Interested persons are invited to submit comments on this action to further extend and delay the effective date of the Security Bars rule by submitting relevant written data, views, or arguments. To provide the most assistance to the Departments, comments should reference a specific portion of the rule; explain the reason for any recommendation; and include data, information, or authority that supports the recommended course of action. Comments must be submitted in English, or an English translation must be provided. Comments submitted in a manner other than those listed above, including emails or letters sent to the Departments' officials, will not be considered comments on the rule and may not receive a response from the Departments.

Instructions: If you submit a comment, you must include the agency name and the DHS Docket No. USCIS 2020-0013 for this rulemaking. All submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary public comment submission you make to the Departments. The Departments may withhold information provided in comments from public viewing that they determine may impact the privacy of an individual or is offensive. For additional information, please read the Privacy and Security Notice available at http://www.regulations.gov .

Docket: For access to the docket and to read background documents or comments received, go to http://www.regulations.gov, referencing DHS Docket No. USCIS 2020-0013. You may also sign up for email alerts on the online docket to be notified when comments are posted or a final rule is published.

On December 23, 2020, the Departments published the Security Bars rule to amend existing regulations to clarify that in certain circumstances there are “reasonable grounds for regarding [an] alien as a danger to the security of the United States” or “reasonable grounds to believe that [an] alien is a danger to the security of the United States” based on emergency public health concerns generated by a communicable disease, making the noncitizen ineligible to be granted asylum in the United States under section 208 of the Immigration and Nationality Act (“INA” or “the Act”), 8 U.S.C. 1158, or the protection of withholding of removal under the Act or subsequent regulations (because of the threat of torture). Security Bars and Processing, 85 FR 84160 (Dec. 23, 2020). The rule was scheduled to take effect on January 22, 2021.

On January 20, 2021, the White House Chief of Staff issued a memorandum asking agencies to consider delaying, consistent with applicable law, the effective dates of any rules that had been published and not yet gone into effect, for the purpose of allowing the President's appointees and designees to review questions of fact, law, and policy raised by those regulations. See Memorandum for the Heads of Executive Departments and Agencies from Ronald A. Klain, Assistant to the President and Chief of Staff, Re: Regulatory Freeze Pending Review (Jan. 20, 2021), available at 86 FR 7424 (Jan. 28, 2021). As of January 21, 2021, the Departments delayed the effective date of the Security Bars rule to March 22, 2021, and then further delayed the effective date of the Security Bars rule to December 31, 2021, consistent with that memorandum and a preliminary injunction in place with respect to a related rule, as discussed below. See Security Bars and Processing; Delay of Effective Date, 86 FR 6847 (Jan. 25, 2021); Security Bars and Processing; Delay of Effective Date, 86 FR 15069 (Mar. 22, 2021).

As stated in the Security Bars and Processing; Delay of Effective Date interim final rule (“March Security Bars Delay IFR”) published on March 22, 2021, the Departments had good cause to delay the Security Bars rule's effective date further without advance notice and comment because implementation of the Security Bars rule was infeasible due to a preliminary injunction against a related rule. See 86 FR at 15070. Specifically, the Security Bars rule relies on revisions to the Departments' regulations previously made on December 11, 2020, by a separate joint rule, Procedures for Asylum and Withholding of Removal; Credible Fear and Reasonable Fear Review (“Global Asylum final rule”). 1 The Global Asylum final rule was scheduled to become effective before the Security Bars rule. However, on January 8, 2021, 14 days prior to the effective date of the Security Bars rule, in the case of Pangea Legal Services v. Department of Homeland Security (“Pangea II”), a district court preliminarily enjoined the Departments “from implementing, enforcing, or applying the [Global Asylum final] rule . . . or any related policies or procedures.”  2 The preliminary injunction remains in place. Thus, implementation of the Security Bars rule continues to be infeasible.

Specifically, the Security Bars rule relies upon the regulatory framework that was established in the Global Asylum final rule in applying bars to asylum eligibility and withholding of removal during credible fear screenings. 3 On July 9, 2020, the Departments published a Notice of Proposed Rulemaking for the Security Bars rule (“Security Bars NPRM”), which proposed regulatory text instructing adjudicators to apply the security bars to asylum eligibility and withholding of removal during credible fear screenings. 4 This proposal would have modified the then-existing regulatory framework instructing that evidence that the individual is, or may be, subject to a bar to asylum eligibility or withholding of removal, including the “danger to the security of the United States” bars underlying the Security Bars rule, does not have an impact on a credible fear determination. 5 The Security Bars NPRM justified this modification as necessary to allow DHS to quickly remove individuals covered by the security bars to asylum eligibility and withholding of removal, rather than sending potentially barred individuals to full removal proceedings pursuant to section 240 of the INA, 8 U.S.C. 1229a (“section 240 removal proceedings”), for consideration of further relief or protection from removal before an immigration judge, which can take months or even years. 6 The Security Bars NPRM further explained that applying the security bars during credible fear screenings was necessary to reduce health and safety dangers to both the public at large and DHS officials. 7

On December 11, 2020, while the Departments were reviewing the comments submitted in response to the Security Bars NPRM, the Global Asylum final rule was published. 8 The Global Asylum final rule changed the general practice described above to apply all bars to asylum eligibility and withholding of removal during credible fear screenings. 9 Most relevant, the Global Asylum final rule changed the then-existing regulatory framework described above, in which evidence of a bar to asylum eligibility or withholding of removal does not have any impact on a credible fear determination (even though the bars would be part of the ultimate adjudication of asylum eligibility or withholding of removal before the Executive Office of Immigration Review), to a framework that instead required asylum officers to apply all of the bars to asylum eligibility or withholding of removal during credible fear screenings. 10

On December 23, 2020, the Security Bars rule was published. In this final rule, the Departments revised the text from the Security Bars NPRM to explicitly rely on the intervening changes made by the Global Asylum final rule. 11 As a result, the regulatory text of significant portions of the Security Bars rule relies upon and repeats broader regulatory text established by the Global Asylum final rule, such as applying bars to asylum eligibility and withholding of removal during credible fear screenings. 12 The Security Bars rule assumed that the Global Asylum final rule would be in effect, and, therefore, the Security Bars rule did not make additional changes to the credible fear framework. 13

Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of this interim final rule. The Department of Homeland Security (DHS) and U.S. Customs and Border Protection (CBP) invite comments that relate to the economic, environmental, or federalism effects that might result from this interim final rule. Comments that will provide the most assistance to CBP will reference a specific portion of the interim final rule, explain the reason for any recommended change, and include data, information, or authority that support such recommended change.

As discussed in detail below, current regulations require commercial vessels and their operators  1 to meet several data submission requirements when arriving in the United States from a foreign place or outlying possession of the United States and when departing the United States for a foreign place or outlying possession of the United States. Both CBP and the U.S. Coast Guard (USCG) collect information in these contexts, and many of the data elements that the two agencies collect overlap. Some of this data must be submitted electronically, while some of it must be submitted on paper, such as the Form I-418, Passenger List—Crew List. See section 251.5 of title 8 of the Code of Federal Regulations (8 CFR 251.5). Through this rule, CBP is streamlining the vessel arrival and departure processes by eliminating redundant data submissions, providing for the electronic submission of the information collected on the Form I-418, simplifying vessel inspections, and automating recordkeeping for the Form I-418.

The USCG requires commercial vessel operators to submit a Notice of Arrival (NOA) to the National Vessel Movement Center (NVMC)  2 through its electronic Notice of Arrival/Departure (eNOA/D) system or via email in advance of U.S. arrival. 3 See 33 CFR 160.201-216. In addition to other data elements, each NOA must include information on the crew and passengers on board the vessel. See 33 CFR 160.206(a). Upon satisfactory submission, USCG processes the information via the eNOA/D web portal and then the system automatically transmits it to CBP as an Advance Passenger Information System (APIS) manifest. An APIS manifest is a CBP pre-arrival requirement. See 8 CFR 231.1(a) and 19 CFR 4.7b.

In addition to the APIS manifest data, which must be submitted electronically to CBP prior to arrival, DHS regulations require the master or agent of every vessel arriving in the United States from a foreign place or outlying possession of the United States, with the exception of certain vessels in the Great Lakes, to present a manifest of all crewmen onboard, on a Form I-418, to CBP at the port of entry where immigration inspection is performed. 4 5 See 8 CFR 251.1(a)(1). Manifest information collected on the Form I-418 includes details about the passengers and crewmen on board the vessel and whether any of the crewmen will be performing longshore work at any U.S. port before the vessel departs from the United States. See 8 CFR 251.1. If longshore work is to be performed, Form I-418 requires the vessel operator to note which exception of the Immigration and Nationality Act permits the work. See 8 CFR 251.1(a)(2)(ii) and 258.2.

If manifest information changes after the initial submission, the vessel operator must update the APIS manifest electronically through the eNOA/D system. See 19 CFR 4.7b(b)(2)(ii). Additionally, a CBP officer at the coastwise port generally updates the vessel's original paper Form I-418 to reflect any changes.

Upon departure from the United States, USCG collects updated manifest information from commercial vessel operators via a Notice of Departure (NOD) submitted to the NVMC through eNOA/D or another electronic format. See 33 CFR 160.201-216. Also at the time of departure, CBP requires vessel operators to update their original paper Form I-418 submission to include a list of departing crew, crew changes, and trip departure details. 6 See 8 CFR 251.3. A CBP officer at the port of departure typically verifies any changes to the Form I-418 information and sends the updated form to the vessel's first port of arrival for final data reconciliation and recordkeeping purposes.

Despite similarities in the vessel arrival and departure data submitted in accordance with the Form I-418, APIS, and USCG requirements, data transmitted electronically, such as through eNOA/D, does not satisfy the current Form I-418 regulatory requirements, which state that Form I-418 must be submitted in paper format. See 8 CFR 251.5. As described in depth below, these overlapping submission requirements create a substantial burden on vessel operators, and the maintenance, verification, and storage of the paper Form I-418 is a significant burden on CBP officers and the agency as a whole.

To reduce redundant data submissions and to ease burdens on vessel operators and the agency itself, CBP is modifying its regulations to allow for the electronic submission of Form I-418 only. The updated regulations require vessel operators to submit the data elements required on Form I-418 electronically via an electronic data interchange system (EDI) approved by CBP. Presently, the CBP-approved EDI is eNOA/D. Data submitted via eNOA/D will be automatically transmitted to CBP, which will use the information to populate an electronic version of the Form I-418. 7 The information currently collected through eNOA/D will satisfy the required data elements for populating the electronic version of the Form I-418 for CBP's purposes. The act of electronically submitting the data elements required on Form I-418 constitutes the Master's certification that CBP baggage declaration requirements have been made known to incoming passengers; that any required CBP baggage declarations have been or will simultaneously be filed as required by law and regulation with the proper CBP officer; that the responsibilities of the vessel operator have been or will be done as required by law or regulation before the proper CBP officer; and that there are no steerage passengers on board the vessel. As explained further below, CBP will no longer collect the vessel operator's signature for the Master's certification during inspection. The electronically submitted information will then be reviewed and confirmed by the inspecting CBP officer. This rule will streamline vessel arrival and departure processes by eliminating redundant data submissions, simplifying vessel inspections, and automating recordkeeping. Any changes regarding the CBP-approved EDI will be announced in a notice published in the Federal Register .

Commercial vessels arriving at and departing from U.S. ports of entry must comply with statutory and regulatory requirements to engage in U.S. trade. 8 Commercial vessels, regardless of whether they are cargo, non-cargo, 9 or cruise ships, traveling to a U.S. port of entry from a foreign port or place must begin their trip by submitting certain manifest information electronically to USCG and CBP prior to arrival. Once at a U.S. port of entry, commercial vessels must submit additional information and undergo customs and immigration inspections and processing. These arrival requirements vary by commercial vessel type and slightly differ by port of entry.

In general, upon a cargo or non-cargo vessel's arrival, CBP officers at the port of entry travel to the vessel's docking station and board it. Next, CBP requests and reviews the vessel's entry and manifest documentation, along with passenger and crew passports and visas. For manifest verification, the vessel's operator or agent typically submits two copies of the vessel's passenger and crew manifest using Form I-418 to the CBP officers aboard the vessel. CBP uses the paper Form I-418 for crew and passenger admissibility inspections and processing.

During the admissibility inspection process, a CBP officer verifies the actual crew and passengers on hand and those departing the vessel using a copy of the paper Form I-418, the previously submitted APIS manifest, pre-arrival screening results, and passports and visas. Barring any unresolvable issues, the CBP officer annotates the inspection results, including any discrepancies, on the paper Form I-418 submissions. The CBP officer collects the vessel operator's signature on the form and signs and stamps the documents. The CBP officer then provides one copy of the signed, stamped, and annotated Form I-418 to the vessel operator to use during coastwise travel and upon departure from the United States. The CBP officer at the first port of arrival retains the other copy of the original signed, stamped, and annotated Form I-418 for subsequent data reconciliation and recordkeeping purposes.

After the admissibility inspections and processing are complete, the CBP officers disembark the vessel, travel back to their port office, manually record the results of their inspections and related actions into CBP data systems, and send applicable Form I-418 supporting documentation, to the next port of arrival.

Once granted entry, the vessel may engage in further coastwise travel within the territorial waters of the United States or depart the United States. If manifest information changes after initial submission, the vessel operator must update the APIS manifest electronically through the eNOA/D system. The vessel operator must also present the initial signed, stamped, and annotated Form I-418 copy to a CBP officer when requested at a coastwise port of arrival. 10 The CBP officers at these subsequent ports of arrival update the Form I-418 to reflect any manifest changes, verify new supporting documentation if applicable, take admissibility actions as necessary, and provide the updated Form I-418 to the vessel operator for further U.S. travel and ultimate departure. The CBP officers at each coastwise port send a copy of the updated Form I-418 to the vessel's first port of arrival for data reconciliation and recordkeeping purposes.

Upon departure from the United States, USCG requires commercial vessel operators to submit a NOD to NVMC through eNOA/D or another electronic format. CBP requires these vessel operators to update their APIS manifest electronically through the eNOA/D system; update their paper Form I-418 to include a list of departing crew, crew changes, and trip departure details; and submit the paper Form I-418 to CBP. A CBP officer at the port of departure verifies any additional modifications to the form information and sends the completed Form I-418 and supporting documentation to the vessel's first port of arrival. There, a CBP officer manually reconciles the original Form I-418 retained during the initial arrival inspection with the subsequently updated versions of the form and related documentation.

CBP officers spend considerable time vetting pre-arrival data, traveling to/from a vessel, boarding/disembarking the ship, and conducting admissibility inspections and processing. In addition, CBP officers typically spend 120 minutes (2 hours) performing post-inspection processing for each vessel's paper Form I-418 submission from arrival to departure. 11 This includes the time CBP spends manually recording form information and actions into CBP systems, communicating between ports of arrival and departure, manually validating and reconciling data, gathering and sending supporting documentation, physically storing and shipping the manifest package, and tracking the manifest package.

Cruise ships follow slightly different procedures from cargo and non-cargo vessels upon arriving at a U.S. port of entry. At their first port of arrival, cruise ship crewmembers and passengers generally offload the ship at a designated terminal, where CBP officers are stationed and readily available to conduct customs and immigration inspections and processing. Under the standard arrival process, the cruise ship operator generally provides two copies of Form I-418's complete passenger and crew manifest with all printed pages. 12 Cruise ship operators arriving at some POEs submit just two copies of the two signature pages of the paper Form I-418 and a compact disc of the manifest in lieu of submitting numerous pages of paper to CBP.

During the standard admissibility inspection process, a CBP officer validates and verifies the cruise ship's actual crew and passengers on hand and those departing the vessel generally using the Form I-418, the previously submitted APIS manifest, pre-arrival screening results, and passports and visas. Any inspection results and admission/landing rights from such processing are directly recorded into CBP data systems. During cruise ship crew and passenger processing, the CBP officer also collects the vessel operator's signature on the form copies, signs and stamps the documents. The CBP officer then provides one copy of the signed and stamped Form I-418 or signature pages for the vessel operator to retain and use in coastwise travel and upon departure from the United States. The CBP officer at the first port of arrival retains the other copy of the signed, stamped, and annotated Form I-418 or signature pages for subsequent data reconciliation and recordkeeping purposes.

Once granted entry, the cruise ship may engage in further coastwise travel or depart the United States. If manifest information changes during coastwise movement, the vessel operator must update the APIS manifest electronically through the eNOA/D system. The vessel operator must also present the initial signed, stamped, and annotated Form I-418 signature pages to a CBP officer at each coastwise port of arrival upon request. The CBP officers at these subsequent ports of arrival review the Form I-418 or signature pages and update CBP data systems to reflect any manifest changes, verify new, applicable supporting documentation, take admissibility actions as necessary, and provide the Form I-418 or signature pages to the vessel operator for further U.S. travel.

As discussed above, upon departure from the United States, USCG requires commercial vessel operators to submit a NOD to the NVMC through eNOA/D or another electronic format. CBP requires these vessel operators to update their APIS manifest electronically through an approved system (currently, the eNOA/D system) and submit the two signature pages of the signed and stamped Form I-418 to CBP. See 8 CFR 251.3. A CBP officer at the port of departure verifies any additional modifications to the form information and sends the completed Form I-418 signature page and supporting documentation to the vessel's first port of arrival. There, a CBP officer manually reconciles the original Form I-418 signature page, supporting documentation, and manifest compact disc with the subsequently updated versions of the form and related documentation.

In addition to time spent vetting pre-arrival data and conducting admissibility inspections and processing, CBP officers spend an average of 20 minutes (0.333 hours) performing post-inspection processing for each cruise ship's Form I-418 submission from arrival to departure. 13 This includes the time CBP spends manually validating and reconciling data, gathering supporting documentation, communicating between ports of arrival and departure (when necessary), physically storing and shipping the manifest package, and tracking the manifest package (when necessary).

Part 4 of title 19 of the CFR provides additional requirements as to when and how a vessel operator must submit Form I-418. Under 19 CFR 4.7(a), the master of every vessel arriving in the United States and required to make entry must have on board a manifest that includes Form I-418. In some instances, a vessel operator may submit a Form I-418 in lieu of the Crew's Effects Declaration, CBP Form 1304, with supporting documentation. See 19 CFR 4.7(a), 4.7a(b)(2), and 4.81(d). However, when given the option, most vessel operators submit CBP Form 1304 instead of Form I-418 with additional supporting documentation, such as individual CBP Forms 5129, Crew Member's Declaration.

Recognizing the need to reduce redundant data collection and implement a seamless process to receive and use vessel arrival and departure information under various regulations, CBP developed a voluntary Form I-418 automation test program. The program tested CBP's ability to gather and reconcile information submitted for eNOA/D, APIS, and other electronic purposes for use in generating an automated, electronic Form I-418. CBP implemented this test in two phases as described below. The test varied somewhat across participating ports. Although the automated test program is still in operation at many ports of entry, the test program will be replaced by the regulatory program addressed in this rule.

CBP launched the first phase of the voluntary automation test program at four ports of entry in January 2011. The first phase allowed CBP officers and ports to evaluate the submission of Form I-418 data in both electronic and paper format to verify the similarity of information captured and identify any anomalies in the methods used. Moreover, it allowed CBP officers to rely solely on electronic manifest data submissions to build a vessel's departure manifest, thus eliminating the need for vessel operators to submit the departure manifest in paper format.

By June 2011, CBP implemented the second and final phase of the voluntary test program, which fully transitioned the submission of Form I-418 data to an automated, paperless process for certain commercial vessel operators. In place of submitting the required I-418 information on the paper Form I-418, vessel operators participating in the I-418 Automation test program could transmit this data through eNOA/D and APIS data submissions. Under the automation test, CBP systems automatically compiled eNOA/D, APIS, and any other electronic manifest data submitted electronically by test participants prior to arrival and at departure into a pre-populated electronic Form I-418. Upon a participating cargo or non-cargo vessel's arrival, CBP largely pre-vetted the electronic Form I-418 and printed out a paper copy of the form for customs and immigration inspection and processing purposes.

As with current arrival requirements for cargo and non-cargo commercial vessels, a CBP officer then boarded the vessel, conducted inspections, annotated the admissibility inspection results on the paper Form I-418, collected the vessel operator's signature on the form, and signed and stamped the document. Before disembarking the vessel, the CBP officer had the vessel operator make a copy of the signed, stamped, and annotated paper Form I-418 for further coastwise travel and departure. The CBP officer then returned to the port office to manually record the inspection results and related actions annotated on the original Form I-418 into CBP data systems.

For cruise ships participating in the I-418 Automation test program, CBP generally pre-vetted the electronic Form I-418, printed out a paper copy of the Form I-418's two signature pages, and conducted passenger and crew processing like the standard process at a terminal. Instead of requiring the submission of a full paper Form I-418 or manifest CDs, CBP officers largely conducted arrival inspections and processing electronically at the terminal. CBP officers also used the two paper Form I-418 signature pages to collect the vessel operator's signature and to sign and stamp the pages to generally meet existing paper Form I-418 retention requirements.

Before departing for their next port of call, test participants could transmit any manifest changes subsequent to the initial inspection at the port of arrival via the eNOA/D system. These changes included, but were not limited to, the sign-on or sign-off of crewmembers. As under the standard commercial vessel arrival/departure process, a CBP officer at the next port of call verified that the information submitted met the vessel's regulatory requirements. Upon departure from the United States, a CBP officer at the port of departure performed an electronic reconciliation of the vessel's arrival, coastwise, and departure manifest data and addressed any discrepancies. Then, the officer sent all paper documentation, typically via fax, to the first port of arrival.

In 2015, CBP migrated to mobile devices that allowed CBP officers to electronically conduct Form I-418 processing for cargo and non-cargo vessel arrivals (including I-418 Automation test program participants and non-participants) at different ports of entry, thereby removing the need to print off a paper Form I-418. With these devices, CBP officers directly recorded the inspection results and related actions into CBP data systems at the time of inspection and processing. In 2016, CBP successfully deployed its preexisting electronic signature (hereafter, “e-signature”) capability through its mobile devices at five major sea ports of entry. This tool allowed for the electronic collection of vessel operator and CBP officer signatures on the Form I-418, which removed the need to print off a copy of the Form I-418 and have the vessel operator sign it. Despite these streamlined electronic processing methods, CBP continued to also record vessel inspection results and signatures on the paper form and physically stamp the form to meet the regulatory requirements in place regarding the submission and retention of paper Form I-418.

Most U.S. ports of entry along with approximately 15 percent of cargo and non-cargo vessels and 56 percent of cruise ships are fully or partially participating in the above-described voluntary automation test program, including electronic submissions and e-signature capabilities. 14

CBP is amending its regulations to require the electronic submission of the data elements required on Form I-418 in lieu of its current paper form. This will streamline vessel arrival and departure processes by eliminating redundant data submissions, simplifying vessel inspections, and automating recordkeeping. The updated regulations will require vessel operators to electronically submit the data elements required on the Form I-418 via an EDI approved by CBP. CBP will continue to use the eNOA/D system as the approved EDI. Under this process, CBP systems will compile eNOA/D, APIS, and any other electronic manifest data submitted by vessel operators to the NVMC prior to arrival and at departure into an automated CBP system. CBP will use its system for all commercial vessel crew and passenger admissibility inspections and processing, and thus generally establish a fully paperless passenger and crew list process for all commercial vessel arrivals and departures. Any changes to the CBP-approved EDI will be announced in a notice published in the Federal Register .

With this automated system, for each commercial vessel arrival from a foreign port or place, CBP will be able to pre-vet the vessel's electronic passenger and crew list, travel to/from and board/disembark the vessel (for cargo and non-cargo vessels only), conduct inspections, and record the admissibility inspection results and related actions in real time using a mobile device or computer station (for the majority of cruise ships). 15 During arrivals/departures processed with mobile devices, CBP officers will directly record the inspection results and related actions into CBP data systems at the time of inspection and processing, eliminating the need for CBP officers to manually input the inspection results and related actions into CBP data systems later at the port office. CBP will also use the mobile devices to verify the electronically submitted data during the inspection process. The inspecting CBP officer will no longer collect the vessel operator's signature for the Master's certification, as now the act of submitting the data electronically will constitute certification. Once the passenger and crew list is verified electronically by the inspecting CBP officer, CBP will generate and transmit a read-only copy of the electronic Form I-418, only upon request, with an electronic CBP receipt number, by email to the vessel operator for use during coastwise movement or upon departure from the United States. The verified electronic passenger and crew list will also be converted to a writeable file and stored in CBP data systems.

As in the automation test program, before departing for their next port of call, vessel operators will be able to transmit any manifest changes subsequent to the vessel's inspection at the first port of arrival via the NVMC. A CBP officer at the next port of arrival will verify these changes and record all updates, inspection results, and related actions in real time in the CBP system using a mobile device or computer station. The CBP officer will then save the updated electronic passenger and crew list in CBP data systems, and email a read-only copy to the vessel operator, if requested. Upon departure from the United States, a CBP officer at the port of departure will verify the vessel's arrival, coastwise, and departure manifest data, which CBP data systems will reconcile automatically, and address any discrepancies. Thereafter, the CBP officer will save the completed electronic passenger and crew lists in CBP data systems, where it will be stored electronically for at least five years. In the limited instances where a paper Form I-418 is submitted, CBP will continue its current process of collecting, verifying, and physically storing all paper Form I-418 supporting documentation.

DHS is amending parts 251 and 258 of title 8 of the CFR, as well as part 4 of title 19 of the CFR, as set forth below, to automate Form I-418 and, in some provisions, eliminate the option to submit the Form I-418 in lieu of other required forms in order to reflect current trade practices and improve efficiency in data submission. The amendments also update the regulations to incorporate “plain language” consistent with Executive Order 13563, “Improving Regulation and Regulatory Review” (76 FR 3821).

Section 251.1 addresses “Arrival manifests and lists” in the immigration context. Section 251.1(a) sets out the requirements for arrival manifests and lists for vessels. Specifically, this section requires the master or agent of every vessel to submit a paper Form I-418 to CBP at the port where immigration inspection is performed and that the master or agent provide certain information regarding longshore work. This section is being amended to reflect the new procedure through which the information requested on Form I-418 and about longshore work is submitted electronically through an EDI approved by CBP. Conforming amendments are being made throughout this section to accommodate the new submission process. For instance, where the regulations state that the master or agent must “note on” the manifest certain information about longshore work, the regulations are being amended to state that this information must now be “indicate[d] in” the manifest, because such additional information and annotations will generally no longer be collected on a hard copy, but will be done through an electronic interface.

Section 251.1(a) is also being amended to include two exceptions to the new general rule that I-418 and longshore work data be submitted electronically. The first exception is where the master or agent of the vessel is unable to electronically submit the data elements required on Form I-418 via an electronic data interchange system approved by CBP due to technical issues, such as when the onboard computer system is malfunctioning, or there is no internet access, and there is no shore-side support available. The second is where CBP is experiencing technical difficulties affecting its receipt or processing of electronically submitted information, or where CBP, in its discretion, determines that a paper Form I-418 is acceptable under the circumstances presented by the master or agent of a vessel. The latter includes, but is not limited to, where there is a medical or weather emergency, or, in the case of longshore work, when information and relevant data cannot be submitted through the eNOA/D system due to its format.

Lastly, additional minor amendments are being made to section 251.1 to incorporate “plain language” including replacing the word “shall” with either “must” or “will”, as appropriate.

Section 251.3 addresses “Departure manifests and lists for vessels” in the immigration context. Specifically, this section requires the master or agent of every vessel to submit a paper Form I-418 to CBP at the port from which the vessel is to depart directly to some foreign place or outlying possession of the United States. This section is being amended to reflect the new procedure through which the information requested on the Form I-418 is submitted electronically through an EDI approved by CBP.

Section 251.3 is also being amended to include two exceptions to the new general rule that I-418 data be submitted electronically. The first is where the master or agent of the vessel is unable to electronically submit the data elements required on Form I-418 via an electronic data interchange system approved by CBP due to technical issues, such as when an onboard computer system is malfunctioning. The second exception allows for a paper Form I-418 to be submitted when CBP is experiencing technical issues or where CBP, in its discretion, determines that a paper Form I-418 is acceptable under the circumstances presented by the master or agent of a vessel.

Section 251.5 requires the master or commanding officer, or authorized agent, owner, or consignee, of a commercial vessel or commercial aircraft arriving in or departing from the United States to submit arrival and departure manifests in a paper format in accordance with §§ 251.1, 251.3, and 251.4. This section is being amended to remove references to paper, as this information will now be submitted electronically in the vessel context.

Section 258.2 requires masters and agents who use nonimmigrant crewmen to perform longshore work under one of the exceptions listed in the section, to indicate on the crew manifest that an exception is being used and to note which exception will be performed. Among other things, it sets forth the documentation that must be presented. This section is being amended to reflect the new procedure through which the information requested on the Form I-418 is submitted electronically through an EDI approved by CBP. This rule does not make changes to any of the other documentation requirements in section 258.2. Additional minor amendments are being made to section 258.2, such as replacing the term “shall” with “must.” The term “Immigration and Naturalization Service” is also being updated and replaced with “CBP.”

Section 4.7 concerns “Inward foreign manifest; production on demand; contents and form; advance filing of cargo declaration.” Pursuant to section 4.7(a), a paper Form I-418 is a required document for the manifest. This section is being amended to reflect the new electronic submission of the data elements required on Form I-418. Section 4.7(a) is being amended to require vessel operators to submit the data elements required on Form I-418 via the EDI approved by CBP, and to provide that the electronic submission will be considered part of the manifest required under this section.

Section 4.7a addresses “Inward manifest; information required; alternative forms.” Pursuant to Section 4.7a(b)(2), the master of a vessel may, in lieu of describing the articles on CBP Form 1304, furnish a CBP Form I-418. However, submitting CBP Form I-418 with the required CBP Form 5129 instead of CBP Form 1304 generally takes more time for the trade community to complete and takes more time for CBP to review and process the forms, as well as providing redundant information contained in other required forms. Therefore, to reflect current trade practices and improve data submission efficiency, this section is being amended to remove the option of filing a paper Form I-418 instead of CBP Form 1304. Conforming edits are also being made to section 4.7(a), for the same reason.

Sections 4.7a(d) and (e) are being amended to incorporate the information submission requirements contained in section 4.7b concerning the APIS data. Section 4.7a(e) is being amended to remove the certification requirements. Currently, the regulation requires a paper form certification to be attached to Form I-418. In light of the automation of CBP Form I-418, it will be impractical to require a paper form certification. Under this rule, vessel operators will be required to submit the data elements required on CBP Form I-418 via an electronic data interchange system approved by CBP. The regulation specifies that the act of electronically submitting the data will serve as the Master's certification, as described further in this preamble's discussion of the amendments to section 4.50.

Section 4.50 concerns the passenger lists that the master of every vessel arriving at a U.S. port from a foreign port or place must submit. Specifically, section 4.50(a) requires the master of the vessel to submit Form I-418 if the vessel is arriving from a noncontiguous foreign territory and is carrying steerage passengers. Section 4.50(a) is being amended to reflect the new procedure for submitting the data elements of Form I-418 through an EDI approved by CBP, including reference to the required information required under section 4.7b(b)(3) for such passengers. Section 4.50 is also being amended to include a new paragraph (c) that will replace the paper form certification requirement in section 4.7a(e). New subsection 4.50(c), provides that by the act of submitting the data elements required on CBP Form I-418 via an electronic data interchange system approved by CBP, the vessel operator certifies that CBP baggage declaration requirements have been made known to incoming passengers; that any required CBP baggage declarations have been or will simultaneously be filed as required by law and regulation with the proper CBP officer; that the responsibilities of the vessel operator have been or will be done as required by law or regulation before the proper CBP officer; and that there are no steerage passengers on board the vessel.

Section 4.81 addresses “Reports of arrivals and departures in coastwise trade.” Section 4.81(d) provides the master of the vessel with an option of either submitting the traveling Crew's Effects Declaration, Customs Form 1304, or Form I-418 with attached Customs Form 5129, with the port director upon arrival at each port in the United States. Like the amendment to remove the option to submit Form I-418 in section 4.7a, this section is being amended to remove the option of filing a Form I-418 instead of CBP Form 1304 to reflect current trade practices and improve data submission and efficiency.

Section 4.91 concerns the diversion of a vessel and the transshipment of cargo. Section 4.91(c) requires that when inward foreign cargo or passengers are transshipped to another vessel under customs supervision, a separate traveling manifest must be used for the transshipped cargo or passengers. Section 4.91(c) provides the master of the vessel with the option of submitting either a Cargo Declaration, CBP Form 1302, or Form I-418. This section is being amended to reflect the new procedure for submitting the data elements of Form I-418 through an EDI approved by CBP.

The Administrative Procedure Act (APA) generally requires agencies to publish a notice of proposed rulemaking in the Federal Register (5 U.S.C. 553(b)) and provide interested persons the opportunity to submit comments (5 U.S.C. 553(c)). However, the APA provides an exception to this prior notice and comment requirement for “rules of agency organization, procedure, or practice” 5 U.S.C. 553(b)(A). This interim final rule is a procedural rule promulgated for efficiency purposes that falls within this exception.

This rule is procedural because it merely automates an existing reporting requirement for vessel masters or agents pursuant to existing statutes and regulations. See 8 U.S.C. 1103, 1182, 1221, 1281, 1282; 8 CFR part 2; 19 U.S.C. 66, 1431, 1433, 1434, 1624, 2071 note; and 19 CFR part 4. The rule changes the format in which vessel masters or agents must present required information to CBP. Under the amended regulations, vessel masters or agents will no longer be required to complete and submit the paper Form I-418. Instead, all required information must be submitted to CBP electronically through the electronic data interchange system approved by CBP, which has been the practice for most vessel masters and agents by submitting the information through eNOA/D. This rule neither affects the substantive criteria by which CBP officers inspect vessels upon arrival or departure nor the nature of the information required by CBP.

Although this procedural rule is exempt from prior notice and comments procedures, DHS is providing the public with the opportunity to comment without delaying implementation of this rule. DHS will respond to the comments received when it issues a final rule.

Executive Orders 13563 (Improving Regulation and Regulatory Review) and 12866 (Regulatory Planning and Review) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

The Office of Management and Budget (OMB) has designated this rule a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by OMB. CBP has also prepared a regulatory impact assessment to help inform stakeholders of the impacts of this rule, which CBP has summarized below. The complete standalone analysis can be found in the public docket for this rulemaking at http://www.regulations.gov. The standalone analysis also focuses on the costs and benefits experienced during the I-418 Automation test program period (FY 2011 through FY 2020).

Through the Automation of CBP Form I-418 for Vessels Interim Final Rule, CBP will amend its regulations under 8 CFR part 251, 8 CFR part 258, and 19 CFR part 4 to require the electronic submission of the data elements required from vessel operators on Form I-418 in lieu of paper form submissions. CBP will no longer require the paper Form I-418. The updated regulations will require vessel operators to electronically submit the data elements required on the Form I-418 via an EDI approved by CBP. CBP will continue to use USCG's eNOA/D system as the approved EDI. Under this process, CBP systems will compile eNOA/D and other electronic manifest data submitted by vessel operators prior to arrival and at departure into a passenger and crew list format reflective of an electronic Form I-418. 16 The act of electronically submitting the data elements required on Form I-418 will also constitute the (vessel) Master's certification that the manifest information is accurate, 17 and eliminate the current need to generally collect Form I-418's vessel master (or operator) and CBP officer signatures for certification. 18 CBP will also retain its authority to require paper Form I-418 submissions in the event of certain technical difficulties, such as system outages and disruptions, that make it impossible to submit or receive manifest data electronically, and according to CBP discretion. 19 This rule will streamline vessel arrival and departure processes by eliminating redundant data submissions, simplifying vessel inspections, and automating recordkeeping.

CBP is currently operating an I-418 Automation test program, which serves as the basis for the regulatory program. The impact of the I-418 Automation regulatory program will slightly differ from the I-418 Automation test program due to its complete paper Form I-418 automation, eased administrative burdens, and elimination of signatures and paper processing. With its transition to a fully automated, electronic passenger and crew list ( i.e., Form I-418) process, the I-418 Automation regulatory program will discontinue the test program. Under the regulatory program, CBP systems will automatically reconcile eNOA/D and other manifest data submitted electronically by vessel operators prior to arrival and at departure into a passenger and crew list format reflective of an electronic Form I-418. This transition will affect commercial vessel operators and CBP.

Vessel operators will generally not incur any costs from this rule, though CBP will. CBP will sustain technology and printing costs from the regulatory program, including costs to maintain mobile devices for real-time, electronic processing and print paper Form I-418s until the admissibility inspection process is completely paperless. Across the period of analysis, these monetized costs will equal $45,000 in present value and $12,000 on an annualized basis. These costs represent the total costs of the rule.

Following this rule's implementation, vessel operators will enjoy $16.1 million in monetized present value cost savings from automated Form I-418 submissions and forgone printing and dual processing between FY 2021 and FY 2025 (using a 7 percent discount rate). During the same period, CBP will experience a total monetized present value cost saving of $37.2 million from the rule's forgone printing requirements, streamlined mobile processing and post-inspection tasks, and forgone storage and shipping costs (using a 7 percent discount rate). CBP may dedicate these cost savings to other agency mission areas, such as improving border security or facilitating trade. In total, the monetized cost savings of this rule will equal $53.3 million in present value and $13.9 million on an annualized basis over the period of analysis (using a 7 percent discount rate).

The Executive Summary Table outlines the estimated costs and benefits (cost savings) of the I-418 Automation regulatory program from FY 2021 to FY 2025. As illustrated, the benefits (cost savings) of this rule outweigh its costs, with the total monetized net benefit (net cost saving) of the regulatory program measuring $53.3 million in present value and $13.9 million on an annualized basis (using a 7 percent discount rate).

Please refer to Docket ID NRC-2020-0133 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2020-0133.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html . To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to pdr.resource@nrc.gov . The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.

• NRC's PDR: You may examine and purchase copies of public documents, by appointment, at the NRC's PDR, Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal holidays.

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2020-0133 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

Because the NRC considers this action to be non-controversial, the NRC is using the “direct final rule process” for this rule. This amendment is effective on March 14, 2022. However, if the NRC receives significant adverse comments on this direct final rule by January 27, 2022, then the NRC will publish a document that withdraws this action and will address the comments received in a subsequent final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register . Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if it meets the following criteria:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required under the following circumstances:

(a) The comment causes the NRC to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC to make a change (other than editorial) to the rule.

For detailed instructions on filing comments, please see the ADDRESSES section of this document.

Certain individuals employed by NRC licensees or their contractors require access to special nuclear material (plutonium, uranium-233, and uranium enriched in the isotopes uranium-233 or uranium-235), restricted data, or national security information. These individuals obtain an access authorization from the NRC. When a licensee requests access authorization for an employee or a contractor, the NRC initiates an investigation of the individual seeking access authorization. Based on the results of that investigation, the NRC determines whether permitting that individual to have access to special nuclear material, restricted data, or national security information would create a security risk.

The Defense Counterintelligence and Security Agency (DCSA) conducts the access authorization background investigations for the NRC and sets the rates charged for these investigations. The combined cost of the DCSA background investigation and any related NRC processing activities (NRC processing fee) is recovered from the licensee through an access authorization fee assessed by the NRC. It is the NRC's practice to publish the fee schedule for special nuclear material access authorization in § 11.15(e) of title 10 of the Code of Federal Regulations (10 CFR) and the corresponding fee schedule for restricted data and national security information access authorization in appendix A to 10 CFR part 25. Both schedules are based on rates charged by DCSA for conducting the access authorization background investigations (DCSA investigation billing rates).

This direct final rule amends 10 CFR parts 11, 25, and 95, along with appendix A to 10 CFR part 25. The NRC is revising the processing fee charged to licensees for work performed under the Material Access Authorization Program (MAAP) and the Information Access Authority Program (IAAP) from 55.8 percent of the DCSA investigation billing rates to 90.2 percent. A September 2019 NRC audit of actual in-house costs incurred in processing licensee applications for access authorization showed an increase in the NRC's review time for each application. The audit also showed that the NRC was not recovering its full-cost fees for the time spent processing the increased number of complex applications; despite a 2016 biennial review indicating increasing costs, the NRC had not adjusted its fees since 2012.

In addition, all requests for reciprocity will be charged a flat fee rate of $95.00. Previously, the NRC did not charge a fee for reciprocity requests because certain applications from individuals with current Federal access authorizations were processed expeditiously and at a reduced cost. This flat fee will be aligned with the level of effort that has recently been expended by DCSA to process reciprocity requests and accounts for inflation as well as recovery of the appropriate cost for conducting this work. In cases where reciprocity is not acceptable and it is necessary to perform a background investigation, then the NRC will charge the appropriate fee based on the DCSA investigation billing rate. This direct final rule continues to allow licensees to calculate the NRC access authorization fee for any given application by referencing the current DCSA investigation billing rates schedule for background investigation services. Reimbursable billing rates for personnel background investigations are published by DCSA in a Federal Investigations Notice (FIN). The current DCSA investigation billing rates are published on the DCSA website and are available at https://www.dcsa.mil/mc/pv/gov_hr_security/billing_rates/ . The NRC's licensees can also obtain the current DCSA investigation billing rates schedule by contacting the NRC's Personnel Security Branch, Division of Facilities and Security, Office of Administration by email at Licensee_Access_Authorization_Fee.Resource@nrc.gov .

The fee-calculation formula is designed to recover the NRC's actual in-house processing costs for each application received from a licensee. The NRC's access authorization fee for any given request is determined using the following formula: The DCSA investigation billing rates on the day the NRC receives the application + the NRC processing fee = the NRC material access authorization fee. The provisions in this direct final rule set the NRC processing fee; the fee is determined by multiplying the DCSA investigation billing rate on the day the NRC receives the application by 90.2 percent ( i.e., DCSA rate × 90.2 percent).

Public Law 115-439, the Nuclear Energy Innovation and Modernization Act (42 U.S.C. 2215), requires the NRC to recover through fees the full cost incurred in providing a service or thing of value. As noted previously, the DCSA investigation billing rates are pulled directly from the current DCSA fee schedule for investigations. The tables in revised § 11.15(e)(3) and appendix A to 10 CFR part 25 cross-reference each type of NRC access authorization request to the appropriate investigation service listed in the DCSA's investigation billing rates schedule. For example, a licensee seeking a special nuclear material “NRC-U” access authorization requiring a Tier 5 (T5) investigation is directed by the table in § 11.15(e)(3) to calculate the NRC processing fee based on the DCSA investigation billing rates for a “standard” T5 investigation. According to the current DCSA investigation billing rates schedule (FIN 20-04, “FY 2021 and FY 2022 Investigations Reimbursable Billing Rates,” June 30, 2020), the DCSA charges $5,465 for a “standard” T5 investigation. The table instructs the licensee to calculate the NRC's application processing fee by multiplying $5,465 by 90.2 percent, which equals $4,929.43. The licensee then rounds the NRC's processing fee to the nearest dollar, or $4,929, and adds that amount to the DCSA investigation billing rate of $5,465 to determine the total NRC access authorization fee: $10,394.

The following table illustrates the calculation process:

Licensees applying for restricted data or national security information access authorization follow a similar procedure. The table in appendix A to 10 CFR part 25 cross-references each type of “Q” or “L” access authorization to the corresponding DCSA investigation type. The DCSA investigation billing rate for the type of investigation referenced is determined by consulting the current DCSA investigation billing rates schedule. This rate is then used in the formula to calculate the correct NRC access authorization fee for the type of application submitted. Copies of the current NRC access authorization fees can be obtained by contacting the NRC's Personnel Security Branch, Division of Facilities and Security, Office of Administration by email to Licensee_Access_Authorization_Fee.Resource@nrc.gov. Any change in the NRC's access authorization fees will be applicable to each access authorization request received on or after the effective date of the DCSA's most recently published investigation billing rates schedule.

In Federal Investigations Notice Number 16-07, dated September 26, 2016 ( https://www.dcsa.mil/Portals/91/Documents/pv/GovHRSec/FINs/FY16/fin-16-07.pdf ), the Office of Personnel Management (OPM) implemented the Federal Investigative Standards according to the phased Federal Investigative Standards Implementation Plan issued by the Suitability and Security Executive Agents. In accordance with the plan, the Access National Agency Check with Inquiries was renamed to Tier 3 (T3) and the National Agency Check with Law and Credit was renamed to Tier 3 reinvestigation (T3R). The T3 investigation is required for positions designated as non-critical sensitive and/or requiring eligibility for “L” or “R” access or access to Confidential or Secret information. The T3R is the reinvestigation product for the same positions. The Single Scope Background Investigation was renamed to Tier 5 (T5) and the Single Scope Background Investigation-Periodic Reinvestigation was renamed to Tier 5R (T5R). The T5 investigation is required for positions designated as critical sensitive, special sensitive, and/or requiring eligibility for “Q” or “U” access or access to Top Secret or Sensitive Compartmented Information. The T5R is the reinvestigation product required for the same positions. This direct final rule revises the definitions in 10 CFR parts 11, 25, and 95 to include the new naming conventions for background investigations case types. The definitions for the NRC “R” and NRC “U” special nuclear material access authorizations include the renamed investigation types Tier 3 and Tier 5, respectively. Also, the definitions for NRC “L” and NRC “Q” access authorizations include the renamed investigation types Tier 3 and Tier 5, respectively.

In 2005, the OPM implemented the Electronic Questionnaires for Investigative Processing (e-QIP) system, which allows applicants to electronically enter, update, and release their personal investigative data over a secure internet connection to an employing agency for review and approval. The e-QIP system is a web-based automated system that facilitates the processing of standard investigative forms used when conducting background investigations for Federal security, suitability, fitness, and credentialing purposes. The NRC allows applicants to complete their security form, the Questionnaire for National Security Positions, Standard Form 86 (SF-86), electronically through the (e-QIP) system to minimize errors and expedite processing. This direct final rule updates 10 CFR parts 11 and 25 to clarify that the NRC uses the e-QIP system for applicants to provide their personal investigative data.

The following paragraphs describe the specific changes in this direct final rule.

This direct final rule revises the definitions in § 11.7 for NRC-“R” special nuclear material access authorization and NRC-“U” special nuclear material access authorization to include the new naming conventions for background investigations case types.

This direct final rule revises § 11.8 to add a new paragraph (c) to clarify that the information collections for the electronic form “Electronic Questionnaire for Investigations Processing (e-QIP), Questionnaire for National Positions—Standard Form 86 (SF-86)” are approved under OMB control number 3206-0005.

This direct final rule revises paragraphs (b)(1) and (c)(1)(ii) to specify the electronic form of the SF-86.

This direct final rule revises paragraph (e)(1) to revise the NRC processing fee charged to licensees for work performed under the MAAP from 55.8 percent of the DCSA investigation billing rates to 90.2 percent.

This direct final rule revises paragraph (e)(3) to (1) change the NRC processing fee charged to licensees for work performed under the MAAP from 55.8 percent of the DCSA investigation billing rates to 90.2 percent, (2) indicate that MAAP requests for reciprocity will be charged at a flat fee rate of $95.00, and (3) include the new naming conventions for background investigations case types.

This direct final rule revises paragraph (e)(4) to clarify that certain applications from individuals with current Federal access authorizations may be processed expeditiously and at a reduced cost.

This direct final rule revises paragraph (f)(1) to include the new naming conventions for background investigations case types.

This direct final rule revises § 11.16 to include the new naming conventions for background investigations case types.

This direct final rule revises the definitions for “ L ” access authorization and “ Q ” access authorization to include the new naming conventions for background investigations case types.

This direct final rule revises § 25.8(c)(2) to clarify that the information collections for the electronic form “Electronic Questionnaire for Investigations Processing (e-QIP), Questionnaire for National Positions—Standard Form 86 (SF-86)” are approved under OMB control number 3206-0005.

This direct final rule revises paragraph (d)(1)(i) to specify the electronic form of the SF-86.

This direct final rule revises paragraph (f)(1) to change the NRC processing fee charged to licensees for work performed under the IAAP from 55.8 percent of the DCSA investigation billing rates to 90.2 percent.

This direct final rule revises paragraph (f)(3) to indicate that IAAP requests for reciprocity will be charged a flat fee rate of $95.00.

This direct final rule revises the table in appendix A to 10 CFR part 25 to include the new naming conventions for background investigations case types.

This direct final rule revises the definitions for NRC “L” access authorization and NRC “Q” access authorization to include the new naming conventions for background investigations case types.

Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this direct final rule amending 10 CFR parts 11, 25, and 95 does not have a significant economic impact on a substantial number of small entities. This direct final rule applies to those licensees who use, process, store, transport, or deliver to a carrier for transport, formula quantities of special nuclear material (as defined in 10 CFR part 73) or generate, receive, safeguard, and store National Security Information or Restricted Data (as defined in 10 CFR part 95). Two licensees, both fuel cycle facilities, are currently required to comply with 10 CFR part 11. Seventy-eight licensees and other organizations, mostly power reactors and fuel cycle facilities, are currently required to comply with 10 CFR part 25. None of these licensees are “small entities” as defined in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810). This direct final rule also applies to contractors of those licensees required to comply with this direct final rule who use, process, store, transport, or deliver to a carrier for transport, formula quantities of special nuclear material (as defined in 10 CFR part 73) or generate, receive, safeguard, and store National Security Information or Restricted Data (as defined in 10 CFR part 95). Some of these contractors may be “small entities” as defined in the Regulatory Flexibility Act or the NRC's size standards. However, some of these contractors are reimbursed through the contract for the cost of securing access authorization. There are not a substantial number of unreimbursed “small entity” contractors who apply for access authorization, nor is the NRC aware of any significant impact on these unreimbursed “small entity” contractors.

A regulatory analysis has not been prepared for this direct final rule. This direct final rule ensures that the NRC recovers the full cost of application processing from licensees submitting access authorization requests, as is required by statute (42 U.S.C. 2214(b)). The formula method for calculating these fees continues to provide an efficient and effective mechanism for updating the NRC access authorization fees in response to changes in the underlying DCSA investigation billing rates schedule for required personnel background investigations. The Nuclear Energy Innovation and Modernization Act (42 U.S.C. 2215) requires the NRC to recover through fees the full cost incurred in providing a service or thing of value. These amendments will neither impose new safety requirements nor relax existing ones and, therefore, do not call for the sort of safety/cost analysis described in the NRC's regulatory analysis guidelines in NUREG/BR-0058, Revision 4, “Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission,” dated September 2004 (ADAMS Accession No. ML042820192).

The NRC has determined that the backfit rule does not apply to this direct final rule and that a backfit analysis is not required. Collection of fees to recover the NRC's costs is required by statute (42 U.S.C. 2214(b)). Therefore, changes to rules designating the amount to be collected are not subject to the backfitting provisions or issue finality provisions in 10 CFR chapter I.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885).

The NRC has determined that this final rule is the type of action described in 10 CFR 51.22(c)(1), which is categorically excluded from environmental review. Therefore, neither an environmental impact statement nor environmental assessment has been prepared for this final rule.

This direct final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget (OMB), Approval Numbers 3150-0046 and 3150-0062.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

In accordance with the Congressional Review Act of 1996 (5 U.S.C. 801-808), the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of the Office of Management and Budget.

The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or is otherwise impractical. In this direct final rule, the NRC will revise the formula for calculating the NRC's access authorization fee charged to licensees for work performed under MAAP and IAAP from 55.8 percent of the DCSA investigation billing rate for an investigation of a given type to 90.2 percent. In addition, MAAP requests for reciprocity will be charged a flat fee rate of $95.00. This action does not constitute the establishment of a standard that contains generally applicable requirements.

For the reasons set forth in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 11, 25, and 95:

The Federal Civil Penalties Inflation Adjustment Act of 1990 (the “Inflation Adjustment Act”), 1 as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the “2015 Act”), 2 requires federal agencies, including the Commission, to adjust for inflation the civil monetary penalties within their jurisdiction according to prescribed formulas. A civil monetary penalty is “any penalty, fine, or other sanction” that (1) “is for a specific monetary amount” or “has a maximum amount” under federal law; and (2) that a federal agency assesses or enforces “pursuant to an administrative proceeding or a civil action” in federal court. 3 Under the Federal Election Campaign Act, 52 U.S.C. 30101 through 45 (“FECA”), the Commission may seek and assess civil monetary penalties for violations of FECA, the Presidential Election Campaign Fund Act, 26 U.S.C. 9001 through 13, and the Presidential Primary Matching Payment Account Act, 26 U.S.C. 9031 through 42.

The Inflation Adjustment Act requires federal agencies to adjust their civil penalties annually, and the adjustments must take effect no later than January 15 of every year. 4 Pursuant to guidance issued by the Office of Management and Budget, 5 the Commission is now adjusting its civil monetary penalties for 2022. 6

The Commission must adjust for inflation its civil monetary penalties “notwithstanding Section 553” of the Administrative Procedure Act (“APA”). 7 Thus, the APA's notice-and-comment and delayed effective date requirements in 5 U.S.C. 553(b) through (d) do not apply because Congress has specifically exempted agencies from these requirements. 8

Furthermore, because the inflation adjustments made through these final rules are required by Congress and involve no Commission discretion or policy judgments, these rules do not need to be submitted to the Speaker of the United States House of Representatives or the President of the United States Senate under the Congressional Review Act, 5 U.S.C. 801 et seq. Moreover, because the APA's notice-and-comment procedures do not apply to these final rules, the Commission is not required to conduct a regulatory flexibility analysis under 5 U.S.C. 603 or 604. See 5 U.S.C. 601(2), 604(a). Nor is the Commission required to submit these revisions for congressional review under FECA. See 5 U.S.C. 30111(d)(1), (4) (providing for congressional review when Commission “prescribe[s]” a “rule of law”).

The new penalty amounts will apply to civil monetary penalties that are assessed after the date the increase takes effect, even if the associated violation predated the increase. 9

The Inflation Adjustment Act requires the Commission to annually adjust its civil monetary penalties for inflation by applying a cost-of-living-adjustment (“COLA”) ratio. 10 The COLA ratio is the percentage that the Consumer Price Index (“CPI”)  11 “for the month of October preceding the date of the adjustment” exceeds the CPI for October of the previous year. 12 To calculate the adjusted penalty, the Commission must increase the most recent civil monetary penalty amount by the COLA ratio. 13 According to the Office of Management and Budget, the COLA ratio for 2022 is 0.01622, or 1.622%; thus, to calculate the new penalties, the Commission must multiply the most recent civil monetary penalties in force by 1.06222. 14

The Commission assesses two types of civil monetary penalties that must be adjusted for inflation. First are penalties that are either negotiated by the Commission or imposed by a court for violations of FECA, the Presidential Election Campaign Fund Act, or the Presidential Primary Matching Payment Account Act. These civil monetary penalties are set forth at 11 CFR 111.24. Second are the civil monetary penalties assessed through the Commission's Administrative Fines Program for late filing or non-filing of certain reports required by FECA. See 52 U.S.C. 30109(a)(4)(C) (authorizing Administrative Fines Program), 30104(a) (requiring political committee treasurers to report receipts and disbursements within certain time periods). The penalty schedules for these civil monetary penalties are set out at 11 CFR 111.43 and 111.44.

FECA establishes the civil monetary penalties for violations of FECA and the other statutes within the Commission's jurisdiction. See 52 U.S.C. 30109(a)(5), (6), (12). Commission regulations in 11 CFR 111.24 provide the current inflation-adjusted amount for each such civil monetary penalty. To calculate the adjusted civil monetary penalty, the Commission multiplies the most recent penalty amount by the COLA ratio and rounds that figure to the nearest dollar.

The actual adjustment to each civil monetary penalty is shown in the chart below.

FECA authorizes the Commission to assess civil monetary penalties for violations of the reporting requirements of 52 U.S.C. 30104(a) according to the penalty schedules “established and published by the Commission.” 52 U.S.C. 30109(a)(4)(C)(i). The Commission has established two penalty schedules: The penalty schedule in 11 CFR 111.43(a) applies to reports that are not election sensitive, and the penalty schedule in 11 CFR 111.43(b) applies to reports that are election sensitive. 15 Each penalty schedule contains two columns of penalties, one for late-filed reports and one for non-filed reports, with penalties based on the level of financial activity in the report and, if late-filed, its lateness. 16 In addition, 11 CFR 111.43(c) establishes a civil monetary penalty for situations in which a committee fails to file a report and the Commission cannot calculate the relevant level of activity. Finally, 11 CFR 111.44 establishes a civil monetary penalty for failure to file timely reports of contributions received less than 20 days, but more than 48 hours, before an election. See 52 U.S.C. 30104(a)(6).

To determine the adjusted civil monetary penalty amount for each level of activity, the Commission multiplies the most recent penalty amount by the COLA ratio and rounds that figure to the nearest dollar. The new civil monetary penalties are shown in the schedules in the rule text, below.

For the reasons set out in the preamble, the Federal Election Commission amends 11 CFR part 111 as follows:

The Safety and Soundness Act requires FHFA to establish annual housing goals for several categories of both single-family and multifamily mortgages purchased by Fannie Mae and Freddie Mac. 1 The annual housing goals are one measure of the extent to which the Enterprises are meeting their public purposes, which include “an affirmative obligation to facilitate the financing of affordable housing for low- and moderate-income families in a manner consistent with their overall public purposes, while maintaining a strong financial condition and a reasonable economic return.”  2 FHFA established housing goals levels for 2021 in a final rule published on December 21, 2020. 3 FHFA proposed housing goals for 2022-2024 in a proposed rule published on August 25, 2021. 4

Single-family goals. The single-family goals as defined under the Safety and Soundness Act include separate categories for home purchase mortgages for low-income families, very low-income families, and families that reside in low-income areas. Performance on the single-family home purchase goals is measured as the percentage of the total home purchase mortgages purchased by an Enterprise each year that qualify for each goal or subgoal. There is also a separate goal for refinancing mortgages for low-income families, and performance on the refinancing goal is determined in a similar way.

Under the Safety and Soundness Act, the single-family housing goals are limited to mortgages on owner-occupied housing with one to four units total. The single-family goals cover conventional, conforming mortgages, defined as mortgages that are not insured or guaranteed by the Federal Housing Administration (FHA) or another government agency and with principal balances that do not exceed the loan limits for Enterprise mortgages.

The performance of the Enterprises on the single-family housing goals is evaluated using a two-part approach, which compares the goal-qualifying share of the Enterprise's mortgage purchases to two separate measures: A benchmark level established by FHFA regulation; and a market level that FHFA computes retrospectively based on Home Mortgage Disclosure Act (HMDA) data.

Multifamily goals. The multifamily goals as defined under the Safety and Soundness Act include separate categories for mortgages on multifamily properties (properties with five or more units) with rental units affordable to low-income families and for mortgages on multifamily properties with rental units affordable to very low-income families. FHFA has also established by regulation a small multifamily low-income subgoal for multifamily properties with 5-50 units. The multifamily goals evaluate the performance of the Enterprises based on numeric targets, not percentages, for the number of affordable units in properties backed by mortgages purchased by an Enterprise. The regulation establishes benchmark levels for the multifamily goals and subgoals, but it does not include a retrospective market level measure for the multifamily goals and subgoals, due in part to a lack of comprehensive data about the multifamily market. Thus, in contrast to the single-family goals, FHFA currently measures Enterprise multifamily goals performance against the benchmark levels only.

If, after publication of this final rule, FHFA determines that any of the single-family or multifamily housing goals should be adjusted due to market conditions that are beyond current expectations, to ensure the safety and soundness of the Enterprises, or for any other reason, FHFA will take any steps that are necessary and appropriate to adjust that goal such as reducing the benchmark level through the processes in the existing regulation. FHFA may take other actions consistent with the Safety and Soundness Act and the Enterprise housing goals regulation based on new information or developments that occur after publication of the final rule.

For example, under the Safety and Soundness Act and the Enterprise housing goals regulation, FHFA may reduce the benchmark levels in response to an Enterprise petition for reduction of any of the single-family or multifamily housing goal benchmark levels in a particular year based on a determination by FHFA that: (1) Market and economic conditions or the financial condition of the Enterprise require a reduction; or (2) efforts to meet the goal or subgoal would result in the constraint of liquidity, over-investment in certain market segments, or other consequences contrary to the intent of the Safety and Soundness Act or the purposes of the Enterprises' charter acts. 5

The Safety and Soundness Act and the Enterprise housing goals regulation also take into account the possibility that achievement of a particular housing goal may or may not have been feasible for an Enterprise to achieve. If FHFA determines that a housing goal was not feasible for an Enterprise to achieve, then the statute and regulation provide for no further enforcement of that housing goal for that year. 6

If FHFA determines that an Enterprise failed to meet a housing goal and that achievement of the housing goal was feasible, then the statute and regulation provide FHFA with discretionary authority to require the Enterprise to submit a housing plan describing the specific actions the Enterprise will take to improve its housing goals performance. 7

On September 6, 2008, FHFA placed each Enterprise into conservatorship. Although the Enterprises remain in conservatorship at this time, they continue to have the mission of supporting a stable and liquid national market for residential mortgage financing. FHFA has continued to establish annual housing goals for the Enterprises and to assess their performance under the housing goals each year during conservatorship.

FHFA published a Notice of Proposed Rulemaking (NPRM or proposed rule) in the Federal Register on August 25, 2021 that proposed new benchmark levels for each of the single-family and multifamily housing goals. The NPRM also proposed the replacement of the existing single-family low-income areas subgoal with separate area-based subgoals targeting the individual components of the low-income areas subgoal (minority census tracts and low-income census tracts). The NPRM also included proposed technical changes to the regulation. 8 The public comment period on the proposed rule ended on October 25, 2021.

Overview. FHFA received 24 comment letters from 27 organizations and individuals in response to the proposed rule. Comments were submitted by both Fannie Mae and Freddie Mac, as well as by five nonprofit organizations, and ten trade associations representing lenders, home builders, credit unions, and other mortgage market participants. FHFA also received four comment letters from policy advocacy organizations, with one letter representing the views of three organizations and another representing the views of two organizations. Individuals submitted the remaining six comments. FHFA has reviewed and considered all of the comments. A number of comments raised issues unrelated to the housing goals or beyond the scope of the proposed rule, and those comments are not addressed in this final rule. Specific provisions of the proposed rule, and the comments received on those provisions, are discussed below and throughout this final rule.

Single-family benchmark levels. FHFA proposed increases to the benchmark levels for the single-family housing goals. FHFA also proposed establishing a new area-based subgoals structure, which divided the existing low-income area purchase subgoal into two subgoals (a minority census tracts subgoal and a low-income census tracts subgoal). A majority of commenters, including Fannie Mae and Freddie Mac, expressed overall support for the proposed benchmark levels for the single-family goals, including the area-based subgoals. Many of these commenters characterized their support for the proposed single-family benchmark levels as “strong” and “enthusiastic.” Several of these commenters specifically commended FHFA for proposing higher benchmark levels, which they described as in-line with the Enterprises' public missions and responsibilities to provide access to stable and affordable housing for all communities. Many of these commenters described the proposed increases in the benchmark levels as the type of concrete action necessary to address the affordable housing needs the country is facing, as well as to build a more equitable housing finance market. Several of them, including Fannie Mae, also described the proposed higher benchmark levels as reasonable, realistic, and achievable. Many of the commenters supporting the proposed benchmark levels described them as appropriately higher and necessary in order to support the Enterprises' mission to enable equitable and sustainable access to affordable housing. A number of these commenters focused on the critical role the goals play in providing credit for low-income and very low-income borrowers by ensuring that the Enterprises properly focus on this important aspect of their mission.

Several commenters noted that higher benchmark levels will incentivize Fannie Mae and Freddie Mac to marshal their considerable resources and market presence to address the nation's affordable housing crisis. A number of commenters found the proposed single-family benchmark levels to be reasonable in relation to the market forecast. One commenter specifically supported setting the proposed benchmark levels for the low-income and very low-income purchase goals slightly above the midpoint of the projected confidence interval in the market forecast, as discussed in the proposed rule, on the basis that this will encourage the Enterprises to expend significant effort and execute thoughtful strategies to meet meaningful, yet attainable, goals.

Single-family home purchase housing goals. Both Fannie Mae and Freddie Mac commented that the proposed increases in the benchmark levels for the single-family home purchase housing goals were substantial compared to the 2018-2020 and 2021 goals. Freddie Mac specifically noted that the proposed increases would set targets that exceed past performance by both Enterprises and the market as a whole in most of the past ten years.

Although Fannie Mae and Freddie Mac expressed support for the proposed increases to the single-family home purchase benchmark levels, both Enterprises expressed concerns about uncertainty in the housing and loan origination markets. Fannie Mae expressed cautious optimism regarding its ability to achieve the proposed single-family home purchase benchmarks based on historical performance, while Freddie Mac committed to making every effort to meet the proposed goals. However, both Fannie Mae and Freddie Mac emphasized that market factors and regulatory issues outside the Enterprises' control could pose risks to their ability to meet the proposed benchmark levels during the period covered by the final rule. Freddie Mac specifically requested a designated “implementation period” to adjust to the significant increases in the single-family benchmark levels in light of the current and foreseeable market conditions. Both Enterprises encouraged FHFA to consider how external factors could complicate their efforts to achieve the proposed benchmark levels given the current and forecasted conditions in the housing and origination markets. They emphasized how extreme home price appreciation, the shortfall in affordable housing supply, and disruptions in income and employment stability resulting from the COVID-19 pandemic could reduce demand and disproportionately impact lower-income borrowers' mortgage loan eligibility. The Enterprises also emphasized how secondary market dynamics, such as lender interest in holding loans in their portfolios rather than selling them, consumer demand, lender preference for conventional loans versus non-conventional loans, and the secondary market activities of other investors will influence the Enterprises' ability to achieve the proposed benchmark levels.

Area-based subgoals. The NPRM proposed establishing a new area-based subgoals structure by dividing the existing low-income areas purchase subgoal into two subgoals: A minority census tracts subgoal and a low-income census tracts subgoal. Most commenters offered strong support for the proposed area-based subgoals structure. Several commenters, including Freddie Mac, applauded FHFA for its focus on equitable housing finance and efforts to address the minority homeownership gap through these proposed subgoals. One commenter stated that the proposed minority census tracts subgoal is a necessary step toward ensuring the Enterprises fulfill their statutory duty to facilitate the financing of affordable housing for all low- and moderate-income families, including families of color. A number of commenters urged FHFA to increase the benchmark level for the minority census tracts subgoal above the proposed 10 percent. Two commenters recommended an increase in the benchmark level for the proposed low-income census tracts subgoal above the proposed 4 percent. Two commenters suggested that restructuring the low-income areas subgoal as proposed might provide FHFA with data to determine “whether the enterprise housing goals are unintentionally contributing to the displacement of low-income families.”

While no commenters objected to the proposed area-based subgoals structure, one commenter expressed concern that the proposed low-income census tracts subgoal would deter the Enterprises from purchasing loans in minority census tracts for moderate- to high-income minority borrowers who opt to live in minority census tracts. FHFA notes that the new subgoals would permit housing goals credit under at least one of the subgoals for many moderate- and high-income borrowers in minority census tracts. All loans to moderate-income borrowers (defined as having incomes no greater than 100 percent of area median income (AMI)) in minority census tracts would be eligible for credit under the minority census tracts subgoal, and in minority census tracts that are also low-income census tracts, loans to borrowers with incomes above 100 percent of AMI would be eligible for credit under the low-income census tracts subgoal. While it is true that loans to higher income borrowers in minority census tracts that are not low-income census tracts would not be eligible for credit under either subgoal, FHFA does not expect this to create a significant disincentive for Enterprise purchases of such loans.

Another commenter recommended future inclusion of race and ethnicity of borrowers into housing goal formulation and modification. FHFA will continue to monitor Enterprise performance on the housing goals and the demographics of borrowers with goals-qualifying loans. FHFA may explore avenues that may be permitted under applicable law in future housing goals rulemakings.

Single-family low-income refinancing goal. In addition to their support for the proposed increases in the benchmark levels for the single-family home purchase goals, a number of commenters specifically expressed support for the proposed benchmark level for the single-family low-income refinancing goal. Several of these commenters emphasized the crucial role that responsible and affordable refinance loans play in preserving homeownership and the important role the Enterprises play in ensuring that more borrowers can benefit from the current refinance boom to save money on mortgage payments. They expressed concern that, during the COVID-19 pandemic and a period of historically low interest rates, the current surge in refinancing is not adequately reaching lower-income families, lower-wealth families, and borrowers with smaller loan balances. To address these concerns, these commenters recommended that FHFA and the Enterprises help reduce the cost of refinancing by ensuring that rate-term refinances are more available, but not more costly, for lower-income families who would save greatly on mortgage payments. They also urged FHFA and the Enterprises to create a streamlined refinance program for low-balance mortgages to ensure that affordable refinances are more accessible to borrowers, and particularly those of color. One commenter that supported the proposed benchmark level for the single-family low-income refinancing goal expressed optimism that the proposed higher benchmark level would encourage the Enterprises to purchase refinance mortgages from credit unions and other financial institutions whose mission is to serve their local communities. Another commenter urged FHFA to increase the benchmark level for the low-income refinancing goal from the proposed 26 percent to 28 percent to help ensure that the Enterprises can respond to current market conditions and promote fair access to affordable housing effectively. One commenter recommended that FHFA increase the income level for mortgages eligible for the low-income refinance goal from 80 percent of AMI to 100 percent of AMI and provide more support to more low‐income homeowners looking to refinance. FHFA notes that while this proposal would be beyond the scope of the current rule, FHFA will continue to consider the needs of moderate-income households that are seeking to refinance loans.

Several commenters expressed support for the higher proposed benchmark level while acknowledging that interest rates are forecast to increase in the years 2022-2024. Two of these commenters described the proposal, which set the low-income refinancing goal slightly below the midpoint of the confidence interval in the market forecast, as appropriate given the greater volatility in refinance projections and the sizable increase over the current benchmark level of 21 percent. One of these commenters endorsed FHFA's proposal to set the benchmark level lower than the projected market level due to fluctuations in interest rates.

Fannie Mae expressed concern over the proposed low-income refinance benchmark level, characterizing the proposed increase over the current benchmark level as significant. Fannie Mae stated that the unpredictability of future interest rates and refinancing volumes could have a significant impact on the low-income refinance share of the market. Fannie Mae further stated that this volatility makes it difficult to determine the likelihood of the Enterprises' ability to meet the proposed benchmark level, particularly in 2023 and 2024. Fannie Mae also stated that meeting the proposed benchmark level may be challenging if future refinance volume stalls because homeowners who have taken advantage of historically low interest rates will have less incentive to refinance their loans, especially those lower income borrowers with low loan balances. FHFA emphasizes that the Enterprises are required to meet the lower of the benchmark level or the market level for each single-family goal. Therefore, if the benchmark level that FHFA set is higher than the market level, then the Enterprise can still meet this goal by exceeding the market level, even if it falls short of the benchmark. However, if FHFA sets a low benchmark level in the context of an expected strong or high market level, then FHFA would be not be meeting its statutory obligation to set meaningful and robust goals to ensure that an appropriate share of Enterprise refinance acquisitions are loans made to low-income borrowers.

Multifamily benchmark levels. The NPRM proposed increases in the benchmark levels for all three multifamily goals. A significant number of commenters supported these proposed increases in the benchmark levels. The commenters characterized the proposed benchmark levels as reasonable and attainable, notwithstanding known market challenges, like the cost of materials, labor shortages and supply chain issues. Several of the commenters stated that the significant and growing need for affordable rental housing across the country aligns with the missions of the Enterprises and should be a priority in the near future. One commenter stated that while the proposed increases in the benchmark levels would be an improvement, FHFA should set the multifamily benchmark levels even higher, citing both the need for more affordable rental housing and the Enterprises' recent performance on these goals. Two commenters expressed concern that the proposed benchmark levels would be too high relative to previous levels.

Measuring multifamily goals. Several commenters suggested expressing the multifamily goals in percentages or dollar volumes instead of numbers of units. Those proposals are outside the scope of this rulemaking, and the final rule does not change how the multifamily goals are measured. FHFA may consider changes to the structure or measurement of the multifamily housing goals in future rulemaking to establish multifamily benchmark levels for 2023 and beyond.

Duration of goals. A number of commenters recommended that FHFA establish the housing goals more frequently than once every three years. Several of these commenters urged FHFA to set the multifamily goal benchmark levels annually, rather than for three years as set forth in the proposed rule. One of these commenters stated that because the 2022-2024 goals are subject to the lasting uncertainty in housing markets due to the COVID-19 pandemic, FHFA should issue one-year multifamily goal benchmark levels applicable to 2022. This commenter argued that a shorter goal duration could also mitigate the potential need for FHFA to adjust longer-term housing goal benchmark levels if unforeseen changes to market conditions arise. Other commenters also recommended a one-year multifamily goal duration, stating that the proposed increases to the benchmark levels may be too high and the three-year time frame too long and may cause the Enterprises to act irrationally if the market dynamics change during the three-year period. One commenter urged FHFA to set two-year benchmark levels for both the single-family and multifamily goals. The commenter reasoned that because forecasts are more accurate in shorter time frames, two-year goals could allow for more aggressive, but feasible, benchmark levels within the upper range of loan purchase forecasts.

Small multifamily subgoal. FHFA received several comment letters, including from Freddie Mac, supporting the proposed increase in the small multifamily housing goal benchmark level. Fannie Mae highlighted concerns around the proposed increase in the benchmark level and identified a potential need to change existing underwriting standards in order to meet the goal.

Other issues. A number of commenters raised concerns in response to the proposed rule that, while important to note, have limited implementation feasibility or relevance in the final housing goals rulemaking. Additionally, commenters recommended changes to the proposed rule that are outside the scope of the housing goals, such as issues related to the Enterprises' Senior Preferred Stock Purchase Agreements (PSPA) with the U.S. Department of Treasury, and recommendations for alignment with other regulatory requirements, such as the Community Reinvestment Act. These comments are further discussed below.

(i) PSPA amendments. A number of commenters expressed general concern over the impact of the covenants added to the PSPA in January 2021 on Enterprise housing goals performance. Several of the commenters recommended permanently suspending these covenants, which were temporarily suspended by the U.S. Department of Treasury in September 2021, to best support communities of color and bolster Enterprise performance. One commenter stated that while FHFA has important safety and soundness responsibilities, those responsibilities should be exercised using supervisory authority rather than as part of the PSPA.

(ii) Equitable Housing Finance Plans. Several commenters, including Fannie Mae, commended FHFA's efforts to support sustainable affordable housing—specifically, FHFA's requirement that the Enterprises prepare three-year Equitable Housing Finance Plans. The Enterprises' Equitable Housing Finance Plans, due by December 31, 2021, will identify barriers to housing opportunities, list measurable objectives and meaningful goals, and describe plans for meaningful actions to reduce the racial homeownership gap. FHFA expects that the Equitable Housing Finance Plans, together with the new housing goals area-based subgoals structure, will contribute to promoting equitable and wide-reaching credit opportunities.

(iii) Disaster-related and climate change considerations. One commenter recommended explicitly including indicators for climate change and environmental justice into the formulation of Enterprise housing goals. Citing apparent disproportionate effects of climate change on historically underserved communities, particularly those of color, the commenter pushed for consideration of environment-related risk into housing goal risk assessment. The commenter asserted that FHFA should take actions to support sustainable affordable housing initiatives in response to the risks posed by climate change to the housing finance market, and low- and moderate-income communities and communities of color in particular. FHFA has been actively engaging with industry stakeholders and working to evaluate climate and natural disaster risk management at the Enterprises and will continue to do so. 9

(iv) Manufactured housing loans. The NPRM did not propose targets specific to the purchase of manufactured housing loans. One commenter urged FHFA to establish a new manufactured housing single-family subgoal based on the commenter's claim that the Enterprises' separate Duty to Serve plans and performance do not adequately support manufactured housing finance. Fannie Mae suggested that FHFA allow housing goals credit for rented units within manufactured housing communities.

FHFA recognizes the importance of manufactured housing as a significant source of affordable housing and homeownership. However, the final rule does not establish a new manufactured housing single-family subgoal and does not allow housing goals credit for rented units in manufactured housing communities. The multifamily Conservatorship Scorecard cap currently requires at least 50 percent of an Enterprise's multifamily loan purchases to be mission-driven, affordable housing, including manufactured housing communities. In addition, the Enterprises' proposed Duty to Serve plans include Enterprise manufactured home loan purchases for 2022-2024. FHFA will continue to evaluate the treatment of loans on manufactured housing communities and may consider changes in connection with the Enterprises' Duty to Serve efforts.

FHFA also will consider providing additional guidance to the Enterprises to permit blanket loans on manufactured housing communities that meet certain conditions to count towards the multifamily housing goals on a case-by-case basis. It is difficult to accurately determine a manufactured housing unit's affordability under the housing goals because bedroom count information on individual manufactured housing units in the communities is typically not collected by the Enterprises, and the pad rent alone does not include the full cost of housing for the residents, which includes paying for their unit financing. Therefore, the practical question of how to determine housing costs and affordability, including how to adjust household size for the number of bedrooms in a unit to accurately apply the rent estimation alternative, cannot be answered at this time given available data.

(v) Multifamily workforce housing goal. One commenter suggested that FHFA establish a multifamily goal targeting support for multifamily properties rented to households with incomes from 60 to 120 percent of AMI (which is the common definition of incomes for workforce housing). The commenter recommended that FHFA give the Enterprises goals credit for purchasing mortgage loans on multifamily rental properties with a prescribed number of rental units that are affordable to moderate‐income families with incomes between 60 and 120 percent of AMI. However, this proposal is outside the scope of this rulemaking. Therefore, the final rule does not change the structure of the multifamily housing goals to expand beyond the statutory requirements for establishing multifamily goals, which limit housing goals credit to households at or below 80 percent of AMI. FHFA acknowledges the importance of this market segment and may take workforce housing into consideration in future rulemakings.

(vi) Qualitative considerations. Fannie Mae and another commenter proposed incorporating qualitative goals in FHFA's final determinations for Enterprise annual performance. The commenters argued that analyzing the Enterprises' qualitative efforts in addition to their quantitative performance metrics will bolster FHFA's determination of appropriate remedies for Enterprise noncompliance with housing goals. The commenters recommended that FHFA give the Enterprises credit for participation in stakeholder efforts to promote affordable and sustainable housing. The commenters also suggested that FHFA explore opportunities for developing qualitative goals in conjunction with the Enterprises' development and implementation of their Equitable Housing Finance Plans and their efforts to advance equity in housing finance.

FHFA agrees that the implementation of qualitative measures plays an important role in the Enterprises' ability to achieve the quantitative housing goals. In particular, quantitative measures may not always reflect the impact of market developments outside the control of the Enterprises that may have a significant impact on the ability of the Enterprises to meet the housing goals. However, FHFA continues to believe that the establishment of quantitative benchmark levels provides clearly defined standards for objectively measuring the Enterprises' performance. FHFA notes that the qualitative efforts of the Enterprises in attempting to meet the housing goals are an appropriate consideration when assessing the feasibility of any housing goals that an Enterprise fails to achieve, as well as whether to require an Enterprise to submit a housing plan if the Enterprise fails to achieve a goal that was feasible.

The final rule establishes the benchmark levels for the single-family housing goals and subgoals for 2022-2024 as follows:

The final rule establishes the benchmark levels for the multifamily goal and subgoals for 2022 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain RRC AE 2100D3 model turboprop engines. The NPRM published in the Federal Register on October 12, 2021 (86 FR 56660). The NPRM was prompted by an uncommanded IFSD of a RRC AE 3007A1 model turbofan engine installed on an Embraer S.A. model EMB-145 airplane (marketed as ERJ-145), while conducting a revenue flight. The manufacturer's investigation of this incident revealed that the IFSD resulted from a low-cycle fatigue crack in the dovetail slot for the blade attachment in the 3rd-stage compressor wheel, causing one 3rd-stage compressor blade to release. The crack initiated in the dovetail slot due to a sharp corner in the wheel slot geometry. The broaching process was identified as the cause of the crack and parts from this manufacturing lot required removal from service.

In response to this event and the manufacturer's subsequent investigation, the FAA issued a final rule; request for comments, AD 2020-16-13 (85 FR 45769, July 30, 2020), requiring replacement of certain 3rd-stage compressor wheels installed on RRC AE 3007A, AE 3007A1, AE 3007A1/1, AE 3007A1/2, AE 3007A1/3, AE 3007A1E, AE 3007A1P, and AE 3007A3 model turbofan engines before the 3rd-stage compressor wheels accumulate a specified number of cycles. The actions required by AD 2020-16-13 address engines that experienced high stresses at the 3rd-stage compressor wheel location and accumulated cycles at a high rate. In the NPRM, the FAA proposed to require replacement of certain AE 2100D3 3rd-stage compressor wheels that were produced in the same lot as the AE 3007 3rd-stage compressor wheels identified in AD 2020-16-13, before they accumulate a specified number of cycles. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from one anonymous commenter. The anonymous commenter 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 a minor editorial change to the contact address for service information, this AD is adopted as proposed in the NPRM.

The FAA reviewed Rolls-Royce Alert Service Bulletin (ASB) AE 2100D3-A-72-330, Engine—3rd Stage Compressor Wheel Removal for Reduced Life Limit, dated June 11, 2021. The ASB describes procedures for removal of a certain 3rd-stage compressor wheel.

The FAA estimates that this AD affects 15 engines installed on airplanes of U.S. registry.

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

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

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

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

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

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

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

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

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 777 airplanes. The NPRM published in the Federal Register on March 26, 2021 (86 FR 16133). The NPRM was prompted by significant changes, including new or more restrictive requirements, made to the AWLs and CDCCLs related to fuel tank ignition prevention, the engine fuel suction feed system, and the nitrogen generation system. In the NPRM, the FAA proposed to require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is issuing this AD to address ignition sources inside the fuel tanks and the increased flammability exposure of the center fuel tank caused by latent failures, alterations, repairs, or maintenance actions, which could result in a fuel tank explosion and consequent loss of an airplane; and to address potential loss of engine fuel suction feed capability, which could result in dual engine flameouts, inability to restart engines, and consequent forced landing of the airplane.

The FAA received comments from The Air Line Pilots Association, International (ALPA), and FedEx Express, who supported the NPRM without change.

The FAA received additional comments from three commenters, including American Airlines (AAL), Boeing, and United Airlines (UAL). The following presents the comments received on the NPRM and the FAA's response to each comment.

Boeing requested delay of issuance of the NPRM until updated service information is available. Boeing stated that the service information has been updated to Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, dated February 2021, of Boeing 777-200/200LR/300/300ER/777F Maintenance Planning Data (MPD) Document, which modified two AWLs that are not currently mandated by AD 2008-11-13, Amendment 39-15536 (73 FR 30737, May 29, 2008) (AD 2008-11-13) (which will be terminated by this AD), and that the AWLs have changed significantly. Boeing commented that using the latest service information eliminates the need for approval of an alternative method of compliance (AMOC) for the revised AWLs.

Boeing also stated that the delay of the NPRM should occur after Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, dated February 2021, of Boeing 777-200/200LR/300/300ER/777F Maintenance Planning Data (MPD) Document, has been migrated to an “SCI [special compliance items]/AWL document D622W001-9-04.” Boeing commented that FAA approval and publication of this document to MyBoeingFleet is anticipated by October 2021. Boeing also commented that the migration of the document will make the method of compliance more manageable for the FAA, Boeing, and the operators, and that it will also eliminate the need for an AMOC to use the “SCI/AWL document.” Boeing asked that paragraph (g) of the proposed AD be revised to the document name and revision date of the new “SCI/AWL document” when approved by the FAA.

The FAA partially agrees with the commenter's request. The FAA agrees to allow operators the option to use Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, dated February 2021, of Boeing 777-200/200LR/300/300ER/777F Maintenance Planning Data (MPD) Document, for the reasons provided above. The February 2021 revision of Section 9 has significant updates to AWL 28-AWL-31 and AWL 28-AWL-32 that were included in the November 2019 revision of Section 9 to clarify the applicability of certain wire harnesses and wire bundles, and certain locations of Teflon sleeving and wire bundles. Either the November 2019 or February 2021 revision of Section 9 provides an adequate level of safety. The FAA has revised the “Related Service Information under 1 CFR part 51” section of this final rule and paragraph (g) of this AD accordingly.

In addition, the FAA has revised paragraph (h) of this AD to clarify certain description headers for 28-AWL-31 and 28-AWL-32 of Section D, “Airworthiness Limitations—Systems,” including Subsections D.1, D.2, and D.3, of Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, dated February 2021, of Boeing 777 200/200LR/300/300ER/777F Maintenance Planning Data (MPD) Document. The FAA has redesigned subsequent paragraphs accordingly.

Since the SCI/AWL document has not yet been issued, the FAA disagrees to delay this final rule any further to wait for document migration. To delay this AD would be inappropriate since the FAA has determined that an unsafe condition exists and that the actions in this AD must be done to ensure continued safety. However, if an operator is unable to accomplish the actions in this AD for whatever reason, it may request approval of an AMOC under the provisions of paragraph (l)(1) of this AD. The FAA has not changed this final rule in this regard.

UAL recommended that airplanes in long-term storage be exempt from the applicable initial compliance times in the proposed AD. UAL also recommended that the airworthiness limitation instructions (ALI) tasks in the proposed AD be accomplished at the applicable initial compliance times after the airplane is returned to service. UAL stated that paragraph (g) of the proposed AD requires the initial compliance time for doing the ALI tasks at the times specified in paragraphs (g)(1) through (10) of the proposed AD. UAL also stated that paragraphs (g)(1) through (5) of the proposed AD provides the flight cycles or days in which to do the ALI tasks after the most recent inspection, and paragraph (g)(6) of the proposed AD requires doing the ALI task within 60 months after the effective date of this AD. UAL commented that due to varying circumstances, however, many of the affected airplanes are now in long-term storage.

The FAA disagrees with UAL's recommendation to provide an exemption for airplanes in long-term storage. While the FAA understands that some airplanes are currently in long-term storage due to varying circumstances, it has determined that due to the unsafe condition, the initial compliance times for doing the ALI tasks represent an adequate amount of time to accomplish the actions required in this AD. If an operator is unable to accomplish the actions in this AD for whatever reason, it may request for an approval of an AMOC under the provisions of paragraph (l)(1) of this AD. The FAA has not changed this AD in this regard.

Boeing requested removal of unqualified wire and wire sleeving types from the list of acceptable wire and wire sleeving types specified in paragraphs (h)(1) and (2) of the proposed AD. Boeing stated that it has qualified and certified wire types BMS 13-48, BMS 13-58 and BMS 13-60, and Teflon wire sleeving TFE-2X, and it has not certified the additional wire and wire sleeving types for Boeing airplanes specified in paragraphs (h)(1) and (2) of the proposed AD.

The FAA disagrees with the commenter's request. Due to the FAA's assessment of the critical design features, it has determined that additional non-Boeing alternative wire types, wire sleeves, and wire sleeving material, as specified in paragraphs (i)(1) and (2) of this AD, are acceptable. Since the issuance of AD 2008-11-13 (which is terminated by this AD), the FAA has received requests for approval of AMOCs from operators and supplemental type certificate (STC) holders (or applicants) to allow the installation of alternative wire types, wire sleeves, and wire sleeving materials. The FAA evaluated certain attributes of those alternative materials for each installation, and issued AMOC approvals for AD 2008-11-13 based on its determination that the installation of those wire types, wire sleeves, and wire sleeving materials would provide an acceptable level of safety. The FAA has not changed the AD in this regard.

AAL requested clarification of previously issued AMOCs. AAL stated that for AD 2008-11-13, it currently uses AMOC 784-17-1576 with AWL 28-AWL-AVDEC and AWL 28-AWL-16, for the installation of STC ST02532LA. AAL commented that the NPRM specifically stated that credit would not be granted for AMOCs previously approved under AD 2008-11-13, to which AMOC 784-17-1576 is applicable.

AAL also commented that the NPRM specifically references operator's incorporating alternative versions of AWL 28-AWL-11, and that the FAA determined that certain critical design features specified in the AMOC-approved versions are not acceptable to meet the intent of AWL 28-AWL-11. AAL stated that the paragraph reads as though all AMOCs associated with AD 2008-11-13 are no longer approved; however, AAL uses AMOC 784-17-1576 to install a series of gaskets that do not require a greasing component, while AWL 28-AWL-11 is associated with requirements for new wiring that penetrates the fuel tank wall.

AAL commented that AMOC 784-17-1576 does not affect AWL 28-AWL-11 or its fundamental elements, and that AMOC 784-17-1576 aligns with the incorporation of AWL 28-AWL-01 through AWL 28-AWL-20, inclusive of Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, dated November 2019, of Boeing 777-200/200LR/300/300ER/777F Maintenance Planning Data (MPD) Document.

The FAA provides the following clarification that was included in the NPRM for AMOCs previously approved for AD 2008-11-13. The FAA previously issued AMOC approvals for compliance with paragraph (g)(2) of AD 2008-11-13 to allow operators to incorporate alternative versions of AWL 28-AWL-11. For those STCs, the FAA approved alternative versions of AWL 28-AWL-11 that specified critical design features associated with STC modifications. The FAA has determined that certain critical design features specified in the AMOC-approved versions of AWL 28-AWL-11 are no longer acceptable in meeting the intent of this AWL. Therefore, this AD does not allow credit for any AMOCs previously approved under AD 2008-11-13; AMOCs approved under AD 2008-11-13 will need to be resubmitted for evaluation. If an operator is unable to accomplish the actions in this AD for whatever reason, it may request an approval of an AMOC under the provisions of paragraph (l)(1) of this AD. The FAA has not changed this AD in this regard.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA has reviewed the following service information.

• Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, dated November 2019, of Boeing 777-200/200LR/300/300ER/777F Maintenance Planning Data (MPD) Document.

• Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, dated February 2021, of Boeing 777-200/200LR/300/300ER/777F Maintenance Planning Data (MPD) Document.

This service information describes airworthiness limitations and CDCCLs tasks related to fuel tank ignition prevention, the engine fuel suction feed system, and the nitrogen generation system. These documents are distinct because the February 2021 revision of Section 9 includes updated information. 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 estimates that this AD affects 219 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

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

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

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

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

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

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

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

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model MD-11 and MD-11F airplanes. The NPRM published in the Federal Register on August 18, 2021 (86 FR 46167). The NPRM was prompted by reports indicating incidents of wires chafing against the inboard upper corner of the observer station circuit breaker panel. In the NPRM, the FAA proposed to require, depending on airplane configuration, doing a general visual inspection of the right observer station upper main circuit breaker panel and wiring for certain missing parts; doing an inspection of the right observer station upper main circuit breaker panel to determine if a certain bracket part number is installed; doing a general visual inspection of certain wire assemblies for any damage; modifying the observer station upper main circuit breaker panel; and applicable on-condition actions. The FAA is issuing this AD to address wire chafing and arcing on the panel, which could cause damage to equipment, and result in loss of electrical power and a possible in-flight fire.

The FAA received comments from The Air Line Pilots Association, International (ALPA) and Boeing who supported the NPRM without change.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Alert Service Bulletin MD11-24A204, Revision 2, dated April 14, 2021. For certain airplanes, this service information describes procedures for doing a general visual inspection of the right observer station upper main circuit breaker panel and wiring for missing installation of sleeving, grommets, and spacers; doing an inspection of the right observer station upper main circuit breaker panel to determine if bracket part number SR11240046-11 is installed; and applicable on-condition actions. On-condition actions include repairing or replacing damaged wires, installing sleeves and routing wires, trimming and re-identifying the bracket, and replacing any missing grommets or spacers.

For certain other airplanes, this service information describes procedures for doing a general visual inspection of wire assemblies ABS9110 and ABS9115 for any damage ( i.e., wire chafing, arcing), modifying the observer station upper main circuit breaker panel, and applicable on-condition actions. On-condition actions include repairing or replacing damaged wires.

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 estimates that this AD affects 118 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 actions that would be required based on the results of the inspection. The FAA has no way of determining the number of aircraft that might need these actions:

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

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

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

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

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

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

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

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

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

The FAA issued AD 2019-18-08, Amendment 39-19735 (84 FR 49944, September 24, 2019), (AD 2019-18-08), for all EA GP7270 and GP7277 model turbofan engines. AD 2019-18-08 required, for certain GP7270 and GP7277 model turbofan engines, an initial and repetitive ECI of the engine fan hub blade slot bottom and blade slot front edge for cracks. For all GP7270 and GP7277 model turbofan engines, AD 2019-18-08 also required an independent inspection of the engine fan hub assembly prior to the reassembly of the engine fan hub blade lock assembly and a visual inspection of the engine fan hub assembly for damage. For certain serial numbered GP7270 and GP7277 model turbofan engines, AD 2019-18-08 required replacement of the engine fan hub blade lock assembly with a part eligible for installation. AD 2019-18-08 resulted from the manufacturer identifying a fatigue crack originating inboard of a blade slot after the manufacturer performed a metallurgical examination of the engine fan hub that was recovered, related to an uncontained engine hub failure that occurred on September 30, 2017. After performing a risk assessment, the manufacturer determined the need to reduce the compliance time for the initial ECI and add a repetitive ECI. The FAA issued AD 2019-18-08 to detect defects, damage, and cracks that could result in an uncontained failure of the engine fan hub assembly.

Since the FAA issued AD 2019-18-08, EA has revised its Alert Service Bulletin, reducing the repetitive ECI interval from 330 cycles to 290 cycles, and adding an inner diameter UT inspection of the rim area for cracks. EA published EA Turbojet Engine Alert Service Bulletin (ASB) No. EAGP7-A72-389, Revision No. 7, dated October 8, 2021, to update the repetitive inspection interval for performing the ECIs and add UT inspections. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA is issuing this AD because the agency determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

The FAA reviewed EA Turbojet Engine ASB No. EAGP7-A72-389, Revision No. 7, dated October 8, 2021. This ASB describes procedures for performing an ECI of the engine fan hub blade slot bottom and blade slot front edge, and performing a UT inspection of the fan hub rim area for engine fan hub assemblies at the LPC module assembly level, at the piece part level, and installed in an engine (on-wing or off-wing). 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 EA Turbojet Engine ASB No. EAGP7-A72-418, Revision No. 1, dated January 11, 2019. This ASB provides guidance on replacement or modification of the engine fan hub blade lock assembly.

The FAA also reviewed the following service information:

Subtask 72-31-42-210-001-A, of Task 72-31-42-000-802-A, from the A380 Aircraft Maintenance Manual (AMM). This subtask describes procedures for performing an on-wing visual inspection after removal of the engine fan hub blade lock assembly.

Figure 405 of Task 72-00-31-420-004 of the EA GP7000 Series Engine Manual (EM). This figure and task describe procedures for performing a visual inspection after removal of the engine fan hub blade lock assembly when the engine is in the shop.

Subtask 72-00-00-210-012-A, of Task 72-00-00-210-806-A, from the A380 AMM. This subtask describes procedures for performing an on-wing visual inspection after reassembly of the engine fan hub blade lock assembly.

Task 72-00-31-420-004, Paragraph 1.E.(13), of the EA GP7000 Series EM. This task describes procedures for performing a visual inspection after reassembly of the engine fan hub blade lock assembly when the engine is in the shop.

Table 601 in Subtask 72-00-00-210-012-A of Task 72-00-00-210-806, from the A380 AMM, and Task 72-00-31-220-010 of the EA GP7000 Series EM. Table 601 and Task 72-00-31-220-010 describe acceptable damage service limits for the engine fan hub assembly.

This AD requires, for GP7270 and GP7277 model turbofan engines with engine fan hub assembly part numbers (P/Ns) 5760221, 5760321, or 5760001, initial and repetitive ECI of the engine fan hub blade slot bottom and blade slot front edge for cracks. Additionally, this AD lowers the repetitive ECI threshold, in conjunction with the added repetitive UT inspection threshold. This AD also requires initial and repetitive UT inspections of the fan hub rim area. This AD also requires an independent inspection of the engine fan hub assembly at the next disassembly and the next reassembly of the engine fan hub blade lock assembly and a visual inspection of the engine fan hub assembly for damage. This AD also requires replacement of the engine fan hub assembly with a part eligible for installation if damage is found outside serviceable limits.

For certain serial-numbered GP7270 and GP7277 model turbofan engines, this AD requires replacement of the engine fan hub blade lock assembly with a part eligible for installation.

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

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.

The FAA has found the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because no domestic operators use this product. It is unlikely that the FAA will receive any adverse comments or useful information about this AD from any U.S. operator. Accordingly, notice and opportunity for prior public comment are unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the foregoing reason(s), 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.

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-2021-1069 and Project Identifier AD-2021-00308-E” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, 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 Stephen Elwin, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

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

The FAA estimates that this AD affects 0 engines installed on airplanes of U.S. registry.

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

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.

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 by adding an AD that would apply to certain The Boeing Company Model 737-200 and -200C series airplanes. The NPRM published in the Federal Register on August 9, 2021 (86 FR 43454). The NPRM was prompted by reports of nuisance stick shaker activation while the airplane was accelerating to cruise speed at the top of a climb. Investigation revealed that the activation was caused when the AOA sensor vanes froze and malfunctioned due to insufficient heat in certain AOA sensors to prevent ice buildup. In the NPRM, the FAA proposed to require inspecting the AOA sensors for certain part numbers or vane shapes, and replacing any affected AOA sensor with a new or serviceable sensor. The FAA is issuing this AD to prevent the AOA sensor vanes from being immobilized, which could result in unreliable or inaccurate AOA sensor data being transmitted to airplane systems, and consequent loss of control of the airplane.

The FAA received a comment from the Air Line Pilots Association, International (ALPA) who supported the NPRM without change.

The FAA received an additional comment from Boeing. The following presents the comment received on the NPRM and the FAA's response.

Boeing asked that clarification be added to the Summary, Background, and Unsafe Condition sections of the proposed AD to specify that the originating AOA vane immobilization report was not on a Model 737 airplane. Boeing stated that this would clarify the service history and align the text with the language used in Boeing Alert Service Bulletin 737-27A1324, dated March 2, 2021.

The FAA agrees to provide clarification, here in the comment section instead of throughout the body of this AD. Initially, AOA vane immobilization was reported on a Model 717 airplane; the associated design issues have been addressed for that airplane model. Although no Model 737-200 airplane has experienced an in-flight incident related to the identified unsafe condition, the design of the AOA sensor vanes is similar on Model 737-200 airplanes. Therefore, the FAA has determined that this AD is necessary to address the unsafe condition on these airplanes. The FAA has not changed this final rule as a result of this comment.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Except for minor editorial changes, and any other change described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Alert Service Bulletin 737-27A1324, dated March 2, 2021. This service information specifies procedures for doing a general visual inspection of the left- and -right-side AOA sensor vane shapes, or inspecting the left and right AOA sensors, to determine the part number, and replacing any affected AOA sensor with a new or serviceable sensor. 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 estimates that this AD will affect 11 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section. The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

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. 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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, CFR part 97, (is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers or aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the typed of SIAPS, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

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. 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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CRF part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

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

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

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

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

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

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

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

When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On September 25, 2017, FDA received Cook Incorporated's request for De Novo classification of the Retrograde Intubation Set. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on December 12, 2018, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 868.5095. 1 We have named the generic type of device retrograde intubation device, and it is identified as a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 868.5090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800).

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

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

At the time of classification, retrograde intubation devices are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, if the conditions of 21 CFR 801.109 are met.

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

While this final order contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this final order. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 868 is amended as follows:

GSA published a proposed rule in the Federal Register on June 15, 2021 (86 FR 31659). The rule proposed to amend the FTR sections pertaining to eligibility for WTA and RITA in accordance with statutory changes to 5 U.S.C. 5724b, update relevant FTR part 302-3 tables to include RITA as a mandatory allowance that agencies must pay or reimburse, and adjust the relocation tables for certain mandatory and discretionary relocation entitlements depending on the individual's type of movement.

The public had 60 calendar days to comment on the proposed rule. GSA received no comments opposing the amendment and one comment supporting its adoption. GSA did not make any changes to this final rule based on the supporting comment.

Federal agencies authorize relocation entitlements to those listed at FTR § 302-1.1 and those assigned under the Government Employees Training Act (GETA) (5 U.S.C. Chapter 41).

Public Law (Pub. L.) 115-97, known as the “Tax Cuts and Jobs Act of 2017,” suspended qualified moving expense deductions along with the exclusion for employer reimbursements and payments of moving expenses effective January 1, 2018, for tax years 2018 through 2025, therefore making almost all relocation entitlements subject to additional tax liability.

Agencies are authorized to pay WTA and RITA to cover “substantially all” of the increased tax liability resulting from receipt of the relocation expense reimbursements either paid directly or indirectly. However, in the version of 5 U.S.C. 5724b immediately preceding the passage of Section 1114 of the “National Defense Authorization Act for Fiscal Year 2020” (Pub. L. 116-92) (“the Act”), WTA and RITA were available only to employees “transferred” in the interest of the Government from one official station or agency to another for permanent duty.

Previously, new appointees (including political appointees), Senior Executive Service (SES) employees performing a “last move home”, employees returning from an overseas assignment for the purpose of separating from Government service, and those assigned under GETA were not eligible for WTA and RITA as such individuals were not “transferred” in the interest of the Government from one official station or agency to another for permanent duty. The suspension of qualified moving expense deductions in Public Law 115-97 substantially increased the tax liability of these individuals, which could not be reimbursed through WTA or RITA.

Section 1114 of the Act amended 5 U.S.C. 5724b to expand eligibility for WTA and RITA beyond “transferred” employees to include all individuals whose travel, transportation, or relocation expenses are reimbursed or furnished in kind pursuant to chapter 57, subchapter II or chapter 41, both of title 5, U.S.C. These individuals include, among others, those not previously eligible for WTA and RITA, e.g., new appointees (including political appointees), employees returning from an overseas assignment for the purpose of separation from Government service, SES employees eligible for “last move home” entitlements, and those assigned under GETA. The Act also includes a retroactive effective date to January 1, 2018, to allow those individuals who received taxable travel, transportation, or relocation allowances since January 1, 2018, to now submit a RITA claim for the additional tax liability.

Of note, 5 U.S.C. 5724b(b) contained an apparent typographical error as shown here in bold: “For purposes of this section, the term `travel, transportation, or relocation expenses' means all travel, transportation, or relocation expenses reimbursed or furnished in kind pursuant to this subchapter of chapter 41.” (emphasis added). A literal implementation of the text would have rendered this statutory provision meaningless because “this subchapter of chapter 41” does not exist. Accordingly, GSA developed a legislative proposal to correct the typographical error. Until the statutory amendment was made, GSA implemented 5 U.S.C. 5724b(b) as if it read “. . . pursuant to this subchapter or chapter 41.” (emphasis added). GSA's decision was based on conversations with Congress, and aimed at avoiding a literal interpretation of the statute which would have produced an absurd result that is demonstrably at odds with Congressional intent. GSA's legislative proposal resulted in section 1121 of the “William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021” (Pub. L. 116-283) which amended 5 U.S.C. 5724b(b) to correct the typographical error. The amendments made to 5724b(b) by section 1121 are retroactively effective as if included in the enactment of section 1114 of the Act.

Pursuant to 5 U.S.C. 5738, the Administrator of General Services is mandated to prescribe necessary regulations regarding Federal employees who relocate in the interest of the Government. The overall implementing authority is the FTR, codified in title 41 of the Code of Federal Regulations, chapters 300 through 304 (41 CFR chapters 300 through 304).

This final rule amends FTR sections pertaining to eligibility for WTA and RITA in accordance with statutory changes to 5 U.S.C. 5724b. Specifically, this amendment updates relevant tables in FTR Part 302-3 to include RITA as a mandatory allowance that agencies must pay or reimburse.

This final rule also adjusts the relocation tables at §§ 302-3.2 and 302-3.101 to update certain mandatory and discretionary relocation entitlements depending on the individual's type of movement. Updates to the tables include, but are not limited to, adding use of a relocation services company, home marketing incentives, and temporary quarters subsistence expense (TQSE) as discretionary allowances to, from, or between non-foreign areas. The tables are also updated to remove home marketing incentives for new appointees who are not entitled to real estate expenses.

Additionally, this final rule indicates, as relevant, where allowances are intended to apply more broadly to other relocating individuals ( e.g., appointments, reassignments, separations, and last move(s) home), in addition to transferred employees.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives, and if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, is not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.

Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (codified at 5 U.S.C. 801-808), also known as the Congressional Review Act or CRA, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The Office of Information and Regulatory Affairs (OIRA) has determined that this rule is not a major rule under 5 U.S.C. 804(2), therefore, GSA did not submit a rule report.

GSA does not expect this final rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because it applies only to Federal agencies and employees and it affects less than one percent of all relocations authorized under FTR part 302. The administrative changes to the FTR provide further clarification on existing statutory changes with no additional impact to agencies.

Therefore, an Initial Regulatory Flexibility Analysis has not been performed. GSA invites comments from small business concerns and other interested parties on the expected impact of this final rule on small entities.

GSA will also consider comments from small entities concerning the existing regulations in subparts affected by the final rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FTR Case 2020-302-1), in correspondence.

The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget (OMB) under 44 U.S.C. 3501, et seq.

Therefore, GSA amends 41 CFR parts 300-3, 302-2, 302-3, 302-12, 302-15, and 302-17 as set forth below: