On March 13, 2020, President Trump declared the ongoing Coronavirus Disease 2019 (COVID-19) pandemic of sufficient severity and magnitude to warrant an emergency declaration for all States, territories, and the District of Columbia. With the COVID-19 emergency, many small businesses nationwide have experienced and continue to experience economic hardship as a direct result of the Federal, State, tribal, and local public health measures that have been taken to minimize the public's exposure to the virus. These measures, some of which are government-mandated, have been implemented nationwide and include the closures of and restrictions on restaurants, bars, gyms, and other businesses. In addition, based on the advice of public health officials, other measures, such as keeping a safe distance from others or even stay-at-home orders, were being and continue to be implemented, resulting in a dramatic decrease in economic activity as the public avoids malls, retail stores, and other businesses.

On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) (Pub. L. 116-136) to provide emergency assistance and health care response for individuals, families, and businesses affected by the coronavirus pandemic. The Small Business Administration (SBA) received funding and authority through the CARES Act to modify existing loan programs and establish a new loan program to assist small businesses nationwide adversely impacted by the COVID-19 emergency. Section 1102 of the CARES Act temporarily permitted SBA to guarantee 100 percent of 7(a) loans under a new program titled the “Paycheck Protection Program” (PPP) under Section 7(a)(36) of the Small Business Act. Section 1106 of the CARES Act provides for forgiveness of up to the full principal amount of qualifying loans guaranteed under the PPP.

On April 2, 2020, SBA posted its first PPP interim final rule (85 FR 20811) (the First Interim Final Rule). Subsequently, SBA issued a number of other interim final rules implementing the PPP. On April 24, 2020, the President signed the Paycheck Protection Program and Health Care Enhancement Act (Pub. L. 116-139), which provided additional funding and authority for the PPP.

On May 22, 2020, SBA and Treasury posted an interim final rule on Loan Review Procedures and Related Borrower and Lender Responsibilities (85 FR 33010) (Loan Review interim final rule (IFR)). The rule stated that SBA would be issuing a separate interim final rule addressing the process for appealing certain SBA loan review decisions under the PPP. On June 5, 2020, the Paycheck Protection Program Flexibility Act of 2020 (Pub. L. 116-142) (Flexibility Act) was signed into law, amending the CARES Act. On June 22, 2020, SBA and Treasury posted an interim final rule that in part revised the Loan Review IFR to incorporate the relevant Flexibility Act amendments, address revisions to the Loan Forgiveness Application (SBA Form 3508), and include a new alternative Loan Forgiveness Application (SBA Form 3508EZ) (85 FR 38304) (Second Loan Review IFR).

On July 4, 2020, Public Law 116-147 extended the authority for SBA to guarantee PPP loans to August 8, 2020. On August 11, 2020, SBA and Treasury posted an interim final rule on Appeals of SBA Loan Review Decisions Under the Paycheck Protection Program (85 FR 52883) (OHA Appeal IFR), inviting the public to submit comments on or before September 28, 2020.

On October 8, 2020, SBA and Treasury posted an interim final rule which made additional revisions to the Loan Review IFR and Second Loan Review IFR (85 FR 66214) (Third Loan Review IFR). The Third Loan Review IFR provided additional guidance concerning the forgiveness and loan review processes for PPP loans of $50,000 or less and, for PPP loans of all sizes, lender responsibilities with respect to review of borrower determinations of eligible costs for forgiveness in excess of a borrower's PPP loan amount.

On December 27, 2020, the President signed the Economic Aid to Hard-Hit Small Businesses, Nonprofits and Venues Act (Economic Aid Act) (Pub. L. 116-260), which, among other things, reauthorized lending under the PPP through March 31, 2021, authorized second draw PPP loans under Section 7(a)(37) of the Small Business Act, modified PPP provisions relating to forgiveness of PPP loans, and codified Section 1106 of the CARES Act under Section 7A of the Small Business Act. On January 19, 2021, SBA and Treasury posted an interim final rule to consolidate prior rules related to forgiveness and reviews of PPP loans and incorporate changes made by the Economic Aid Act (86 FR 8283) (Fourth Loan Review IFR).

On March 11, 2021, the American Rescue Plan Act of 2021 (American Rescue Plan Act) was enacted to, among other things, expand eligibility for first and second draw PPP loans and revise the exclusions from payroll costs for purposes of loan forgiveness. On March 18, 2021, SBA and Treasury posted an interim final rule on PPP to incorporate the American Rescue Plan Act's amendments to the PPP, as well as other changes (86 FR 15083). On March 30, 2021, the PPP Extension Act of 2021 (Pub. L. 117-6) was enacted, extending SBA's PPP program authority through June 30, 2021. On July 30, 2021, SBA published an interim final rule on PPP establishing a direct borrower forgiveness process for loans of $150,000 or less, among other changes (86 FR 40921).

As described below, this final rule sets forth procedures for PPP borrowers and Lenders on the process for a PPP borrower to appeal certain final SBA loan review decisions under the PPP to the SBA Office of Hearings and Appeals (OHA). The interim final rule supplemented the interim final rule on Loan Review Procedures and Related Borrower and Lender Responsibilities posted on SBA's and Treasury's websites on May 22, 2020 (published on June 1, 2020, in the Federal Register ), as revised by the interim final rules posted on SBA's and Treasury's websites on June 22, 2020, October 8, 2020, and January 19, 2021 (published on June 26, 2020, October 19, 2020, and February 5, 2021, respectively), and as further amended.

This rule revises subpart L, as added by the interim final rule posted on the websites of the SBA and the U.S. Department of the Treasury on August 11, 2020 (published in the Federal Register on August 27, 2020), to reflect SBA's responses to public comments on the interim final rule. The revision to § 134.102, Jurisdiction of OHA, is adopted without change.

This final rule adopts with changes portions of the previously-published interim final rule on Appeals of SBA Loan Review Decisions Under the Paycheck Protection Program. This rule revises 13 CFR part 134, subpart L, as added by the interim final rule, to reflect SBA's responses to public comments on the interim final rule, as detailed in Part III below. This final rule has accordingly satisfied the Administrative Procedure Act's advance notice-and-comment requirements.

SBA has found that there is good cause to dispense with the 30-day delayed effective date provided in the Administrative Procedure Act. The intent of the CARES Act is to afford SBA the flexibility to provide relief to America's small businesses expeditiously. This intent, along with the need to provide lenders and borrowers with certainty regarding PPP loan forgiveness (if any), provides good cause for immediate implementation of changes to the OHA appeal feature of this program. Specifically, it is critical to meet lenders' and borrowers' need for clarity concerning the OHA appeal process as rapidly as possible. Borrowers have been applying for loan forgiveness, lenders have been issuing loan forgiveness decisions to SBA, and SBA has been reviewing PPP loans in connection with those forgiveness applications and decisions. SBA currently has pending final SBA loan review decisions that are ready to be issued and is continuing to conduct loan reviews and make final SBA loan review decisions that will need to be issued. Borrowers and lenders are expecting these decisions to be issued in accordance with the statutory and regulatory timelines requiring SBA to remit the appropriate forgiveness amount to the lender (if any), within 90 days of the lender issuing its decision to SBA, subject to any SBA review of the loan or the loan application. This final rule will allow SBA to immediately issue such decisions and provide certainty around the appeals process to these potential appellants without further delay. Because this final rule also provides increased accessibility to borrowers in response to comments previously received by the public, allowing the borrowers that receive an appealable final SBA loan review decision to immediately appeal under the final rule is in the best interests of the borrowers.

The comment period for the OHA Appeal IFR was open from August 27, 2020, to September 28, 2020, and SBA received 16 comments. This section includes a description of the comments and SBA's response.

Two of the comments received proposed an extension of time to file an appeal to account for appellants who may be unfamiliar with the appeals process. In the interest of efficiency and to ensure a speedy resolution of disputes concerning final SBA loan review decisions, the 30-calendar day requirement will remain. To promote clarity and fairness, SBA will no longer begin counting days to file an appeal based on when an appellant receives notification from the lender that a final SBA loan review decision has been issued without actually receiving the final loan review decision document detailing the reasons for the decision. Instead, the clock for counting days will begin only after the borrower has received the actual final SBA loan review decision document. This will provide the borrower with 30 calendar days to formulate its arguments as to why the decision is clearly erroneous. See 13 CFR 134.1202(a).

Two of the comments raised issue with the inability of the borrower to file arguments after the administrative record has been transmitted to OHA. Although OHA's general rules of procedure found at 13 CFR 134.206(e) allows for a party to request leave to reply to a response, this final rule explicitly directs a party to seek leave to file a reply or supplemental pleading. (13 CFR 134.1208(e).) Also, an appellant is given 30 calendar days after the issuance of the Notice and Order to file any objections to the administrative record, should the appellant find the administrative record is incomplete. See 13 CFR 134.1207(e).

One comment proposed that the time to file an objection to the administrative record should be extended to 15 calendar days. The commenter reasoned that a non-attorney may have difficulty understanding the role of the administrative record, what documents are included and excluded from the record, and the applicable privileges. Because the appellant will have participated in the process of providing documents submitted by the lender to SBA during the loan forgiveness process and the loan review process, the appellant should be familiar with the documents included in the administrative record, making 30 calendar days from the issuance of the Notice and Order (where the administrative record is due 20 calendar days after issuance of the Notice and Order) a sufficient time to assert an objection. The Notice and Order that will be issued under 13 CFR 134.1206 will provide a description of the documents included in the administrative record and will note the appellant's ability to object to the administrative record by the due date. The appellant can also avail itself of 13 CFR 134.1207, which provides more detail on the administrative record and appellant's ability to object to the administrative record. Appellant will also have the ability to request leave to file a supplementary pleading after review of the SBA's appeal response, should one be filed, and administrative record under 13 CFR 134.1208(e) and 134.211 (Motions), which is incorporated into subpart L.

One comment proposed that the SBA should disclose that the appellant may object to the administrative record at the time of the transmission of the administrative record. Such notice is included in 13 CFR 134.1207 and will be provided to the appellant in the Notice and Order under 13 CFR 134.1206, which SBA deems sufficient notice of the ability to object to the administrative record.

Two comments were received regarding the need for simplicity of the appeals process as there is a large number of appellants who will be filing their appeals without the assistance of an attorney. Overall, the commenters requested a more simplified process in light of the information appellant is required to submit to OHA at the time of the appeal. One commenter suggested that pro se litigants should disclose their status so that OHA will assist the appellant throughout the appeals process and construe their filings liberally, taking into consideration their non-attorney status. The rules, policies, and procedures of OHA are tailored to address and accommodate all appellants, regardless of whether they are represented by an attorney. The information an appellant is required to file with an appeal is minimal, but necessary for the Judge to render a decision based on the relevant facts and law. In furtherance of OHA's commitment to ensure the appeals process is accessible to all appellants, OHA has reduced the information required to file an appeal. See 13 CFR 134.1204. OHA will also provide appellants with an electronic case management system ( https://appeals.sba.gov ) that will provide a simple electronic way to file, process, and track the appeal before OHA, including the automation of serving parties, and accessing appeal documents and the administrative record.

Four comments were received regarding the exhaustion of remedies requirement under 13 CFR 134.1216 that required an appellant to request review by the SBA Administrator before appealing an OHA decision to Federal district court. One comment suggested that OHA should provide language in the decision disclosing an appellant's ability to request review of OHA's decision by the SBA Administrator. The commenters also argued that this exhaustion of administrative remedies requirement was in violation of the Administrative Procedures Act and deprives appellants of due process. A number of commenters asserted that the Administrator's review of OHA's decision is a circular review process since the commenters believed that the Administrator would issue the final SBA loan review decision. The Administrator will not be issuing the final SBA loan review decision. The decision will be made by the appropriate SBA official in accordance with published delegations of authority. Additionally, various commenters asserted that OHA's ability to render an independent decision on a final SBA loan review decision is in question because OHA is a subordinate office to the Administrator. Although SBA disagrees with the assertions in those comments, SBA has determined to remove the requirement for a borrower to request a review by the SBA Administrator before any further appeal because of the limited resources within the Office of the Administrator to render a decision on the anticipated high number of requests for review. In addition, SBA believes that it is appropriate, consistent with due process requirements, and most efficient for borrowers to be able to seek relief in Federal district court, without requiring review by the Administrator. Therefore, borrowers have the option to either (1) request reconsideration by the presiding OHA judge under 13 CFR 134.1211(c) and then appeal the final decision to Federal district court under 13 CFR 134.1211(g); or (2) appeal a final decision directly to the appropriate Federal district court under 13 CFR 134.1211(g).

In lieu of the provision requiring the borrower to request review by the Administrator and in order to vest reviewable discretion with the appropriate SBA official, SBA will add a provision giving the SBA Administrator the option to review or reverse an initial OHA decision or a reconsidered initial OHA decision, in the Administrator's sole discretion. Although the Administrator has the discretion to review or reverse such decisions, borrowers may not request, and are not required to request, a review from the Administrator in order to exhaust administrative remedies before appealing to the appropriate Federal district court. See 13 CFR 134.1211(d).

Three comments were received regarding the standard of review and burden of proof for PPP appeals. One commenter stated that OHA should remove the requirement that the appellant establish a clear error of fact or law by SBA and only require appellant to establish error. The suggestion, however, is based on the commenter's inaccurate understanding of the administrative process, stating that OHA is reviewing a lender's decision and is not reviewing the decision of a public officer, i.e., an SBA official. This is incorrect, as OHA's jurisdiction is limited to reviewing final SBA loan review decisions as provided for in 13 CFR 134.1201(b). Further, the regulation establishing OHA's jurisdiction explicitly states that it will not accept an appeal based solely on a lender's decision. See 13 CFR 134.1201(c). One commenter suggested a de novo review of the final SBA loan review decision due to the lack of guidance on the loan review process. Another commenter voiced concern with the use of the preponderance of the evidence standard in conjunction with the requirement to establish clear error on the part of SBA. The commenter found issue with the preponderance of the evidence standard because such a standard is usually required at the initial review level, and the commenter disagreed with the use of the clear error standard in light of the lack of guidance on the loan review process. The commenters also stated the appellant will be completely deprived of the opportunity to review any evidence.

SBA has determined that it will remove the burden of proof requirement of preponderance of the evidence. However, a decision by an SBA official is entitled to the deference afforded by the clear error standard. Therefore, it is appropriate and reasonable for OHA to assess the final SBA loan review decision using a clear error standard. An appellant will not be completely deprived of the opportunity to review the evidence. An appellant will be provided with a copy of the final SBA loan review decision that will set forth the reasons for the decision prior to filing an appeal, and an appellant should be familiar with the documents included in the administrative record because the appellant will have participated in the process of providing documents submitted by the lender to SBA during the loan forgiveness process and the loan review process. In addition, an appellant has the opportunity to review and object to the administrative record as provided for in 13 CFR 134.1207(e).

Three comments were received regarding the inability of appellants to request discovery, while allowing SBA to request discovery. SBA has determined that an OHA decision should be based on a review of the administrative record, the appeal petition, any response, any reply or supplemental pleading, and filings related to objection to the administrative record. See 13 CFR 134.1209(c). Thus, neither discovery nor oral hearings will be permitted for appellant or SBA. See 13 CFR 134.1209(b).

One comment received suggested that OHA provide a description of the OHA procedural rules incorporated into subpart L in addition to citing to those rules. SBA agrees that such a change is minimal and promotes clarity and guidance. Thus, this final rule provides a description of each rule incorporated into subpart L at 13 CFR 134.1201(h).

One comment received proposed a change in the rule to account for borrowers who may have been acquired by another entity between the time the initial PPP loan was issued and the filing of a PPP appeal. The rule now includes language to address both borrowers and their legal successors under 13 CFR 134.1203.

Six commenters argued that SBA should have regulations which formalize the procedures for final SBA loan review decisions. They assert that the existing interim final rules are too broad and lacking in specifics about the process and have no criteria for making the decisions or compiling the administrative record. One commenter also requested that more information be provided on the loan forgiveness process. As to the administrative record, this final rule sets forth what should be included in the administrative record at 13 CFR 134.1207. As to the criteria for making final SBA loan review decisions and the loan forgiveness process, SBA has issued various rules and guidance on the process for SBA loan reviews including, but not limited to, the Loan Review IFR;  1 Second Loan Review IFR;  2 Third Loan Review IFR;  3 Fourth Loan Review IFR;  4 SBA Procedural Notice: Procedures for Lender Submission of Paycheck Protection Program Loan Forgiveness Decisions to SBA and SBA Forgiveness Loan Reviews;  5 and SBA Procedural Notice: PPP Borrower Resubmissions of Loan Forgiveness Applications Using Form 3508S, Lender Notice Responsibilities to PPP Borrowers, and Offset of Remittances to Lenders for Lender Debts. 6 Additional information is available at https://www.sba.gov/funding-programs/loans/covid-19-relief-options/paycheck-protection-program and https://home.treasury.gov/policy-issues/coronavirus/assistance-for-small-businesses/paycheck-protection-program. SBA has issued sufficient guidance for the loan forgiveness process and the issuance of final SBA loan review decisions. SBA received a few other comments which recommended changes to the loan forgiveness application process. Such comments are not relevant to this final rule and need not be addressed here.

Five comments received stated that the requirement to repay the loans should be held in abeyance pending appeal. SBA has determined that, in order to avoid the potential administrative burden of having to reverse implementation of the final SBA loan review decision, including the refund of borrower payments by the Lender and the processing of forgiveness payments by SBA, a timely appeal by a PPP borrower of a final SBA loan review decision should extend the deferment period of the PPP loan. Payment of the PPP loan will be deferred until there is a final decision on an appeal under 13 CFR 134.1211. In addition, SBA believes that allowing for continued deferment is in the best interest of the borrower. 7 This decision has been added to the regulation at 13 CFR 134.1202(d). 8

SBA also received some comments from borrowers that sought relief from SBA for a PPP loan application that was denied by a Lender. Such comments are not relevant to this final rule and cannot be addressed here. Further, the rule, at 13 CFR 134.1201(c), provides that a borrower cannot directly file an appeal of a decision made by a lender concerning a PPP loan to OHA.

This rule makes technical amendments to ensure efficiency, transparency, and consistency throughout the appeals process. This includes: Removal of the deduction of any Economic Injury Disaster Loan (EIDL) advance (located in the OHA Appeal IFR at 13 CFR 134.1201(b)(3)) to be consistent with Section 333 of the Economic Aid Act which repealed the CARES Act provision at section 1110(e)(6) requiring SBA to deduct the EIDL advance; explicitly stating that a borrower cannot directly file an appeal of a decision by a lender concerning a PPP loan to OHA (13 CFR 134.1201(c)); informing an appellant that they must first file an appeal of the final SBA loan review decision with OHA before appealing to Federal district court (13 CFR 134.1201(d)); and incorporating provisions from OHA's General Rules of Practice into this section with descriptions of those provisions (13 CFR 134.1201(h)).

This final rule makes a procedural change to require appellants to use the OHA Case Portal to file and manage their appeals (13 CFR 134.1202(a)); this provision also establishes “Commencement of Appeals of Final SBA Loan Review Decisions” to outline the process of how and when an appeal must be filed (13 CFR 134.1202); and removes the requirement that timeliness of the appeal could be based on a notification by the lender of a final SBA loan review decision rather than actual receipt of the final SBA loan review decision (13 CFR 134.1202(a)).

SBA has also simplified the information required to file an appeal by eliminating a requirement to provide a basis for jurisdiction and relief sought; only requiring the borrower to produce a final SBA loan review decision (and not merely a description of a final SBA loan review decision) and the date it was received to determine timeliness of the appeal; removing requirements that the appellant provide tax documents; and removing the requirement that a borrower include a certificate of service with its appeal or any other subsequent documents filed with OHA. (13 CFR 134.1204). This rule also requires borrowers to provide their lender with a copy of their appeal in order for the lender to extend the deferment period of the PPP loan until a final decision is issued under § 134.1211. (13 CFR 134.1202(b)).

This rule also specifies that lenders and individual owners of a borrower entity do not have standing to file an appeal. (13 CFR 134.1203). The new provision, titled “Notice and Order,” now provides an overview of the information that will be included within the Notice and Order (13 CFR 134.1206). This rule provides for the deadline to produce the Administrative Record within the “Administrative Record” provision (13 CFR 134.1207(a)); clarifies that SBA may, but is not required to, respond to an appeal and, if SBA does not respond it will not be construed against SBA (13 CFR 134.1208); provides that a response to an appeal is due 45 calendar days from the date of the Notice and Order instead of from the appeal filing date (13 CFR 134.1208(b)); removes language making final decisions precedential (13 CFR 134.1211 (b) & (e)); discloses that final decisions rendered under this section may be published by OHA within its discretion with any necessary redactions (13 CFR 134.1211(f)); and removes language pertaining to protective orders, as the only parties involved in PPP appeals are the appellant and SBA, both of which will already have access to all documents that will not be accessible to the public; and adds language in 13 CFR 134.1207 to provide for a non-waiver provision.

This final rule adopts with changes portions of the previously-issued interim final rule on Appeals of SBA Loan Review Decisions Under the Paycheck Protection Program. This final rule does not make any changes to 13 CFR 134.102(w) regarding OHA's jurisdiction over PPP appeals, and the current provision in the Code of Federal Regulations will remain the same. This final rule revises the authority citation for subpart L to incorporate 15 U.S.C. 636(a)(37) and 15 U.S.C. 636m, which were included in the Economic Aid Act. This final rule also revises subpart L as set forth in the prior interim final rule.

Section 134.1201, Scope of rules in this subpart, provides a process for appeal to OHA of certain final SBA loan review decisions under the PPP and any other PPP matter referred to OHA by the Administrator. PPP loans include first draw PPP loans made under Section 7(a)(36) of the Small Business Act and second draw PPP loans made under Section 7(a)(37) of the Small Business Act. Subpart L provides that an appealable final SBA loan review decision is an official written decision by SBA, after SBA completes a review of a PPP loan, that a borrower (1) was ineligible for a PPP loan; (2) was ineligible for the PPP loan amount received or used the PPP loan proceeds for unauthorized uses; (3) is ineligible for PPP loan forgiveness in the amount determined by the lender in its full approval or partial approval decision issued to SBA; and/or (4) is ineligible for PPP loan forgiveness in any amount when the lender has issued a full denial decision to SBA.

Subpart L applies to loan review decisions made by SBA after SBA completes a review of a PPP loan as set forth in Part III.1 and Part III.2c. of the Loan Review IFR, as amended by the Second Loan Review IFR, Third Loan Review IFR, and Fourth Loan Review IFR and as further amended. Subpart L further provides that any decision by a lender concerning a PPP loan, including a borrower's PPP loan application or a borrower's PPP loan forgiveness application, may not be appealed directly to OHA. In addition, this section sets forth other types of decisions and determinations that are not covered by subpart L, and makes clear that subpart C, Rules of Practice for Appeals From Size Determinations and NAICS Code Designations, is not applicable to appeals from final SBA loan review decisions. This section sets forth the specific provisions from subpart B, OHA's general Rules of Practice, that are applicable to subpart L. Other provisions from subpart B that are not specifically referenced in subpart L do not apply to subpart L. As stated above, a timely appeal by a PPP borrower of a final SBA loan review decision will extend the deferment period of the PPP loan until a final decision is issued pursuant to § 134.1211. However, if SBA remits to the lender the PPP loan forgiveness amount set forth in the decision issued by the lender to SBA, the borrower may not file an OHA appeal, and the borrower must begin repayment of any remaining balance of its PPP loan. This section makes clear that a borrower must file an appeal with OHA on a final SBA loan review decision before appealing to the appropriate Federal district court.

Section 134.1202, Commencement of appeals of final SBA loan review decisions, provides that an appellant must file its appeal with OHA within 30 calendar days of receipt of the final SBA loan review decision and references OHA's website, where an appellant will be able to file and manage its appeal using the OHA Case Portal. By utilizing the OHA Case Portal, an appellant's appeal will automatically be served upon the Associate General Counsel for Litigation at OLITService@sba.gov. The section also provides specific information on how to calculate days. In addition, this section makes clear that a timely appeal by a PPP borrower of a final SBA loan review decision extends the deferment period of the PPP loan until a final decision is issued pursuant to § 134.1211. This section also requires an appellant to provide the lender with a copy of its appeal in order for the lender to extend the deferment period of the PPP loan until a final decision is issued pursuant to § 134.1211.

Section 134.1203, Standing, provides that only the borrower on a loan for which SBA has issued a final SBA loan review decision has standing to appeal the final SBA loan review decision to OHA. Individual owners of a borrower entity and lenders do not have standing to appeal a final SBA loan review decision.

Section 134.1204, The appeal petition, provides that an appeal petition must include the following information: (1) A copy of the final SBA loan review decision that is being appealed and the date it was received; (2) a full and specific statement as to why the final SBA loan review decision is alleged to be erroneous, together with all factual information and legal arguments supporting the allegations; and (3) the name, address, telephone number, email address and signature of the appellant or its attorney. This section makes clear that a Notice of Paycheck Protection Program Forgiveness Payment does not provide a borrower with a right to appeal to OHA. This section further provides that an appeal petition that does not include the above may be dismissed by the Judge and permits SBA to move for a motion for more definite statement or otherwise comply with the requirements of this section.

Section 134.1205, Dismissal, provides that the Judge must dismiss the appeal if: (1) The appeal is beyond OHA's jurisdiction as set forth under § 134.1201; (2) the appeal is untimely under § 134.1202; (3) the appellant lacks standing to appeal under § 134.1203; or (4) is premature because SBA has not yet made a final SBA loan review decision. This section also provides that the Judge may dismiss the appeal if, among other things, the appeal does not, on its face, allege specific facts that if proven to be true, warrant reversal or remand of the final SBA loan review decision.

Section 134.1206, Notice and Order, provides that upon receipt of an appeal challenging a final SBA loan review decision, OHA will assign the matter to either an Administrative Law Judge or an Administrative Judge in accordance with § 134.218. Unless the appeal will be dismissed under § 134.1205, the Judge will issue a Notice and Order establishing a deadline for production of the administrative record and specifying the deadline by which SBA may respond to the appeal.

Section 134.1207, The administrative record, provides that the administrative record is due 20 calendar days after issuance of the Notice and Order. The administrative record shall include non-privileged, relevant documents that SBA considered in making its decision or that were before SBA at the time of the decision. The administrative record need not, however, contain all documents pertaining to the appellant. SBA will file the administrative record with OHA and serve it on appellant utilizing the OHA Case Portal. This provision states that in the event that privileged or confidential information is disclosed in the administrative record, such disclosure shall not operate as a waiver of any claim of privilege or confidentiality by SBA. This section permits the appellant to object to the absence of any document from the administrative record that the appellant believes should have been included in the administrative record. Generally, such objections must be filed with OHA and served on SBA no later than 30 calendar days after issuance of the Notice and Order utilizing the OHA Case Portal. The Judge will rule upon such objections and may direct or permit that the administrative record be supplemented.

Section 134.1208, Response to an appeal petition, prescribes that only SBA, though not required, may respond to an appeal. In addition, OHA can request SBA to respond for good cause shown by OHA. The response should set forth the relevant facts and legal arguments to the issues presented on appeal. If SBA elects not to respond to the appeal, such election shall not be interpreted to be an admission or waiver of any allegation of law or fact. Except for good cause shown, a response filed after the close of record established by the Judge will not be considered. If SBA elects to respond, SBA must file its response with OHA and serve a copy of the response upon the appellant utilizing the OHA Case Portal. No reply to a response will be permitted unless the Judge directs otherwise.

Section 134.1209, Evidence beyond the record, discovery and oral hearings, provides that, generally, the Judge may not admit evidence beyond the written administrative record. Neither discovery nor oral hearings will be permitted in appeals from final SBA loan review decisions. All appeals under subpart L will be decided solely on a review of the written administrative record, the appeal petition, any response, any reply, and filings related to objection to the administrative record.

Section 134.1210, Standard of review, provides that the standard of review is whether the final SBA loan review decision was based on clear error of fact or law. The appellant has the burden of proof.

Section 134.1211, Decision on appeal, provides that the Judge will issue his or her decision within 45 calendar days after the close of record, as practicable. The decision will contain findings of fact and conclusions of law, the reasons for such findings and conclusions, and any relief ordered. The decision will be served upon appellant and SBA utilizing the OHA Case Portal. The Judge's decision on the appeal is an initial decision. However, unless a request for reconsideration is filed pursuant to paragraph (c) of § 134.1211 or the Administrator, solely within the Administrator's discretion, decides to review or reverse the initial decision pursuant to paragraph (d) of § 134.1211, an initial decision shall become the final decision of SBA 30 calendar days after its service and is thereafter appealable to the appropriate Federal district court. This section allows for a request for reconsideration pursuant to paragraph (c) of § 134.1211 by SBA or appellant. This section also provides the Administrator, solely within the Administrator's discretion, with the right to review or reverse an initial OHA decision or a reconsidered initial OHA decision pursuant to paragraph (d) of § 134.1211. Such discretionary authority of the Administrator does not create additional rights of appeal on the part of an appellant not otherwise specified in SBA regulations. This section also provides that decisions rendered by OHA under subpart L are not precedential. This section provides that final decisions rendered under this section may be published by OHA within its discretion with any necessary redactions of confidential business and financial information or personally identifiable information. Lastly, this section provides that final decisions may be appealed to the appropriate Federal district court only.

Section 134.1212, Effects of the decision, provides that OHA may affirm, reverse, or remand a final SBA loan review decision. If remanded, OHA no longer has jurisdiction over the matter unless a new appeal is filed as a result of a new final SBA loan review decision.

Section 134.1213, Equal Access to Justice Act (EAJA), provides that a prevailing appellant is not entitled to recover attorney's fees. Appeals to OHA from final SBA loan review decisions under the PPP are not proceedings that are required to be conducted by an Administrative Law Judge under § 134.603.

Section 134.1214, Confidential information, provides that if a filing or other submission made pursuant to an appeal in subpart L contains confidential business and financial information; personally identifiable information; source selection sensitive information; income tax returns; documents and information covered under § 120.1060; or any other exempt information, that information is not available to the public pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. 552.

OMB's Office of Information and Regulatory Affairs (OIRA) has determined that this final rule is economically significant for the purposes of Executive Orders 12866 and 13563 SBA, however, is proceeding under the emergency provision at Executive Order 12866 Section 6(a)(3)(D) based on the need to move expeditiously to mitigate the current economic conditions arising from the COVID-19 emergency.

SBA has drafted this rule, to the extent practicable, in accordance with the standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988, to minimize litigation, eliminate ambiguity, and reduce burden. The rule has no preemptive or retroactive effect.

SBA has determined that this rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various layers of government. Therefore, SBA has determined that this rule has no federalism implications warranting preparation of a federalism assessment.

SBA has determined that this final rule does not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act.

OIRA has also determined that this rule is a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act or CRA), 5 U.S.C. 804(2). If a rule is deemed major, the CRA generally provides that the rule may not take effect until at least 60 days following its publication unless the agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 808. For the reasons discussed in Section II above, SBA finds that there is good cause to dispense with the CRA effective date requirement. The agency believes that delaying the effective date of this final rule would be contrary to the public interest.

The Regulatory Flexibility Act (RFA) generally requires that when an agency issues a proposed rule, or a final rule pursuant to section 553(b) of the APA or another law, the agency must prepare a regulatory flexibility analysis that meets the requirements of the RFA and publish such analysis in the Federal Register . 5 U.S.C. 603, 604. Rules that are exempt from notice and comment are also exempt from the RFA requirements, including conducting a regulatory flexibility analysis, when among other things the agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. SBA Office of Advocacy guide: How to Comply with the Regulatory Flexibility Act, Ch. 1. p. 9. Since this rule finalizes an interim final rule that was exempt from notice and comment and did not require an initial regulatory flexibility analysis, SBA is likewise not required to conduct a regulatory flexibility analysis.

For the reasons stated in the preamble, the Small Business Administration interim rule amending 13 CFR part 134, which was published at 85 FR 52883 on August 27, 2020, is adopted as final with the following changes:

The FAA issued AD 2020-26-02, Amendment 39-21357 (85 FR 81790, December 17, 2020) (AD 2020-26-02), which applied to Yaborã Indústria Aeronáutica S.A. (type certificate previously held by Embraer S.A.) Model ERJ 190-400 airplanes. AD 2020-26-02 required amending the existing AFM to incorporate a new limitation and revise certain normal procedures. The FAA issued AD 2020-26-02 to address uncontained release of the LPC rotor 1 and damage to the engine and airplane structure, which could result in loss of control of the airplane.

AD 2020-26-02 and the corresponding ANAC AD 2020-07-01 considered their requirements interim action. ANAC AD 2020-07-01 indicated that further mandatory actions may be necessary as a result of the investigation into failures in engines similar to those on affected airplanes. The manufacturer has since developed upgraded EEC software that will prevent the unsafe condition. The FAA has determined that further rulemaking is necessary; this AD follows from that determination.

Since the FAA issued AD 2020-26-02, ANAC, which is the aviation authority for Brazil, has issued ANAC AD 2020-07-01R01, effective March 26, 2021 (ANAC AD 2020-07-01R01) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain Model ERJ 190-400 airplanes. ANAC AD 2020-07-01R01 supersedes ANAC AD 2020-07-01.

This AD was prompted by a report of an IFSD due in part to failure in the LPC rotor 1 during operation in high altitude at high thrust settings, and the development of upgraded EEC software, which eliminates the need for the amendments to the existing AFM required by AD 2020-26-02. The FAA is issuing this AD to address uncontained release of the LPC rotor 1 and damage to the engine and airplane structure, which could result in loss of control of the airplane. See the MCAI for additional background information.

Although this AD does not explicitly restate the requirements of AD 2020-26-02, this AD retains all of the requirements of AD 2020-26-02. Those requirements are referenced in ANAC AD 2020-07-01R01, which, in turn, is referenced in paragraph (g) of this AD.

ANAC AD 2020-07-01R01 describes procedures for amending the existing AFM to incorporate a new limitation and revise the normal procedures to limit the engine N1 setting for flights above 33,000 ft. ANAC AD 2020-07-01R01 also describes procedures for upgrading the EEC software and subsequently removing the AFM amendments. 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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD because the FAA has evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in the MCAI described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, ANAC AD 2020-07-01R01 is incorporated by reference in this AD. This AD requires compliance with ANAC AD 2020-07-01R01 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Service information required by ANAC AD 2020-07-01R01 for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0701 after this AD is published.

There are currently no domestic operators of these products. Therefore, the FAA finds that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

The FAA invites you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0701; Project Identifier MCAI-2021-00365-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Krista Greer, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3221. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA considers this AD interim action. Investigation into failures in engines similar to those installed on the affected airplanes will enable the manufacturer to obtain better insight into the nature, cause, and extent of the IFSDs, and eventually to develop final action to address the unsafe condition. Once final action has been identified, the FAA might consider further rulemaking.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, the FAA provides the following cost estimates to comply with this AD:

According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators. The FAA does not control warranty coverage for affected operators. As a result, the FAA has included all known costs in the cost estimate.

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

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

The FAA determined that this 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, and

(2) Will not affect intrastate aviation in Alaska.

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 to supersede AD 2020-15-12, Amendment 39-21175 (85 FR 45081, July 27, 2020), (AD 2020-15-12). AD 2020-15-12 applied to certain RRD Trent 1000-A2, Trent 1000-AE2, Trent 1000-C2, Trent 1000-CE2, Trent 1000-D2, Trent 1000-E2, Trent 1000-G2, Trent 1000-H2, Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2 model turbofan engines. The NPRM published in the Federal Register on April 22, 2021 (86 FR 21233). The NPRM was prompted by IPC rotor blade separations resulting in engine failures. Subsequently, the manufacturer identified the need to add new inspections and an optional terminating action, amend the asymmetric power condition for engine inspection, and to add an inspection after a cabin depressurization event. In the NPRM, the FAA proposed to continue to require initial and repetitive ultrasonic or visual inspection of the IPC stage 1 rotor blade root (front face), IPC stage 2 rotor blade root (front and rear face), and IPC shaft stage 2 dovetail post (front face), removal of any cracked parts from service, and an inspection after asymmetric power and cabin depressurization events until the installation of the IPC stage 1 and stage 2 rotor blades with the IPC stage 1 and stage 2 rotor blades in kitted sets. The FAA is issuing this AD to address the unsafe condition on these products.

The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2020-0240, dated November 5, 2020 (referred to after this as “the MCAI”), to address the unsafe condition on these products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0306.

The FAA received comments from 1 commenter. The commenter was The Boeing Company (Boeing). Boeing supported the NPRM without change.

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

The FAA reviewed Rolls-Royce Alert Non-Modification Service Bulletin (NMSB) Trent 1000 72-AK313, Revision 1, dated August 22, 2019; and Rolls-Royce Alert Service Bulletin (SB) Trent 1000 72-AK430, Initial Issue, dated August 17, 2020. Rolls-Royce Alert NMSB Trent 1000 72-AK313 defines the initial inspection threshold and repeat inspection intervals for Trent 1000 IPC stage 1 rotor blade, IPC stage 2 rotor blade, and IPC shaft stage 2 dovetail posts. Rolls-Royce Alert SB Trent 1000 72-AK430 introduces the IPC stage 1 and stage 2 rotor blades in kitted sets and provides kitting instructions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in ADDRESSES .

The FAA reviewed Rolls-Royce Alert NMSB Trent 1000 72-AJ814, Revision 5, dated May 3, 2019; Rolls-Royce Alert NMSB Trent 1000 72-AJ819, Revision 4, dated May 3, 2019; Rolls-Royce Alert NMSB Trent 1000 72-AK092, Revision 4, dated May 3, 2019; Rolls-Royce SB Trent 1000 72-J871, Revision 6, dated December 12, 2019; and Rolls-Royce SB Trent 1000 72-J941, Revision 1, dated February 6, 2019.

Rolls-Royce Alert NMSB Trent 1000 72-AJ814 describes procedures for performing an ultrasonic inspection (USI) of the IPC stage 1 rotor blades. Rolls-Royce Alert NMSB Trent 1000 72-AJ819 describes procedures for performing a visual borescope inspection of the IPC stage 2 rotor blades and IPC shaft stage 2 dovetail posts. Rolls-Royce Alert NMSB Trent 1000 72-AK092 describes procedures for performing a USI of the IPC stage 2 rotor blades. Rolls-Royce SB Trent 1000 72-J871 describes procedures for reworking or replacing the affected parts. Rolls-Royce SB Trent 1000 72-J941 specifies procedures for installing the redesigned IPC stage 1 and stage 2 rotor blades.

The FAA estimates that this AD affects 7 engines installed on airplanes 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 replacements 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 these replacements:

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

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

The FAA has determined that 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 invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0790; Project Identifier MCAI-2021-01007-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Tom Rodriguez, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226; email Tom.Rodriguez@faa.gov . Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA Emergency AD 2021-0202-E, dated September 9, 2021 (EASA Emergency AD 2021-0202-E) (also referred to as the MCAI), to correct an unsafe condition for all Dassault Aviation Model FALCON 7X airplanes. EASA subsequently issued EASA AD 2021-0202R1, dated September 10, 2021 (EASA AD 2021-0202R1) to address an incorrect reference to a non-existing part number within the definition of the affected part.

This AD was prompted by a report of plastic molding burrs and defects found on the piston hole associated with the O 2 saver feature during production of certain SAFRAN flightcrew oxygen masks. The O 2 saver function allows the flightcrew to wear the oxygen mask with limited oxygen consumption to save oxygen by delivering it only when needed, either automatically in case of depressurization, or manually by switching the 100% or EMERG mode button. Defects on the piston hole may prevent efficient deactivation of the O 2 saver function. The FAA is issuing this AD to address this condition, which could lead to inadequate oxygen supply to the flightcrew in case of decompression of the airplane or smoke or fire in the flight deck. See the MCAI for additional background information.

EASA AD 2021-0202R1 specifies procedures for amending the existing AFM to incorporate a specific check to ensure that the O 2 saver function is not activated and an operating limitation to prevent use of the O 2 saver function. EASA AD 2021-0202R1 also limits the installation of affected parts under certain conditions. 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.

This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI described above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in EASA AD 2021-0202R1 described previously, except for any differences identified as exceptions in the regulatory text of this AD.

EASA AD 2021-0202R1 requires operators to “inform all flight crews” of amendments to the AFM, and thereafter to “operate the aeroplane accordingly.” However, this AD does not specifically require those actions as they are already required by FAA regulations. FAA regulations require operators furnish to pilots any changes to the AFM ( e.g., 14 CFR 121.137), and to ensure that pilots are familiar with the AFM ( e.g., 14 CFR 91.505). As with any other training requirement, training on the updated AFM content is tracked by the operators and recorded in each pilot's training record, which is available for the FAA to review. FAA regulations also require pilots to follow the procedures in the existing AFM including all updates. 14 CFR 91.9 requires that no person may operate a civil aircraft without complying with the operating limitations specified in the AFM. Therefore, including a requirement in this AD to operate the airplane according to the amended AFM would be redundant and unnecessary.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2021-0202R1 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2021-0202R1 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0202R1 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0202R1. Service information required by EASA AD 2021-0202R1 for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0790 after this AD is published.

The FAA considers this AD interim action. If final action is later identified, the FAA might consider further rulemaking then.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies foregoing notice and comment prior to adoption of this rule because failure to deactivate the O 2 saver function could lead to inadequate oxygen supply to the flightcrew in case of decompression of the airplane or smoke or fire in the flight deck. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forego notice and comment.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 20 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, and

(2) Will not affect intrastate aviation in Alaska.

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 D airspace, the Class E airspace area designated as an extension to Class D airspace, and the Class E airspace extending upward from 700 feet above the surface at Scott AFB/MidAmerica St. Louis Airport, Belleville, IL, to support instrument flight rule operations at this airport.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register (86 FR 33586; June 25, 2021) for Docket No. FAA-2021-0477 to amend the Class D and Class E airspace at Scott AFB/MidAmerica St. Louis Airport, Belleville, IL. 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 D and E airspace designations are published in paragraph 5000, 6004, and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the order.

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.

Subsequent to the publication of the NPRM, the FAA discovered a typographic error in the Class E airspace extending upward from 700 feet above the surface to at Scott AFB/MidAmerica St. Louis Airport airspace legal description. In the northeast extension, the extension should extend from the 7.4-mile radius vice 4.9-mile. Additionally, it was discovered that the extension proposed to be added southeast of the airport is captured by another extension and is therefore not required. As these changes do not affect the Class E airspace as proposed, they are incorporated into this rule.

This amendment to 14 CFR part 71:

Amends the Class D airspace at Scott AFB/MidAmerica St. Louis Airport, Belleville, IL, by removing the city associated with the airport to comply with changes to FAA Order 7400.2N, Procedures for Handling Airspace Matters; updating the name (previously Scott AFB/MidAmerica Airport) of the airport to coincide with the FAA's aeronautical database; and replacing the outdated term “Airport/Facility Directory” with “Chart Supplement”;

Amends the Class E airspace area designated as an extension to Class D airspace at Scott AFB/MidAmerica St. Louis Airport by adding an extension 1.3 miles each side of the 048° bearing from the Scott TACAN extending from the 4.9-mile radius of the airport to 5.7 miles northeast of the Scott TACAN; amends the northwest extension to 1 mile (decreased from 1.5 miles) each side of the 314° (previously 312°) radial from the Scott TACAN extending from the 4.9-mile radius from the airport to 9.5 miles (decreased from 10 miles) northwest of the Scott TACAN; removes the city associated with the airport to comply with changes to FAA Order 7400.2N; updates the name of the airport (previously Scott AFB/MidAmerica Airport) to coincide with the FAA's aeronautical database; and replaces the outdated term “Airport/Facility Directory” with “Chart Supplement”;

And amends the Class E airspace extending upward from 700 feet above the surface to at Scott AFB/MidAmerica St. Louis Airport by adding an extension 8 miles northwest and 10 miles southeast of the 048° bearing from the Scott TACAN extending from the 7.4-mile radius of the airport to 22 miles northeast of the Scott TACAN; amends the southeast extension to 1.5 miles (decreased from 1.7 miles) each side of the 142° (previously 140°) radial from the Scott TACAN extending from the 7.4-mile radius of the airport to 12.7 miles (decreased from 14 miles) southeast of the Scott TACAN; amends the northwest extension to 4 miles (increased from 1.5 miles) each side of the 314° (previously 312°) radial from the Scott TACAN extending from the 7.4-mile radius of the airport to 10.5 miles (increased from 10 miles) northwest of the Scott TACAN; removes the city associated with the airport to comply with changes to FAA Order 7400.2N; updates the name of the airport (previously Scott AFB/MidAmerica Airport) to coincide with the FAA's aeronautical database; and removes the exclusionary language as it is not required.

This action is due to the results of a biennial airspace review.

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 Fair and Accurate Credit Transactions Act of 2003 (“FACT Act”) was signed into law on December 4, 2003. Public Law 108-159, 117 Stat. 1952. Section 214 of the FACT Act added a new section 624 to the FCRA. This provision gives consumers the right to restrict a person from using certain information obtained from an affiliate to make solicitations to that consumer. Section 624 generally provides that if a person receives certain consumer eligibility information from an affiliate, the person may not use that information to make solicitations to the consumer about its products or services, unless the consumer is given notice and an opportunity (via a simple method) to opt out of such use of the information, and the consumer does not opt out. The statute also provides that Section 624 does not apply, for example, to a person using eligibility information: (1) To make solicitations to a consumer with whom the person has a pre-existing business relationship; (2) to perform services for another affiliate subject to certain conditions; (3) in response to a communication initiated by the consumer; or (4) to make a solicitation that has been authorized or requested by the consumer. Unlike the FCRA affiliate sharing opt-out (15 U.S.C. 1681a(d)(2)(A)(iii)) and the opt-out of sharing with non-affiliated third parties under the Gramm-Leach-Bliley Act (“GLBA”), 15 U.S.C. 6801 et seq., which apply indefinitely, Section 624 provides that a consumer's affiliate marketing opt-out election must be effective for a period of at least five years. Upon expiration of the opt-out period, the consumer must be given a renewal notice and an opportunity to renew the opt-out before information received from an affiliate may be used to make solicitations to the consumer.

The Commission published regulations implementing Section 624, the Affiliate Marketing Rule, 16 CFR part 680, on October 30, 2007. 1

The Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) was signed into law in 2010. 2 The Dodd-Frank Act substantially changed the federal legal framework for financial services providers. Among the changes, the Dodd-Frank Act transferred to the Consumer Financial Protection Bureau (“CFPB”) the Commission's rulemaking authority under portions of the FCRA. 3 Accordingly, in 2012, the Commission rescinded several of its FCRA rules, which had been replaced by rules issued by the CFPB. 4 The FTC retained rulemaking authority for other rules promulgated under the FCRA to the extent the rules apply to motor vehicle dealers described in section 1029(a) of the Dodd-Frank Act  5 predominantly engaged in the sale and servicing of motor vehicles, the leasing and servicing of motor vehicles, or both (“motor vehicle dealers”). 6 The rules for which the FTC retains rulemaking authority include the Affiliate Marketing Rule, which now applies only to motor vehicle dealers. 7 Entities that are not motor vehicle dealers are covered by the CFPB's Regulation V, subpart C, which is substantially similar to the Commission's rule. 8

On September 22, 2020, the Commission solicited comments on the Affiliate Marketing Rule as part of its periodic review of its rules and guides. 9 The Commission sought information about the costs and benefits of the rule, and its regulatory and economic impact. In addition, the Commission proposed amending the rule to narrow its scope to motor vehicle dealers excluded from CFPB jurisdiction as described in the Dodd-Frank Act. 10 The Commission received no comments.

The Commission promulgated the Affiliate Marketing Rule at a time when it had rulemaking authority for a broader group of entities. While the Dodd-Frank Act did not change the Commission's enforcement authority for the Affiliate Marketing Rule, it did narrow the Commission's rulemaking authority with respect to the rule. It now covers only motor vehicle dealers. The amendments in the Dodd-Frank Act necessitate a technical revision to the Affiliate Marketing Rule to ensure the regulation is consistent with the text of the amended FCRA. Accordingly, the Commission amends the Affiliate Marketing Rule to properly reflect the rule's scope.

The amendment to § 680.1(b) narrows the scope description of the Affiliate Marketing Rule to the entities excluded from CFPB jurisdiction as described in the Dodd-Frank Act. 11 It does so by replacing the broad term “person” with the term “motor vehicle dealer,” as defined in amended § 680.3.

The amendment to § 680.3 adds a definition of “motor vehicle dealer” that defines motor vehicle dealers as those entities excluded from CFPB jurisdiction as described in the Dodd-Frank Act. 12

The amendments do not change the substantive provisions of the rule or the examples in the rule, even where those provisions and examples involve entities covered by the CFPB's rule rather than the Commission's rule. The primary reason for retaining these provisions and examples is that the rule addresses the relationship between covered motor vehicle dealers and their affiliates, which may not be motor vehicle dealers. The obligations and exceptions set forth by the rule are inextricably linked to a consumer's relationship and actions in relation to all affiliates, both motor vehicle dealers and non-motor vehicle dealers. In order for the rule to apply meaningfully, it must address both types of entities, even those not directly covered by the rule. This will not create any conflict with the CFPB's corresponding rule, as the Commission's Affiliate Marketing Rule and the CFPB's rule are substantially similar and impose the same obligations and exceptions on entities they cover.

The Affiliate Marketing Rule contains information collection requirements as defined by 5 CFR 1320.3(c), the definitional provision within the Office of Management and Budget (“OMB”) regulations that implement the Paperwork Reduction Act (“PRA”). 44 U.S.C. 3501 et seq. OMB has approved the rule's existing information collection requirements through February 28, 2023 (OMB Control No. 3084-0131). Under the existing clearance, the FTC has attributed to itself the estimated burden regarding all motor vehicle dealers and shares equally the remaining estimated PRA burden with the CFPB for other persons for which both agencies have enforcement authority.

The Final Rule amends 16 CFR part 680. The amendments do not modify or add to information collection requirements previously approved by OMB. The amendments make no substantive changes to the rule, other than to clarify that the scope of the rule is limited to motor vehicle dealers. The rule's OMB clearance already reflects that scope. Therefore, the Commission does not believe the amendments substantially or materially modify any “collections of information” as defined by the PRA.

The Regulatory Flexibility Act (“RFA”), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires an agency to either provide an Initial Regulatory Flexibility Analysis (“IRFA”) with a proposed rule, or certify that the proposed rule will not have a significant impact on a substantial number of small entities. 13 The Commission published an Initial Regulatory Flexibility Analysis in order to inquire into the impact of the proposed rule on small entities. 14 The Commission received no responsive comments.

The Commission does not believe these amendments have the threshold impact on small entities. The amendments effectuate changes to the Dodd-Frank Act and will not impose costs on small motor vehicle dealers because the amendments are for clarification purposes and will not result in any increased burden on any motor vehicle dealer. Thus, a small entity that complies with current law need not take any different or additional action under the Final Rule. Therefore, the Commission certifies that amending the Affiliate Marketing Rule will not have a significant economic impact on a substantial number of small businesses.

Although the Commission certifies under the RFA that the Final Rule will not have a significant impact on a substantial number of small entities, and hereby provides notice of that certification to the Small Business Administration, the Commission nonetheless has determined publishing a final regulatory flexibility analysis (“FRFA”) is appropriate to ensure the impact of the rule is fully addressed. Therefore, the Commission has prepared the following analysis:

To address the Dodd-Frank Act's changes to the Commission's rulemaking authority, the amendments clarify that the rule applies only to motor vehicle dealers.

The Commission did not receive any comments that addressed the burden on small entities. In addition, the Commission did not receive any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (“SBA”).

The Commission anticipates many covered motor vehicle dealers may qualify as small businesses according to the applicable SBA size standards. As explained in the IRFA, however, determining a precise estimate of the number of small entities is not readily feasible. No commenters addressed this issue. Nonetheless, as discussed above, these amendments do not add any additional burdens on any covered small businesses.

The amendments impose no new reporting, recordkeeping, or other compliance requirements.

The Commission did not propose any specific small entity exemption or other significant alternatives because the amendments will not increase reporting requirements and will not impose any new requirements or compliance costs.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a “major rule,” as defined by 5 U.S.C. 804(2).

For the reasons stated above, the Federal Trade Commission amends part 680 of title 16 of the Code of Federal Regulations as follows:

The Parole Commission's regulation at 28 CFR 2.15 provides that after the prisoner has served the minimum term, the Bureau of Prisons (“BOP”) may petition the Commission to reopen the case under 28 CFR 2.28(a) to consider the case for parole prior to the date set by the Commission at the initial or review hearing. The regulation requires that the BOP's request show cause for earlier release and provides examples such as “an emergency, hardship, or the existence of other extraordinary circumstances that would warrant consideration of early parole.” These examples encompass a very broad set of circumstances that the Commission could consider, which would include illness and aging.

The Commission is not limited to only considering requests from the BOP, the regulation at 28 CFR 2.28(a), which is used for reopening a case for favorable information, can be used to consider a request from other sources, such as the prisoner or a family member. Revising the heading of the regulation will help to highlight its use to consider prisoners for compassionate release in addition to the “favorable information” that the Commission usually considers, such as program achievement in the institution. Revising the text of the regulation to include medical and other “extraordinary and compelling” information will broaden the circumstances that the Commission can consider for possible advancement of the release date.

Section 2.28(a) permits advancement of a presumptive parole date to an earlier presumptive parole date, advancement of a presumptive parole date to an earlier effective parole date, advancement of a continue to expiration decision to a presumptive or effective parole date, and advancement of a 15-year reconsideration hearing to a presumptive or effective parole date without conducting a hearing. The Commissioner reopening the decision does have the option of ordering a reconsideration hearing to consider this new information.

The Commission is promulgating this rule as an interim rule and is providing a 30-day period for public comment. The revised rule will take effect upon publication in the Federal Register .

This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulation Planning and Review,” section 1(b), Principles of Regulation, and in accordance with Executive Order 13565, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation. The Commission has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has not been reviewed by the Office of Management and Budget.

This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Under Executive Order 13132, this rule does not have sufficient federalism implications requiring a Federalism Assessment.

This rule will not have a significant economic impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 605(b).

This rule will not cause State, local, or tribal governments, or the private sector, to spend $100,000,000 or more in any one year, and they will not significantly or uniquely affect small governments. No action under the Unfunded Mandates Reform Act of 1995 is necessary.

This rule is not a “major rule” as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 Subtitle E—Congressional Review Act, now codified at 5 U.S.C. 804(2). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on the ability of United States-based companies to compete with foreign-based companies. Moreover, this is a rule of agency practice or procedure that does not substantially affect the rights or obligations of non-agency parties, and does not come within the meaning of the term “rule” as used in Section 804(3)(C), now codified at 5 U.S.C. 804(3)(C). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.

Accordingly, the U. S. Parole Commission amends 28 CFR part 2 as follows:

In April 2019, the Virginia Department of Transportation (VDOT) awarded the design and construction of the Hampton Roads Bridge-Tunnel (HRBT) Expansion Project to the Hampton Roads Connector Partners (HRCP), as the Design-Build contactor. The HRBT Expansion Project is a major road transport infrastructure project that will create an 8-lane facility with 6 consistent use lanes along 9.9 miles of Interstate 64 (I-64), from Settler's Landing Interchange in Hampton, Virginia, to the Interstate 564 (I-564) interchange in Norfolk, Virginia. To better understand the waterways impact from the project, the USCG and U.S. Army Corps of Engineers (USACE) recommended the submission of a formal Navigation Safety Risk Assessment (NSRA) and Tunnel Construction Plan (TCP) prior to any permit or approval action by the U.S. Army Corps of Engineers. 1 The NSRA identified three key objectives for consideration. The first included potential impacts to current and forecasted vessel traffic directly related to the bridge and tunnel construction including all on-water operations and staging areas. The second aimed to identify the best/least disruptive times to schedule movement of construction-related vessels. Finally, it identified the measures necessary for implementation in order to minimize potential hazards to navigation. On-water construction activities are expected to last approximately 5 years (2021-2025). In support of construction efforts, multiple surface craft will be necessary on-site, transiting to and from, as well as pre-staged, to ensure continued operations are maintained. The increase in waterborne traffic in the vicinity of construction areas and staging areas will introduce hazards to waterways users prior to and throughout the duration of the construction project. Specific hazards during the construction project include the proximity of dozens of construction-related vessels in the bridge area and fleeting areas, including material barges and construction equipment barges. In addition, construction of navigable spans by this equipment, as well as construction lighting and loud construction activity noises will make normal passage through the bridge areas unsafe except in areas specifically established as safe transit corridors by the project contractors, HRCP. The Sector Virginia Captain of the Port (COTP) has determined that these potential hazards associated with the HRBT Expansion Project will be a safety concern for anyone transiting in the vicinity of on-water construction activities related to the project. To discuss these safety concerns, representatives of the HRCP along with the COTP's staff conducted a series of outreach meetings. These meetings covered the HRBT Expansion Project and the notional safety zones that would mitigate the hazards discussed above. Due to the COVID-19 pandemic, those outreach meetings were conducted virtually on May 5th, 6th, and 7th, 2020. They were announced beforehand by a marine safety information bulletin  2 issued by the COTP, which is distributed to over 1,000 subscribed maritime stakeholders by email, along with direct email notification to community organizations in the coastal areas of the cities of Norfolk and Hampton, Virginia, which are the two cities in the immediate area of the construction activity. Twenty-six individuals in addition to Coast Guard personnel participated in the meetings. The feedback received was consistent that the HRBT Expansion Project would create hazards to navigation for recreational vessels and that the suggested safety zones would help mitigate the risks. Additionally, community members expressed support that HRCP would have the ability to designate safe transit corridors through the South Trestle Bridge and Willoughby Bay Bridge to ensure that coastal property owners could still access the waters of Hampton Roads and southern Chesapeake Bay during the duration of the construction project. The text of the regulation has been drafted to incorporate feedback from these sessions.

On August 5, 2021, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Safety Zones; Hampton Roads Bridge-Tunnel Expansion Project,” 86 FR 42758. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this project. During the comment period that ended September 7, 2021, we received no comments.

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 impracticable and contrary to the public interest. Immediate action is needed to respond to the potential safety hazards associated with the HRBT construction project.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Virginia (COTP) has determined that potential hazards associated with the Hampton Roads Bridge Tunnel Project beginning in summer 2021 will be a safety concern for anyone operating within the vicinity of the construction related activity. The purpose of this rule is to ensure safety of vessels operating in the vicinity of all construction related activity in support of the HRBT and the navigable waters in the safety zone for the duration of the project.

As noted above, we received no comments on our NPRM published August 7, 2021. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes multiple safety zones to promote safety to waterways users during the HRBT Expansion Project. The Coast Guard currently anticipates the need for 6 safety zones. The safety zones will be used to accommodate pre-staged waterborne equipment and establish buffer zones around two marine staging areas, one safe harbor in case of anticipated severe weather, and the marine construction work sites expected in the vicinity of the North Trestle Bridge and North Island, South Trestle Bridge and South Island and the north and south side of the Willoughby Bay Bridge.

The first safety zone ( Zone 1: Hampton Flats Mooring Area) is being established in the Hampton Flats covering a mooring/staging area to accommodate 6 barges. Specifically, the first safety zone covers all waters of the Hampton Flats, from surface to bottom, encompassed by a line connecting the following points beginning at 36°59′40.41″ N, 76°22′10.66″ W, thence to 37°00′01.84″ N, 76°21′01.69″ W, thence to 36°59′52.62″ N, 76°20′57.23″ W, thence to 36°59′31.19″ N, 76°22′06.20″ W, and back to the beginning point. The Hampton Flats Mooring Area will provide critical staging capability necessary to the project. Once the HRCP begins the installation of mooring buoys within the mooring area, the public will be restricted entry or mooring within the safety zone. Mariners will be required to observe lighted marker buoys along the perimeter and at each of the corners marking the safety zone. In the event of inclement weather, this mooring/staging area will not be able to be used for safe refuge.

The second safety zone ( Zone 2: Phoebus Safe Harbor Area) is being established as a safe harbor area between Phoebus Channel and the North Trestle Bridge in the event of anticipated severe weather. Specifically, it covers all waters west of the Phoebus Channel, from surface to bottom, encompassed by a line connecting the following points beginning at 37°00′34.26″ N, 76°19′10.58″ W, thence to 37°00′23.97″ N, 76°19′06.16″ W, thence to 37°00′22.52″ N, 76°19′11.41″ W, thence to 37°00′32.81″ N, 76°19′15.81″ W, and back to the beginning point. While this rule is effective, no vessel or person would be permitted to anchor within the safety zone during announced enforcement periods without first obtaining permission from the COTP or designated representative. Such announcements will be made by Sector Virginia Broadcast Notice to Mariners and broadcasts on VHF-FM radio. During enforcement periods, mariners will be required to observe lighted marker buoys along the perimeter and at each of the corners marking the safety zone.

The third safety zone ( Zone 3: Willoughby Safe Harbor/Mooring Area) is being established as a mooring area/safe harbor area in Willoughby Bay. Specifically, it covers all waters of Willoughby Bay, from surface to bottom, encompassed by a line connecting the following five points beginning at 36°57′48.68″ N, 76°17′08.20″ W, thence to 36°57′44.84″ N, 76°16′44.48″ W, thence to 36°57′35.31″ N, 76°16′42.80″ W, thence to 36°57′28.78″ N, 76°16′51.75″ W, thence to 36°57′33.17″ N, 76°17′19.43″ W, and back to the beginning point. Once the HRCP begins the installation of mooring buoys within the mooring area, the public will be restricted entry or mooring within the safety zone unless permission from the COTP, HRCP, or their designated representative is granted on a case-by-case basis. Mariners will be required to observe lighted marker buoys along the perimeter and at each of the corners marking the safety zone.

The fourth safety zone ( Zone 4: North Trestle Bridge and North Island) is being established from surface to bottom for the safety of waterways users in the vicinity of ongoing construction activity on the east and west sides of the Hampton Roads Bridge-Tunnel's north bridge trestle and North Island. No vessel or person at any time will be permitted within the fixed safety zone, 300 feet from the east or west side of the North Trestle Bridge or the North Island. All mariners attempting to enter or depart the Hampton Creek Approach Channel or the Phoebus Channel in the vicinity of the North Island will be required to proceed with extreme caution and maintain a safe distance from construction equipment. Passing arrangements, if necessary, will be allowed to be requested from the on-site foreman via VHF Channel 13 and 16 at any time.

The fifth safety zone ( Zone 5: South Trestle Bridge and South Island) is being established, from surface to bottom, 300 feet from the east or west side of the South Trestle Bridge or the South Island. This zone is needed for the safety of waterways users in the vicinity of ongoing construction activity on the east and west sides of the Hampton Roads Bridge-Tunnel's south bridge trestle and South Island. No vessel or person at any time will be permitted within the fixed safety zone without permission of the COTP or HRCP, or their designated representatives. HRCP may establish and post visual identification of safe transit corridors that vessels may use to freely proceed through the safety zone. All mariners attempting to enter or depart the Willoughby Bay Approach Channel in the vicinity of the South Island will be required to proceed with extreme caution and maintain a safe distance from construction equipment.

The sixth safety zone ( Zone 6: Willoughby Bay Bridge) is being established, from surface to bottom, within 50 feet of the north side and 300 feet of the south side of the Willoughby Bay Bridge. This safety zone is needed for the safety of waterways users in the vicinity of ongoing construction activity on the north and south sides of the Willoughby Bay Bridge. No vessel or person may enter or remain in the safety zone without permission of the COTP, HRCP, or designated representative, except that vessels are allowed to transit through marked safe transit corridors that HRCP shall establish for the purpose of providing navigation access for residents located north of the Willoughby Bay Bridge through the safety zone. All mariners attempting to enter or depart residences or commercial facilities north of the Willoughby Bay Bridge through the safe transit corridors or other areas of the safety zone when granted permission shall proceed with caution and maintain a safe distance from construction equipment. Mariners requesting to transit through other areas of the safety zone may do so at any time by contacting the on-site foreman via VHF Channel 13 and 16.

The regulatory text appears at the end of this document.

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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. 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 a comprehensive marine traffic survey conducted for all current and forecasted vessel traffic in the vicinity of the HRBT Expansion Project. The survey was used to inform mitigation strategies, minimize disruptions to navigation, reduce risks of marine casualties and determine the size, location, duration and time-of-day of the recommended safety zones.

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 received no comments from the Small Business Administration on this rulemaking. 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 6 safety zones that will be activated for the duration of the HRBT Expansion Project. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A 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:

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, which would include the SNUR requirements. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, 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)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

The docket includes 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-2020-0513, 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. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.

Due to the public health emergency, 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 chemical substances which were the subject of PMNs P-18-175 and P-19-38. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

Previously, in the Federal Register of November 16, 2020 (85 FR 73007) (FRL-10016-39), EPA proposed SNURs for these chemical substances. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the public comments received on the proposed rules, as described in Unit IV.

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 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 same 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), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, 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 before manufacture or processing for the significant new use can commence. 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.

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 the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit. During its review of these chemicals, EPA identified certain conditions of use that are not intended by the submitters, but reasonably foreseen to occur. EPA is designating those reasonably foreseen conditions of use as well as certain other circumstances of use as significant new uses.

EPA received public comments from four identifying entities on the proposed rule. The Agency's responses are described in a separate Response to Public Comments document that is available in the public docket for this rulemaking. Two of the comments were broadly supportive of the rule and requested no changes to the rule itself; therefore, no response is required. EPA made no changes to the final rule as a result of these 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 SNUR, EPA provided the following information for each chemical substance:

• PMN number.

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

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

• Basis for the SNUR.

• Potentially useful information.

• CFR citation assigned in the regulatory text section of this final rule.

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.

During review of the PMNs submitted for the chemical substances that are the subject of these SNURs and as further discussed in Unit IV. of the proposed rule, EPA identified certain other reasonably foreseen conditions of use in addition to those conditions of use intended by the submitter. EPA has determined that the chemical under the intended conditions of use is not likely to present an unreasonable risk. However, EPA has not assessed risks associated with the reasonably foreseen conditions of use. EPA is designating these conditions of use as well as certain other circumstances of use as significant new uses. As a result, those significant new uses cannot occur without going through a separate, subsequent EPA review and determination process associated with a SNUN.

EPA is issuing these SNURs because the Agency wants:

• To 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.

• To 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 section 5(a)(3)(C) that the 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.

• To be able to complete its review and determination on each of the PMN substances, while deferring analysis on the significant new uses proposed in these rules unless and until the Agency receives a SNUN.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the 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 were undergoing premanufacture review at the time of signature of the proposed rule and were not on the TSCA inventory. 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 the chemical substances subject to these SNURs, EPA concluded at the time of signature of the proposed rule that the designated significant new uses were not ongoing.

EPA designated November 16, 2020 (the date of web posting of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under TSCA section 5 allowing manufacture or processing to proceed.

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, 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, 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 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 here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be 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, which may assist with EPA's analysis of the SNUN.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. 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.

The potentially useful information described in Unit IV. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data 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 which provide detailed information on the following:

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

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 analysis is available in the docket for this rulemaking.

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 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).

According to 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 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.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. 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.

The listing of the OMB control numbers of the collection instruments and their subsequent codification in the table in 40 CFR 9.1 satisfies the display requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. Since this ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table in 40 CFR part 9, 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 in 40 CFR 9.1 without further notice and comment.

Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR 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, it appears 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, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. 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 federalism implications because it is not expected to 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 will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments and does not 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.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not a significant regulatory action under Executive Order 12866.

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

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:

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, which would include the SNUR requirements. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, 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)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

The docket includes 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-2020-0411, 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. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.

Due to the public health emergency, 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 chemical substances which were the subject of PMNs P-16-538, and P-18-308. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

Previously, in the Federal Register of October 16, 2020 (85 FR 65782) (FRL-10014-34), EPA proposed SNURs for these chemical substances. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the public comments received on the proposed rules, as described in Unit IV.

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 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 same 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), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, 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 before manufacture or processing for the significant new use can commence. 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.

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 the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit. During its review of these chemicals, EPA identified certain conditions of use that are not intended by the submitters, but reasonably foreseen to occur. EPA is designating those reasonably foreseen conditions of use as well as certain other circumstances of use as significant new uses.

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 annual production volume limit is not exceeded by the amount 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 two identifying entities on the proposed rule. In addition, EPA received three anonymous comments. The three anonymous comments and one of the comments from identifying entities were either general in nature and did not pertain to the proposed rule or were broadly supportive of the rule; therefore, no response is required. The Agency's response to the other comment is described in a separate Response to Public Comments document that is available in the public docket for this rulemaking. EPA made no changes to the final rule based on these 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 SNUR, EPA provided the following information for each chemical substance:

• PMN number.

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

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

• Basis for the SNUR.

• Potentially useful information.

• CFR citation assigned in the regulatory text section of this final rule.

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.

During review of the PMNs submitted for the chemical substances that are the subject of these SNURs and as further discussed in Unit IV. of the proposed rule, EPA identified certain other reasonably foreseen conditions of use in addition to those conditions of use intended by the submitter. EPA has determined that the chemical under the intended conditions of use is not likely to present an unreasonable risk. However, EPA has not assessed risks associated with the reasonably foreseen conditions of use. EPA is designating these conditions of use as well as certain other circumstances of use as significant new uses. As a result, those significant new uses cannot occur without going through a separate, subsequent EPA review and determination process associated with a SNUN.

EPA is issuing these SNURs because the Agency wants:

• To 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.

• To 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 section 5(a)(3)(C) that the 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.

• To be able to complete its review and determination on each of the PMN substances, while deferring analysis on the significant new uses proposed in these rules unless and until the Agency receives a SNUN.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the 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 were undergoing premanufacture review at the time of signature of the proposed rule and were not on the TSCA inventory. 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 the chemical substances subject to these SNURs, EPA concluded at the time of signature of the proposed rule that the designated significant new uses were not ongoing.

EPA designated September 8, 2020 (the date of web posting of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under TSCA section 5 allowing manufacture or processing to proceed.

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, 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, 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 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 here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be 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, which may assist with EPA's analysis of the SNUN.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. 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 .

The potentially useful information described in Unit IV. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data 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 which provide detailed information on the following:

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

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 analysis is available in the docket for this rulemaking.

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 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).

According to 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 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.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. 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.

The listing of the OMB control numbers of the collection instruments and their subsequent codification in the table in 40 CFR 9.1 satisfies the display requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. Since this ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table in 40 CFR part 9, 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 in 40 CFR 9.1 without further notice and comment.

Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR 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, it appears 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, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. 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 federalism implications because it is not expected to 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 will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments, and does not 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.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not a significant regulatory action under Executive Order 12866.

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

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: