainment area for the 1997 8-hour ozone NAAQS.
On March 12, 2008, EPA revised the 8-hour ozone NAAQS.
On October 1, 2015, EPA again revised the 8-hour ozone NAAQS.
EPA is proposing to approve changes to the I/M regulations in Chapter 391-3-20—
Further, EPA is proposing to approve additional changes to Georgia's I/M regulations that were provided to EPA through a cover letter dated June 6, 2023. Specifically, Georgia's 2023 I/M SIP revision seeks to update Rule 391-3-20-.01,
Collectively, the proposed changes remove obsolete references and provisions, update Georgia's I/M requirements, update terminology, correct punctuation, and make other minor changes to Georgia's SIP-approved I/M requirements. EPA is proposing to find that the changes submitted by Georgia will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable CAA requirement.
Both Georgia's 2022 and 2023 I/M SIP revisions update Rule 391-3-20-.01,
Georgia's 2022 I/M SIP revision updates the definition for “Emission Inspection” in Rule 391-3-20-.01. The revision changes the order of tests and inspections listed in the definition. Specifically, the “on-board diagnostic system check” test is moved to the beginning of listed tests and inspections, and the “exhaust emissions test” is moved to the end of the list. The purpose of this change is to highlight the more current widespread use of OBD as the primary method used for emission tests. Since this minor update does not change any applicable limits or requirements, it will have no impact on emissions and is consistent with CAA requirements.
Georgia's 2023 I/M SIP revision further updates Rule 391-3-20-.01 by adding a definition, removing two definitions, revising one definition, making minor grammatical changes in three definitions, and then renumbering the section to reflect these changes. First, the revision adds a definition for “Biometrics.” The revision adds this definition to reflect another method of identification that can be used by an inspector to initiate an inspection. Specifically, inspectors will now be able to use their own biometric login in lieu of using their personal access code to perform and record any inspections. Second, the revision removes the definitions “Grandfathered Vehicle” and “Gray Market Vehicle” since both are encompassed in the newly revised definition of “Non-conforming Vehicle.” The new definition for “Non-conforming Vehicle” applies to those vehicles that have not obtained an EPA certification or ones that have an emissions control component that is obsolete according to the manufacturer. Further, the revision to this definition adds that vehicles that qualify as non-conforming “would be subject to an alternative tail pipe emissions standard
Georgia's 2023 I/M SIP revision updates Rule 391-3-20-.03,
Both Georgia's 2022 and 2023 I/M SIP revisions update Rule 391-3-20-.04,
Georgia's 2022 I/M SIP revision updates Rule 391-3-20-.04,
Georgia's 2023 I/M SIP revision further updates Rule 391-3-20-.04,
Both Georgia's 2022 and 2023 I/M SIP revisions update Rule 391-3-20-.05,
Georgia's 2022 I/M SIP revision updates Rule 391-3-20-.04,
Georgia's 2023 I/M SIP revision updates Rule 391-3-20-.05,
Georgia's 2022 I/M SIP revision updates Rule 391-3-20-.09,
Georgia's 2022 I/M SIP revision updates Rule 391-3-20-.10,
Both Georgia's 2022 and 2023 I/M SIP revisions update Rule 391-3-20-.11,
Georgia's 2022 I/M SIP revision updates Rule 391-3-20-.11,
Georgia's 2023 I/M SIP revision further updates Rule 391-3-20-.11 by adding language to reflect the use of biometric identification to initiate an inspection, to include some new requirements, and to make one minor grammatical change. First, paragraph 391-3-20-.11(8) is revised to require inspectors to notify the Management Contractor of a change to telephone or email address contact information after applying for and receiving a Certificate of Authorization. Previously, inspectors only needed to notify the Management Contractor of a change of address. Second, the revision revises paragraphs 391-3-20-.11(9) and .11(10) to reflect that, in addition to using a personal access code, inspectors may also use a
Georgia's 2022 I/M SIP revision updates Rule 391-3-20-.13,
Georgia's 2022 I/M SIP revision amends Rule 391-3-20-.15,
Georgia's 2022 I/M SIP revision updates Rule 391-3-20-.17,
Georgia's 2022 I/M SIP revision updates Rule 391-3-20-.22,
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 40 CFR 51.5, and as explained in sections I and II of this preamble, EPA is proposing to incorporate by reference Georgia Rules 391-3-20-.09—
EPA is proposing to approve changes to Georgia's SIP-approved I/M rules as provided in Georgia's June 8, 2022, and June 6, 2023, SIP revisions. These SIP revisions include changes to 391-3-20-.01—
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 (88 FR 21879, April 11, 2023);
• 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 subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because they approve a state program;
• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• 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.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
EPD did not evaluate EJ considerations as part of its SIP submittals; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in these proposed actions. Due to the nature of the actions being proposed here, these proposed actions are expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of these proposed actions, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving EJ for people of color, low-income populations, and Indigenous peoples.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
On December 1, 2022, the U.S. Environmental Protection Agency (EPA) determined that revised water quality standards are necessary to protect aquatic life in certain water quality management zones of the Delaware River. Specifically, the EPA issued an Administrator's Determination, pursuant to the Clean Water Act (CWA), finding that a revised designated use to protect aquatic life propagation and corresponding dissolved oxygen criteria to protect that use are necessary in Zone 3, Zone 4, and the upper portion of Zone 5 (in total, river miles 108.4 to 70.0) of the Delaware River. The CWA requires the EPA to publish proposed water quality standards following an Administrator's Determination. Thus, the EPA is proposing to promulgate an aquatic life designated use that includes propagation and protective water quality criteria for dissolved oxygen for Zone 3, Zone 4, and upper Zone 5 of the Delaware River.
Comments must be received on or before February 20, 2024. Public hearing: the EPA will hold two public hearings during the public comment period. Please refer to the
You may send comments, identified by Docket ID No. EPA-HQ-OW-2023-0222, by any of the following methods:
•
•
•
Hannah Lesch, Office of Water, Standards and Health Protection Division (4305T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (202) 566-1224; email address:
This proposed rule preamble is organized as follows:
Submit your comments, identified by Docket ID No. EPA-HQ-OW-2023-0222, at
The EPA is offering two public hearings so that interested parties may also provide oral comments on this proposed rulemaking. For more details on the public hearings and to register to attend the hearings, please visit
A range of individuals and entities could be affected by this rulemaking, if finalized. For example, entities that discharge pollutants to certain waters under the jurisdiction of the states of Delaware, New Jersey, and Pennsylvania—such as industrial facilities and municipalities that manage stormwater, separate sanitary, or combined sewer systems—could be indirectly affected by this rulemaking because Federal water quality standards (WQS) promulgated by the EPA would be the applicable WQS for these waters for CWA purposes (Table 1 of this preamble). Specifically, these WQS would be the applicable standards that must be used in CWA regulatory programs, such as permitting under the National Pollutant Discharge Elimination System (NPDES) under CWA section 402
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities that could be indirectly affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the
CWA section 101(a)(2) establishes a national goal of “water quality which provides for the protection and propagation of fish, shellfish, and wildlife, and provides for recreation in and on the water” (hereafter, collectively referred to as “101(a)(2) uses” or “101(a)(2) goals”), wherever attainable. The EPA's regulation at 40 CFR 131.10(g) implements this statutory
Under the CWA, states have the primary responsibility for reviewing, establishing, and revising WQS applicable to their waters (CWA section 303(c)). WQS define the desired condition of a water body, in part, by designating the use or uses to be made of the water and by setting the numeric or narrative water quality criteria to protect those uses (40 CFR 131.2, 131.10, and 131.11). There are two primary categories of water quality criteria: human health criteria and aquatic life criteria. Human health criteria protect designated uses such as public water supply, recreation, and fish and shellfish consumption. Aquatic life criteria protect designated uses such as protection and propagation of fish, invertebrates, and other aquatic species. Regardless of their category, water quality criteria “must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use. For waters with multiple use designations, the criteria shall support the most sensitive use” (40 CFR 131.11(a)(1)).
States are required to hold a public hearing to review applicable WQS at least once every three years and, if appropriate, revise or adopt new standards (CWA section 303(c)(1); 40 CFR 131.20(a)). Every three years, states must also reexamine water body segments that do not include the 101(a)(2) uses to determine if new information has become available that indicates the 101(a)(2) uses are attainable, and if so, revise the WQS accordingly (40 CFR 131.20(a)). Any new or revised WQS must be submitted to the EPA for review and approval or disapproval (CWA section 303(c)(2)(A) and (c)(3)).
CWA section 303(c)(4)(B) independently authorizes the Administrator to determine that a new or revised standard is necessary to meet CWA requirements; this action is frequently referred to as an “Administrator's Determination.” Pursuant to CWA section 303(c)(4)(B), after making an Administrator's Determination, the EPA must propose and promulgate WQS specified in the Administrator's Determination. If a state adopts and the EPA approves WQS that address the Administrator's Determination prior to the EPA's promulgation, then the EPA would no longer be required to promulgate WQS.
The Delaware River has historically been home to numerous species of ecological, recreational, and economic importance; however, centuries of anthropogenic water quality impacts and habitat degradation, peaking in the mid-twentieth century, made portions of the river unsuitable for many aquatic species. In the 1700s and 1800s, many native fish species in the Delaware River faced declining populations due to overharvesting and the installation of physical barriers that prevented fish passage.
Dissolved oxygen is an important water quality parameter that can significantly influence the distribution and abundance of aquatic organisms and ecological relationships in aquatic ecosystems. Aquatic organisms need to obtain adequate levels of dissolved oxygen to maintain and support normal functioning, including during sensitive life stages, such as spawning, larval development, and juvenile growth.
Discharges of untreated or poorly treated municipal and industrial wastewater into the specified zones of the Delaware River have historically been a major cause of water quality degradation, including oxygen depletion.
Along the Delaware River, untreated wastewater discharges typically occur during and after rainfall due to combined sewer overflows (CSOs), which are a source of nutrients (
Although most point source discharges today are treated, treated effluent can still contain high levels of ammonia nitrogen, which depletes oxygen in the water as bacteria oxidize ammonia into nitrite, nitrate and dinitrogen gas.
The Delaware River is home to two oxygen-sensitive fish species—Shortnose Sturgeon and Atlantic Sturgeon—that are protected under the Federal Endangered Species Act (ESA). All populations of Shortnose Sturgeon were listed as endangered in 1967.
In addition to being listed as endangered under the ESA, available evidence suggests that Shortnose Sturgeon and Atlantic Sturgeon are the most oxygen-sensitive species in the specified zones of the Delaware River. In general, all sturgeon species share common life history traits,
Dissolved oxygen levels in Zone 3, Zone 4, and the upper portion of Zone 5 of the Delaware River mirror trends in historic pollutant loading and recent pollution control efforts in the river. Average summer dissolved oxygen levels in the Delaware River near Chester, Pennsylvania (Zone 4) declined from near saturation in the late 1880s to near zero (
In 1961, the Delaware River Basin Compact established the Delaware River Basin Commission (DRBC), comprised of the states of Delaware, New Jersey, New York,
Pursuant to the Delaware River Basin Compact, DRBC adopts WQS for interstate waters, including the Delaware River Estuary.
Given the unique interjurisdictional management of the Delaware River Estuary, WQS are submitted to the EPA for review through a process coordinated across the state, regional, and Federal levels. This process begins when DRBC adopts WQS for the Delaware River Estuary. To comply with CWA section 303(c), the Estuary states of Delaware, New Jersey, and Pennsylvania have provisions in their state WQS regulations that explicitly reference or implicitly incorporate DRBC's WQS as the applicable WQS for the portions of the river under their jurisdictions. When DRBC adopts new or revised WQS, each relevant member state submits a certification to the EPA from that state's attorney general or other appropriate legal authority, in accordance with 40 CFR 131.6(e). Those certifications provide that DRBC's new or revised WQS were duly adopted pursuant to state law. The EPA then reviews whether those WQS are consistent with the CWA and the EPA's implementing regulation and approves or disapproves them.
In 1967, DRBC adopted WQS for the zones of the Delaware River included in this proposed rule.
As described in section III.C. of this preamble, Delaware, New Jersey, and Pennsylvania each has its own WQS for the specified zones of the Delaware River under its jurisdiction. Delaware's current aquatic life designated use for the specified zones of the Delaware River includes all life stages, thus including the propagation component of the CWA section 101(a)(2) use. New Jersey's aquatic life designated use for the specified zones of the Delaware River incorporate by reference the designated uses in DRBC's Water Quality Regulations. Pennsylvania's aquatic life designated uses for the specified zones of the Delaware River align with DRBC's “maintenance” and “passage” designated use (Table 2 of this preamble). Therefore, neither New Jersey's nor Pennsylvania's aquatic life designated use for the specified zones of the Delaware River include the propagation component of the CWA section 101(a)(2) use.
For dissolved oxygen in the relevant zones, all three states incorporate DRBC's water quality criteria by reference; therefore, DRBC's dissolved oxygen criteria are the applicable criteria for the relevant zones in each state (Table 3 of this preamble). As explained above with respect to the aquatic life designated use, DRBC's dissolved oxygen criteria for the specified zones of the Delaware River do not protect for aquatic life propagation and are therefore not consistent with CWA section 101(a)(2) goals.
Table 4 of this preamble provides a summary outlining whether Delaware's, New Jersey's, and Pennsylvania's current aquatic life designated uses align with CWA section 101(a)(2) goals and whether each state's current dissolved oxygen criteria are protective of an aquatic life designated use that includes propagation. As explained above, Delaware is the only state that includes aquatic life propagation in its designated uses for the specified zones of the Delaware River. However, none of the three states' dissolved oxygen water quality criteria for the specified zones are protective of fish and shellfish propagation. Therefore, none of the states, and by extension none of the specified zones of the Delaware River, currently has a set of WQS for aquatic life that are fully consistent with the CWA section 101(a)(2) goals (
On December 1, 2022, the EPA determined that the CWA section 101(a)(2) use of propagation is now attainable and therefore revised WQS are necessary to protect aquatic life in certain water quality management zones of the Delaware River.
In accordance with the Administrator's Determination, the EPA's proposed rule, if finalized, would apply to Zone 3, Zone 4, and the upper portion of Zone 5 of the Delaware River (in total, river miles 108.4 to 70.0), for the states of Delaware, New Jersey, and Pennsylvania (Table 5 of this preamble).
The EPA is proposing to promulgate a revised aquatic life designated use for the specified zones of the Delaware River to meet the CWA section 101(a)(2) goals (
As explained in section III.D. of this preamble, Delaware's “Fish, Aquatic Life & Wildlife” designated use includes all life stages of indigenous and migratory organisms; therefore, Delaware's aquatic life designated use in the specified zones under its jurisdiction is already consistent with the CWA section 101(a)(2) goals and no revisions to Delaware's aquatic life designated use are necessary to meet CWA requirements. In contrast, New Jersey's and Pennsylvania's aquatic life designated uses for the relevant zones of the Delaware River under their jurisdiction do not include “propagation” and are therefore not consistent with CWA section 101(a)(2) goals. As explained in section III.E. of this preamble, the EPA determined that propagation is now an attainable use in the specified zones of the Delaware River.
Thus, the EPA is proposing to promulgate an aquatic life designated use for Zone 3, Zone 4, and the upper portion of Zone 5 of the Delaware River (in total, river miles 108.4 to 70.0) for the states of New Jersey and Pennsylvania, as follows:
The EPA is proposing to establish dissolved oxygen criteria—derived from the latest sound scientific information—for Delaware, New Jersey, and Pennsylvania, for the specified zones of the Delaware River. The proposed dissolved oxygen criteria would protect the EPA's proposed designated use for New Jersey and Pennsylvania, as well as Delaware's current aquatic life designated use for the specified zones.
To derive protective dissolved oxygen criteria for the specified zones of the Delaware River, the EPA used methods adapted from peer-reviewed literature and data from laboratory studies relevant to oxygen-sensitive sturgeon species in the Delaware River. Although the methods and data are from peer-reviewed scientific literature, the EPA is nonetheless in the process of completing an external peer review on the application of these methods and data in this context where the EPA is proposing criteria to protect proposed and applicable aquatic life designated uses that include propagation. This section presents a summary of the data and methods that the EPA used to derive protective dissolved oxygen criteria for this proposed rulemaking. First, the EPA describes the Agency's existing dissolved oxygen national recommendations and guidance documents. Then, the EPA explains how the Agency selected three seasons to derive criteria protective of oxygen-sensitive species in the relevant zones of the Delaware River. Next, the EPA details an Atlantic Sturgeon cohort model used to derive criteria protective of juvenile Atlantic Sturgeon during the season associated with their growth and development. After that, the EPA explains how criteria were developed to protect oxygen-sensitive species during the other two seasons. Lastly, the EPA concludes with an explanation for proposing criteria expressed as percent oxygen saturation, rather than as concentration. This section is intended to be a high-level summary of the EPA's criteria derivation methods and results for this proposed rulemaking. More details and information are available in the associated technical support document,
Under CWA section 304(a), the EPA publishes, from time to time, national recommended aquatic life criteria for a variety of pollutants and parameters. The EPA's national recommended criteria for dissolved oxygen in freshwater and saltwater environments are from the 1986
In consideration of available information, including information developed by DRBC, the EPA is proposing to delineate three distinct seasons for dissolved oxygen criteria development that are intended to protect Atlantic Sturgeon early life stages, while also protecting a range of other aquatic species' sensitive life stages in the specified zones. The EPA is proposing to define the
The EPA obtained recent and high-quality data from a variety of sources, described below and detailed in the associated technical support document, to evaluate oxygen requirements of Atlantic Sturgeon in each season. The EPA quantified water quality conditions in the specified zones of the Delaware River using recent and high-quality monitoring data from two locations in the Delaware River. Since the Atlantic Sturgeon was listed as an endangered species in 2012, there have been few recent studies documenting their oxygen requirements. However, available data on sturgeon growth and mortality from Campbell and Goodman (2004), Niklitschek and Secor (2009a), and EPA (2003), along with methods from Niklitschek and Secor (2005) and Niklitschek and Secor (2009b), water quality monitoring data, and juvenile Atlantic Sturgeon abundance data from the Delaware Department of Natural Resources and Environmental Control (DNREC) provided the EPA with sufficient data to establish quantitative relationships between age-0 juvenile sturgeon growth, mortality, and habitat suitability.
The EPA followed the peer-reviewed cohort modeling approach of Niklitschek and Secor (2005) to evaluate the effects of temperature, salinity, and dissolved oxygen on the potential growth and mortality of a hypothetical cohort or group of juvenile Atlantic Sturgeon spawned during a single year.
As part of the cohort model, the EPA developed a new mortality model and implemented a peer-reviewed bioenergetics-based growth model described by Niklitschek and Secor (2009b) to predict the daily instantaneous mortality rate and growth rate, respectively, for members of the cohort. To develop a mortality model, the EPA fit a regression to experimental data to predict mortality resulting from low dissolved oxygen at any given temperature and percent oxygen saturation.
Habitat Suitability Indices have been used in the context of fish-habitat relationships, conservation management, and habitat evaluation to quantify the capacity of a given habitat to support essential life functions (
The EPA followed the approach of Niklitschek and Secor (2005) to define suitable habitat for juvenile Atlantic Sturgeon growth and survival as habitats with water quality resulting in HSI greater than zero. When HSI is less than or equal to zero, seasonal average mortality rates are greater than or equal to seasonal average growth rates and the overall biomass of the cohort is likely to decrease. Conversely, a cohort of
The predicted HSI value relies on an expected distribution of percent oxygen saturation values during the season; therefore, the EPA selected two percent oxygen saturation percentiles as thresholds at or above which median HSI is expected to be greater than zero to maintain the expected distribution of percent oxygen saturation values. These two percentiles—the 10th percentile and the 50th percentile—describe the protective seasonal distribution of dissolved oxygen values. When both the 10th percentile and 50th percentile are attained, they function together to ensure that a detrimental shift in the oxygen distribution (
The Atlantic Sturgeon cohort model described above relies on experimental studies that were conducted using juvenile Atlantic Sturgeon and therefore provide information that is most relevant to juvenile growth and survival.
Instead, the EPA concluded that Atlantic Sturgeon larvae were likely to be as sensitive to low dissolved oxygen as juvenile Atlantic Sturgeon
Finally, the EPA derived the proposed criteria in terms of percent oxygen saturation, rather than in units of concentration (such as milligrams per liter or mg/L) for two main reasons.
The EPA's proposed dissolved oxygen criteria cover three distinct seasons based largely on Atlantic Sturgeon early life stages and are intended to protect all oxygen-sensitive species in the Delaware River, as explained above. The
Each season has water quality criteria that each consist of three components: magnitude, duration, and exceedance frequency. The magnitude component indicates the required level of dissolved oxygen in the water, which in this proposal is presented in units of percent oxygen saturation. The duration component specifies the time period over which water quality is averaged before comparison with the criteria magnitude; in this proposal, the duration is a daily average.
In this proposed rulemaking, the
During the criteria derivation process, the EPA made several decisions based on the best available sound scientific information to ensure the dissolved oxygen criteria would be protective of the applicable and proposed aquatic life designated uses. In this section, the EPA presents three alternative options the Agency considered. For each alternative, the EPA examined information currently available at the time of this proposal. The EPA has concerns about whether each alternative would be protective of the aquatic life designated uses that include propagation; therefore, the EPA did not include any of these alternatives as part of its lead proposed criteria. However, the EPA requests comment and additional information on whether and how one or more of these alternatives could protect the applicable and proposed aquatic life designated uses in the specified zones of the Delaware River and if so, what anticipated benefits would be associated with the alternative compared to the EPA's proposed criteria.
The EPA's proposed dissolved oxygen criteria are expressed as percent oxygen saturation, as described in section IV.C.1 of this preamble. However, the EPA recognizes that some stakeholders might be more familiar with dissolved oxygen criteria expressed as concentration or might have other reasons for preferring criteria expressed as concentration. The EPA is seeking comment on whether dissolved oxygen criteria expressed as concentration (mg/L) would be protective of oxygen-sensitive species during each season.
To calculate
To calculate dissolved oxygen criteria expressed as concentration for the
In table 7 below, the EPA leads with alternative criteria based on the 90th percentile water temperatures because existing dissolved oxygen criteria guidance and criteria derivation efforts in other states have commonly focused on the warmest conditions that occur, which are the most critical for mitigating impacts to aquatic life due to low oxygen.
Concentration-based criteria derived using the EPA's first approach (based on the 90th percentile water temperatures) would be equivalent to the EPA's proposed 66% oxygen saturation when water temperature is near the 90th percentile temperature and oxygen is near the lowest point in each season. However, during periods in each season when water temperature is lower than the 90th percentile temperature, the concentration-based criteria would be below the level that is equivalent to the EPA's proposed 66% oxygen saturation level. For example, when water temperature is 2 °C in mid-winter, oxygen saturation is 66% when the dissolved oxygen concentration is 9.1 mg/L. The EPA therefore has concerns about whether dissolved oxygen criteria expressed as concentration for this alternative would be protective for the
The EPA provided the concentrations in table 7 of this preamble that result from the methods described above to help facilitate public comment. The EPA also requests public input and supporting information about other ways the Agency could develop dissolved oxygen criteria expressed as concentration—particularly for the
The EPA's proposed dissolved oxygen criteria for the critical
The EPA is seeking comment and supporting information on applying a single dissolved oxygen criterion with a 10% exceedance frequency during the
The EPA also requests public input and supporting information about other potential options the Agency could consider for dissolved oxygen criteria in the form of a single criterion to protect the aquatic life uses in accordance with the CWA.
The EPA's proposed criteria do not include an interannual exceedance frequency and therefore would need to be met every year. However, the EPA recognizes that some stakeholders might prefer criteria with an interannual exceedance frequency to help accommodate the impact of environmental variability on dissolved oxygen conditions in the specified zones of the Delaware River. The EPA is seeking comment and supporting information on the addition of a 1-in-3-year interannual exceedance frequency as part of the dissolved oxygen criteria. The EPA is particularly interested in how and why this approach would protect the applicable and current aquatic life uses.
If a 1-in-3-year interannual exceedance frequency were included as part of the dissolved oxygen criteria, it would mean that in any three-year period, all criteria would need to be attained in at least two years. An exceedance would occur in any year where one or more of the criteria were not attained. The following two examples describe how a 1-in-3-year interannual exceedance frequency could function.
The EPA has historically considered it appropriate to apply a 1-in-3-year exceedance frequency in the context of aquatic life criteria for toxic pollutants, based on the ability of aquatic ecosystems to recover from criteria exceedances and natural variations in flow and the concentrations of the pollutant in a waterbody.
Section 7(a)(2) of the Endangered Species Act (ESA) requires that each Federal Agency ensure that any action authorized, funded, or carried out by such Agency is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of critical habitat. Pursuant to section 7(a)(2) of the ESA, the EPA will consult with NOAA Fisheries concerning this rulemaking action proposing a designated aquatic life use including propagation and associated dissolved oxygen criteria in the specified zones of the Delaware River. The EPA will work closely with NOAA Fisheries to ensure that any WQS the Agency finalizes are not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat in the specified zones of the Delaware River. As a result of this consultation, the EPA may modify some provisions of this proposed rule.
The EPA is proposing a Federal designated use that would apply in New Jersey and Pennsylvania, in addition to those states' designated uses that are already applicable. This means that for the specified zones of the Delaware River, the EPA is proposing to supplement, rather than replace, New Jersey's and Pennsylvania's currently applicable aquatic life designated uses. Therefore, New Jersey's and Pennsylvania's currently applicable aquatic life designated uses would remain applicable for CWA purposes. Those states' current water quality criteria associated with those uses would also remain applicable for CWA purposes, with the exception of any aquatic life criteria for dissolved oxygen, which would be replaced by the criteria that the EPA promulgates through this rulemaking, if finalized.
In addition, the EPA is proposing dissolved oxygen criteria that would replace Delaware's, New Jersey's, and Pennsylvania's existing dissolved oxygen criteria for the specified zones of the Delaware River. The EPA notes that there are aquatic life criteria for pollutants and parameters other than dissolved oxygen that are in effect for CWA purposes—not only in the zones covered by this proposed rulemaking, but also for other zones of the Delaware River that already include aquatic life propagation as a designated use; those criteria are not impacted by this rulemaking.
Since the EPA is only proposing to promulgate revised dissolved oxygen criteria for the specified zones of the Delaware River, Delaware, New Jersey, and Pennsylvania should evaluate whether other aquatic life criteria should similarly be added or revised for the specified zones or other zones of the Delaware River. One way these states can review their WQS is through the triennial review process. As explained in section III of this preamble, states must review their WQS at least once every three years and, if appropriate, revise standards or adopt new standards (40 CFR 131.20(a)). The EPA recommends that Delaware, New Jersey, and Pennsylvania review their existing aquatic life criteria during their next triennial review to determine if new or revised aquatic life criteria would be appropriate to protect all applicable aquatic life designated uses, including any Federal designated use that the EPA may promulgate as part of a final rule.
As noted, under the CWA, states and authorized tribes have the primary responsibility for developing and adopting WQS for their navigable waters (CWA section 303(a) through (c)). Although the EPA is proposing a revised aquatic life designated use and protective dissolved oxygen criteria for the specified zones of the Delaware River, each state retains the option to adopt and submit to the EPA for review its own revised designated use and dissolved oxygen criteria that are consistent with CWA section 303(c) and the EPA's implementing regulation to address the EPA's Administrator's Determination.
If Delaware, New Jersey, and Pennsylvania adopt and submit revised WQS that addresses the EPA's December 1, 2022, Administrator's Determination, and the EPA approves those WQS before finalizing this proposed rulemaking, then a Federal promulgation would no longer be required under the CWA. Similarly, if one state adopts and submits WQS consistent with this proposed rulemaking, and the EPA approves those WQS before finalizing this proposed rulemaking, then a Federal promulgation would no longer be required under the CWA for that state.
If the EPA finalizes this proposed rulemaking and Delaware, New Jersey, and Pennsylvania subsequently adopt and submit revised WQS to the EPA, and the EPA approves those WQS, then the EPA would undertake a rulemaking to withdraw the federally promulgated use and/or dissolved oxygen criteria (40 CFR 131.21(c)). Similarly, if one state adopts and submits revised WQS to the EPA, and the EPA approves those WQS, then the EPA would undertake a rulemaking to withdraw the federally promulgated WQS for that state.
If Delaware's, New Jersey's, and/or Pennsylvania's adopted dissolved oxygen criteria are as stringent or more stringent than the federally promulgated criteria, then that state's criteria would immediately become the CWA-applicable criteria upon the EPA's approval. If Delaware's, New Jersey's, and/or Pennsylvania's adopted dissolved oxygen criteria are less stringent than the federally promulgated criteria, and the EPA approves those less stringent criteria, then those EPA-approved criteria would become the applicable criteria for CWA purposes only after the EPA withdraws its federally promulgated criteria for the relevant state(s).
The Federal WQS regulations at 40 CFR part 131 provide several approaches that Delaware, New Jersey, and Pennsylvania could use at each state's discretion when implementing or deciding how to implement the federally promulgated dissolved oxygen criteria, if finalized. The EPA has identified two approaches—WQS Variances and NPDES Permit Compliance Schedules—that might be of particular interest for the states covered by this proposed rulemaking. Additionally, the EPA included a discussion about CWA section 303(d)/305(b) water quality assessments to clarify potential options that may be available to states in the specific circumstances relevant to this rulemaking.
A WQS variance is a time-limited designated use and criterion, for a specific pollutant or water quality parameter, that reflects the highest attainable condition (HAC) during the term of the WQS variance (40 CFR 131.3(o)). WQS variances can be used to incrementally improve water quality where the designated use and criterion are unattainable for a period of time. The state would need to demonstrate that attaining the applicable designated use and dissolved oxygen criterion would not be feasible for a period of time (
If Delaware, New Jersey, and/or Pennsylvania choose/s to adopt a WQS variance, the state/s must specify in the WQS variance the term and the interim requirements of the WQS variance. The term must be justified by describing the pollutant control activities expected to occur over that term to achieve the HAC. The interim requirements must be a quantitative expression that reflects the HAC using one of the options provided at 40 CFR 131.14(b)(1)(ii).
WQS variances adopted in accordance with 40 CFR 131.14 and approved by the EPA for CWA purposes provide a legal avenue for states to write NPDES permit limits that are based on the HAC during the term of the WQS variance, while simultaneously implementing controls to make incremental water quality improvements toward ultimately attaining the applicable designated use and dissolved oxygen criterion.
The EPA's regulations at 40 CFR 122.47 and 131.15 address how permitting authorities can use schedules for compliance with a water-quality-based effluent limitation (WQBEL) in an NPDES permit, if the discharger needs time to undertake an enforceable sequence of actions—such as facility upgrades or operation changes—leading to compliance with the WQBEL. The EPA's regulation at 40 CFR 122.47 allows states authorized to administer the NPDES program to include compliance schedules in NPDES permits, when appropriate and where authorized by the state's WQS, provided the compliance schedule authorizing provision was approved by the EPA. Such compliance schedules may be used to implement any CWA-effective WQS, including any WQS that the EPA promulgates as part of a final rule.
If the EPA promulgates revised aquatic life WQS for the specified zones of the Delaware River and they become effective for CWA purposes, Delaware, New Jersey, and Pennsylvania will have an obligation under CWA sections 303(d) and 305(b) to assess whether the WQS are being attained. The EPA anticipates there may be a period of time immediately after promulgation of the revised WQS when the WQS will not be attained because the actions and procedures required to achieve compliance will take time to implement. In this scenario, any of the relevant zones not attaining the WQS should be classified as impaired on the relevant 303(d)/305(b) Integrated Report(s) (IR) that is submitted to the EPA for review.
Per the CWA and the EPA's implementing regulations, waters that are assessed as impaired by a pollutant typically require the development of a Total Maximum Daily Load (TMDL), which is a regulatory planning tool designed to restore water quality via allocations of pollutant reductions to relevant point and non-point sources. The EPA regulations also recognize that other pollution control requirements may obviate the need for a TMDL. Specifically, impaired waters do not require a TMDL if: (1) technology-based effluent limitations required by the CWA; (2) more stringent effluent limitations required by a state, local, or Federal authority; or (3) other pollution control requirements (
DRBC developed a model to evaluate sources of pollution that affect dissolved oxygen levels in the specified zones of the Delaware River and concluded that point sources are the primary contributor to oxygen depletion within those zones.
The EPA conducted an economic analysis to evaluate the potential costs and benefits associated with this proposed rulemaking. In the high-level summary of the EPA's economic analysis below, the EPA first describes a baseline scenario that is intended to characterize the world in the absence of the EPA's proposed rule. Next, the EPA describes development of a policy scenario based on potential pollution control actions that, if implemented, can be expected to meet the EPA's proposed dissolved oxygen criteria. Finally, the EPA evaluates the anticipated costs and benefits associated with the policy scenario and the EPA's proposed criteria. More details and information
The baseline is intended to characterize the world in the absence of the EPA's proposed rule. The EPA typically assumes full compliance with existing regulations and requirements—including CSO long-term control plans (LTCPs)—even if they are not yet fully implemented, as a basis for estimating the cost and benefits of proposed regulations. This baseline approach ensures that the cost and benefits of the existing regulations and requirements are not double counted.
In this economic analysis, the EPA assumes that without the proposed rule, the less stringent WQS (that do not support aquatic life propagation) currently in effect for CWA purposes would remain in effect (section III.D. of this preamble). Accordingly, the EPA assumes that water quality conditions in the specified zones of the Delaware River, particularly during the
DRBC modeled the effect of pollution reduction on dissolved oxygen levels in the Delaware River and provided the EPA with water quality simulation results under both baseline and “restored” conditions for the years 2012, 2018, and 2019.
Of the three available years (2012, 2018, and 2019), the EPA selected the 2019 year as representative of the most typical conditions in the relevant zones of the Delaware River. In comparison, 2012 had atypically poor conditions (low percent oxygen saturation, high water temperature), while 2018 had atypically good conditions (high percent oxygen saturation, low water temperature). Therefore, model runs used in this economic analysis are based on 2019 conditions.
There is a wide range of potential paths that Delaware, New Jersey, and Pennsylvania may choose to take when implementing the EPA's proposed WQS. For this economic analysis, the EPA relied on available data to develop a policy scenario based on modeled pollution controls developed by DRBC that the EPA expects would meet the Agency's proposed dissolved oxygen criteria. Actual benefits, costs, and impacts will depend on the choices that states would make in implementing the proposed WQS, which may differ from the policy scenario in this economic analysis.
The EPA's proposed dissolved oxygen criteria apply to three seasons (section IV.C. of this preamble). Therefore, when developing a policy scenario for this proposed rulemaking, the EPA evaluated potential pollution control actions that would be expected to meet the EPA's criteria in each of the three seasons. The EPA began by evaluating water quality monitoring data for the past decade from two continuous monitoring stations in the relevant zones of the Delaware River—Penn's Landing in Zone 3 and Chester in Zone 4. Based on the monitoring data, the EPA expects that the Agency's proposed dissolved oxygen criteria for the
The EPA estimated compliance costs for the proposed WQS based on estimates for WWTPs to reduce effluent ammonia nitrogen concentrations and raise effluent dissolved oxygen concentrations. Although there are several causes that contribute to low dissolved oxygen conditions in the specified zones of the Delaware River, DRBC identified ammonia nitrogen loadings from WWTPs as the leading cause of oxygen-depletion in the river.
The EPA relied on cost information from several DRBC studies to estimate the costs of achieving the proposed WQS.
The EPA used WWTP-specific (capital, operations and maintenance (O&M)) compliance costs from Kleinfelder Inc. (2021, 2023) to estimate compliance costs, based on the discharger classification. Total compliance costs include the costs associated with both of the following:
1. Class A′ Facilities: Costs associated with reductions in effluent ammonia nitrogen concentrations to 1.5 mg/L from May 1 through October 31 and increases in effluent oxygen concentrations to a monthly average of 6 mg/L year-round for the seven WWTPs categorized as Class A′ facilities.
2. Class A Facilities: Costs associated with reductions in effluent ammonia nitrogen concentrations to 5 mg/L from May 1 through October 31 for the two WWTPs categorized as Class A facilities.
To estimate annualized compliance costs, the EPA assumed capital costs occur upfront in 2024 followed by a 5-year construction period. Consistent with Kleinfelder Inc. (2021, 2023), the EPA assumed O&M costs occur over a 25-year period from 2029 through 2053. The EPA thus annualized costs over a 30-year analysis period between 2024 and 2053 and discounted all cost values to 2024, using a 3 percent discount rate.
Table 10 of this preamble presents the annualized compliance costs associated with achieving the EPA's proposed WQS, using a 3 percent discount rate. The estimated total annualized compliance cost across nine WWTPs is $137.1 million (2022$). These costs vary considerably between the nine WWTPs, ranging from $1.9 million at the Lower Bucks County Joint Municipal Authority WWTP to $37.6 million at the Philadelphia Water Department (PWD) Southwest Water Pollution Control Plant (2022$). Among the dischargers, PWD bears the highest proportion of total costs, with its three facilities' combined costs accounting for over 50 percent of total costs. Overall, 66 percent of the costs are attributable to capital and 34 percent are attributable to O&M.
Water quality improvements can have a wide range of effects on water resources and the environmental goods and services that they provide, including services valued by people (
To value non-market benefits, the EPA used a benefit transfer approach based on a meta-analysis of surface water valuation studies to evaluate the use and nonuse benefits of improved surface water quality resulting from achievement of the EPA's proposed WQS in the 2019 restored scenario.
1. Estimating water quality improvements associated with attainment of the EPA's proposed WQS relative to the baseline;
2. Translating these improvements into a water quality index (WQI) that can be linked to ecosystem services and uses that are valued by society. The WQI used for this analysis includes six parameters: dissolved oxygen, biological oxygen demand (BOD), fecal coliform (FC), total nitrogen (TN), total phosphorus (TP), and total suspended solids (TSS); and
3. Estimating the dollar value of the estimated water quality improvements based on estimates of the public's willingness-to-pay (WTP) derived from a meta-analysis of surface water valuation studies.
To estimate changes in ecosystem services provided in the specified zones of the Delaware River following attainment of the proposed WQS, the EPA obtained water quality modeling data from DRBC, including dissolved oxygen, TN, and TP levels for various effluent treatment scenarios. The EPA used DRBC's modeled output of dissolved oxygen levels in the specified zones following implementation of effluent controls (described in the cost section) and based on 2019 conditions (as described in the policy scenario
The effluent treatment measures implemented in response to the proposed WQS would directly affect the amount of ammonia nitrogen discharged to the specified zones of the Delaware River and therefore also reduce BOD. However, DRBC's model does not account for the changes in BOD. The EPA approximated BOD concentrations following effluent treatment by assuming that baseline BOD concentrations are reduced by the same percentage change that dissolved oxygen improves within each zone (
Table 11 of this preamble summarizes the percent change in dissolved oxygen and BOD by zone between the baseline and the 2019 restored scenario.
To quantify benefits of water quality improvements, as is consistent with past practice, the EPA analyzed the values held by households residing within 100 miles of the specified zones of the Delaware River for water quality improvements associated with the EPA's proposed WQS.
The EPA estimated the economic value of water quality changes using results of a meta-analysis of 189 estimates of total WTP (including both use and nonuse values) for water quality improvements, provided by 59 original studies conducted between 1981 and 2017. The estimated econometric model allows calculation of total WTP for changes in a variety of environmental services affected by water quality and valued by people, including changes in recreational fishing opportunities, other water-based recreation, and existence services such as aquatic life, wildlife, and habitat designated uses. The model also allows the EPA to adjust WTP values based on the core geospatial factors predicted by theory to influence WTP, including: scale (the size of affected resources or areas), market extent (the size of the market area over which WTP is estimated), and the availability of substitute waters. The model also takes into account important sociodemographic characteristics, such as population and income, which vary spatially.
Table 12 in this preamble presents estimated household and total annualized WTP value for water quality improvements following attainment of the EPA's proposed WQS, based on a 3 percent discount rate. The total annualized value of water quality improvements from attainment of the proposed WQS is $112.8 million.
The United States Office of Management and Budget requires that for “significant regulatory actions” (as defined in Executive Order 12866 and as amended and reaffirmed by Executive Order 14094), that the EPA conduct an economic analysis. While this proposed rulemaking was not deemed significant, the EPA nonetheless conducted an economic analysis to evaluate the potential costs and benefits associated with the WQS in the EPA's proposed rule. For this proposed rulemaking, the EPA determined that the potential benefits justify the potential costs. The EPA estimates that the implementation of additional effluent treatment controls at certain WWTPs could lead to $137.1 million in annualized costs over 30 years (2022$, 3% discount rate). The EPA quantified estimated non-market benefits through average annual household WTP for water quality improvements. Annualized non-market benefits total $112.8 million per year over 30 years (2022$, 3% discount rate). The EPA's monetary estimation of benefits does not account for benefits related to protections for a critically endangered species (Atlantic Sturgeon), increased housing values, or increased commercial fishing, among other benefits. Therefore, the EPA's estimation of non-market benefits is likely an underestimate of total benefits and thus total benefits could potentially equal or exceed estimated total costs.
This action is not a significant regulatory action as defined in Executive Order 12866, as amended by Executive Order 14094, and was therefore not subject to a requirement for Executive Order 12866 review.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2040-0049. While actions to implement these WQS, if finalized, could entail additional paperwork burden, this action does not directly contain any information collection, reporting, or record-keeping requirements.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Small entities, such as small businesses or small governmental jurisdictions, are not directly regulated by this rulemaking.
EPA-promulgated WQS are implemented through various water quality control programs including the NPDES program, which limits discharges to navigable waters, except in compliance with a NPDES permit. CWA section 301(b)(1)(C) and the EPA's implementing regulations at 40 CFR 122.44(d)(1) and 122.44(d)(1)(A) provide that all NPDES permits must include any limits on discharges that are necessary to meet applicable WQS. Thus, under the CWA, the EPA's promulgation of WQS establishes standards that states implement through the NPDES permit process. While states have discretion in developing discharge limits, those limits “must control all pollutants or pollutant parameters (either conventional, nonconventional, or toxic pollutants) which the Director determines are or may be discharged at a level that will cause, have the reasonable potential to cause, or contribute to an excursion above any [s]tate water quality standard, including [s]tate narrative criteria for water quality” (40 CFR 122.44(d)(1)(i)).
As a result of this action, if finalized, the states of Delaware, New Jersey, and Pennsylvania will need to ensure that permits they issue include any limitations on discharges necessary to comply with the WQS established in the final rule. In doing so, each state will have several choices associated with permit writing. While each state's implementation of the rule may ultimately result in new or revised permit conditions for some dischargers, including small entities, the EPA's action, by itself, does not impose any of these requirements on small entities; in other words, these requirements are not self-implementing.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or Tribal governments or the private sector.
The EPA has concluded that this action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. This rulemaking would not alter Delaware's, New Jersey's, or Pennsylvania's considerable discretion in implementing these WQS, nor would it preclude any of those states from adopting revised WQS and submitting them to the EPA for review and approval either before or after promulgation of the final rule. If the states submit and the EPA approves revised WQS consistent with the CWA, then the EPA would no longer be required to promulgate Federal WQS.
Consistent with the EPA's policy to promote communications between the EPA and state and local governments, the EPA met with the states of Delaware, New Jersey, and Pennsylvania and DRBC in the process of developing this rulemaking to enable them to have meaningful input into its development. During these discussions, the EPA explained the scientific basis for the dissolved oxygen criteria to protect aquatic life propagation in the specified zones of the Delaware River and the overall timing of the Federal rulemaking effort. The EPA took these discussions with the states into account during the drafting of this rulemaking. The EPA specifically solicits comments on this proposed action from state and local officials.
This action does not have Tribal implications as specified in Executive Order 13175. This rulemaking will not affect federally recognized Indian tribes in Delaware, New Jersey, or Pennsylvania because the WQS would not apply to waters in Indian lands nor affect Tribal interests. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions considered significant under section 3(f)(1) of Executive Order 12866 and that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order. Therefore, this action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. Since this action does not concern human health, the EPA's Policy on Children's Health also does not apply.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action proposes to establish Federal CWA aquatic life water quality criteria for specified zones of the Delaware River under the jurisdiction of the states of Delaware, New Jersey, and Pennsylvania.
This rulemaking does not involve technical standards.
The information supporting this Executive order review is summarized below and detailed in the associated document,
The EPA believes that the human health or environmental conditions that exist prior to this proposed action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with environmental justice (EJ) concerns. For this EJ analysis, the EPA evaluated socioeconomic characteristics of communities living near the relevant zones of the Delaware River compared to communities living near other zones of the mainstem
The EPA obtained data from the United States Census Bureau's American Community Survey (ACS) 5-year estimates for the years 2017-2021 at the Census block group level to construct a set of eight metrics for use in this analysis: (1)
The EPA extended a five-mile buffer from the specified zones to capture communities living in close proximity to waters affected by the EPA's proposed rule, if finalized.
•
•
•
•
•
•
The EPA aggregated data across multiple block groups using aerial apportionment and a population-weighted mean approach to ensure that block groups with larger or smaller populations were accounted for proportionally to their size. This calculation relies on an assumption that households are evenly distributed within each block group. For
The results of the urban and rural proximity analyses differed significantly. Urban communities in Pennsylvania near the specified zones surpassed the comparison group average (or were less than the comparison group for
On the other hand, rural communities near the specified zones did not greatly differ from rural communities near other parts of the mainstem river. While rural communities near the specified zones did exceed the comparison group average for four metrics (
While neither the urban nor the rural proximity analyses directly indicate which communities may be experiencing potential EJ concerns, they provide insight into community composition surrounding an environmental resource. In general, the Delaware River has had two contrasting areas of water quality for decades. In the relevant zones, water quality for aquatic life has been significantly worse than in the other zones of the river.
The EPA believes that this action would be likely to reduce existing disproportionate and adverse effects on communities with EJ concerns. Specifically, the EPA identified an inequitable distribution of an environmental resource where communities with environmental justice concerns have inequitable access to clean surface waters that support CWA section 101(a)(2) goals for aquatic life. The EPA's proposed rule, if finalized and implemented, could help to lessen this inequitable distribution of an environmental resource by ensuring that WQS to protect aquatic life in the specified zones of the Delaware River meet the objectives of the CWA.
In addition to the proximity analysis, the EPA evaluated the potential distribution of costs associated with the proposed rule under the implementation (policy) scenario described in section IX of this preamble and further detailed in the EPA's associated document,
The EPA used two methods to assess the potential financial impact to Philadelphia households resulting from costs associated with the proposed rule. First, the EPA calculated household burden by quantifying the potential increase to consumer water and wastewater bills and calculating the percentage of median household income spent on water bills with and without costs from additional wastewater treatment plant controls. Second, the EPA examined existing water rate structures in Philadelphia and customer assistance programs to identify possible ways in which the affected municipalities could adjust rates to lessen the financial burden on low-income households.
To determine household burden, the EPA analyzed how annual water and wastewater bills might change if costs associated with additional wastewater treatment plant controls at PWD facilities are passed on to households through increased water bills.
In July 2017, Philadelphia became the first to implement an income-based alternative water rate structure through creation of the Tiered Assistance Program (TAP). This program is structured based on household income relative to the Federal poverty level such that monthly bills are capped at 2%, 2.5%, 3%, and 4% of monthly income for consumers whose income is 0-50%, >50-100%, >100-150%, and >150% of the Federal poverty level, respectively.
For illustrative purposes, the EPA analyzed how the TAP rate structure might apply to eligible low-income consumers with water bills that include 15% of the costs associated with additional PWD wastewater treatment plant controls.
However, the effectiveness of the TAP rate structure depends in large part on participation by eligible households. When Philadelphia launched TAP in 2017, it was estimated that around 60,000 consumers would be eligible for the program.
Based on the structure of TAP and the current low participation rates, low-income communities are not necessarily protected from high water bills and increasing water rates. The way the program is designed, non-TAP customers subsidize the discounts applied to TAP customers. When there is high participation, the majority of program costs are borne by higher income households and participating low-income households are protected from high water bills and increasing water rates (including potential rate increases to offset costs associated with additional wastewater treatment plant technologies). With low-participation rates, a higher proportion of low-income households are paying the TAP surcharge and face higher water rates, thus placing an undue burden on low-income households not participating in the program.
In theory, costs associated with the EPA's proposed rule—if partially or fully passed on to residential consumers—should not impact the lowest income households in Philadelphia, assuming high participation in TAP. However, the current low participation rates in TAP indicate that some low-income communities are likely burdened by high water bills and could potentially indirectly bear costs associated with the EPA's proposed rule. Although Philadelphia's TAP is innovative, additional work to increase participation (through increased enrollment and decreased attrition rates) can further advance water affordability and protect low-income households.
The example of Philadelphia's TAP illustrates how an income-based rate structure can potentially have a measurable impact on low-income communities. Municipalities potentially affected by the EPA's proposed rule might consider holistic ways to advance water affordability, which can include adoption of alternative water rate structures and assistance programs that lower water bills for low-income households. There are several considerations for municipalities if choosing to implement a program similar to TAP in Philadelphia.
Environmental protection, Indians-lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water pollution control.
For the reasons set forth in the preamble, the EPA proposes to amend 40 CFR part 131 as follows:
33 U.S.C. 1251
(a)
(2) The aquatic life criteria in paragraph (c) of this section apply to river miles 108.4 to 70.0 of the Delaware River for the states of Delaware, New Jersey, and Pennsylvania.
(b)
(c)
(d)
(2) The dissolved oxygen aquatic life water quality criteria in paragraph (c) of this section are the applicable dissolved oxygen criteria in Delaware, New Jersey, and Pennsylvania for river miles 108.4 to 70.0 of the Delaware River and apply concurrently with applicable water quality criteria for other parameters.
(3) The designated use and criteria established are subject to Delaware's, New Jersey's, and Pennsylvania's general rules of applicability in the same way and to the same extent as are other federally promulgated and state-adopted water quality standards in those states.
Federal Transit Administration (FTA), United States Department of Transportation (DOT).
Notice of proposed rulemaking; extension of comment period.
The Federal Transit Administration (FTA) is extending the comment period for the notice of proposed rulemaking regarding FTA's State Safety Oversight program, which was published on November 15, 2023, with the original comment period closing on January 16, 2024.
The comment period for the proposed rule published November 15, 2023, at 88 FR 78269, is extended. Comments are requested by February 15, 2024. Late-arriving comments will be considered to the extent practicable.
You may file comments identified by docket number FTA-2023-0008 by any of the following methods:
•
•
•
•
For program matters, contact Loretta Bomgardner, Office of Transit Safety and Oversight, FTA, telephone (202) 577-5896 or
In a letter submitted to the docket dated November 16, 2023, the American Public Transportation Association (APTA), on behalf of more than 1,300 member organizations, requested a 30-day extension of the comment period for the State Safety Oversight notice of proposed rulemaking (NPRM) published in the
As justification for this extension, APTA cited two current rulemakings for which FTA is seeking comments, the Public Transportation Safety Certification Training NPRM (88 FR 73573) and the Hours of Service and Fatigue Risk Management ANPRM (88 FR 74107). APTA noted that transit agencies, State safety oversight agencies, and APTA are already reviewing and preparing comments, and replying to a third would be burdensome. In addition, APTA notes three Federal holidays between the time the NPRM was published and comments are due, and that many offices, including APTA, will be closed between Christmas and New Year's Day. APTA believes an extension of time would ensure that APTA and its members have the necessary time to produce a thoughtful response to the NPRM.
Given the importance of public transportation safety and the need for a more fulsome dialogue on FTA's safety priorities, FTA believes an extension of time is justified and is extending the comment period until February 15, 2024.
To ensure that comments are filed correctly, please follow the instructions in the
Federal Transit Administration (FTA), United States Department of Transportation (DOT).
Advance notice of proposed rulemaking, extension of comment period.
The Federal Transit Administration (FTA) is extending the comment period for the advance notice of proposed rulemaking regarding transit worker hours of service and fatigue risk management, published on October 30, 2023, with the original comment period closing on December 29, 2023. The extension is based on concerns from the American Public Transportation Association (APTA) that the comment period did not provide sufficient time to review and provide comprehensive comments to the ANPRM due to two Federal holidays and the closure of many offices between Christmas and New Year's Day. FTA recognizes that others interested in commenting may have similar concerns and agrees that the comment period should be extended.
The comment period for the proposed rule published October 30, 2023, at 88 FR 74107, is extended. Comments are requested by January 29, 2024. FTA will consider comments received after that date to the extent practicable.
You may file comments, identified by docket number FTA-2023-0018, by any of the following methods:
•
•
•
•
For program matters, contact Valerie Beck, Office of Transit Safety and Oversight, FTA, telephone (202) 366-9178 or email
In a letter submitted to the docket dated November 29, 2023, the American Public Transportation Association (APTA) requested a 30-day extension of the comment period for the advance notice of proposed rulemaking (ANPRM) published in the
As justification for this extension, APTA believed that it could synthesize consensus comments from the industry by the December 29, 2023, deadline, but it will be nearly impossible due to two Federal holidays between the time the NPRM was published and comments are due, and the fact that that many offices, including APTA's, will be closed between Christmas and New Year's Day. APTA also notes that it held a webinar for safety coordinators to collect comments and plans to hold another one in later December to synthesize comments. APTA also stated that intends to hold a meeting for transit CEOs to collect their thoughts on an initial draft response in late December or early January. APTA believes an extension of time would ensure that APTA and its members have the necessary time to survey, draft, and vet consensus comments and to produce a more complete response to the NPRM.
Given the importance of public transportation safety and the desire for a robust dialogue on the issues surrounding transit worker fatigue, and the likelihood that other commenters may have similar concerns, FTA believes an extension of time is justified and is extending the comment period until January 29, 2024.
FTA is not republishing the questions in this document. Instead, please refer to the ANPRM (88 FR 74107). To ensure that comments are filed correctly, please follow the instructions in the
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service (Service), propose to list the coal darter (
We will accept comments received or postmarked on or before February 20, 2024. Comments submitted electronically using the Federal eRulemaking Portal (see
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
William Pearson, Field Supervisor, U.S. Fish and Wildlife Service, Alabama Ecological Services Field Office, 1208 Main Street, Daphne, AL 36526; telephone 251-441-5181. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. Please see Docket No. FWS-R4-ES-2023-0220 on
We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:
(1) The species' biology, range, and population trends, including:
(a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;
(b) Genetics and taxonomy;
(c) Historical and current range, including distribution patterns and the locations of any additional populations of this species;
(d) Historical and current population levels, and current and projected trends; and
(e) Past and ongoing conservation measures for the species, its habitat, or both.
(2) Threats and conservation actions affecting the species, including:
(a) Factors that may be affecting the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors;
(b) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this species; and
(c) Existing regulations or conservation actions that may be addressing threats to this species.
(3) Additional information concerning the historical and current status of this species.
(4) Information on regulations that may be necessary and advisable to provide for the conservation of the coal darter and that we can consider in developing a 4(d) rule for the species. In particular, we seek information concerning the extent to which we should include any of the Act's section 9 prohibitions in the 4(d) rule or whether we should consider any additional exceptions from the prohibitions in the 4(d) rule.
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.
Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, do not provide substantial information necessary to support a determination. Section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made solely on the basis of the best scientific and commercial data available.
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on
Our final determination may differ from this proposal because we will consider all comments we receive during the comment period as well as any information that may become available after this proposal. Based on the new information we receive (and, if relevant, any comments on that new information), we may conclude that the species is endangered instead of threatened, or we may conclude that the species does not warrant listing as either an endangered species or a threatened species. In addition, we may change the parameters of the prohibitions or the exceptions to those prohibitions in the 4(d) rule if we conclude it is appropriate in light of comments and new information received. For example, we may expand the prohibitions to include prohibiting additional activities if we conclude that those additional activities are not compatible with conservation of the species. Conversely, we may establish additional exceptions to the prohibitions in the final rule if we conclude that the activities would facilitate or are compatible with the conservation and recovery of the species. In our final rule, we will clearly explain our rationale and the basis for our final decision, including why we made changes, if any, that differ from this proposal.
Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in
On April 20, 2010, we received a petition from the Center for Biological Diversity (CBD), Alabama Rivers Alliance, Clinch Coalition, Dogwood Alliance, Gulf Restoration Network, Tennessee Forests Council, and West Virginia Highlands Conservancy to list 404 aquatic, riparian, and wetland species, including the coal darter, as endangered or threatened species under the Act. In response to the petition, we published a partial 90-day finding on September 27, 2011 (76 FR 59836), in which we announced our finding that the petition contained substantial information indicating that listing may be warranted for numerous species, including the coal darter.
A species status assessment (SSA) team prepared an SSA report for the coal darter. The SSA team was composed of Service biologists, in consultation with other species experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.
In accordance with our joint policy on peer review published in the
As discussed in Peer Review, above, we received comments from one peer reviewer on the draft SSA report. We reviewed the comment for substantive issues and new information regarding the information contained in the SSA report. The peer reviewer generally provided constructive suggestions and was broadly supportive. No substantive changes to our analysis and conclusions within the SSA report were deemed necessary, and peer reviewer comments are addressed in version 1.1 of the SSA report.
A thorough review of the taxonomy, life history, and ecology of the coal darter is presented in the SSA report (version 1.1; Service 2023, pp. 11-15).
The coal darter (
The coal darter is a small, elongated, slightly compressed freshwater fish reaching up to 50 millimeters (mm) (1.96 inches (in)) in total length with smaller fins compared to other
The coal darter is endemic to the eastern and central part of the Mobile River Basin in the State of Alabama. The species primarily occupies habitat above the Fall Line within the Piedmont, Ridge and Valley, and Southwestern Appalachians level III ecoregions. Additionally, there are several historical records below the Fall Line in the Cahaba River and Black Warrior River that are in the Southeastern Plains ecoregion.
Presently, the species has a disjunct distribution, with populations in the Cahaba River, the Locust Fork of the Black Warrior River, and two tributaries in the lower Coosa River (Weogufka Creek and Hatchet Creek). Within the Locust Fork watershed, occurrences are mostly in the Locust Fork mainstem, but there are also occurrences in Turkey Creek, the Little Warrior River, and Blackburn Fork. In the Cahaba River system, the coal darter is predominantly found in the mainstem of the Cahaba River with occurrences in Shades Creek and the Little Cahaba River.
Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for endangered and threatened species. In 2019, jointly with the National Marine Fisheries Service, the Service issued a final rule that revised the regulations in 50 CFR part 424 regarding how we add, remove, and reclassify endangered and threatened species and the criteria for designating listed species' critical habitat (84 FR 45020; August 27, 2019). On the same day, the Service also issued final regulations that, for species listed as threatened species after September 26, 2019, eliminated the Service's general protective regulations automatically applying to threatened species the prohibitions that section 9 of the Act applies to endangered species (84 FR 44753; August 27, 2019). Our analysis for this decision applied the regulations that are currently in effect, which include the 2019 revisions. However, we proposed further revisions to these regulations on June 22, 2023 (88 FR 40764). In case those revisions are finalized before we make a final status determination for this species, we have also undertaken an analysis of whether the decision would be different if we were to apply those proposed revisions. We concluded that the decision would have been the same if we had applied the proposed 2023 regulations. The
The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following 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.
These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.
We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.
However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the Act's definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species now and in the foreseeable future.
The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term “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. In other words, the foreseeable future is the period of time in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.
It is not always possible or necessary to define the foreseeable future as a particular number of years. Analysis of the foreseeable future uses the best scientific and commercial data available and should consider the timeframes applicable to the relevant threats and to the species' likely responses to those threats in view of its life-history characteristics. Data that are typically relevant to assessing the species' biological response include species-specific factors such as lifespan, reproductive rates or productivity, certain behaviors, and other demographic factors.
The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be proposed for listing as an endangered or threatened species under the Act. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies.
To assess the coal darter's viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency is the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy is the ability of the species to withstand catastrophic events (for example, droughts, large pollution events); and representation is the ability of the species to adapt to both near-term and long-term changes in its physical and biological environment (for example, climate conditions, pathogens). In general, species viability will increase with increases in resiliency, redundancy, and representation (Smith et al. 2018, p. 306). Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.
The SSA process can be categorized into three sequential stages. During the first stage, we evaluated the individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of a species to sustain populations in the wild over time. We use this information to inform our regulatory decision.
The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket No. FWS-R4-ES-2023-0220 on
In this discussion, we review the biological condition of the species and its resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability.
A thorough review of the coal darter's resource needs is presented in chapter
For the coal darter to survive and reproduce, individuals need suitable habitat that supports essential life functions at all life stages (see table 1, below). Four elements appear to be essential to the survival and reproduction of individuals: sufficient water quality, flowing water, stable substrates, and habitat heterogeneity.
For coal darter populations to be resilient, the needs of individuals require sufficient water quality, flowing water, stable substrates, and habitat heterogeneity to be met on a larger scale (see table 1, below). Stream reaches with suitable habitat must be large enough to support a sufficient reservoir of potential mates for coal darters to breed with and maintain sufficient genetic health while avoiding issues associated with small population sizes, such as genetic drift and inbreeding depression.
Connectivity is also an important factor for populations because it facilitates genetic health for populations and enables movement of individuals to suitable habitats that can accommodate the life-history needs for the species (
At the species level, the coal darter needs a sufficient number and distribution of healthy populations to withstand environmental stochasticity (resiliency) and catastrophes (redundancy), and to adapt to biological and physical changes in its environment (representation). For the species to be viable, there must be adequate redundancy (suitable number, distribution, and connectivity of populations to allow the species to withstand catastrophic events) and representation (genetic and environmental diversity to allow the species to adapt to changing environmental conditions). Redundancy improves with increasing numbers of resilient populations distributed across the species' range, and connectivity (either natural or human-facilitated) allows connected populations to “rescue” each other after catastrophes. Representation improves with the persistence of populations having greater genetic and ecological diversity across the species' range, resulting in an increased ability to adapt to changing environmental conditions. Long-term viability will require resilient populations; for the coal darter, this will mean maintaining quality stream habitat (for example, sufficient water quality, natural flow regime, stable substrate, and adequate habitat heterogeneity) to support multiple populations across the species' range (see table 1, below).
At the species level, the coal darter requires sufficient connectivity between populations to facilitate gene flow and ensure adaptive potential. Genetic diversity should be high enough that the species will be able to adapt to changing environmental factors through the process of natural selection. Additionally, the species needs to have sufficient connectivity between enough individuals to promote an effective population size that is high enough to maintain evolutionary potential and genetic adaptive capacity. To evaluate the current and future viability of the coal darter, we assessed a range of conditions to allow us to consider the species' resiliency, representation, and redundancy.
A thorough review of the threats affecting the coal darter is presented in chapter 4 of the SSA report (version 1.1, Service 2023, pp. 23-31).
The coal darter is influenced by stressors affecting water quality, water flow, stream connectivity, and genetic diversity. The main threat is habitat loss or degradation from the following activities or conditions: hydrologic alteration by impoundments, including dams and other barriers; agriculture (poultry farming); diminished water quality from point and nonpoint source chemical contamination and sedimentation; urban development or change in land cover, including increased density of residential and commercial infrastructure; resource extraction, including mining and silviculture operations that do not follow State-approved BMPs; and climate change (Service 2023, p. 23).
Impoundment of rivers is a primary threat to aquatic species in the Southeast (Service 2023, pp. 23-24). Dams modify habitat conditions and aquatic communities both upstream and downstream of an impoundment. Upstream of dams, habitat is flooded and in-channel conditions change from flowing to still water, with increased depth, decreased levels of dissolved oxygen, and increased sedimentation. Downstream of dams, flow regimes of the released tailwater vary with resulting fluctuations in water temperature and dissolved oxygen levels, the substrate is scoured, and downstream reaches are eroded. These negative tailwater effects on habitat can extend many kilometers downstream. Dams fragment habitat for the coal darter by blocking corridors for
The Cahaba River, at 190 rmi/305.8 rkm long, is often referred to as Alabama's longest free-flowing stream. However, two barriers have impacted the flow of the river. The first is a low-head dam, located at Highway 280 near Acton, Alabama, and built in 1891. It is 15 feet tall and backs up water for withdrawal by Birmingham. This low-head dam is significantly smaller than the dams on the Black Warrior River and Coosa River, and as such, the Highway 280 dam has not converted vast areas of habitat, meaning habitat for the coal darter is still present and the species is still able to occupy habitat both upstream and downstream of the dam. Although coal darters occur upstream and downstream of the Highway 280 dam, this dam represents a significant barrier to upstream movement of coal darters. Downstream dispersal could be possible when larvae enter the water column and are carried downstream during a process known as pelagic larval drift (PLD). Because individuals upstream of the dam are isolated from those downstream, the upstream subpopulation is at a higher risk of genetic drift and inbreeding depression. The second barrier, the Marvel Slab, was removed in 2004; it is discussed in more detail under
In general, darters tend to be sensitive to poor water quality (Service 2023, pp. 24-26). According to the Fishery Index Biotic Integrity (IBI) reports and related fish community survey work, coal darters are consistently labeled as a “disturbance-sensitive” or an “intolerant” (of habitat impairments) species. Based on its narrow distribution and habitat conditions (including water quality parameters) where coal darters are found, the coal darter needs clean, relatively clear, flowing water to survive and carry out its basic life-history functions; thus, water quality degradation is considered a threat to the species. Below, we discuss the causes of water quality degradation in more detail.
Nonpoint source pollution may originate from agricultural activities, poultry and cattle feedlots, abandoned mine runoff, construction, silviculture operations that do not follow State-approved BMPs, failing septic tanks, and contaminated runoff from urban areas. These sources have the potential to contribute pollution, including sediments, heavy metals, fertilizers, pesticides (
Increases in sedimentation from sources such as agriculture, silviculture operations that do not follow State-approved BMPs, mining, and
Agricultural practices such as traditional farming, feedlot operations, and associated land-use practices can contribute pollutants to rivers. These practices can also degrade habitat by encouraging the erosion of stream banks, which results in alterations to stream hydrology and geomorphology. Nutrients, bacteria, pesticides, and other organic compounds are generally found in higher concentrations in areas around agriculture than in forested areas. Contaminants associated with agriculture (fertilizers, pesticides, herbicides, and animal waste) can cause degradation of water quality and habitats through instream oxygen deficiencies, excess nutrification, and excessive algal growths, with a related alteration in fish community composition. In the Alabama Department of Environmental Management's (ADEM's) 2022 list of impaired waters, which was prepared in accordance with section 303(d) of the Clean Water Act (CWA; 33 U.S.C. 1251
Poultry farming, undertaken primarily in poultry houses, occurs within the range of the coal darter, especially in and around the Locust Fork watershed. Poultry houses have an estimated ability to produce approximately 100 tons of litter a year (assuming a 20,000-square-foot poultry house stocked at one bird per square foot and six flocks produced per year, which is a probable underestimate of litter production per broiler house). Poultry litter is a mixture of chicken manure, feathers, spilled food, and bedding material that is used to fertilize pastureland or row crops that frequently occur adjacent to rivers and streams.
Runoff from heavy rains carries excess nutrients from chicken manure into nearby streams as a result of surface-spreading of litter. Litter can also contain arsenic, which is formed from a chemical routinely used as a feed additive to prevent disease and stimulate growth, and it enters streams through runoff (Stolze et al. 2007, p. 821). Other substances often found in poultry litter include fecal coliform, S
Coal mining in Alabama began in the early 1800s. Currently, there are active and reclaimed mines operating throughout the Black Warrior and Cahaba watersheds, and one proposed graphite mine permitted for future operations in the Coosa watershed. Surface and subsurface coal mines have the potential to degrade water quality from erosion and sedimentation, and the presence of mines near rivers and streams elevates the risk of water contamination. These mining processes expose metallic minerals, which can then enter the surrounding waterways, increasing conductivity, increasing acidity, and contaminating the waterways with heavy metals, creating toxic conditions for aquatic fauna (Stiefel and Busch 1983, pp. 187-212; Neves et al. 1997, pp. 69-70).
In addition to surface and subsurface mining, oil and gasoline extraction and transportation is also present within the range of the coal darter. In 2016, there was a near disaster in the range of the coal darter when 252,000 gallons of gasoline spilled from the Colonial Pipeline into an old mining pond that feeds into a tributary of the Cahaba (EPA 2016, unpaginated). The spill was contained before reaching the Cahaba River; however, this incident illustrates that the risk of threat to the species from resource extraction does exist.
The forestry industry, in the form of monoculture pine plantations, is prevalent throughout the range of the coal darter. Forestry can have negative implications for water quality in the form of nonpoint source pollution, especially when BMPs are not implemented. Excessive sedimentation in Hatchet Creek has been documented since the mid-1990s. The excessive sedimentation and subsequent loss of clean gravel and pool habitat has been attributed to forestry activities, including removal of riparian vegetation (Alabama Department of Conservation and Natural Resources (ADCNR) 2006, p. 3). Sedimentation of streams and waterways has the potential to increase due to accelerated erosion from logging roads and timber harvest. We recognize that modern silvicultural operations are widely implemented in accordance with State-approved BMPs, and the adherence to these BMPs broadly protects water quality, particularly related to sedimentation. However, in many cases, sedimentation in streams is a continuing legacy effect from past eras of poor logging practices (Service 2023, p. 27).
Urbanization is a significant source of water quality degradation that can reduce the survival of aquatic organisms, including the coal darter. Urbanization refers to a change in land cover and land use from forests or agriculture to increased density of residential and commercial infrastructure. Urban development can stress aquatic systems in a variety of ways, including increasing the frequency and magnitude of high flows in streams, increasing sedimentation (construction activities) and nutrient loads (lawn fertilization), increasing contamination and toxicity (from household pesticides and herbicides), altering flows because of an increase in impervious surfaces (
Changes to both frequency and magnitude of stream flows have direct effects on important structural habitat for coal darters. Stream channelization and higher flows reduce overall stream cover and other natural substrates like boulders, cobble, and gravel, and they remove large woody structures and other terrestrial plant materials. As a result, urban streams have lower habitat heterogeneity, stable substrates, and amounts of plant material, which negatively impacts the coal darter's sheltering, breeding, and feeding.
Birmingham is the third largest city in the State of Alabama and was ranked as the largest city until the 2020 census. It continues to be one of the fastest growing metropolitan areas in the State.
Changing climate conditions can influence coal darter viability through changes in water temperature and precipitation patterns that result in increased flooding, prolonged droughts, or reduced stream flows. Since the 1970s, moderate to severe droughts in the Southeast have increased by 12 percent during spring months and by 14 percent during summer months (Jones et al. 2015, p. 126). Reduced baseflows due to droughts can cause population declines, habitat loss, and degraded water quality (decreased dissolved oxygen and temperature alteration) leading to death, crowding of individuals leading to stress, and decreased reproduction in stream fish populations. Increased groundwater withdrawal for agriculture or other human needs during droughts may potentially exacerbate the impacts of reduced quantity or frequency of precipitation.
Climate models for the southeastern United States project that average annual temperatures will increase, cold days will become less frequent, the freeze-free season will lengthen by up to a month, days with temperatures exceeding 95 degrees Fahrenheit will increase, heat waves will become longer, and the number of category 5 hurricanes will increase (Ingram et al. 2013, p. 32; IPCC 2021, entire). While these climate models predict variability into the future, they suggest that the region will be subjected to more frequent large storms (hurricanes) with severe flooding and extremely low flows during droughts. Average and extreme precipitation is expected to increase, and subsequently, river flooding is also expected to increase. Extreme weather events, such as flash flooding associated with heavy precipitation events, are projected to increase in the future within the range of the coal darter, and these events can impact the coal darter through habitat degradation and displacement, injury, or even mortality (Service 2023, pp. 29-30).
Future changes in climate within the coal darter's range include increases in temperatures, especially for summer and fall, and increases in overall precipitation. Therefore, the watersheds occupied by coal darters could experience moderate to significant changes in climate by the 2050s, especially under scenarios run for representative concentration pathway (RCP) 8.5 (corresponding to high levels of carbon emissions). Increases in summer temperatures coupled with decreased instream flow can increase water temperatures and reduce dissolved oxygen levels, while flashier flows can increase soil erosion and stream sedimentation.
Low genetic diversity makes the coal darter vulnerable to threats. Greater genetic diversity results in greater potential to adapt to a changing environment through natural selection. Reduced genetic diversity in a population can limit its adaptive potential. Small populations often have lower genetic diversity because there are fewer individuals. Small populations are also susceptible to genetic phenomena of inbreeding depression, population bottlenecks, and genetic drift, which can lead to a greater reduction in genetic diversity over time and reduced fitness of the population, leaving it more vulnerable to changing environmental conditions. The combination and interaction of these negative demographic and genetic effects on a small population can lead the population into an extinction vortex.
Effective population size (
In 2018 to 2020, range-wide genetic analyses were carried out for the coal darter, which included samples from the Cahaba River, Locust Fork, and Hatchet Creek. No samples were included in the analysis from Weogufka Creek, because individuals at that site were discovered in 2021, after this genetic work was completed. As such, the Coosa River system is represented only by Hatchet Creek in the genetics analysis.
Results show that populations were historically connected and shared gene flow, however they are currently functionally isolated, showing no gene flow between the three watersheds (Jones and Sandel 2019, entire; Jones 2021, entire). Genetic diversity was relatively low across all three watersheds as indicated by the observed and expected heterozygosity (H
A summary of the threats acting on coal darter populations in each river system is presented below in table 3. The magnitude of each of these threats varies from river system to river system. Details on the impacts of the different threats on coal darter populations are provided below under
The coal darter is not State-protected in Alabama but is included in the Alabama State Wildlife Action Plan (SWAP), where it is assigned a “priority 2” (“high conservation concern”) status (ADCNR 2015, pg. 19). There have been no captive propagation efforts for the species. The Geological Survey of Alabama (GSA) completed targeted surveys for the species in the Locust Fork in 2001, and rangewide in 2022 in partnership with the Service. Additionally, GSA, ADEM, ADCNR, and other partners have conducted fish Index of Biotic Integrity (IBI) assessments, a fish community-based assessment of stream health, in waterways throughout the State, including areas within the coal darter's range (Service 2023, pp. 31-32).
Priority watersheds within the range of the coal darter have been designated as “strategic habitat units” (SHUs) by the Alabama Rivers and Streams Network (ARSN). The SHU concept was created to prioritize efforts and leverage capacity among partners (government, nongovernmental organizations, private industry) to implement restoration and recovery of listed and rare aquatic species. Locust Fork, the Cahaba River, and Hatchet Creek have all been designated as SHUs. However, Weogufka Creek does not have an SHU designation.
Habitat restoration has been one of the most influential conservation efforts positively affecting coal darters. Projects, such as stream bank stabilization and dam removal, have been completed or planned by State and Federal partners, nonprofit organizations, and private landowners. These types of restoration projects are not specifically targeting coal darter conservation, but they aim to improve the habitat quality in general for the benefit of imperiled aquatic species.
The Cahaba River has a long history of water quality declines and subsequent remediation activities (Thom et al. 2013, pp. 60-62). In recognition of these water quality challenges, EPA and the State of Alabama began working on measures to improve the water quality of the river under the auspices of the CWA. The CWA regulates water quality standards for surface waters and discharges of pollutants into the waters of the United States. The CWA made point source discharge into navigable waters without a permit unlawful in 1972. The EPA has authority to enforce the CWA, and with that authority, has developed national water quality criteria recommendations for pollutants found in surface waters and has implemented various pollution control programs (
Stormwater runoff containing pollutants is often transported through municipal separate stormwater sewer systems (MS4s), which discharge without treatment into local waterways (Service 2023, p. 33). An MS4 is owned by a public entity and is designed to collect and convey stormwater that discharges to waters of the United States. It is not part of a combined sewer or a publicly owned treatment facility or works (EPA 2023, entire). Administered under the National Pollution Discharge Elimination System (NPDES) permit program, MS4 permits require development and implementation of a comprehensive storm water management program (SWMP) that addresses prevention, treatment, removal, monitoring, and other measures to control the quality of stormwater that travels through storm drains to waters of the United States (EPA 2021, introduction). At present, several urban areas in the Upper Cahaba are designated as part of the MS4 program. These permits are regulated under the NPDES system, are treated as point sources by the EPA, and receive waste load allocations (WLAs) under the total maximum daily load (TMDL) program, which is a calculation of the maximum amount of a particular pollutant that can enter a water body and allow that water body to meet water quality standards (Service 2023, p. 34). Thereby, under the CWA, point source discharges of pollutants (including stormwater) are currently being regulated.
In addition, there are processes in place to manage new discharges into the river from industrial sources (
Significant habitat restoration efforts have also taken place in the Cahaba River. For example, in 2004, The Nature Conservancy, the U.S. Army Corps of Engineers, and other partners removed a vented ford dam named the Marvel Slab. Built in the 1960s and 1970s, the dam was originally used for transporting coal and timber across the river. It was 67 meters (219 feet) long, 1.8 meters (5.9 feet) tall, and 7.6 meters (24.9 feet) wide with 40 culverts through which water could flow. Ecologically, the barrier functioned as a dam, blocking upstream movement of aquatic fauna. Removal of the structure restored connectivity between the river reaches. When compared with historical records, fish monitoring conducted after the dam was removed indicated that several fish species, including two that are Federally listed under the Act, have extended their ranges as a result of the removal (Bennett et al. 2015, pp. 51-61).
Currently, within the Black Warrior River system, the coal darter is restricted to the Locust Fork. The Locust Fork has its own history of water quality issues and remediation. In 1998, it was added to the EPA's list of impaired and threatened waters in Alabama (
From these assessments, the macroinvertebrate community was characterized as “fair” for each of the four segments; habitat quality was “optimal” at the most upstream segment, “sub-optimal” at the middle two segments, and “marginal” at the most downstream segment; and the numerical water quality parameters (total suspended solids and turbidity) were below the eco-reference guidelines for all four segments (ADEM 2018, pp. 14-16). Based on these monitoring results, in 2018, the Locust Fork was removed from the 303(d) list for siltation, and it was also removed from the 303(d) list for nutrients because a TMDL was established (Service 2023, p. 36).
We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have not only analyzed individual effects on the species, but we have also analyzed their potential cumulative effects. We incorporate the cumulative effects into our SSA analysis when we characterize the current and future conditions of the species. Our assessment of the current and future conditions encompasses and incorporates the threats individually and primary threats cumulatively. Our current and future conditions assessment is iterative because it accumulates and evaluates the effects of all the factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative effects analysis.
A thorough review of the coal darter's current condition is presented in chapter 5 of the SSA report (version 1.1, Service 2023, pp. 39-53).
Currently, the coal darter is known from three tributary systems of the Mobile River Basin: Locust Fork of the Black Warrior River, Cahaba River, and Hatchet and Weogufka Creeks of the Coosa River. Coal darter movements and dispersal patterns within these systems are not well understood. Recent population genetics work by University of West Alabama supports gene flow within each river system. However, migration rate estimates indicate no individuals migrating between river systems; thus, no contemporary gene flow exists between systems. These results indicate that each river system is demographically independent of each other. Using these data, populations were delineated based on river system, resulting in three populations that will serve as the resiliency units for assessing population resiliency: the Black Warrior, the Cahaba, and the Coosa. Currently, each population is found in a different Level III ecoregion. Since no other biologically meaningful boundaries are known to exist for the coal darter, we determined the representative units to be the same as the resiliency units (populations).
Based on the coal darter's individual and population needs, such as adequate water quality and quantity, the availability of clean gravel/cobble substrates, sufficient food sources, and appropriate population size and connectivity to support reproduction and recruitment within a population, we developed an approach using key habitat and demographic factors to assess population resiliency. We assessed two demographic condition parameters (genetic health and persistence through time) and two habitat condition parameters (Human Disturbance Gradient Index and habitat quantity) (see table 4, below). Based on the coal darter's lifespan, we used the time period from 2007 to 2022 to inform the current condition of the species.
For a population to be resilient in the context of genetic health, a population should have sufficient standing genetic variation and effective population size (
We consider a population with high resiliency to have high or moderate genetic diversity and an
When determining the current condition of the coal darter, the extent of the current range in the context of the historical range was important to consider (see table 4, below). Impoundments constructed in the Black Warrior and Coosa Rivers in the late 1800s to the mid-1900s, converted mainstem areas once occupied by coal darters to unsuitable conditions, resulting in large-scale extirpation throughout the species' historical range. This was an important consideration for the species because coal darters are now restricted to smaller areas than they were previously, which has
To better assess coal darter resiliency, thresholds were standardized for each population by using a percentage of historical range in each river system to represent potential habitat for the species (see table 4, below). We determined that a population with high resiliency would have lost no more than one third of its historical range; a population with moderate resiliency would have lost between one third and two thirds of its historical range; and a population with low resiliency would have lost more than two thirds of its historical range.
The coal darter's sensitivity to habitat alterations from human activities were also used to assess resiliency. In order to describe the level of impairment and risk to natural aquatic habitats that arise from human activities, the Human Disturbance Gradient Index (HDGI) was used (see table 4, below). The HDGI considers a variety of landscape variables associated with disturbance to aquatic environments. Specifically, these variables include: human density (population count/kilometer of watershed), phosphorus load (kilograms/hectare/year), percent developed (percentage of the watershed that is developed), percent barren (percentage of the watershed that is barren due to human activities), percent pasture (percentage of the watershed that is pasture), percent crop (percentage of watershed that is used for row crops), road density (kilometers of roads/square kilometer of watershed), and road-stream crossings (number of road-stream crossings per kilometer of road). Each landscape variable is weighted by a factor known as the landscape development intensity (LDI) index, which ranges between 0 and 10, and relates land-use classifications with the intensity of nonrenewable energy consumption. An LDI of 0 corresponds to natural environments, and an LDI of 10 corresponds to highly developed urban environments. The sum of the weighted landscape variables calculated for each hydrologic unit code (HUC) 12 watershed in the range equates to the HDGI (Service 2023, pp. 42-43).
The final HDGI for each population of the coal darter was found by averaging the HDGI of its constituent HUC 12 watersheds. Stream reaches with HDGI values that exceed 200 were found to correspond to poor biological condition with low diversity of fish species, mostly inhabited by generalist species tolerant of habitat uneasiness (Service 2023, p. 43). Therefore, we expect the abundance and probability of coal darter presence to decline when HDGI scores approach and exceed 200. However, we acknowledge that landscape heterogeneity within the scale of a HUC 12 watershed may allow suitable environmental conditions to persist within an otherwise largely disturbed landscape. Further, based on our analysis, we are most confident that HDGI scores below 175 reflect good conditions and those above 300 reflect poor conditions. For these reasons, HDGI scores below 175 were classified as high condition or most suitable for the coal darter, with high probability of occurrence and high abundance; scores between 176 and 300 as moderate condition, with moderate probability of occurrence and moderate abundance; and scores greater than 300 as low condition, with the lowest probability of occurrence or very low abundance and posing the highest levels of risk to the species (Service 2023, pp. 42-43; see table 4, below).
Habitat quantity is another important metric to assess the current condition of the coal darter using HUC 12 watersheds as our units. The greater quantity of connected, suitable habitat available within a population, the greater the population resiliency. Resiliency was classified into one of three classes: High, Moderate, and Low. Thresholds for habitat quantity were established by enumerating extent of coal darter presence in the context of the historical range limits (see table 4, below).
For each parameter, we assigned a score from 1 to 3 (1 = low, 2 = moderate, 3 = high) based on condition categories that we developed in coordination with species experts. For the overall resiliency of a population, scores were summed for all parameters. The minimum possible sum is 4 (a score of low for each of the four parameters), and the maximum possible sum is 12 (a score of high for each of the four parameters). We set thresholds for overall resiliency scores based on the minimum and maximum possible sums and the number of categories (3: high, moderate, low) (see table 5, below). The following discussion describes our reasoning for each parameter, the condition categories, and the methodology we used to derive an overall score for each factor.
The overall resiliency for the Cahaba population is moderate (see table 6, below). Genetic diversity of the Cahaba population is low, and the effective population size is higher than 500 or 1,000 “rules of thumb” threshold at 3,145 (range of 2,423-4,480) (Jones and Sandel 2019, pg. 5; Jones 2021, pg. 22). Due to the low genetic diversity but high effective population size (exceeding the 500/1,000 threshold), the Cahaba population scores moderate for genetic health (see table 6, below). The population genetic results indicate that the Cahaba population currently has a lower expected heterozygosity and percent polymorphic loci when compared to the Black Warrior population, yet a higher effective population size than the Black Warrior population (Service 2023, p. 46). One explanation for this could be a decrease in population size because of degraded water quality in the Cahaba River beginning in the early 1900s up to the enactment of the CWA (1972). A significant decrease in the number of individuals in this population would have resulted in a loss of genetic diversity. Because of their short generation time, coal darter numbers may have been able to rebound faster than it would take to increase genetic diversity since the latter would be dependent on the accumulation of novel mutations which would be expected to occur over thousands of years.
The Cahaba population has experienced the least reduction in range of the three populations. No major impoundments were constructed within the mainstem of the Cahaba River. However, a single low head dam located at Highway 280 currently prevents movement of coal darters upstream. While the species still occupies sites approximately 20 miles upstream of this dam, those individuals are isolated from downstream individuals and gene flow is likely unidirectional, creating a greater risk of further loss in genetic diversity in this portion of the river (Zarri et al. 2022, entire). To date, no range reduction of the species due to this dam has been observed. The Cahaba population scores high for the percentage of historical range with current records metric (see table 6, below).
The Cahaba River HDGI score is largely influenced by intense urbanization associated with the City of Birmingham and its suburbs. The averaged HDGI for currently occupied HUC 12 watersheds is 356 (Service 2023, p. 46), which results in a score of low for the Cahaba population (see table 6, below). Eight HUC 12 watersheds are currently occupied, which results in a score of high for habitat quantity (see table 6, below).
The Coosa population has experienced the greatest range reduction of the three coal darter populations. With a 90 percent reduction in range compared to pre-impoundment historical condition, this population is assessed a score of low for the percentage of historical range with current records metric (see table 6, below).
The HDGI for the Lower Weogufka Creek HUC 12 had a value of 51.5, and the HDGI for the Lower Hatchet Creek HUC 12 had a value of 40.7 (Service 2023, p. 49). The averaged HDGI score for currently occupied HUC 12 watersheds is 46, which results in a score of high for the HDGI metric for this population (see table 6, below).
Regarding the habitat quantity metric for the Coosa population, only two HUC 12 watersheds are currently occupied: Lower Hatchet Creek and Lower Weogufka Creek. Within these two HUC 12 boundaries, the coal darter is only known from one site in Weogufka Creek and 14.5 rkm (9 rmi) of Hatchet Creek. Because of the low quantity of occupied habitat, this population scores low for the habitat quantity factor.
Representation is the ability of a species to adapt to both near-term and long-term changes in its physical and biological environment. The best available scientific information suggests using population genetic analyses to characterize the coal darter's current adaptive capacity. Due to the current isolation of coal darter populations, it is unlikely that gene flow exists among rivers (to increase genetic diversity), or that darter populations are able to shift to track suitable habitat conditions. Isolated coal darter populations must adapt to changing conditions in place, requiring sufficient genetic variation in order to respond to shifting selection pressures and any unexpected selection events, such as introduction of a novel disease or invasive species (Service 2023, p. 52).
The Cahaba River and Black Warrior populations meet the effective population size threshold “rule of thumb” of 500 or 1,000 to maintain evolutionary potential and adaptive capacity over time. By contrast, the Coosa population does not meet these effective population size thresholds for retaining adaptive potential. Coupled with its low genetic diversity, this population is at high risk of ongoing losses of standing genetic variation, lowering its capacity to respond to changing selection pressures.
We estimate that the coal darter has low adaptive capacity based on the poor genetic condition of the Coosa population; the low genetic diversity, yet sufficient effective population sizes, of the Black Warrior and Cahaba populations; and the lack of connectivity between populations. Overall representation for the coal darter is currently low.
Redundancy refers to the ability of a species to withstand catastrophic events and is measured by the amount and distribution of resilient populations across the species' range. Catastrophic events that could severely affect or extirpate entire coal darter populations include gas pipeline bursts and associated spills, changes in upstream land use that alter stream characteristics and water quality, and potential effects of climate change such as drought and increases in occurrence of flash-flooding events.
Redundancy is characterized by having multiple, resilient and representative populations of the coal darter distributed throughout the species' range. While there remain three populations distributed throughout the range and at a scale for which it would be unlikely for a single event to catastrophically affect all, one population (Coosa) has low resiliency to stochastic events and a higher risk of extirpation. The remaining two populations (Black Warrior and Cahaba) were found to be moderately resilient to stochastic events. Each population's reduced resiliency prevents them from fully contributing to a high level of redundancy; therefore, the coal darter currently exhibits a moderate level of redundancy.
A thorough review of the coal darter's future condition is presented in chapter 6 of the SSA report (version 1.1, Service 2023, pp. 54-58).
In our SSA report (version 1.1, Service 2023, entire), we define viability as the ability of the coal darter to sustain natural populations in river and stream systems over time. In our assessments of factors influencing viability and current condition, we found that disturbance on the landscape negatively affects the coal darter's ability to sustain natural populations and these disturbances can be attributed and measured by quantifying land use and cover types. To help address uncertainty associated with the degree and extent of potential future stressors and their impacts on the species' needs, the concepts of resiliency, redundancy, and representation were assessed using two scenarios and time stepped them at years 2040 and 2050. We devised these scenarios by identifying information on primary threat factors arising from increasing human populations and resulting alterations to the habitat. The four scenarios use the EPA's Integrated Climate and Land Use (ICLUS; version 2.1.1, EPA 2017) model, which uses human demography as a primary means to project local land-use changes in the future with consideration of climate change. It is consistent with updated global socioeconomic scenarios (shared
We used the best available data and models to project changes in human disturbance under a high impact scenario and a moderate impact scenario at year 2040 and 2050 (20 and 30 years). This timeframe was reasonably certain to predict patterns of urbanization and agriculture, and how these land uses forecast patterns in the species' range relevant to the coal darter and its habitat given the species' short lifespan. In addition, catastrophic events (for example, invasive species, disease, and chemical spills) could have an immediate impact on the species, especially on the Coosa population due to its limited abundance and distribution.
Results of HDGI under the two future scenarios did not vary greatly between the two scenarios within each population (Black Warrior: 610 and 635; Cahaba: 636 and 661; Coosa: 77 and 141) (Service 2023, pp. 56-59). As stated above under
When compared to the current condition's HDGI, the Black Warrior and Cahaba populations' future HDGI scores nearly tripled and doubled, respectively. Therefore, aquatic habitats currently occupied by the coal darter will experience substantial levels of disturbance due to human urbanization activities, and the species' likelihood of presence and abundance will continue to decline. Furthermore, the habitat quantity will also decrease. Due to the significant projected increase in human disturbance within the Black Warrior and Cahaba populations, resiliency of each of these populations is projected to decrease from moderate to low under all future scenarios (Service 2023, p. 56).
While the future HDGI did not indicate poor habitat condition in the Coosa population, no habitat improvements are projected. The Coosa population of the coal darter is confined to small reaches of Hatchet and Weogufka creeks. These two tributaries of the Coosa River likely represent peripheral habitat that was sustained by now extirpated source populations in the Coosa River. As flow appears to be a predictor of species presence, population expansion in these streams is constrained by the lack of suitable flows and habitat in the upstream reaches. Further, given the natural state of these streams, it is unlikely density could increase. That is, the populations are likely at carrying capacity within these refugia. The Coosa population's poor genetic health is projected to decline without the influx of any new genetic material. Therefore, projected resiliency of the Coosa population remains low (Service 2023, p. 56).
The overall projected decline in resiliency decreases the Black Warrior and Cahaba populations' contribution to future redundancy. Therefore, catastrophic events that occur across the regional or State scale could cause extirpation in both populations. Furthermore, the current low resiliency in the Coosa population leaves it susceptible to extirpation, and with heavy land-use changes projected to occur on the landscape surrounding this population, this population is likely to be extirpated by the 2040 and 2050 time steps. For these reasons, the overall redundancy under all future scenarios is low.
We do not anticipate any improvement to the connectivity or adaptive capacity of the species. While our current condition assessment finds sufficient effective population size in the Black Warrior and Cahaba populations, the amount of habitat disturbance projected to occur, and probable range contraction, will reduce the effective population size and genetic diversity of these two populations. The overall representation for the coal darter under all future scenarios is assessed as low.
Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of an endangered species or a threatened species. The Act defines an “endangered species” as a species in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether a species meets the definition of an endangered species or a threatened species because of any of the following 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.
We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the coal darter. We considered whether the coal darter is presently in danger of extinction. Our review of the best available information indicates there are three populations across the known historical range in the Locust Fork of the Black Warrior River system, the Cahaba River system, and the Hatchet and Weogufka Creeks of the Coosa River system in Alabama. Genetic analysis indicates that the three populations were previously connected but are currently isolated and uniquely identifiable populations. Based on the coal darter's individual and population needs, an approach including two key habitat (Human Disturbance Gradient Index (HDGI) and habitat quantity) factors and two demographic (genetic health and persistence through time) factors was used to assess population resiliency with an assigned score of high, moderate, or low.
The current resiliency for both the Black Warrior and Cahaba populations is moderate. Impacts from habitat destruction and modification; the reduction of range as a result of impoundments (Black Warrior); and water quality degradation resulting from urbanization, mining, and agriculture (Factors A and E) appear to be affecting the coal darter at the population level
The Coosa population has low resiliency due to habitat destruction and degradation resulting from dams and impoundments (Factors A and E). Only two HUC 12 watersheds are currently occupied in the Coosa population: Lower Hatchet Creek and Lower Weogufka Creek. Within these two HUC 12 boundaries, the coal darter is only known from one site in lower Weogufka Creek and 9 rmi (14.5 rkm) of lower Hatchet Creek. The genetic diversity is currently very low for this population (an order of magnitude lower than the other two populations), and its inadequate effective population size is vulnerable to the deleterious effects of inbreeding depression and genetic drift. This low effective population size may also reflect the ongoing harmful genetic effects of a population bottleneck or the ongoing habitat limitations that prevent population sizes reaching those found in the other two populations or both.
The species is currently extant in all three representation units, with two resiliency units (Black Warrior and Cahaba) having moderate resiliency. Both units with moderate resiliency contain effective populations sizes necessary for retaining adaptive potential. In contrast, the one unit (Coosa) with low resiliency does not meet the effective population size threshold for retaining adaptive potential. Coupled with low genetic diversity, the Coosa unit is currently at high risk of ongoing losses of standing genetic variation, lowering its capacity to respond to changing selection pressures.
The three populations are distributed across northern Alabama, and two of the three units across the range currently have moderate resiliency, which bolsters the species' ability to withstand catastrophic events. However, a catastrophic event (such as a chemical spill, change in upstream land use that alters stream characteristics and water quality, new impoundment, drought, or flash flood) could severely affect or extirpate coal darter populations such that the species is affected as a whole. This is exacerbated by one population (Coosa) having low resiliency to stochastic events and being at a higher risk of extirpation, while the remaining two populations (Black Warrior and Cahaba) have moderate resiliency to respond to stochastic events. Connectivity does not exist between any of the extant units. However, the species is not presently facing threats that place it at risk of extinction throughout all its range. Further, while multiple populations exist, each population's low or moderate resiliency contributes to a moderate level of redundancy for the species. Therefore, we find that the species does not meet the definition of an endangered species.
We forecasted the viability of the coal darter under four plausible scenarios into the future (summarized above under
Taking into account the primary factors influencing the species in the future (habitat destruction and degradation caused by land uses, and loss of connectivity between populations) and the potential impacts to the species' needs, we project a decline in resiliency for the coal darter throughout its range. The current low resiliency in the Coosa population leaves it vulnerable to extirpation, especially considering the major land-use changes expected to occur to this landscape, and this population is projected to remain in low condition. Furthermore, the Black Warrior and Cahaba populations are projected to decline in resiliency, as will their projected contribution to redundancy over the next 30 years. Therefore, potential catastrophic events occurring across the Southeast or in the State of Alabama could result in extirpation of any of the populations. Given the scenarios assessed, it is projected that aquatic habitats currently occupied by the coal darter will experience substantial levels of disturbance due to human activities, reducing the amount of habitat available to the species and corresponding to declines in the species' likelihood of presence and abundance. For these reasons, the overall projected redundancy for the coal darter under all future scenarios is low.
Future projections also indicate that the coal darter will continue to have low adaptive capacity (low representation) based on (1) the poor genetic condition of the Coosa population, if it remains extant in the future; (2) the low genetic diversity of the Black Warrior and Cahaba populations; and (3) the lack of connectivity between populations. Further, while the current condition assessment found sufficient effective population sizes in the Black Warrior and the Cahaba populations, the amount of habitat disturbance and range contractions that are projected to occur would likely reduce the effective population sizes and genetic diversity of these two populations. For these reasons, the overall projected representation for the coal darter under all future scenarios is low. From our future scenario assessment, we find that the coal darter will be at risk of extinction, and therefore is likely to become endangered, within the foreseeable future (
Based on projected future threats, the coal darter will not have sufficient resiliency, redundancy, and representation to support species' viability. Overall, the future threats are projected to increase in magnitude and severity such that the coal darter is at risk of extinction throughout all of its range. Thus, after assessing the best available information, we conclude that the coal darter is likely to become in danger of extinction within the foreseeable future throughout all of its range.
Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so within the foreseeable future throughout all or a significant portion of its range. The court in
Therefore, we proceed to evaluating whether the species is endangered in a significant portion of its range—that is, whether there is any portion of the species' range for which both (1) the portion is significant; and (2) the species is in danger of extinction in that portion. Depending on the case, it might be more efficient for us to address the “significance” question or the “status” question first. We can choose to address either question first. Regardless of which question we address first, if we reach a negative answer with respect to the first question that we address, we do not need to evaluate the other question for that portion of the species' range.
Following the court's holding in
We evaluated the range of the coal darter to determine if the species is in danger of extinction now in any portion of its range. The range of a species can theoretically be divided into portions in an infinite number of ways. We focused our analysis on portions of the species' range that may meet the definition of an endangered species. For the coal darter, we considered whether the threats or their effects on the species are greater in any biologically meaningful portion of the species' range than in other portions such that the species is in danger of extinction now in that portion.
The statutory difference between an endangered species and a threatened species is the timeframe in which the species becomes in danger of extinction; an endangered species is in danger of extinction now while a threatened species is not in danger of extinction now but is likely to become so within the foreseeable future. Thus, we considered the time horizon for the threats that are driving the coal darter to warrant listing as a threatened species throughout all of its range. We then considered whether these threats or their effects are occurring in any portion of the species' range such that the species is in danger of extinction now in that portion of its range. We examined the following threats: habitat degradation or loss stemming from hydrologic alteration by impoundments, including dams and other barriers; habitat degradation or loss stemming from urban development or change in land cover, including increased density of residential and commercial infrastructure; resource extraction, including mining and timber operations; agriculture, including poultry farming; and diminished water quality from point and nonpoint source chemical contamination and siltation, including cumulative effects.
We identified that the Coosa portion of the species' range is experiencing a concentration of the following threat at a biologically meaningful scale: habitat destruction and degradation from land uses and impoundments resulting in poor water quality (Factor A). Currently, the Coosa population unit has low resiliency, with only two HUC 12 watersheds currently occupied: Lower Hatchet Creek and Lower Weogufka Creek. This population unit has experienced the greatest range reduction (a loss of 90 percent of its historical range) of the three coal darter populations, and its low effective population size is an order of magnitude lower than the other two populations. Overall, the Coosa population lacks any adaptive potential, and it is likely that a single catastrophic event would result in the extirpation of the species from this portion. Based on this information, we conclude that the impacts are having a biologically meaningful effect on the Coosa population. Therefore, the best scientific and commercial information indicates that the Coosa population may have a different status than the other two populations in the species' range.
We then proceeded to consider whether this portion of the range (
Currently, the Coosa population represents a small portion (less than 5 percent based on current occurrences and occupied stream reaches) of the coal darter's range. In addition, this portion does not have any areas of habitat that are unique or that contain high-quality or high-value habitat relative to the remaining portions of the range. The Coosa population also does not contain habitat that is essential to a specific life-history function. Overall, we found no information that would indicate that the Coosa population constitutes a portion of the range that may be significant in terms of its geographic portion of suitable habitat, or that it is significant in terms of high-quality habitat or otherwise important for the species' life history.
The best scientific and commercial data available indicate that no portion of the species' range provides a basis for determining that the species is in danger of extinction in a significant portion of its range, and we determine that the species is likely to become in danger of extinction within the foreseeable future throughout all of its range. This does not conflict with the courts' holdings in
Our review of the best available scientific and commercial information
Conservation measures provided to species listed as endangered or threatened species under the Act include recognition as a listed species, planning and implementation of recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, State, Tribal, and local agencies, private organizations, and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies, including the Service, and the prohibitions against certain activities are discussed, in part, below.
The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Section 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.
The recovery planning process begins with development of a recovery outline made available to the public soon after a final listing determination. The recovery outline guides the immediate implementation of urgent recovery actions while a recovery plan is being developed. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) may be established to develop and implement recovery plans. The recovery planning process involves the identification of actions that are necessary to halt and reverse the species' decline by addressing the threats to its survival and recovery. The recovery plan identifies recovery criteria for review of when a species may be ready for reclassification from endangered to threatened (“downlisting”) or removal from protected status (“delisting”), and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery outline, draft recovery plan, final recovery plan, and any revisions will be available on our website as they are completed (
Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (
If this species is listed, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost-share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Alabama would be eligible for Federal funds to implement management actions that promote the protection or recovery of the coal darter. Information on our grant programs that are available to aid species recovery can be found at:
Although the coal darter is only proposed for listing under the Act at this time, please let us know if you are interested in participating in recovery efforts for this species. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see
Section 7 of the Act is titled, “Interagency Cooperation,” and it mandates all Federal action agencies to use their existing authorities to further the conservation purposes of the Act and to ensure that their actions are not likely to jeopardize the continued existence of listed species or adversely modify critical habitat. Regulations implementing section 7 are codified at 50 CFR part 402.
Section 7(a)(2) states that each Federal action agency shall, in consultation with the Secretary, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Each Federal agency shall review its action at the earliest possible time to determine whether it may affect listed species or critical habitat. If a determination is made that the action may affect listed species or critical habitat, formal consultation is required (see 50 CFR 402.14(a)), unless the Service concurs in writing that the action is not likely to adversely affect listed species or critical habitat. At the end of a formal consultation, the Service issues a biological opinion, containing its determination of whether the Federal action is likely to result in jeopardy or adverse modification.
In contrast, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of critical habitat proposed to be designated for such species. Although the conference procedures are required only when an action is likely to result in jeopardy or adverse modification, action agencies may voluntarily confer with the Service on actions that may affect species proposed for listing or critical habitat proposed to be designated. In the event that the subject species is listed or the relevant critical habitat is designated, a conference opinion may be adopted as a biological opinion and serve as compliance with section 7(a)(2) of the Act.
Examples of discretionary actions for the coal darter that may be subject to conference and consultation procedures under section 7 of the Act are land management or other landscape-altering activities on Federal lands administered by the U.S. Department of Agriculture's U.S. Forest Service or Natural Resources Conservation Service, the U.S. Geological Survey, and the U.S. Army Corps of Engineers, as well as actions on State, Tribal, local, or private lands that require a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the CWA or a permit from the Service under section 10 of the Act) or that involve some other Federal action (such as funding from the Federal Highway Administration, Federal Aviation
It is the policy of the Service, as published in the
At this time, we are unable to identify specific activities that will or will not be considered likely to result in violation of section 9 of the Act beyond what is already clear from the descriptions of prohibitions and exceptions we would establish by protective regulation under section 4(d) of the Act (see Provisions of the Proposed 4(d) Rule, below).
Questions regarding whether specific activities would constitute violation of section 9 of the Act should be directed to the Alabama Ecological Services Field Office (see
Section 4(d) of the Act contains two sentences. The first sentence states that the Secretary shall issue such regulations as she deems necessary and advisable to provide for the conservation of species listed as threatened species. The U.S. Supreme Court has noted that statutory language similar to the language in section 4(d) of the Act authorizing the Secretary to take action that she “deems necessary and advisable” affords a large degree of deference to the agency (see
The courts have recognized the extent of the Secretary's discretion under this standard to develop rules that are appropriate for the conservation of a species. For example, courts have upheld, as a valid exercise of agency authority, rules developed under section 4(d) that included limited prohibitions against takings (see
The provisions of this proposed 4(d) rule would promote conservation of the coal darter by encouraging management of the landscape in ways that meet both watershed and riparian management purposes and facilitate the conservation of the species. The provisions of this proposed 4(d) rule are one of many tools that we would use to promote the conservation of the coal darter. This proposed 4(d) rule would apply only if and when we make final the listing of the coal darter as a threatened species.
As mentioned previously in Available Conservation Measures, section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species. In addition, even before the listing of any species or the designation of its critical habitat is finalized, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any agency action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of critical habitat proposed to be designated for such species.
These requirements are the same for a threatened species with a species-specific 4(d) rule. For example, as with an endangered species, if a Federal agency determines that an action is “not likely to adversely affect” a threatened species, it will require the Service's written concurrence (see 50 CFR 402.13(c)). Similarly, if a Federal agency determinates that an action is “likely to adversely affect” a threatened species, the action will require formal consultation with the Service and the formulation of a biological opinion (see 50 CFR 402.14(a)).
Exercising the Secretary's authority under section 4(d) of the Act, we have developed a proposed rule that is designed to address the coal darter's conservation needs. As discussed previously under Summary of Biological Status and Threats, we have concluded that the darter is likely to become in danger of extinction within the foreseeable future primarily due to habitat loss or degradation from the following activities or conditions: hydrologic alteration by impoundments, including dams and other barriers;
The protective regulations we are proposing for the coal darter incorporate prohibitions from section 9(a)(1) of the Act to address the threats to the species. Section 9(a)(1) prohibits the following activities for endangered wildlife: importing or exporting; take; possession and other acts with unlawfully taken specimens; delivering, receiving, carrying, transporting, or shipping in interstate or foreign commerce in the course of commercial activity; or selling or offering for sale in interstate or foreign commerce. This protective regulation includes all of these prohibitions because the coal darter is at risk of extinction within the foreseeable future and putting these prohibitions in place would help to preserve the species' remaining populations and decrease synergistic, negative effects from other ongoing or future threats.
In particular, this proposed 4(d) rule would provide for the conservation of the coal darter by prohibiting the following activities, unless they fall within specific exceptions or are otherwise authorized or permitted: import or export; take; possession and other acts with unlawfully taken specimens; delivery, receipt, carriage, transport, or shipment in interstate or foreign commerce in the course of commercial activity; and sale or offer for sale in interstate or foreign commerce. We also include several exceptions to these prohibitions, which, along with the prohibitions, are set forth below.
Under the Act, “take” means to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. Some of these provisions have been further defined in regulations at 50 CFR 17.3. Take can result knowingly or otherwise, by direct and indirect impacts, intentionally or incidentally. Regulating take would help preserve the species' remaining populations and slow their rate of decline. Therefore, we propose to prohibit take of the coal darter, except for take resulting from those actions and activities specifically excepted by the 4(d) rule. Exceptions to the prohibition on take would include all of the general exceptions to the prohibition on take of endangered wildlife, as set forth in 50 CFR 17.21, and additional exceptions, as described below.
The proposed 4(d) rule would also provide for the conservation of the species by allowing exceptions that incentivize conservation actions or that, while they may have some minimal level of take of the coal darter, are not expected to rise to the level that would have a negative impact (
Despite these prohibitions regarding threatened species, we may under certain circumstances issue permits to carry out one or more otherwise-prohibited activities, including those described above. The regulations that govern permits for threatened wildlife state that the Director may issue a permit authorizing any activity otherwise prohibited with regard to threatened species. These include permits issued for the following purposes: for scientific purposes, to enhance propagation or survival, for economic hardship, for zoological exhibition, for educational purposes, for incidental taking, or for special purposes consistent with the purposes of the Act (50 CFR 17.32). The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.
We recognize the special and unique relationship with our State natural resource agency partners in contributing to conservation of listed species. State agencies often possess scientific data and valuable expertise on the status and distribution of endangered, threatened, and candidate species of wildlife and plants. State agencies, because of their authorities and their close working relationships with local governments and landowners, are in a unique position to assist us in implementing all aspects of the Act. In this regard, section 6 of the Act provides that we must cooperate to the maximum extent practicable with the states in carrying out programs authorized by the Act. Therefore, any qualified employee or agent of a State conservation agency that is a party to a cooperative agreement with us in accordance with section 6(c) of the Act, who is designated by his or her agency for such purposes, would be able to conduct activities designed to conserve coal darter that may result in otherwise prohibited take without additional authorization.
Nothing in this proposed 4(d) rule would change in any way the recovery planning provisions of section 4(f) of the Act, the consultation requirements under section 7 of the Act, or the ability of the Service to enter into conservation partnerships for the management and protection of the coal darter. However, interagency cooperation may be further streamlined through planned programmatic consultations for the species between Federal agencies and the Service, where appropriate. We ask the public, particularly State agencies and other interested stakeholders that may be affected by the proposed 4(d) rule, to provide comments and suggestions regarding additional guidance and methods that the Service could provide or use, respectively, to streamline the implementation of this proposed 4(d) rule (see Information Requested, above).
Critical habitat is defined in section 3 of the Act as:
(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features
(a) Essential to the conservation of the species, and
(b) Which may require special management considerations or protection; and
(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
We have found critical habitat to be prudent and determinable for the coal darter and have developed a proposed critical habitat rule for this species. On October 25, 2023, we were informed that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) determined that our proposed critical habitat rule is significant under Executive Order 12866. Therefore, we will publish a proposed critical habitat rule for the coal darter following interagency review of the proposed critical habitat rule.
We are required by E.O.s 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(1) Be logically organized;
(2) Use the active voice to address readers directly;
(3) Use clear language rather than jargon;
(4) Be divided into short sections and sentences; and
(5) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
Regulations adopted pursuant to section 4(a) of the Act are exempt from the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), E.O. 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at
A complete list of references cited in this rulemaking is available on the internet at
The primary authors of this proposed rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Alabama Ecological Services Field Office.
Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
(h) * * *
(ii) Coal darter (
(1)
(i) Import or export, as set forth at § 17.21(b) for endangered wildlife.
(ii) Take, as set forth at § 17.21(c)(1) for endangered wildlife.
(iii) Possession and other acts with unlawfully taken wildlife, as set forth at § 17.21(d)(1) for endangered wildlife.
(iv) Interstate or foreign commerce in the course of commercial activity, as set forth at § 17.21(e) for endangered wildlife.
(v) Sale or offer for sale, as set forth at § 17.21(f) for endangered wildlife.
(2)
(i) Conduct activities as authorized by a permit under § 17.32.
(ii) Take, as set forth at § 17.21(c)(2) through (c)(4) for endangered wildlife.
(iii) Take, as set forth at § 17.31(b).
(iv) Possess and engage in other acts with unlawfully taken wildlife, as set forth at § 17.21(d)(2) for endangered wildlife.
(v) Take incidental to an otherwise lawful activity caused by:
(A) Channel restoration projects that create natural, physically stable, ecologically functioning streams. These projects can be accomplished using a variety of methods, but the desired outcome is a natural channel with geomorphically stable stream channels that maintain the appropriate lateral dimensions, longitudinal profiles, and sinuosity patterns over time without an aggrading or degrading bed elevation and include stable riffle-run-pool complexes that consist of silt-free gravel, coarse sand, cobble, boulders, woody structure, and river weed (
(B) Streambank stabilization projects that use bioengineering methods to replace pre-existing, bare, eroding stream banks with natively vegetated, stable stream banks, thereby reducing bank erosion and instream sedimentation, and improving habitat conditions for the coal darter. Stream banks may be stabilized using native live stakes (live, vegetative cuttings inserted or tamped into the ground in a manner that allows the stake to take root and grow), native live fascines (live branch cuttings, usually willows, bound together into long, cigar-shaped bundles), planting of bare-root seedlings or native brush layering (cuttings or branches of easily rooted tree species layered between successive lifts of soil fill). Stream banks must not be stabilized solely through the use of quarried rock (riprap) or the use of rock baskets or gabion structures.
(C) Activities that improve the watershed, riparian, or habitat conditions for the coal darter within the range of the species. Activities carried out under the Working Lands for Wildlife program of the Natural Resources Conservation Service, U.S.
(D) Silviculture and forest management activities that use State-approved best management practices to protect water and sediment quality and stream and riparian habitat. Best management practices must be designed to reduce sedimentation, erosion, and bank destruction, thereby protecting instream habitat for the coal darter.
Agricultural Marketing Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Agricultural Marketing Service's (AMS) intention to request approval from the Office of Management and Budget for an extension of and revision to the currently approved information collection Cotton Classification and Market News Service.
Comments on this notice must be received by February 20, 2024 to be assured consideration.
Written comments may be submitted via mail or hand delivery to Cotton Research and Promotion, Cotton and Tobacco Program, AMS, USDA, 100 Riverside Parkway, Suite 101, Fredericksburg, Virginia, 22406. All comments received will be posted without change, including any personal information provided, at
Shethir M. Riva, Director, Research and Promotion, Cotton and Tobacco Program, AMS, USDA, 100 Riverside Parkway, Suite 101, Fredericksburg, Virginia, 22406, Telephone (540) 361-2726, Facsimile (540) 361-1199, or Email at
The information collection requirements in this request are essential to carry out the intent of the Acts and to provide the cotton industry the type of information they need to make sound business decisions. The information collected is the minimum required. Information is requested from growers, cooperatives, merchants, manufacturers, and other government agencies. This includes information on cotton, cottonseed and cotton linters.
The information collected is used only by authorized employees of the USDA, AMS. The cotton industry is the primary user of the compiled information and AMS and other government agencies are secondary users.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding; whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by January 22, 2024 will be considered. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number, and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Failing to collect this information could result in APHIS not receiving information about where infestations may exist, causing them to linger unreported and grow. Infestations of high-consequence pests or diseases, such as Asian longhorned beetle, emerald ash borer beetle, citrus greening, and others, could lead to significant economic damage to crops, forests, and landscapes.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On September 22, 2023, the U.S. Department of Commerce (Commerce) issued the preliminary results of the first full five-year sunset review of the antidumping duty (AD) order on citric acid and certain citrate salts (citric acid) from Belgium. We received no comment from interested parties in opposition to our preliminary results. As a result of our analysis, Commerce finds that revocation of the AD order on citric acid from Belgium would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Applicable December 21, 2023.
Deborah Cohen, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4521.
On June 1, 2023, Commerce published the initiation of the sunset review of the AD order on citric acid from Belgium
On September 22, 2023, Commerce published the
We received no further case or rebuttal briefs from interested parties; thus, the record reflects no opposition to the
The merchandise covered by this
Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the
As noted above, Commerce received no comments in opposition to its
This notice also serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the disposition 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.
This five-year sunset review and notice are in accordance with sections 751(c)(5)(A), 752(c), and 777(i) of the Act and 19 CFR 351.218(f)(3).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that oil country tubular goods (OCTG) from Ukraine were sold at prices below normal value during the period of review (POR) July 1, 2021, through June 30, 2022.
Applicable December 21, 2023.
Toni Page, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1398.
On August 3, 2023, Commerce published the
The products covered by the
All issues raised in Interpipe's case brief and Vallourec's letter in lieu of rebuttal brief are addressed in the Issues and Decision Memorandum. A list of these issues is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
We have calculated the following estimated weighted-average dumping
Normally, Commerce will disclose the calculations performed in connection with the final results of a review to interested parties within five days of the date of publication of the notice of final results in the
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with these final results of review.
Consistent with Commerce's assessment practice, for entries of subject merchandise during the POR produced by Interpipe for which it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Interpipe will be equal to the weighted-average dumping margin established in these final results; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review or in a prior segment of the proceeding, but the producer was covered, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be the all-others rate of 7.47 percent established in the less-than-fair-value investigation.
These cash deposit requirements, when imposed, shall remain in effect until further notice.
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 review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these final results in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that Nan Ya Plastics Corporation (Nan Ya) made no sales of subject merchandise to the United States at less than normal value during the period of review (POR) July 1, 2021, through June 30, 2022. We also continue to find that Shinkong Materials Technology Corporation (SMTC)/Shinkong Synthetic Fibers Corporation (SSFC) had no shipments of subject merchandise to the United States during the POR.
Applicable December 21, 2023.
Charles DeFilippo, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3797.
On June 26, 2023, Commerce published the
The products covered by this
We address the issue raised in the case and rebuttal briefs in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is included in the appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
In the
As a result of this review, Commerce determines that the following weighted-average dumping margin exists for the period July 1, 2021, through June 30, 2022:
Commerce intends to disclose the calculations performed in connection with these final results of review to interested parties within five days after public announcement of the final results or, if there is no public announcement, within five days of the date of publication of this notice in the
Pursuant to section 751(a)(2) of the Act and 19 CFR 351.212(b)(1), Commerce has determined, and CBP shall assess, antidumping duties on all appropriate entries covered by this review. Because we calculated a zero percent margin in the final results of this review for Nan Ya, in accordance with 19 CFR 351.212 we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. In addition, as Commerce continues to find that SMTC/SSFC did not have any shipments of subject merchandise during the POR, we will instruct CBP to liquidate any suspended entries of subject merchandise associated with SMTC/SSFC at the all-others rate.
Commerce intends to issue appropriate assessment instructions directly to CBP no earlier than 35 days after the date of publication of the final results of this administrative review in the
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Nan Ya will be zero, the rate established in the final results of this review; (2) for previously reviewed or investigated companies not covered in this review, the cash deposit rate will continue to be the company specific rate published for the most recent period; (3) if the exporter is not a firm covered in this or any previous review or in the original less-than-fair-value (LTFV) investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in this or any previous review or the LTFV investigation, the cash deposit rate will continue to be the all-others rate of 2.40 percent, which is the all-others rate established by Commerce in the LTFV investigation.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties
This notice also serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(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 sanctionable violation.
These results are being issued and published 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.
The U.S. Department of Commerce (Commerce) determines that gas powered pressure washers (pressure washers) from the People's Republic of China (China) are being, or are likely to be, sold in the United States at less-than-fair value (LTFV). The period of investigation is April 1, 2022, though September 30, 2022.
Applicable December 21, 2023.
Hermes Pinilla, AD/CVD Operations, Office I, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3477.
On August 3, 2023, Commerce published in the
For a complete description of the events that occurred since the
The products covered by this investigation are pressure washers from China. For a complete description of the scope of this investigation,
During this LTFV investigation, Commerce received scope comments from interested parties. Commerce issued a Preliminary Scope Memorandum to address the comments and set aside a period of time for parties to address scope issues in scope-specific case and rebuttal briefs.
All issues raised in the case and rebuttal briefs by parties in this investigation are addressed in the Issues and Decision Memorandum and are listed in Appendix II of this notice.
For the
No parties submitted comments regarding this finding. Thus, our determination of critical circumstances is unchanged for the final determination. Accordingly, pursuant to section 735(a)(3)(B) of the Act and 19 CFR 351.206, we continue to find that critical circumstances exist for JD Power and the China-wide entity.
Regarding the companies receiving a separate rate, we preliminarily found that critical circumstances do not exist.
Commerce was unable to conduct an on-site verification of the information relied upon in making its final determination. However, from August 20 through 22, 2023, we took additional steps, in lieu of an on-site verification to verify the information relied upon in
For the final determination, we continue to find that JD Power, Sumec Hardware and Tools Co., Ltd., and Zhejiang Danau Machine Co., Ltd., are eligible for separate rates. Generally, Commerce looks to section 735(c)(5)(A) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for separate rate respondents which we did not individually examine. The statute further provides that, where all margins are zero,
In the
For the purposes of this final determination, consistent with the
As discussed in the Issues and Decision Memorandum, we determined that total AFA is warranted regarding JD Power, and thus, for purposes of this final determination, we have applied a dumping margin rate of 274.37, which represents the highest individual dumping margin calculated for a mandatory respondent in this investigation and is the same rate applied to the China-wide entity. Because this constitutes primary information from the normal course of the investigation, the statutory corroboration requirement in section 776(c) of the Act does not apply.
Commerce determines that the following estimated weighted-average dumping margins exist for the period April 1, 2022, through September 30, 2022:
Normally, Commerce will disclose to the parties in a proceeding the calculations performed in connection with a final determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of final determination in the
As a result of our
For the separate rate companies, we will instruct CBP to continue to suspend liquidation of subject merchandise, entered, or withdrawn from warehouse, for consumption, on or after August 3, 2023, which is the date of publication of the affirmative
Pursuant to section 735(c)(1)(B)(ii) of the Act and 19 CFR 351.210(d), we will instruct CBP to require a cash deposit for such entries of merchandise equal to the amount by which the normal value exceeds the U.S. price as follows: (1) the cash deposit rate for the exporter/producer combination listed in the table above will be the rate identified in the table; (2) for all combinations of Chinese producers/exporters of subject merchandise that have not established eligibility for their own separate rates, the cash deposit rate will be the rate established for the China-wide entity; and (3) for all third country exporters of subject merchandise, the cash deposit rate will be the cash deposit rate applicable to the Chinese producer/exporter that supplied that third country exporter.
In accordance with section 735(d) of the Act, we will notify the ITC of our affirmative determination of sales at LTFV. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without consent of the Assistant Secretary for Enforcement and Compliance.
Because the final determination in this proceeding is affirmative, in accordance with section 735(b) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of gas pressure washers from China no later than 45 days after our final determination. If the ITC determines that material injury or threat of material injury does not exist, the proceeding will be terminated, and all cash deposits will be refunded or canceled, as Commerce determines to be appropriate.
If the ITC determines that such injury does exist, Commerce intends to issue an antidumping duty order, in accordance with section 736(a) of the Act, directing CBP to assess, upon further instruction by Commerce, antidumping duties on all imports of the subject merchandise that are entered, or withdrawn from warehouse, for consumption on or after the effective date of suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.
In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to an APO of their responsibility concerning the disposition of proprietary disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanctions.
This determination is issued and published in pursuant with sections 735(d) and 777(i) of the Act, and 19 CFR 351.210(c).
The merchandise covered by this investigation is cold water gas powered pressure washers (also commonly known as power washers), which are machines that clean surfaces using water pressure that are powered by an internal combustion engine, air-cooled with a power take-off shaft, in combination with a positive displacement pump. This combination of components (
For purposes of this investigation, an unfinished and/or unassembled cold water gas powered pressure washer consists of, at a minimum, the power unit or components of the power unit, packaged or imported together. Importation of the power unit whether or not accompanied by, or attached to, additional components including, but not limited to a frame, spray guns, hoses, lances, and nozzles constitutes an unfinished cold water gas powered pressure washer for purposes of this scope. The inclusion in a third country of any components other than the power unit does not remove the cold water gas powered pressure washer from the scope. A cold water gas powered pressure washer is within the scope of this investigation regardless of the origin of its engine. Subject merchandise also includes finished and unfinished cold water gas powered pressure washers that are further processed in a third country or in the United States, including, but not limited to, assembly or any other processing that would not otherwise remove the merchandise from the scope of this investigation if performed in the country of manufacture of the in-scope cold water gas powered pressure washers.
The scope excludes hot water gas powered pressure washers, which are pressure washers that include a heating element used to heat the water sprayed from the machine.
Also specifically excluded from the scope of this investigation is merchandise covered by the scope of the antidumping and countervailing duty orders on certain vertical shaft engines between 99cc and up to 225cc, and parts thereof from the People's Republic of China.
The cold water gas powered pressure washers subject to this investigation are classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheadings 8424.30.9000 and 8424.90.9040. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope is dispositive.
National Institute of Standards and Technology (NIST), Commerce.
Notice; request for Information.
The National Institute of Standards and Technology (NIST) is seeking information to assist in carrying out several of its responsibilities under the Executive order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence issued on October 30, 2023. Among other things, the E.O. directs NIST to undertake an initiative for evaluating and auditing capabilities relating to Artificial Intelligence (AI) technologies and to develop a variety of guidelines, including for conducting AI red-teaming tests to enable deployment of safe, secure, and trustworthy systems.
Comments containing information in response to this notice must be received on or before February 2, 2024. Submissions received after that date may not be considered.
Comments may be submitted by any of the following methods:
1. Go to
2. Click the “Comment Now!” icon, complete the required fields, and
3. Enter or attach your comments.
Electronic submissions may also be sent as an attachment to
Written comments may also be submitted by mail to Information Technology Laboratory, ATTN: AI E.O. RFI Comments, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8900, Gaithersburg, MD 20899-8900.
Response to this RFI is voluntary. Submissions must not exceed 25 pages (when printed) in 12-point or larger font, with a page number provided on each page. Please include your name, organization's name (if any), and cite “NIST AI Executive order” in all correspondence.
Comments containing references, studies, research, and other empirical data that are not widely published should include copies of the referenced materials. All comments and submissions, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. Relevant comments will generally be available on the Federal eRulemaking Portal at
For questions about this RFI contact:
NIST is responsible for contributing to several deliverables assigned to the Secretary of Commerce. Among those is a report identifying existing standards, tools, methods, and practices, as well as the potential development of further science-backed and non-proprietary standards and techniques, related to synthetic content, including potentially harmful content, such as child sexual abuse material and non-consensual intimate imagery of actual adults. NIST will also assist the Secretary of Commerce to establish a plan for global engagement to promote and develop AI standards.
Respondents may provide information on one or more of the topics in this RFI and may elect not to address every topic.
NIST is seeking information to assist in carrying out several of its responsibilities under Sections 4.1, 4.5, and 11 of E.O. 14110. This RFI addresses the specific assignments cited below. Other assignments to NIST in E.O. 14110 related to cybersecurity and privacy, synthetic nucleic acid sequencing, and supporting agencies' implementation of minimum risk-management practices are being addressed separately. Information about NIST's assignments and plans under E.O. 14110, along with further opportunities for public input, may be found here:
In considering information for submission to NIST, respondents are encouraged to review recent guidance documents that NIST has developed with significant public input and feedback, including the NIST AI Risk Management Framework (
Information that is specific and actionable is of special interest, versus general statements about the challenges and needs. Copyright protections of materials, if any, should be clearly noted. Responses which include information generated by means of AI techniques should be identified clearly.
NIST is interested in receiving information pertinent to any or all of the assignments described below.
NIST is seeking information regarding topics related to generative AI risk management, AI evaluation, and red-teaming.
a. E.O. 14110 Sections 4.1(a)(i)(A) and (C) direct NIST to establish guidelines and best practices in order to promote consensus industry standards in the development and deployment of safe, secure, and trustworthy AI systems. Accordingly, NIST is seeking information regarding topics related to this assignment, including:
(1) Developing a companion resource to the AI Risk Management Framework (AI RMF), NIST AI 100-1 (
• Risks and harms of generative AI, including challenges in mapping, measuring, and managing trustworthiness characteristics as defined in the AI RMF, as well as harms related to repression, interference with democratic processes and institutions, gender-based violence, and human rights abuses (see
• Current standards or industry norms or practices for implementing AI RMF core functions for generative AI (govern, map, measure, manage), or gaps in those standards, norms, or practices;
• Recommended changes for AI actors to make to their current governance practices to manage the risks of generative AI;
• The types of professions, skills, and disciplinary expertise organizations need to effectively govern generative AI, and what roles individuals bringing such knowledge could serve;
• Roles that can or should be played by different AI actors for managing risks and harms of generative AI (
• Current techniques and implementations, including their feasibility, validity, fitness for purpose, and scalability, for:
○ Model validation and verification, including AI red-teaming;
○ Human rights impact assessments, ethical assessments, and other tools for identifying impacts of generative AI systems and mitigations for negative impacts;
○ Content authentication, provenance tracking, and synthetic content labeling and detection, as described in Section 2a below; and
○ Measurable and repeatable mechanisms to assess or verify the effectiveness of such techniques and implementations.
• Forms of transparency and documentation (
• Economic and security implications of watermarking, provenance tracking, and other content authentication tools;
• Efficacy, validity, and long-term stability of watermarking techniques and content authentication tools for provenance of materials, including in derivative work;
• Criteria for defining an error, incident, or negative impact;
• Governance policies and technical requirements for tracing and disclosing errors, incidents, or negative impacts;
• The need for greater controls when data are aggregated; and
• The possibility for checks and controls before applications are presented forward for public consumption.
(2) Creating guidance and benchmarks for evaluating and auditing AI capabilities, with a focus on capabilities and limitations through which AI could be used to cause harm. Following is a non-exhaustive list of possible topics that may be addressed in any comments relevant to AI evaluations:
• Definition, types, and design of test environments, scenarios, and tools for evaluating the capabilities, limitations, and safety of AI technologies;
• Availability of, gap analysis of, and proposals for metrics, benchmarks, protocols, and methods for measuring AI systems' functionality, capabilities, limitations, safety, security, privacy, effectiveness, suitability, equity, and trustworthiness. This includes rigorous measurement approaches for risks and impacts such as:
○ Negative effects of system interaction and tool use, including from the capacity to control physical systems or from reliability issues with such capacity or other limitations;
○ Exacerbating chemical, biological, radiological, and nuclear (CBRN) risks;
○ Enhancing or otherwise affecting malign cyber actors' capabilities, such as by aiding vulnerability discovery, exploitation, or operational use;
○ Introduction of biases into data, models, and AI lifecycle practices;
○ Risks arising from AI value chains in which one developer further refines a model developed by another, especially in safety- and rights-affecting systems;
○ Impacts to human and AI teaming performance;
○ Impacts on equity, including such issues as accessibility and human rights; and
○ Impacts to individuals and society; including both positive and negative impacts on safety and rights.
• Generalizability of standards and methods of evaluating AI over time, across sectors, and across use cases;
• Applicability of testing paradigms for AI system functionality, effectiveness, safety, and trustworthiness including security, and transparency, including paradigms for comparing AI systems against each other, baseline system performance, and existing practice, such as:
○ Model benchmarking and testing; and
○ Structured mechanisms for gathering human feedback, including randomized controlled human-subject trials; field testing, A/B testing, AI red-teaming.
b. E.O. 14110 Section 4.1(a)(ii) directs NIST to establish guidelines (except for AI used as a component of a national security system), including appropriate procedures and processes, to enable developers of AI, especially of dual-use foundation models, to conduct AI red-teaming tests to enable deployment of safe, secure, and trustworthy systems. The following is a non-exhaustive list of possible topics that may be addressed in any comments relevant to red-teaming:
• Use cases where AI red-teaming would be most beneficial for AI risk assessment and management;
• Capabilities, limitations, risks, and harms that AI red-teaming can help identify considering possible dependencies such as degree of access to AI systems and relevant data;
• Current red-teaming best practices for AI safety, including identifying threat models and associated limitations or harmful or dangerous capabilities;
• Internal and external review across the different stages of AI life cycle that are needed for effective AI red-teaming;
• Limitations of red-teaming and additional practices that can fill identified gaps;
• Sequence of actions for AI red-teaming exercises and accompanying necessary documentation practices;
• Information sharing best practices for generative AI, including for how to share with external parties for the purpose of AI red-teaming while protecting intellectual property, privacy, and security of an AI system;
• How AI red-teaming can complement other risk identification and evaluation techniques for AI models;
• How to design AI red-teaming exercises for different types of model risks, including specific security risks (
• Guidance on the optimal composition of AI red teams including different backgrounds and varying levels of skill and expertise;
• Economic feasibility of conducting AI red-teaming exercises for small and large organizations; and
• The appropriate unit of analysis for red teaming (models, systems, deployments, etc.)
NIST is seeking information regarding topics related to synthetic content creation, detection, labeling, and auditing.
a. E.O. 14110 Section 4.5(a) directs the Secretary of Commerce to submit a report to the Director of the Office of Management and Budget (OMB) and the Assistant to the President for National Security Affairs identifying existing standards, tools, methods, and practices, along with a description of the potential development of further science-backed standards and techniques for reducing the risk of synthetic content from AI technologies. NIST is seeking information regarding the following topics related to reducing the risk of synthetic content in both closed and open source models that should be included in the Secretary's report, recognizing that the most promising approaches will require multistakeholder input, including scientists and researchers, civil society, and the private sector. Existing tools and the potential development of future tools, measurement methods, best practices, active standards work, exploratory approaches, challenges and gaps are of interest for the following non-exhaustive list of possible topics and use cases of particular interest.
• Authenticating content and tracking its provenance;
• Techniques for labeling synthetic content, such as using watermarking;
• Detecting synthetic content;
• Resilience of techniques for labeling synthetic content to content manipulation;
• Economic feasibility of adopting such techniques for small and large organizations;
• Preventing generative AI from producing child sexual abuse material or producing non-consensual intimate imagery of real individuals (to include intimate digital depictions of the body or body parts of an identifiable individual);
• Ability for malign actors to circumvent such techniques;
• Different risk profiles and considerations for synthetic content for models with widely available model weights;
• Approaches that are applicable across different parts of the AI development and deployment lifecycle (including training data curation and filtering, training processes, fine-tuning incorporating both automated means and human feedback, and model release), at different levels of the AI system (including the model, API, and application level), and in different modes of model deployment (online services, within applications, open-source models, etc.);
• Testing software used for the above purposes; and
• Auditing and maintaining tools for analyzing synthetic content labeling and authentication.
NIST is seeking information regarding topics related to the development and implementation of AI-related consensus standards, cooperation and coordination, and information sharing that should be considered in the design of standards.
a. E.O. 14110 Section 11(b) directs the Secretary of Commerce, within 270 days and in coordination with the Secretary of State and the heads of other relevant agencies, to establish a plan for global engagement on promoting and developing AI consensus standards, cooperation, and coordination, ensuring that such efforts are guided by principles set out in the NIST AI Risk Management Framework (
• AI nomenclature and terminology;
• Best practices regarding data capture, processing, protection, quality, privacy, transparency, confidentiality, handling, and analysis, as well as inclusivity, fairness, accountability, and representativeness (including non-discrimination, representation of lower resourced languages, and the need for data to reflect freedom of expression) in the collection and use of data;
• Examples and typologies of AI systems for which standards would be particularly impactful (
• Best practices for AI model training;
• Guidelines and standards for trustworthiness, verification, and assurance of AI systems;
• AI risk management and governance, including managing potential risk and harms to people, organizations, and ecosystems;
• Human-computer interface design for AI systems;
• Application specific standards (
• Ways to improve the inclusivity of stakeholder representation in the standards development process;
• Suggestions for AI-related standards development activities, including existing processes to contribute to and gaps in the current standards landscape that could be addressed, and including with reference to particular impacts of AI;
• Strategies for driving adoption and implementation of AI-related international standards;
• Potential mechanisms, venues, and partners for promoting international collaboration, coordination, and information sharing on standards development;
• Potential implications of standards for competition and international trade; and
• Ways of tracking and assessing whether international engagements under the plan are having the desired impacts.
Across all these topics, NIST is seeking information about costs and ease of implementation for tools, systems, practices, and the extent to which they will benefit the public if they can be efficiently adopted and utilized.
Office of Marine and Aviation Operations (OMAO), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of availability; request for comments.
The National Oceanic and Atmospheric Administration (NOAA), Office of Marine and Aviation Operations (OMAO) has prepared a draft programmatic environmental
The Draft PEA assesses the direct, indirect, and cumulative environmental impacts from OMAO vessel operations while NOAA ships are underway, during which time OMAO conducts training, testing, calibration, and troubleshooting of vessel equipment and instruments in preparation for use by other NOAA Line Offices (LOs) or organizations outside of NOAA. OMAO's Proposed Action in the Draft PEA would ensure that NOAA's current and future fleet is maintained and operated in a safe, environmentally compliant manner, thus allowing NOAA to fulfill its at-sea mission objectives and data collection requirements in marine, coastal, and freshwater environments. The purpose of this NOA is to invite affected government agencies, non-governmental organizations, tribes and tribal organizations, and interested members of the public to participate in the Draft PEA process and provide comments on the structure, contents, and analysis in the Draft PEA. Publication of this document begins the 40-day public comment period for the Draft PEA.
Written comments on the Draft PEA will be accepted on or before January 31, 2024.
The Draft PEA can be viewed or downloaded from the OMAO website at
•
•
Hannah Staley, Sea Grant Fellow,
The Draft PEA examines the environmental effects of OMAO's operation of NOAA vessels in United States (U.S.) waters, including the oceans from the U.S. baseline, also known as the territorial sea baseline, to the limits of the U.S. Exclusive Economic Zone (EEZ), and the U.S. portions of the Great Lakes. The geographic scope extends to the international maritime boundaries with Canada and Mexico. The PEA also considers OMAO's operations in areas outside of U.S. jurisdiction. Under the Draft PEA's Proposed Action, OMAO would continue to operate, maintain, and manage the NOAA fleet as the existing fleet is updated and aging vessels are replaced with new vessels. Specifically, the Draft PEA focuses its analysis on the environmental impacts of OMAO's vessel operations while NOAA ships are underway (
OMAO has prepared the Draft PEA to analyze the physical, biological, economic, and social impacts to the human environment from OMAO vessel operations over a 15-year timeframe from 2023 to 2038. OMAO notes that almost half of NOAA's ships will exceed their design service life during the timeframe of this Draft PEA; therefore, NOAA needs to invest in modernizing its fleet to maintain fleet capabilities for its primary missions. OMAO supports NOAA's primary missions by operating, managing, and maintaining NOAA's fleet of vessels, vessel equipment, and instruments, and NOAA's Uncrewed Systems Operation Program, of which only Uncrewed Marine Systems (UMS) and Uncrewed Aerial Systems (UAS) deployed directly from NOAA vessels are considered in this Draft PEA. OMAO maintains these vessels, equipment, and systems at mission-readiness levels, facilitating all of NOAA's at-sea and data collection requirements.
OMAO's Draft PEA evaluates three alternatives:
• Alternative A—No Action—Continue Vessel Operations with Current NOAA Fleet: Under Alternative A, OMAO would continue to use the current NOAA fleet to conduct routine vessel operations, in addition to the testing, calibrating, training, and troubleshooting of vessel equipment and instruments, to support NOAA's primary missions and at-sea capabilities. OMAO would operate ships in the NOAA fleet until the end of their service life, and would continue to support projects undertaken by other NOAA Line Offices or organizations outside of NOAA at the current level of activity, for as long as the fleet capacity allows. Additionally, OMAO is constructing two oceanographic research vessels that are expected to come online in 2025, and awarded contracts in July 2023 for two new charting and mapping vessels that are expected to come online in 2027 and 2028 for a total of four new ships. This alternative also analyzes impacts from the additional “greening” techniques that are currently being implemented across the NOAA fleet, which include goals for fuel efficiency and emissions reductions. New ships would be integrated with greener technologies including improvements in wastewater and solid waste management, supplemental power generation, and hull protection; new technologies for data collection; and advancements in ship infrastructure. This alternative reflects the ships, technology, equipment, fleet utilization, scope, and methods currently in use by OMAO.
• Alternative B—Vessel Operations with Fleet Modernization and Optimizing At-Sea Capabilities: This alternative consists of Alternative A plus implementing measures for long-term modernization of the NOAA fleet and fleet management best practices. Fleet modernization is expected to result in a NOAA fleet of similar size to the current fleet, but with new ships coming online as older ships retire, in addition to newer and more efficient technologies and fleet utilization resulting in the capacity to provide more days-at-sea (DAS) than Alternative A. Specific examples of additional measures adopted under Alternative B over the next 15 years would include:
○ Designing and constructing up to four additional ships needed to replace vessels that would reach the end of their design service life between 2023 and 2038 (resulting in a total of 8 new ships when combined with the four new ships being constructed under Alternative A);
○ Extending service life of the existing fleet by conducting material condition assessment surveys and mid-life repairs; and
○ Increasing NOAA fleet utilization, which would provide more DAS compared to Alternative A;
Under Alternative B, all the activities described in Alternative A would continue, many at a higher level of effort. The nature of these actions would not change, but the overall level of activity would be increased.
• Alternative C—Vessel Operations with Fleet Modernization and Optimization with Greater Funding Support: Alternative C includes all the activities and measures described in Alternative B, but with an increase in overall funding of 20 percent relative to Alternative B, resulting in the capacity to provide more DAS. Specific examples of additional measures adopted under Alternative C over the next 15 years would include:
○ Designing and constructing two new ships in addition to the eight new ships that would be added to the NOAA fleet between 2023 and 2038 under Alternative B;
○ Increasing the number of uncrewed systems integrated into new ships that would be added to the NOAA fleet;
○ Shortening the timeframe of fleet improvement activities and the induction of new ships into the fleet;
○ Greening techniques proposed for the new ships would be implemented across the current fleet over a shorter timeframe;
○ Shortening of the timeframe to improve the OMAO small boat fleet; and
• Purchasing or developing technology to enable more efficient scheduling of vessels, equipment, and personnel to maximize crew productivity and enhance overall fleet performance, which would provide more DAS.
Under Alternative C, all the activities described in Alternative B would occur, many at a higher level of effort. The nature of these actions would not change, but the overall level of activity would be increased.
The official public review and comment period ends on January 31, 2024. Please visit the OMAO website for additional information and to access the Draft PEA:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Shannon Atkinson, Ph.D., University of Alaska Fairbanks, 17101 Point Lena Loop Road, Juneau, AK 99801 has applied in due form for a permit to import, export, and receive marine mammal parts for scientific research.
Written comments must be received on or before January 22, 2024.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
Written comments on this application should be submitted via email to
Those individuals requesting a public hearing should submit a written request via email to
Jennifer Skidmore or Erin Markin, Ph.D., (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant proposes to receive, import, and export marine mammal parts from cetaceans and pinnipeds annually for scientific research. Marine mammal parts will not exceed 1,000 animals per year within order Cetacea (dolphins, porpoises, and whales) and 500 animals per year within order Pinnipedia (seals and sea lions, excluding walrus). Secondary to research, marine mammal parts may also be used for educational purposes. Import and export activities would occur world-wide. Sources of samples include U.S. subsistence harvests and stranded animals in foreign countries. Samples may also be obtained within the United States or abroad from animals held in captivity, authorized researchers or collections, and soft or hard parts that sloughed, excreted, or naturally discharged. No live animals would be harassed or taken, lethally or otherwise, under the requested permit. The requested duration of the permit is 5 years.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of new member solicitation for the United States Integrated Ocean Observing System (U.S. IOOS) Advisory Committee.
The National Oceanic and Atmospheric Administration (NOAA) is soliciting applications for membership on the United States Integrated Ocean Observing System Advisory Committee (the Committee), which is a Federal advisory committee. Members of the Committee will fulfill the requirements of the Integrated Coastal and Ocean Observation System (ICOOS) Act of 2009 (the Act). The Committee provides advice to the Under Secretary of Commerce for Oceans and Atmosphere and to the Interagency Ocean Observation Committee on the planning, integrated design, operation, maintenance, enhancement, and expansion of the United States Integrated Ocean Observing System (U.S. IOOS).
Nominations should be submitted no later than January 17, 2024. Applications received after January 17, 2024 may not be considered during this membership application cycle, but may be considered for future membership cycles. Please note the original deadline of January 2, 2024 has been extended to January 17, 2024 to allow more time for application submissions.
Submit an application for Committee membership, including cover letter, resume, and requested items below, to Laura Gewain via Email
Krisa Arzayus, 1315 East-West Highway, Station 2616, Silver Spring, MD 20910; Telephone: 240-533-9455; Email:
U.S. IOOS promotes research to develop, test, and deploy innovations and improvements in coastal and ocean observation technologies and modeling systems, addresses regional and national needs for ocean information, gathers data on key coastal, ocean, and Great Lakes variables and ensures timely and sustained dissemination and availability of these data for societal benefits. U.S. IOOS benefits national safety, the economy, and the environment through support for national defense, marine commerce and forecasting, navigation safety, weather, climate, energy siting and production, economic development, ecosystem-based management of marine and coastal areas, conservation of ocean and coastal resources and public safety.
The Act requires the establishment and administration of this Committee by the Under Secretary of Commerce for Oceans and Atmosphere.
NOAA will hereby accept applications for membership on the Committee to fill ten vacancies that will occur on September 14, 2024. These appointments shall serve for a three-year term, which will end September 13, 2027. An individual so appointed may subsequently be appointed for an additional three-year term. The ICOOS Act states: “Members shall be qualified by education, training, and experience to evaluate scientific and technical information related to the design, operation, maintenance, or use of the [Integrated Ocean Observing] System, or use of data products provided through the System.” NOAA encourages individuals with expertise in Great Lakes; philanthropy; NGO; scientific institutions (Academic); IOOS regional interests; state, local and tribal interests; renewable energy, including offshore wind; blue economy; social science; public-private partnerships; marine technologies industries; data management and architecture; ocean and coastal leadership; and other science-related fields to submit applications for Committee membership. This notice responds to the ICOOS Act of 2009 (Pub. L. 111-11, section 12304), which requires the Under Secretary of Commerce for Oceans and Atmosphere to solicit nominations for Committee membership. The Committee will advise the NOAA Administrator or Interagency Ocean Observation Committee on matters related to the responsibilities and authorities set forth in section 12302 of the ICOOS Act of 2009 and other appropriate matters as the Under Secretary refers to the Committee for review and advice.
The United States Integrated Ocean Observing System Advisory Committee will provide advice on:
(a) administration, operation, management, and maintenance of the Integrated Coastal and Ocean Observation System (the System);
(b) expansion and periodic modernization and upgrade of technology components of the System;
(c) identification of end-user communities, their needs for information provided by the System, and the System's effectiveness in disseminating information to end-user communities and to the general public; and
(d) additional priorities, including—
(1) a national surface current mapping network designed to improve fine scale sea surface mapping using high frequency radar technology and other emerging technologies to address national priorities, including Coast Guard search and rescue operation planning and harmful algal bloom forecasting and detection that—
(i) is comprised of existing high frequency radar and other sea surface current mapping infrastructure operated by national programs and regional coastal observing systems;
(ii) incorporates new high frequency radar assets or other fine scale sea surface mapping technology assets, and other assets needed to fill gaps in coverage on United States coastlines; and
(iii) follows a deployment plan that prioritizes closing gaps in high frequency radar infrastructure in the United States, starting with areas demonstrating significant sea surface current data needs, especially in areas where additional data will improve Coast Guard search and rescue models;
(2) fleet acquisition for unmanned maritime systems for deployment and data integration to fulfill the purposes of this subtitle;
(3) an integrative survey program for application of unmanned maritime systems to the real-time or near real-time collection and transmission of sea floor, water column, and sea surface data on biology, chemistry, geology, physics, and hydrography;
(4) remote sensing and data assimilation to develop new analytical methodologies to assimilate data from the System into hydrodynamic models;
(5) integrated, multi-State monitoring to assess sources, movement, and fate of sediments in coastal regions;
(6) a multi-region marine sound monitoring system to be—
(i) planned in consultation with the IOOC, NOAA, the Department of the Navy, and academic research institutions; and
(ii) developed, installed, and operated in coordination with NOAA, the Department of the Navy, and academic research institutions; and (e) any other purpose identified by the Administrator or the Council.
The Committee's voting members will be appointed by the Under Secretary of Commerce for Oceans and Atmosphere. Members shall be qualified by education, training, and experience to evaluate scientific and technical information related to the design, operation, maintenance, or use of the System, or the use of data products provided through the System. Members are selected on a standardized basis, in accordance with applicable Department of Commerce guidance. Members will be appointed for three-year terms, renewable once. One Committee member will be designated by the Under Secretary as chairperson. Full-time officers or employees of the United States may not be appointed as a voting member. Members will be appointed as special Government employees (SGEs) for purposes of section 202(a) of title 18, United States Code. Members serve at the discretion of the Under Secretary and are subject to government ethics standards. Members of the Committee will not be compensated for service on the Committee, but they may be allowed travel expenses, including per diem in lieu of subsistence, in accordance with subchapter I of chapter 57 of title 5, United States Code.
The Committee will meet at least once each year, and at other times at the call of the Under Secretary, the Interagency Ocean Observation Committee, or the Committee Chairperson. The Committee has approximately fifteen voting members. This solicitation is to obtain candidate applications for up to ten full voting member vacancies.
To apply for membership, applicants must submit the following five items, including a cover letter that responds to the five questions below. The entire package should be a maximum length of eight pages or fewer. NOAA is an equal opportunity employer.
(1) A cover letter that responds to the five questions listed below and serves as a statement of interest to serve on the panel. Please see “Short Response Questions” below.
(2) Highlight the nominee's specific area(s) of expertise relevant to the purpose of the Panel from the list in the
(3) A short biography of 300 to 400 words.
(4) A current resume
(5) The nominee's full name, title, institutional affiliation, mailing address, email, phone, fax and contact information.
Short Response Questions:
(1) List your area(s) of expertise, as listed above.
(2) List the geographic region(s) of the country with which you primarily associate your expertise. This does not need to be the region in which the nominee currently resides.
(3) Describe your leadership or professional experience that you believe will contribute to the effectiveness of this panel.
(4) Describe your familiarity and experience with U.S. IOOS data, products, and services.
(5) Generally describe the breadth and scope of your knowledge of stakeholders, users, or other groups who interact with NOAA or other U.S. IOOS
Upon selection and agreement to serve on the United States Integrated Ocean Observing System Advisory Committee, one becomes a Special Government Employee (SGE) of the United States Government. An SGE is an officer or employee of an agency who is retained, designated, appointed, or employed to perform temporary duties, with or without compensation, for not to exceed 130 days during any period of 365 consecutive days, either on a full-time or intermittent basis. After the membership selection process is complete, applicants who are selected to serve on the Committee must complete the following actions before they can be appointed as a Committee member:
(a) Background Check (on-line Background Check process and fingerprinting conducted through NOAA Office of Human Capital Services); and
(b) Confidential Financial Disclosure Report: As an SGE, one is required to file annually a Confidential Financial Disclosure Report to avoid involvement in a real or apparent conflict of interest. One may find the Confidential Financial Disclosure Report at the following website:
Authority. The collection of information concerning nominations to the IOOS AC is authorized under the FACA, 5 U.S.C. App. and its implementing regulations, 41 CFR part 102-3, and in accordance with the Privacy Act of 1974, as amended, (Privacy Act) 5 U.S.C. 552a.
Purpose. The collection of names, contact information, resumes, professional information, and qualifications is required in order for the Under Secretary to appoint members to the IOOS AC.
Routine Uses. NOAA will use the nomination information for the purpose set forth above. The Privacy Act of 1974 authorizes disclosure of the information collected to NOAA staff for work-related purposes and for other purposes only as set forth in the Privacy Act and for routine uses published in the Privacy Act System of Records Notice COMMERCE/DEPT-11, Candidates for Membership, Members, and Former Members of Department of Commerce Advisory Committees, available at
Disclosure. Furnishing the nomination information is voluntary; however, if the information is not provided, the individual would not be considered for appointment as a member of the IOOS AC.
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
Commodity Futures Trading Commission.
Notice of meeting.
The Commodity Futures Trading Commission (CFTC) announces that on January 8, 2024, from 12:30 p.m. to 4:30 p.m. Eastern Standard Time, the Technology Advisory Committee (TAC or Committee) will hold an in-person public meeting at the CFTC's Washington, DC headquarters with options for the public to attend virtually. At this meeting, the TAC will discuss digital assets and blockchain technology, cybersecurity, and emerging and evolving technologies.
The meeting will be held on January 8, 2024, from 12:30 p.m. to 4:30 p.m. Eastern Standard Time. Please note that the meeting may end early if the TAC has completed its business. Members of the public who wish to submit written statements in connection with the meeting should submit them by January 15, 2024.
The meeting will take place in the Conference Center at the CFTC's headquarters, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581. You may submit public comments, identified by “Technology Advisory Committee,” through the CFTC website at
Anthony Biagioli, TAC Designated Federal Officer, Commodity Futures Trading Commission, 2600 Grand Boulevard, Suite 210, Kansas City, MO 64108; (816) 960-7722; or
The meeting will be open to the public with seating on a first-come, first-served basis. Members of the public may also listen to the meeting by telephone by calling a domestic or international toll or toll-free number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.
Members of the public may also view a live webcast of the meeting via the
After the meeting, a transcript of the meeting will be published through a link on the CFTC's website,
Department of the Air Force, Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by February 20, 2024.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to USAF Information Collections Office, 1800 USAF Pentagon, Suite 4C146, Washington, DC 20330, ATTN: Ms. Mia Day, or call 703-697-4593.
Department of the Army, Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by February 20, 2024.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to United States Army Installation Management Command Headquarters, 2405 Gun Shed Road, Bldg. 2261 JBSA-Fort Sam Houston, TX 78234, ATTN: Mrs. Kelly Frank, or call 210-466-1200.
Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)), Department of Defense (DoD).
30-Day information collection notice.
The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by January 22, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Angela Duncan, (571) 344-1358,
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Ms. Duncan, 571-372-0493,
National Security Agency, Department of Defense (DoD).
Notice of intent.
The National Security Agency hereby gives notice of its intent to grant Kapalya, Inc. a revocable, non-assignable, exclusive, license to practice the following Government-Owned invention as described and claimed United States Patent Serial Number (USPSN), 17/934,216, Security System for Hardening a Digital System Against Malware and Method of Operation.
Anyone wishing to object to the grant of this license has until January 5, 2024 to file written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Written objections are to be filed with the National Security Agency Technology Transfer Program, 9800 Savage Road, Suite 6843, Fort George G. Meade, MD 20755-6843.
Linda L. Burger, Director, Technology Transfer Program, 9800 Savage Road, Suite 6843, Fort George G. Meade, MD 20755-6843, telephone (443) 634-3518.
The prospective exclusive license will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The patent rights in these inventions have been assigned to the United States Government as represented by the National Security Agency.
Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD(A&S)), Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by February 20, 2024.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the OLDCC, 2231 Crystal Drive, Arlington, Virginia, 22202, ATTN: Ms. Michelle Volkema, or call 703-697-2176.
Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD(A&S)), Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by February 20, 2024.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Armed Forces Pest Management Board (AFPMB), Contingency Liaison Office, ATTN: Captain Eric Hoffman, 2460 Linden Lane, Bldg. 172, Silver Spring, MD 20910, or call the AFPMB Contingency Liaison Office at 301-295-7476.
Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)), Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by February 20, 2024.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to DHA, 7700 Arlington Blvd., Falls Church, VA 22042, Amanda Grifka, 703-681-1771.
Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD(A&S)), Department of Defense (DoD).
60-Day information collection notice.
In compliance with the
Consideration will be given to all comments received by February 20, 2024.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to DTRA, 8725 John J. Kingman Road, Stop 6210, Fort Belvoir, VA 22060-6201 Attn: LCDR James D. Franks, USN; or call (800) 462-3683.
Department of Education (ED), Institute of Education Sciences (IES).
Correction notice.
On December 18, 2023, the U.S. Department of Education published a 60-day comment period notice in the
The PRA Coordinator, Strategic Collections and Clearance, Office of the Chief Data Officer, Office of Planning, Evaluation and Policy Development, hereby issues a correction notice as required by the Paperwork Reduction Act of 1995.
Office of Career, Technical, and Adult Education, Department of Education.
Proposed waiver and extension of the project period.
The Secretary proposes to waive the requirements in the Education Department General Administrative Regulations that generally prohibit project periods exceeding five years and project period extensions involving the obligation of additional Federal funds. Under the proposed waiver and extension, for projects funded in fiscal year (FY) 2019 under the Tribally Controlled Postsecondary Career and Technical Institutions Program (TCPCTIP), Assistance Listing Number 84.245A, the project period would be extended through FY 2027, if Congress continues to appropriate funds under the existing program authority.
We must receive your comments on or before January 22, 2024.
Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
•
•
Hugh Reid. Telephone: (202) 245-7491. Email:
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866, 13563, and 14094 and their
Section 117 of the Carl D. Perkins Career and Technical Education Act of 2006 (Pub. L. 115-224) (Perkins V or the Act), authorizes the Secretary to make grants to Tribally controlled postsecondary career and technical institutions that do not receive Federal support under Title I of the Tribally Controlled Colleges and Universities Assistance Act of 1978 (25 U.S.C. 1802,
Current TCPCTIP grantees, selected based on the TCPCTIP notice inviting applications published in the
For these projects, the Secretary proposes to waive the requirements of
Moreover, with the proposed waiver and extension, the Department would not announce a new competition or make new awards until FY 2027, if Congress continues to authorize and appropriate funds under the existing program authority. Instead, current TCPCTIP projects funded under the NIA could be continued at least through the FY 2027 budget and project period, if Congress continues to appropriate funds for TCPCTIP under the existing program authority.
We believe that the proposed waiver and extension is in the public interest, given that the Navajo Technical University and the United Tribes Technical College are the only two eligible entities for the TCPCTIP program, and those entities are the current grantees. Running another competition in which the same entities would receive awards is not an effective use of Department and grantee resources. Further, allowing these grantees to continue their projects would provide continuity in the current projects and resources for the current beneficiaries of the grantees' programs.
If we announce the proposed waiver and extension as final, we will base our decisions regarding annual continuation awards on the program narratives, budgets, budget narratives, and program performance reports, submitted by current grantees, and the requirements in
The proposed extension of the project period and waiver of
The Secretary certifies that the proposed waiver and extension would not have a significant economic impact on a substantial number of small entities.
The only small entities that would be affected by the proposed waiver and extension are the two grantees selected based on the NIA currently receiving Federal funds. These are the only entities eligible to receive a grant under this program.
The Secretary certifies that the proposed waiver and extension would not have a significant economic impact on these entities because the proposed waiver and extension would impose minimal compliance costs to extend projects already in existence, and the activities required to support the additional year or years of funding would not impose additional regulatory burdens or require unnecessary Federal supervision.
The proposed waiver and extension do not contain any information collection requirements.
The TCPCTIP is not subject to Executive Order 12372 and the regulations in
You may also access documents of the Department published in the
Energy Information Administration (EIA), Department of Energy (DOE).
Notice and request for comments.
EIA invites public comment on the proposed three-year extension, with change, of Form EIA-111
EIA must receive all comments on this proposed information collection no later than February 20, 2024. If you anticipate difficulty in submitting comments within that period, contact the person listed in
Written comments may only be sent electronically by email to
Glenn McGrath at (202) 586-4325 or by email at
This information collection request contains:
(1)
(2)
(3)
(4)
(4a)
(5)
(6)
(7)
(8)
Comments are invited on whether or not: (a) The proposed collection of information is necessary for the proper performance of agency functions, including whether the information will have a practical utility; (b) EIA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used, is accurate; (c) EIA can improve the quality, utility, and clarity of the information it will collect; and (d) EIA can minimize the burden of the collection of information on respondents, such as automated collection techniques or other forms of information technology.
Federal Energy Regulatory Commission.
Notice of extension 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 extension to the information collection, FERC-717 (Standards for Business Practices and Communication Protocols for Public Utilities) (OMB Control No. 1902-0173), which will be submitted to the Office of Management and Budget (OMB) for review.
Comments on the collection of information are due [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE
Send written comments on the information collections to OMB through
A copy of the comments should also be sent to the Commission, in Docket No. IC23-14-000 by any of the following methods:
•
•
• Effective July 1, 2020, delivery of filings other than by eFiling or the U.S. Postal Service should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
Jean Sonneman may be reached by email at
Section 205 of the Federal Power Act (FPA) requires that all rates and charges for the transmission or sale of electric energy and all rules and regulations affecting or pertaining to such rates and charges be just and reasonable. Section 206 of the FPA (16 U.S.C. 824e) authorizes FERC to initiate a proceeding to address any “rate, charge or classification” related to the transmission or sale of electricity that the agency determines is “unjust, unreasonable, unduly discriminatory or preferential.”
Commission regulations at 18 CFR 35.28 and 18 CFR part 37 are in accordance with FPA Sections 205 and 206. The regulation at 18 CFR 35.28 applies to any public utility that owns, operates, or controls interstate transmission facilities and any non-public utility seeking voluntary compliance with jurisdictional transmission tariff reciprocity conditions. These entities must offer transmission service on an open and non-discriminatory basis pursuant to a pro forma Open Access Transmission Tariff (OATT).
Part 37 applies to any public utility that owns, operates, or controls facilities used for the transmission of electric energy in interstate commerce and to transactions performed under the pro forma OATT established under 18 CFR 35.28. As stated at 18 CFR 37.2, the purpose of 18 CFR part 37 is to ensure that potential customers of open access transmission service receive access to information that will enable them to obtain transmission service on a non-discriminatory basis from any Transmission Provider.
Regulations at 18 CFR part 37 authorize Transmission Providers to operate an OASIS either individually or jointly with other Transmission Providers. These regulations also provide that a Transmission Provider may delegate this responsibility to a Responsible Party
The collection of information in accordance with FERC-717 is necessary for the implementation of OASIS. The regulation at 18 CFR 37.6 lists the information that Transportation Providers or Responsible Parties must calculate and post on OASIS. Paragraph (a) of section 37.6 provides that the information posted on OASIS must be in such detail and the OASIS must have such capabilities as to allow Transmission Customers
(1) Make requests for transmission services offered by Transmission Providers, Resellers
(2) View and download in standard formats, using standard protocols,
(3) Post, view, upload and download information regarding available products and desired services;
(4) Clearly identify the degree to which transmission service requests or schedules were denied or interrupted;
(5) Obtain access, in electronic format, to information to support available transmission capability calculations and historical transmission service requests and schedules for various audit purposes; and
(6) Make file transfers and automated computer-to-computer file transfers and queries as defined by the Standards and Communications Protocols Document.
The regulation at 18 CFR 37.6(b)(2) provides that information used to calculate any posting of ATC and TTC
On request, the Responsible Party must make all data used to calculate ATC, TTC, Capacity Benefit Margin,
System planning studies, facilities studies, and specific network impact studies performed for customers or the Transmission Provider's own network resources are to be made publicly available in electronic form on request and a list of such studies must be posted on the OASIS. A study is required to be provided only in the electronic format in which it was created, along with any necessary decoding instructions, at a cost limited to the cost of reproducing the material. These studies are to be retained for five years.
Paragraph (b)(3) of 18 CFR 37.6 requires Transmission Providers to calculate and post the ATC, TTC, CBM, and TRM in megawatts for each Posted Path.
The Commission established Standards of Conduct at 18 CFR 37.4 requiring that personnel engaged in transmission system operations function independently from personnel engaged in marketing functions. The Standards of Conduct were designed to prevent employees of a public utility (or any of its affiliates) engaged in marketing functions from preferential access to OASIS-related information or from engaging in unduly discriminatory business practices. Companies were required to separate their transmission operations/reliability functions from their marketing/merchant functions and prevent system operators from providing merchant employees and employees of affiliates with transmission-related information not available to all customers at the same time through public posting on the OASIS.
The information that must be posted at OASIS sites is listed at 18 CFR 37.6. The required postings include business practices, communication protocols, transfer capacity, transmission service products, and prices. Some of the required business practices and communication protocols are incorporated by reference at 18 CFR 38.1(b).
The 60-day notice was published on October 13, 2023 (88 FR 70967) and no comments were received during the comment period.
The estimated annual number of responses for the ongoing information collection activity are adjusted in this information collection request from 162 to 216, an increase of 54 responses. Based on a review of the information collection since our last submission, we have determined this change in number of responses is due to changes in the regulated industry.
The current
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, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) 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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the South Louisiana Project, proposed by Florida Gas Transmission Company, LLC (FGT) in the above-referenced docket. FGT requests to increase its certificated capacity and throughput by 100,000 million British thermal units per day to its shipper, Florida Power & Light Company, to diversify its supply sources of natural gas for downstream customers. FGT would accomplish this by modifying certain compressor stations in St. Landry, East Baton Rouge, and Washington Parishes, Louisiana, and Perry County, Mississippi.
The EA assesses the potential environmental effects of the construction and operation of the South Louisiana Project in accordance with the requirements of the National Environmental Policy Act. The FERC
The proposed South Louisiana Project includes the following facilities:
• uprating two existing natural gas-fired compressor turbine units at FGT's existing Compressor Station 7.5 in St. Landry Parish, Louisiana from 6,500 horsepower (hp) to 7,700 hp, each;
• adding process cooling units to support the existing gas compressor units at FGT's existing Compressor Station 8 in East Baton Rouge Parish, Louisiana;
• installing one new 7,700 hp natural gas-fired turbine compressor unit at FGT's existing Compressor Station 9 in Washington Parish, Louisiana;
• installing one new 15,900 hp natural gas-fired compressor turbine unit at FGT's existing Compressor Station 10 in Perry County, Mississippi; and
• installing and modifying auxiliary facilities as needed at each location.
The Commission mailed a copy of the
The EA is not a decision document. It presents Commission staff's independent analysis of the environmental issues for the Commission to consider when addressing the merits of all issues in this proceeding. Any person wishing to comment on the EA may do so. Your comments should focus on the EA's disclosure and discussion of potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this project, it is important that we receive your comments in Washington, DC on or before 5:00 p.m. Eastern Time on January 16, 2024.
For your convenience, there are three methods you can use to file your comments to the Commission. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the eComment feature on the Commission's website (
(2) You can also file your comments electronically using the eFiling feature on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the Commission. Be sure to reference the project docket number (CP23-492-000) on your letter. Submissions sent via the U.S. Postal Service must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
Filing environmental comments will not give you intervenor status, but you do not need intervenor status to have your comments considered. Only intervenors have the right to seek rehearing or judicial review of the Commission's decision. At this point in this proceeding, the timeframe for filing timely intervention requests has expired. Any person seeking to become a party to the proceeding must file a motion to intervene out-of-time pursuant to Rule 214(b)(3) and (d) of the Commission's Rules of Practice and Procedures (18 CFR 385.214(b)(3) and (d)) and show good cause why the time limitation should be waived. Motions to intervene are more fully described at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Notice is hereby given that, on March 28, 2024, the eXtensible Business Reporting Language (XBRL) taxonomies, validation rules, and rendering files needed to file the FERC Form Nos. 1, 1-F, 2, 2-A, 3-Q electric, 3-Q natural gas,
The draft updated (Version 2024-01-01) taxonomies, validation rules, and rendering files are currently available for download in the eForms portal (
FERC Form filings due after March 28, 2024, must be filed using the Version 2024-04-01 taxonomies, validation rules, and rendering files, including the 2023 FERC Form Nos. 60 and 714
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding. The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes.
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Environmental Protection Agency (EPA).
Notice.
This notice announces that pesticide related information submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), including information that may have been claimed as Confidential Business Information (CBI) by the submitter, will be transferred to RTI International and its subcontractor, ToxStrategies LLC., in accordance with the CBI regulations. RTI International and its subcontractor, ToxStrategies LLC., have been awarded a contract to perform work for OPP, and access to this information will enable RTI International and its subcontractor, ToxStrategies LLC., to fulfill the obligations of the contract.
RTI International and its subcontractor, ToxStrategies LLC., will be given access to this information on or before December 26, 2023.
William Northern, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-1493 email address:
This action applies to the public in general. As such, the Agency has not attempted to describe all the specific entities that may be affected by this action.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2019-0188, is available at
Under Contract No. 68HERC24F0015, RTI International and its subcontractor, ToxStrategies LLC., will manage all aspects of the task order including, but not limited to, the technical, quality assurance, schedule, cost, and communication requirements.
The Contractor shall only work on tasks in the Performance Work Statement as directed by the TOCOR. The TOCOR shall identify specific due dates for deliverables for Tasks 3-4 via technical direction. Technical direction will be provided in writing by the Contracting Officer or the TOCOR as delegated by the Contracting Officer.
The Contractor shall schedule at least biweekly meetings (teleconference, in-person, Skype, Adobe Connect, or other media) with the TOCOR to discuss the status of the work including reporting any issues with respect to schedule slip or cost overruns. The TOCOR will identify, as needed, other individuals who should participate in these calls. Additional teleconference calls may be scheduled by the TOCOR as needed. Note: Telephone or in-person reports are not replacements for required written communications.
In addition to biweekly meetings, the Contractor shall update the TOCOR via telephone (and follow-up via email) and, in writing, via email, of any issues on an ongoing basis.
The Contractor shall immediately inform the TOCOR when any hours or costs for any task has exceeded or is expected to exceed the contractor estimate by >10%.
The Contractor shall immediately inform the TOCOR of any problems that may impact the production, budget, and/or delivery of deliverables.
The Contractor shall provide the combined monthly status report and financial in PDF format, with the financial report also provided in a spreadsheet format such as Excel or CSV.
OPP has determined that access by RTI International and its subcontractor, ToxStrategies LLC., to information on all pesticide chemicals is necessary for the performance of this contract.
Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under FIFRA sections 3, 4, 6, and 7 and under FFDCA sections 408 and 409.
In accordance with the requirements of 40 CFR 2.307(h)(2), the contract with RTI International and its subcontractor, ToxStrategies LLC., prohibits use of the information for any purpose not specified in the contract; prohibits disclosure of the information to a third party without prior written approval from the Agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (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. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
Written PRA comments should be submitted on or before February 20, 2024. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No
The Commission notes that the information sharing framework established in the Second Report and Order allows for access to be granted not only for DIRS, but also to the Commission's Network Outage Reporting System (NORS). We note that the process and requirements for Participating Agencies under this framework is identical, regardless of whether they seek access to NORS, DIRS, or both. Because the Commission anticipates that NORS and DIRS access will be requested together in most cases, it believes that the estimated burden hours and costs for Participating Agencies associated with DIRS access are fully included in the estimates that it has separately submitted as part of its collection on Part 4 of the Commission's Rules Concerning Disruptions to Communications, OMB Control No. 3060-0484. To avoid double-counting the estimated burden hours and costs associated with both collections, the Commission estimates the marginal cost of the Participating Agency aspect of this collection to be zero.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before February 20, 2024. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
In its November 2011
Under this new information collection, the Commission will collect the information, disclosures, and certifications required by sections 1.21001(b) and 54.1014(a) of the Commission's rules from each applicant seeking to participate in a 5G Fund auction, and will use the information, disclosures, and certifications to determine whether an applicant is legally, technically, and financially qualified to participate in a 5G Fund auction. To aid in collecting this information, the Commission has created FCC Form 184, which will be used to provide the information, disclosures, and certifications required by sections 1.21001(b) and 54.1014(a). Commission staff will review the information, disclosures, and certifications collected on FCC Form 184 as part of the pre-auction process, prior to the start of the auction, and determine whether each applicant satisfies the Commission's requirements to participate in an auction for 5G Fund support. Without the information collected on FCC Form 184, the Commission will not be able to determine if an applicant is legally qualified to participate in a 5G Fund auction and has complied with the various applicable regulatory and statutory auction requirements for such participation. This approach provides an appropriate screen to ensure serious participation without being unduly burdensome.
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
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 January 5, 2024.
1.
Board of Governors of the Federal Reserve System.
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Notice.
The No Surprises Act, enacted as part of the Consolidated Appropriations Act, 2021, requires the Secretary of Health and Human Services (HHS), the Secretary of Labor, and the Secretary of the Treasury (the Secretaries) to establish and convene an advisory committee for the purpose of reviewing options to improve the disclosure of charges and fees for ground ambulance services, better inform consumers of insurance options for such services, and protect consumers from balance billing (the “GAPB Advisory Committee” or the “Committee”). The Secretaries established the GAPB Advisory Committee on November 16, 2021 with a standard 2-year expiration period ending November 16, 2023. In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the charter for the Advisory Committee on Ground Ambulance and Patient Billing (GAPB) was renewed effective November 16, 2023.
The charter for the Advisory Committee on GAPB was renewed is November 16, 2023.
Inquiries about the Committee can be mailed to Center for Consumer Information & Insurance Oversight, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop WB-22-75, Baltimore, MD 21244-8016.
Shaheen Halim, CMS, by phone (410) 786-0641 or via email at gapbadvisorycommittee
Press inquiries may be submitted by phone at (202) 690-6145 or via email at
Section 117(a) of the No Surprises Act, enacted as part of the Consolidated Appropriations Act, 2021, div. BB, tit. I, Public Law 116-260 (Dec. 27, 2020), requires the Secretaries of Labor, HHS, and the Treasury to establish and convene an advisory committee for the purpose of reviewing options to improve the disclosure of charges and fees for ground ambulance services, better inform consumers of insurance options for such services, and protect consumers from balance billing. The GAPB Advisory Committee is governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463 (Oct. 6, 1972), as amended, 5 U.S.C. App. 2.
The GAPB Advisory Committee first convened in 2023. It will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the Departments of Labor, Health and Human Services, and the Treasury (the Departments) and relevant States, and the prevention of balance billing to consumers. The recommendations shall address options, best practices, and identified standards to prevent instances of balance billing; steps that can be taken by State legislatures, State insurance regulators, State attorneys general, and other State officials as appropriate, consistent with current legal authorities regarding consumer protection; and legislative options for Congress to prevent balance billing. The purpose of renewing the GAPB Advisory Committee is to provide the Committee with more time to review relevant information, review options and best practices, and consider the recommendations that it has been charged with making. A copy of the charter and other information regarding the GAPB Advisory Committee's activity can be found at:
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Notice with request for comment.
This proposed notice acknowledges the receipt of an application from the Compliance Team (TCT) for continued recognition as a national accrediting organization (AO) for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
To be assured consideration, comments must be received at one of the addresses provided below, by January 22, 2024.
In commenting, refer to file code CMS-3455-PN.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Joy Webb (410) 786-1667.
Shonte Carter (410) 786-3532.
Under the Medicare program, eligible beneficiaries may receive covered services from a Medicare-participating Rural Health Clinic (RHC), provided certain requirements are met. Sections 1861(aa)(1) and (2) and 1905(l)(1) of the Social Security Act (the Act) establish distinct criteria for an entity seeking designation as an RHC. Regulations concerning provider agreements are at 42 CFR part 489, and those pertaining to activities relating to the survey and certification of facilities and other entities are at 42 CFR part 488. The regulations at 42 CFR part 491 specify the conditions that a RHC must meet to participate in the Medicare program.
Generally, to enter into an agreement, a RHC must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 491 of our regulations. Thereafter, the RHC is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements.
However, there is an alternative to surveys by State agencies. Section 1865(a)(1) of the Act provides that if a provider entity demonstrates through accreditation by a Center for Medicare & Medicaid Services (CMS) approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation.
If an AO is recognized by the Secretary of Health and Human Services (the Secretary) as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national AO applying for approval of its accreditation program under 42 CFR part 488, subpart A must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AO are set forth at § 488.4 and 488.5. The regulations at § 488.5(e)(2)(i) require AOs to reapply for continued approval of their accreditation program every 6 years or sooner as determined by CMS.
The Compliance Team's (TCT's) term of approval for their RHC accreditation program expires July 17, 2024.
Section 1865(a)(2) of the Act and our regulations at § 488.5 require that our findings concerning review and approval of a national AO's requirements consider, among other factors, the applying AO's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of TCT's request for continued approval for its RHC accreditation program. This notice also solicits public comment on whether TCT's requirements meet or exceed the Medicare conditions for certification (CfCs) for RHCs.
TCT submitted all the necessary materials to enable us to make a determination concerning its request for continued approval of its RHC accreditation program. This application was determined to be complete on October 25, 2023. Under section 1865(a)(2) of the Act and our regulations at § 488.5 (Application and re-application procedures for national accrediting organizations), our review and evaluation of TCT will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of TCT's standards for RHCs as compared with CMS' RHC CfCs.
• TCT's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.
++ The comparability of TCT's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited RHCs.
++ TCT's processes and procedures for monitoring RHCs found out of compliance with TCT's program requirements. These monitoring procedures are used only when TCT identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at § 488.9(c).
++ TCT's capacity to report deficiencies to the surveyed RHCs and respond to the RHC's plan of correction in a timely manner.
++ TCT's capacity to provide us with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
++ The adequacy of TCT's staff and other resources, and its financial viability.
++ TCT's capacity to adequately fund required surveys.
++ TCT's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.
++ TCT's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys or participate in accreditation decisions.
++ TCT's agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require (including corrective action plans).
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Because of the large number of public comments we normally receive on
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.” This draft guidance provides FDA's current thinking regarding the 510(k) Third Party (3P510k) Review Program and review of Emergency Use Authorizations (EUA) requests by a third party review organizations (3PEUA review). The 3P510k Review Program and 3PEUA review create an alternative process for manufacturers to seek review of 510(k) submissions and EUA requests to assist FDA in reviewing in a timely manner. This draft guidance is not final nor is it for implementation at this time.
Submit either electronic or written comments on the draft guidance by February 20, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-6524.
FDA is announcing the availability of a draft guidance entitled “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.” This draft guidance updates the previously issued “510(k) Third Party Review Program” guidance to further clarify the 3P510k Review Program and outline how FDA may use third party review organizations to review EUA requests under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3) and consistent with section 565(i) of the FD&C Act (21 U.S.C. 360bbb-4(i)).
This draft guidance distinguishes FDA's expectations for the 3P510k Review Program and for 3PEUA review; describes the factors FDA will use in determining device type eligibility for review by 3P510k Review Organizations; describes FDA's expectations for third party organizations when conducting substantial reviews of 510(k) submissions and EUA requests; outlines FDA's process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations; and describes the expectations regarding compensation to third party review organizations. This draft guidance, when final, will also outline FDA's current thinking on leveraging the International Medical Device Regulators Forum's documents for the 3P510k Review Program. When finalized, this guidance will supersede the final guidance entitled “510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” published in the
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LYBALVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory
FDA has approved for marketing the human drug product, LYBALVI (olanzapine and samidorphan), which is indicated for the treatment of:
Subsequent to this approval, the USPTO received patent term restoration applications for LYBALVI (U.S. Patent Nos. 7,262,298; 9,119,848; 9,126,977; 10,300,054; and 10,716,785) from Alkermes Inc. and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 28, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of LYBALVI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for LYBALVI is 4,564 days. Of this time, 4,003 days occurred during the testing phase of the regulatory review period, while 561 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 311 days, 646 days, 1,325 days, 1,328 days, or 5 years of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or 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
Either electronic or written comments on the collection of information must be submitted by February 20, 2024.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Jonna Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
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 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.
The mission of the Office of Prescription Drug Promotion (OPDP) is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated, so that patients and healthcare providers can make informed decisions about treatment options. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission, focusing in particular on three main topic areas: advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and the characteristics of the disease and product impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience. Our focus on research quality aims at maximizing the quality of our research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first topic area, advertising features.
Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage at
Direct-to-consumer (DTC) prescription drug promotion may include truthful and non-misleading claims about the product. A particular claim may be direct (explicit) or indirect (implied or implicit). Some prior
The current project will test the impact of several implied claims in DTC prescription drug advertising on consumer perceptions. The project has two phases: experimental and conjoint analysis. In the experimental phase, participants will view one version of a DTC television ad containing both explicit and one of four implicit product claims of interest or a control ad containing only explicit claims, and be asked their impressions of the product's risks, benefits, and other attributes. In the conjoint analysis phase, we will conduct a best-worst scaling (BWS) experiment to elicit the relative importance of various characteristics of immunotherapies indicated to treat patients with advanced melanoma, including several implied claims. For this study, we will use an object case design, which does not require us to manipulate different levels of the characteristics included in the design. Participants will be shown a series of choice tasks that are each made up of different subsets of an experiment-wide list of characteristics. Each participant will complete several tasks, and will be asked to first select which one they would care about the most if they were considering an immunotherapy, followed by the characteristic they would care about the least.
We are proposing to include 13 characteristics in our BWS experiment. Each task will include only four of those characteristics, the combination of which will be drawn from a balanced incomplete block design (BIBD; see Ref. 3). A BIBD ensures that (1) each task contains the same number of characteristics; (2) each characteristic occurs the same number of times across tasks; and (3) each pair of characteristics is shown to participants the same number of times over the entire experiment. These three properties are desirable for meeting estimation assumptions (
We estimate that participation in the study will take approximately 20 minutes. Adult voluntary participants aged 18 years or older will be recruited by email through an internet panel, and participant eligibility will be determined with a screener at the beginning of the online survey. We will exclude individuals who work in healthcare settings, employees of the Department of Health and Human Services, or individuals who work in the marketing, advertising, or pharmaceutical industries. Half the sample will consist of individuals who self-identify as cancer survivors, excluding survivors of certain nonmelanoma skin cancers.
The target sample size for the experimental phase is 1,030 adults and the target sample size for the conjoint analysis phase is 800 adults. Prior to conducting the main study for both the experimental phase and conjoint analysis phase, we will conduct at least one wave of pretests for each study phase: one before the experimental phase and one before the conjoint analysis phase. If the first pretest wave reveals that changes to the measurement instruments, stimuli, or procedures are required, a second pretest wave (for either the experimental phase, conjoint phase, or both) will be conducted with revised materials. The target sample size for each wave of pretests is 120 adults, split evenly between the experimental and conjoint analysis phases.
FDA estimates the burden of this collection of information as follows:
As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for
The following references are on display with the Dockets Management Staff (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization.” This guidance provides recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2 intended for the prevention or treatment of COVID-19, including addressing the impact of emerging variants. The recommendations focus on the data and information that may be used to support a request for emergency use authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance supersedes the guidance entitled “Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency” issued on February 22, 2021.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see § 10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building,
Maria Clary, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4638, Silver Spring, MD 20993-0002, 240-402-8615.
FDA is announcing the availability of a final guidance for industry entitled “Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization.” This guidance provides recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2 intended for the prevention or treatment of COVID-19. The recommendations focus on the data and information that may be used to support a request for EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3). Specifically, the guidance discusses the manufacturing, pharmacology/toxicology, virologic, and clinical considerations to support EUA.
This guidance supersedes the guidance for industry entitled “Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency,” which was published in February 2021. FDA issued the guidance to communicate its policy for the duration of the COVID-19 public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). In the
Although circumstances have improved, SARS-CoV-2 remains in broad circulation throughout the United States. The virus has and continues to evolve over time, and in certain instances, mutations in the virus have greatly reduced the activity of monoclonal antibody therapies available for the prevention or treatment of COVID-19, resulting in vulnerable populations having limited preventative and therapeutic options. FDA retains the ability to issue an EUA under section 564 of the FD&C Act for products to treat or prevent COVID-19, so the recommendations in this guidance are still pertinent (88 FR 16644). This guidance is intended to remain in effect only for the duration of the declaration by the Secretary of HHS under section 564 of the FD&C Act effective March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic (85 FR 18250). In revising this guidance, FDA considered comments received on the 2021 guidance as well as the Agency's experience issuing COVID-19-related EUAs. In addition, editorial changes were made to improve clarity.
Given the need to ensure that sponsors are aware of our current recommendations to facilitate timely development of monoclonal antibody products targeting SARS-CoV-2, FDA is issuing this guidance for immediate implementation without initially seeking prior comment because the Agency has determined that prior public participation is not feasible or appropriate (see § 10.115(g)(2) and section 701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i))). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices (see § 10.115(g)(3)).
The guidance represents the current thinking of FDA on “Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 314 pertaining to new drug applications have been approved under 0910-0001. The collections of information pertaining to EUA of medical products have been approved under OMB control number 0910-0595.
Persons with access to the internet may obtain the guidance at
Office of Minority Health, Office of the Secretary, U.S. Department of Health and Human Services.
Notice of meeting.
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for the public to attend the meeting, provide comments, and/or distribute printed material(s) to ACMH members. Information about the meeting is available from the designated contact person and will be posted on the HHS Office of Minority Health (OMH) website:
The ACMH meeting will be held on February 13-14, 2024 from 8:30 a.m. to 5:30 p.m. EST each day. If the Committee completes its work before 5:30 p.m., the meeting will adjourn early.
The meeting will be held at the Tower Building at 1101 Wootton Parkway, Lower Level Conference Room, Rockville, Maryland 20852 and will be accessible by webcast. Members of the public must register for the meeting by 5:00 p.m. EST on January 30, 2024. Registered webcast participants will receive webcast access information prior to the meeting.
Violet Woo, Designated Federal Officer,
In accordance with Public Law 105-392, the ACMH was established to provide advice to the Deputy Assistant Secretary for Minority Health on the development of goals and program activities related to OMH's duties. The topic to be discussed during the meeting is the implementation of the anticipated updates to the Office of Management and Budget (OMB) federal race and ethnicity data collection standards. The focus will be on opportunities for supporting community awareness of and engagement in future efforts to implement the revised race and ethnicity data collection standards, anticipated to be published by the OMB no later than Summer 2024. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform efforts related to implementation of the revised OMB standards. Information on OMB's Interagency Technical Working Group on Race and Ethnicity Standards can be found on this website:
The meeting is open to the public. Any individual who wishes to attend the meeting must register by sending an email to
Registered members of the public will have an opportunity to provide comments at the meeting. Public comments will be limited to two minutes per speaker during the time allotted. Individuals of the public may also submit and distribute electronic or printed statements or material(s) related to this meeting's topic. Written comments should not exceed two pages in length. Individuals planning to submit material should email the material to
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Literature Selection Technical Review Committee.
The meeting will be open to the public as indicated below. Individuals who plan to attend as well as those who need special assistance, such as sign language interpretation or other reasonable accommodations, must notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
The meeting is devoted to the review and evaluation of journals for potential indexing by the National Library of Medicine and will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), title 5 U.S.C., as amended. Premature disclosure of the titles of the journals as potential titles to be indexed by the National Library of Medicine, the discussions, and the presence of individuals associated with these publications could significantly frustrate the review and evaluation of individual journals.
In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice at least 10 days in advance of the meeting.
Information is also available on the Institute's/Center's home page:
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Regents of the National Library of Medicine.
The meeting will be open to the public as indicated below. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any member of the public may submit written comments no later than 15 days in advance of the meeting. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting.
The meeting will be open to the public as indicated below. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the National Library of Medicine, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any member of the public may submit written comments no later than 15 days in advance of the meeting. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Open sessions will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
Notice is hereby given of a change in the meeting of the National Advisory Council for Biomedical Imaging and Bioengineering, January 23, 2024, 12 p.m. to January 23, 2024, 04 p.m., National Institutes of Health, Democracy II, 6707 Democracy Boulevard, Bethesda, MD 20892 which was published in the
There is a time change for the National Advisory Council for Biomedical Imaging and Bioengineering meeting on January 23, 2024. The Open Session of the Council meeting will begin at 11:00 a.m. and conclude at 2:00 p.m. on January 23, 2024. The meeting is partially Closed to the public.
Federal Emergency Management Agency, Department of Homeland Security.
30-Day notice of revision and request for comments.
The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, this notice seeks comments concerning the information collected as required for Fire Management Assistance Grant Program (FMAGP) eligibility determinations, grants management, and compliance with other Federal laws and regulations.
Comments must be submitted on or before January 22, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Antonio Jones, FMAG Program Manager, at (540) 326-1928 or
The information collected is required for Fire Management Assistance Grant
This proposed information collection previously published in the
The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance.
Comments may be submitted as indicated in the
Bureau of Land Management, Interior.
Notice of realty action.
The Bureau of Land Management (BLM) is proposing a noncompetitive (direct) sale of 7.55 acres of public land in Eagle County, Colorado, to Sweetwater Rydev LLC, to resolve an inadvertent unauthorized use of public lands. The sale will be subject to the applicable provisions of the Federal Land Policy and Management Act of 1976 (FLPMA) and BLM land sale regulations. The proponent would purchase the parcel for the appraised fair market value of the land, which is $24,000.
Interested parties may submit written comments regarding this direct sale by February 5, 2024.
Mail written comments to Larry W. Sandoval Jr., BLM Field Manager, Colorado River Valley Field Office, 2300 River Frontage Road, Silt, CO 81652, or by email to
Jill Bogdanovich, Realty Specialist, BLM, Colorado River Valley Field Office, phone (970) 876-9024, or by email at
The BLM will consider the direct sale in accordance with Section 203 of FLPMA for the following public lands:
The area described contains 7.55 acres, according to the official plat of the survey of the said land, on file with the BLM.
The proposed sale is in conformance with the BLM Colorado River Valley Field Office Record of Decision and Approved Resource Management Plan decision LRT-MA-10 (page 108) approved in June 2015. A parcel-specific Environmental Assessment (EA), document number DOI-BLM-CO-N040-2018-0009-EA, was prepared in connection with this realty action. It can be viewed online at
Pursuant to the requirements of 43 CFR 2711.1-2(d), publication of this notice in the
The patent, if issued, will be subject to the following terms, covenants, conditions, and reservations:
1. A mineral reservation to the United States for all minerals;
2. A reservation to the United States for ditches and canals constructed by authority of the United States under the Act of August 30, 1890;
3. Valid existing rights issued prior to conveyance;
4. An appropriate indemnification clause protecting the United States from claims arising out of the patentee's use, occupancy, or operations on the patented lands;
5. Additional terms and conditions that the authorized officer deems appropriate.
The EA, appraisal, maps, and Environmental Site Assessment are available for review (see the
The BLM Colorado State Director will review any adverse comments regarding this direct sale and may sustain, vacate, or modify this realty action, in whole or in part. In the absence of timely objections, this realty action will become the final determination of the Department of the Interior. In addition to the publication in the
Before including your address, phone number, email address, or other personal identifying information in your comments, the BLM will make your entire comment—including your personal identifying information—publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Notice is hereby given that, on December 1, 2023, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also during GFY 2022, Adsys Controls, Inc., Irvine, CA; AimLock, Littleton, CO; Alion Science and Technology, McLean, VA; Ametek | Spectro Scientific, Chelmsford, MA; AVL Powertrain Engineering, Inc., Plymouth, MI; BlackHorse Solutions, Inc., Herndon, VA; Brenner Tank Services LLC, Fond du Lac, WI; Brighton Cromwell, LLC, Randolph, NJ; Buffalo Armory LLC, Buffalo, NY; CertTech LLC, Saginaw, MI; Chase Defense Partners, Hampton, VA; Cherokee Nation Aerospace & Defense, Tulsa, OK; Compusult Systems Inc., Chantilly, Virginia; ContiTech USA, Inc. (Formerly Veyance Technologies, Inc.), St Marys, OH; CoorsTek Incorporated, Golden, CO; Czero, Inc., Fort Collins, CO; Embedded Systems Inc dba ESI Motion, Simi Valley, CA; EndoSec LLC, Washington, DC; Florida Institute for Human and Machine Cognition, Inc. (IHMC), Pensacola, FL; Galvion Ltd, Portsmouth, NH; Gravikor, Inc., Ann Arbor, MI; IERUS Technologies, Inc., Huntsville, AL; Island City Engineering LLC, Merrill, WI; iXblue Defense Systems, Inc., Natick, MA; John H. Northrop & Associates, Inc., Alexandria, VA; Kaman Precision Products (div of Kaman Aerospace Corp), Middletown, CT; Kevin Diaz, Niceville, FL; Kopis Mobile, Flowood, MS; L3 Technologies, Inc. (Communication Systems-East), Camden, NJ; LiquidPiston, Inc., Bloomfield, CT; Lynntech, Inc., College Station, TX; Maynard Steel Casting Company, Milwaukee, WI; Military Systems Group, Inc., Nashville, TN; Mission Secure, Inc., Charlottesville, VA; Nahsai, LLC, Ann Arbor, MI;
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and NAMC intends to file additional written notifications disclosing all changes in membership.
On October 15, 2009, NAMC filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on October 17, 2022. A notice was published in the
On July 12, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Joeseph Potter, D.D.S. (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 2, at 1, 3. The OSC proposed the revocation of Registrant's Certificate of Registration No. FP7517456 at the registered address of 3145 Larimer Street, Denver, Colorado 80205.
The OSC notified Registrant of his right to file with DEA a written request for hearing, and that if he failed to file such a request, he would be deemed to have waived his right to a hearing and be in default.
Further, “[i]n the event that a registrant . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] § 1316.67.”
The Agency finds that, in light of Registrant's default, the factual allegations in the OSC are admitted. According to the OSC, the Colorado Dental Board issued an Order of Suspension, effective October 12, 2022, suspending Registrant from the practice of dentistry in the state of Colorado. RFAAX 2, at 2. According to Colorado online records, of which the Agency takes official notice, Registrant's Colorado dental license remains suspended.”
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under 21 U.S.C. 823 “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration.
According to Colorado statute, “[e]very person who manufactures, distributes, or dispenses any controlled substance within this state . . . shall obtain . . . a registration, issued by the respective licensing board . . . . For purposes of this section and this article [ ], `registration' or `registered' means . . . the licensing of dentists by the Colorado dental board . . . .” Colo. Rev. Stat. 18-18-302(1) (2023).
Here, the undisputed evidence in the record is that Registrant lacks authority to practice dentistry in Colorado. As discussed above, a dentist must be a licensed practitioner to dispense a controlled substance in Colorado. Thus, because Registrant lacks authority to practice dentistry in Colorado and, therefore, is not authorized to handle controlled substances in Colorado, Registrant is not eligible to maintain a DEA registration. Accordingly, the Agency will order that Registrant's DEA registration be revoked.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FP7517456 issued to Joeseph Potter, D.D.S. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Joeseph Potter, D.D.S, to renew or modify this registration, as well as any other pending application of Joeseph Potter, D.D.S., for additional registration in Colorado. This Order is effective January 22, 2024.
This document of the Drug Enforcement Administration was signed on December 12, 2023, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
On July 14, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Mark R. Young, M.D. (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 2, at 1, 3. The OSC proposed the revocation of Registrant's Certificate of Registration No. BY9053240 at the registered address of 401 23rd Street Suite 207, Glenwood Springs, Colorado 81601.
The OSC notified Registrant of his right to file with DEA a written request for hearing, and that if he failed to file such a request, he would be deemed to have waived his right to a hearing and be in default.
Further, “[i]n the event that a registrant . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] § 1316.67.”
The Agency finds that, in light of Registrant's default, the factual allegations in the OSC are admitted. According to the OSC, the Colorado Medical Board issued an Order of Suspension, effective April 20, 2023, suspending Registrant from the practice of medicine in the state of Colorado. RFAAX 2, at 2. According to Colorado online records, of which the Agency takes official notice, Registrant's Colorado physician license remains suspended.”
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under 21 U.S.C. 823 “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration.
According to Colorado statute, “[e]very person who manufactures, distributes, or dispenses any controlled substance within this state . . . shall obtain . . . a registration, issued by the respective licensing board . . . . For purposes of this section and this article [ ], `registration' or `registered' means . . . the licensing of physicians by the Colorado medical board . . . .” Colo. Rev. Stat. 18-18-302(1) (2023).
Here, the undisputed evidence in the record is that Registrant lacks authority to practice medicine in Colorado. As discussed above, a physician must be a licensed practitioner to dispense a controlled substance in Colorado. Thus, because Registrant lacks authority to practice medicine in Colorado and, therefore, is not authorized to handle controlled substances in Colorado, Registrant is not eligible to maintain a DEA registration. Accordingly, the Agency will order that Registrant's DEA registration be revoked.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. BY9053240 issued to Mark Young, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Mark Young, M.D., to renew or modify this registration, as well as any other pending application of Mark Young, M.D., for additional registration in Colorado. This Order is effective January 22, 2024.
This document of the Drug Enforcement Administration was signed on December 12, 2023, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
On June 6, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Frank A. Hooper, D.V.M. (Respondent). OSC, at 1, 3. The OSC proposed the revocation of Respondent's DEA Certificate of Registration No. BH4810518 at the registered address of 100B Old Woodruff Road, POB 123, Greer, South Carolina 29651.
On July 19, 2023, Respondent requested a hearing. On July 27, 2023, the Government filed a Motion for Summary Disposition, to which Respondent did not respond. On August 14, 2023, the Chief Administrative Law Judge (Chief ALJ) granted the Government's Motion for Summary Disposition and recommended the revocation of Respondent's registration, finding that because Respondent lacks state authority to handle controlled substances in South Carolina, the state in which he is registered with DEA, “there is no other fact of consequence for this tribunal to decide.” Order Granting the Government's Motion for Summary Disposition and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (RD), at 5. Respondent did not file exceptions to the RD.
Having reviewed the entire record, the Agency adopts and hereby incorporates by reference the entirety of the Chief ALJ's rulings, findings of fact, conclusions of law, and recommended sanction as found in the RD and summarizes and expands upon portions thereof herein.
On February 21, 2023, the South Carolina State Board of Veterinary Medical Examiners issued an Order of Temporary Suspension that suspended Respondent's South Carolina veterinary license. RD, at 4.
According to South Carolina online records, of which the Agency takes official notice, Respondent's South Carolina veterinary license remains suspended.
Accordingly, the Agency finds that Respondent is not currently licensed to engage in veterinary practice nor to handle controlled substances in South Carolina, the state in which he is registered with the DEA.
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the CSA “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration.
According to South Carolina statute, “[e]very person who manufactures, distributes, or dispenses any controlled substance or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance, shall obtain a registration issued by the [Department of Health and Environmental Control] in accordance with its rules and regulations.” S.C. Code 44-53-290(a) (2023). Further, “dispense” means “to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for the delivery.”
Here, the undisputed evidence in the record is that Respondent currently lacks authority to dispense controlled substances in South Carolina because his South Carolina controlled substance registration has been cancelled. As discussed above, an individual must hold a controlled substance registration to dispense a controlled substance in South Carolina. Thus, because Respondent lacks authority to handle controlled substances in South Carolina, Respondent is not eligible to maintain a DEA registration. RD, at 5. Accordingly, the Agency will order that Respondent's DEA registration be revoked.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. BH4810518 issued to Frank A. Hooper, D.V.M. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Frank A. Hooper, D.V.M., to renew or modify this registration, as well as any other pending application of Frank A. Hooper, D.V.M., for additional registration in South Carolina. This Order is effective January 22, 2024.
This document of the Drug Enforcement Administration was signed on December 12, 2023, by Administrator
Drug Enforcement Administration, Department of Justice.
60-Day notice.
The Drug Enforcement Administration, Department of Justice (DOJ), 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.
Comments are encouraged and will be accepted for 60 days until February 20, 2024.
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 Scott A Brinks, Regulatory Drafting and Policy Support Section, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3261; Email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
7.
If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.
On November 1, 2023, the Department of Justice lodged two proposed consent decrees with the United States District Court for the District of Oregon in the lawsuit entitled
On December 11, 2023, Plaintiffs in the above-captioned settlement received a request to extend the comment period by an additional forty-five (45) days. After considering this request, Plaintiffs have decided to extend the original comment period by an additional thirty (30) days. This extension provides a total comment period of seventy-five (75) days, through and including January 28, 2024.
Comments on the proposed Consent Decrees 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 Consent Decrees may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $45.25 (without attachments) or $631.25 (with attachments) (25 cents per page reproduction cost) payable to the United States Treasury.
Drug Enforcement Administration, Department of Justice.
60-Day notice.
The Drug Enforcement Administration, Department of Justice (DOJ), 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.
Comments are encouraged and will be accepted for 60 days until February 20, 2024.
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 Scott A Brinks, Regulatory Drafting and Policy Support Section, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3261; Email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
7.
If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.
Request for public comments.
The Department of Labor's (DOL) Veterans' Employment and Training Service (VETS) is soliciting comments concerning a proposed authority to conduct the information collection request (ICR) titled, “Employment Navigator Data Collection and Matching.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
All comments must be received on or before February 20, 2024.
A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained at no cost by contacting Serge King by telephone at 202.693.2982 (this is not a toll-free number), or by email at
Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Veterans' Employment and Training Service, Transition Assistance Program, 200 Constitution Ave NW, Room S1212, Washington DC 20210; or by email:
Contact Serge King by telephone at 202.693.2982 (this is not a toll-free number) or by email at
DOL, as part of continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.
DOL seeks approval of a new information collection request (ICR) titled “Employment Navigator Data Collection and Matching”. This request is for a “common forms” clearance process. There are three forms included in this ICR. The first form is a data collection mechanism for transitioning service members to provide general characteristics and background information as services are received from Employment Navigators. The second form includes additional data that is captured from government and non-government partners who will provide the service member, veteran, or spouse addition job seeker assistance after Employment Navigator data entry is complete. This form also includes any employment-related outcomes (
Interested parties are encouraged to provide comments to the contact shown in the
Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.
DOL is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, (
National Endowment for the Humanities; National Foundation on the Arts and the Humanities.
Notice of meeting.
The National Endowment for the Humanities (NEH) will hold two meetings of the Humanities Panel, a federal advisory committee, during January 2024. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and the Humanities Act of 1965.
See
Elizabeth Voyatzis, Committee Management Officer, 400 7th Street SW, Room 4060, Washington, DC 20506; (202) 606-8322;
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. 10), notice is hereby given of the following meetings:
This meeting will discuss applications on the topics of History, International Relations, and Law, for the Kluge Fellowships grant program, submitted to the Library of Congress.
This meeting will discuss applications on the topics of Arts, Literature, Media, and Communication, for the Kluge Fellowships grant program, submitted to the Library of Congress.
Because these meetings will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, the meetings will be closed to the public pursuant to sections 552b(c)(4) and 552b(c)(6) of title 5, U.S.C., as amended. I have made this determination pursuant to the authority granted me by the Chair's Delegation of Authority to Close Advisory Committee Meetings dated April 15, 2016.
National Science Foundation (NSF).
Notice and request for comments.
The National Science Foundation (NSF) is announcing plans to renew this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, NSF is providing the opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection.
Written comments on this notice must be received by February 20, 2024, to be assured consideration. Comments received after that date will be considered to the extent practicable. Send comments to the address below.
Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Suite E7465, Alexandria, Virginia 22314; telephone (703) 292-7556; or send email to
The INCLUDES initiative is supported by NSF's Eddie Bernice Johnson INCLUDES Coordination Hub (INCLUDES Coordination Hub;
NSF is requesting OMB approval for the INCLUDES Coordination Hub to collect information from members of the INCLUDES National Network.
Please submit one copy of your comments by only one method. All submissions received must include the agency name and collection name identified above for this information collection. Commenters are strongly encouraged to transmit their comments electronically via email. Comments, including any personal information provided become a matter of public record. They will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request.
National Science Foundation.
Notice.
The National Science Foundation (NSF) is announcing plans to renew this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing the opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection for no longer than 3 years.
Written comments on this notice must be received by February 20, 2024 to be assured consideration. Comments received after that date will be considered to the extent practicable. Send comments to address below.
Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Suite E7465, Alexandria, Virginia 22314; telephone (703) 292-7556; or send email to
Previously, NRT awardees provided NSF with information on their activities through periodic research performance progress reports. The NRT monitoring system (also referred to as the NRT reporting system) has replaced these reports with a tailored program monitoring system that uses internet-based information and communication technologies to collect, review, and validate specific data on NRT awards. EDU is committed to ensuring the efficiency and effectiveness with which respondents provide and NSF staff can access and analyze data on funded projects within the NRT programs.
The NRT monitoring system includes subsets of questions aimed at the different project participants (
Since this collection will primarily be used for accountability and evaluation purposes, including responding to queries from COVs and other scientific experts, a census, rather than sampling design, typically is necessary. At the individual project level, funding can be adjusted based on individual project's responses to some of the surveys. Some data collected under this collection will serve as baseline data for separate research and evaluation studies.
NSF-funded contract or grantee researchers and internal or external evaluators in part may identify control, comparison, or treatment groups for NSF's education and training portfolio using some of the descriptive data gathered through this collection to conduct well-designed, rigorous research and portfolio evaluation studies.
Nuclear Regulatory Commission.
Renewal of existing information collection; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, “Criteria and Procedures for Emergency Access to Non-Federal and Regional Low-Level Waste Disposal Facilities.”
Submit comments by February 20, 2024. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
David C. Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2023-0149 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
•
•
•
•
The NRC encourages electronic comment submission through the Federal rulemaking website (
The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized below.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
The NRC is seeking comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? Please explain your answer.
2. Is the estimate of the burden of the information collection accurate? Please explain your answer.
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Proposed information collection; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on this proposed information collection. The information collection is entitled, NRC Form 833, “Form to Propose a Generic Issue (GI).”
Submit comments by February 20, 2024. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2023-0083 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
•
•
•
•
The NRC encourages electronic comment submission through the Federal rulemaking website (
The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized below.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
The NRC is seeking comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? Please explain your answer.
2. Is the estimate of the burden of the information collection accurate? Please explain your answer.
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the Market Dominant or the Competitive product list, or the modification of an existing product currently appearing on the Market Dominant or the Competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
1.
2.
3.
This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 12, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 12, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 15, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 12, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 15, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 12, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 11, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 11, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 15, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 12, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 14, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 12, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 14, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 12, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 14, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2023, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 11, 2023, it filed with the Postal Regulatory Commission a
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 489 (17 CFR 230.489) under the Securities Act of 1933 (15 U.S.C. 77a
The Commission received an average of 25 Form F-N filings per year over the last three years (2020-2022). The Commission has previously estimated that the total annual burden associated with information collection and Form F-N preparation and submission is one hour per filing. Based on the Commission's experience with disclosure documents generally, the Commission continues to believe that this estimate is appropriate. Thus the estimated total annual burden for rule 489 and Form F-N is 25 hours.
Estimates of the average burden hours are made solely for the purposes of the Paperwork Reduction Act and are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules and forms. Compliance with the collection of information requirements of rule 489 and Form F-N is mandatory to obtain the benefit of the exemption. Responses to the collection of information will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below.
Section 19(a) (15 U.S.C. 80a-19(a)) of the Investment Company Act of 1940 (the “Act”) (15 U.S.C. 80a) makes it unlawful for any registered investment company to pay any dividend or similar distribution from any source other than the company's net income, unless the payment is accompanied by a written statement to the company's shareholders which adequately discloses the sources of the payment. Section 19(a) authorizes the Commission to prescribe the form of such statement by rule.
Rule 19a-1 (17 CFR 270. 19a-1) under the Act, entitled “Written Statement to Accompany Dividend Payments by Management Companies,” sets forth specific requirements for the information that must be included in statements made pursuant to section 19(a) by or on behalf of management companies.
The purpose of rule 19a-1 is to afford fund shareholders adequate disclosure of the sources from which distribution payments are made. The rule is intended to prevent shareholders from confusing income dividends with distributions made from capital sources. Absent rule 19a-1, shareholders might receive a false impression of fund gains.
Based on a review of filings made with the Commission, the staff estimates that approximately 12,900 series of registered investment companies that are management companies may be subject to rule 19a-1 each year,
The staff estimates that approximately one-third of the total annual burden (8,600 hours) would be incurred by a paralegal with an average hourly wage rate of approximately $253 per hour,
To comply with state law, many investment companies already must distinguish the different sources from which a shareholder distribution is paid and disclose that information to shareholders. Thus, many investment companies would be required to distinguish the sources of shareholder dividends whether or not the Commission required them to do so under rule 19a-1.
These estimates are made solely for the purposes of the Paperwork Reduction Act, and are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules. Compliance with the collection of information required by rule 19a-1 is mandatory for management companies that make statements to shareholders pursuant to section 19(a) of the Act. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view background documentation for this information collection at the following website:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend IM-7150-1 and Rule 7250 (Quote Mitigation). The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to modernize and improve the operation of the rules. Specifically, the Exchange is proposing to amend: (1) IM-7150-1 to remove certain language to provide better consistency with the surveillance the Financial Industry Regulatory Authority, Inc. (“FINRA”) currently provides for the Exchange; and (2) Rule 7250 (Quote Mitigation) to update and clarify the quote mitigation process used by the Exchange. The Exchange is proposing to make such changes in response to requests from Exchange Regulation Staff in an effort to improve the efficacy of the Exchange's existing regulatory framework.
IM-7150-1 (a) currently provides that: “it shall be considered conduct inconsistent with just and equitable principles of trade for any Initiating Participant to engage in a pattern of conduct where the Initiating Participant submits Primary Improvement Orders into the PIP process for two (2) contracts or less for the purpose of manipulating the PIP process in order to gain a higher allocation percentage than the Initiating Participant would have otherwise received in accordance with the allocation procedures set forth in Rule 7150.”
FINRA currently provides surveillance for this requirement for the Exchange and other options exchanges. FINRA's surveillance program monitors for manipulative activity by a market participant and includes surveillance designed to detect activity where an Initiating Participant submits Primary Improvement Orders into the PIP process for four (4) contracts or less for the purpose of manipulating the PIP process in order to gain a higher allocation percentage than the Initiating Participant would have otherwise received. Even though IM-7150-1 as written, notates that a pattern of orders for two (2) contracts may indicate manipulation of the PIP Process, FINRA has identified the potential for manipulation for orders greater than two (2) contracts and expanded such surveillance accordingly. For example, unbundling an order for 50 contracts into four (4) lots may have the same effect as unbundling the order for two (2) contracts.
BOX Rule 7250 currently states that: “in order to control the number of quotations the Exchange disseminates, the Exchange shall utilize a mechanism so that newly-received quotations and other changes to the Exchange's best bid and offer are not disseminated for a period of up to, but not more than one second.”
BOX's Quote Mitigation mechanism was originally adopted over fifteen years ago as a response to the implementation of the Penny Pilot Program
Through internal review, the Exchange found that, while this mechanism and functionality still exists on the Exchange, it is not always necessary. The Exchange is proposing to amend the rule to replace the “shall” with “may” and instead provide that “the Exchange may utilize a mechanism so that newly-received quotations and other changes to the Exchange's best bid and offer are not disseminated for a period of up to, but not more than one second.” This proposed amendment will modernize the Rule by still allowing the Exchange to control the number of quotations that the Exchange disseminates using the aforementioned mechanism if the need arises but will enable the Exchange to rely on other methods within the overall BOX quote mitigation strategy. For example, BOX actively monitors the quotation activity of its Market Makers. When the Exchange detects that a Market Maker is disseminating an unusual number of quotes, the Exchange contacts that Market Maker and alerts it to such activity. Such monitoring frequently reveals that the Market Maker may have internal system issues or has incorrectly set system parameters that were not immediately apparent. Alerting a Market Maker to possible excessive quoting usually leads the market maker to take steps to reduce the number of its quotes. BOX also has a policy of withdrawing approval of underlying securities with low trading volume, thereby eliminating the quotation traffic attendant to such listings.
The Exchange believes that the rule, as written, is outdated and while the Exchange still has the ability to utilize the quote mitigation mechanism, it is not always necessary to do so. The Exchange believes this proposed change will better align Rule 7250 with current Exchange practices and provide greater efficacy and flexibility to the current quote mitigation strategies in place at the Exchange.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,
Specifically, the Exchange believes that the proposed amendment to IM-7150-1 to remove the language that limits the prohibition for any Initiating Participant to engage in a pattern of conduct where the Initiating Participant submits Primary Improvement Orders into the PIP process for the purpose of manipulating the PIP process to only cover Primary Improvement Orders of two (2) contracts or less will help protect investors and the public interest by allowing greater protection against manipulative behaviors. Although the Rule currently covers orders of two (2) contracts or less, FINRA currently surveils and reviews the submission of four (4) contracts or less for the Exchange. Even though IM-7150-1 as written, notates that a pattern of orders for two (2) contracts may indicate manipulation of the PIP Process, FINRA has identified the potential for manipulation for orders greater than two (2) contracts and now the Exchange seeks to expand the rule language accordingly. This proposed amendment to remove the two (2) contracts or less limitation from IM-7150-1 is designed to promote just and equitable principles of trade, remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general protect investors and the public interest, by aligning the Rule to current surveillance practices and allowing FINRA to prosecute and deter manipulative behavior in violation of this Rule relating to three (3) or four (4) contracts on behalf of the Exchange more effectively. The Exchange believes that the removal of the two (2) contracts or less language would improve the efficacy of FINRA's surveillance by helping FINRA and the Exchange prosecute and deter manipulative behavior in situations where the Initiating Participant submits Primary
The Exchange believes that amending BOX Rule 7250 to provide that the Exchange may utilize a mechanism so that newly-received quotations and other changes to the Exchange's best bid and offer are not disseminated for a period of up to, but not more than one second, will allow the Exchange to control the number of quotations that the Exchange disseminates through the use of the aforementioned mechanism but will enable the Exchange to rely on other methods within the overall BOX quote mitigation strategy, such as monitoring and delisting. The Exchange believes that the current rule, as written, is outdated and while the Exchange still has the ability to utilize the quote mitigation mechanism, it is not always necessary to do so. The Exchange believes this proposed change will better align the Rule with current Exchange practices, provide greater efficacy and flexibility to the current quote mitigation strategies in place at the Exchange, and make the Rule clearer for Participants. As such, the Exchange believes the proposed rule change is in the public interest, and therefore, consistent with the Act.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed change will not impose a burden on intermarket or intramarket competition. While the Exchange does not believe that the proposed non-controversial change is a burden on competition, or is competitive in nature, the Exchange believes that proposed updates seek to modernize and improve the operation of the rules.
The proposed amendment to IM-7150-1 is designed to help the Exchange and FINRA more effectively prosecute and deter manipulative behavior in violation of this Rule relating to three (3) or four (4) contracts. This rule change is being proposed to help deter manipulative behaviors on the Exchange and is not intended to address competitive issues. The proposed change to Rule 7250 is intended to modernize and help optimize the quotation mitigation practices on the Exchange and is not intended to address competitive issues. The proposed changes to IM-7150-1 and Rule 7250 will apply equally to all market participants.
For the foregoing reasons, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has neither solicited nor received comments on the proposed rule change.
Pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act normally does not become operative for 30 days after the date of its filing. However, Rule 19b-4(f)(6)(iii)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (“Commission”) has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information described below.
Section 2(a)(41) of the Investment Company Act of 1940 (“Investment Company Act”)
Rule 2a-5 provides requirements for determining in good faith the fair value of the investments of a registered investment company or companies that have elected to be treated as business development companies under the Investment Company Act (“BDCs” and, collectively, “funds”) for purposes of section 2(a)(41) of the Investment Company Act and rule 2a-4 thereunder.
To facilitate the board's oversight, the rule also includes certain reporting and other requirements in the case of designation to a valuation designee.
Specifically, on a periodic basis, the valuation designee must provide to the board:
• Quarterly Reports.
At least quarterly, in writing, (1) any reports or materials requested by the board related to the fair value of designated investments or the valuation designee's process for fair valuing fund investments and (2) a summary or description of material fair value matters that occurred in the prior quarter. This summary or description must include (1) any material changes in the assessment and management of valuation risks, including any material changes in conflicts of interest of the valuation designee (and any other service provider), (2) any material changes to, or material deviations from, the fair value methodologies, and (3) any material changes to the valuation designee's process for selecting and overseeing pricing services, as well as any material events related to the valuation designee's oversight of pricing services.
• Annual Reports.
At least annually, in writing, an assessment of the adequacy and effectiveness of the valuation designee's process for determining the fair value of the designated portfolio of investments. At a minimum, this annual report must include a summary of the results of the testing of fair value methodologies required under the rule and an assessment of the adequacy of resources allocated to the process for determining the fair value of designated investments, including any material changes to the roles or functions of the persons responsible for determining fair value.
Further, the rule requires the valuation designee to provide a written notification to the board of the occurrence of matters that materially affect the fair value of the designated portfolio of investments (defined as “material matters”) within a time period determined by the board, but in no event later than five business days after the valuation designee becomes aware of the material matter. Material matters in this instance include, as examples, a significant deficiency or material weakness in the design or effectiveness of the valuation designee's fair value determination process or of material errors in the calculation of net asset value. The valuation designee must also provide such timely follow-on reports as the board may reasonably determine are appropriate.
The Commission staff estimates that 9,800 funds are subject to rule 2a-5. The internal annual burden estimate is 34 hours for a fund. Based on these estimates, the total annual burden hours associated with the rule is estimated to be 333,200 hours. The estimated burden hours associated with rule 2a-5 have increased by 15,810 hours from the current allocation of 317,390 hours. The external cost associated with this collection of information is approximately $3,674 per fund, and the total annual external cost burden is $36,005,200. The estimated external cost has increased by $6,319,900 from the current estimate of $29,685,300. These increases are due to an increase in the estimated number of affected entities, as well as in the estimated hourly burden and the external cost
The estimate of average burden hours is made solely for purposes of the Paperwork Reduction Act and is not derived from a comprehensive or even a representative survey or study of the cost of Commission rules. The collection of information required by rule 2a-5 is necessary to obtain the benefits of the rule. Other information provided to the Commission in connection with staff examinations or investigations is kept confidential subject to the provisions of applicable law. If information collected pursuant to rule 2a-5 is reviewed by the Commission's examination staff, it is accorded the same level of confidentiality accorded to other responses provided to the Commission in the context of its examination and oversight program. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view background documentation for this information collection at the following website:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 15c2-1 prohibits broker-dealers from commingling under the same lien securities of their margin customers with securities of the broker-dealer and those of other customers without their written consent. The rule also prohibits the re-hypothecation of customers' margin securities for a sum in excess of the customer's aggregate indebtedness. Respondents must collect information necessary to prevent the re-hypothecation of customer securities, issue and retain copies of notices of hypothecation of customer securities, and collect written consents from customers.
There are approximately 59 respondents. Each of these respondents makes an estimated 45 responses per year and each response takes approximately 0.5 hours to complete, resulting in an industry-wide annual burden of approximately 1,327 hours.
The retention period for the recordkeeping requirement under Rule 15c2-1 is not less than two years following the date the notice is submitted. The recordkeeping requirement under this rule is mandatory to assist the Commission in monitoring respondents who fail to collect the information required under the rule. This rule does not involve the collection of confidential information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
(i)
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its Rules at Options 7, Section 6, Ports and Other Services.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Options 7, Section 6, Ports and Other Services. Specifically, the Exchange proposes to amend the monthly caps for SQF Ports
Today, MRX assesses $1,250 per port, per month for an SQF Port as well as an SQF Purge Port. Today, MRX waives one SQF Port fee per Market Maker per month. Also, today, SQF Ports and SQF Purge Ports are subject to a monthly cap of $17,500, which cap is applicable to Market Makers.
At this time, the Exchange proposes to increase the SQF Port and SQF Purge Port monthly cap fee of $17,500 per month to $27,500 per month. The Exchange is not amending the $1,250 per port, per month SQF Port and SQF Purge Port fees and the Exchange would continue to waive one SQF Port fee per Market Maker per month. As is the case today, the Exchange would not assess a Member an SQF Port or SQF Purge Port fee beyond the monthly cap once the Member has exceeded the monthly cap for the respective month. Despite increasing the monthly cap for SQF Ports and SQF Purge Ports from $17,500 per month to $27,500 per month, the Exchange will continue to offer Members the opportunity to cap their SQF Port and SQF Purge Port fees so that they would not be assessed these fees beyond the cap. Further, an MRX Market Maker requires only one SQF Port to submit quotes in its assigned options series into MRX. An MRX Market Maker may submit all quotes through one SQF Port and utilize one SQF Purge Port to view its purge requests. While a Market Maker may elect to obtain multiple SQF Ports and SQF Purge Ports to organize its business,
The Exchange proposes to remove the italicized language in Options 7, Section 6 related to a technology migration that took place in 2022. In 2022, MRX filed a pricing change
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The proposed pricing change to increase the monthly cap applicable to SQF Ports and SQF Purge Ports is reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for options securities transaction services that constrain its pricing determinations in that market. The fact that this market is competitive has long been recognized by the courts. In
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Numerous indicia demonstrate the competitive nature of this market. Within this environment, market participants can freely and often do shift their order flow among the Exchange and competing venues in response to changes in their respective pricing schedules.
The proposed pricing change to increase the SQF Port and SQF Purge Port monthly cap from $17,500 per month to $27,500 per month is reasonable because despite the increase in the monthly cap, the Exchange will
The Exchange's proposed pricing change to increase the SQF Port and SQF Purge Port monthly cap from $17,500 per month to $27,500 per month is equitable and not unfairly discriminatory because the Exchange would uniformly not assess any Market Makers that exceeded the proposed monthly cap any SQF Port and SQF Purge Port fees for that month beyond the cap. Market Makers are the only market participants that are assessed SQF Port and SQF Purge Port fees because they are the only market participants that are permitted to quote on the Exchange.
The Exchange's proposal to remove the italicized language in Options 7, Section 6 related to a technology migration that took place in 2022 is reasonable, equitable and not unfairly discriminatory because the rule text related to the technology migration is no longer necessary because the migration is complete and the fees are no longer applicable. No Member is subject to the pricing described for the 2022 technology migration.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The proposal does not impose an undue burden on intermarket competition. The Exchange believes its proposal remains competitive with other options markets who also offer order entry protocols. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The Exchange's proposed pricing change to increase the SQF Port and SQF Purge Port monthly cap from $17,500 per month to $27,500 per month does not impose an undue burden on competition because the Exchange would uniformly not assess any Market Makers that exceeded the proposed monthly cap any SQF Port and SQF Purge Port fees for that month beyond the cap. Market Makers are the only market participants that are assessed SQF Port and SQF Purge Port fees because they are the only market participants that are permitted to quote on the Exchange. The Exchange's proposal to remove the italicized language in Options 7, Section 6 related to a technology migration that took place in 2022 does not impose an undue burden on competition because the rule text related to the technology migration is no longer necessary because the migration is complete and the fees are no longer applicable. No Member is subject to the pricing described for the 2022 technology migration.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 350l-3520), the Securities and Exchange Commission (the “Commission”) has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below.
Rule 17g-1 (17 CFR 270.17g-1) under the Investment Company Act of 1940 (the “Act”) (15 U.S.C. 80a-17(g)) governs the fidelity bonding of officers and employees of registered management investment companies (“funds”) and their advisers. Rule 17g-1 requires, in part, the following:
The form and amount of the fidelity bond must be approved by a majority of the fund's independent directors at least once annually, and the amount of any premium paid by the fund for any “joint insured bond,” covering multiple funds or certain affiliates, must be approved by a majority of the fund's independent directors.
The amount of the bond may not be less than the minimum amounts of coverage set forth in a schedule based on the fund's gross assets. The bond must provide that it shall not be cancelled, terminated, or modified except upon 60-days written notice to the affected party and to the Commission. In the case of a joint insured bond, 60-days written notice must also be given to each fund covered by the bond. A joint insured bond must provide that the fidelity insurance company will provide all funds covered by the bond with a copy of the agreement, a copy of any claim on the bond, and notification of the terms of the settlement of any claim prior to execution of that settlement. Finally, a fund that is insured by a joint bond must enter into an agreement with all other parties insured by the joint bond regarding recovery under the bond.
Upon the execution of a fidelity bond or any amendment thereto, a fund must file with the Commission within 10 days: (i) a copy of the executed bond or any amendment to the bond, (ii) the independent directors' resolution approving the bond, and (iii) a statement as to the period for which premiums have been paid on the bond. In the case of a joint insured bond, a fund must also file: (i) a statement showing the amount the fund would have been required to maintain under the rule if it were insured under a single insured bond; and (ii) the agreement between the fund and all other insured parties regarding recovery under the bond. A fund must also notify the Commission in writing within five days of any claim or settlement on a claim under the fidelity bond.
A fund must notify by registered mail each member of its board of directors of: (i) any cancellation, termination, or modification of the fidelity bond at least 45 days prior to the effective date; and (ii) the filing or settlement of any claim under the fidelity bond when notification is filed with the Commission.
Rule 17g-1's independent directors' annual review requirements, fidelity bond content requirements, joint bond agreement requirement, and the required notices to directors are designed to ensure the safety of fund assets against losses due to the conduct of persons who may obtain access to those assets. These requirements also seek to facilitate oversight of a fund's fidelity bond. The rule's required filings with the Commission are designed to assist the Commission in monitoring funds' compliance with the fidelity bond requirements.
Based on conversations with representatives in the fund industry, the Commission staff calculates that for each of the estimated 2,543 active funds (respondents),
These estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act. These estimates are not derived from a comprehensive or even a representative survey or study of Commission rules. The collection of information required by Rule 17g-1 is mandatory and will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view background documentation for this information collection at the following website:
On September 1, 2023, BOX Exchange LLC (“Exchange” or “BOX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to (1) adopt Rules 5055 and 7605 which will govern the trading of flexible exchange options (“FLEX Equity Options”) on BOX; and (2) make related changes to Rules 100 (Definitions), 7620 (Accommodation Transactions), and 12140 (Imposition of Fines for Minor Rule Violations). The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website at.
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to (1) adopt Rules 5055 and 7605 which will govern the trading of flexible exchange options (“FLEX Equity Options”) on BOX; and (2) make related changes to Rules 100 (Definitions), 7620 (Accommodation Transactions), and 12140 (Imposition of Fines for Minor Rule Violations). The proposed rule change was published in the
This Amendment No. 2 makes the following changes to the Original Filing: (i) clarifies that FLEX Equity Options may not be traded using any other order type or trading mechanism offered by the Exchange; (ii) relocates previously proposed Rule 5055(f)(1) to new proposed Rule 5055(e)(1) and renumbers previously proposed paragraph (e)(1) as (e)(2); (iii) renumbers the remaining text of proposed Rule 5055(f) as proposed Rule 5055(f)(1), (2), and (3); (iv) amends the title of proposed Rule 5055(f); (v) clarifies that exercise settlement is by physical delivery; (vi) includes a requirement for FLEX Equity Option position reporting and margin review; (vii) clarifies the trading procedures that would apply to close a position if a Non-FLEX Equity Option series is added intra-day for a component leg(s) of a Complex FOO Order or Multi-Leg FOO Order; (viii) clarifies the trading procedures that would apply to close a position if a Non-FLEX Equity Option series is added for a component leg(s) of a Complex FOO Order or Multi-Leg FOO Order on a trading day after the position is established; and (ix) makes additional clarifying changes to the description of
The Exchange is amending the rule text to clarify that FLEX Equity Options may not be traded using any other order type or trading mechanism offered by the Exchange. The Exchange is proposing this change to provide greater clarity on how FLEX Equity Options may be traded. The Exchange believes this change is reasonable as it adds more clarity to the rule text by emphasizing that FLEX Equity Options shall not be traded other than as FOO Orders.
The Exchange is amending the rule text to relocate currently proposed Rule 5055(f)(1) to new proposed Rule 5055(e)(1), renumber currently proposed paragraph (e)(1) as (e)(2), and renumber the remaining text of proposed Rule 5055(f) as proposed Rules 5055(f)(1), (2), and (3). The Exchange believes this change will provide greater clarity to the rule text by reorganizing previously proposed text in a more readable, understandable, and user-friendly manner. The Exchange is also amending the title of proposed Rule 5055(f) to “Fungibility of FLEX Equity Options.” The Exchange is proposing this change to more appropriately reflect the purpose of the section following these reorganizational changes.
The Exchange is amending rule text by adding proposed Rule 5055(e)(3) to clarify that the exercise settlement of FLEX Equity Options shall be by physical delivery of the underlying security. The Exchange is proposing this change to provide greater clarity on how FLEX Equity Options may be traded and settled. The Exchange believes this change is reasonable as it adds more clarity to the rule text by specifying that the exercise settlement for FLEX Equity Options shall be by physical delivery of the underlying security.
The Exchange is amending the rule text to include a requirement for FLEX Equity Option position reporting and margin review. The Exchange is proposing this change to better align the proposed rules with the already established rules of other exchanges. The Exchange believes this change is reasonable as it conforms the proposed rule with the rest of the industry.
The Exchange is amending the rule text to clarify the trading procedures that would apply to close a position if a Non-FLEX Equity Option series is added intra-day or on a subsequent trading day for a component leg(s) of a Complex FOO Order or Multi-Leg FOO Order. The Exchange is proposing these changes to provide greater clarity on the treatment of FLEX Equity Options after the same Non-FLEX Equity Option is added. The Exchange believes these changes are reasonable as they add more clarity to the rule text on how to close FLEX Equity Option positions.
The Exchange proposes to adopt rules to govern FLEX Equity Options and a new order type to trade FLEX Equity Options on the BOX Trading Floor.
The Securities and Exchange Commission (“Commission”) approved the trading of FLEX options in 1993.
The Exchange notes that FLEX options are currently traded on CBOE, NYSE American LLC (“NYSE American”), NYSE Arca, Inc. (“NYSE Arca”), and Nasdaq PHLX LLC
In August 2017, the Commission approved the Exchange's proposal to adopt rules for an open outcry trading floor.
The Exchange proposes to adopt Rule 5055 titled FLEX Equity Options which describes and governs FLEX Equity Options. Rule 5055(a) details the applicability of other Exchange rules with respect to the proposed FLEX Equity Options. Specifically, the trading of FLEX Equity Options is subject to all other Rules applicable to the trading of options on the Exchange, unless otherwise provided in Rules 5055 and 7605.
The rules proposed by the Exchange are uniquely applicable to FLEX Equity Options in order to accommodate their special characteristics. For example, the BOX Book
FLEX Equity Options will only be permitted in puts and calls that do not have the same exercise style (American or European), same expiration date and same exercise price as Non-FLEX Equity Options that are already available for trading on the same underlying security.
The Exchange proposes Rule 5055(b) which defines the following terms: FLEX Equity Option,
The Exchange proposes Rule 5055(c) which states that certain Exchange rules do not apply to transactions in FLEX Equity Options. Specifically, Rule 7600 “Qualified Open Outcry Orders—Floor Crossing” and Rule 7620 “Accommodation Transactions” do not apply to transactions in FLEX Equity Options.
The Exchange proposes Rule 5055(d) which states that FLEX Equity Options will have no trading rotations.
Further, the Exchange proposes Rule 5055(e) which provides that FLEX Equity Options will not be preestablished for trading and, provided the options on an underlying security are otherwise eligible for FLEX trading, FLEX Equity Options shall be permitted in puts and calls that do not have the same exercise style, same expiration date, and same exercise price as Non-FLEX Equity Options that are already available for trading on the same underlying security. Proposed Rule 5055(e) further provides that FLEX Equity Options must include one of each of the terms of a FLEX Equity Option that are described in the proposed Rule.
Next, the Exchange proposes Rule 5055(f) titled Fungibility of FLEX Equity Options. Proposed Rule 5055(e)(1), described above, limits FLEX Equity Option terms such that options on an underlying security otherwise eligible for FLEX trading will only be permitted in puts and calls that do not have the same exercise style (American or European), same expiration date and same exercise price as Non-FLEX Equity Options that are already available for trading on the same underlying security.
The Exchange proposes Rule 5055(g) which states that the minimum quoting and trading increment for FLEX Equity Option contracts traded on BOX will be one cent ($0.01) for all series.
The Exchange proposes Rule 5055(h) which states that FLEX Equity Options will be subject to the exercise by exception provisions of Rule 805 of the OCC, titled Expiration Exercise Procedure.
The Exchange proposes Rule 5055(i) which details position limits for FLEX Equity Options. Specifically, 5055(i)(1) states that FLEX Equity Options will not be subject to position limits, except as long as the options positions remain open, positions in FLEX Equity Options that expire on a third Friday-of-the-month shall be aggregated with
The Exchange proposes that rather than be subject to FLEX position limits, each Participant (other than a Market Maker) that maintains a position on the same side of the market in excess of the standard position limit for Non-FLEX Equity Options of the same class on behalf of its own account or for the account of a customer shall report information on the FLEX Equity Option position, positions in any related instrument, the purpose or strategy for the position and the collateral used by the account. This report shall be in the form and manner prescribed by the Exchange. In addition, whenever the Exchange determines that a higher margin requirement is necessary in light of the risks associated with a FLEX Equity Option position in excess of the standard position limit for Non-FLEX Equity Options of the same class, the Exchange may, pursuant to its authority under Rule 10130(b), consider imposing additional margin upon the account maintaining such under-hedged position. Additionally, it should be noted that the clearing firm carrying the account will be subject to capital charges under Rule 15c3-1 under the Act
The Exchange proposes Rule 5055(j) which governs exercise limits for FLEX Equity Options. Specifically, proposed Rule 5055(j) states that exercise limits for FLEX Equity Options shall be equivalent to the position limits established in this proposal; accordingly, there shall be no exercise limits for FLEX Equity Options.
The Exchange proposes Rule 5055(k) which details the Letter of Guarantee required for Market Makers to trade FLEX Equity Options. Specifically, proposed Rule 5055(k) states that no Market Maker shall effect any transaction in FLEX Equity Options unless a Letter of Guarantee has been issued by a clearing member organization and filed with the Exchange pursuant to Rule 8070 specifically accepting financial responsibility for all FLEX Equity Option transactions made by such Market Maker and such letter has not been revoked under Rule 8070(c).
Similarly, the Exchange proposes Rule 5055(l), which provides that no Floor Broker
The Exchange proposes to introduce a new order type to facilitate FLEX Equity Option transactions on the BOX Trading Floor. Specifically, the Exchange proposes to adopt a FOO Order type and to model it after a current order type on the Trading Floor—QOO Orders.
On the BOX Trading Floor today, a Floor Broker may bring an unmatched order to the Trading Floor in order to seek liquidity. The Floor Broker may announce the unmatched order (
Next, pursuant to proposed Rule 7605(d), FOO Orders may be Complex Orders (“Complex FOO Order”) or Multi-Leg Orders (“Multi-Leg FOO Order”) as defined in Rules 7240(a)(7) and (10) with no more than the applicable number of legs, as determined by the Exchange and communicated to Participants,
The Exchange proposes Rule 7605(e) which details announcement and representation of FOO Orders on the BOX Trading Floor that is consistent with the current Trading Floor requirements.
There will be an initiating side and a contra-side of a FOO Order. The initiating side is the order which must be filled in its entirety. The contra-side must guarantee the full size of the initiating side of the FOO Order and can be composed of multiple firms. When the Floor Broker is soliciting interest from the trading crowd when the initiating side was announced or to the extent the trading crowd offers a better price, the contra-side will be the solicited interest from the trading crowd.
The FOO Order is not deemed executed until it is processed by the Trading Host. Once the Floor Broker submits the FOO Order to the BOG there will be no opportunity for the submitting Floor Broker,
The Exchange notes that the proposed floor interaction practice is consistent with the process in BOX Rule 7600 for QOO Orders on the BOX Trading Floor where the main differences are that FOO Orders will not be eligible for the BOX Book or the Complex Order Book, there is no NBBO, and that Floor Brokers must allow Floor Participants a minimum period of time (which amount of time must be between three seconds and five minutes) that qualifies as a reasonable amount of time that a Floor Broker must allow Floor Participants to respond to FOO Orders. Consistent with QOO Orders, a FOO Order is not deemed executed until it is processed by the Trading Host.
The Exchange proposes Rule 7605(f) which states that the minimum size for FLEX Equity Options transactions and quotations shall be one (1) contract.
Pursuant to proposed Rule 7605(h), FLEX Market Makers have an obligation to quote a FLEX Equity Option in response to any request for quote by a Floor Broker or Options Exchange Official and must provide a two-sided market.
Next, the Exchange proposes Rule 7605(i) which details the allocation process for FOO Orders. Specifically, the FOO Order will be matched by the Trading Host against the contra-side of the FOO Order, regardless of whether the contra-side order submitted by the Floor Broker is ultimately entitled to receive an allocation pursuant to proposed Rules 7605(i)(1)-(2). If no Floor Participant, other than the executing Floor Broker, is entitled to an allocation, then no further steps are necessary. If however, Floor Participants are entitled to an allocation, the remaining balance of the initiating side of the FOO Order will be allocated as described below.
First, if the FOO Order satisfies the provisions of proposed Rule 7605(k), discussed below, the executing Floor Broker is entitled to 40% of the remaining quantity of the initiating side of the FOO Order.
The Exchange proposes that after execution of the FOO Order, the executing Floor Broker is responsible for providing the correct allocations of the initiating side of the FOO Order to an Options Exchange Official or his or her designee, if necessary, who will properly record the order in the Exchange's system.
Similar to the allocation process in place for QOO Orders, the Exchange proposes to allow for a participation guarantee for certain FOO Orders executed by Floor Brokers on the Trading Floor. Specifically, when a Floor Broker holds an option order of the eligible order size or greater, the Floor Broker is entitled to cross 40% of the remaining contracts of the original order, after all bids or offers at better prices are filled, with other orders that the Floor Broker is holding.
The below examples are designed to illustrate the allocation of the initiating side of a FOO Order.
1. 200 contracts (40%, or 500 * .40) for the contra-side order submitted by the Floor Broker.
2. 250 contracts for FLEX Market Maker 1 with time priority.
3. Remaining 50 contracts to FLEX Market Maker 2.
1. 20 contracts for FLEX Market Maker 1 with time priority.
2. 20 contracts for FLEX Market Maker 2.
3. The initiating side is filled and the executing Floor Broker will receive no allocation.
1. FOO Order at 1.06—20 contracts for FLEX Market Maker 1.
2. FOO Order at 1.05—20 contracts for FLEX Market Maker 2.
3. The executing Floor Broker will receive no allocation of either FOO Order.
The Exchange also proposes that all orders entrusted to a Floor Broker will be considered Not Held Orders, unless otherwise specified by a Floor Broker's client. A Not Held Order is an order marked “not held”, “take time”, or which bears any qualifying notation giving discretion as to the price or time at which such order is to be executed.
The Exchange further proposes IM-7605-1 which allows Floor Brokers to bring unmatched orders (
The Exchange proposes IM-7605-2 to guide conduct on the floor.
The Exchange proposes to amend Rule 100(b)(3) to provide: “All Exchange options transactions shall be executed automatically by the Trading Host as provided in applicable Exchange Rules.”
The Exchange proposes to amend Rule 7620, titled Accommodation Transactions, and IM-7620-1 to exclude FLEX Equity Options as defined in proposed Rule 5055.
The Exchange has not yet determined the fees for FOO transactions executed on the Trading Floor. Prior to commencing trading of the proposed FOO Orders on the Trading Floor, the Exchange intends to submit a proposed rule change to the Commission setting forth the proposed fees.
The Exchange has also analyzed its capacity and represents that it believes the Exchange and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle the additional message traffic associated with the listing of new series that may result from the introduction of FLEX Equity Options.
The proposed FLEX Equity Option rules are based predominately on the rules of NYSE Arca. However, the Exchange omitted certain NYSE Arca rules from the proposed rules discussed herein due to differences in the scope and operation of FLEX Option
Next, NYSE Arca Rule 5.40-O requires at least $1 million of net liquidating equity in the account of a FLEX Appointed Market Maker. However, FLEX Appointed Market Makers are appointed for FLEX Index Options on NYSE Arca but are not required for FLEX Equity Options.
An additional difference in the appointment of FLEX Market Makers is that NYSE Arca appoints FLEX Qualified Market Makers to each FLEX Equity Option of a given class, while the Exchange will qualify FLEX Market Makers for all FLEX Equity Options. The Exchange believes that the structure of its Trading Floor, with one crowd or trading area, will operate more efficiently without qualifying FLEX Market Makers by class.
Further, the Exchange notes differences between the proposed quoting obligations and those applicable on NYSE Arca. Specifically, a NYSE Arca FLEX Qualified Market Maker may, but shall not be obligated to, enter a FLEX Quote in response to a Request for Quotes on a FLEX Equity Option of the class in which he or she is qualified.
Among other NYSE Arca provisions not incorporated by the Exchange, are certain of NYSE Arca's “Special Terms for FLEX Equity Options.”
Another NYSE Arca provision not adopted by the Exchange in this proposal allows discretionary orders where Floor Brokers have discretion regarding the quantity of FLEX contracts traded.
Another NYSE Arca rule not proposed by the Exchange provides that NYSE Arca may designate FLEX Officials.
As mentioned above, rather than adopt the NYSE Arca RFQ procedure for FLEX Equity Options,
The Exchange notes that the manner in which the Exchange has proposed rules with respect to announcement of orders and responsive quotes is similar to how CBOE treats its FLEX Options; specifically, CBOE allows a FLEX Order
The Exchange's disciplinary rules, including Exchange Rules applicable to “minor rule violations,” are set forth in the Rule 12000 Series of the Exchange's current Rules. As described in Rule 12140, the MRVP provides that in lieu of commencing a disciplinary proceeding, the Exchange may, subject to the certain requirements set forth in the Rule, impose a fine, not to exceed $5,000, on any Options Participant, or person associated with or employed by an Options Participant, with respect to any Rule violation listed in Rules 12140(d) or (e) as discussed below. Any fine imposed pursuant to this Rule that (i) does not exceed $2,500 and (ii) is not contested, shall be reported on a periodic basis, except as may otherwise be required by Rule 19d-1 under the Act or by any other regulatory authority. Further, the Rule provides that any person against whom a fine is imposed under the Rule shall be served with a written statement setting forth: (i) the Rule(s) allegedly violated; (ii) the act or omission constituting each such violation; (iii) the fine imposed for each violation; and (iv) the date by which such determination becomes final and such fine must be paid or contested, which date shall be not less than twenty-five (25) calendar days after the date of service of such written statement. Rules 12140 (d) and (e) set forth the list of specific Exchange Rules under which an Options Participant or person associated with or employed by an Options Participant may be subject to a fine for violations of such Rules and the applicable fines that may be imposed by the Exchange. As with all the violations incorporated into its MRVP, the Exchange will proceed under this Rule only for violations that are minor in nature. Any other violation will be addressed pursuant to Rules 12030 (Letters of Consent) or 12040 (Charges).
The Exchange proposes to amend its MRVP to add certain rules relating to FLEX Equity Options to the list of rules eligible for minor rule violation plan treatment by amending Rule 12140. Specifically, the Exchange proposes to amend Rule 12140(e)(3), which covers the failure to properly execute a QOO Order, to include failure to properly execute a FOO Order (proposed Rule 7605).
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange further believes that the proposal is designed to prevent fraudulent and manipulative acts and practices as the Exchange will review all current surveillance in light of any changes required, including surveillance and technology to detect disruptive or manipulative trading activity for FOO Orders on the Trading Floor, and will modify or add any surveillance as appropriate. As described above, the Exchange will apply its existing surveillance program to FLEX Equity Options and has developed FLEX-specific surveillance reports.
As described below, the Exchange also believes the proposed changes to Rule 12140(e) are consistent with Section 6(b)(6) of the Act,
The Exchange believes that proposed Rule 5055(a) stating that the trading of FLEX Equity Options is subject to all other Rules applicable to the trading of options on the Exchange, unless otherwise provided in Rules 5055 and 7605, is consistent with the Act because it will ensure that, except where otherwise provided in Rules 5055 and 7605, the Exchange's existing rules will continue to apply to FLEX Equity Options, which will provide increased consistency for Participants trading FLEX Equity Options and Non-FLEX Equity Options on BOX. The Exchange reiterates that rules which contemplate the operation of or interaction with the BOX Book and the Complex Order Book will not apply to FLEX Equity Options, given that FLEX Equity Options may only be traded as FOO Orders and FOO Orders may not be placed in the BOX Book or the Complex Order Book.
The Exchange believes that the definitions proposed in Rule 5055(b) will provide increased clarity to market participants which will protect investors and the public interest by specifying definitions for FLEX Equity Options and Non-FLEX Equity Options, and by specifying that FLEX Equity Option transactions will be governed as proposed in Rule 7605 and shall not be traded other than as FOO Orders. The Exchange believes further that the term “FLEX Market Maker” will clarify the difference between Floor Market Makers and FLEX Market Makers, where the latter are qualified for trading FLEX Equity Options and have an obligation to provide quotes in response to FOO Orders. The Exchange also believes that specifying that FLEX Equity Options may not be traded using any other order type or trading mechanism offered by the Exchange will provide increased clarity to Participants that the only means by which the Exchange intends to permit FLEX Equity Options to be traded is via the proposed FOO order type. The Exchange notes that, should it decide to propose additional order types or electronic trading for FLEX Equity Options, it will revise the defined term “FLEX Open Outcry Order” accordingly.
The Exchange believes that proposed Rule 5055(d) which specifies that there shall be no trading rotations in FLEX Equity Options is designed to promote just and equitable principles of trade and to remove impediments to and perfect the mechanism of a free and open market and a national market system because it provides notice to Participants regarding the mechanisms applicable to FLEX trading, which will not include trading rotations due to the customized nature of FLEX Equity Options and the fact that there will be no requirement for specific FLEX Equity Option series to be quoted or traded each day.
The Exchange believes that the terms of FLEX Equity Options pursuant to proposed Rule 5055(e) serve to perfect the mechanism of a free and open market and a national market system because they will permit investors to customize some of the terms of their FLEX Equity Options to implement more precise trading strategies and hedges which may not be possible using Non-FLEX Equity Options.
Proposed rule 5055(e)(2)(v)(a) allowing a FLEX Equity Option order to be submitted on any trading day, including the expiration date, serves to perfect the mechanism of a free and open market and a national market system because it will allow investors to execute FLEX Equity Options at a time of their choosing. These investors may have improved capability to execute strategies to meet their specific investment objectives. Further, this rule is designed to provide clarity about when FLEX Equity Options may be executed. The Exchange believes that Floor Participants benefit from increased flexibility and clarity. The Exchange notes that, in another context, new series may be listed the day they expire. Specifically, Short Term Option Series may be added up to and including on the Short Term Option Expiration Date for that options series.
The Exchange also believes that proposed Rule 5055(e)(1) to prevent FLEX Equity Options and Non-FLEX Equity Options with the same terms from trading concurrently is designed to promote just and equitable principles of trade and prevent fraudulent and manipulative acts and practices.
Further, the Exchange believes that allowing FLEX Equity Options to trade in minimum increments of $0.01
The Exchange further believes that subjecting FLEX Equity Options to the exercise by exception provisions of Rule 805 of the OCC
Position and exercise limits are designed to address potential manipulative schemes and adverse market impacts surrounding the use of options, such as disrupting the market in the security underlying the options. While position and exercise limits should address and discourage the potential for manipulative schemes and adverse market impact, if such limits are set too low, participation in the options market may be discouraged. The Exchange believes that any decision regarding imposing position and exercise limits for FLEX Equity Options must therefore be balanced between mitigating concerns of any potential manipulation and the cost of inhibiting potential hedging activity that could be used for legitimate economic purposes.
Similar to the other exchanges that trade FLEX Equity Options, the Exchange believes that eliminating position and exercise limits for FLEX Equity Options, while requiring positions in FLEX Equity Options that expire on a third Friday-of-the-month to be aggregated with positions in Non-FLEX Equity Options on the same underlying security,
The Exchange believes that the proposed elimination of position and exercise limits for FLEX Equity Options may encourage market participants to transfer their liquidity demands from OTC markets to exchanges and enable liquidity providers to provide additional liquidity to BOX through transactions in FLEX Equity Options. The Exchange notes that the Commission previously approved the elimination of position and exercise limits for FLEX Equity
Additionally, the Exchange believes that requiring positions in FLEX Equity Options that expire on a third Friday-of-the-month to be aggregated with positions in Non-FLEX Equity Options on the same underlying security subjects FLEX Equity Options and Non-FLEX Equity Options to the same position and exercise limits on third Friday-of-the-month expirations. These limitations are intended to serve as a safeguard against potential adverse effects of large FLEX Equity Option positions expiring on the same day as Non-FLEX Equity Option positions. The Exchange notes that another exchange has the same requirement.
The Exchange believes that any potential risk of manipulative activity is mitigated by existing surveillance technologies, procedures, and reporting requirements at the Exchange, which allows the Exchange to properly identify disruptive and/or manipulative trading activity. In addition to its own surveillance programs, the Exchange also works with other SROs and exchanges on intermarket surveillance related issues. Through its participation in the Intermarket Surveillance Group (“ISG”)
The Exchange believes that proposed Rule 5055(i)(1) further mitigates concerns for potential market manipulation and/or disruption in the underlying markets and thus protects investors and the public interest because position reporting will be required (other than for a Market Maker) and the Exchange may determine that a higher margin requirement is necessary in light of the risks associated with a FLEX Equity Option position in excess of the standard limit for Non-FLEX Equity Options of the same class. The Exchange may, pursuant to its authority under Rule 10130(b), impose additional margin upon the account maintaining such under-hedged position as a safeguard against potential adverse effects of large FLEX Equity Option positions. The Exchange notes that the clearing firm carrying the account will be subject to capital charges under SEC Rule 15c3-1 to the extent of any margin deficiency resulting from a higher margin requirement imposed by the Exchange. The Exchange also notes that other exchanges currently trading FLEX options have similar position and exercise limits.
Pursuant to proposed Rule 5055(k), the Exchange will require FLEX Market Makers to provide a Letter of Guarantee issued by a clearing member organization and filed with the Exchange specifically accepting financial responsibility for all FLEX Equity Option transactions made by such person as long as such letter has not been revoked under Rule 8070(c).
Pursuant to proposed Rule 5055(l), prior to effecting any transaction in FLEX Equity Options, Floor Brokers are required to provide a Letter of Authorization issued by a clearing member organization and filed with the Exchange specifically accepting financial responsibility for all FLEX Equity Option transactions made by such person, and such letter remains in effect until a written revocation is received by the Exchange.
The Exchange believes that the proposed rule change to adopt a new order type
Under this proposal, Floor Brokers will continue to allow a reasonable amount of time for Floor Participants to participate in a FOO Order. Additionally, the Exchange will establish and communicate via Regulatory Notice a minimum time that Floor Brokers must provide for Floor Participants to respond to FOO Orders, which amount of time must be between three seconds and five minutes. While other exchanges have adopted RFQ processes for FLEX Equity Options,
The Exchange similarly proposes to align its open outcry process for FLEX Equity Options with that of Non-FLEX Equity Options and to establish a minimum time for responses to FOO Orders. The Exchange also believes that, in addition to the required minimum time, it is appropriate to continue to have Options Exchange Officials determine whether Floor Participants have been provided a reasonable amount of time to respond to a FOO Order, which is consistent with the current procedure on the BOX Trading Floor for QOO Orders.
Proposed Rule 7605(b) states that FOO Orders will be limited solely to the Trading Floor. The Exchange believes that limiting FOO Orders to the Trading Floor is consistent with the Act because, due to their unique and customizable nature, FLEX Equity Option transactions are well suited for a trading floor environment where the terms of such options can be effectively negotiated. The Exchange notes that other exchanges limit FLEX Equity Options trading to their respective trading floors.
Proposed Rule 7605(c) provides that FLEX Market Makers must be registered under Rule 8000 and must be Floor Market Makers in good standing under Rule 8500, which protects investors and the public interest by ensuring that Market Makers are qualified to perform their duties, including filing an application, demonstrating knowledge of FLEX Equity Options, and providing additional information as the Exchange may consider necessary. The Exchange shall qualify at least three FLEX Market Makers in accordance with a FLEX-specific qualification process prescribed by the Exchange to provide competition for FOO Orders and reasonable opportunities for Participants to get quotes on FLEX Equity Options. The requirement to qualify at least three FLEX Market Makers is designed to remove impediments to and perfect the mechanism of a free and open market and a national market system. Similarly to Floor Market Makers, FLEX Market Makers will also be subject to Rule 8510, including provisions for the course and conduct of dealings, class assignments, and option priority and parity, unless otherwise specified in proposed Rule 7605.
Proposed Rule 7605(d) states that FOO Orders may be Complex FOO Orders or Multi-Leg FOO Orders, including as tied hedge orders, and that these orders may be crossed.
Another provision designed to maintain order and structure on the Trading Floor is the Exchange's proposal that FOO Orders entrusted to a Floor Broker will be considered a Not Held Order, unless otherwise specified by a Floor Broker's client.
Additionally, the requirement, in proposed IM-7605-2, that Participants disclose Public Customer Orders subject to crossing with an order that is not a
Proposed Rule 7605(e) is designed to aid Floor Brokers in their duties and to maintain structure and order on the Trading Floor. For example, by providing that a FOO Order is not executed until it is processed by the Trading Host,
The Exchange believes that the proposed rules applicable to FLEX Market Makers are reasonable and will foster cooperation and coordination with persons engaged in facilitating transactions in securities, promote just and equitable principles of trade, and remove impediments to and perfect the mechanism of a free and open market and a national market system. Specifically, proposed Rules 7605(f), (g) and (h) state: (1) that the minimum size for FLEX Equity Option transactions and quotations shall be 1 contract; (2) that there are no maximum bid to ask spread differentials for FLEX Equity Option quotes; and (3) that FLEX Market Makers have an obligation to quote a FLEX Equity Option in response to any request for quote by a Floor Broker or Options Exchange Official and must provide a two-sided market.
The Exchange believes that the proposed rule to provide a Floor Broker with a guarantee or entitlement to cross 40% of the remaining contracts of the original order, after all bids or offers at better prices are filled, with other orders that he is holding,
The Exchange believes that, after the allocation of any bids and offers at better prices and any eligible Floor Broker guarantee, allocating FLEX Equity Option trades between Floor Participants pursuant to the priority provisions of Rule 7610 is reasonable and promotes just and equitable principles of trade. The Exchange notes that, pursuant to Rule 7610, bids and offers are considered in order of the highest bid/lowest offer and priority shall be afforded to such bids and offers in the sequence in which they are made. In situations where the sequence cannot be determined, Floor Participants are treated on an equal basis and receive an equal number of contracts to the extent mathematically possible.
The Exchange believes that the proposed rule change to add certain proposed rules as eligible for a minor rule fine disposition under its MRVP will assist the Exchange in preventing fraudulent and manipulative acts and practices and promoting just and equitable principles of trade, and will serve to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, protect investors and the public interest. In particular, the Exchange believes that the proposed rule changes to Rule 12140(e) are consistent with Section 6(b)(6) of the Act,
In requesting the proposed additions to BOX Rule 12140(e), the Exchange in no way minimizes the importance of compliance with Exchange Rules and all other rules subject to the imposition of fines under the MRVP. Minor rule fines provide a meaningful sanction for minor or technical violations of rules when the conduct at issue does not warrant stronger, immediately reportable disciplinary sanctions. The inclusion of a rule in the Exchange's MRVP does not minimize the importance of compliance with the rule, nor does it preclude the Exchange from choosing to pursue violations of eligible rules through a Letter of Consent if the nature of the violations or prior disciplinary history warrants more significant sanctions. Rather, the Exchange believes that the proposed rule change will strengthen the Exchange's ability to carry out its oversight and enforcement responsibilities in cases where full disciplinary proceedings are unwarranted in view of the minor nature of the particular violation. Rather, the option to impose a minor rule sanction gives the Exchange
The Exchange believes that amending Rule 7620 and IM-7620-1 to exclude FLEX Equity Options is consistent with proposed Rule 5055(c) which provides that Rule 7620 shall not apply to transactions in FLEX Equity Options. The amendment is designed to provide clarity by adding FLEX Equity Options to the exclusion list in Rule 7620 and IM-7620-1 to clarify that neither Cabinet orders nor Sub-Penny Cabinet orders will be available for FLEX Equity Options. The Exchange believes further that this amendment will protect investors and the public interest by removing potential ambiguity between Rule 7620 and proposed Rules 5055 and 7605 and is therefore consistent with the Act.
Lastly, the amendment of Rule 100(b)(3) to remove specific rule references is designed to clarify that all Exchange options transactions shall be executed automatically by the Trading Host as provided in applicable Exchange Rules. The Exchange believes that this amendment will protect investors and the public interest by removing potential ambiguity created by a list of specific rule references that may not be complete and is therefore consistent with the Act.
The Exchange reiterates that FLEX Equity Options are currently traded on four other options exchanges currently conducting options trading.
The proposed rule change is consistent with Section 11(a) of the Act and the rules thereunder. Section 11(a)(1) of the Act
As described above, the Exchange proposes to apply existing IM-7600-5 to FLEX Equity Options,
In addition to statutory exemptions, Rule 11a2-2(T) under the Act,
Rule 11a2-2(T)'s first requirement is that orders for covered accounts be transmitted from off the Trading Floor. The Commission has found that the off-floor transmission requirement is met if a covered account order is transmitted from a remote location directly to an exchange's floor by electronic means.
Second, Rule 11a2-2(T) requires that neither the initiating Participant nor an associated person of the initiating Participant participate in the execution of the transaction at any time after the order for the transaction has been transmitted. At no time following the submission of a FOO Order utilizing the Trading Floor will the submitting Participant or any associated person of such Participant acquire control or influence over the result or timing of the order's execution.
Third, Rule 11a2-2(T) requires that the order be executed by a Participant that is not associated with the Participant initiating the order. To rely on the exemption in Rule 11a2-2(T), a Participant could submit a FOO Order for a covered account from off the Trading Floor to an unaffiliated Floor Broker. A Participant relying on Rule 11a2-2(T) could not submit a FOO Order for a covered account to its “house” Floor Broker on the Trading Floor for execution. If a Participant sends its FOO Order from off the floor to an affiliated Participant that is on the floor, who then directs the order into the Trading Host for execution, the off-floor Participant may not rely on the exemption in Rule 11a2-2(T).
Fourth, in the case of a transaction effected for an account with respect to which the initiating Participant or an associated person thereof exercises investment discretion, neither the initiating Participant nor any associated person may retain any compensation in connection with effecting the transaction, unless the person authorized to transact business for the account has expressly provided otherwise by written contract referring to Section 11(a) of the Act and Rule 11a2-2(T) thereunder.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that other exchanges currently offer FLEX option trading on their respective trading floors. The Exchange believes that the proposed rules will allow BOX to compete with these other exchanges and provide an additional execution venue for these transactions for market participants. Thus, the proposed rules will promote intermarket competition by increasing the number of exchanges where FLEX Equity Options can be traded. The proposal also promotes intermarket competition by providing another alternative, exchange markets, to bilateral OTC trading of options with flexible terms. Exchange markets, in contrast with bilateral OTC trading, are centralized, transparent, and have the guarantee of the OCC for options traded.
Additionally, the Exchange believes that this proposal does not impose an undue burden on intramarket competition because Participants are not required to trade FLEX Equity Options and those that choose to trade FLEX Equity Options may do so on the same terms and pursuant to the same rules. To the extent that the proposed rules differ for FLEX Market Makers and Floor Brokers, these differences are based on the unique roles and obligations of Floor Brokers (
Lastly, the proposed MRVP changes are not intended to address competitive issues but rather are concerned solely with updating the Exchange's MRVP in connection with the proposed rules eligible for a minor rule fine disposition. Further, the proposal relates to the Exchange's role and responsibilities as a self-regulatory organization and the manner in which it disciplines its Participants and associated persons for violations of its rules. The Exchange believes the proposed MRVP changes, overall, will strengthen the Exchange's ability to carry out its oversight and enforcement functions and deter potential violative conduct.
Based on the foregoing, the Exchange believes that the proposed rule changes discussed herein do not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has neither solicited nor received comments on the proposed rule change.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
Under the Commission's Rules of Practice, the “burden to demonstrate that a proposed rule change is consistent with the Exchange Act and the rules and regulations issued thereunder . . . is on the self-regulatory organization [`SRO'] that proposed the rule change.”
For these reasons, the Commission believes it is appropriate to institute proceedings pursuant to Section 19(b)(2)(B) of the Exchange Act to determine whether the proposal should be approved or disapproved.
The Commission requests that interested persons provide written submissions of their data, views, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposed rule change, as modified by Amendment No. 2, is consistent with Section 6(b)(5) of the Act
Interested persons are invited to submit written data, views, and arguments regarding whether the proposed rule change, as modified by Amendment No. 2, should be approved or disapproved by January 11, 2024. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by January 25, 2024.
The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, which are set forth in Amendment No. 2,
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its Rules at Options 7, Section 6, C, Ports and Other Services.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Options 7, Section 6, C, Ports and Other Services. Specifically, the Exchange proposes to amend the monthly caps for SQF Ports
Today, GEMX assesses $1,250 per port, per month for an SQF Port as well as an SQF Purge Port.
At this time, the Exchange proposes to increase the SQF Port and SQF Purge Port monthly cap fee of $17,500 per month to $27,500 per month. The Exchange is not amending the $1,250 per port, per month SQF Port and SQF Purge Port. As is the case today, the Exchange would not assess a Member an SQF Port or SQF Purge Port fee beyond the monthly cap once the Member has exceeded the monthly cap for the respective month. Despite increasing the monthly cap for SQF Ports and SQF Purge Ports from $17,500 per month to
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The proposed pricing change to increase the monthly cap applicable to SQF Ports and SQF Purge Ports is reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for options securities transaction services that constrain its pricing determinations in that market. The fact that this market is competitive has long been recognized by the courts. In
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Numerous indicia demonstrate the competitive nature of this market. Within this environment, market participants can freely and often do shift their order flow among the Exchange and competing venues in response to changes in their respective pricing schedules.
The proposed pricing change to increase the SQF Port and SQF Purge Port monthly cap from $17,500 per month to $27,500 per month is reasonable because despite the increase in the monthly cap, the Exchange will continue to offer Members the opportunity to cap their SQF Port and SQF Purge Port fees so that they would not be assessed these fees beyond the cap. Additionally, a GEMX Market Maker requires only one SQF Port to submit quotes in its assigned options series into GEMX. A GEMX Market Maker may submit all quotes through one SQF Port and utilize one SQF Purge Port to view its purge requests. While a Market Maker may elect to obtain multiple SQF Ports and SQF Purge Ports to organize its business,
The Exchange's proposed pricing change to increase the SQF Port and SQF Purge Port monthly cap from $17,500 per month to $27,500 per month is equitable and not unfairly discriminatory because the Exchange would uniformly not assess any Market Makers that exceeded the proposed monthly cap any SQF Port and SQF Purge Port fees for that month beyond the cap. Market Makers are the only market participants that are assessed SQF Port and SQF Purge Port fees because they are the only market participants that are permitted to quote on the Exchange.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The proposal does not impose an undue burden on intermarket competition. The Exchange believes its proposal remains competitive with other options markets who also offer order entry protocols. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The Exchange's proposed pricing change to increase the SQF Port and SQF Purge Port monthly cap from $17,500 per month to $27,500 per month does not impose an undue burden on competition because the Exchange would uniformly not assess any Market Makers that exceeded the proposed monthly cap any SQF Port and SQF Purge Port fees for that month beyond the cap. Market Makers are the only market participants that are assessed SQF Port and SQF Purge Port fees because they are the only market participants that are permitted to quote on the Exchange.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 609 (17 CFR 230.609) under the Securities Act of 1933 (15 U.S.C. 77a
Although there have been no filings of Form 2-E since 2017, for administrative purposes the Commission estimates that, on average, approximately one respondent submits a Form 2-E filing each year. The Commission further estimates that this information collection imposes an annual burden of four hours and imposes no annual external cost burden.
The collection of information under Form 2-E is mandatory. The information provided by the form will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Written comments continue to be invited on: (a) whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden imposed by the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend The Nasdaq Options Market LLC's (“NOM”) Rules at Options 7, Section 3, Nasdaq Options Market—Ports and Other Services.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Options 7, Section 3, Nasdaq Options Market—Ports and Other Services. Specifically, the Exchange proposes to amend Options 7, Section 3(i) to increase the per port, per month SQF Port
Today, NOM assesses SQF Ports and SQF Purge Ports a per port, per month fee based on a tiered fee schedule. Specifically, NOM assesses an SQF Port and an SQF Purge Port fee of $1,500 per port, per month for the first 5 ports (1-5), a $1,000 per port, per month fee for the next 15 ports (6-20), and a $750 per port, per month fee for all ports over 20 ports (21 and above).
The Exchange proposes to amend the per port, per month fee for SQF Ports and SQF Ports above 20 ports (21 and above) from $500 to $750 per port, per month. The Exchange is not amending the SQF Port and SQF Purge Port fees for ports below 20 ports. SQF Ports and SQF Purge Ports over 20 ports are unnecessary for a NOM Market Maker to fulfill its regulatory requirements.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposed pricing change to increase fees for certain SQF Ports and SQF Purge Ports is reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for options securities transaction services that constrain its pricing determinations in that market. The fact that this market is competitive has long been recognized by the courts. In
The Commission and the courts have repeatedly expressed their preference
Numerous indicia demonstrate the competitive nature of this market. Within this environment, market participants can freely and often do shift their order flow among the Exchange and competing venues in response to changes in their respective pricing schedules.
The Exchange believes that increasing the fee for SQF Ports and SQF Purge Ports over 20 ports (21 and above) from $500 to $750 per port, per month is reasonable because SQF Ports and SQF Purge Ports over 20 ports are unnecessary for a NOM Market Maker to fulfill its regulatory requirements.
The Exchange believes that increasing the fee for SQF Ports and SQF Purge Ports over 20 ports (21 and above) from $500 to $750 per port, per month is equitable and not unfairly discriminatory because all NOM Market Makers would be assessed the same fees for SQF Ports and SQF Purge Ports to the extent that these NOM Market Makers have subscribed to more than 20 SQF Ports or SQF Purge Ports. NOM Market Makers are the only market participants that are assessed SQF Port and SQF Purge Port fees because they are the only market participants that are permitted to quote on the Exchange.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The proposal does not impose an undue burden on intermarket competition. The Exchange believes its proposal remains competitive with other options markets who also offer order entry protocols. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The Exchange believes that increasing the fee for SQF Ports and SQF Purge Ports over 20 ports (21 and above) from $500 to $750 per port, per month does not impose an undue burden on competition because all NOM Market Makers would be assessed the same fees for SQF Ports and SQF Purge Ports to the extent that these NOM Market Makers have subscribed to more than 20 SQF Ports or SQF Purge Ports. NOM Market Makers are the only market participants that are assessed SQF Port and SQF Purge Port fees because they are the only market participants that are permitted to quote on the Exchange.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Tennessee (FEMA-4751-DR), dated 12/13/2023.
Issued on 12/13/2023.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 12/13/2023, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 20131C and for economic injury is 201320.
Social Security Administration (SSA).
Notice of a new matching program.
In accordance with the provisions of the Privacy Act, as amended, this notice announces a new matching program with Office of Personnel Management (OPM). This matching program sets forth the terms, conditions, and safeguards under which SSA uses identifying information (
Submit comments on the proposed matching program no later than January 22, 2024.
The matching program will be applicable on January 20, 2024, or once a minimum of 30 days after publication of this notice has elapsed, whichever is later. The matching program will be in effect for a period of 9 months.
You may submit comments by any one of three methods—internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA-2023-0046 so that we may associate your comments with the correct regulation. CAUTION: You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information.
1.
2.
3.
Interested parties may submit general questions about the matching program to Cynthia Scott, Division Director, Office of Privacy and Disclosure, Office of the General Counsel, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401, at telephone: (410) 965-1416, or send an email to
None.
Legal authority for OPM's disclosures under this agreement are the Privacy Act (5 U.S.C. 552a(b)(1) & (3)) and section 101(c) of the PSRA (Pub. L. 117-108, Title I, 101(c); 5 U.S.C. 8903c note).
Section 1837(o) of the Social Security Act (42 U.S.C. 1395p(o)) authorizes a one-time Medicare Part B PSRA SEP for certain eligible Postal Service annuitants and their family members.
Department of State.
Notice of pilot program.
The Department of State (the “Department”) is announcing a pilot program to resume domestic visa renewal for qualified H-1B nonimmigrant visa applicants who meet certain requirements. This notice describes the requirements for participation in the pilot and provides information on how those falling within the bounds of the pilot program may apply for domestic visa renewal.
The pilot program will accept applications from January 29 to April 1, 2024. Applicants who meet the requirements may choose to participate during the application window by applying online at
Interested parties may submit comments, identified by Department docket number DOS-2023-0042 or RIN 1400-AF79, through the Federal eRulemaking Portal at
Comments submitted in a manner other than the one listed above, including emails or letters sent to Department officials, will not be considered comments on the Notice, and may not be considered by the Department.
Jami Thompson, Senior Regulatory Coordinator, Visa Services, Bureau of Consular Affairs, Department of State; email:
In 2004, the Department discontinued the domestic renewal of non-diplomatic nonimmigrant visas primarily because of the passage of the Enhanced Border Security and Visa Entry Reform Act of 2002 (Pub. L. 107-173), which required that U.S. visas issued after October 26, 2004, include biometric identifiers
Pursuant to 22 CFR 41.111(b)(3), the Deputy Assistant Secretary for Visa Services (VO DAS) and Department officials designated by them, are authorized to issue, in their discretion, nonimmigrant visas in the United States, to qualified applicants who meet specific criteria. Based on this discretionary authority, the VO DAS sets the limitations and parameters of the domestic renewal pilot, including establishing parameters that limit the types of applications that fall within the pilot's scope. Consequently, applicants that fall outside of this scope are not eligible to apply for, nor be issued, a visa domestically.
Participation in this pilot will be limited to applicants who(se):
1. Are seeking to renew an H-1B visa; during the pilot phase, the Department will not process any other visa classifications;
2. Prior H-1B visa that is being renewed was issued by Mission Canada with an
3. Are not subject to a nonimmigrant visa issuance fee (Note: this is commonly referred to as a “reciprocity fee”);
4. Are eligible for a waiver of the in-person interview requirement;
5. Have submitted ten fingerprints to the Department in connection with a previous visa application;
6. Prior visa does not include a “clearance received” annotation;
7. Do not have a visa ineligibility that would require a waiver prior to visa issuance;
8. Have an approved and unexpired H-1B petition;
9. Were most recently admitted to the United States in H-1B status;
10. Are currently maintaining H-1B status in the United States;
11. Period of authorized admission in H-1B status has not expired; and
12. Intend to reenter the United States in H-1B status after a temporary period abroad.
Some of these requirements are mandated by statute or regulation. Others are discretionary requirements and are designed to limit the pilot population to a size that is manageable and consistent with available resources, and control the costs of conducting the pilot, while still testing the efficacy of a domestic renewals program.
Specifically, the Department is limiting the scope of the pilot to applicants who were previously issued visas within specified dates by Missions Canada or India to properly assess the performance and capabilities of contractors who manage the majority of the Department's worldwide visa processing. The population of visa applicants in India and Canada is sufficiently representative of the global population and visa issuances during the referenced periods provide enough cases to make the pilot results meaningful, without overwhelming available resources.
Additionally, the Department is limiting the scope of the pilot to include only H-1B applicants. After careful consideration, the Visa Office determined that including other visa categories, including H-4s (dependents of H-1B principal applicants), created additional technical and operational challenges that cannot be resolved before the pilot launch date. For instance, developing standard operating procedures and training staff to recommence domestic renewals is a time-consuming process that requires months of practice currently underway for H-1B adjudications. Developing processes to adjudicate additional visa categories will continue concurrent with the pilot, leveraging real time data and feedback to expand the program.
Limiting the pilot to only H-1B principal applicants will also maximize the Department's direct impact on U.S. industry partners, whose H-1B employees may need to travel abroad for work purposes and risk being unable to immediately return if their visa is expired.
As the Department does not conduct in-person nonimmigrant visa interviews or collect fingerprints domestically, a key requirement for participation in the pilot is that applicants for domestic visa renewal must qualify for a waiver of the in-person interview requirement under section 222(h) of the Immigration and Nationality Act (INA) and have fingerprints on file with the Department that may be used for biometric vetting. Just like any individual applying for a nonimmigrant visa overseas, including those whose in-person interview is waived, all applicants for domestic visa renewal must undergo screening and vetting. With certain exceptions set out in the law, most applicants seeking to renew their H-1B visas, whether overseas or domestically, within 48 months of the expiration of their prior visa in the same classification, will be eligible for a waiver of the in-person interview requirement. Based on statutory requirements for an interview waiver under INA section 222(h)(2), applicants for domestic visa renewal must reside in the United States. Applicants are not required to submit evidence of residence in the United States at the time they submit their application beyond the information requested in the visa application; however, additional information may be requested at any time prior to visa issuance.
Some applicants may not be fully aware of the facts that caused them to be ineligible for interview waiver, even though the reasons are tied to a specific statutory ground. For example, applicants requiring a Department clearance are ineligible for interview waiver, but such clearance requirements are not public information. Any such requirement would be based on the applicant's individual circumstances. Applicants who do not meet the requirements for domestic adjudication as published in this notice, including eligibility for a waiver of the in-person interview requirement, are not eligible to apply for, nor be issued a visa domestically. Fees will not be refunded and these applicants must submit a new application, pay the associated fee, and apply overseas where they have a residence or are physically present if they wish to pursue a new visa. Participation in the pilot is voluntary. Individuals who do not wish to participate in this pilot may continue to apply overseas at a U.S. embassy or consulate where they have a residence or are physically present.
The pilot aligns with the Administration's commitment to transform federal customer experience and service delivery to rebuild trust in government, as outlined in Executive Order 14058, signed on December 13, 2021 (
The Department will begin accepting online applications January 29, 2024 via
Every application received will be counted against an approximate 2,000 maximum weekly limit for each participating Mission. Once the limit is reached, the online portal will be locked until the next tranche of slots are released for each participating Mission group on the next application date. Applicants who are unable to apply on one application date may attempt to apply on any of the remaining application dates during the entry period. The application period for the pilot will close when all application slots are filled or on April 1, 2024, whichever comes first.
To complete an application, applicants must navigate to the dedicated domestic visa renewal website available at
Applications will be considered in the order received. The Department will not provide non-automated status reports on individual applications, other than the return of the application, issuance of the visa, or refusal, nor will it expedite applications. Applicants may check the status of their application at:
The application processing is as follows:
After online submission of the DS-160 and payment of the
The average processing time for a domestic visa renewal application is expected to be six to eight weeks from the time that the passport and other required documents are received by the Department. The Department aims to complete processing of all applications no later than May 1, 2024. The Department will not consider requests for expedited processing. If an applicant anticipates urgent travel, the applicant may wish to apply for visa renewal overseas where they have a residence or are physically present. If an applicant applies for domestic visa renewal and learns that they must travel urgently, the applicant may withdraw their application and request through the online portal that their passport be returned to them. If the applicant withdraws their application during the adjudication process, it will be refused under INA 221(g) and the MRV fee will
Domestic issuance of a visa through the pilot program is
Each applicant for a domestic H-1B visa renewal must submit the following documentation:
• A properly completed
• One photograph (taken within the last six months), which meets the specifications at:
• A passport valid for travel to the United States, which is valid for at least six months beyond the visa application date, and contains a blank, unmarked page for placement of a visa foil.
• The original or a copy of the applicant's current Form I-797, Notice of Action.
• The original or a copy of the applicant's Form I-94, Arrival-Departure Record (available at
After completing their DS-160, applicants must pay the required $205.00
After completing the DS-160 and paying the MRV fee, applicants will be provided information via the portal on where and how to send their passports and required documentation.
Issued visas, passports, and other documents submitted by the applicant will be returned via U.S. Postal Service or a commercial courier. It is important to note that issuance of a visa in the United States is
The Department will return the following out-of-scope cases
• Any application that seeks to renew a visa other than an H-1B visa.
• Any application where the prior H-1B visa was not issued by Mission Canada with an
• Any application which is subject to a nonimmigrant visa issuance fee (reciprocity fee). An applicant may research reciprocity fees by country and visa class here: U.S. Visa: Reciprocity and Civil Documents by Country (
• Any application where the prior visa includes a “clearance received” annotation.
Visa applications will be refused under section 221(g) of the INA if the application is accepted for domestic adjudication, but the applicant is subsequently found to be ineligible for a waiver of the in-person interview requirement under section 222(h) of the INA, or otherwise fails to satisfy the requirements for domestic renewal set out above in Section II, 9-12. In such cases, any applicant seeking to pursue a visa application will have to do so by filing a new DS-160 with a new MRV fee payment at an embassy or consulate overseas. The Department will not transfer applications to an overseas embassy or consulate or refund the MRV fee for applications returned or refused under the pilot program.
The Department also will refuse an application under section 221(g) of the INA if the applicant fails to provide required documentation or information but is expected to overcome the refusal before the end of the pilot. In such instances, the Department will provide specific instructions to the applicant with an opportunity to provide any outstanding documents or information, or correct any minor errors in the application, by April 15, 2024, before completing adjudication. Applicants who are instructed to provide such documentation or information, or those who are instructed to correct minor errors in their application, will not be required to pay an additional MRV fee. If the applicant provides the requested information by April 15, 2024, and the Department can issue the visa through the pilot program, the Department will overcome the 221(g) refusal and issue the visa. As the pilot concludes on May 1, 2024, any refusal due to missing documents or information will not be able to be overcome after that time. Some examples of additional information or documents that may be required include:
• Properly completed Form DS-160,
• Photograph meeting Department standards, and
• Evidence the applicant is resident in the United States.
This notice provides updated information pertaining to the outer limits of the U.S. continental shelf.
These limits are in effect as of December 21, 2023.
Brian Van Pay, Executive Director, U.S. Extended Continental Shelf Project, Department of State,
By Presidential Proclamation No. 2667 made on September 28, 1945, the United States asserted jurisdiction and control over the natural resources of its continental shelf. Subsequent to that Presidential Proclamation and through its domestic laws, the United States has exercised sovereign rights and jurisdiction over its continental shelf, consistent with international law.
The Department of State on behalf of the Government of the United States hereby announces the outer limits of the continental shelf of the United States of America. The coordinates in this notice describe the outer limits of the continental shelf of the United States in areas beyond 200 nautical miles from the baseline from which the breadth of the territorial sea is measured, in accordance with international law.
The limits set forth in this notice are subject to future revision, including with respect to maritime boundary delimitation with neighboring countries. The Government of the United States has been, is, and will be engaged in consultations and negotiations with governments of neighboring countries concerning the delimitation of areas subject to the respective jurisdiction of the United States and of these countries. The outer limits of the continental shelf of the United States as set forth in this notice are without prejudice to any negotiations with these countries or to any positions that may have been or may be adopted respecting the limits of maritime jurisdiction in such areas.
The coordinates in this notice are expressed in decimal degrees and have six decimal places. All coordinates use the World Geodetic System 1984 (“WGS 84”) datum, unless otherwise noted.
The term “straight line” means a geodesic line, which is the shortest distance between two points on the referenced ellipsoid and is the most common method of linking coordinates defining maritime limits and boundaries.
This notice is exempt from the requirements of 5 U.S.C. 553, to the extent those requirements apply, as it relates to a foreign affairs function of the United States. (See Title 5 U.S.C. 553 (a)(1).) This notice “`clearly and directly' involve[s] activities or actions characteristic of the conduct of international relations,”
In the Arctic, the outer limits of the continental shelf are defined by straight lines connecting the following fixed points:
ARC-OL-001 is located on the 200 nautical mile limit of Canada. ARC-OL-674 is located on the maritime boundary set forth in the U.S.-Russia maritime boundary agreement of 1990.
In the Atlantic (East Coast), the outer limits of the continental shelf are defined by straight lines connecting the following fixed points:
ATL-OL-001 is located on a seaward extension of the maritime boundary between the United States and Canada delimited by a chamber of the International Court of Justice in 1984.
In the Bering Sea, the outer limits of the continental shelf are defined by lines and arcs connecting the following fixed points:
Outer limit points BER-OL-001 to BER-OL-021 correspond to boundary points 36 to 56 of the U.S.-Russia boundary agreement of 1990.
• Between BER-OL-001 and BER-OL-002, the outer limit “extends along an arc with a radius of 200 nautical miles and a center at 60°38′23″ N, 173°06′54″ W.”
• Between BER-OL-002 and BER-OL-003, the outer limit “extends . . . along the rhumb line, defined by the following points: 64°05′08″ N, 172°00′00″ W, 53°43′42″ N, 170°18′31″ E.”
• Between BER-OL-003 and BER-OL-004, the outer limit “extends along an arc with a radius of 200 nautical miles and a center at 62°16′09″ N, 179°05′34″ E.”
• Outer limit points BER-OL-004 to BER-OL-021 are connected by straight lines.
In the Eastern Gulf of Mexico, the outer limits of the continental shelf are defined by straight lines connecting the following fixed points:
Outer limit points GME-OL-001 to GME-OL-007 correspond to boundary points 1 to 7 of the 2017 U.S.-Mexico maritime boundary treaty.
In the Western Gulf of Mexico, the outer limits of the continental shelf are defined by straight lines connecting the following fixed points:
Outer limit points GMW-OL-001 to GMW-OL-016 correspond to the 16 boundary points set forth in the 2000 U.S.-Mexico maritime boundary treaty.
In the area northeast of the Mariana Islands, the outer limits of the continental shelf are defined by a straight line connecting the following fixed points:
Outer limit point MAR-OL-001 is located on the 200 nautical mile limit of Japan. Outer limit point MAR-OL-002 is located on the 200 nautical mile (exclusive economic zone) limit of the United States.
In the Pacific (West Coast), the outer limits of the continental shelf are defined by straight lines connecting the following fixed points:
PAC-OL-001 and PAC-OL-382 are located on the 200 nautical mile (exclusive economic zone) limit of the United States.
This notice provides updated information pertaining to the outer limits of the U.S. exclusive economic zone.
These limits are in effect as of December 21, 2023.
Amanda Williams, Maritime Geographer, Department of State,
By Presidential Proclamation No. 5030 made on March 10, 1983, the United States established an exclusive economic zone, within which the United States may exercise its sovereign rights and jurisdiction as permitted under international law. The outer limit of the exclusive economic zone extends to a maximum distance of 200 nautical miles from the baseline from which the breadth of the territorial sea is measured.
The Department of State on behalf of the Government of the United States hereby announces updated information pertaining to the outer limits of the exclusive economic zone of the United States of America. The Government of
This Public Notice supersedes all limits defined in the following Public Notices that variously defined the outer limits of the U.S. fishery conservation zone before 1984 and the U.S. exclusive economic zone beginning in 1983: Public Notice 506, 41 FR 48619 (November 4, 1976); Public Notice 526, 42 FR 12937 (March 7, 1977); Public Notice 544, 42 FR 24134 (May 12, 1977); Public Notice 4710-01, 43 FR 1658 (January 11, 1978); Public Notice 585, 43 FR 1978 (January 11, 1978); Public Notice 910, 49 FR 31973 (August 9, 1984); and Public Notice 2237, 60 FR 43825 (August 23, 1995). This Public Notice incorporates the limits agreed to in treaties that entered into force or are being provisionally applied since publication of Public Notice 2237, is based on more recent survey data, and corrects typographical errors.
The coordinates in this notice use the World Geodetic System 1984 (“WGS 84”) datum, unless otherwise noted. For the purpose of this notice, the North American 1983 Datum (“NAD 83” (1986)) is considered equivalent to WGS 84. Some coordinates in this notice were derived from coordinates that used the North American Datum 1927 (“NAD 27”) or the World Geodetic System 1972 (“WGS 72”) datum. For those coordinates, the conversions to the WGS 84 datum were done using the National Geospatial-Intelligence Agency's Mensuration Services Program (MSP) Geographic Translator (GEOTRANS) version 3.8 and are noted in the relevant footnotes. In the case of a discrepancy, treaties and the judgment given by a Chamber of the International Court of Justice take precedence over the contents of this notice.
The term “straight line” means a geodesic line, which is the shortest distance between two points on the referenced ellipsoid and is the most common method of linking coordinates defining maritime limits and boundaries.
This notice is exempt from the requirements of 5 U.S.C. 553, to the extent those requirements apply, as it relates to a foreign affairs function of the United States. (See Title 5 U.S.C. 553 (a)(1).) This notice “ `clearly and directly' involve[s] activities or actions characteristic of the conduct of international relations,”
In the Gulf of Maine area, the outer limit of the exclusive economic zone is defined by straight lines connecting the following points:
Between points 15 (seaward of the Gulf Maine) and 16 (north of the Straits of Florida), the outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured.
From north of the Straits of Florida to the eastern Gulf of Mexico, the outer limit of the exclusive economic zone is defined by straight lines connecting the following points:
In the eastern Gulf of Mexico, between points 139 and 140, the outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured. The 200 nautical mile exclusive economic zone limit in this area intersects with the line connecting points 138 and 139 and with the line connecting points 140 and 141.
In the central Gulf of Mexico, the outer limit of the exclusive economic zone is determined by straight lines connecting the following points:
In the western Gulf of Mexico, between points 143 and 144, the outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured. The 200 nautical mile exclusive economic zone limit in this area intersects with the line connecting points 142 and 143 and with the line connecting points 144 and 145.
To the west, the outer limit is defined by straight lines connecting the following points:
From point 147 westward, the limit of United States jurisdiction is the territorial sea boundary with Mexico.
The outer limit of the exclusive economic zone around the Commonwealth of Puerto Rico and the Virgin Islands of the United States is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured, except that to the east, south, and west, the limit is defined by straight lines connecting the following points:
The outer limits of the exclusive economic zone around Navassa Island remain to be determined.
In the area seaward of the Strait of Juan de Fuca (Washington), the outer limit of the exclusive economic zone is defined by straight lines connecting the following points:
Between point 17 (seaward of the Strait of Juan de Fuca) and 18 (off the southern California coast), the outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured.
In the area off the southern California coast, the outer limit of the exclusive economic zone is defined by straight lines connecting the following points:
From point 21 to the coast, the limit of United States jurisdiction is the territorial sea boundary with Mexico.
Off the coast of Alaska, in the Beaufort Sea, the outer limit of exclusive economic zone is defined by straight lines connecting the following points:
Between point 21 (Beaufort Sea) and point 22 (Chukchi Sea), the outer limit
From the Chukchi Sea through the Bering Strait to the northern Bering Sea, the outer limit of the exclusive economic zone is defined by straight lines connecting the following points:
In the Bering Sea, between points 58 and 59, the outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured.
In the southern Bering Sea and North Pacific Ocean, the outer limit of the exclusive economic zone is defined by straight lines connecting the following points:
In the North Pacific Ocean, between points 87 and 88, the outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured.
From point 88, the limit of the exclusive economic zone off the coast of Alaska, seaward of the Dixon Entrance, is defined by straight lines connecting the following points:
The 1990 Agreement between the United States of America and the Union of Soviet Socialist Republics on the Maritime Boundary (U.S.-Russia Agreement of 1990) recognizes areas on the east side (
The outer limit of the exclusive economic zone is 200 nautical miles from the baselines from which the breadth of the territorial sea is measured.
The outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured, except that to the north of the Northern Mariana Islands, the limit is defined by straight lines connecting the following points:
The outer limit of the exclusive economic zone is 200 nautical miles from the baselines from which the breadth of the territorial sea is measured.
The outer limit of the exclusive economic zone is defined by straight lines connecting the following points:
The outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured, except that to the southeast and south of Palmyra Atoll and Kingman Reef the limit is defined by straight lines connecting the following points:
The outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured, except that to the south of Wake Island the limit is defined by straight lines connecting the following points:
The outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured, except that to the north and east of Jarvis Island the limit is defined by straight lines connecting the following points:
The outer limit of the exclusive economic zone is 200 nautical miles from the baseline from which the breadth of the territorial sea is measured, except that to the southeast and south of Howland and Baker Islands the limit is defined by straight lines connecting the following points:
Federal Aviation Administration, DOT.
Notice.
The Federal Aviation Administration (FAA) announces its findings on the Noise Compatibility Program (NCP) Update submitted by the City of Westfield, Massachusetts, through its Aviation Department, for Westfield-Barnes Regional Airport. The Final Noise Compatibility Program (NCP) was submitted to FAA for review and approval on May 26, 2023. The NCP was found to be sufficient for consideration by the FAA, and a
The applicable start date of the FAA's approval is December 14, 2023.
Cheryl Quaine, Federal Aviation Administration, New England Regional Office Environmental Protection Specialist, Airports Division, Federal Aviation Administration, 1200 District Avenue, Burlington, Massachusetts 01803. Phone number: 781-238-7613.
This notice announces that the FAA's approval of the NCP Update for the Westfield-Barnes Regional Airport. Per United States Code section 47504 (49 U.S.C. 47504) and Title 14, Code of Federal Regulations (CFR) part 150, an airport sponsor who previously
a. The noise compatibility program was developed in accordance with the provisions and procedures of 14 CFR 150.23;
b. Program measures are reasonably consistent with achieving the goals of reducing existing non-compatible land uses around the airport and preventing the introduction of additional noncompatible land uses;
c. Program measures would not create an undue burden on interstate or foreign commerce, unjustly discriminate against types or classes of aeronautical uses, violate the terms of airport grant agreements, or intrude into areas preempted by the Federal Government; and
d. Program measures relating to the use of flight procedures can be implemented within the period covered by the program without derogating safety, adversely affecting the efficient use and management of the navigable airspace and air traffic control systems, or adversely affecting other powers and responsibilities of the Administrator prescribed by law.
Specific limitations of FAA's approval of NCPs are delineated in 14 CFR 150.5. Approval is not a determination concerning the acceptability of land uses under Federal, state, or local law. Approval does not by itself constitute an FAA implementing action. A request for Federal action or approval to implement specific noise compatibility measures may be required, and an FAA decision on the request may require an environmental assessment of the proposed action. Approval does not constitute a commitment by the FAA to financially assist in the implementation of the noise compatibility program nor a determination that all measures covered by the NCP are eligible for grant-in-aid funding from the FAA. Where federal funding is sought, requests must be submitted to the FAA New England Regional Office at 1200 District Ave., Burlington, MA 01803.
The City of Westfield submitted the noise exposure maps, descriptions, and other documentation produced during the noise compatibility planning study to the FAA and the FAA determined that the NEMs for BAF were in compliance with applicable requirements under 14 CFR 150, effective June 3, 2019 (Noise Exposure Map Notice; Westfield-Barnes Regional Airport, Westfield, Massachusetts, volume 84,
It was requested that the FAA evaluate and approve this material as a noise compatibility program as described in 49 U.S.C. 47504. The FAA began its review and was required by a provision of 49 U.S.C. 47504 to approve or disapprove the program within 180 days, other than the use of new or modified flight procedures for noise control. The submitted program contained 23 proposed measures to minimize impacts of aviation noise on and off the airport. The FAA completed its review and determined that the procedural and substantive requirements of the 49 U.S.C. 47504 and 14 CFR part 150 were satisfied. A Record of Approval for the overall program was issued by the FAA effective December 14, 2023.
The specific program elements and their individual determinations are as follows:
NA-1—Maintain Runway Heading to East Mountain Ridge after Departing Runway 15. Approved as voluntary.
NA-2—Prohibit the Use of Intersection Departures on Runway 33. Approved as voluntary.
NA-3—Turn to 360-degrees Heading after Departing Runway 02. No action at this time.
NA-4—Barnes ANG Preferential Runway Use Program. Approved as voluntary.
NA-5: Barnes ANG Fighter Aircraft “High Initial” Approach Procedures. Disapproved for Purposes of Part 150.
NA-6: Barnes ANG Noise Abatement Departure Procedures. Approved as voluntary.
NA-7: Helicopter Noise Abatement Approach Procedures to Runway 02. Approved as voluntary.
NA-8: Helicopter Noise Abatement Departure Procedures from Runway 02. Approved as voluntary.
NA-9: Helicopter Noise Abatement Approach Procedures to Runways 15 and 33. Approved as voluntary.
NA-10: Helicopter Noise Abatement Departure Procedures to Runways 15 and 33. Approved as voluntary.
LU-1: Sound Insulate Noise-Sensitive Structures. Approved.
LU-2: Acquire Non-Compatible Residential Property. Approved.
LU-3: Acquire Avigation Easements. Approved.
LU-4: Modify Local Land Use Zoning. Approved.
LU-5: Modify Local Subdivision Regulations. Approved.
LU-6: Review Proposed Land Use Development within the 65 dB DNL Contour and Higher Contours. Approved.
LU-7: Voluntary Acquisition of Undeveloped Land. Approved.
LU-8: Real Estate Disclosure. Approved.
LU-9: Acquire the Arbor Mobile Home Park. Approved.
PM-1: Re-establish and Maintain a Noise Mitigation Advisory Committee. Approved.
PM-2: Continue the Community Awareness Program. Approved.
PM-3: Expand the Fly Quiet Program. Approved as Voluntary.
PM-4: Periodically Evaluate Noise Exposure. Approved.
These determinations are set forth in detail in the Record of Approval signed by the FAA Airports New England Deputy Director on December 14, 2023. The Record of Approval, as well as other evaluation materials and the documents comprising the submittal, are available for review at the FAA office listed above. The Record of Approval will also be available on the internet on the FAA's website at
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Random drug and alcohol testing percentage rates of covered aviation employees for the period January 1, 2024 to December 31, 2024; correction.
On December 15, 2023, the Federal Aviation Administration (FAA) published a correction to the Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period January 1, 2024 to December 31, 2024. In that document, the FAA inadvertently provided the incorrect docket number in the heading and corrections sections. This document corrects that error.
This correction is effective December 21, 2023.
Ms. Vicky Dunne, Federal Aviation Administration, Office of Aerospace Medicine, Drug Abatement Division, Program Policy Branch; Email
On December 15, 2023, the Federal Aviation Administration (FAA) published the Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period January 1, 2024 to December 31, 2024; Correction. In the heading and corrections section of the document, the docket number appeared as “Docket Number FAA-2023-25488” instead of “Docket No. FAA-2013-0259.” This document corrects that error.
On page 87046 of the
Issued in Washington, DC.
Federal Highway Administration (FHWA), DOT.
Notice of request for extension of currently approved information collection.
The FHWA has forwarded the information collection request described in this notice to the Office of Management and Budget (OMB) for approval of a renewal of information collection. We published a
Please submit comments by January 22, 2024.
You may submit comments identified by DOT Docket ID Number 0056 by any of the following methods:
John Berg, (202) 740-4602, Office of Freight Management and Operations, Federal Highway Administration, Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, Monday through Friday, except Federal holidays.
Section 141 also authorizes the Secretary to require States to file such information as is necessary to verify that their certifications are accurate. To determine whether States are adequately enforcing their size and weight limits, FHWA requires that each State submit to the FHWA an updated plan for enforcing their size and weight limits. The plan goes into effect at the beginning of each Federal fiscal year. At the end of the fiscal year, States must submit their certifications and sufficient information to verify that their enforcement goals established in the plan have been met.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for 11 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before January 22, 2024.
You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2006-25854, Docket No. FMCSA-2013-0106, Docket No. FMCSA-2013-0107, Docket No. FMCSA-2013-0108, Docket No. FMCSA-2015-0117, Docket No. FMCSA-2015-0119, Docket No. FMCSA-2017-0178, Docket No. FMCSA-2018-0052, or Docket No. FMCSA-2019-0028 using any of the following methods:
•
•
•
•
To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001,
If you submit a comment, please include the docket numbers for this notice (Docket No. FMCSA-2006-25854, Docket No. FMCSA-2013-0106, Docket No. FMCSA-2013-0107, Docket No. FMCSA-2013-0108, Docket No. FMCSA-2015-0117, Docket No. FMCSA-2015-0119, Docket No. FMCSA-2017-0178, Docket No. FMCSA-2018-0052, or Docket No. FMCSA-2019-0028), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. DOT posts these comments, without edit, including any personal information the commenter provides, to
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 statutes also allow the Agency to renew exemptions at the end of the 5-year period. However, 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 physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria
The 11 individuals listed in this notice have requested renewal of their exemptions from the epilepsy and seizure disorders prohibition in § 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable 2-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b), FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 11 applicants has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition. The 11 drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous 2-year exemption period. In addition, for commercial driver's license (CDL) holders, the Commercial Driver's License Information System and the Motor Carrier Management Information System are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency. These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of 2 years is likely to achieve a level of safety equal to that existing without the exemption.
In accordance with 49 U.S.C. 31136(e) and 31315(b), the following groups of drivers received renewed exemptions in the month of December and are discussed below. As of December 16, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following seven individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
The drivers were included in docket numbers FMCSA-2013-0106, FMCSA-2013-0107, FMCSA-2015-0117, FMCSA-2015-0119, FMCSA-2017-0178, or FMCSA-2018-0052. Their exemptions are applicable as of December 16, 2023 and will expire on December 16, 2025.
As of December 23, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following four individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
The drivers were included in docket numbers FMCSA-2006-25854, FMCSA-2013-0108, or FMCSA-2019-0028. Their exemptions are applicable as of December 23, 2023 and will expire on December 23, 2025.
The exemptions are extended subject to the following conditions: (1) each driver must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified ME, as defined by § 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (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 before it was 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).
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 on its evaluation of the 11 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8). In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for 2 years unless revoked earlier by FMCSA.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of availability and request for comments.
This document provides the public with notice that, on December 12, 2023, the Northern Indiana Commuter Transportation District (NICD) submitted a request for amendment (RFA) to its FRA-approved Positive Train Control Safety Plan (PTCSP). As this RFA requests FRA's approval of NICD's proposed material modifications to its FRA-certified positive train control (PTC) system, FRA is publishing this notice and inviting public comment on the railroad's RFA to its PTCSP.
FRA will consider comments received by January 10, 2024. FRA may consider comments received after that date to the extent practicable and without delaying implementation of valuable or necessary modifications to a PTC system.
Gabe Neal, Staff Director, Signal, Train Control, and Crossings Division, telephone: 816-516-7168, email:
In general, title 49 United States Code (U.S.C.) section 20157(h) requires FRA to certify that a host railroad's PTC system complies with title 49 Code of Federal Regulations (CFR) part 236, subpart I, before the technology may be operated in revenue service. Before making certain changes to an FRA-certified PTC system or the associated FRA-approved PTCSP, a host railroad must submit, and obtain FRA's approval of, an RFA to its PTCSP under 49 CFR 236.1021.
Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will publish a notice in the
Interested parties are invited to comment on NICD's RFA to its PTCSP by submitting written comments or data. During FRA's review of this railroad's RFA, FRA will consider any comments or data submitted within the timeline specified in this notice and to the extent practicable, without delaying implementation of valuable or necessary modifications to a PTC system.
In accordance with 49 CFR 211.3, FRA solicits comments from the public to better inform its decisions. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that by letter dated December 13, 2022, Union Pacific Railroad Company (UPRR) and Canadian National Railway Co. (CN) petitioned the Federal Railroad Administration (FRA) to join an existing waiver of compliance in Docket Number FRA-2016-0086.
UPRR and CN seek to form test waiver teams operating under the current test committee overseeing the relief in this docket to test UPRR's 2,113 NYAB CCBII-equipped and 660 Fastbrake-equipped locomotives and CN's 772 NYAB CCB-2 equipped locomotives.
This document also provides the public notice that BNSF, who is already a party to the relief in this docket, petitioned FRA to extend the existing relief and make the relief permanent.
A copy of the petitions from UPRR, CN, and BNSF, as well as any written communications concerning the petitions, are available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted at
Communications received by February 20, 2024 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable. Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Maritime Administration, Department of Transportation.
Notice.
The Maritime Administration (MARAD) announces a public meeting of the Peer Review Group (PRG). The PRG was established pursuant to the requirements of the National Historic Preservation Act (NHPA) and its implementing regulations to plan for the decommissioning and disposition of the Nuclear Ship Savannah (NSS). PRG membership is comprised of officials from the U.S. Department of Transportation, MARAD, the U.S. Nuclear Regulatory Commission (NRC), the Advisory Council on Historic Preservation (ACHP), and the Maryland State Historic Preservation Officer (SHPO) and other consulting parties. The public meeting affords the public an opportunity to participate in PRG activities, including reviewing and providing comments on draft deliverables. MARAD encourages public participation and provides the PRG meeting information below.
The meeting will be held on Tuesday, January 16, 2024, from 2:30 p.m. to 4:00 p.m. Eastern Standard Time (EST). Requests to attend the meeting must be received by 5:00 p.m. EST one week before the meeting, Tuesday, January 9, 2024, to facilitate entry or to receive instructions to participate online. Requests for accommodations for a disability must also be received one week before the meeting, Tuesday, January 9, 2024.
The meeting will be held onboard the NSS, online, or by phone. The NSS is located at Pier 13 Canton Marine Terminal, 4601 Newgate Avenue, Baltimore, MD 21124. To attend onboard the NSS or attend the meeting online, members of the public must submit a request to attend as described in the Public Participation section below. Online information will be provided to members of the public in response to their requests to attend. Members of the public may call-in using the following number: 312-600-3163 and entering conference ID: 930 866 814#.
Erhard W. Koehler, (202) 680-2066 or via email at
The decommissioning and disposition of the NSS is an Undertaking under Section 106 of the NHPA. Section 106 requires that federal agencies consider views of the public regarding their Undertakings; therefore, in 2020, MARAD established a Federal docket at
The NHPA Programmatic Agreement (PA) for the Decommissioning and Disposition of the NSS is available on the MARAD docket located at
The agenda will include (1) welcome and introductions; (2) program update; (3) status of PA stipulations; (4) other business; and (5) date of next meeting. The agenda topic titled PA stipulations involves deliverables identified in the PA. MARAD will provide status updates for the following items: the Disposition
The meeting will be open to the public. Members of the public who wish to attend in person or online must submit a request to attend to the person listed in the
By Order of the Maritime Administrator.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act (FACA), 5 U.S.C. ch. 10, that the Veterans and Community Oversight and Engagement Board (Board) will meet on January 31-February 1, 2024, at the VA Greater Los Angeles Healthcare System (VAGLAHS), 11301 Wilshire Boulevard, Building 500, Room 1281, Los Angeles, CA. The meeting sessions will begin and end as follows:
The meetings are open to the public and will be recorded. Sessions are open to the public, except during the time the Board is conducting tours of VA facilities. Tours of VA facilities are closed, to protect Veterans' privacy and personal information, in accordance with 5 U.S.C 552b(c)(6).
The Board was established by the West Los Angeles Leasing Act of 2016 on September 29, 2016. The purpose of the Board is to provide advice and make recommendations to the Secretary of Veterans Affairs on identifying the goals of the community and Veteran partnership; improving services and outcomes for Veterans, members of the Armed Forces, and the families of such Veterans and members; and on the implementation of the Draft Master Plan approved by VA Secretary on January 28, 2016, and on the creation and implementation of any successor master plans.
On Wednesday, January 31, 2024, from 8:30 a.m. to 12:00 p.m. PDT, the Board will meet in open session with key staff of VAGLAHS. The Advisory Committee Management Office will present, FACA 101 training. The agenda will include opening remarks from the Committee Chair, Executive Sponsor, and other VA officials. There will be a general update from the Director of VAGLAHS. The Designated Federal Officer will provide an update on the status of recommendation packages. The Board will receive an overview of matters associated with the new Hospital Construction from Office of Construction and Facilities Management. From 12:30 p.m. to 5:00 p.m. PDT, the Board will convene with a closed tour of VAGLAHS. Tours of VA facilities are closed to protect Veterans' privacy and personal information, in accordance with 5 U.S.C 552b(c)(6).
On Thursday February 1, 2024, the Board will reconvene in open session from 8:30 a.m. to 3:00 p.m. PDT, at the VAGLAHS facility. The Office of Asset Enterprise Management will provide a comprehensive presentation on the Principal Developer's contractual relationships, terms, conditions, and commitments for permanent supportive housing to include any negotiations regarding Town Center development construction. The Office of General Counsel, Real Property Group will provide an overview of policies that govern the rights to public access on VA medical and residential facilities.
Time will be allocated for receiving public comments on February 1, at 1:45 p.m. PDT. Individuals wishing to make public comments should contact Chihung Szeto at (562) 708-9959 or at
Any member of the public seeking additional information should contact Mr. Eugene W. Skinner Jr. at (202) 631-7645 or at
Internal Revenue Service (IRS), Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services (HHS).
Final rules.
This document finalizes rules related to the fees established by the No Surprises Act for the Federal independent dispute resolution (IDR) process, as established by the Consolidated Appropriations Act, 2021 (CAA). These final rules amend existing regulations to provide that the administrative fee amount charged by the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) to participate in the Federal IDR process, and the ranges for certified IDR entity fees for single and batched determinations, will be set by the Departments through notice and comment rulemaking. The preamble to these final rules also sets forth the methodology used to calculate the administrative fee and the considerations used to develop the certified IDR entity fee ranges. This document also finalizes the amount of the administrative fee for disputes initiated on or after the effective date of these rules. Finally, this document finalizes the certified IDR entity fee ranges for disputes initiated on or after the effective date of these rules.
These final rules are effective on January 22, 2024.
Shira B. McKinlay or William Fischer, Internal Revenue Service, Department of the Treasury, 202-317-5500;
Shannon Hysjulien or Rebecca Miller, Employee Benefits Security Administration, Department of Labor, 202-693-8335; and
Jacquelyn Rudich or Nora Simmons, Centers for Medicare & Medicaid Services, Department of Health and Human Services, 301-492-5211.
On December 27, 2020, the CAA was enacted.
Section 103 of the No Surprises Act established a Federal IDR process that plans and issuers and nonparticipating providers and facilities may utilize to resolve certain disputes regarding out-of-network rates under section 9816 of the Code,
Section 105 of the No Surprises Act added section 9817 of the Code,
The No Surprises Act also added provisions to title XXVII of the PHS Act in a new part E
The Departments, along with the Office of Personnel Management (OPM), have issued rules in 2021 and 2022 to implement various provisions of the No Surprises Act. More specifically relevant to this rulemaking, the Departments and OPM issued interim final rules (July 2021 interim final
The July 2021 interim final rules and October 2021 interim final rules generally apply to plans and issuers (including grandfathered health plans) for plan years (in the individual market, policy years) beginning on or after January 1, 2022, and to health care providers, facilities, and providers of air ambulance services for items and services furnished during plan years (in the individual market, policy years) beginning on or after January 1, 2022.
The October 2021 interim final rules implement the Federal IDR process under sections 9816(c) and 9817(b) of the Code,
To implement the Federal IDR process, the October 2021 interim final rules include requirements governing the costs of the Federal IDR process. Under section 9816(c)(5)(F)(i) of the Code,
Additionally, pursuant to section 9816(c)(8) of the Code,
Contemporaneously with the October 2021 interim final rules, the Departments released the Calendar Year 2022 Fee Guidance for the Federal Independent Dispute Resolution Process Under the No Surprises Act (October 2021 guidance), setting the administrative fee for both parties to a dispute at $50 per party.
• 2-20 line items: 100 percent of the approved batched determination fee;
• 21-50 line items: 110 percent of the approved batched determination fee;
• 51-80 line items: 120 percent of the approved batched determination fee; and
• 81 line items or more: 130 percent of the approved batched determination fee.
In December 2022, the Departments released the Amendment to the Calendar Year 2023 Fee Guidance for the Federal Independent Dispute Resolution Process Under the No Surprises Act: Change in Administrative Fee (December 2022 guidance), which amended the $50 per party administrative fee set in the October 2022 guidance to $350 for calendar year 2023.
On November 30, 2022, the Texas Medical Association, Tyler Regional Hospital, and a Texas physician filed a lawsuit (
On January 30, 2023, the Texas Medical Association, Houston Radiology Associated, Texas Radiological Society, Tyler Regional Hospital, and a Texas physician filed a lawsuit (
On October 6, 2023, the Departments and OPM released “FAQs About Consolidated Appropriations Act, 2021 Implementation Part 62”
On November 3, 2023, the Departments published the Federal Independent Dispute Resolution Operations proposed rules
With respect to the administrative fee, the Departments proposed in the IDR Operations proposed rules to collect the administrative fee directly from the parties rather than having the certified IDR entities collect the administrative fee on the Departments' behalf. The Departments also proposed required timeframes for the initiating and non-initiating parties to pay the administrative fee and proposed to establish consequences for non-payment of the administrative fee for each party. Finally, to ensure that the Federal IDR process is accessible to all parties, the Departments proposed to charge both parties a reduced administrative fee when the highest offer made during open negotiation by either party was less than a predetermined threshold and proposed to charge the non-initiating party a reduced administrative fee when the dispute is determined ineligible by either the certified IDR entity or the Departments, as applicable.
To align with these proposals, the Departments also set forth the methodology inputs used to calculate the proposed administrative fee amounts in the preamble to the IDR Operations proposed rules that would be effective for disputes initiated on or after January 1, 2025. The Departments proposed that the full administrative fee amount would be $150 per party per dispute, the reduced administrative fee for both parties when the highest offer made by either party during open negotiation was less than the threshold would be $75 per party per dispute (50 percent of the full administrative fee amount), and the reduced administrative fee for non-initiating parties in ineligible disputes would be $30 per non-initiating party per ineligible dispute (20 percent of the full administrative fee amount).
The inputs to the methodology set forth in this preamble and the administrative fee amount the Departments are finalizing in these final rules are effective for disputes initiated on or after the effective date of these final rules. In contrast, the proposed administrative fee structure and administrative fee amounts based on inputs to the methodology set forth in the IDR Operations proposed rules, if finalized, would be effective for disputes initiated on or after January 1, 2025. The administrative fee policies finalized in these final rules are effective, and unchanged by the proposals in the IDR Operations proposed rules, unless and until superseding administrative fee policies in the IDR Operations proposed rules are adopted.
In the September 26, 2023
The Departments received 44 comments on many different aspects of the IDR Fees proposed rules. In
Many comments concerned matters that were outside of the scope of the proposed rules and therefore are not addressed in these final rules. For example, the Departments received comments stating that the current Federal IDR process lacks the efficiency needed to resolve disputes quickly. The Departments also received many comments related to the eligibility determination process, including on difficulties determining eligibility in States with a specified State law and the lack of information provided by plans and issuers. Comments on the efficiency of the Federal IDR process and eligibility determinations relate to operations that are outside of the scope of these final rules' limited focus on the administrative fee and certified IDR entity fee ranges and the processes for setting such amounts. The Departments encourage interested parties to submit comments regarding the proposals included in the IDR Operations proposed rules, including the proposal to establish a Departmental eligibility review process, in accordance with the instructions set forth in those proposed rules.
Some other out-of-scope comments addressed the impacts of the Federal IDR portal closure, which occurred in response to litigation previously described in this preamble. For example, the Departments received comments requesting that, as a result of
Finally, the Departments received many comments suggesting different administrative fee structures. For example, the Departments received comments suggesting that the administrative fee amount be split between the parties, be refundable to the prevailing party, be funded 75 percent by plans and issuers and 25 percent by providers or be payable at the end of the Federal IDR process. The Departments also received comments recommending a variable administrative fee amount tied to the amount in dispute or the QPA, either for all disputes or just for batched disputes. Further comments suggested capping the administrative fee amount or imposing a base administrative fee amount and an additional tiered fee amount based on the amount in dispute.
As a result of the
The Departments did not propose any changes to the structure of the administrative fee as this would take longer to develop and implement and would be more efficiently operationalized with the changes proposed in the IDR Operations proposed rules, which are intended to be more comprehensive. While the Departments considered alternative fee structures in this rulemaking, the Departments were of the view that addressing the structure of the administrative fee in the IDR Operations proposed rules would give interested parties more time to comment, consider, and prepare for any fee structure change, because the effective date of the IDR Operations proposed rules, if finalized, will be later than the effective date of these final rules.
Additionally, the policies proposed in the IDR Operations proposed rules would require more time for the Departments to develop and implement due to the substantial changes to the Federal IDR portal required by those proposals, if finalized, including adopting new processes to collect the administrative fees directly from the parties and collecting differing amounts of administrative fees from different parties in certain circumstances, as described further in the IDR Operations proposed rules. Therefore, the Departments deferred those proposed changes to the Federal IDR process and administrative fee structure and collection procedures to the IDR Operations proposed rules and prioritized completing this rulemaking.
The Departments encourage interested parties to submit relevant comments
The Departments also sought to establish in rulemaking certified IDR entity fee ranges that would be effective as close to January 1, 2024 as possible, because this effective date would provide predictability for certified IDR entities, who must plan for and finalize their 2024 certified IDR entity fixed fee amounts, and parties, who must budget for their participation in the Federal IDR process taking into account both the administrative and certified IDR entity fees. Establishing the certified IDR entity fee ranges in rulemaking with an effective date close to January 1, 2024 would also allow for greater transparency than the current method of establishing the fee ranges in guidance.
These final rules amend 26 CFR 54.9816-8(d)(2)(ii) and (e)(2)(vii), 29 CFR 2590.716-8(d)(2)(ii) and (e)(2)(vii), and 45 CFR 149.510(d)(2)(ii) and (e)(2)(vii) to provide that the administrative fee amount and the ranges for certified IDR entity fees for single and batched disputes will be set by the Departments through notice and comment rulemaking, rather than in guidance published annually. The preamble to this rulemaking also sets forth the methodology used to calculate the administrative fee amount and the considerations used to develop the certified IDR entity fee ranges. These rules also finalize the administrative fee amount and certified IDR entity fee ranges for disputes initiated on or after the effective date of these rules. The finalized administrative fee amount and certified IDR entity fee ranges in these rules will remain in effect until changed by notice and comment rulemaking.
The IDR Fees proposed rules proposed that the administrative fee amount and certified IDR entity fee ranges finalized in these final rules would be effective for disputes initiated on or after the later of the effective date of these rules or January 1, 2024. As these final rules will not be effective by January 1, 2024, the Departments are finalizing the proposal that the administrative fee amount and certified IDR entity fee ranges in these rules will be effective for disputes initiated on or after the effective date of these rules, which is 30 calendar days from publication in the
Under section 9816(c)(8)(A) of the Code,
The Departments proposed to establish the amount of the administrative fee through notice and comment rulemaking by amending 26 CFR 54.9816-8(d)(2)(ii), 29 CFR 2590.716-8(d)(2)(ii), and 45 CFR 149.510(d)(2)(ii). The Departments also proposed at 26 CFR 54.9816-8(d)(2)(ii), 29 CFR 2590.716-8(d)(2)(ii), and 45 CFR 149.510(d)(2)(ii) that, for disputes initiated on or after the later of the effective date of these rules or January 1, 2024, the administrative fee amount would be $150 per party per dispute, which would remain in effect until changed by notice and comment rulemaking.
The Departments proposed to set the administrative fee amount by estimating the amount of expenditures made by the Departments in carrying out the Federal IDR process and dividing this amount by the estimated total number of administrative fees paid by the parties. As explained in the preamble to the IDR Fees proposed rules, the Departments estimated the total number of administrative fees paid based on the total volume of closed disputes.
For the purpose of calculating the administrative fee amount in the IDR Fees proposed rules, the Departments projected that approximately 225,000 disputes would be closed annually, resulting in 450,000 administrative fees paid. Additionally, the Departments estimated that the expenditures made by the Departments for carrying out the Federal IDR process in 2024 would be approximately $70 million.
After considering comments received on the proposals, as discussed further in this preamble section, the Departments are finalizing the policy to set the administrative fee amount in notice and comment rulemaking no more frequently than once per calendar year. The Departments may set the administrative fee less frequently than annually if the Departments estimate
Additionally, in response to comments received on the proposals, the Departments are modifying the administrative fee methodology used to estimate the number of administrative fees paid. The Departments will use the estimated number of administrative fees paid to certified IDR entities, rather than the estimated number of closed disputes, to estimate the total number of administrative fees paid. In addition, the Departments will not assume, as set forth in the IDR Fees proposed rules, a 25 percent reduction in the volume of disputes as the result of the District Court vacating certain batching requirements in
Many commenters supported the proposal to establish the administrative fee in notice and comment rulemaking. Commenters stated that this transparent process would allow the public to evaluate the administrative fee amount and provide feedback on the feasibility of providers using the Federal IDR process. However, several commenters opposed the proposal to establish the administrative fee amount more or less frequently than annually and stated that adopting this proposal would introduce uncertainty in the Federal IDR process and would make budgeting more challenging. These commenters requested that the Departments update the administrative fee annually, to balance stability, transparency, and responsiveness, which they stated would mitigate the impact of changes to the administrative fee. One commenter supported the proposal to establish the administrative fee amount more or less frequently than annually, but only if a mid-year change led to a decrease to the administrative fee amount. Commenters also stated that any increases to the administrative fee amount should be on an annual basis with advance notice to interested parties. One of these commenters stated that the administrative fee amount should be set predictably and with at least 90 days' advance notice. Some commenters requested further clarification on the process for proposing and finalizing administrative fee amounts in notice and comment rulemaking.
The Departments agree that one of the goals of establishing the administrative fee amount in notice and comment rulemaking is to foster transparency and allow interested parties to provide feedback on the methodology and process for setting the proposed fee amount. The Departments recognize commenters' concerns about establishing the administrative fee amount more or less frequently than annually, and the Departments are finalizing a policy under which they would establish the administrative fee amount no more frequently than once per calendar year. In addition, the Departments are finalizing as proposed the proposal to change the administrative fee amount less frequently than annually if the expenditures estimated to be made by the Departments in carrying out the Federal IDR process and the estimated total amount of administrative fees paid in the upcoming year are estimated to be equal. If the Departments determine that the estimated total amount of administrative fees paid in a future year at the current administrative fee amount would be less than the expenditures estimated to be made by the Departments in carrying out the Federal IDR process for that year, the Departments would propose to raise the administrative fee amount in notice and comment rulemaking. Alternatively, if the Departments determine that the estimated total amount of administrative fees paid in a future year at the current administrative fee amount would be more than the expenditures estimated to be made in carrying out the Federal IDR process for that year, the Departments would propose to lower the administrative fee amount in notice and comment rulemaking. Consistent with the statute, the Departments will set the administrative fee such that the estimated total amount of administrative fees paid is equal to the amount of expenditures estimated to be made by the Departments in carrying out the Federal IDR process.
The Departments also reiterate that using the notice and comment rulemaking process to establish the administrative fee amount will provide interested parties with substantial advance notice of fee changes, so additional advance notice is not needed. As described in the IDR Fees proposed rules, the Departments will provide details on the methodology used to determine the proposed administrative fee amount, and the proposed administrative fee amount, if finalized, would be effective prospectively. Interested parties will be provided with a period to submit public comments on the proposals, and the Departments will consider all comments submitted within the comment period in developing the final rules.
In addition, other commenters raised concerns regarding the amount of the administrative fee changing between any proposed and final rules. One commenter did not support making changes to the administrative fee amount between the proposed and final rules, while another commenter stated that any such changes should be by no more than 10 percent.
The Departments acknowledge these commenters' suggestions but note that the Departments may have more recent data available to estimate the total amount of administrative fees paid or the amount of expenditures estimated to be made by the Departments in carrying out the Federal IDR process while developing the final rules than they had while developing the IDR Fees proposed rules, and it is reasonable for the Departments to rely on the more recent data in developing the final rules, provided that they use the methodology described in the preamble to the IDR Fees proposed rules or a methodology modified from the preamble to the IDR Fees proposed rules in response to comments. As in these final rules, these circumstances may result in the Departments finalizing a different administrative fee amount than the amount proposed. The finalized
One commenter was concerned about the ability to comment on the administrative fee amount rather than just the methodology used to calculate the amount and stated that only seeking comment on the methodology could inhibit commenters' ability to accurately express the impact of the proposed fee amount on a disputing party's access to the Federal IDR process.
As previously explained, the Departments are finalizing a policy to establish the administrative fee amount in notice and comment rulemaking no more frequently than once per calendar year and will provide opportunity for comment on any new proposed administrative fee amount, as well as any changes to the methodology used to calculate the administrative fee amount.
Many commenters opposed the Departments' proposed administrative fee methodology for estimating the total number of administrative fees to be paid. Many commenters suggested that estimating the total number of administrative fees paid based on the projected total number of disputes closed would not capture all disputes in which administrative fees are paid. Some commenters were concerned that this methodology could result in an overpayment of administrative fees to the Departments. One of these commenters was concerned that the data from the six-month period in 2023 used to estimate the number of disputes closed would be radically different from 2024 data. Several commenters suggested using other metrics to calculate the estimated total number of administrative fees paid, including the number of disputes initiated, the number of disputes for which a certified IDR entity fee was paid, and the number of disputes for which parties submitted offers. Moreover, some commenters asserted that using disputes closed contradicts the Departments' regulations requiring each party to pay the administrative fee at the time the certified IDR entity is selected and the Departments' guidance permitting certified IDR entities to collect the administrative fee from parties up to the time of offer submission.
The Departments proposed to use the projected total number of disputes closed to calculate the administrative fee amount because that metric reflected collections under current collections processes,
In the preamble to the IDR Fees proposed rules, the Departments set the administrative fee amount based on the projection that 225,000 disputes would be closed annually. Because both initiating and non-initiating parties to a dispute are required to pay the administrative fee, the Departments estimated in the preamble to the IDR Fees proposed rules that 450,000 administrative fees would be paid annually, or 37,500 per month. As explained above, in setting the administrative fee in these final rules, the Departments are using the total number of administrative fees paid to certified IDR entities for disputes in any stage of the Federal IDR process after certified IDR entity selection. Using the methodology being adopted in these final rules, the Departments estimate that 492,000 administrative fees will be paid annually, or 41,000 administrative fees will be paid per month, by the parties. The Departments estimate the total number of administrative fees paid annually based on the monthly average number of administrative fees paid to certified IDR entities between February 2023 and July 2023. This monthly average was approximately 41,000, and the Departments projected this figure forward by 12 months to estimate that 492,000 administrative fees will be paid annually.
The Departments are using data from the same time period that was used in the IDR Fees proposed rules (February 2023 to July 2023), without updating to newer data. Data from this time period remains the best available data to project future trends due to portal closures and other Federal IDR process changes that began in August 2023 due to the
The Departments considered comments providing alternatives for estimating the total number of administrative fees paid in calculating the administrative fee amount. Some commenters wanted the Departments to estimate the total number of administrative fees paid based on the number of disputes initiated. This metric is inaccurate for purposes of calculating the administrative fee amount because the administrative fee may not be collected for all disputes initiated. The obligation for parties to pay the administrative fee attaches at the time of certified IDR entity selection (with guidance permitting certified IDR entities to collect the administrative fee from parties until the time of offer submission). Therefore, if a dispute is withdrawn before selection of the certified IDR entity, there is no obligation for the parties to pay
Other commenters requested the Departments to estimate the total number of administrative fees paid based on the number of disputes for which a certified IDR entity fee was paid. Because parties are not required to pay their certified IDR entity fees and administrative fees at the same time, the number of certified IDR entity fees paid would not necessarily reflect the number of administrative fees paid. Therefore, this metric would also be inaccurate for purposes of calculating the administrative fee amount.
Finally, the Departments also considered estimating the total number of administrative fees paid based on the number of disputes for which parties submitted offers. However, the Departments did not believe this metric would accurately reflect the estimated number of administrative fees that would be paid, since parties may pay administrative fees without submitting offers. Thus, the metric could understate the total number of administrative fees paid.
In summary, the Departments are of the view that it is most accurate to use the total number of administrative fees paid to certified IDR entities in the administrative fee methodology rather than the other metrics suggested by commenters in the prior paragraphs, as this metric reflects actual administrative fees that have been paid for disputes in any stage of the Federal IDR process after certified IDR entity selection.
The Departments also received comments regarding the Departments' projections of the total number of closed disputes used to estimate the total number of administrative fees paid. Several commenters suggested that the Departments' estimate of 225,000 closed disputes is too low. A few commenters suggested that the Departments are underestimating utilization of the Federal IDR process and recommended that the Departments analyze the available data from States implementing similar policies before the No Surprises Act.
In the IDR Fees proposed rules, the Departments estimated that 225,000 disputes would be closed annually, and because both the initiating and non-initiating parties to a dispute are required to pay the administrative fee, 450,000 administrative fees would be paid annually. The Departments now estimate that 492,000 administrative fees will be paid to certified IDR entities in the year, as described earlier in this preamble section. The Departments continue to be of the view that Federal IDR process data is the best available data to project trends in the Federal IDR process, especially because regulations and volume differ in State IDR processes. As mentioned in the IDR Fees proposed rules, the Departments initially anticipated 17,333 disputes involving non-air ambulance services would be initiated during the first year of implementation of the Federal IDR process. The Departments developed this estimate based on the experience of New York State. However, the use of State data resulted in the Departments underestimating utilization of the Federal IDR process, as nearly 335,000 disputes were initiated in the Federal IDR process between April 2022 and March 2023.
In addition, several commenters disagreed with the Departments' assumption of a 25 percent reduction in the volume of disputes in estimating the total number of administrative fees paid to account for the impact of
After reviewing the comments, the Departments have reconsidered the assumption that the number of disputes will decrease by 25 percent as a result of
The Departments recognize that certain batching criteria remain in place,
The Departments also received comments related to their estimated expenditures for purposes of calculating the administrative fee amount. Several commenters suggested that the Departments should disclose more data supporting the estimated costs to carry out the Federal IDR process in the administrative fee methodology to provide the public with an opportunity to comment. Some of these commenters asserted that the IDR Fees proposed rules did not provide enough detail on the estimated expenditures to allow interested parties to provide meaningful comment on the proposed administrative fee amount. One commenter urged the Departments to establish a regular process for detailing the Departments' data on the administrative fee, including an annual disclosure statement with a balance sheet, to promote transparency and predictability. A few commenters disputed the Departments' reference that Freedom of Information Act (FOIA) regulations prevent the Departments from providing detail on certain estimated expenditure amounts. These commenters stated that without this transparency, interested parties were not afforded an opportunity to meaningfully comment on the proposals related to the administrative fee amount and methodology inputs.
The Departments are finalizing the administrative fee amount based on a methodology that divides the “estimated,” rather than “projected,” expenditures to carry out the Federal IDR process by the estimated total number of administrative fees to be paid in the year. The use of “estimated” rather than “projected” expenditures is to ensure the terminology used to describe the methodology is consistent with that of the statutory text.
While the Departments described the contract costs and Federal resources associated with estimated expenditures to carry out the Federal IDR process in the preamble to the IDR Fees proposed rules, in response to comments requesting additional specifics on the estimated expenditures and in an effort to promote transparency, the Departments are providing further detail on costs included in the total estimated expenditures in these final rules within the bounds of the Departments' ability to disclose these amounts. To avoid releasing sensitive contract information, the Departments are breaking down the costs, which include the future contract and Federal personnel costs, by category of expenditure, and providing approximate cost estimates for carrying out the following categories of Federal IDR process activities:
• Maintaining, operating, and improving the Federal IDR portal, certifying IDR entities, and collecting data from certified IDR entities (approximately $26,360,000);
• Conducting program integrity activities, such as certain QPA audits (as further described subsequently in this preamble) and IDR decision audits, and receiving and investigating Federal IDR process-related complaints (approximately $13,060,000, of which QPA audits resulting from complaints filed by providers, facilities, or providers of air ambulance services comprise approximately $5,000,000);
• Providing outreach to parties and technical assistance to certified IDR entities, including assisting with eligibility determinations when the volume of disputes submitted exceeds the capacity of certified IDR entities to perform those determinations (approximately $11,630,000, of which assisting with eligibility determinations comprises approximately $10,000,000);
• Collecting administrative fees (approximately $5,530,000), which includes costs to invoice certified IDR entities for administrative fees collected, provide the system infrastructure for certified IDR entities to record and remit administrative fees collected, track data on fees collected and make continuous improvements to the collections process and invoicing systems.
The Departments are publishing summary-level estimated budget information and have provided meaningful data for public input for the purposes of calculating the administrative fee amount. The Departments intend to continue to provide data on the Federal IDR process to promote transparency and predictability in the administrative fee amount, including publishing quarterly public reports with the Departments' expenditures and administrative fee collections.
In response to commenters' concerns regarding the Departments' reference to the applicability of FOIA exemptions to information shared during the rulemaking process, the Departments clarify that they will disclose information in response to any requests in accordance with the FOIA and accompanying regulations. However, the Departments are not publishing specific future contract estimates in this rule in response to commenters' requests for more detail on estimated expenditures of Federal IDR process activities and the data underlying those estimates because publishing those contract estimates could undermine future contract procurements. For example, if the Departments were to publish the projected future cost of the contracts used to maintain the Federal IDR portal, the Federal Government would be meaningfully disadvantaged in future contract negotiations related to the Federal IDR portal, as bidders would know how much the Departments anticipate such a future contract being worth. Although current contract awards are published and publicly available,
The Departments are of the view that interested parties had sufficient information to meaningfully comment on the IDR Fees proposed rules. For example, commenters provided valuable information in their comments regarding how the Departments should estimate the total number of administrative fees paid. Based on these comments, the Departments modified the methodology accordingly. Similarly, the Departments provided detailed information in the IDR Fees proposed rules on their calculation of the estimated expenditures to carry out the Federal IDR process. Specifically, the Departments detailed the types of activities included in estimating the annual expenditures of approximately $70 million and received comments on these activities. After considering comments received on these details of the administrative fee methodology, the Departments have revised this estimate of annual expenditures down to approximately $56.6 million, as explained in later paragraphs.
In addition, many commenters raised concerns about the inclusion of certain types of expenses in the administrative fee methodology. Several commenters recommended excluding all or some of the QPA audit costs given that the QPA also serves a purpose outside of the Federal IDR process in calculating patient cost sharing. Some commenters asked the Departments to disclose their total expenditures on QPA audits and the portion proposed to be funded by administrative fees compared to other sources.
As previously mentioned, the Departments are required to include estimated expenditures to carry out the Federal IDR process, which include contract costs and Federal resources, in calculating the administrative fee amount. Accordingly, the Departments disagree with commenters who suggested that QPA audit costs should not be included in the calculation of the administrative fee amount and are adopting an administrative fee methodology that includes certain QPA audit costs in the estimated expenditures. For any dispute in the Federal IDR process, a plan or issuer would have been required to disclose the QPA to the provider along with the initial payment or notice of denial of payment for items and services, and disputing parties must include the QPA for items and services when initiating a dispute. Certified IDR entities are required to consider the QPA when selecting between the offers submitted by disputing parties when determining the total out-of-network payment rate for items and services subject to the Federal IDR process.
Furthermore, it is the responsibility of the Departments (or the applicable State authorities), rather than the provider, facility, provider of air ambulance services, or the certified IDR entity, to monitor plan and issuer compliance with the QPA requirements.
Moreover, addressing concerns about inaccurately calculated QPAs helps to ensure plans and issuers provide correctly calculated QPAs when they participate in the Federal IDR process. For example, in the absence of QPA audits to investigate complaints from providers, facilities, and providers of air ambulance services that one or more of a plan's or issuer's QPAs are inaccurate, plan and issuer compliance with QPA requirements would go unchecked.
In estimating the expenditures to carry out the Federal IDR process, the Departments are including estimated costs only for certain QPA audits that the Departments anticipate incurring to investigate complaints regarding inaccurate QPAs made by providers, facilities, and providers of air ambulance services under the Federal IDR process. The Departments are not including the costs of QPA audits conducted: (1) in connection with Department of Labor, OPM, or Department of the Treasury investigations; (2) randomly; or (3) in response to complaints from consumers, as not all of these audits are necessarily related to the Federal IDR process. The Departments are of the view that only the costs related to QPA audits conducted in response to complaints from entities that are potential parties to a payment determination are sufficiently related to the Federal IDR process to justify their inclusion in the administrative fee calculation. For example, consumers who complain that a plan or issuer inaccurately calculated their cost sharing based on an erroneously calculated QPA will not be involved in the Federal IDR process, and therefore the costs of such audits are appropriately excluded from those costs supported by administrative fees paid by parties to the Federal IDR process. Because HHS is primarily responsible for the implementation of the Federal IDR process, the Departments view similarly random QPA audits that may be conducted by the Departments, as well as any QPA audits in connection with Department of Labor, OPM, and Department of the Treasury investigations.
The costs of HHS conducting QPA audits for complaints that a plan's or issuer's QPAs are inaccurate are estimated to be approximately $5,000,000 in 2024. As plans and issuers improve their compliance in calculating QPAs correctly, the Departments anticipate that the costs of conducting these audits will decrease, which would be reflected in the estimated expenditures used to determine future administrative fee amounts.
Several commenters also disagreed with including costs associated with assisting with eligibility reviews in the estimated expenditures to carry out the Federal IDR process. A few of these commenters noted that certified IDR entities are responsible for conducting eligibility reviews and therefore certified IDR entity fees should cover this cost. Some commenters asserted that such costs should be recovered through the non-prevailing party's certified IDR entity fee, as the eligibility determination is part of the payment determination. One of these commenters expressed concern that including this expense would incentivize certified IDR entities to understaff as HHS would intervene to address a staffing shortage.
The Departments disagree that the costs of assisting with eligibility determinations should be excluded from estimated expenditures. Certified IDR entities voluntarily participate in the Federal IDR process and set their certified IDR entity fees within ranges established by the Departments to ensure they remain financially viable and that such fees can cover their operating expenses to participate in the Federal IDR process, which include the costs incurred in determining the eligibility of items and services for the Federal IDR process. While certified IDR entities are responsible for making eligibility determinations, and therefore incur costs associated with this activity, the Departments have also incurred costs since November 2022 to assist certified IDR entities in making these determinations by performing research and outreach on disputes pending eligibility determinations, including identifying and obtaining information necessary for certified IDR entities to make eligibility determinations, and will continue to incur such costs in 2024.
When the Departments first developed the Federal IDR process and the rules and guidance establishing how certified IDR entities were to calculate their fees for the scope of work they were expected to perform, the Departments and the certified IDR entities did not anticipate the significant difficulty and costs involved in determining eligibility for the Federal IDR process. After six months of operating the Federal IDR process and receiving feedback from disputing parties and certified IDR entities, the Departments determined that it was necessary to assist certified IDR entities with determining eligibility through performing research and outreach on disputes pending eligibility determinations, including identifying and obtaining information necessary to make an eligibility determination.
In the IDR Operations proposed rules, the Departments proposed several policies aimed at improving communication between the parties that would make eligibility determinations less burdensome for certified IDR entities and speed up the Federal IDR process, as well as allow the Departments to make eligibility determinations under extenuating circumstances.
However, after reviewing comments, the Departments have reconsidered the amount of estimated costs associated with pre-eligibility reviews that should be included in the estimated expenditures to carry out the Federal IDR process in calendar year 2024. In estimating the expenditures of approximately $70 million in the IDR
Furthermore, the Departments do not anticipate that the decision to focus their assistance with pre-eligibility reviews on more complex disputes and the revised administrative fee amount finalized in these rules will impact the fees certified IDR entities choose to charge. Given the backlog of disputes, utilization of the Federal IDR process strains the current capacity of certified IDR entities to make timely determinations. While the Departments' assistance with eligibility determinations is currently helping to alleviate the backlog of disputes, certified IDR entities' operating expenses are not expected to decrease as a result. If the Departments are able to decrease their assistance with eligibility determinations, the costs of pre-eligibility reviews would decrease, which would be reflected in the estimated expenditures used to determine future administrative fee amounts.
In addition, some commenters disagreed with including the costs of investigating complaints of non-compliance in the administrative fee methodology. Commenters asked for clarity in the “investigating relevant complaints” expense and asserted that “relevant” complaints beyond the Federal IDR process would be inappropriate to include in the calculation of the administrative fee amount. A few of these commenters suggested that the party found to be non-compliant should bear the costs of the investigation and asked the Departments to publicly report summary data on these investigations and the costs covered by non-compliant parties compared to those covered by administrative fees. One commenter suggested that the investigation of complaints related to violations of the No Surprises Act should be funded by a congressional appropriation as these are largely unrelated to the Federal IDR process.
The Departments clarify that the complaints costs included in the estimated expenditures in the administrative fee methodology only include costs associated with receiving and investigating Federal IDR process-related complaints. For example, such costs include investigating complaints within the Departments' jurisdiction regarding the failure of a non-prevailing party to pay the payment determination amount to the prevailing party within 30 days of the certified IDR entity's payment determination as required by the No Surprises Act.
Many commenters suggested that the Departments consider other funding sources besides the administrative fee to fund expenditures. Several commenters suggested that implementing penalties could help fund expenditures, including penalties for submitting ineligible disputes, failing to comply with disclosure obligations, or delaying the Federal IDR process. Some commenters suggested the CAA's $500 million appropriation to implement the No Surprises Act should cover at least a portion of the Departments' estimated expenditures. One commenter asked for confirmation that the implementation appropriation has been exhausted fully and suggested requesting additional funds from Congress in upcoming budget requests to support the funding of the Departments' ongoing implementation. Another commenter asserted that the administrative fee methodology set forth in the IDR Fees proposed rules did not take into account any appropriations funding.
As required by the No Surprises Act,
In addition, commenters urged the Departments to consider strategies to decrease utilization of the Federal IDR process, decrease administrative burden, increase the efficiency of the Federal IDR process, and ultimately reduce the cost of administering the Federal IDR process. Examples of commenters' suggestions include enforcing disclosure requirements, requiring plans and issuers to include remittance advance remark codes (RARCs) at the time of initial claim determination, easing batching requirements, disincentivizing bad faith conduct, making improvements to the Federal IDR portal, and implementing a required initial payment amount for out-of-network emergency services. Several commenters suggested that the volume of ineligible disputes and the cost of conducting eligibility reviews would be reduced or eliminated if the Departments enforced disclosure requirements or required plans and issuers to provide adequate information for providers to determine whether a claim is eligible for the Federal IDR process. One commenter suggested that plans and issuers should cover the cost of eligibility reviews when they fail to inform the provider of eligibility for the Federal IDR process. Another commenter suggested that the cost of eligibility reviews should be assessed to the party that challenges eligibility as this cost would be avoidable if the plan or issuer provided sufficient information. One commenter suggested that the Departments could reduce the administrative burden of the Federal IDR process by contracting with an established claims processing clearinghouse that currently possesses the capabilities to perform real-time eligibility determinations to create an in-portal eligibility validation process.
The Departments continue to consider improvements to the Federal IDR process and recently published the IDR Operations proposed rules,
Recognizing that the cost of certifying IDR entities is included in the administrative fee methodology, one commenter sought clarity on how the methodology considers efficiencies gained from certifying more IDR entities to make payment determinations and therefore reduce the backlog.
The Departments note that the benefits of certifying new IDR entities will be achieved over time, as new certified IDR entities acclimate to the process and increase the speed at which they move disputes through the Federal IDR process. As efficiencies in the Federal IDR process are adopted over time, the expenditures required to carry out the Federal IDR process could decrease, exerting downwards pressure on the administrative fee amount. If any of these situations results in changes to the data used to calculate the administrative fee amount, the Departments intend to take these changes into consideration when establishing the administrative fee amount in the future.
The Departments sought comments on whether, when calculating the administrative fee amount in future years, they should apply an inflationary adjustment, such as the consumer price index for all urban consumers (CPI-U), to the amount of estimated expenditures to be made by the Departments in carrying out the Federal IDR process. A few commenters supported using an inflationary adjustment, such as the CPI-U, to adjust the administrative fee amount in future years. Other commenters opposed this approach, stating that it would not necessarily correlate with the Departments' expenditures to operate the Federal IDR process and may not align with the established methodology of dividing the Departments' estimated expenditures by the estimated total number of administrative fees to be paid. Another commenter stated that this proposal would be unnecessary if the Departments finalize the proposal to establish the administrative fee amount more or less frequently than annually. Finally, another commenter asked the Departments to revisit this proposal when data are more predictable after implementing planned improvements to the Federal IDR process.
Upon consideration of the comments, the Departments are not finalizing the use of an inflationary adjustment, such as the CPI-U, to adjust the administrative fee amount in future years. The Departments agree with commenters that the CPI-U may not correlate with projected increases in the Departments' estimated expenditures to carry out the Federal IDR process and therefore using it could be inconsistent with the statute.
Several commenters urged the Departments to improve the Federal IDR process before increasing the administrative fee amount by decreasing the backlog, enforcing timely payment, and holding all parties accountable to the regulatory requirements. Some commenters recommended maintaining the current administrative fee amount until there is stability in the Federal IDR process and more data are available to accurately forecast long-term costs. A few commenters suggested that the Departments modify the administrative fee amount in future years to make up for any shortfall or surplus created by the finalized administrative fee amount.
As previously mentioned, the Departments continue to consider improvements to the Federal IDR process; however, implementing these improvements would increase the costs of carrying out the Federal IDR process in the short term and would take time to operationalize. As previously mentioned, the Departments proposed policies in the IDR Operations proposed rules aimed to improve the overall efficiency and operations of the Federal
Many commenters opposed the proposed $150 per party per dispute administrative fee amount and stated that it would make the Federal IDR process cost-prohibitive to pursue for many providers, especially small providers, rural providers, independent practices, and certain medical specialties, such as psychiatry, emergency medicine, radiology, and anesthesiology. Some commenters requested that the Departments analyze how the proposed administrative fee amount would be cost-prohibitive for providers and would deter and limit dispute resolution for small providers. A few commenters asserted that the administrative fee amount would unfairly favor plans and issuers over providers in the Federal IDR process. One commenter recommended against using a methodology to calculate the administrative fee amount that did not consider the increased financial burdens on providers compared to plans and issuers. Another commenter stated that the proposed administrative fee amount prioritizes the interest of certified IDR entities and the Departments in covering their costs at the expense of parties' access to the Federal IDR process.
Similarly, some commenters stressed that it is important to keep the administrative fee amount low to prevent the administrative fee from serving as a
A few commenters suggested that patients would also be impacted by the increased administrative fee amount, either through plans and issuers narrowing provider networks or increasing premiums and cost-sharing amounts, or providers passing on costs to patients or going out of business. However, several commenters noted that the proposed fee amount was an improvement from the previous $350 amount.
For reasons described throughout this preamble, the Departments are finalizing the administrative fee amount for disputes initiated on or after the effective date of these rules as $115 per party per dispute. This change in the administrative fee amount between the proposed and final rules reflects modifications to the estimated expenditures and to the administrative fee methodology described elsewhere in this preamble.
While the Departments are statutorily required to set the administrative fee amount such that the total amount of administrative fees paid is estimated to be equal to the amount of expenditures estimated to be made by the Departments in carrying out the Federal IDR process, the Departments acknowledge the concerns of commenters related to accessibility and affordability of the Federal IDR process and the impact of the proposed administrative fee amount on the parties and patients. In the Departments' effort to balance their statutory obligations with the priority of ensuring equitable access for parties to engage in the Federal IDR process, the Departments proposed in the IDR Operations proposed rules to reduce the administrative fee amount in certain circumstances. In the IDR Operations proposed rules, the Departments proposed to reduce the administrative fee amount to $75 (50 percent of the full administrative fee amount proposed in those proposed rules) for both parties when the highest offer by either party in open negotiation was less than the full administrative fee amount ($150 as proposed in those proposed rules)
The administrative fee amount being finalized in these final rules is applied equally to both parties to a dispute. The Departments are of the view that it would be inequitable to charge a smaller party a lower administrative fee, because a dispute initiated by a smaller party costs the Departments the same amount to process as a dispute initiated by a larger party. Furthermore, the value of a dispute, rather than the size of the party, determines whether it will be cost-effective for the party to pursue the dispute. For example, a smaller party could initiate a high dollar value dispute, while a larger party could initiate a small dollar value dispute. The Departments proposed in the IDR Operations proposed rules to charge both parties a reduced administrative fee when the highest offer made during open negotiation is less than the full administrative fee amount,
The Departments considered the impact of the proposed $150 administrative fee amount on the parties compared to the current $50 administrative fee amount and the previous $350 administrative fee amount. While the Departments understand that it may be economically infeasible to initiate some claims in the Federal IDR process due to the administrative and certified IDR entity fees associated with accessing the process, as discussed previously, the Departments are statutorily obligated to
Congress did not include a dollar-value threshold for Federal IDR process disputes in the No Surprises Act. Rather, Congress opted to include a requirement in the No Surprises Act for each party to a dispute for which a certified IDR entity is selected to pay to the Departments, at such time and in such manner as specified by the Departments, a fee for participating in the Federal IDR process.
In regard to comments stating that the administrative fee could result in narrowing networks, many factors may impact whether a provider, facility, or provider of air ambulance services and a plan or issuer will enter a network agreement with one another, including the market power of each party, Federal and State network adequacy laws, and other factors. The Departments acknowledge that the amount paid for out-of-network services is one of the factors that impacts market participants' decisions whether to enter network agreements. The No Surprises Act represents a substantial change to the way the parties come to agreement on payment for out-of-network services by prohibiting, in many circumstances, the practice of sending surprise medical bills to patients and establishing a Federal IDR process for determining the appropriate out-of-network rate. Many providers report that initial payments made by plans and issuers for out-of-network services are now substantially lower than such payments were before enactment of the No Surprises Act. Some providers report that plans' and issuers' abilities to make lower payments for out-of-network services has impacted their willingness to offer acceptable in-network payment rates in network agreement negotiations. To the extent that the Federal IDR process and the prohibition on surprise medical billing change this equilibrium among parties, they could impact the number of providers and plans and issuers that are able to agree on terms for entering a network agreement and consequently network breadth.
In the IDR Operations proposed rules, the Departments are proposing a number of steps to accelerate throughput in the Federal IDR process,
The Departments also do not anticipate that the policies finalized in these rules would cause plans and issuers to increase premiums, as further discussed in section IV.G of this preamble, or patient cost sharing, because administrative fees paid would likely represent a very small percentage of the costs considered by plans and issuers in calculating annual premiums or cost sharing.
Many commenters emphasized the importance of considering the proposed administrative fee amount alongside batching requirements to determine whether the administrative fee amount would be cost-prohibitive. Some commenters suggested that batching policies could mitigate the financial challenges providers and facilities face, especially when pursuing low-dollar claims. A few commenters suggested it was premature to update the administrative fee amount or provide feedback on a proposed amount until batching guidance is updated. One commenter viewed an administrative fee of $150 per party as reasonable so long as a claim is defined as an episode of care or a single medical encounter in the batching policy.
The Departments are continuing to assess batching flexibilities and the impact of batching on various parts of the Federal IDR process. To further improve batching requirements, the Departments proposed provisions in the IDR Operations proposed rules
While the Departments continue to consider improvements to the Federal IDR process, including policies surrounding batching and low-dollar claims, the No Surprises Act requires that the administrative fee be estimated to cover the expenditures estimated to be made by the Departments in carrying out the Federal IDR process in the year, and the Departments estimate that $115 per party per dispute is the appropriate administrative fee amount to meet this requirement for disputes initiated on or after the effective date of these rules.
Under current regulations at 26 CFR 54.9816-8T(e)(2)(vii), 29 CFR 2590.716-8(e)(2)(vii), and 45 CFR 149.510(e)(2)(vii), the certified IDR entity fees for single and batched determinations are set by the certified IDR entities within the upper and lower limits of ranges for each as set forth in guidance issued annually by the Departments.
In the IDR Fees proposed rules, the Departments proposed to amend the provisions of the regulations establishing the ranges for certified IDR entity fees for single and batched disputes to establish the ranges in notice and comment rulemaking, rather than in guidance, at 26 CFR 54.9816-8(e)(2)(vii), 29 CFR 2590.716-8(e)(2)(vii), and 45 CFR 149.510(e)(2)(vii). Further, the IDR Fees proposed rules provided that, consistent with current rules, certified IDR entities must annually provide a fixed fee for single determinations and separate fixed fees for batched determinations within the upper and lower limits for each as set in notice and comment rulemaking. Additionally, the IDR Fees proposed rules provided that the certified IDR entity fee ranges established by the Departments in rulemaking would remain in effect until new certified IDR entity fee ranges are established by notice and comment rulemaking,
The Departments proposed that for disputes initiated on or after the later of the effective date of these rules or January 1, 2024, certified IDR entities would be permitted to charge a fixed certified IDR entity fee for single determinations within the range of $200 to $840, unless a fee not within that range is approved by the Departments pursuant to paragraphs 26 CFR 54.9816-8(e)(2)(vii)(A) and (B), 29 CFR 2590.716-8(e)(2)(vii)(A) and (B), and 45 CFR 149.510(e)(2)(vii)(A) and (B). The Departments also proposed that for disputes initiated on or after the later of the effective date of these rules or January 1, 2024, certified IDR entities would be permitted to charge a fixed certified IDR entity fee for batched determinations within the range of $268 to $1,173, unless a fee outside this range is approved by the Departments pursuant to paragraphs 26 CFR 54.9816-8(e)(2)(vii)(A) and (B), 29 CFR 2590.716-8(e)(2)(vii)(A) and (B), and 45 CFR 149.510(e)(2)(vii)(A) and (B). The Departments proposed to continue to use a tiered fee structure based on the number of line items within the batch.
If a certified IDR entity wishes to charge a fee outside either of these fee ranges, it would continue to follow the existing process for requesting written approval from the Departments outlined in 26 CFR 54.9816-8(e)(2)(vii)(A) and (B), 29 CFR 2590.716-8(e)(2)(vii)(A) and (B), and 45 CFR 149.510(e)(2)(vii)(A) and (B).
Since the publication of the IDR Fees proposed rules, the Departments have analyzed updated data and assumptions as applied to the factors considered in the IDR Fees proposed rules' preamble to set the fee ranges, and the Departments found that the results of the analysis remain the same. The Departments received comments on these proposals.
The Departments are finalizing as proposed the policy to establish the certified IDR entity fee ranges through notice and comment rulemaking, rather than guidance. The Departments are also finalizing the certified IDR entity fee ranges for single and batched disputes as proposed. Finally, the Departments are finalizing the fixed tier fee structure for batched disputes, as well as the range for this structure, as proposed.
However, after considering the public comments, the Departments are not finalizing the proposal which would have allowed the Departments to set the certified IDR entity fee ranges more frequently than annually but are instead finalizing the proposal with modifications to reflect that the certified IDR entity fee ranges may be established by the Departments no more frequently than annually through notice and comment rulemaking. Further, the Departments are finalizing the proposal that the certified IDR entity or IDR entity seeking certification may seek advance written approval from the Departments to update its fees more often than once annually, with modifications to reflect that in addition to setting their initial fee for the calendar year, certified IDR entities may only request approval from the Departments to update their fees one additional time per year, and with additional non-substantive modifications for readability. Finalizing this policy would result in a process where the certified IDR entity or IDR entity seeking certification sets their fixed fees for single and batched determinations for the year, and then is allowed one opportunity at any point during the calendar year to update their fixed fees, provided that their request is approved by the Departments.
Many commenters supported the proposal to establish the certified IDR entity fee ranges through notice and comment rulemaking. Several commenters noted that establishing the certified IDR entity fee ranges through notice and comment rulemaking would increase transparency and allow interested parties to provide feedback that would help the Departments appropriately adjust the fee ranges. Many commenters expressed opposition to the Departments' proposal to establish the certified IDR entity fee ranges more or less frequently than annually. The majority of these commenters encouraged the Departments to update the certified IDR entity fee ranges only once annually to create a more predictable and stable Federal IDR process. Several commenters expressed concern that changing the certified IDR entity fee ranges more frequently than once annually would prevent providers from effectively budgeting for participation in the Federal IDR process, which would create a barrier to access. A few commenters noted that unpredictable changes to the certified IDR entity fee ranges could impact plans' and issuers' abilities to budget for the Federal IDR process and could lead plans and issuers to budget more conservatively and pass on the cost increase to consumers.
A few commenters generally supported the flexibility to update the certified IDR entity fee ranges more or less frequently than annually. However, one commenter supported the proposed flexibility only if the Departments adjusted the fee ranges less frequently than annually, while another commenter supported the proposed flexibility if the Departments provided adequate notice, such as 90 days, before implementing the changed fee ranges. Further, several commenters opposed the proposal to allow certified IDR entities or IDR entities seeking certification to seek advance written approval from the Departments to set their certified IDR entity fees more often than annually. Similar to the proposal to establish the certified IDR entity fees through notice and comment rulemaking more or less frequently than annually, some commenters expressed concerns that the proposed policy would cause unpredictability for the parties, which would impact their ability to effectively budget for the Federal IDR process. One commenter misinterpreted the proposed policy as proposing to require certified IDR entities to adjust their fees whenever operational or technological efficiencies could justify a decrease in cost, and expressed concern that the proposed policy may discourage certified IDR entities from participating in the Federal IDR process. One commenter opposed multiple fee adjustments within a given year but supported allowing certified IDR entities a limit of one additional fee adjustment per year following a compelling request and formal approval.
The Departments agree with commenters that the proposal to establish the certified IDR entity fee ranges through notice and comment rulemaking will improve transparency and provide opportunity for greater engagement by interested parties in the establishment of the ranges. The Departments recognize commenters' concerns that the proposed flexibility to set the certified IDR entity fee ranges through notice and comment rulemaking more or less frequently than annually would enable multiple changes to the certified IDR entity fee ranges over the course of a year. In general, the Departments recognize that frequent changes to the established certified IDR entity fee ranges could increase unpredictability in the Federal IDR process and potentially burden parties, but note that they did not propose this policy with the intention of pursuing such frequent changes. The Departments contemplated establishing this proposed flexibility so that the certified IDR entity fee ranges could remain effective for multiple years. Further, updating the certified IDR entity fee ranges does not guarantee that certified IDR entities will set new fixed fee amounts. Each certified IDR entity determines their fee amounts independently, and there is no requirement to make a corresponding adjustment each time the certified IDR entity fee ranges established by the Departments change, provided the certified IDR entity's fee stays within the new range.
While it would be unlikely that the Departments would pursue multiple notice and comment rulemakings in a single year to adjust the certified IDR entity fee ranges, the Departments acknowledge the potential for the proposed policy to increase uncertainty within the Federal IDR process. Therefore, to be responsive to commenters' concerns, the Departments are finalizing this proposal with modifications to reflect that the certified IDR entity fee ranges may be established no more frequently than once per calendar year. This allows the certified IDR entity fee ranges to remain effective over multiple years until they are updated in notice and comment rulemaking, while addressing commenters' concerns by preventing multiple adjustments of the certified IDR entity fee ranges in a single year.
The Departments acknowledge that frequent increases to certified IDR entity fees could lead to unpredictability and complicate the ability of the parties to effectively budget for the Federal IDR process. The Departments are of the view that the proposed mechanism for certified IDR entities to request to set their fees more than once annually includes sufficient guardrails to ensure that any changes to the certified IDR entities' fees would not prevent parties from accessing the Federal IDR process. Specifically, the Departments proposed to require certified IDR entities to submit the following information to the Departments in their requests: (1) the fixed fee that the certified IDR entity is seeking to charge; (2) a description that reasonably explains the circumstances that require a change to its fee; and (3) a detailed description that reasonably explains how the change to its fee will be used to mitigate the effects of these circumstances. The Departments would use their discretion to determine if the explanations included in the request demonstrate that the change would ensure the certified IDR entity's financial viability and would not impose on parties an undue barrier to accessing the Federal IDR process.
The Departments seek to strike a balance between predictable fees for parties participating in the Federal IDR process and certified IDR entities' need for flexibility to respond to circumstances that require fee adjustments to maintain program operations. For example, the Departments acknowledge that certified IDR entities consider various factors, including operational costs, in setting fees for the Federal IDR process. However, certified IDR entities have needed to increase staff resources, implement system updates, and adjust operations to respond to unexpectedly frequent changes to guidance or regulations governing the Federal IDR process or the volume of disputes initiated and closed under the Federal IDR process. To ensure that certified IDR entities have sufficient funding to respond to such circumstances, providing certified IDR entities with the ability to request an update to their fees one additional time during a calendar year is appropriate.
To address some of the concerns expressed by commenters, the Departments are finalizing this proposal with modifications to reflect that certified IDR entities may only request approval from the Departments to set their fee one additional time for a
If a certified IDR entity requests to update its fees after initially setting its fee for the calendar year, and the request is approved by the Departments, the change to its fees will be made public before those fees are effective, in a form and manner specified by the Secretary, to allow the parties time to consider the fee change in their decision making. Updated fees will apply to disputes initiated on or after the effective date of the fee amount. The modified policy will provide an appropriate amount of flexibility to certified IDR entities to make a fee adjustment to account for efficiencies and fluctuations in the conditions of the Federal IDR process in future years, while also capping the number of fee adjustments in a given calendar year and limiting cost volatility for parties participating in the Federal IDR process.
The Departments solicited comment on whether they should apply an inflationary adjustment, such as the CPI-U, to the considerations used to develop the certified IDR entity fee ranges in future years. One commenter supported the use of an inflationary adjustment and suggested updating the certified IDR entity fee ranges annually based on inflation rather than through notice and comment rulemaking. A few commenters opposed updating the certified IDR entity fee ranges using an inflationary adjustment such as the CPI-U. Specifically, one commenter posited that since the CPI-U is updated on a monthly basis, the Departments might pursue monthly adjustments to the certified IDR entity fee ranges, which would severely complicate the Federal IDR process. Another commenter expressed concern that applying an inflationary adjustment would only drive costs up over time, prompting plans and issuers to pass any additional costs on to consumers. One commenter neither explicitly supported nor opposed the general use of an inflationary adjustment to set the certified IDR entity fee ranges but noted that setting the certified IDR entity fee ranges through notice and comment rulemaking could be an opportunity to adjust based on inflation. This commenter cautioned that if the Departments pursued the use of an inflationary adjustment, such an adjustment should be the only consideration used to update the certified IDR entity ranges.
The Departments appreciate the comments on the use of an inflationary adjustment to update the certified IDR entity fee in future years. The Department share the commenters' desire to maintain predictable and accessible costs for participating in the Federal IDR process and agree that additional adjustments to the fee ranges more frequently than annually would complicate the Federal IDR process for all parties. As stated earlier in this preamble, based on the comments received, the Departments are finalizing the proposal to establish the certified IDR entity fee ranges through notice and comment rulemaking, which will allow for greater transparency and feedback related to the establishment of the ranges. Further, the Departments are of the view that the considerations being finalized in this rulemaking are necessary to develop reasonable certified IDR entity fee ranges, and that the addition of inflationary adjustment to the considerations, or the exclusive use of an inflationary adjustment to develop the ranges, is not practical or necessary at this time. The Departments will continue to carefully consider whether such a policy may be appropriate in future rulemaking.
Several commenters expressed concerns with the proposed certified IDR entity fee ranges' increased upper limits. Some of these commenters stated that the proposed certified IDR entity fee ranges may be cost-prohibitive and limit access to the Federal IDR process, particularly for small providers. A few of the commenters opposed to the proposed increase in the upper limits of the certified IDR entity fee ranges asserted that any increase in the certified IDR entity fee ranges would limit participation in the Federal IDR process. Specifically, one of these commenters asserted that the proposed ranges would result in costs passed on to patients in the form of increased premiums and cost-sharing amounts.
Some commenters, however, supported the proposed certified IDR entity fee ranges. Some of these commenters asserted that the increase to the upper limit of the certified IDR fee ranges is reasonable and will encourage greater plan and issuer participation prior to the Federal IDR process, such as during open negotiation, and will reduce the time needed for certified IDR entities to render payment determinations.
The Departments maintain the view that the proposed certified IDR entity fee ranges will keep costs reasonable such that participating in the Federal IDR process will not be cost-prohibitive, including for smaller providers, while also ensuring that certified IDR entities are able to cover their operating costs and continue participating in the Federal IDR process. The Departments acknowledge that broadening the certified IDR entity fee ranges could have an impact on the cost to parties to engage in the Federal IDR process. However, the current range of fees charged by certified IDR entities reflects that, since the opening of the Federal IDR process, certified IDR entities do not all charge the same fees, nor do they all charge the maximum fee amount in the ranges set by the Departments.
The Departments agree with commenters asserting that the increases to the certified IDR entity fee ranges will encourage greater plan and issuer participation prior to the Federal IDR process, such as during open negotiation. The Departments believe that the increases to the certified IDR entity fee ranges will encourage parties to actively participate in open negotiation to preclude the need for the Federal IDR process, thereby eliminating the need for parties to pay the certified IDR entity fee.
The Departments emphasize that while they establish ranges for the certified IDR entity fees, certified IDR entities choose the fixed fees they
Several commenters opposed the proposed tiered fee structure for batched determinations. Commenters were concerned that the proposed tiered fee structure would be cost-prohibitive, particularly due to the absence of a limitation on the number of line items considered in the price tiers (that is, no line item cap to the application of the tiered fee, as currently exists). Further, some commenters asserted that the proposed tiered fee structure and range would disincentivize the submission of batched disputes.
A few commenters supported an increased fee for larger batched determinations but recommended that the tiering structure reflect intervals of 50 line items rather than 25. Further, one commenter supported a fixed-dollar tiered fee, as opposed to a range, suggesting that a fixed-dollar fee would provide more consistency across the fees charged by different certified IDR entities and avoid potential issues such as certified IDR entities being overwhelmed with disputes and resulting delays in the Federal IDR process.
The proposed tiered fee structure and range reflect the Departments' intent to keep the costs of participating in the Federal IDR process affordable while ensuring that certified IDR entities are compensated for their work in rendering payment determinations on complex batched disputes. Certified IDR entities have indicated to the Departments that making determinations on large batches of dissimilar items and services is particularly complex and burdensome and that they generally do not realize economies of scale as the number of batched line items increases. The Departments considered the impact of the
Several commenters stated that the proposed tiered fee structure might increase the costs to disputing parties submitting batched disputes with many line items because there is no cap to the number of line items within a batched dispute after which the tiered fee would no longer apply.
A tiered fee selected by each certified IDR entity from a dollar range established by the Departments allows for greater flexibility, as opposed to applying a standard fixed dollar amount or applying a percentage of the certified IDR entity's batched determination fee as is currently used.
The Departments also considered whether certified IDR entities should be permitted to charge only an additional fixed dollar amount (for example, $125, $150, $200, etc.) per every additional 25 line items but determined that the proposed range for a tiered fee would provide the appropriate operational flexibility for certified IDR entities. Providing this flexibility is important to maintain participation of certified IDR entities in the Federal IDR process. The operational costs for the Federal IDR process incurred by each certified IDR entity may vary, requiring certified IDR entities to consider their unique circumstances in determining their fixed fee amounts to maintain financial viability. Therefore, allowing certified IDR entities to select a tiered fee within a dollar range established by the Departments will allow the certified IDR entities the flexibility to tailor their pricing to fit their company's needs, while ensuring reasonable costs for parties participating in the Federal IDR process.
For the purposes of the batched tiered fee range intervals, the Departments considered whether a grouping of 50 line items would be a more appropriate interval than the proposed interval of 25 line items. A few commenters suggested that 50 line items would be a more appropriate interval than the proposed 25-line-item increment. In determining the interval appropriate for the tiered fee range for batched determinations, the Departments considered historical trends in the number of line items submitted in batched disputes in addition to the anticipated changes in batching behaviors due to the
In the event that any portion of these final rules is declared invalid, the Departments intend that the various aspects of the finalized administrative fee provisions and certified IDR entity fee provisions be severable. The Departments proposed at 26 CFR 54.9816-8(d)(3)(i), 29 CFR 2590.716-8(d)(3)(i), and 45 CFR 149.510(d)(3)(i) that any provision of paragraph (d) or paragraphs (e)(2)(vii) through (e)(2)(ix) held to be invalid or unenforceable as applied to any person or circumstance would be construed so as to continue to give the maximum effect to the provision permitted by law, including as applied to persons not similarly
A few commenters supported the proposed severability provisions. These commenters stated that the provisions would help mitigate uncertainty that may result from future court decisions if a lawsuit occurs.
The Departments agree that the severability clause will help mitigate uncertainty. After considering the comments, the Departments are finalizing these policies as proposed, with a technical modification that the provisions in 26 CFR 54.9816-8(d) and (e)(2)(vii) and (viii), 29 CFR 2590.716-8(d) and (e)(2)(vii) and (viii), and 45 CFR 149.510(d) and (e)(2)(vii) and (viii) are intended to be severable, rather than 26 CFR 54.9816-8(d) and (e)(2)(vii) through (ix), 29 CFR 2590.716-8(d) and (e)(2)(vii) through (ix), and 45 CFR 149.510(d) and (e)(2)(vii) through (ix). This technical modification is due to the restructuring of the regulatory text in these final rules pertaining to certified IDR entity fees at 26 CFR 54.9816-8(e)(2)(vii) and (viii), 29 CFR 2590.716-8(e)(2)(vii) and (viii), and 45 CFR 149.510(e)(2)(vii) and (viii) compared to what was proposed, as discussed further in section II.B of this preamble.
The Departments further clarify their intent that the methodology being adopted here to set the administrative fee amount and the considerations the Departments used in developing the certified IDR entity fee ranges are also intended to be severable. Should any aspect of the methodology or considerations be determined to be unlawful, the Departments intend for the administrative fee amount or certified IDR entity fee ranges to be adjusted by applying the methodology in accordance with the remaining elements of the methodology or considerations. For instance, if it is determined that certain expenditures should not have been included in calculating the administrative fee amount, then the Departments would implement these rules by eliminating those expenditures from the total expenditures estimated to be made by the Departments in carrying out the Federal IDR process, and dividing the new expenditures amount by the same estimated number of administrative fees paid to calculate the new administrative fee amount. The resulting administrative fee amount would be immediately effective, without requiring additional notice and comment rulemaking.
These final rules establish the administrative fee amount and the certified IDR entity fee ranges in notice and comment rulemaking, and the preamble sets forth the methodology for setting the administrative fee amount and the considerations used to develop the certified IDR entity fee. The Departments have examined the effects of these final rules as required by Executive Order 13563 (76 FR 3821, January 21, 2011, Improving Regulation and Regulatory Review); Executive Order 12866 (58 FR 51735, October 4, 1993, Regulatory Planning and Review); Executive Order 14094 (88 FR 21879, April 11, 2023, Modernizing Regulatory Review); the Regulatory Flexibility Act (Pub. L. 96-354, September 19, 1980); section 1102(b) of the Social Security Act (42 U.S.C. 1102(b)); section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995); and Executive Order 13132 (64 FR 43255, August 10, 1999, Federalism).
Executive Orders 12866, 13563, and 14094 direct Federal 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). Under Executive Order 12866, “significant” regulatory actions are subject to review by the Office of Management and Budget (OMB). Executive Order 14094, entitled “Modernizing Regulatory Review” (hereinafter, the Modernizing E.O.), amends section 3(f) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $200 million or more in any 1 year (adjusted every 3 years by the Administrator of OMB's Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product), or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in this Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.
A regulatory impact analysis (RIA) must be prepared for rules deemed significant. OMB's OIRA has deemed this rule significant. The Departments have prepared an RIA that to the best of their ability presents the costs and benefits of these rules. OMB has reviewed these final regulations, and the Departments have provided the following assessment of their impact.
The Departments are amending the certified IDR entity and administrative fee provisions of the rules for the Federal IDR process to set the administrative fee amount and the certified IDR entity fee ranges in notice and comment rulemaking, and set forth the methodology for setting the administrative fee amount and the considerations for developing the certified IDR entity fee ranges. These policies will ensure that all interested parties are sufficiently notified and provided an opportunity to comment on the fees associated with the Federal IDR process.
The expected benefits and costs of these final rules are summarized in Table 1 and discussed in this section of the preamble. In accordance with OMB Circular A-4, Table 1 depicts an
The primary benefit of these final rules is to allow the Federal IDR process to function through establishing the administrative fee amount and certified IDR entity fee ranges in rulemaking and establishing the amounts of these fees for disputes initiated on or after the effective date of these rules. In response to the opinion and order in
The Departments are finalizing the proposal to establish the administrative fee amount in notice and comment rulemaking for disputes initiated on or after the effective date of these rules, and the Departments are setting forth the methodology for determining the administrative fee amount. Utilizing notice and comment rulemaking will increase transparency of the administrative fee-setting process and allow interested parties to provide feedback to the Departments prior to the Departments setting the administrative fee amount.
The Departments sought comment on these benefits. The Departments received comments on these benefits and respond to these comments in section II.A of this preamble. The Departments are finalizing these benefits as proposed.
The Departments proposed to establish the certified IDR entity fee ranges for single and batched determinations, which include a tiered fee range for batched determinations that exceed 25 line items, in notice and comment rulemaking for disputes initiated on or after the effective date of these rules. Utilizing notice and comment rulemaking to set the appropriate ranges for certified IDR entity fees will increase transparency for parties interested in the certified IDR entity fee ranges and allow these parties to identify in advance the impacts of changing the certified IDR entity fee ranges.
The Departments sought comment on these benefits. The Departments received comments on these benefits and respond to these comments in section II.B of this preamble. The Departments are finalizing these benefits as proposed.
The Departments are finalizing the proposal to establish the administrative fee amount in notice and comment rulemaking for disputes initiated on or after the effective date of these rules, and set forth the methodology for setting the administrative fee amount with modifications described in section II.A of this preamble to ensure that disputing and other parties are sufficiently notified and provided an opportunity to comment on the administrative fee amount. The Departments are also finalizing the administrative fee amount for disputes initiated on or after the effective date of these rules at $115 per party per dispute.
The current administrative fee is $50 per party per dispute.
The Departments sought comment on these costs and assumptions. The Departments received comments on these assumptions.
Several commenters suggested that the Departments' estimate of 225,000 closed disputes is too low. A few commenters suggested that the Departments are underestimating utilization of the Federal IDR process and recommended that the Departments analyze the available data from States implementing similar policies before the No Surprises Act. Several commenters disagreed with the assumption used to calculate the 225,000 closed disputes, which assumed that
As discussed in section II.A of this preamble, after consideration of comments, the Departments are finalizing the administrative fee using the estimated total number of administrative fees paid to certified IDR entities, rather than the projected total number of closed disputes, to estimate the number of administrative fees to be paid under the administrative fee methodology. Federal IDR process data show that the monthly average number of administrative fees paid to certified IDR entities between February 2023 and July 2023 was 41,000. The Departments project this monthly average forward by 12 months to estimate 492,000 administrative fees paid in a year.
After consideration of public comments, the Departments are modifying the proposed assumptions and cost estimates as follows. If the current administrative fee were to remain applicable, the parties would pay approximately $24.6 million in administrative fees annually (492,000 administrative fees paid × $50 per party per dispute). As stated in section II.A of this preamble, the estimated $24.6 million in administrative fee collections if the Departments were to retain the current $50 administrative fee would be inadequate for the Departments to carry out the Federal IDR process in 2024, as they estimate the expenditures to be made in 2024 to be approximately $56.6 million. As the Departments are now finalizing an administrative fee amount of $115 per party per dispute for disputes initiated on or after the effective date of these rules, the Departments estimate that the parties will pay approximately $56.6 million in administrative fees annually beginning in 2024 (492,000 administrative fees paid × $115 per party per dispute), which is sufficient to cover the estimated annual expenditures of approximately $56.6 million, assuming the number of administrative fees paid remains stable year over year and the administrative fee amount is not subsequently changed through notice and comment rulemaking. Therefore, the costs associated with this policy are approximately $32.0 million ($56.6 million minus $24.6 million if the status quo were to continue).
The Departments are finalizing the proposal to set the certified IDR entity fee ranges for single and batched determinations, with a tiered fee range for batched determinations that exceed 25 line items, in notice and comment rulemaking for disputes initiated on or after the effective date of these rules in response to the opinion and order in
While the certified IDR entities are responsible for setting their fees for single and batched determinations, the Departments acknowledge that the changes to the certified IDR entity fee ranges may impact the cost to the parties to participate in the Federal IDR process. The Departments anticipate that the vacatur of batching standards by the District Court's opinion and order in
Based on internal Federal IDR process data, the Departments estimate that certified IDR entities collect a certified IDR entity fee for approximately 135,000 disputes annually.
To develop a reasonable estimate for the certified IDR entity fee amount for both single and batched disputes, the Departments assume that the certified IDR entities will set single determination fixed fees that approximate the median value of the finalized fee range and will set batched determination fixed fees that approximate the 3rd quartile of the finalized fee range.
Further, the Departments estimate that using the finalized tiered fee range for batched determinations, certified IDR entities will set and apply a fixed fee that approximates the average of the proposed range ($75-$250) for batched determinations based on the number of line items. The Departments estimate that certified IDR entities will typically set their tiered fee at approximately $163. The Departments acknowledge the uncertainty surrounding the number of line items that may be submitted in batched disputes due to the
The calendar year 2023 certified IDR entity fee ranges for single determinations and batched determinations are $200-$700 and $268-$938, respectively. Certified IDR entities currently charge a median fixed fee of $549 for single determinations and $770 for batched determinations in 2023. Therefore, for approximately 108,000 single determinations and 24,840 batched determinations (not subject to the batched percentage fee amount) annually,
• 2-20 line items: 100 percent of the approved batched determination fee;
• 21-50 line items: 110 percent of the approved batched determination fee;
• 51-80 line items: 120 percent of the approved batched determination fee; and
• 81 line items or more: 130 percent of the approved batched determination fee.
The Departments sought comment on these costs and assumptions. The Departments did not receive comments on these costs or assumptions and are finalizing them as proposed.
It is unclear whether the Federal IDR process will experience the same operating conditions when these rules are effective compared to the current state, such as the number of disputes initiated, future policy changes finalized after future notice and comment rulemaking, or increased or decreased costs by the Departments to carry out the Federal IDR process. Due to the need to take point-in-time estimates of volume and expenditures for the purposes of developing the analyses in the preamble to these rules, there is inherent uncertainty in the estimates in these analyses as the data are constantly changing. It is difficult to project the impact on the administrative fee amount charged to the parties if the Federal IDR process landscape changes. Although the Departments have analyzed the Federal IDR process data available to inform their projections, it is uncertain whether the trends in these data will remain applicable in the future. At the same time, the Departments do not know what impact the changes to the Federal IDR process as a result of the District Court's opinions and orders in
If regulations impose administrative costs on entities, such as the time needed to read and interpret rules, regulatory agencies should estimate the total cost associated with regulatory review. Based on comments received for the July 2021 interim final rules and October 2021 interim final rules, the Departments estimate that more than 2,100 entities will review these final rules, including 1,500 issuers, 205 third party administrators (TPAs), and at least 395 other interested parties (for example, State insurance departments, State legislatures, industry associations, advocacy organizations, and providers and provider organizations). The Departments acknowledge that this assumption may understate or overstate the number of entities that will review these final rules.
Using the median hourly wage rate from the Bureau of Labor Statistics for a Lawyer (Code 23-1011) to account for average labor costs (including a 100 percent increase for the cost of fringe benefits and other indirect costs), the Departments estimate that the cost of reviewing these final rules will be $130.52 per hour.
The Departments sought comments in the IDR Fees proposed rules on this approach to estimating the total burden and cost for interested parties to read and interpret the IDR Fees proposed rules, which is the same approach used to estimate the total burden and cost for interested parties to read and interpret these final rules. The Departments did not receive comments on this approach and cost. The Departments are finalizing these estimates as proposed.
In developing these final rules, the Departments considered various alternative approaches.
In its
The Departments considered proposing other administrative fee policies in the IDR Fees proposed rules, such as those proposed in the IDR Operations proposed rules.
The Departments considered maintaining the current policy that the allowable ranges for certified IDR entity
These final rules are not subject to the requirements of the Paperwork Reduction Act of 1995,
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601,
The provisions in these final rules will affect plans (or their TPAs),
For purposes of analysis under the RFA,
In 2021, there were 1,500 issuers in the U.S. health insurance market
These final rules also affect health care providers and facilities due to the proposed requirements related to the certified IDR entity and administrative fees. The Departments estimate that 140,270 physicians, on average, bill on an out-of-network basis annually.
The Departments do not have the same level of data for the air ambulance subsector. In 2020, the total revenue of providers of air ambulance services was estimated to be $4.2 billion, with 1,114 air ambulance bases.
Although based on the Departments' experience operating the Federal IDR process, significantly fewer than 67,320 small providers and facilities have accessed the process to date,
Additionally, as discussed in the
The Departments are finalizing the policy to establish the administrative fee amount in notice and comment rulemaking and are finalizing that the administrative fee amount for disputes initiated on or after the effective date of these rules is $115 per party per dispute. The annual burden per small provider or facility associated with this policy is $115,
The Departments are finalizing the policy to establish the certified IDR entity fee ranges in notice and comment rulemaking and are finalizing that the ranges are $200-$840 for single determinations and $268-$1,173 for batched determinations, with a $75-$250 tiered fee range for disputes that contain more than 25 line items. The annual burden per small provider or facility associated with this policy is $657,
Thus, the per-entity annual cost for small providers and facilities is $772, and the per-entity annual cost for small issuers and TPAs is $2,776. The total estimated annual cost for small providers and facilities is $51,971,040, and the total estimated annual cost for small issuers and TPA is $194,320. See Tables 2 and 3.
The annual cost per small provider or facility of $772 is approximately 0.07 percent of the average annual receipts per small provider and approximately 0.04 percent of the average annual receipts per small facility. The Departments anticipate that small providers and facilities would be unlikely to initiate disputes and thereby incur these costs unless they anticipate prevailing in the dispute and receiving payment from plans or issuers that exceed the costs incurred to initiate the dispute. Additionally, data from the public reports on the Federal IDR process released to date by the Departments show that providers and facilities prevail in approximately 70 percent of disputes.
The annual cost per small issuer/TPA of $2,776 is approximately 0.15 percent of the average annual receipts per small issuer/TPA. While small issuers/TPAs could pass on these increased costs to consumers in the form of higher premiums (or for TPAs, higher administration fees), resulting in an increase in receipts commensurate with the increase in costs, the actual increase in costs and subsequent impact on revenue would be
As its measure of significant economic impact on a substantial number of small entities, HHS uses a change in revenue of more than 3 to 5
The Departments sought comment on this analysis and sought information on the number of small plans (or TPAs), issuers, providers, and facilities that may be affected by the provisions in the IDR Fees proposed rules. The Departments did not receive comments on this analysis. The Departments received comments on the impact of the provisions in the IDR Fees proposed rules on small providers and respond to those comments in section II of this preamble.
In addition, section 1102(b) of the Social Security Act requires the Departments to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA.
Pursuant to the Memorandum of Agreement, Review of Treasury Regulations under Executive Order 12866 (June 9, 2023), tax regulatory actions issued by the IRS are not subject to the requirements of section 6 of Executive Order 12866, as amended. Therefore, a regulatory impact assessment is not required. Pursuant to section 7805(f) of the Code,
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
Executive Order 13132 outlines the fundamental principles of federalism. It requires adherence to specific criteria by Federal agencies in formulating and implementing policies that have “substantial direct effects” on the States, the relationship between the National Government and States, or on the distribution of power and responsibilities among the various levels of government. Federal agencies issuing regulations that have these federalism implications must consult with State and local officials and describe the extent of their consultation and the nature of the concerns of State and local officials in the preamble to the IDR Fees proposed rules.
The Departments do not anticipate that these final rules will have federalism implications or limit the policy-making discretion of the States in compliance with the requirement of Executive Order 13132.
State and local government health plans may be subject to the Federal IDR process where a specified State law or All-Payer Model Agreement does not apply. The No Surprises Act authorizes States to enforce the new requirements, including those related to balance billing, for issuers, providers, facilities, and providers of air ambulance services, with HHS enforcing only in cases where the State has notified HHS that the State does not have the authority to enforce or is otherwise not enforcing, or HHS has made a determination that a State has failed to substantially enforce the requirements. However, in the Departments' view, the federalism implications of these final rules are substantially mitigated because some States have their own process for determining the total amount payable under a plan or coverage for out-of-network emergency services and to out-of-network providers for patient visits to in-network facilities for non-emergency services. Where a State has a specified State law, the State law, rather than the Federal IDR process, will apply.
In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have federalism implications or limit the policy making discretion of the States, the Departments have engaged in efforts to consult with and work cooperatively with affected States, including participating in conference calls with and attending conferences of the National Association of Insurance Commissioners and consulting with State insurance officials on an individual basis.
While developing these rules, the Departments attempted to balance the States' interests in regulating health insurance issuers with the need to ensure market stability. By doing so, the Departments complied with the requirements of Executive Order 13132.
In accordance with Federal law, a summary of these rules may be found at
Excise taxes, Pensions, Reporting and recordkeeping requirements.
Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements.
Balance billing, Health care, Health insurance, Reporting, and recordkeeping requirements, Surprise billing.
For the reasons stated in the preamble, the Department of the Treasury and the IRS amend 26 CFR part 54 as set forth below:
26 U.S.C. 7805 * * *
Section 54.9816-8 also issued under 26 U.S.C. 9816.
(a)
(b)
(c)
(d)
(2)
(ii) The administrative fee amount will be established through notice and comment rulemaking no more frequently than once per calendar year in a manner such that the total administrative fees paid for a year are estimated to be equal to the amount of expenditures estimated to be made by the Secretaries of the Treasury, Labor, and Health and Human Services for the year in carrying out the Federal IDR process. The administrative fee amount will remain in effect until changed by notice and comment rulemaking. For disputes initiated on or after January 22, 2024, the administrative fee amount is $115 per party per dispute.
(3)
(ii) The provisions in this paragraph (d) and paragraphs (e)(2)(vii) and (viii) of this section are intended to be severable from each other.
(e)
(2)
(ii) through (vi) [Reserved]
(vii) Provide, no more frequently than once per calendar year, a fixed fee for single determinations and a separate fixed fee for batched determinations, as well as additional fixed tiered fees for batched determinations, if applicable, within the upper and lower limits for each, as established by the Secretary in notice and comment rulemaking. The certified IDR entity fee ranges established by the Secretary in rulemaking will remain in effect until changed by notice and comment rulemaking. The certified IDR entity may not charge a fee outside the limits set forth in rulemaking unless the certified IDR entity or IDR entity seeking certification receives advance written approval from the Secretary to charge a fixed fee beyond the upper or lower limits by following the process described in paragraph (e)(2)(vii)(A) of this section. A certified IDR entity may also seek advance written approval from the Secretary to update its fees one additional time per calendar year by meeting the requirements described in paragraph (e)(2)(vii)(A). The Secretary will approve a request to charge a fixed fee beyond the upper or lower limits for fees as set forth in rulemaking or to update the fixed fee during the calendar year if, in their discretion, they determine the information submitted by a certified IDR entity or IDR entity seeking certification demonstrates that the proposed change to the certified IDR entity fee would ensure the financial viability of the certified IDR entity or IDR entity seeking certification and would not impose on parties an undue barrier to accessing the Federal IDR process.
(A) In order for the certified IDR entity or IDR entity seeking certification to receive the Secretary's written approval to charge a fixed fee beyond the upper or lower limits for fees as set forth in rulemaking or to update the fixed fee during the calendar year, the certified IDR entity or IDR entity seeking certification must submit to the Secretary, in the form and manner specified by the Secretary:
(
(
(
(B) [Reserved]
(viii) For disputes initiated on or after January 22, 2024, certified IDR entities are permitted to charge a fixed certified IDR entity fee for single determinations within the range of $200 to $840, and a fixed certified IDR entity fee for batched determinations within the range of $268 to $1,173, unless a fee outside such ranges is approved by the Secretary, pursuant to paragraph (e)(2)(vii)(A) of this section. As part of the batched determination fee, certified IDR entities are permitted to charge an additional fixed tiered fee within the range of $75 to $250 for every additional 25 line items within a batched dispute, beginning with the 26th line item. The ranges for the certified IDR entity fees for single and batched determinations will remain in effect until changed by notice and comment rulemaking.
(ix) For further guidance, see § 54.9816-8T(e)(2)(ix) through (xii).
(x) through (xii) [Reserved]
(f)
(g)
The revisions and additions read as follows:
(d) * * *
(2) * * *
(ii) For further guidance, see § 54.9816-8(d)(2)(ii).
(3)
(e) * * *
(2) * * *
(vii) For further guidance, see § 54.9816-8(e)(2)(vii).
(viii) For further guidance, see § 54.9816-8(e)(2)(viii).
For the reasons stated in the preamble, the Department of Labor amends 29 CFR part 2590 as set forth below:
29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a-n, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Pub. L. 104-191, 110 Stat. 1936; sec. 401(b), Pub. L. 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111-148, 124 Stat. 119, as amended by Pub. L. 111-152, 124 Stat. 1029; Division M, Pub. L. 113-235, 128 Stat. 2130; Pub. L. 116-260, 134 Stat. 1182; Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).
The revisions and additions read as follows:
(d) * * *
(2) * * *
(ii) The administrative fee amount will be established through notice and comment rulemaking no more frequently than once per calendar year in a manner such that the total administrative fees paid for a year are estimated to be equal to the amount of expenditures estimated to be made by the Secretaries of the Treasury, Labor, and Health and Human Services for the year in carrying out the Federal IDR process. The administrative fee amount will remain in effect until changed by notice and comment rulemaking. For disputes initiated on or after January 22, 2024, the administrative fee amount is $115 per party per dispute.
(3)
(ii) The provisions in this paragraph (d) and paragraphs (e)(2)(vii) and (viii) of this section are intended to be severable from each other.
(e) * * *
(2) * * *
(vii) Provide, no more frequently than once per calendar year, a fixed fee for single determinations and a separate fixed fee for batched determinations, as well as an additional fixed tiered fee for batched determinations, if applicable, within the upper and lower limits for each, as established by the Secretary in notice and comment rulemaking. The certified IDR entity fee ranges established by the Secretary in rulemaking will remain in effect until changed by notice and comment rulemaking. The certified IDR entity may not charge a fee outside the limits set forth in rulemaking unless the certified IDR entity or IDR entity seeking certification receives advance written approval from the Secretary to charge a fixed fee beyond the upper or lower limits by following the process described in paragraph (e)(2)(vii)(A) of this section. A certified IDR entity may also seek advance written approval from the Secretary to update its fees one additional time per calendar year by meeting the requirements described in paragraph (e)(2)(vii)(A). The Secretary will approve a request to charge a fixed fee beyond the upper or lower limits for fees as set forth in rulemaking, or to update the fixed fee during the calendar year if, in their discretion, they determine the information submitted by a certified IDR entity or IDR entity seeking certification demonstrates that the proposed change to the certified IDR entity fee would ensure the financial viability of the certified IDR entity or IDR entity seeking certification and would not impose on parties an undue barrier to accessing the Federal IDR process.
(A) In order for the certified IDR entity or IDR entity seeking certification to receive the Secretary's written approval to charge a fixed fee beyond the upper or lower limits for fees as set forth in rulemaking or to update the fixed fee during the calendar year, the certified IDR entity or IDR entity seeking certification must submit to the Secretary, in the form and manner specified by the Secretary:
(
(
(
(B) [Reserved]
(viii) For disputes initiated on or after January 22, 2024, certified IDR entities are permitted to charge a fixed certified IDR entity fee for single determinations within the range of $200 to $840, and a fixed certified IDR entity fee for batched determinations within the range of $268 to $1,173, unless a fee outside such ranges is approved by the Secretary pursuant to paragraph (e)(2)(vii)(A) of this section. As part of the batched determination fee, certified IDR entities are permitted to charge an additional fixed tiered fee within the range of $75 to $250 for every additional 25 line items within a batched dispute, beginning with the 26th line item. The ranges for the certified IDR entity fees for single and batched determinations will remain in effect until changed by notice and comment rulemaking.
For the reasons stated in the preamble, the Department of Health and Human Services amends 45 CFR part 149 as set forth below:
42 U.S.C. 300gg-92 and 300gg-111 through 300gg-139, as amended.
The revisions and additions read as follows:
(d) * * *
(2) * * *
(ii) The administrative fee amount will be established through notice and comment rulemaking no more frequently than once per calendar year in a manner such that the total administrative fees paid for a year are estimated to be equal to the amount of expenditures estimated to be made by the Secretaries of the Treasury, Labor, and Health and Human Services for the year in carrying out the Federal IDR process. The administrative fee amount will remain in effect until changed by notice and comment rulemaking. For disputes initiated on or after January 22, 2024, the administrative fee amount is $115 per party per dispute.
(3)
(ii) The provisions in this paragraph (d) and paragraphs (e)(2)(vii) and (viii) of this section are intended to be severable from each other.
(e) * * *
(2) * * *
(vii) Provide, no more frequently than once per calendar year, a fixed fee for single determinations and a separate fixed fee for batched determinations, as well as an additional fixed tiered fee for batched determinations, if applicable, within the upper and lower limits for each, as established by the Secretary in notice and comment rulemaking. The certified IDR entity fee ranges established by the Secretary in rulemaking will remain in effect until changed by notice and comment rulemaking. The certified IDR entity may not charge a fee outside the limits set forth in rulemaking unless the certified IDR entity or IDR entity seeking certification receives advance written approval from the Secretary to charge a fixed fee beyond the upper or lower limits by following the process described in paragraph (e)(2)(vii)(A) of this section. A certified IDR entity may also seek advance written approval from the Secretary to update its fees one additional time per calendar year by meeting the requirements described in paragraph (e)(2)(vii)(A). The Secretary will approve a request to charge a fixed fee beyond the upper or lower limits for fees as set forth in rulemaking or to update the fixed fee during the calendar year if, in their discretion, they determine the information submitted by a certified IDR entity or IDR entity seeking certification demonstrates that the proposed change to the certified IDR entity fee would ensure the financial viability of the certified IDR entity or IDR entity seeking certification and would not impose on parties an undue barrier to accessing the Federal IDR process.
(A) In order for the certified IDR entity or IDR entity seeking certification to receive the Secretary's written approval to charge a fixed fee beyond the upper or lower limits for fees as set forth in rulemaking or to update the fixed fee during the calendar year, the certified IDR entity or IDR entity seeking certification must submit to the Secretary, in the form and manner specified by the Secretary:
(
(
(
(B) [Reserved]
(viii) For disputes initiated on or after January 22, 2024, certified IDR entities are permitted to charge a fixed certified IDR entity fee for single determinations within the range of $200 to $840, and a fixed certified IDR entity fee for batched determinations within the range of $268 to $1,173, unless a fee outside such ranges is approved by the Secretary, pursuant to paragraph (e)(2)(vii)(A) of this section. As part of the batched determination fee, certified IDR entities are permitted to charge an additional fixed tiered fee within the range of $75 to $250 for every additional 25 line items within a batched dispute, beginning with the 26th line item. The ranges for the certified IDR entity fees for single and batched determinations will remain in effect until changed by notice and comment rulemaking.