The Rural Housing Service (RHS), the Rural Business-Cooperative Service (RBCS), and the Rural Utilities Service (RUS), agencies of the USDA Rural Development mission area, hereinafter collectively referred to as the Agency, published a final rule with comment on July 14, 2020 (85 FR 42494) that created a unified guaranteed loan platform for enhanced delivery of four existing guaranteed loan programs: Community Facilities (CF) administered by RHS; Water and Waste Disposal (WWD) administered by RUS; and Business and Industry (B&I) and Rural Energy for America (REAP) administered by RBCS. The final rule was effective on October 1, 2020, and Rural Development began operating under the new guarantee loan platform on that date.

Collectively, Rural Development's guaranteed loan programs work to assist in building and maintaining sustainable rural communities. Through the public comment period and monthly office hours with lenders and staff, the Agency has solicited feedback on the requirements and policies contained in the rule implemented on October 1, 2020. The Agency has identified areas for revision or clarification that are amended with this final rule with comment. This oneRD final rule with comment incorporates revisions intended to simplify, clarify, improve, expand, and enhance the delivery of the four guaranteed loan programs.

Through the public comment period and monthly office hours with lenders and staff, the Agency has solicited feedback on the requirements and policies contained in the rule implemented on October 1, 2020. The Agency has identified needed revisions and clarification based on the comments received.

Rural Development received 87 comments from 24 commenters on the final rule with comment issued on July 14, 2020. Five commenters were private citizens, 10 commentors were anonymous and 9 comments were from lenders.

The following discusses each comment and the Agency's response, organized by section with the comment paragraph and then Agency response paragraph. Sections with multiple comments will continue the comment/response paragraph pairing format until all comments for that section are addressed.

Comment: Four commenters requested additional definitions to be included in the regulation.

Agency Response: The Agency has reviewed the request and has determined the additional definitions would not add additional clarity to the regulation. However during our review it came to our attention that the definition of affiliate needed some additional clarification and two definitions needed updating to conform with changes made to those definitions in 7 CFR 4280. Additionally, due to the COVID pandemic the Agency has extended the timeline some businesses need for start-up; this has highlighted a potential loophole in the regulation and definitions for new businesses and existing businesses. We thought the 12-month timeline to be adequate for full ramp-up, but we are seeing issues with this, thus we made technical revisions to the definition of Existing business as well as New business as enumerated in Section III, Summary of Changes.

Agency Comment: The Agency has identified a revision needed to improve consistency and clarity of Section 5001.104; this revision is included in Section III, Summary of Changes to Rule.

Comment: The Agency received several comments that the OneRD rule language is much stricter for project eligibility than what the existing Business and Industry regulation, 7 CFR 4279, had been.

Agency Response: Upon evaluation, it was not the Agency's intention to further restrict project eligibility. Several clarifications have been identified and are included in Section III, Summary of Changes to Rule.

Comment: Several comments were received on the revised equity requirements under 7 CFR 5001.105(d). The commenters believed the equity requirement for new businesses has increased from 20% to 25% of the total eligible project costs under Table 1 to 5001.105(d). They believe this additional 5% makes it even more difficult for new businesses to open in rural America. They recommended that the equity requirements for new businesses be 20% regardless if calculated as balance sheet equity or as a percentage of the total eligible project costs.

Agency Response: The Agency believes that there may have been some confusion over the requirement—it's 25% of project cost OR 20% balance sheet equity at loan closing. In fact, there are 3 other options available to meet the equity requirements. This issue has been addressed with Lenders during monthly office hours the Agency held for lenders. Therefore, the Agency believes the issue has been resolved and no regulatory amendments are needed.

Comment: Several commenters requested that 7 CFR 5001.115(a) “any investment or arbitrage” be removed as an ineligible purpose as it seems to be excluding. They believe that excluding arbitrage from program eligibility, in its strictest sense, would leave many businesses, that it would seem the Agency would want to promote ineligible for program assistance.

Agency Response: The Agency does not agree. The intent of the provision is to prevent borrowing money to buy stock and holding such stock for future increases in value, therefore the regulation will not be amended.

Comment: Seven comments were received in reference to 7 CFR 5001.115(n) which states “owner-occupied housing or self-storage facilities” are ineligible. The commentors felt that the intent is for the owner to have control over the facility, which the owner(s) would if determining who can and cannot be a lessee. Self-storage facilities provide construction jobs, permanent jobs, and increase the tax base in rural communities.

Agency Response: The Agency agrees with the comments in part and is therefore amending 5001.115(n) to clarify when owner occupied housing is considered eligible and removed the ineligibility of self-storage facilities.

Agency Comment: The Agency issued a final rule with comment on September 15, 2020, after the publication of the OneRD Guarantee regulation on July 1, 2020, promulgating Special Authority to Enable Funding of Broadband and Smart Utility Facilities Across Select Rural Development Programs (Smart Utility). A cross reference to 7 CFR 1980, subpart M has been added to the opening paragraph of Section 5001.121 as discussed in Section III, Summary of Changes to Rule.

Agency Comment: The Agency revised 7 CFR 4280 to remove references to the guarantee loan program and cross referencing to 7 CFR 5001. In the process of this revision, it was determined that 7 CFR 5001.126(e) needed to be amended to add “New Users” to conform with the revisions to 7 CFR 4280.

Agency Comment: The Office of Management and Budget promulgated revisions to 7 CFR 25, “Universal Identifier and System for Award Management” on August 13, 2020, after the publication of the OneRD regulation on July 14, 2020. Therefore, a cross reference to 7 CFR 25 is needed in 5001.130 which requires an awardee of Federal financial assistance be registered in and maintain an active account in the System for Award Management (SAM). Section 5001.130(a) is amended to include the new requirements for lenders to be registered in and maintain an account in SAM in accordance with 7 CFR 25.200.

Comment: The Agency Received a couple of comments on the need for the Lender to discuss the feasibility study, as well as other applicable studies and reports in the credit presentation pursuant to § 5001.202(b)(5) and submit such supporting documentation when applicable. However, the commenter felt that it appeared that the Agency will have its own policy. The commenter felt it is incumbent on the Agency to disclose its feasibility study policy to Lenders.

Agency Response: The Agency agrees with the comment and therefore is amending 7 CFR 5001.202(b)(2) to further clarify when feasibility studies are required.

Agency Comment: The Agency has identified a revision needed to improve consistency and clarity of Section 5001.204; this revision is included in Section III, Summary of Changes to Rule.

Comment: Six lenders commented that they are happy to see that the Agency is allowing Loan Note Guarantees (LNG) prior to construction, however they feel the adoption of the current procurement process and standards to regulate construction loan guarantees is not in the borrower, lender or government's interest. They believe the adoption of the federal process would be an injurious and crippling barrier to entry into the LNG prior to construction, defeating the whole purpose of this rule. They stated all lenders have a construction policy in place to mitigate risk and by adding the requirements to mirror the USDA construction disbursement only increases the burden for the lender and urged us to reconsider this approach.

Agency Response: The Agency agrees with the comments that the lenders have the capacity and experience to manage this issue and therefore is amending Section 5001.205(e)(2)(ii) to allow the lender the flexibility when it documents the loan to include provisions to disburse funds and monitor progress of the construction project.

Comment: The Agency received five comments pertaining to the Council for Environmental Quality (CEQ) publication in the Federal Register on July 16, 2020. The commenters requested the Agency to comply with newly published CEQ requirements.

Agency Response: The Agency is in the process of reviewing the new requirements and has determined not to make any changes to OneRD at this time. However, any appropriate conforming changes necessitated from updates to 7 CFR 1970, Environmental Policies and Procedures” will be made to 7 CFR 5001 to ensure compliance with CEQ's regulations.

Comment: The Agency received three comments seeking some clarity and guidance on the need to now submit draft loan agreements. The commenters stated that one of the attractive features of the Agency guaranteed programs is the fact that lenders use their own debt and security instruments to document the loan. The way Section 5001.303 is currently written, the Agency is forcing lenders to modify their existing systems to meet the requirements.

Agency Comment: Based on the comments received, the Agency has identified several revisions to improve the clarity of Section 5001.303 and these revisions are included in Section III, Summary of Changes to Rule.

Agency Comment: The Agency has identified revisions needed to improve consistency and clarity of Section 5001.304; these revisions are included in Section III, Summary of Changes to Rule.

Comments: The Agency received a comment in reference to giving priority points to a loan which offers a decreased guarantee percentage on a B&I project. They pointed out that this would be giving priority points to a guaranteed loan for violating the rule.

Agency Response: The Agency agrees, it was not the intention to allow priority points be given to a guaranteed loan that decreases the guarantee percentage for the loan. Since OneRD sets the guaranteed percentage on an annual basis and does not allow for any deviations of the set guaranteed percentage, the Agency will no longer grant priority points for a guaranteed loan that decreases the maximum allowable guaranteed percentage. Therefore, 7 CFR 5001.318(c)(3) has been removed.

Agency Comment: The Agency has identified a technical correction needed to improve clarity of Section 5001.401; this revision is included in Section III, Summary of Changes to Rule.

Comments: Nine commenters requested the Community Facility Program provide for a 90% guarantee as they believe that being capped at 80% in addition to the possibility of raising fees will discourage wide-spread lender participation in a market of non-profit borrowers who in many cases are providing critical services to the rural community.

Agency Response: While the Agency understands the concerns, no changes in the regulation are being made, however the Agency continues to do everything it can and will continue to review the fees and guarantee percentages on an annual basis to ensure there are no negative impacts on program participation.

Comments: Since publication of the OneRD rule, the Agency has received feedback from lenders on the requirement to charge a minimum 50 basis point lender's servicing fee in Section 5001.408(b) when selling to a holder or participating to another lender.

Agency Response: Based on the concerns we have heard during monthly lender office hours or through direct lender contact with program staff, the Agency has reviewed this policy and determined to remove this requirement and allow lenders to determine their own interest rate spreads when assigning to a holder or participating to another lender.

Comments: The Agency received two comments regarding the lender requesting an extension of a conditional commitment based on the following statement in the regulation “no major changes have been made in the lender's loan conditions and requirements and no material adverse changes in the borrower or the borrower's financial condition have occurred since issuance of the conditional commitment.” The concern is what constitutes a “major” change to request a change. It was suggested that the word “major” be defined or to remove the word “major” to avoid confusion.

Agency Response: The Agency agrees with the comments and is revising the sentence to remove this language as changes are not included in an extension of a conditional commitment.

Comment: Four comments were received on loan closing and the conditions precedent to issuance of the Loan Note Guarantee. There was a concern with Section 5001.452 as it seems to limit the presentation of note sale assignment documents to USDA with or immediately after the guaranteed loan closing. Many lenders may choose to hold a loan for a period, then, based on the financial goals of the lender, sell the guaranteed portion of the loan at any point during the life of the loan.

Agency Response: The Agency concurs with the comments and is removing the text “any secondary market assignment documents,” as these documents are not required immediately after loan closing and may be submitted at any time subsequently.

Comment: Several comments were also received in reference to the requirement to obtain a title opinion or title insurance showing the borrower has good and marketable title to the real property and other collateral and all mortgages or other lien defects, restrictions, or encumbrances, if any. In most cases the guaranteed loan is closed based on a title commitment, which includes gap coverage until the issuance of a title insurance policy. Title companies can take weeks after a loan closing to issue title insurance policies. This requirement would leave the lender unable to fund the loan for weeks after a closing and filing of security instruments, as they await the receipt of the title insurance policy.

Agency Response: The Agency believes that this is a reasonable request, therefore the revisions have been made to § 5001.452(b)(8)(iii)(L)(2) and a new § 5001.452(b)(8)(iii)(L)(3) has been added to provide clarity.

Comment: The Agency received a comment for clarification for the requirement of issuing a certificate of incumbency. The commenter stated some secondary market holders require the certificate of incumbency and signature and some do not require the certificate of incumbency and signature. Therefore, the certificate of incumbency and signature form should be eliminated. In lieu of the form, a certificate of incumbency and signature block should be included on the relevant forms, i.e., lender's agreement, loan note guarantee, and assignment guarantee agreement to be completed when the form is originally prepared.

Agency Response: The Agency reviewed this request and determined that since some lenders require this form and some do not, we did not want to add this requirement to the “relevant” forms and leave as a stand-alone form that lenders may or may not complete based on their process.

Comment: Two commenters had an issue with 7 CFR 5001.454(c) and the additional 0.50 percent guarantee fee for issuing the loan note guarantee prior to construction which may not be passed on to the borrower. The commenters stated rather than invite potential conflict with the lender, why not just accept that the fee is 0.50 percent higher for construction loans. It is a benefit to the borrower as well as to the lender. The borrower is likely not to have its project financed unless the lender obtains the guarantee during construction.

Agency Response: The Agency agrees with the lender's comment that not allowing the lender to pass the fee on to the borrower may have unintended consequences. Issuing the guarantee prior to construction completion (enabling the borrower to avoid cost of construction financing) is a significant benefit to the borrower, therefore the Agency has removed this restriction.

Comments: Some commenters requested consideration be given to allowing a borrower to switch to a fixed interest rate even if it is higher than the variable rate in effect on the loan.

Agency response: The Agency reviewed this and has determined that if the borrower is requesting the rate change whether to a lower or a higher fixed rate, the Agency has removed the restriction of only allowing a rate change to a lower interest rate.

1. The definition of “affiliate” is updated to further clarify what constitutes an affiliate.

2. The definition of “energy efficiency improvement” is updated to conform with 7 CFR 4280.

3. The definition of “existing business” is updated to further define what it means for an existing business to be in operation.

4. The definition of “new business” is updated to further define what it means for a new business to be in operation.

5. The definition of “final loss claim” is updated to correct an incorrect site reference.

6. The definition of “power purchase agreement” is updated to conform with 7 CFR 4280.

Paragraph (a) is revised to clarify what constitutes an electronic signature.

Paragraph (d) is revised to update the website address where this regulation and forms referenced can be found.

Paragraph (e) is revised to clarify what constitutes an electronic signature for the Lender.

Paragraph (c) is revised to clarify when a utility project that is serving both rural and non-rural areas is eligible for a loan guarantee.

1. The introductory paragraph is revised to clarify that the list of eligible projects is not an exhaustive list of the types of projects that will be considered as eligible B&I projects.

2. Paragraph (b)(1) is updated to clarify that a B&I guaranteed loan may be used for the purchase and development of land, buildings, or infrastructure for public or private commercial enterprises.

3. Paragraph (b)(8) is revised to clarify exclusion of owner-occupied housing in the B&I guarantee program.

4. Paragraphs (b)(9) and (b)(10) are combined and edited to clarify when B&I funds may be utilized to fund a CF project.

5. A new paragraph (b)(10) is added to clarify when B&I funds may be used for the development and construction of broadband and telecommunication systems, including modification of existing systems, that are not otherwise eligible under RUS, existing RUS borrowers, or if funding is not available in the eligible RUS program, subject to the public notice filing requirements of 7 CFR 1738.106(a) and the additional reporting requirements of 7 CFR 1738.107.

6. Paragraph (d)(1)(i) is revised to clarify the length of time the minimum balance sheet equity must be maintained.

7. Paragraph (d)(1)(ii) is revised to clarify the length of time the minimum balance sheet equity must be maintained.

8. Paragraph (d)(2)(i) is revised to clarify the length of time the minimum balance sheet equity must be maintained.

9. Paragraph (d)(2)(ii) is revised to clarify the length of time the minimum balance sheet equity must be maintained.

10. Paragraph (d)(3)(i) is revised to align it with Section 105(d)(2)(i).

11. Paragraph (d)(3)(ii) is revised to align it with Section 105(d)(2)(ii).

12. Paragraph (d)(4)(i) is revised to align it with Section 105(d)(2)(i).

13. Paragraph (d)(4)(ii) is revised to align it with Section 105(d)(2)(ii).

14. Paragraph (d)(5)(ii) is revised by removing the requirement for historical financial statements for personal loan guarantors, as this was added in error.

Paragraph (n) is amended to clarify when owner occupied housing is considered eligible and removed paragraph (s) the ineligibility of self-storage facilities.

(1) The introductory paragraph is updated to allow a recipient of a loan guarantee to use up to 10 percent of project funds to construct, improve, or acquire broadband infrastructure related to the project financed, to conform with the requirements of 7 CFR part 1980, subpart M.

(2) Paragraph 7 CFR 5001.121 (c)(6) is amended to revise the reference to a preliminary review.

Paragraph (e) is amended to add a new subparagraph (3) End users, to conform with 7 CFR 4280. This revision brings consistency to REAP on the analysis of the eligibility of the applicant controlling interest of an end-user.

Paragraph (a) is amended to include new requirements for lenders to be registered in and maintain an account in the System for Award Management (SAM) to conform with 2 CFR 25.

Paragraph (a)(2) is amended to revise an incorrect section reference.

Paragraph (b)(5) is amended to clarify where to find the specific program requirements for supporting documentation.

Paragraph (b) is amended to remove the reference to the Federal Credit Reform Act of 1990.

1. Paragraph (e)(2) is amended to provide clarity and consistency with § 5001.454(c).

2. Paragraph (e)(2)(ii) is amended to provide Lenders the opportunity to provide project monitoring under specific criteria.

3. Paragraph (f)(4) is amended to remove the words “and inspection reports” as this is covered in (f)(5).

1. Paragraph (b)(4)(ii) is amended to remove the words “and any guarantor(s)” as this requirement was unintentional and not required in previous B&I and REAP regulations.

2. Paragraph (b)(5) is renumbered to § 5001.303(c)(1) to improve flow and readability.

3. Paragraph (b)(5)(i) through (xiii) was moved to § 5001.451 and renumbered as (b)(3)(i) through (xiii) to improve flow and readability.

1. Paragraph (a)(1) is revised to provide consistency with the B&I program.

2. Paragraph (b) is amended to add a new (4) to coincide with B&I's requirements for feasibility studies.

1. The introductory paragraph in § 5001.318 is amended to correct the total maximum points allowed to 100. This is being done as the points total changed with the removal of § 5001.318(c)(3).

2. Paragraph (c)(3) is removed as it gives priority points to decreasing the guarantee percentage which violates the policy in the regulation and paragraph (c)(4) becomes (c)(3).

Paragraph (d) is amended to clarify when a request for an interest rate change is to be made.

Paragraph (b)(3) is amended to clarify that the repayment schedule must be in consideration of the borrower's cash flow as provided in § 5001.402(b).

Paragraph (b) is amended by removing the requirement of the lender to maintain a minimum servicing fee of 50 basis points from any holder. This will allow the lenders to determine their own interest rate spreads when selling to a holder or participating to another lender.

1. Paragraphs (b)(5)(i) through (xiii) have been moved from § 5001.303 to paragraphs (b)(3)(i) through (xiii) of § 5001.451 which will improve flow and readability.

2. The third sentence in paragraph (e) is amended to remove the text “major changes have been made in the lender's loan conditions and requirements and no.” This requirement is not needed to consider an extension of the conditional commitment; therefore, it has been removed.

1. Paragraph (b) is amended by deleting the text, “any secondary market assignment documents.” Such documents are not required immediately after loan closing and may be submitted at any time subsequently.

2. Paragraph (b)(8)(iii)(L)(2) is amended by adding that a commitment for title insurance or title commitment, when including gap coverage, is acceptable and to clarify that a title opinion or title commitment is not required for anything other than real estate.

Paragraph (c) is amended by removing the restriction of the lender not being able to pass the additional .50 percent on to the borrower when issuing the loan note guarantee prior to construction.

Paragraph (e) is amended to allow variable rate changes to be changed to fixed rates whether the fixed rate is higher or lower at the request of the borrower, agreement of the holder, if any, and Agency concurrence.

Sections 5001.601 through 5001.603 are added to define basic information on delegation and loan approval authorities for the programs within the OneRD regulation.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches to maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This final rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866 and therefore has not been reviewed by the Office of Management and Budget (OMB).

In accordance with the National Environmental Policy Act of 1969, Public Law 91-190, this final rule has been reviewed in accordance with 7 CFR part 1970 (“Environmental Policies and Procedures”). The Agency has determined that (i) this action meets the criteria established in 7 CFR 1970.53(f); (ii) no extraordinary circumstances exist; and (iii) the action is not “connected” to other actions with potentially significant impacts, is not considered a “cumulative action” and is not precluded by 40 CFR 1506.1. Therefore, the Agency has determined that the action does not have a significant effect on the human environment, and therefore neither an Environmental Assessment nor an Environmental Impact Statement is required.

This final rule has been reviewed under Executive Order 12988 (Civil Justice Reform). The Agency has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all State and local laws and regulations that conflict with this rule will be preempted. No retroactive effect will be given to this rule.

The policies contained in this final rule do not have a substantial direct effect on 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. Nor does this rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with the states is not required.

The Regulatory Flexibility Act (5 U.S.C. 601-602) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act (“APA”) or any other statute. The APA exempts from notice and comment requirements rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” (5 U.S.C. 553(a)(2)), so therefore an analysis has not been prepared for this rule.

This final rule is excluded from the scope of Executive Order 12372 (Intergovernmental Consultation), which may require a consultation with State and local officials. See the final rule related notice entitled, “Department Programs and Activities Excluded from Executive Order 12372” (50 FR 47034).

This executive order imposes requirements on the Agency. The Agency has determined that the rule does not have a substantial direct effect on one or more Indian tribe(s) or on either the relationship or the distribution of powers and responsibilities between the Federal Government and Indian tribes. Thus, this rule is not subject to the requirements of Executive Order 13175. If tribal leaders are interested in consulting with the Agency on this rule, they are encouraged to contact USDA's Office of Tribal Relations or the Agency's Native American Coordinator at: AIAN@usda.gov to request such a consultation.

The Catalog of Federal Domestic Assistance (CFDA) numbers assigned to the 4 programs within this rule are: 10.766 for Community Facility Programs, 10.760 for Water and Waste Disposal Programs, 10.768 for Business and Industry Programs and 10.868 for Rural Energy for America Program. The Catalog is available on the internet at https://beta.sam.gov. The SAM.gov website also contains a PDF file version of the Catalog that, when printed, has the same layout as the printed document that the Government Printing Office (GPO) provides. GPO prints and sells the CFDA to interested buyers. For information about purchasing the CFDA from GPO, call the Superintendent of Documents at 202-512-1800 or toll free at 866-512-1800, or access GPO's online bookstore at http://bookstore.gpo.gov.

This rule contains no new reporting or recordkeeping burdens under OMB control number 0572-0166 that would require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

Rural Development is committed to complying with the E-Government Act of 2002, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

Rural Development has reviewed this rule in accordance with USDA Regulation 4300-4, “Civil Rights Impact Analysis,” to identify any major civil rights impacts the rule might have on program participants on the basis of age, race, color, national origin, sex, disability, or marital or familial status. Based on the review and analysis of the rule and all available data, issuance of this Final Rule is not likely to negatively impact low and moderate-income populations, minority populations, women, Indian tribes or persons with disability, by virtue of their age, race, color, national origin, sex, disability, or marital or familial status.

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its agencies, offices, and employees, and institutions participating in or administering USDA Programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

(1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; or

(2) email: OAC@usda.gov .

USDA is an equal opportunity provider, employer, and lender.

For the reasons set forth in the preamble, under the authority at 5 U.S.C. 301 and 7 U.S.C. 1989, Chapter L of title 7 of the Code of Federal Regulations is amended as follows:

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0046, dated February 12, 2021 (EASA AD 2021-0046) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all Airbus Helicopters Model EC120B helicopters. Although EASA AD 2021-0046 applies to all Model EC120B helicopters, this AD applies to helicopters with an affected part installed instead.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2021-04-21, Amendment 39-21443 (86 FR 17278, April 2, 2021) (AD 2021-04-21). AD 2021-04-21 applied to certain Airbus Helicopters Model EC120B helicopters. The NPRM published in the Federal Register on September 23, 2021 (86 FR 52859). The NPRM was prompted by a report of broken and bent attachment bolts of the MR hub scissors assembly and a determination that additional part markings of the washer, scissor branch, and mast ring of the corresponding nut side, and repetitive inspections of those part markings, are necessary to detect any rotation. The NPRM proposed to continue to require the actions in AD 2021-04-21, as specified in an EASA AD. The NPRM also proposed to require part marking of the washer, scissor branch, and mast ring of the corresponding nut side, and repetitive inspections of the additional part markings and repair if necessary, as specified in an EASA AD.

The FAA is issuing this AD to address broken and bent attachment bolts of the MR hub scissors assembly, which could lead to detachment of a MR hub scissors attachment bolt, possibly resulting in complete loss of control of the helicopter. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA received no comments on the NPRM or on the determination of the cost to the public.

The FAA reviewed the relevant data and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

EASA AD 2021-0046 specifies procedures for an inspection of the attachment bolts of the MR hub scissors assembly for discrepancies (discrepancies include corrosion, fretting, wear, cracking, bolt play, and bolt tightening torque) and repair if necessary; part marking of the washer, scissor branch, and mast ring of the attachment bolts and corresponding nut side of the MR hub scissors assembly; and repetitive inspections, after part marking, for discrepancies, and repair if necessary. The inspections of the attachment bolts of the MR hub assembly include checking the play and torque of the scissors attachment bolts and making sure that there are no hard spots in the scissors link hinge.

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 ADDRESSES section.

The FAA estimates that this AD affects 89 helicopters of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates that it would take about 1 hour per product to comply with the reporting requirement in this AD. The average labor rate is $85 per hour. Based on these figures, the FAA estimates the cost of reporting on U.S. operators to be $7,565, or $85 per product.

The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of helicopters that might need these on-condition actions:

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Pkwy., Fort Worth, TX 76177-1524.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0066, dated March 8, 2021 (EASA AD 2021-0066), to correct an unsafe condition for Airbus Helicopters Deutschland GmbH (formerly Eurocopter Deutschland GmbH and Eurocopter España S.A.) Model EC135 P2+, EC135 P3, EC135 T2+, EC135 T3, EC635 P2+, EC635 P3, EC635 T1, EC635 T2+, and EC635 T3 helicopters, serial numbers (S/Ns) 0866 to 1166 inclusive, except S/Ns 1007, 1102, and 1145, and except helicopters on which Airbus Helicopters Service Bulletin EC135-85-063 has been embodied in service. Model EC635 P2+, EC635 P3, EC635 T1, EC635 T2+, and EC635 T3 helicopters are not certificated by the FAA and are not included on the U.S. type certificate data sheet, except where the U.S. type certificate data sheet explains that the Model EC635T2+ helicopter having serial number 0858 was converted from Model EC635T2+ to Model EC135T2+. This AD, therefore, does not include Model EC635 P2+, EC635 P3, EC635 T1, EC635 T2+, and EC635 T3 helicopters in the applicability.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Helicopters Deutschland GmbH Model EC135P2+, EC135P3, EC135T2+, and EC135T3 helicopters. The NPRM published in the Federal Register on September 23, 2021 (86 FR 52851). The NPRM was prompted by reports that aft and forward fitting assemblies, having part number L851M2810103, were installed as part of the outboard load system on helicopters having S/Ns 0886 and up. The affected fitting assemblies are not approved for installation on helicopters having those serial numbers. Operators of those helicopters might not be aware of the applicable overhaul or life limits for those fitting assemblies. The NPRM proposed to require inspecting the aft and forward fitting assemblies of the outboard load system to determine the part number, re-identifying the part if necessary, inspecting each affected part for damage (which may be indicated by signs of corrosion, mechanical damage, loose rivets, or cracks) and, depending on the findings, corrective actions, as specified in EASA AD 2021-0066.

The FAA is issuing this AD to address failure of affected aft and forward fitting assemblies and consequent loss of external cargo, resulting in personal injury or injury to persons on the ground. See EASA AD 2021-0066 for additional background information.

The FAA received no comments on the NPRM or on the determination of the costs.

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 reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these helicopters. Except for minor editorial changes, this AD is adopted as proposed in the NPRM.

EASA AD 2021-0066 requires a onetime inspection of each aft and forward fitting assembly of the outboard load system to identify the part number, re-identifying the part number if necessary, a one-time inspection of an affected fitting assembly for damage, and corrective action. The corrective action includes replacing any damaged fitting.

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 ADDRESSES section.

The FAA estimates that this AD affects 69 helicopters of U.S. Registry. The FAA estimates the following costs to comply with this AD.

The FAA estimates the following costs to do any necessary actions that would be required based on the results of the inspection. The agency has no way of determining the number of helicopters that might need these actions:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0182, dated July 26, 2019 (EASA AD 2019-0182), to correct an unsafe condition for Leonardo S.p.A. Helicopters, formerly Finmeccanica S.p.A. Helicopter Division, AgustaWestland S.p.A., Agusta S.p.A., Model A109E, A109LUH, A109S, and AW109SP helicopters, all serial numbers. Model A109LUH helicopters are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those helicopters in the applicability. Although EASA AD 2019-0182 applies to Model A109E, A109S and AW109SP helicopters, all manufacturer serial numbers, this AD applies to helicopters with an affected assembly installed.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Leonardo S.p.a. Model A109E, A109S, and AW109SP helicopters, certificated in any category, with an affected assembly as identified in EASA AD 2019-0182. The NPRM published in the Federal Register on July 30, 2021 (86 FR 40964). The NPRM was prompted by reports of MLG wheel assembly failure on Model A109E helicopters. Subsequent investigations identified stress corrosion and hydrogen embrittlement on the threaded end of the MLG strut, where lack of cadmium plating was observed, and determined that a certain batch of “enhanced” MLGs may be affected. Due to design similarity Model A109S and AW109SP helicopters are also affected. The NPRM proposed to require repetitive inspections of each affected MLG strut assembly and, depending on the findings, replacement of an affected MLG strut assembly with a serviceable assembly, or application of corrosion preventive compound, as specified in EASA AD 2019-0182.

The FAA is issuing this AD to address stress corrosion and hydrogen embrittlement on the threaded end of the MLG strut in the MLG wheel assembly. This condition, if not addressed, could lead to cracks on the affected MLG assembly, resulting in damage or failure of the MLG and consequent damage to the helicopter and injury to occupants. See EASA AD 2019-0182 for additional background information.

The FAA received a comment from one commenter. The commenter was Air Methods Corporation. The following presents the comment received on the NPRM and the FAA's response to that comment.

Air Methods Corporation requested that paragraph (h)(6) of the proposed AD be revised to include an option so an operator can replace a part or assembly that has an inspection finding of “questionable/intermediate” at the operator's discretion, instead of having to coordinate with the manufacturer. The commenter explained that the instructions for replacing a part or assembly that has a determinate inspection finding (for example, a crack) are already in the service information referenced in EASA AD 2019-0182 and these same instructions could be used for parts that have a “questionable/intermediate” inspection finding.

The FAA partially agrees with the commenter's request and will provide clarification regarding the requirement specified in paragraph (h)(6) of this AD. The FAA identified an error in paragraph (h)(6) of the proposed AD that could have caused an operator to misinterpret when to contact the manufacturer for corrective action if there was an inspection finding of “some burr” from the liquid penetrant inspection specified in Annex A of the service information referenced in EASA AD 2019-0182. In the proposed AD, paragraph (h)(6) stated “Where Annex A of the service information referenced in EASA AD 2019-0182 specifies to contact the manufacturer if there is any indication of cracking due to `some burr' . . . .” This language should not have included “of cracking” because any burr indication finding requires contacting the manufacturer. The FAA has revised paragraph (h)(6) of this AD to remove the words “of cracking.”

The FAA does not agree with the commenter's request to provide an option for the removal and replacement of a part having an indication of “some burr”, or signs of arcing or burning, without contacting the manufacturer. The FAA contacted EASA, the foreign authority that has State of Design for these helicopter models, and discussed an option to permit the replacement of a potentially discrepant component without contacting the manufacturer. Based upon this discussion the FAA concluded that the affected part is still under investigation and the manufacturer needs to gather additional information from operators to determine the extent of the identified conditions and if additional corrective actions are needed. The FAA has not changed this AD regarding this issue.

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 reviewed the relevant data, considered the comment received, and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator. Accordingly, the FAA is issuing this AD to address the unsafe condition on these helicopters.

EASA AD 2019-0182 requires repetitive inspections of each affected MLG assembly and, depending on the findings, replacement of an affected MLG strut assembly with a serviceable assembly, or application of corrosion preventive compound. EASA AD 2019-0182 allows the installation of an affected MLG strut assembly on any helicopter, provided it is a serviceable assembly, as defined in EASA AD 2019-0182.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 99 helicopters of U.S. Registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary replacement actions that would be required based on the results of the inspection. The agency has no way of determining the number of aircraft that might need this replacement:

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Gulfstream Aerospace Corporation (Gulfstream) Model GV and GV-SP airplanes. The NPRM published in the Federal Register on September 17, 2021 (86 FR 51842). The NPRM was prompted by notification from Gulfstream that a life limit for replacing MLG trunnion pin part number (P/N) 1159SCL566-15 had been omitted from the ALS of the maintenance manual for Model GV and GV-SP airplanes. Gulfstream revised the ALS for the applicable airplanes to establish a life limit of 20,000 flight cycles for the affected MLG trunnion pin. A trunnion pin remaining in service beyond its fatigue life could lead to fracture and failure of the trunnion pin.

In the NPRM, the FAA proposed to require revising the ALS of your ICA or inspection program for the airplane to establish a life limit of 20,000 flight cycles for the affected MLG trunnion pin. The FAA is issuing this AD to prevent MLG failure, which could lead to a runway excursion.

The FAA received no comments on the NPRM or on the determination of the costs.

The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.

The FAA reviewed Gulfstream GV Aircraft Maintenance Manual, Revision 53, dated March 15, 2021; Gulfstream G550 Aircraft Maintenance Manual, Revision 34, dated March 15, 2021; and Gulfstream G500-5000 Aircraft Maintenance Manual, Revision 34, dated March 15, 2021. For the applicable marketing designation specified on each document, the revised service information adds a life limit for MLG trunnion pin P/N 1159SCL566-15.

The FAA estimates that this AD affects 516 airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 50862; September 13, 2021) for Docket No. FAA-2021-0740 to amend the Class E airspace at Greenville, TX, and establish Class E airspace at Terrell, TX. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

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

This amendment to 14 CFR part 71:

Amends the Class E airspace extending upward from 700 feet above the surface to within a 6.4-mile (decreased from a 6.5-mile) radius of Caddo Mills Municipal Airport, Caddo Mills, TX, contained within the Greenville, TX, airspace legal description; removes the Caddo Mills RBN and associated extension from the Greenville, TX, airspace legal description; removes Terrell Municipal Airport and the associate airspace from the Greenville, TX, airspace legal description as the airspace no longer adjoins and separate airspace is being established for Terrell, TX; removes the city associated with Majors Airport, Greenville, TX, to comply with updates to FAA Order 7400.2N, Procedures for Handling Airspace Matters; updates the geographic coordinates of the Caddo Mills Municipal Airport to coincide with the FAA's aeronautical database; and removes the exclusionary language as it is no longer required;

And establishes Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Terrell Municipal Airport, Terrell, TX.

These actions are the result of airspace reviews caused by the decommissioning of the Caddo Mills NDB which provided guidance to instrument procedures at these airports.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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

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

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace extending upward from 700 feet above the surface at Ashland Regional Airport, Ashland, KY, by updating the geographic coordinates of the airport in the airspace legal description to coincide with the FAA's aeronautical database.

Class E airspace areas extending upward from 700 feet AGL above the surface are used to transition to/from the terminal or enroute environment. During a recent review of the Ashland Regional Airport, Ashland, KY, airspace, the FAA identified that the geographic coordinates of the airport were incorrect. This action updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database. This action does not change the airspace boundaries or operating requirements.

Class E airspace designations are published in paragraph 6005 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

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

This amendment to 14 CFR part 71 amends the Class E airspace extending upward from 700 feet above the surface at Ashland Regional Airport, Ashland, KY, by updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

This action is an administrative change and does not affect the airspace boundaries or operating requirements; therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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

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

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

Upon request, FDA has classified the ingested, transient, space occupying device for weight management and/or weight loss as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On November 15, 2018, Gelesis, Inc. submitted a request for De Novo classification of the ingested, transient, space occupying device for weight management and/or weight loss. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on April 12, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 876.5982. 1 We have named the generic type of device ingested, transient, space occupying device for weight management and/or weight loss, and it is identified as an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).

At the time of classification, ingested, transient, space occupying devices for weight management and/or weight loss are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

Upon request, FDA has classified the negative pressure wound therapy device for reduction of wound complications as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On March 15, 2018, KCI USA, Inc. submitted a request for De Novo classification of the PREVENA 125 and PREVENA PLUS 125 Therapy Units. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on April 19, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 878.4783. 1 We have named the generic type of device negative pressure wound therapy device for reduction of wound complications, and it is identified as a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, negative pressure wound therapy devices for reduction of wound complications are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

Upon request, FDA has classified the transcutaneous electrical nerve stimulator for ADHD as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On July 30, 2018, NeuroSigma, Inc. submitted a request for De Novo classification of the Monarch eTNS System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on April 19, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 882.5898. 1 We have named the generic type of device transcutaneous electrical nerve stimulator for ADHD, and it is identified as a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, transcutaneous electrical nerve stimulators for ADHD are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

The Coast Guard will enforce the safety zones established in 33 CFR 165.1191 Table 1, Item number 25, for the Sacramento New Year's Eve Fireworks Display from 8:30 p.m. until 9:45 p.m. on December 31, 2021, or as announcement via Broadcast Notice to Mariners. The safety zone will extend to all three safety zones established in 33 CFR 165.1191 Table 1, Item number 25. During the period of enforcement, the three safety zones for the Sacramento New Year's Eve Fireworks Display will encompass the navigable waters, from surface to bottom, around the fireworks firing sites within three respective circles each with a radius of 700 feet with the respective circle centers in approximate positions:

The safety zones will be enforced from 8:30 p.m. until 9:45 p.m. on December 31, 2021, or as announced via Broadcast Notice to Mariners.

In addition to this notification in the Federal Register , the Coast Guard plans to provide notification of the safety zone and its enforcement period via the Local Notice to Mariners.

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM or other Official Patrol defined as a federal, state, or local law enforcement agency on scene to assist the Coast Guard in enforcing the regulated area. Additionally, each person who receives notice of a lawful order or direction issued by the PATCOM or Official Patrol shall obey the order or direction. The PATCOM or Official Patrol may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.

If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard did not receive final details for this event until November 10, 2021. It is impracticable to go through the full notice and comment rule making process because the Coast Guard must establish this safety zone by December 19, 2021 and lacks sufficient time to provide a reasonable comment period and to consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to public interest because action is necessary to protect personnel, vessels, and the marine environment from the potential safety hazards associated with the fireworks display near Chase Center in the San Francisco Bay on December 19, 2021.

The Coast Guard is issuing this rule under authority 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port San Francisco has determined that potential hazards associated with the Frantic Inc Chase Center Fireworks on December 19, 2021, will be a safety concern for anyone within a 100-foot radius of the fireworks vessel during loading and staging, and anyone within a 700-foot radius of the fireworks vessel starting 30 minutes before the fireworks display is scheduled to commence and ending 30 minutes after the conclusion of the fireworks display. For this reason, this temporary safety zone is needed to protect personnel, vessels, and the marine environment in the navigable waters around the fireworks vessel and during the fireworks display.

This rule establishes a temporary safety zone from 11 a.m. until 10:40 p.m. on December 19, 2021, during the loading, staging, and transit of the fireworks vessel in San Francisco Bay from Pier 50 to 1000 feet off Chase Center, San Francisco, CA, and until 30 minutes after completion of the fireworks display. During the loading, staging, and transit of the fireworks vessel scheduled to take place between 11 a.m. and 9:15 p.m. on December 19, 2021, until 30 minutes prior to the start of the fireworks display, the safety zone will encompass the navigable waters around and under the fireworks vessel, from surface to bottom, within a circle formed by connection of all points 100 feet out from the fireworks vessel. The fireworks display is scheduled to start at 10:00 p.m. December 19, 2021 and end at approximately 10:10 p.m. on December 19, 2021, 1,000 feet from Chase Center in San Francisco, CA.

The fireworks vessel will remain at Pier 50 until the start of its transit to the display location. Movement of the vessel from Pier 50 to the display location is scheduled to take place from 8:45 p.m. to 9:15 p.m. on December 19, 2021, where it will remain until the conclusion of the fireworks display.

At 9:30 p.m. on December 19, 2021, 30 minutes prior to the commencement of the 10-minute fireworks display, the safety zone will increase in size and encompass the navigable waters around and under the fireworks vessel, from surface to bottom, within a circle formed by all connecting points 700 feet from the circle center at approximate position 37°46′02.82″ N, 122°22′56.00″ W (NAD 83), or as announced via Broadcast Notice to Mariners. The safety zone will terminate at 10:40 p.m. on December 19, 2021.

This regulation is necessary to keep persons and vessels away from the immediate vicinity of the fireworks loading, staging, transit, and display site. Except for persons or vessels authorized by the COTP or the COTP's designated representative, no person or vessel may enter or remain in the restricted area. A “designated representative” means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel, or a Federal, State, or local officer designated by or assisting the Captain of the Port San Francisco (COTP) in the enforcement of the safety zone. This regulation is necessary to ensure the safety of participants, spectators, and transiting vessels.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the limited duration and narrowly tailored geographic area of the safety zone. Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterways users will be notified to ensure the safety zone will result in minimum impact. The vessels desiring to transit through or around the temporary safety zone may do so upon express permission from the COTP or the COTP's designated representative.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone in the navigable waters around the loading, staging, transit, and display of fireworks near Pier 50 and 1,000 feet off Chase Center in San Francisco Bay. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce the safety zone established in 33 CFR 165.1191, Table 1, Item number 30, for the Sausalito Lighted Boat Parade Fireworks on December 11, 2021. The Captain of the Port has delegated the authority to issue the notification of enforcement for this regulation to the Prevention Department Head. The Coast Guard will enforce a 100-foot safety zone around the fireworks barge during the loading, transit, and setup of the fireworks barge from the loading location to the display location and until the commencement of the fireworks display. From 10 a.m. until 5 p.m. on December 11, 2021, the fireworks barge will be loading pyrotechnics at Pier 50 in San Francisco, CA. The fireworks barge will remain at the loading location until its transit to the display location. From 5:30 p.m. to 7:00 p.m. on December 11, 2021 the loaded fireworks barge will transit from Pier 50 to the launch site near Sausalito Point in approximate position 37°51′15.99″ N, 122°28′41.70″ W (NAD 83), where it will remain until the conclusion of the fireworks display. Starting at 7:15 p.m. on December 11, 2021, 30 minutes prior to the commencement of the 10-minute fireworks display, the safety zone will encompass the navigable waters, from surface to bottom, surrounding the fireworks barge near Spinnaker Point in Sausalito, CA within a radius of 1,000 feet from approximate position 37°51′15.99″ N, 122°28′41.70″ W (NAD 83) for the Sausalito Lighted Boat Parade Fireworks Display as set forth in 33 CFR 165.1191, Table 1, Item number 30. The safety zone will be enforced until 8:25 p.m. on December 11, 2021, or as announced via Broadcast Notice to Mariners.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners.

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM or other Official Patrol defined as a federal, state, or local law enforcement agency on scene to assist the Coast Guard in enforcing the regulated area. Additionally, each person who receives notice of a lawful order or direction issued by the PATCOM or Official Patrol shall obey the order or direction. The PATCOM or Official Patrol may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.

If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

The Coast Guard is issuing this temporary final 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)(3)(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 and contrary to the public interest. It is impracticable to publish an NPRM because we must establish this safety zone by December 3, 2021, and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule is contrary to public interest because it would delay the safety measures necessary to respond to potential safety hazards associated with this project. Immediate action is needed to protect vessels and mariners from the safety hazards associated with the bridge construction project on the waterway.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Mobile (COTP) has determined that potential hazards associated with the bridge construction project on December 3rd will be a safety concern for any vessels or persons within 100 yards from the pilings, work equipment, and structures of the Pensacola Bay Bridge, Pensacola Beach, FL, including the channel at the center span which will be impassable at the time. This rule is needed to protect the public, mariners, and vessels from the potential hazards associated with the bridge construction project on the waterway.

The Coast Guard is establishing a temporary safety zone, effective for 24 hours a day, starting at 6 a.m. on December 3rd through 6 a.m. December 31, 2021. The safety zone encompasses the navigable waters within 100 yards from the pilings, work equipment, and structures of the Pensacola Bay Bridge, Pensacola Beach, FL, including the channel at the center span which will be impassable at the time. The location and duration of this safety zone is intended to protect persons and vessels during the bridge construction project that will take place on this navigable waterway. No person or vessel will be permitted to enter or transit within the safety zone, unless specifically authorized by the COTP or a designated representative. Public notifications will be made to the local maritime community through Broadcast Notice to Mariners (BNM). Mariners and other members of the public may also contact the COTP or designated representative to inquire about the safety zone by telephone at 251-441-5490.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protectors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB). This regulatory determination is based on the size, location, and duration, of the safety zone. This temporary safety zone will only restrict navigation within 100 yards from the pilings, work equipment and structures of the Pensacola Bay Bridge, Pensacola Beach, FL, for duration of the bridge construction. Moreover, the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V. A. above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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 expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1., associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will prohibit mariners and the public 100 yards from the pilings, work equipment and structures of the Pensacola Bay Bridge, Pensacola Beach, FL, including the channel at the center span that will be impassable at this time. It is categorically excluded from further review under paragraph L60 (a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev.01.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

On September 30, 2021, the Postal Service published a notice of proposed rulemaking (NPRM) (86 FR 54142) to revise the postage calculation standards for Periodicals pending authorization. In response to the proposed rule, four commenters submitted comments.

Comment: One commenter supported the proposal changes, stating that it would make pricing Pending periodicals more efficient and effective.

USPS Response: The Postal Service is grateful for the support.

Comment: One commenter opposed the proposal, characterizing it as a price increase unsupported by data, analysis, or fiscal studies that would assess its effects.

USPS Response: The Postal Service believes this comment misunderstands the proposal. The Postal Service was not proposing a price increase, which in any event would have to be brought as a price case before the Postal Regulatory Commission, not a change to the Domestic Mail Manual. Rather, the Postal Service proposed an alternative method of assigning non-Periodicals prices to mailings while a mailer's application for Periodicals mailing privileges is pending.

Mailers seeking Periodicals mailing privileges must submit an application for approval, together with appropriate fees and supporting information to demonstrate eligibility (DMM 207.4.1-207.4.2; 207.4.13; 207.5.1.1-207.5.1.10; 207.10.7.1-207.10.7.3). While this application is pending, a mailer may prepare its mailing as Periodicals and make use of all available dropshipping and pre-sorting options available for Periodicals, but the mailing is not eligible for Periodicals prices.

As such, the mailer must provide two postage statements with each mailing, a Periodicals postage statement and a postage statement for the non-Periodicals price most closely applicable to the mailing (DMM 207.17.2.5). The process is automated, however, and a mailer that has an account with the Postal Service need only enter a Periodicals postage statement into the Postal Service computer systems, which then automatically generate the non-Periodicals postage statement and calculate the closest applicable non-Periodicals prices. It is the methodology its computer systems use to assign non-Periodicals prices that the Postal Service proposed to revise because the current methodology is unwieldy and limited.

On the one hand, maintaining the underlying mapping between Periodicals and non-Periodicals prices is labor intensive. There are hundreds of possible rate cells to map between Periodicals prices and possible non-Periodicals prices. The price for out-of-county Periodicals, for example, includes a per-pound price for the percentage of advertising space; a per-pound price for the percentage of non-advertising space; a per-piece price that varies by shape ( i.e., letters, flats, or parcels), sorting level ( e.g., CR, 5-Digit, 3-Digit, ADC, etc.), and machinability; and a per-bundle or per container price, the latter of which varies by dropship level (Notice 123, August 29, 2021).

On the other hand, and more importantly, the current methodology does not provide exact pricing. In some cases, for example, a mailing might receive a non-Periodical rate that most closely matches by size, weight, and shape but for which the mailing nevertheless does not qualify because it does not meet volume requirements. The minimum volume requirement for a mailing pre-sorted to ADC, 3-Digit, or 5-Digit, for example, is 6 pieces for Periodicals and 10 pieces for Marketing Mail, the most closely analogous price. Pending Periodicals mailings between 6 and 9 pieces receive the Marketing Mail price even though those mailings do not qualify for that price.

In other cases, an equivalent appropriate rate simply may not exist. For example, an out-of-county Periodical mailing will pay one price, an identical in-county Periodical mailing will pay a different and lower price, id., but no other mail product makes an equivalent in-county/outside-county pricing distinction. Thus, the most closely applicable price to charge pending in-county Periodicals as opposed to pending outside-county Periodicals is unclear.

Accordingly, in the September 30 NPRM, the Postal Service proposed a simplified way to charge current non-Periodical rates for Periodicals mailings while a mailer's application for Periodicals privileges is pending. Mailers pay non-Periodical rates based upon commonalities of size, shape, and weight between the Periodicals mailed and other products. Table 1, an expanded version of DMM Exhibit 5.2.3, sets out possible Periodical types, corresponding non-Periodicals products, the reason for the association, the relevant average per-piece prices, and the non-Periodicals price to be paid, expressed as a percentage to be added to the Periodicals prices.

For example, for Periodicals under one pound that meet the size requirements for Flats, mailers pay Marketing Mail Flats prices, achieved by multiplying the applicable Periodicals Flats price by 1.63, ( i.e., adding an additional 63 percent of the Periodicals price to the average per-piece Periodicals price to reach the average, per-piece Periodicals Flats price) and not, as some commenters understood it, by paying only 63 percent of the Periodicals price. For Periodicals weighing more than one pound or that are more than 0.75″ thick, mailers pay Bound Printed Matter Parcels prices, achieved by multiplying the Periodicals Parcels price by 2.46. All of this is detailed on the Periodicals postage statement, PS Form 3541.

The non-Periodicals prices to be paid are expressed as the percentage difference between the current, average per-piece price for Periodicals and the current, average per-piece price for the corresponding product. The average prices are derived from volume and revenue data for the previous four quarters, and thus the Postal Service may update the percentages in Exhibit 5.2.3 each quarter to reflect quarterly changes in volumes and revenues.

For all of the foregoing reasons, the Postal Service disagrees with the commenter's contention that the September 30 proposal for calculating pending Periodicals prices is a price increase and is making no changes as a result of the comment. The Postal Service is, however, revising the pending postage table from the proposed rule (Exhibit 5.2.3) by adding “Nonprofit USPS Marketing Mail Parcels” as an option for eligible Periodicals during the pending authorization process. This option was inadvertently omitted from the proposal.

Comment: The two remaining commenters oppose the proposal on a number of grounds, though they stated that they generally support the intent to simplify and improve the current process for calculating rates for pending Periodicals.

Primarily, these commenters state that the proposed rule appears to be a price change that must first be approved by the Commission. If the Postal Service's intent was to apply existing prices, that was not clear from, or supported by, information or discussion in the proposed rule.

The commenters also state that the proposal would result in widely divergent, often too-high, prices and, therefore, that the Postal Service should either reduce the percentages given or provide an intermediate appeals process for the mailer to seek review of the pending Periodicals price charged.

USPS Response: The Postal Service appreciates the commenters' support for improving the process for assessing prices for pending Periodicals.

As explained in its response to the previous comment, the Postal Service disagrees that the proposal for changing the methodology for calculating prices for pending Periodicals also proposed a change in prices. Again, the Postal Service proposed an alternative method of assigning prices to mailings while a mailer's application for Periodicals mailing privileges is pending. The new methodology assigns closely applicable non-Periodicals prices to pending Periodicals, and these prices are expressed as a percentage difference between the current, average per-piece price for Periodicals and the corresponding current, average per-piece price for the corresponding product, based upon volume and revenue for the previous four quarters. The overall result is to assess, averaged across all mailings, the same amount before and after the proposal is adopted.

Looked at somewhat differently, just as the proposal makes no direct changes in prices, it makes no indirect changes in prices either. Nothing about the proposal will force pending Periodical mailings into a higher price category because existing, associated prices are already applied, nor has the Postal Service eliminated any rate cells or categories. United States Postal Service v. Postal Regulatory Commission, 785 F.3d 740, 751-52 (D.C. Cir. 2015); United States Postal Service v. Postal Regulatory Commission, 886 F.3d 1261, 1273 (D.C. Cir. 2018) (indirect changes in prices). In short, with no changes in prices or in available rate categories or cells, the proposal can have no price cap implications. Moreover, there is no technical way to map the changes described here on to the billing determinants—a prerequisite for any price cap analysis—because billing determinants data do not separately set out non-Periodicals rates paid by pending Periodicals volume.

The Postal Service apologizes that the proposal was not sufficiently clear and trusts that this explanation shows that it is not seeking to change prices for pending Periodicals.

As to wide fluctuation or variability in prices under the new methodology, the Postal Service does not agree that the proposed methodology results in higher prices. Because the proposed methodology is based upon historical volumes and current, average prices, it is possible that for any given mailing, a mailer may pay a different price than it would have paid under the existing methodology. But those prices may be higher than, lower than, or unchanged from the existing methodology, though the Postal Service expects the prices to be close to those given by the present methodology.

Over multiple mailings during the pendency of an application for Periodicals privileges, however, mailers should collectively be paying approximately the same prices under both the previous and proposed methodologies. As such, the Postal Service disagrees that it should reduce the proposed percentage multipliers in DMM Exhibit 5.2.3.

For that same reason, the Postal Service disagrees that it should provide an additional opportunity for review of pending Periodicals pricing. What is more, the opportunity for this review already exists. When the Postal Service grants a mailer's application for Periodicals mailing privileges, the Postal Service refunds to the mailer the difference between the Periodicals prices for the mailings made while the application was pending and the higher, non-Periodicals prices the mailer actually paid for those mailings (DMM 207.5.2.2b, 207.5.3.5). Any mailer whose application for Periodicals privileges is denied and who therefore does not receive this refund may appeal the denial (DMM 207.5.3.7). This appeal was available to the approximately 25 percent of 289 applications for Periodicals privileges denied by the Postal Service in FY 2020 and 2021.

The Postal Service is revising the process to calculate pending postage by assigning the existing applicable class of mail prices based upon common characteristics of shape and weight. Each applicable class of mail price will be expressed as a percentage from the corresponding Periodicals price. This new process will simplify the calculation process during the authorization review period, and the refund process when a Periodicals publication is approved.

We believe this revision will provide customers with a more efficient and easier process.

The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

Accordingly, 39 CFR part 111 is amended as follows:

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA, which would include the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

The dockets include information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0131, is available at https://www.regulations.gov and at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

EPA is finalizing SNURs under TSCA section 5(a)(2) for certain chemical substances which were the subject of PMNs. EPA will address the other proposed SNURs in future FR notices.

Previously, EPA proposed SNURs for these chemical substances and established the record for these SNURs in the following Federal Register and docket ID number:

• October 9, 2020 (85 FR 64280) (FRL-10011-86); Docket ID No. EPA-HQ-OPPT-2020-0131.

The dockets include information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the public comments received.

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the significant new use notice (SNUN) requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN and before the manufacture or processing for the significant new use can commence, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

When the Agency issues an order under TSCA section 5(e), section 5(f)(4) requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the TSCA Order or publish a statement describing the reasons for not initiating the rulemaking. TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to other SNURs.

Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

EPA received public comments from three identifying entities on the proposed rules. The Agency's responses are presented in the Response to Public Comments document that is available in the public docket for this rulemaking. In addition, EPA received three anonymous comments. The anonymous comments were either general in nature and did not pertain to the proposed rule or were broadly supportive of the rule and requested no changes to the rule itself; therefore, no response is required. EPA made changes to 27 of the proposed rules as described in the response to comments.

EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the proposed SNURs, EPA provided the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as confidential business information (CBI)).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Effective date of and basis for the TSCA Order.

• Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.

• CFR citation assigned in the regulatory text section of these rules.

The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.

These final rules include PMN substances that are subject to orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The final SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA Order usually requires that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs provisions in TSCA Orders include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. No comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA Order.

During review of the PMNs submitted for the chemical substances that are subject to these SNURs and as further discussed in Unit IV. of the proposed rules, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on such findings, TSCA Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.

EPA is issuing these SNURs because the Agency wants to:

• Receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

• Have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use; and

• Be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under TSCA section 5(a)(3)(C) that significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted, EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA Orders have been issued for all the chemical substances that are the subject of this rule, and the PMN submitters are prohibited by the TSCA Orders from undertaking activities which will be designated as significant new uses. The identities of many of the chemical substances subject to this rule have been claimed as confidential (per 40 CFR 720.85). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

Furthermore, EPA designated the publication dates of the proposed rules (see Unit II.) as the cutoff dates for determining whether the new uses are ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule.

In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of the abovementioned dates, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, that person would have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, TSCA Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, TSCA Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to them or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the proposed rule lists potentially useful information for all SNURs listed in this document. Descriptions are provided for informational purposes. The information identified in Unit IV. of the proposed rule will be potentially useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance.

EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

In some of the TSCA Orders for the chemical substances identified in this rule, EPA has established production volume and time limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same limits as the TSCA Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

Any request by EPA for the triggered and pended testing described in the TSCA Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

The potentially useful information identified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance associated with the designated significant new uses. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analyses are available in each docket listed in Unit II.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

This action establishes SNURs for several new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

This action is not subject to Executive Order 13771 (82 FR 9339, February 3, 2017), because this action is not a significant regulatory action under Executive Order 12866.

According to the PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The information collection requirements associated with SNURs have already been approved by OMB pursuant to the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This rule does not impose any burden requiring additional OMB approval.

The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. The Information Collection Request (ICR) covering the SNUR activities was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq. ), the Agency hereby certifies that promulgation of these SNURs would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, EPA has concluded that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, EPA received 7 SNUNs in Federal fiscal year (FY) 2013, 13 in FY2014, 6 in FY2015, 10 in FY2016, 14 in FY2017, and 11 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This action will not have a substantial direct effect on 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

In addition, since this action does not involve any technical standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report containing this rule and other required information 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).

Therefore, for the reasons stated in the preamble, 40 CFR chapter I is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On September 15, 2021, EPA published a notice of proposed rulemaking (NPRM) for the State of Rhode Island. See 86 FR 51310. The NPRM proposed approval of a Rhode Island SIP revision that addresses the CAA requirement to prohibit emissions from the state that significantly contribute to nonattainment or interfere with maintenance of the 2015 8-hour ozone NAAQS in other states. See CAA section 110(a)(2)(D)(i)(I) (the “good neighbor provision”). The SIP revision was submitted to EPA by Rhode Island on September 23, 2020. The rationale for EPA's proposed action is given in the NPRM and will not be repeated here. EPA received two public comments on the NPRM, which are addressed below.

One anonymous comment supported the EPA's proposed action and suggested that EPA solicit information from residents of the State of Rhode Island as well as from residents of downwind states. We note that, before providing the submission to EPA, the Rhode Island Department of Environmental Management (RIDEM) distributed it to the public via the RIDEM website and an electronic mailing list. RIDEM also gave state residents and other interested parties a 30-day period to request a public hearing and provide public comments. In addition, EPA provided the public with a 30-day period to comment in the Federal Register , the official journal of the U.S. Government that is available to all downwind states, on the proposed approval of Rhode Island's SIP revision following publication on September 15, 2021.

The other commenter questioned why the analyses considered the effects of emissions from Rhode Island on Connecticut and New York, but seemingly not on Massachusetts—particularly Bristol County, Massachusetts, parts of which lie directly east of Rhode Island. The comment states that “prevailing winds [in this region] travel eastward” and that “EPA data shows [sic] that Bristol County . . . experiences a disproportionately high `Percent of Total US Anthropogenic Ozone from Upwind States' compared to other Mass counties.”

EPA acknowledges that the prevailing winds described by the commenter do generally move from west to east in the New England area, and therefore, Massachusetts is downwind of Rhode Island. In fact, EPA's modeling analysis does consider the impact of emissions from Rhode Island on all downwind areas within the contiguous 48 states, including Bristol County, Massachusetts, and, indeed, the data indicate that the highest projected contribution in 2021 from Rhode Island sources to an out-of-state area is 2.50 ppb to Bristol County (monitoring site 250051004; line number 242 on the Design Values and Contributions spreadsheet). 1

As explained in the NPRM for this action, EPA uses a four-step interstate transport framework to address the requirements of the good neighbor provision for the 2015 ozone NAAQS. The first step is to identify downwind areas that may have problems attaining and maintaining the standard ( i.e., receptors). The Bristol County monitor's projected average design value is 63.4 ppb and projected maximum design value is 65.5 ppb in 2021, which are both below the 2015 ozone NAAQS of 70 ppb. Using EPA's definition of a projected nonattainment or maintenance receptor provided in the NPRM (a definition that Rhode Island adopted), EPA's analysis indicates that the monitor in Bristol County, Massachusetts, is not projected to be a nonattainment or maintenance receptor in 2021 or later years for the 2015 ozone NAAQS.

While Bristol County is considered downwind of, and impacted by, Rhode Island's emissions, EPA's analysis in this first step did not identify Bristol County as a receptor expected to have problems maintaining the 2015 ozone NAAQS. Thus, EPA concluded that emissions from Rhode Island sources, while having an impact on ozone levels in Bristol County, do not contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in Bristol County (or elsewhere in Massachusetts), which is the relevant inquiry under CAA section 110(a)(2)(D)(i)(I).

By comparison, EPA's analysis at step one identified other receptors, including monitoring sites west of Rhode Island in Connecticut and in New York that are projected to have problems attaining and maintaining the 2015 ozone NAAQS. For these receptors, EPA proceeded to step 2 of the four-step interstate transport framework, which considers whether emissions from Rhode Island impact air-quality problems at those receptors sufficiently such that the state is considered “linked” to those receptors and therefore warrants further review and analysis.

Based on the results of EPA's air-quality analysis described in the proposal of this action, EPA determined that Rhode Island contributes well below the screening threshold of one percent of the 2015 ozone NAAQS (0.70 ppb) to any of these Connecticut or New York receptors, and is, therefore, not linked to downwind nonattainment and/or maintenance receptors. 2 3 EPA also analyzed emissions trends for ozone precursors, concluding that emissions from sources in Rhode Island will continue to decline, which lends further support to the findings from the air-quality analysis.

In sum, EPA's analysis considered the impact of emissions from Rhode Island sources on Massachusetts (including Bristol County) but found that Rhode Island does not contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in Massachusetts, because that state is not expected to have problems maintaining ozone concentrations below the NAAQS. Furthermore, EPA's entire analysis concluded that Rhode Island does not significantly contribute to nonattainment or interfere with maintenance in any other state for the 2015 ozone NAAQS.

EPA is approving a Rhode Island SIP revision, which was submitted on September 23, 2020. This submission is approved as meeting CAA section 110(a)(2)(D)(i)(I) requirements that Rhode Island's SIP includes adequate provisions prohibiting any source or other type of emissions activity within the State from emitting any air pollutant in amounts that will contribute significantly to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state.

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, 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 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, 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

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 8, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

On May 1, 2020, we published the CMS Interoperability and Patient Access final rule (85 FR 25510) to establish policies that advance interoperability and patient access to health information. The rule required Medicare Advantage (MA) organizations, Medicaid managed care plans, Children's Health Insurance Program (CHIP) managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) (collectively referred to as “impacted payers”), to facilitate enhanced data sharing by exchanging data with other payers at the patient's request, starting January 1, 2022, for:

• MA organizations (42 CFR 422.119(f)); or

• Medicaid managed care plans (42 CFR 438.62(b)(1)(vi)); and CHIP managed care entities (42 CFR 457.1216).

For plan or policy years beginning on or after January 1, 2022, for QHP issuers on the FFEs (45 CFR 156.221(f)), as applicable. We also required these impacted payers to incorporate and maintain the data they receive through this payer-to-payer data exchange into the enrollee's record, with the goal of increasing transparency for patients, promoting better coordinated care, reducing administrative burden, and enabling patients to establish a collective patient health care record as they move throughout the health care system (see applicable regulations at (§ 422.119(f) for MA organizations; § 438.62(b)(1)(vi) for Medicaid managed care plans (and by extension under existing rules at § 457.1216, to CHIP managed care entities); and § 156.221(f)(i) through (iii) for QHP issuers on the FFEs). These policies are collectively referred to as the payer-to-payer data exchange requirement.

To provide payers with flexibility to support timely adoption and rapid implementation, CMS did not require an application programming interface (API) or any a specific mechanism for the payer-to-payer data exchange. Rather, we required impacted payers to receive data in whatever format it was sent and to send data in the form and format it was received, which ultimately complicated implementation by requiring payers to accept data in different formats.

Since the rule was finalized in May 2020, multiple impacted payers have indicated to CMS that the absence of a required standard or specification for the payer-to-payer data exchange requirement is creating challenges for implementation and may lead to differences in implementation across industry, poor data quality, operational challenges, and increased administrative burden. For example, payers expressed concerns about receiving volumes of portable document format (pdf) documents and files from other payers using a variety of technical approaches—from file transfer protocols (FTP), to email, to Fast Healthcare Interoperability Resources (FHIR). Payers explained that differences in implementation approaches may create gaps in patient health information that conflict directly with the intended goal of an interoperable payer-to-payer data exchange.

After listening to stakeholder concerns about implementing the payer-to-payer data exchange requirement and considering the potential for negative outcomes that impede, rather than support, interoperable payer-to-payer data exchange, CMS published three frequently asked questions (FAQs) on the CMS and HHS Good Guidance websites  1 to announce that it would be exercising enforcement discretion for the payer-to-payer data exchange requirement. In one of the FAQs, CMS encouraged payers that have already developed FHIR-based application API solutions to support the payer-to-payer data exchange to continue to move forward with implementation. The FAQ noted that for those impacted payers that are not capable of making the data available in a FHIR-based format, we believed that this policy of exercising enforcement discretion would alleviate industry tension regarding implementation; avoid the risk of discordant, non-standard data flowing between payers; provide time for data standards to mature further; and allow payers additional time to implement the more sophisticated payer-to-payer data exchange solutions. We are now announcing that we expect to extend this exercise of enforcement discretion of the payer-to-payer data exchange requirement until we are able to address the identified implementation challenges through future rulemaking. We anticipate providing an update on any evaluation of this enforcement discretion notification and related actions during calendar year 2022. We continue to encourage impacted payers that have already developed FHIR-based API solutions to support payer-to-payer data exchange to continue to move forward with implementation and make this functionality available on January 1, 2022, or for plan or policy years beginning on or after January 1, 2022, in accordance with the CMS Interoperability and Patient Access final rule policies. However, for those impacted payers that are not capable of making the data available in a FHIR-based API format, we believe this exercise of enforcement discretion will alleviate issues regarding implementation; avoid the risk of discordant, non-standard data flowing between payers; provide time for data standards to further mature through constant development, testing, and reference implementations; and allow payers additional time to implement more sophisticated payer-to-payer data exchange solutions.

While the policy in this notification may result in temporary delay of some enrollees' ability to bring their data with them from one payer to the next, we believe this decision could ultimately lead to more standardization and cohesion of data about enrollees as CMS provides additional implementation guidance through future rulemaking.

Finally, our decision to exercise enforcement discretion for the payer-to-payer policy until future rulemaking is finalized does not affect any other existing regulatory requirements and implementation timelines finalized in the CMS Interoperability and Patient Access rule finalized on May 1, 2020.

Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on October 15, 2021.

The Pacific Coast Groundfish Fishery Management Plan (PCGFMP) and its implementing regulations at title 50 in the Code of Federal Regulations (CFR), part 660, subparts C through G, regulate fishing for over 90 species of groundfish off the coasts of Washington, Oregon, and California. The Pacific Fishery Management Council (Council) develops groundfish harvest specifications and management measures for 2-year periods ( i.e., a biennium). NMFS published the final rule to implement harvest specifications and management measures for the 2021-2022 biennium for most species managed under the PCGFMP on December 11, 2020 (85 FR 79880). In general, the management measures set at the start of the biennial harvest specifications cycle help the various sectors of the fishery attain, but not exceed, the catch limits for each stock. The Council, in coordination with Pacific Coast Treaty Indian Tribes and the states of Washington, Oregon, and California, recommends adjustments to the management measures during the fishing year to achieve this goal.

At the September 2021 Council meeting, the Council's Groundfish Management Team (GMT) received requests from industry members and members of the Council's Groundfish Advisory Subpanel to examine the potential to increase sablefish trips limits for the fixed gear (FG), limited entry (LE) and open access (OA) Daily Trip Limit (DTL) fisheries north of 36° N lat., and to increase trip limits for lingcod north of 42° N latitude. The intent of increasing the sablefish limits was to increase harvest opportunities for vessels targeting sablefish, under a mix of daily, weekly, and bimonthly landings accumulation limits (commonly referred to collectively as “trip limits”); attainment of harvest targets for each DTL fishery, and the northern FG harvest guidelines for sablefish have been trending much lower than anticipated throughout 2021. To evaluate potential increases to sablefish trip limits, the GMT made model-based projections of landings under current regulations, as well as alternative sablefish trip limits, including the limits ultimately recommended by the Council, through the remainder of the year. Under the current trip limits, models predict that landings of sablefish will be far below the harvest targets for LE, and OA fixed gear sablefish DTL fisheries north of 36° N lat. Under the Council's recommended trip limits, sablefish attainment is projected to increase in the LE DTL fishery north of 36° N latitude, from between 54-59 percent attainment, up to between 86 and 95 percent. For the OA DTL fishery, north of 36° N latitude, the projected gains are more modest (from between 53 and 60 percent attainment, to between 57 and 66 percent); however, the OA model is more uncertain and less well informed than the LE model, the changes (both to LE and OA) should allow some beneficial increase in attainment, while being sufficiently precautionary.

The Council also recommended changes to trip limits for lingcod north of 42° N latitude, after request from industry and analysis by the GMT, in order to reduce regulatory discard, which results in waste and lost revenue. Projected impacts to total fishing mortality are nearly identical between the current and recommended trip limits for lingcod, and well within the margin for error, but based on the analysis by the GMT, the higher landing limits are predicted to convert lost fish as discard, into landings and revenue, rather than inspire additional effort. By maintaining the same level of effort, and total fishing mortality, this increase in trip limits is not predicted to increase bycatch of yelloweye rockfish, which is managed under a rebuilding plan, and is a constraint to this fixed gear lingcod attainment.

At its meeting on September 9-15, 2021, the Council recommended increasing trip limits for the LE and OA FG sablefish, DTL fisheries north of 36° N latitude. The Council also recommended increasing trip limits for the FG lingcod fishery, north of 42° N latitude (LE and OA), beginning as soon as possible, for the remainder of the 2021 fishing year and for subsequent November-December periods in later years until superseded. NMFS published these inseason adjustments on October 29, 2021 (86 FR 59876), for vessels using gear other than pot/trap gear. This gear-based limitation was because of the lack of a Marine Mammal Protection Act (MMPA) 101(a)(5)(E) permit for the incidental taking of marine mammals in the sablefish pot gear commercial fisheries. West coast sablefish pot gear fisheries are considered Category II fisheries under the MMPA's List of Fisheries, indicating occasional interactions with marine mammals, due to occasional incidental mortality and serious injury to Endangered Species Act-listed humpback whales (the CA/OR/WA stock of humpback whales). Vessels fishing for sablefish with pot gear also incidentally catch and retain other groundfish species, including lingcod. All other West Coast groundfish fisheries, including trawl and longline fisheries, are considered Category III fisheries under the MMPA, indicating a remote likelihood of, or no known serious injuries or mortalities to, marine mammals. Because sablefish pot gear fisheries are Category II fisheries, NMFS is required to issue a MMPA 101(a)(5)(E) permit for the taking of marine mammals after making a negligible impact determination (NID). NMFS published a notice of proposed issuance of a MMPA 101(a)(5)(E) permit and proposed NID in the Federal Register on October 22, 2021 (86 FR 58641). On December 8, 2021, NMFS issued an MMPA section 101(a)(5)(E) permit for the sablefish pot gear fishery.

These inseason adjustments increase the trip limits for vessels using pot/trap gear to match the limits in place for other FGs since October 29, 2021. The background on the rationale for the trip limit increases and the modeling that was completed in support of these inseason recommendations can be found in the preamble to 86 FR 59876 (October 29, 2021).

Trip limit increases for sablefish are intended to increase attainment of the LE and OA DTL fisheries, which each contribute to attainment of the non-trawl HG for sablefish north of 36° N latitude. The proposed trip limit increases do not change projected impacts to co-occurring rebuilding species as analyzed in the 2021-2022 harvest specifications because the projected impacts to those species assume that the entire sablefish Annual Catch Limit (ACL) is harvested. Recommended increases to lingcod north of 42° N latitude are intended to convert regulatory discards into landings and associated revenue, and are not predicted to increase effort or bycatch of co-occurring rebuilding species. Therefore, the Council recommended, and NMFS is implementing, by modifying Table 2, North and South to part 660, subpart E, trip limit changes for the LE FG fishery north of 40°10′ N lat., as well as Table 3, North and South to part 660, subpart F, to increase the limits as shown in tables 1 and 2 in this rule.

This final rule makes routine inseason adjustments to groundfish fishery management measures, based on the best scientific information available, consistent with the PCGFMP and its implementing regulations.

This action is taken under the authority of 50 CFR 660.60(c) and is exempt from review under Executive Order 12866.

The aggregate data upon which these actions are based are available for public inspection by contacting Dr. Sean Matson in the West Coast Region (see FOR FURTHER INFORMATION CONTACT , above), or by visiting the NMFS West Coast Groundfish website: https://www.westcoast.fisheries.noaa.gov/fisheries/groundfish/index.html.

Pursuant to 5 U.S.C. 553(b), NMFS finds good cause to waive prior public notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. The adjustments to management measures in this document increase trip limits for fisheries off Washington, Oregon, and California to allow for greater attainment of allocations. No aspect of this action is controversial, and changes of this nature were anticipated in the final rule for the 2021-2022 harvest specifications and management measures, which was published on December 11, 2020 (85 FR 79880).

The Council recommended sablefish limit changes to increase opportunity to attain harvest targets and allocations for the respective fisheries, and contribute to attainment of the ACL. New information became available at the Council's September 2021 meeting showing that harvest was tracking much lower than projections made during the harvest specifications process due to changing fishery conditions. The updated trip limits being implemented in this rule are anticipated to increase landings and fishing community revenue, while maintaining harvest within scientifically informed conservation limits, concomitant with the goals of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

The Council recommended increased lingcod landing limits to reduce regulatory discard; new information became available at the Council's September 2021 meeting indicating that current levels of landing limits were having the unintended consequence of causing fishers to discard substantial amounts of catch. Implementing the recommended trip limits is projected to reduce regulatory discards, without changing attainment rate of the allocation, by enabling those fish to be landed rather than wasted, and produce fisher and community revenue.

Delaying implementation to allow for public comment would reduce the economic benefits to the commercial fishing industry and the businesses that rely on that industry because it is unlikely the new regulations would publish and could be implemented before the end of the calendar year. Therefore, providing a comment period for this action could significantly limit the economic benefits to the fishery, and would hamper the achievement of optimum yield from the affected fisheries.

Therefore, NMFS finds reason to waive the 30-day delay in effectiveness pursuant to 5 U.S.C. 553(d)(1) so that this final rule may become effective upon publication in the Federal Register . The adjustments to management measures in this document affect commercial fisheries by increasing opportunity and relieving participants of the lower trip limits in light of information showing lower than usual attainment. These adjustments were requested by the Council's advisory bodies, as well as by members of industry during the September 2021 meeting, and recommended unanimously by the Council. No aspect of this action is controversial, and changes of this nature were anticipated in the biennial harvest specifications and management measures established through a notice and comment rulemaking for 2021-2022 (85 FR 79880).

For the reasons set out in the preamble, 50 CFR part 660 is amended as follows: