On March 18, 2020 (85 FR 15347), the NRC published a direct final rule amending part 34 of title 10 of the Code of Federal Regulations (10 CFR), “Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations”; 10 CFR part 36, “Licenses and Radiation Safety Requirements for Irradiators”; and 10 CFR part 39, “Licenses and Radiation Safety Requirements for Well Logging,” to authorize the use of modern personnel dosimeters. The amendments align personnel dosimetry requirements in these areas with the requirements for all other NRC licensees.

The NRC also issued supplemental guidance (ADAMS package Accession No. ML19360A184) in conjunction with the direct final rule. The existing guidance for 10 CFR parts 34, 36, and 39 is provided in NUREG-1556, “Consolidated Guidance About Materials Licenses,” in the volumes for industrial radiography (Volume 2), irradiators (Volume 6), and well logging (Volume 14). The supplemental guidance documents are in a markup format to these NUREG-1556 volumes and reflect the provisions in the direct final rule. The NRC intends to incorporate this supplemental guidance into the next comprehensive revision of NUREG-1556. Beginning on June 16, 2020, licensees may use the supplemental guidance to comply with the provisions in the direct final rule.

In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on June 16, 2020. As described more fully in the direct final rule, 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.

The NRC received one comment from the public, which agreed with the proposed changes to the regulations. Because no significant adverse comments were received, the direct final rule will become effective as scheduled.

On April 3, 2020 (85 FR 18857), the NRC published a direct final rule amending its regulations in part 72 of title 10 of the Code of Federal Regulations by revising the TN Americas LLC NUHOMS® EOS Dry Spent Fuel Storage System listing within the “List of approved spent fuel storage casks” to include Amendment No. 1 to Certificate of Compliance No. 1042. Amendment No. 1 makes the following changes: Adds a new basket type (Type 4) to allow for the loading of intact, damaged, or failed fuel; adds another new basket type (Type 5); accepts fuel assemblies with a minimum two-year cooling time, in selected locations within the basket; and adds the NUHOMS® MATRIX design as an alternative to the EOS horizontal storage module design for the storage of spent fuel. Amendment No. 1 also makes other additional revisions to the certificate of compliance and the technical specifications for consistency and clarity.

In the direct final rule published on April 3, 2020, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on June 17, 2020. The NRC received and docketed two comments on the companion proposed rule (85 FR 18876; April 3, 2020). Electronic copies of these comments can be obtained from the Federal Rulemaking website https://www.regulations.gov under Docket ID NRC-2019-0224, and are also available in ADAMS under Accession Nos. ML20118C707 and ML20126G364.

The NRC evaluated the comments against the criteria described in the direct final rule and determined that they were not significant and adverse. Specifically, the comments were outside the scope of this rulemaking, did not oppose the rule, or did not propose a change to the rule, such that the rule would be ineffective or unacceptable without incorporation of the change. Therefore, the direct final rule will become effective as scheduled.

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

On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act or the Act) (Pub. L. 116-136) to provide emergency assistance and health care response for individuals, families, and businesses affected by the coronavirus pandemic. The Small Business Administration (SBA) received funding and authority through the Act to modify existing loan programs and establish a new loan program to assist small businesses nationwide adversely impacted by the COVID-19 emergency.

Section 1102 of the Act temporarily permits SBA to guarantee 100 percent of 7(a) loans under a new program titled the “Paycheck Protection Program.” Section 1106 of the Act provides for forgiveness of up to the full principal amount of qualifying loans guaranteed under the Paycheck Protection Program. A more detailed discussion of sections 1102 and 1106 of the Act is found in section III below.

On April 24, 2020, the President signed the Paycheck Protection Program and Health Care Enhancement Act (Pub. L. 116-139), which provided additional funding and authority for the PPP. On June 5, 2020, the President signed the Paycheck Protection Program Flexibility Act of 2020 (Flexibility Act) (Pub. L. 116-142), which changes key provisions of the Paycheck Protection Program, including provisions relating to the maturity of PPP loans, the deferral of PPP loan payments, and the forgiveness of PPP loans. Section 3(d) of the Flexibility Act provides that the amendments relating to PPP loan forgiveness and extension of the deferral period for PPP loans shall be effective as if included in the CARES Act, which means that they are retroactive to March 27, 2020. Section 2 of the Flexibility Act provides that the amendment relating to the extension of the maturity date for PPP loans shall take effect on the date of enactment (June 5, 2020). Under the Flexibility Act, the extension of the maturity date for PPP loans is applicable to PPP loans made on or after that date, and lenders and borrowers may mutually agree to modify PPP loans made before such date to reflect the longer maturity.

This interim final rule is effective without advance notice and public comment because section 1114 of the CARES Act authorizes SBA to issue regulations to implement Title I of the Act without regard to notice requirements. In addition, SBA has determined that there is good cause for dispensing with advance public notice and comment on the grounds that that it would be contrary to the public interest. Specifically, advance public notice and comment would defeat the purpose of this interim final rule given that SBA's authority to guarantee PPP loans expires on June 30, 2020, and that many PPP borrowers can now apply for loan forgiveness following the end of their eight-week covered period. Providing borrowers and lenders with certainty on both loan requirements and loan forgiveness requirements following the enactment of the Flexibility Act will enhance the ability of lenders to make loans and process loan forgiveness applications, particularly in light of the fact that most of the Flexibility Act's provisions are retroactive to March 27, 2020. Specifically, small businesses that have yet to apply for and receive a PPP loan need to be informed of the terms of PPP loans as soon as possible, because the last day on which a lender can obtain an SBA loan number for a PPP loan is June 30, 2020. Borrowers who already have applied for and received a PPP loan need certainty regarding how loan proceeds must be used during the covered period, as amended by the Flexibility Act, so that they can maximize the amount of loan forgiveness. These same reasons provide good cause for SBA to dispense with the 30-day delayed effective date provided in the Administrative Procedure Act. Although this interim final rule is effective on or before date of filing, comments are solicited from interested members of the public on all aspects of the interim final rule, including section III below. These comments must be submitted on or before July 16, 2020. The SBA will consider these comments, comments received on the interim final rule posted on SBA's website April 2, 2020 (the First Interim Final Rule) and published in the Federal Register on April 15, 2020, and the need for making any revisions as a result of these comments.

The CARES Act was enacted to provide immediate assistance to individuals, families, and businesses affected by the COVID-19 emergency. Among the provisions contained in the CARES Act are provisions authorizing SBA to temporarily guarantee loans under a new 7(a) loan program titled the “Paycheck Protection Program.” Loans guaranteed under the Paycheck Protection Program (PPP) will be 100 percent guaranteed by SBA, and the full principal amount of the loans may qualify for loan forgiveness. The Flexibility Act amends the CARES Act and amends provisions relating to loan terms and loan forgiveness. The purpose of this interim final rule is to make changes to the First Interim Final Rule, posted on SBA's website on April 2, 2020, and published in the Federal Register on April 15, 2020 (85 FR 20811). The First Interim Final Rule, as amended by this interim final rule, should be interpreted consistent with the frequently asked questions (FAQs) regarding the PPP that are posted on SBA's website  1 and the other interim final rules issued regarding the PPP. 2

Section 3(a) of the Flexibility Act amended the definition of “covered period” for a PPP loan from “the period beginning on February 15, 2020 and ending on June 30, 2020” to “the period beginning on February 15, 2020 and ending on December 31, 2020.” Therefore, Part III.2.g.iii. of the First Interim Final Rule (85 FR 20811, 20813) is revised by striking “June 30, 2020” and replacing it with “December 31, 2020”. Section 3(d) of the Flexibility Act provides that this amendment shall be effective as if included in the CARES Act, which was signed into law on March 27, 2020.

This amendment by the Flexibility Act applies to the definition of “covered period” that appears in section 1102 of the CARES Act, governing loan use, loan eligibility, and related requirements. It does not alter the meaning of “covered period” that appears in section 1106 of the CARES Act governing loan forgiveness, which is addressed by a different provision of the Flexibility Act.

Section 2(a) of the Flexibility Act amended the CARES Act to provide a minimum maturity of five years for all PPP loans made on or after the date of enactment of the Flexibility Act. Therefore, Part III.2.j. of the First Interim Final Rule (85 FR 20811, 20813) is revised to read as follows:

j. What will be the maturity date on a PPP loan?

For loans made before June 5, 2020, the maturity is two years; however, borrowers and lenders may mutually agree to extend the maturity of such loans to five years. For loans made on or after June 5, the maturity is five years.

Section 2 of the Paycheck Protection Program Flexibility Act of 2020 (Flexibility Act) amended the CARES Act to provide a minimum maturity of 5 years for all PPP loans made on or after its enactment. The Administrator, in consultation with the Secretary, determined that the date SBA assigns a loan number to the PPP loan provides an efficient, transparent, and auditable means of determining when a PPP loan is “made” that provides certainty to lenders. While the CARES Act provides that a loan will have a maximum maturity of up to ten years from the date the borrower applies for loan forgiveness, the Administrator, in consultation with the Secretary, determined that a five-year loan term is sufficient in light of the temporary economic dislocations caused by the coronavirus. Specifically, the considerable economic disruption caused by the coronavirus is expected to abate well before the five-year maturity date such that borrowers will be able to resume business operations and pay off any outstanding balances on their PPP loans.

Section 3(c) of the Flexibility Act extended the deferral period on PPP loans. Therefore, Part III.2.n. of the First Interim Final Rule (85 FR 20811, 20813) is revised to read as follows:

n. When will I have to begin paying principal and interest on my PPP loan?

If you submit to your lender a loan forgiveness application within 10 months after the end of your loan forgiveness covered period, you will not have to make any payments of principal or interest on your loan before the date on which SBA remits the loan forgiveness amount on your loan to your lender (or notifies your lender that no loan forgiveness is allowed).

Your “loan forgiveness covered period” is the 24-week period beginning on the date your PPP loan is disbursed; however, if your PPP loan was made before June 5, 2020, you may elect to have your loan forgiveness covered period be the eight-week period beginning on the date your PPP loan was disbursed. 3 Your lender must notify you of remittance by SBA of the loan forgiveness amount (or notify you that SBA determined that no loan forgiveness is allowed) and the date your first payment is due. Interest continues to accrue during the deferment period.

If you do not submit to your lender a loan forgiveness application within 10 months after the end of your loan forgiveness covered period, you must begin paying principal and interest after that period. For example, if a borrower's PPP loan is disbursed on June 25, 2020, the 24-week period ends on December 10, 2020. If the borrower does not submit a loan forgiveness application to its lender by October 10, 2021, the borrower must begin making payments on or after October 10, 2021.

Section 3(b) of the Flexibility Act amended the requirements concerning forgiveness of PPP loans to reduce the amount of PPP loan proceeds that must be used for payroll costs in order to be forgivable, and the law also created a new exemption for borrowers to avoid a reduction in loan forgiveness amount when they have a reduction in full-time equivalent employees. While the Flexibility Act provides that a borrower shall use at least 60 percent of the PPP loan for payroll costs to receive loan forgiveness, the Administrator, in consultation with the Secretary, interprets this requirement as a proportional limit on nonpayroll costs as a share of the borrower's loan forgiveness amount, rather than as a threshold for receiving any loan forgiveness. This interpretation is consistent with the new safe harbor in the Flexibility Act. The new safe harbor provides that if a borrower is unable to rehire previously employed individuals or similarly qualified employees, the borrower will not have its loan forgiveness amount reduced based on the reduction in full-time equivalent employees. It would be incongruous to interpret the Flexibility Act's 60 percent requirement as a threshold for receiving any loan forgiveness, because in some cases it would directly conflict with the flexibility provided by the new safe harbor. Further, the 60 percent requirement in the Flexibility Act was enacted against the backdrop of SBA's existing rules governing the PPP, which Congress was aware of and which provided for proportional reductions in loan forgiveness for borrowers that used less than 75% of their loan amount during the eight-week covered period for payroll costs. In addition, this interpretation of the 60 percent requirement under the Flexibility Act is most consistent with Congress's purpose in that legislation—namely, to increase the flexibility provided to borrowers related to PPP loan forgiveness.

In addition, as noted in paragraph d. above, in seeking loan forgiveness, an eligible borrower whose loan was made before June 5, 2020 may elect to apply the original eight-week covered period under the CARES Act instead of the 24-week covered period referenced above. See Flexibility Act, section 3(b)(3).

SBA will be issuing revisions to its interim final rules on loan forgiveness and loan review procedures to address amendments the Flexibility Act made to the loan forgiveness requirements. SBA will also be issuing additional guidance on advance purchases of PPP loans, which will include any effect of the amendments made to the loan forgiveness requirements. For the reasons described above, Part III.2.o. of the First Interim Final Rule (85 FR 20811, 20813) is revised to read as follows:

o. Can my PPP loan be forgiven in whole or in part?

Yes. The amount of loan forgiveness can be up to the full principal amount of the loan and any accrued interest. An eligible borrower will not be responsible for any loan payment if the borrower uses all of the loan proceeds for forgivable purposes as described below and employee and compensation levels are maintained or, if not, an applicable safe harbor applies. The actual amount of loan forgiveness will depend, in part, on the total amount of payroll costs, payments of interest on mortgage obligations incurred before February 15, 2020, rent payments on leases dated before February 15, 2020, and utility payments for service that began before February 15, 2020, over the loan forgiveness covered period. However, to receive full loan forgiveness, a borrower must use at least 60 percent of the PPP loan for payroll costs, and not more than 40 percent of the loan forgiveness amount may be attributable to nonpayroll costs. For example, if a borrower uses 59 percent of its PPP loan for payroll costs, it will not receive the full amount of loan forgiveness it might otherwise be eligible to receive. Instead, the borrower will receive partial loan forgiveness, based on the requirement that 60 percent of the forgiveness amount must be attributable to payroll costs. For example, if a borrower receives a $100,000 PPP loan, and during the covered period the borrower spends $54,000 (or 54 percent) of its loan on payroll costs, then because the borrower used less than 60 percent of its loan on payroll costs, the maximum amount of loan forgiveness the borrower may receive is $90,000 (with $54,000 in payroll costs constituting 60 percent of the forgiveness amount and $36,000 in nonpayroll costs constituting 40 percent of the forgiveness amount).

For consistency with the amendments made in the Flexibility Act regarding the percentage of loan proceeds that must be used for payroll costs in order to be forgiven, discussed in paragraph 2.e. above, Part III.2.r. of the First Interim Final Rule (85 FR 20811, 20814) is revised to read as follows:

r. How can PPP loans be used?

The proceeds of a PPP loan are to be used for:

i. payroll costs (as defined in the Act and in 2.f.);

ii. costs related to the continuation of group health care benefits during periods of paid sick, medical, or family leave, and insurance premiums;

iii. mortgage interest payments (but not mortgage prepayments or principal payments);

iv. rent payments;

v. utility payments;

vi. interest payments on any other debt obligations that were incurred before February 15, 2020; and/or

vii. refinancing an SBA EIDL loan made between January 31, 2020 and April 3, 2020. If you received an SBA EIDL loan from January 31, 2020 through April 3, 2020, you can apply for a PPP loan. If your EIDL loan was not used for payroll costs, it does not affect your eligibility for a PPP loan. If your EIDL loan was used for payroll costs, your PPP loan must be used to refinance your EIDL loan. Proceeds from any advance up to $10,000 on the EIDL loan will be deducted from the loan forgiveness amount on the PPP loan.

At least 60 percent of the PPP loan proceeds shall be used for payroll costs. For purposes of determining the percentage of use of proceeds for payroll costs, the amount of any EIDL refinanced will be included. For purposes of loan forgiveness, however, the borrower will have to document the proceeds used for payroll costs in order to determine the amount of forgiveness. While the Act provides that PPP loan proceeds may be used for the purposes listed above and for other allowable uses described in section 7(a) of the Small Business Act (15 U.S.C. 636(a)), the Administrator believes that finite appropriations and the structure of the Act warrant a requirement that borrowers use a substantial portion of the loan proceeds for payroll costs, consistent with Congress' overarching goal of keeping workers paid and employed. This percentage is consistent with the limitation on the forgiveness amount set forth in the Flexibility Act. This limitation on use of the loan funds will help to ensure that the finite appropriations available for these loans are directed toward payroll protection, as each loan that is issued depletes the appropriation, regardless of whether portions of the loan are later forgiven.

For consistency with the changes discussed in paragraphs 2.e. and f. above, Parts III.2.t.iii., iv., and v. of the First Interim Final Rule (85 FR 20811, 20814) are revised to read as follows:

t. What certifications need to be made?

The FAA issued AD 2011-20-01, Amendment 39-16810 (76 FR 59240, September 26, 2011) (“AD 2011-20-01”), for certain serial-numbered Empresa Brasileira de Aeronáutica S.A. (now Embraer S.A.) Model EMB-505 airplanes. AD 2011-20-01 required replacing the bolts that attach the balance mass weights to the elevator structure. AD 2011-20-01 resulted from a determination that there was a possibility of freeplay between the mass-balance weight and the elevator structure. AD 2011-20-01 was prompted by MCAI issued by the Agência Nacional de Aviação Civil (ANAC), which is the aviation authority for Brazil. The FAA issued AD 2011-20-01 to address this condition which, if not corrected, could lead to elevator flutter and loss of airplane control.

Since the FAA issued AD 2011-20-01, there have been reports of corrosion in the mass-balance weights of the flight control surfaces. The FAA has determined that new airworthiness limitations are necessary for all Embraer S.A. Model EMB-505 airplanes.

The ANAC has issued Brazilian Emergency AD No. 2020-01-01, dated January 9, 2020 (referred to after this as “the MCAI”), to address the unsafe condition on all Embraer S.A. Model EMB-505 airplanes. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-0466.

The FAA reviewed Embraer Alert Service Bulletin SB505-55-A004, Revision 5, dated December 12, 2019. The service information applies to certain serial-numbered Model EMB-505 airplanes and contains procedures for inspecting the mass-balance weights of the elevators, ailerons, and rudders (flight control surfaces) and their respective attachment parts for corrosion and fragmentation, and corrective actions. Corrective actions include installation of a stainless steel mass-balance, replacement of the mass-balance, and replacement of attachment parts. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Embraer has issued Embraer Alert Service Bulletin SB505-55-A004, Revision 2, dated November 6, 2019; Embraer Alert Service Bulletin SB505-55-A004, Revision 3, dated November 13, 2019; Embraer Alert Service Bulletin SB505-55-A004, Revision 4, dated November 21, 2019. The actions specified in these service bulletins are the same as those specified in Embraer Alert Service Bulletin SB505-55-A004, Revision 5, dated December 12, 2019; however, revision 5 was issued to add serial-numbered airplanes to the applicability.

This product has been approved by the aviation authority of Brazil, and is approved for operation in the United States. Pursuant to our bilateral agreement with Brazil, it has notified the FAA of the unsafe condition described in the MCAI and service information referenced above. The FAA is issuing this AD because the agency evaluated all the relevant information provided by ANAC and determined the unsafe condition described previously exists and is likely to exist or develop in other products of the same type design.

For certain serial-numbered airplanes, this AD requires accomplishing the actions specified in the service information described previously, except as specified in “Differences Between this AD and the Service Information.” This AD also requires sending certain inspection results to Embraer. For all Model EMB-505 airplanes, this AD requires revising the airworthiness limitations section of the existing maintenance manual or instructions for continued airworthiness to incorporate new airworthiness limitations.

Compliance with the airworthiness limitations section is required by 14 CFR 91.403(c). If an airplane has been previously modified, altered, or repaired in the areas addressed by this AD, and an operator is unable to accomplish the actions described in the revisions to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance using the procedures in paragraph (n)(1) of this AD.

Embraer Alert Service Bulletin SB505-55-A004, Revision 5, dated December 12, 2019, contains procedures for inspecting for the integrity of the mass-balance weights of the elevators, ailerons, and rudder (flight control surfaces) and their attachment parts. This AD does not include that requirement.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because of reports of corrosion in the mass-balance weights of the flight control surfaces, which may lead to loss of mass or the detachment of the mass-balance weights, resulting in an unbalanced control surface, which, could lead to flutter and possible loss of airplane control. Additionally, the compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, the FAA finds that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and the FAA did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2020-0466 and project identifier MCAI-2020-00504-A at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

The FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this final rule.

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 the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 376 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 installations or replacements 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:

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

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

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

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

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

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

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

(2) Will not affect intrastate aviation in Alaska.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

Discussion

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2019-24, dated July 5, 2019 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model BD-100-1A10 airplanes. You may examine the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-1081.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model BD-100-1A10 airplanes. The NPRM published in the Federal Register on January 27, 2020 (85 FR 4614). The NPRM was prompted by reports of the loss of all air data system information provided to the flightcrew, which was caused by icing at high altitudes. The NPRM proposed to require revising the existing airplane flight manual (AFM) to provide the flightcrew with procedures to stabilize the airplane's airspeed and attitude. The FAA is issuing this AD to address the loss of all air data system information provided to the flightcrew. If not addressed, this condition may adversely affect continued safe flight and landing. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. Two commenters indicated support for the NPRM. The following presents the comments received on the NPRM and the FAA's response to each comment.

NetJets Inc. requested it be allowed to use Bombardier Challenger 350 Airplane Flight Manual (AFM), Publication No. CH 350 AFM, Revision 24, dated January 15, 2020, for accomplishing the proposed actions. The proposed AD referred to Revision 22, dated July 8, 2019.

The FAA acknowledges the commenter's request and provides the following clarification: This AD requires including the information that is provided in the referenced AFM revisions in paragraph (g) of this AD. The language in paragraph (g) of this AD is designed to allow incorporating the specific information, regardless of the revision level of the AFM in use, provided the language is identical to the referenced AFM revisions specified in paragraph (g) of this AD. The language in the latest AFM revisions is the same. We have not changed this AD in this regard.

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

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

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

Bombardier has issued the following service information, which provides a procedure for “Unreliable Airspeed” in the Emergency Procedures section, and also provides a procedure for “Go-Around” in the Normal Procedures section of the applicable AFM. These documents are distinct since they apply to different airplane models.

• Bombardier Challenger 300 AFM, Publication No. CSP 100-1, Revision 56, dated July 8, 2019.

• Bombardier Challenger 350 AFM, Publication No. CH 350 AFM, Revision 22, dated July 8, 2019.

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

The FAA estimates that this AD affects 560 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

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

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

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

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

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

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

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

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Gold Beach Municipal Airport, Gold Beach, OR, to ensure the safety and management of Instrument Flight Rules (IFR) operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (85 FR 17791; March 31, 2020) for Docket No. FAA-2020-0234 to establish Class E airspace at Gold Beach Municipal Airport, Gold Beach, OR. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E5 airspace designations are published in paragraph 6005 of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet or more above the surface at the Gold Beach Municipal Airport, Gold Beach, OR. The airspace supports the airport's transition from VFR to IFR operations.

The first airspace area extends upward from 700 feet above the surface within a 6.3-mile radius to the airport, and within 1 mile each side of the 325° bearing from the airport, extending from the 6.3-mile radius to 9.3 miles northwest of the airport.

The second airspace area extends upward from 1,200 feet above the surface within a 15-mile radius of the Gold Beach Municipal Airport, excluding that airspace that extends beyond 12 miles from the coast.

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

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

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

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

Section 101(a)(27)(D) of the Immigration and Nationality Act (INA), 8 U.S.C. 1101(a)(27)(D), authorizes the granting of special immigrant status in exceptional circumstances for employees, or honorably retired former employees, of the U.S. government abroad, or of the American Institute in Taiwan, who have performed faithful service for a total of fifteen years or more, in addition to their accompanying spouse and children. For special immigration status to be granted, this provision requires that the principal officer of a Foreign Service establishment recommend granting of special immigrant status in an exercise of discretion to aliens in exceptional circumstances. The statute provides that the Secretary of State may choose to approve such a recommendation after finding that it is in the national interest to grant such status, for the status to be conferred. Upon notification that the Secretary of State, or designee, has approved a recommendation and found that granting special immigrant status is in the national interest, the applicant must submit a completed Form DS-1884, Petition to Classify Special Immigrant Under INA 203(b)(4) as an Employee or Former Employee of the U.S. Government Abroad, to the Department of State (“Department”) within one year. Once the DS-1884 is submitted and approved, the employee must submit an immigrant visa application, which a consular officer adjudicates in accordance with relevant provisions in the INA. If the consular officer approves the visa application and issues the visa, the applicant then has six months to immigrate to the United States. To avoid potential confusion, the Department emphasizes that this regulation affects only the granting of special immigrant status to long term employees of the U.S. government abroad under INA section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(D); this regulation does not affect the granting of special immigrant status under any of the authorities for special immigrant status, including any of the other provisions in INA section 101(a)(27), 8 U.S.C. 1101(a)(27), or those specific to nationals of Iraq and Afghanistan.

This rule codifies the circumstances that will be considered “exceptional” for purposes of assessing special immigrant status qualification. The scope of “exceptional circumstances” set out in this rule departs, in certain respects, from the Department's policies that preceded this rule, which were articulated only in the Foreign Affairs Manual (FAM), specifically 9 FAM 502.5-3(C)(2)(d), not in the CFR. Specifically, the excluded criteria, formerly in 9 FAM 502.5-3(C)(2)(d)(3)(c)(ii)-(vi), that will no longer constitute exceptional circumstances, are: Recognition with multiple individual awards; high visibility in a sensitive position; control over key aspects of the operations or overall functioning of a Foreign Service post; valuable services and assistance to the U.S. community at post apart from performance of official duties; and faithful service in a country foreign to the employee that resulted in the employee losing economic and social ties to his or her home country. The regulation also adds two new criteria that will constitute exceptional circumstances moving forward, specifically: Recognition with a “Foreign Service National of the Year” award; and disclosure of waste, fraud, abuse, or other issues that result in significant action against an offending party. The FAM will be revised in accordance with this rule on the effective date of this rule.

The rule also makes several technical and organizational edits to 22 CFR 42.32. This rule moves relevant portions of 22 CFR 42.32(d)(2) on special immigrant status (specific to INA section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(d)) into a new section, 22 CFR 42.34; and 22 CFR 42.32(d)(2) is amended to include a cross reference to 22 CFR 42.34. The new 22 CFR 42.34 expands upon the application process and the qualifications for special immigrant status, and more clearly organizes these topics.

This rule also eliminates 22 CFR 42.32(d)(2)(ii), Special immigrant status for certain aliens employed at the United States mission in Hong Kong, because the window to apply for special immigrant status under this section closed on January 1, 2002. The remaining provisions of 22 CFR 42.32(d)(2), including 22 CFR 42.32(d)(2)(i) and 22 CFR 42.32(d)(2)(iii)-(vi), are revised and moved to 22 CFR 42.34 and consolidated with current guidance drawn from 9 FAM 502.5-3. Sections 42.32(d)(2)(i)(A) and (C) are moved to section 42.34(b), and the Department has revised the description of accompanying or following-to-join spouses and children to more precisely align with INA section 203(d), 8 U.S.C. 1153(d). The description of following-to-join spouses and children that is being superseded by this rule had stated they were “entitled to a derivative status corresponding to the classification and priority date of the beneficiary of the petition.” This language has been amended to remove reference to “derivative status” to more accurately reflect INA section 203(d), 8 U.S.C. 1153(d), which states that such spouses and children if not otherwise entitled to an immigrant status and the immediate issuance of a visa, are entitled to the same classification and priority date of the beneficiary of the petition. Text formerly in section 42.32(d)(2)(i)(B) is now consolidated with the definition of “qualifying full-time service” in section 42.34(c)(1).

In the definitions section, the rule clarifies what is meant by fulfilling 15 years of qualifying full-time service, explaining that it can be achieved in a number of ways. For example, working full-time for 10 years and half-time for at least 10 more would qualify the employee for consideration.

The rule also codifies a definition of “faithful service,” which is a statutory requirement for special immigrant status under INA section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(D). This definition reflects longstanding Department practice and guidance on what constitutes “faithful service,” and the responsibility of the principal officer to determine that the alien's service has been faithful. Department guidance that preceded this rule, and will continue, instructs principal officers at foreign service post to consider employees' disciplinary records and other similar factors in making this assessment.

The Department has also incorporated into the regulation, with some changes, guidance at 9 FAM 502.5-3(C)(2)(d)(3)(a)(iii) since March 27, 2019, explaining that “exceptional circumstances” includes situations where the United States and the host country have strained relations and the employee may be subjected to persecution or pressure to divulge information. Because the term “persecution,” as defined in certain other U.S. legal contexts, does not accurately reflect the Department's policy relative to finding exceptional circumstances for this special immigrant status, the regulation adopts a standard of “retribution,” to more accurately reflect the Department's policy and practice in this area. The Department does not anticipate this change in terminology will affect the application of this exceptional circumstance provision, because the Department, for the purposes of this provision, has historically considered conduct to be “persecution” within the meaning of the FAM guidance, as amended, despite not necessarily meeting the elements of “persecution” as defined in other contexts, such as in the asylum context, and as informed by the Board of Immigration Appeals and opinions by the Attorney General. Since the inception of this program, as a matter of policy, the Department has viewed 20 or more years of faithful service as prima facie evidence of “exceptional circumstances,” because the employee has devoted such a large portion of his or her career to the U.S. government. This rule retains that understanding.

Section 42.32(d)(2)(iii) is now § 42.34(b)(2). The last sentence from 22 CFR 42.32(d)(2)(iv), stating “In cases described in § 42.33(d)(2)(ii), the validity of the petition shall not in any case extend beyond January 1, 2002” is not included in this rule, because it no longer applies.

This rule makes technical, but non-substantive changes to the text previously in § 42.32(d)(2)(v), and now in § 42.32(b)(5). First, the rule adds “or designee's” after “Secretary of State,” and removes the “'s” after “Secretary of State.” This rule also re-phrases the former reference to the Secretary of State's “approval of special immigrant status” to “approval of the principal officer's recommendation” for consistency with other references in this rule. Additional reorganization includes moving § 42.32(d)(2)(iv) to § 42.34(b)(4); § 42.32(d)(2)(vi) to § 42.34(b)(1); and § 42.32(d)(2)(vii) to § 42.34(b)(3).

Pursuant to INA section 104(a), 8 U.S.C. 1104(a), the Secretary of State may establish regulations necessary for the administration of the INA. INA section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(D), provides for the granting of special immigrant status in exceptional circumstances to immigrants who are employees, or honorably retired former employees, of the U.S. government abroad, or of the American Institute in Taiwan, and who have performed faithful service for at least 15 years, as well as their accompanying spouse and children. Further, INA section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(D), provides that the Secretary of State must approve each recommendation and find that it is in the national interest to grant special immigrant status. INA section 203(b)(4), 8 U.S.C. 1153(b)(4), allocates visas to be made available to qualified special immigrants each fiscal year.

Until now, Department regulations have not addressed the criteria used by the Department in implementing statutory eligibility standards for special immigrant status. Certain criteria that were included in Volume 9 of the FAM were subjective or otherwise led to inconsistency in recommendations submitted by different overseas posts. This likely resulted in uncertainty for special immigrant status applicants and, potentially, inconsistent results for similarly situated applicants. The Department is revising the eligibility criteria to exclude the most subjective of criteria and adding new objective bases for establishing exceptional circumstances. The Department aims to promote consistency in adjudications of applications for special immigrant status. Codifying these objective criteria is intended to increase the likelihood that similar service is rewarded similarly around the world and increase the fairness and integrity of the special immigrant status process through more consistent application of the law. These transparent standards will aid the U.S. government abroad in recruiting and retaining loyal and committed foreign nationals.

There is a six-month delay in the effective date of this rule for the Department to continue the orderly adjudication of cases that are ready or nearly ready for consideration by the principal officer or the Secretary, or designee. The new standards will apply to all recommendations from the principal officer of a Foreign Service establishment submitted to the Department for consideration by the Secretary of State, or designee, on or after the effective date. The Department considers a recommendation to be submitted when the Department has received the principal officer's recommendation through the proper submission methods from post. This rulemaking provides prospective applicants seeking to qualify under INA section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(D), for special immigrant status notice regarding the Department's implementation of the program.

This rule relates to a foreign affairs function, and consequently, in accordance with 5 U.S.C. 553(a)(1), it is not subject to the notice-and-comment rule making procedures set forth in 5 U.S.C. 553. This rule affects the U.S. government's ability to recruit and retain locally employed staff for its overseas missions. It also clearly and directly impacts foreign affairs functions of the United States and “implicat[es] matters of diplomacy directly.” City of N.Y. v. Permanent Mission of India to the U.N. , 618 F.3d 172, 202 (2d Cir. 2010).

This rule involves the Secretary of State's authority to determine that it is in the national interest to grant special immigrant status to a current or former employee of the U.S. government, a determination that involves a wide range of foreign affairs considerations and functions, including the U.S. government's bilateral relationship with the host country, the impact on the U.S. government's ability to recruit qualified personnel in the country, and the impact of special immigrant status availability on the willingness of foreign nationals to become, and remain as, employees of the U.S. government.

Special immigrant status eligibility is critical for the U.S. government to recruit and retain loyal, valuable local staff outside the United States, without which the Department could not efficiently function overseas. The Department alone employs approximately 50,000 local staff at over 200 Foreign Service posts overseas, excluding local staff employed on behalf of all the other U.S. government agencies operating overseas, for which we lack data. 1 Because special immigrant status is only available to locally employed staff with at least fifteen years of faithful service, and under exceptional circumstances, potential eligibility encourages employees to remain in their jobs and to provide long-term, institutional memory to U.S. government agencies abroad. This is particularly essential in countries where local staff members face retribution by the host government, making it even more challenging to recruit and retain a locally employed workforce. The potential for locally employed staff to obtain special immigrant status for their spouses and children, in particular, is central to the U.S. government's ability to recruit and retain loyal and committed foreign nationals to support U.S. missions overseas. Consequently, the approval of recommendations for special immigrant status, and the promulgation of standards for such approval under the Secretary of State's authority in INA section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(D), involve foreign affairs functions of the Department of State.

Because this rule is exempt from notice and comment rulemaking under 5 U.S.C. 553, it is exempt from the regulatory flexibility analysis requirements set forth by the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Nonetheless, consistent with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Department certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments.

The Office of Information and Regulatory Affairs has determined that this rule is not a major rule as defined by 5 U.S.C. 804(2).

The Office of Information and Regulatory Affairs has determined that this is a significant regulatory action under Executive Order 12866 and has reviewed this document. The Department has also reviewed this rulemaking to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866. The Department has also considered this rule in light of Executive Order 13563 and affirms that this regulation is consistent with the guidance therein. This regulation is de minimis under Executive Order 13771.

This regulation is being promulgated to avoid unfair variation in the administration of the special immigrant status program and to ensure consistent application of certain provisions of immigration law to principal officer recommendations for special immigrant status at U.S. foreign missions around the world. The Department estimates that approximately 60 recommendations from a principal officer per year may be initially impacted by this rule, because an employee's qualifications will not demonstrate the requisite exceptional circumstances to qualify for special immigrant status due to the changes in standards implemented through this rule. The Department is unable to reliably estimate the number of dependents who may also be restricted in their ability to qualify for derivative status until their spouse or parent is recommended by a principal officer under this new rule. Assuming an average of 2 derivatives per principal applicant, the rule could affect approximately 180 people worldwide per year. The Department derived the estimate of affected principal officer recommendations from recent data regarding applicants who previously qualified for this program under the exceptional circumstances that are being removed or changed under this rule. 2

The majority of the affected principal officer recommendations related to employee qualifications each year are likely to be delayed rather than permanently eliminated, as there are several other circumstances through which employees may receive principal officer recommendations and qualify for special immigrant status in the future. For example, some principal officer recommendations for applicants with at least 15 years of service, but less than 20 years of service, could previously qualify under the grounds of receiving at least two individual honor awards. This rule eliminates this category of exceptional circumstance. However, these same principal officer recommendations may still qualify under a separate exceptional circumstance in the future by reaching 20 years of service. As a result, while an estimated 60 recommendations from principal officers regarding the qualification of applicants may be affected, the Department does not expect that a significant number of principal officer recommendations will be permanently affected.

The Department notes that there is a possibility that this rule may make it more difficult to hire foreign workers; however, as this program will remain intact and the effect is more likely to delay rather than eliminate eligibility, the Department expects this impact to be minimal. The Department will incur de minimis administrative costs to provide clear guidance and messaging regarding this change to all posts and to locally employed staff that may be impacted by the rule. While some locally employed staff may believe a principal officer would likely recommend them for special immigrant status on bases eliminated by this rule, there are several other categories, as discussed above, through which they may qualify in the future.

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. The rule will not have federalism implications warranting the application of Executive Orders 12372 and 13132.

The Department has reviewed the regulation in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of section 5 of Executive Order 13175 do not apply to this rulemaking.

Special immigrant status applicants complete the DS-1884 (OMB Control Number 1405-0082) and the DS-260 (OMB Control Number 1405-0185) after the Secretary, or designee, approves the recommendation from the principal officer. This rule has no effect on the DS-1884 or the cost burdens for individual applicants completing these forms. Rather, this rule applies to the adjudication standards applied internally by the Department's personnel. The Department believes this rule may initially reduce the overall number of DS-1884, Petition to Classify Special Immigrant Under INA 203(b)(4), by approximately 60 per year due to a decrease either in the number of principal officer recommendations submitted to the Department or the number of recommendations approved by the Secretary, or his designee. However, many of the affected applicants will likely eventually qualify and file both the form DS-1884 and DS-260. Because this rule is likely to delay, rather than prevent, most affected applicants from completing these forms, the Department does not believe that this proposal will affect the burden of these forms.

The Department estimates a related reduction in the overall number of immigrant visa applications on form DS-260 by approximately 180 per year, based on the past average of approximately two derivative family members per applicant for this applicant pool. The Department is unable to reliably estimate the number of dependents of affected applicants for special immigrant status who will not file a DS-260, if the principal subsequently is approved for SIV status, because, e.g., they will age out of dependent eligibility or they will be unable or unwilling to wait.

Accordingly, for the reasons set forth in the preamble, the Department of State amends 22 CFR part 42 as follows:

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. A barge is aground in the St. Marys River and immediate action is needed to mitigate the potential safety hazards associated with the response. It is impracticable to publish an NPRM because we must establish this safety zone immediately.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with the aground vessel.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sault Sainte Marie (COTP) has determined that potential hazards associated in the navigable waters near an aground barge in the lower St. Marys River is a safety concern for anyone within a 500-yard radius. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the vessel is aground.

This rule establishes a safety zone immediately until June 24, 2020. The safety zone will cover all navigable waters within 500 yards of the barge PML2501. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, and duration of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the St. Marys River. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via CHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will prohibit entry within 500 yards of navigable waters of an aground barge in the St. Marys River. It is categorically excluded from further review under paragraph L[60(d)] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

Purpose of Program: The purpose of the Technical Assistance on State Data Collection program is to improve the capacity of States to meet IDEA data collection and reporting requirements. Funding for the program is authorized under section 611(c)(1) of IDEA, which gives the Secretary the authority to reserve not more than 1/2 of 1 percent of the amounts appropriated under Part B for each fiscal year to provide TA activities authorized under section 616(i), where needed, to improve the capacity of States to meet the data collection requirements under Parts B and C of IDEA. The maximum amount the Secretary may reserve under this set-aside for any fiscal year is $25,000,000, cumulatively adjusted by the rate of inflation. Section 616(i) of IDEA requires the Secretary to review the data collection and analysis capacity of States to ensure that data and information determined necessary for the implementation of section 616 of IDEA are collected, analyzed, and accurately reported to the Secretary. It also requires the Secretary to provide TA (from funds reserved under section 611(c)(1)), where needed, to improve the capacity of States to meet the data collection requirements under Parts B and C of IDEA, which include the data collection and reporting requirements in sections 616 and 618 of IDEA. Additionally, the Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019; and the Further Consolidated Appropriations Act, 2020 give the Secretary the authority to use funds reserved under section 611(c) to “administer and carry out other services and activities to improve data collection, coordination, quality, and use under parts B and C of the IDEA.” Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019, and Continuing Appropriations Act, 2019, Div. B, Title III of Public Law 115-245, 132 Stat. 3100 (2018); Further Consolidated Appropriations Act, 2020, Div. A, Title III of Public Law 116-94, 133 Stat. 2590 (2019).

Program Authority: 20 U.S.C. 1411(c), 1416(i), 1418(c), and 1442; the Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019, and Continuing Appropriations Act, 2019, Div. B, Title III of Public Law 115-245, 132 Stat. 3100 (2018); Further Consolidated Appropriations Act, 2020, Div. A, Title III of Public Law 116-94, 133 Stat. 2590 (2019).

Applicable Program Regulations: 34 CFR 300.702.

We published a notice of proposed priority and requirements (NPP) for this program in the Federal Register on December 10, 2019 (84 FR 67395). The NPP contained background information and our reasons for proposing the priority and requirements.

There are no substantive differences between the proposed priority and requirements and the final priority and requirements, as discussed in the Analysis of Comments and Changes section of this document.

Public Comment: In response to our invitation to comment in the NPP, three parties submitted comments on the proposed priority and requirements.

Generally, we do not address technical and other minor changes. In addition, we do not address comments that raised concerns not directly related to the proposed priority and requirements.

Analysis of Comments and Changes: An analysis of the comments related to the priority and requirements follows. OSERS received comments on specific topics including support for the proposed center, recommendations for the funding of feasibility studies, and enhanced data collection and reporting. Each topic is addressed below.

Comment: One commenter expressed support for the proposed Fiscal Data Center. The commenter further requested that additional resources be made available to support the Fiscal Data Center's expanded scope addressing IDEA Part C fiscal data.

Discussion: The Department appreciates the commenter's support. Centers funded under this program provide necessary and valuable technical assistance to States. The Department will establish a funding amount that is appropriate based on the outcomes and requirements outlined in this document.

Changes: None.

Comment: One commenter recommended that the Department support the implementation of feasibility studies to evaluate strengths and weaknesses of State fiscal reporting structures to meet the reporting requirements of IDEA.

Discussion: The Department appreciates the comment, and notes that the purpose of the priority is to support States in collecting, reporting, and determining how to best analyze and use their IDEA Parts B and C fiscal data to establish and meet high expectations for each child with a disability. Additionally, the Fiscal Data Center will customize its TA and support to meet each State's specific needs. This support frequently includes an evaluation of the strengths and weaknesses of State fiscal structures addressing IDEA fiscal reporting requirements.

Changes: None.

Comment: One commenter requested that the Department ensure an accurate count of students with disabilities, account for assistive technology utilization in classrooms, track student transitions for both the IDEA Part B and Part C programs, and invest in competitive integrated employment strategies.

Discussion: The Department appreciates the comment; however, we believe that the suggestions fall outside of the scope of the Fiscal Data Center. The commenter requested that the Department expand its data collection rather than indicating how the Fiscal Data Center can provide TA to States. We note that under IDEA section 618, the Department is required to collect from States their IDEA Part B and Part C annual child count data for infants, toddlers, and children with disabilities, and that, under IDEA sections 616 and 618, States report on IDEA Part B and Part C transitions through their exit data as well as their State Performance Plan (SPP) and Annual Performance Reports (APR). 1

Changes: None.

Final Priority:

National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B and Part C Fiscal Data.

The purpose of this priority is to fund a cooperative agreement to establish and operate the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B and Part C Fiscal Data (Fiscal Data Center).

The Fiscal Data Center will provide TA to improve the capacity of States to meet the IDEA Parts B and C fiscal data collection requirements under IDEA section 618 and increase States' knowledge of the underlying IDEA fiscal requirements and calculations necessary to submit valid and reliable data for the following collections: (1) Maintenance of State Financial Support (MFS) in Section V of the IDEA Part B Annual State Application; (2) Local Educational Agency (LEA) Maintenance of Effort (MOE) Reduction and Coordinated Early Intervening Services (CEIS); (3) Description of Use of Federal IDEA Part C Funds for the State Lead Agency (LA) and the Interagency Coordinating Council (ICC) in Section III of the IDEA Part C Annual State Application; and (4) Restricted Indirect Cost Rate/Cost Allocation Plan Information in Sections III and IV of the IDEA Part C Annual State Application. States will also receive TA from the Fiscal Data Center on the underlying fiscal requirements of IDEA related to these collections and how they impact the States' ability to meet IDEA fiscal data collection requirements.

The Fiscal Data Center must be designed to achieve, at a minimum, the following outcomes:

(a) Increased capacity of States to collect, report, analyze, and use high-quality IDEA Part B and Part C fiscal data;

(b) Increased State knowledge of underlying statutory and regulatory fiscal requirements and the calculations necessary to submit valid and reliable fiscal data under IDEA Part B and Part C;

(c) Improved fiscal infrastructure ( e.g., sample interagency agreements, standard operating procedures and templates) by coordinating and promoting communication and effective fiscal data collection and reporting strategies among relevant State offices, including SEAs, LAs and other State agencies, LEAs, schools, and early intervention service (EIS) programs or providers;

(d) Increased capacity of States to submit accurate and timely fiscal data to enhance current State validation procedures to prevent errors in State-reported IDEA data;

(e) Increased capacity of States to train personnel to meet the IDEA fiscal data collection and reporting requirements under sections 616 and 618 of IDEA through development of effective tools and resources ( e.g., templates, tools, calculators, and documentation of State data processes); and providing opportunities for in-person and virtual cross-State collaboration about IDEA fiscal data collection and reporting requirements (required under section 618 of IDEA);

(f) Improved capacity of SEAs, LEAs, LAs, and EIS programs or providers to collect and use IDEA fiscal data to identify issues and address those issues through monitoring, TA, and stakeholder involvement; and

(g) Improved IDEA fiscal data validation using results from data reviews conducted by the Department to work with States and generate tools that can be used by States to accurately communicate fiscal data to local consumers ( e.g., parents, LEAs, EIS programs or providers, the general public) and lead to improvements in the validity and reliability of fiscal data required by IDEA.

Types of Priorities:

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register . The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

Final Requirements:

The Assistant Secretary establishes the following requirements for this program. We may apply one or more of these requirements in any year in which this program is in effect.

Requirements:

Applicants must—

(a) Describe, in the narrative section of the application under “Significance,” how the proposed project will—

(1) Use knowledge of how SEAs, LAs, LEAs, and EIS programs and providers are meeting IDEA Part B and Part C fiscal data collection and reporting requirements and the underlying statutory and regulatory fiscal requirements, as well as knowledge of State and local data collection systems, as appropriate;

(2) Examine applicable national, State, and local data to determine the current capacity needs of SEAs, LAs, LEAs, and EIS programs and providers to meet IDEA Part B and Part C fiscal data collection and reporting requirements;

(3) Train SEAs and LAs on how to use IDEA section 618 fiscal data as a means of both improving data quality and identifying programmatic strengths and areas for improvement; and

(4) Disseminate information regarding how SEAs and LAs are currently meeting IDEA fiscal data collection and reporting requirements and are using IDEA section 618 data as a means of both improving data quality and identifying programmatic strengths and areas for improvement.

(b) Demonstrate, in the narrative section of the application under “Quality of project services,” how the proposed project will—

(1) Ensure equal access and treatment for members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—

(i) Identify the needs of the intended recipients for TA and information; and

(ii) Ensure that services and products meet the needs of the intended recipients of the grant;

(2) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—

(i) Measurable intended project outcomes; and

(ii) In Appendix A, the logic model (as defined in 34 CFR 77.1) by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project;

(3) Use a conceptual framework to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework. Include a copy of the conceptual framework in Appendix A;

Purpose: The USPTO is revising the rules of practice pertaining to the patent term adjustment provisions of 35 U.S.C. 154(b) in view of the decision by the Federal Circuit in Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019). The Federal Circuit in Supernus held that a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. The regulations pertaining to a reduction of patent term adjustment due to a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application are set forth in 37 CFR 1.704. Several provisions in 37 CFR 1.704 ( i.e., 37 CFR 1.704(c)(2), (3), (6), (9), and (10)) specify a period of reduction corresponding to the consequences to the USPTO of the applicant's failure to engage in reasonable efforts to conclude prosecution, rather than “the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution,” as provided for in Supernus. 913 F.3d at 1359. Therefore, the USPTO is revising these provisions of 37 CFR 1.704 for consistency with the Federal Circuit's decision in Supernus.

Summary of Major Provisions: This rulemaking pertains to the patent term adjustment regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application and resulting reduction of any patent term adjustment (37 CFR 1.704). This rulemaking specifically revises the period of reduction of patent term adjustment in the provisions of 37 CFR 1.704 pertaining to deferral of issuance of a patent (37 CFR 1.704(c)(2)), abandonment of an application (37 CFR 1.704(c)(3)), submission of a preliminary amendment (37 CFR 1.704(c)(6)), submission of papers after a decision by the Patent Trial and Appeal Board or by a Federal court (37 CFR 1.704(c)(9)), and submission of papers after a notice of allowance under 35 U.S.C. 151 (37 CFR 1.704(c)(10)) to specify a period of reduction corresponding to “the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution” (rather than corresponding to the consequences to the USPTO of the applicant's failure to engage in reasonable efforts to conclude prosecution) for consistency with the Federal Circuit's decision in Supernus. 913 F.3d at 1359. This rulemaking also revises 37 CFR 1.704(c)(10) to exclude after-allowance amendments or other after-allowance papers that are “expressly requested by the Office” from the after-allowance amendments or other after-allowance papers that will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10).

Costs and Benefits: This rulemaking is not economically significant under Executive Order 12866 (Sept. 30, 1993).

Section 532(a) of the Uruguay Round Agreements Act, or URAA (Pub. L. 103-465, 108 Stat. 4809 (1994)), amended 35 U.S.C. 154 to provide that the term of a patent ends on the date that is twenty years from the filing date of the application, or the earliest filing date for which a benefit is claimed under 35 U.S.C. 120, 121, or 365(c). The URAA also contained provisions, codified at 35 U.S.C. 154(b), for patent term extension due to certain examination delays. Under the patent term extension provisions of 35 U.S.C. 154(b), as amended by the URAA, an applicant is entitled to patent term extension for delays due to interference (which has since been replaced by derivation), secrecy order, or successful appellate review. See 35 U.S.C. 154(b) (1995).

The American Inventors Protection Act of 1999, or AIPA (Pub. L. 106-113, 113 Stat. 1501, 1501A-552 through 1501A-591 (1999)), further amended 35 U.S.C. 154(b) to include additional bases for patent term extension (termed “patent term adjustment” in the AIPA). Generally, under the patent term adjustment provisions of 35 U.S.C. 154(b), as amended by the AIPA, an applicant is entitled to patent term adjustment for the following reasons: (1) If the USPTO fails to take certain actions during the examination and issue process within specified time frames (35 U.S.C. 154(b)(1)(A)) (known as “A” delays); (2) if the USPTO fails to issue a patent within three years of the actual filing date of the application (35 U.S.C. 154(b)(1)(B)) (known as “B” delays); and (3) for delays due to interference (and now derivation), secrecy order, or successful appellate review (35 U.S.C. 154(b)(1)(C)) (known as “C” delays). See 35 U.S.C. 154(b)(1). The AIPA, however, sets forth a number of conditions and limitations on any patent term adjustment accrued under 35 U.S.C. 154(b)(1). See 35 U.S.C. 154(b)(2). 35 U.S.C. 154(b)(2)(C) sets forth one such limitation, providing, in part, that “[t]he period of adjustment of the term of a patent under [35 U.S.C. 154(b)(1)] shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application” and that “[t]he Director shall prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. 154(b)(2)(C)(i) and (iii). The USPTO implemented the AIPA patent term adjustment provisions of 35 U.S.C. 154(b), including setting forth circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application and resulting in a reduction of any patent term adjustment, in a final rule published in September of 2000. See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR 56365 (Sept. 18, 2000) (AIPA patent term adjustment final rule). The regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application and resulting reduction of any patent term adjustment are set forth in 37 CFR 1.704.

In January 2019, the Federal Circuit issued a decision in Supernus pertaining to the patent term adjustment provisions of 35 U.S.C. 154(b)(2)(C). The Federal Circuit confirmed that 37 CFR 1.704(c)(8) “ `is a reasonable interpretation of the [patent term adjustment] statute' insofar as it includes `not only applicant conduct or behavior that result in actual delay, but also those having the potential to result in delay irrespective of whether such delay actually occurred.' ” Supernus, 913 F.3d at 1356 (quoting Gilead Scis., Inc. v. Lee, 778 F.3d 1341, 1349-50 (Fed. Cir. 2015)). The Federal Circuit, however, held that the USPTO may not reduce patent term adjustment by a period that exceeds the “time during which the applicant failed to engage in reasonable efforts” to conclude prosecution, specifically stating that “[o]n the basis of the plain language of [35 U.S.C. 154(b)(2)(C)(i),] . . . the [USPTO] may not count as applicant delay a period of time during which there was no action that the applicant could take to conclude prosecution of the patent.” Id. at 1358. The Federal Circuit specifically stated that:

37 CFR 1.704(c)(1) through (c)(14) set forth: (1) The exemplary circumstances prescribed by the USPTO “that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application” pursuant to 35 U.S.C. 154(b)(2)(C)(iii); and (2) the resulting period of reduction of any patent term adjustment. The Federal Circuit decision in Supernus involved a reduction to patent term adjustment under the provisions of 37 CFR 1.704(c)(8). The period of reduction of patent term adjustment in 37 CFR 1.704(c)(8) is as follows: “the number of days, if any, beginning on the day after the date the initial reply was filed and ending on the date that the supplemental reply or other such paper was filed.” 37 CFR 1.704(c)(8). This period corresponds to “the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution,” except in the rare situation in which such period includes “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus, 913 F.3d at 1359. The USPTO published a notice in May of 2019 setting out its implementation of Supernus with respect to the provisions of 37 CFR 1.704(c)(8) and other provisions of 37 CFR 1.704(c) that may include “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” See Patent Term Adjustment Procedures in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 84 FR 20343 (May 9, 2019).

While the Federal Circuit decision in Supernus involved 37 CFR 1.704(c)(8), there are several provisions in 37 CFR 1.704(c)(1) through (c)(14) whose period of reduction corresponds to or includes the consequences to the USPTO of the applicant's failure to engage in reasonable efforts to conclude prosecution, rather than “the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution.” Supernus, 913 F.3d at 1359. Therefore, the USPTO is revising the periods of reduction of patent term adjustment in 37 CFR 1.704(c) for consistency with the Federal Circuit's decision in Supernus. The USPTO is also revising 37 CFR 1.704(c)(10) to exclude after-allowance amendments or other after-allowance papers that are “expressly requested by the Office” from the after-allowance amendments or other after-allowance papers that will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10).

The following is a discussion of amendments to title 37 of the Code of Federal Regulations, part 1:

Section 1.704(c)(2) is amended to change “the date the patent was issued” to “the earlier of the date a request to terminate the deferral was filed or the date the patent was issued.” The period of reduction of patent term adjustment in § 1.704(c)(2) is now as follows: “the number of days, if any, beginning on the date a request for deferral of issuance of a patent under § 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued.”

Section 1.704(c)(3) is amended to change “the earlier of: (i) The date of mailing of the decision reviving the application or accepting late payment of the issue fee; or (ii) The date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed” to “the date the grantable petition to revive the application or accept late payment of the issue fee was filed.” The period of reduction of patent term adjustment in § 1.704(c)(3) is now as follows: “the number of days, if any, beginning on the date of abandonment or the day after the date the issue fee was due and ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed.”

Section 1.704(c)(6) is amended to change “the lesser of: (i) The number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the date of mailing of the supplemental Office action or notice of allowance; or (ii) Four months” to “the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed.” This eight-month period corresponds to the eight-month period in § 1.704(c)(13) for placing an application in condition for examination. See Changes to Implement the Patent Law Treaty, 78 FR 62367, 62385 (Oct. 21, 2013) (an application is expected to be in condition for examination no later than eight months from its filing date (or date of commencement of the national stage in an international application)). The period of reduction of patent term adjustment in § 1.704(c)(6) is now as follows: “the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed.”

Section 1.704(c)(9) is amended to change “the lesser of: (i) The number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance; or (ii) Four months” to “the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a Federal court and ending on date the amendment or other paper was filed.” The period of reduction of patent term adjustment in § 1.704(c)(9) is now as follows: “the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a Federal court and ending on date the amendment or other paper was filed.”

Section 1.704(c)(10) is amended to change “the lesser of: (i) The number of days, if any, beginning on the date the amendment under § 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under § 1.312 or such other paper; or (ii) Four months” to “the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under § 1.312 or other paper was filed.” The period of reduction of patent term adjustment in § 1.704(c)(10) is now as follows: “the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under § 1.312 or other paper was filed.”

Section 1.704(c)(10) is also amended to exclude “an amendment under § 1.312 or other paper expressly requested by the Office” from the amendments under § 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment under § 1.704(c)(10). Thus, an amendment under § 1.312 or other paper not expressly requested by the USPTO ( i.e., a “voluntary” amendment under § 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under § 1.704(c)(10). An amendment under § 1.312 or other paper going beyond what was requested by the USPTO ( i.e., including material not expressly requested by the USPTO in addition to what was requested by the USPTO) would not be considered “an amendment under § 1.312 or other paper expressly requested by the Office” under § 1.704(c)(10). In addition, the phrase “expressly requested by the Office” requires a specific request in an Office action or notice, or in an Examiner's Interview Summary (PTOL-413), for the amendment under § 1.312 or other paper. For example, generic language in an Office action or notice, such as a statement in a notice of allowability containing an examiner's amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by § 1.312 (section 1302.04 of the Manual of Patent Examining Procedure (MPEP)), is not a basis for considering an amendment under § 1.312 to be “expressly requested by the Office” within the meaning of § 1.704(c)(10) as adopted in this final rule. Similarly, the provisions of §§ 1.56, 1.97, and 1.98 are not a basis for considering an information disclosure statement including information that has come to the attention of the applicant after a notice of allowance has been given or mailed to be a paper “expressly requested by the Office” within the meaning of § 1.704(c)(10). An information disclosure statement in compliance with §§ 1.97 and 1.98, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution of the application under § 1.704(c)(10) (or § 1.704(c)(6), (8), or (9) if the information disclosure statement is accompanied by a statement under § 1.704(d)). Finally, an amendment under § 1.312 or other paper expressly requested by the USPTO not filed within three months from the date of mailing or transmission of the USPTO communication notifying the applicant of such request will result in a reduction of patent term adjustment under § 1.704(b).

Section 1.704(c) is also amended to change “mailing date” to “date of mailing” throughout for consistency with the other regulations pertaining to AIPA patent term adjustment (§§ 1.702 through 1.705) and URAA patent term extension (§ 1.701). The USPTO has been issuing Office actions and notices through the Electronic Office Action Program since June of 2009 for patent applicants choosing this form of notification. See Electronic Office Action, 1343 Off. Gaz. Pat. Office 45 (June 2, 2009). The term “date of mailing” as used in the regulations pertaining to AIPA patent term adjustment and URAA patent term extension means the mailroom/notification date indicated on the form PTOL-90 accompanying the Office action or notice communication. See Electronic Office Action, 1343 Off. Gaz. Pat. Office at 46 (“The mailroom/notification date will also be considered the date of mailing of the correspondence for all other purposes ( e.g., [§§ ] 1.71(g)(2), 1.97(b), 1.701 through 1.705)”).

The AIPA patent term adjustment provisions apply to original utility and plant patents issuing from applications filed on or after May 29, 2000 (applications and patents eligible for patent term adjustment). The changes in this final rule apply to all applications and patents eligible for patent term adjustment in which a notice of allowance was mailed on or after July 16, 2020. The USPTO makes the patent term adjustment determination indicated in the patent by a computer program that uses the information recorded in the USPTO's Patent Application Locating and Monitoring (PALM) system (except when an applicant requests reconsideration pursuant to § 1.705(b)). See 65 FR at 56381 (response to comment 25). The USPTO is in the process of modifying its patent term adjustment program to implement the changes in this final rule. The USPTO calculates the patent term adjustment manually when an applicant requests reconsideration of a patent term adjustment determination pursuant to § 1.705(b) (the fee required for a reconsideration of a patent term adjustment determination pursuant to § 1.705(b) partially covers the USPTO's cost of performing a manual patent term adjustment determination). The USPTO will decide any timely request for reconsideration in compliance with § 1.705(b) of a patent term adjustment determination in applications and patents eligible for patent term adjustment in which a notice of allowance was mailed on or after July 16, 2020, consistent with the changes in this final rule.

While the USPTO has adopted ad hoc procedures for seeking reconsideration of the patent term adjustment determination in the past when there have been changes to the interpretation of the provisions of 35 U.S.C. 154(b) as a result of court decisions, these ad hoc procedures were adopted because former 35 U.S.C. 154(b)(4) provided a time period for seeking judicial review that was not related to the filing of a request for reconsideration of the USPTO's patent term adjustment determination or the date of the USPTO's decision on any request for reconsideration of the USPTO's patent term adjustment determination. See Revisions to Implement the Patent Term Adjustment Provisions of the Leahy-Smith America Invents Act Technical Corrections Act, 79 FR 27755, 27759 (May 15, 2014). As § 1.705(b) now provides that its two-month time period may be extended under the provisions of § 1.136(a) (permitting an applicant to request reconsideration of the patent term adjustment indicated on the patent as late as seven months after the date the patent was granted), the USPTO is not adopting an ad hoc procedure for requesting a patent term adjustment recalculation directed to the changes in this final rule. The USPTO will decide any timely request for reconsideration in compliance with § 1.705(b) of a patent term adjustment determination in applications and patents eligible for patent term adjustment in which a notice of allowance was mailed before July 16, 2020, consistent with the changes in this final rule, if requested by the patentee.

The USPTO published a notice proposing changes to the rules of practice pertaining to patent term adjustment in view of the decision by the Federal Circuit in Supernus. See Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 84 FR 53090 (Oct. 4, 2019). In response to the notice of proposed rulemaking, the USPTO received seven comments from three submitters, more particularly, from an intellectual property organization, a healthcare company, and an individual patent practitioner. The comments were supportive of the proposed changes to § 1.704(c) but included specific suggestions and questions. The comments and the USPTO's responses thereto follow:

Comment (1): One comment suggests that the USPTO confirm that the patent term reduction under § 1.704(c)(3) does not apply where a notice of abandonment has been withdrawn by the USPTO, either sua sponte or as the result of a petition.

Response: Section 1.704(c)(3) addresses the situation in which an abandoned application has been revived (§ 1.137), whereas § 1.704(c)(4) addresses the situation in which a holding of abandonment is withdrawn, and § 1.704(c)(4) has not been amended in this final rule. Section 1.704(c)(4) continues to provide that the failure to file a petition to withdraw the holding of abandonment or to revive an application within two months from the date of mailing of a notice of abandonment will result in the period of adjustment set forth in § 1.703 being reduced by “the number of days, if any, beginning on the day after the date two months from the date of mailing of a notice of abandonment and ending on the date a petition to withdraw the holding of abandonment or to revive the application was filed.”

Comment (2): One comment seeks clarification whether the USPTO would extend the eight-month period to respond to the next business day if the eight-month period ends on a Saturday, Sunday, or Federal holiday under proposed § 1.704(c)(6).

Response: Under 35 U.S.C. 21(b), “[w]hen the day, or the last day, for taking any action or paying any fee in the United States Patent and Trademark Office falls on Saturday, Sunday, or a Federal holiday within the District of Columbia, the action may be taken, or fee paid, on the next succeeding secular or business day.” Accordingly, any reduction under § 1.704(c)(6), as adopted in this final rule, would begin on the day after the next succeeding secular or business day in this situation. For example, if an application was filed on May 18, 2019, and the USPTO mailed an Office action on February 28, 2020, but the applicant had filed a preliminary amendment on February 17, 2020, that required a supplemental Office action addressing the preliminary amendment, the eight-month period would end on Tuesday January 21, 2020, under § 1.704(c)(6), as adopted in this final rule, because January 18 and 19, 2020, were weekend days and January 20, 2020, was a Federal holiday. Thus, the period of reduction under § 1.704(c)(6), as adopted in this final rule, would begin on Wednesday, January 22, 2020 ( i.e., Wednesday, January 22, 2020, would be “day one”), and end on February 17, 2020.

Comment (3): One comment requests clarification whether an applicant could avoid a reduction of patent term adjustment under § 1.704(c)(6) for the submission of a preliminary amendment or other paper by having the examiner expressly request that the applicant submit the preliminary amendment or other paper.

Response: Section 1.706(c)(6) does not contain a provision for preliminary amendments or other papers expressly requested by the examiner (like § 1.704(c)(8)). Section 1.704(c)(6), however, does not result in a reduction of patent term adjustment unless the preliminary amendment or other preliminary paper: (1) Is submitted less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151; and (2) requires the mailing of a supplemental Office action or notice of allowance. A preliminary amendment or other paper expressly requested by the examiner should not require the mailing of a supplemental Office action or notice of allowance.

Comment (4): One comment suggests that the USPTO do a further study of the impact to § 1.704(c)(6).

Response: The eight-month period in § 1.704(c)(6), as adopted in this final rule, is consistent with the eight-month period in § 1.704(c)(13), which is the time period at which an application is expected to be in condition for examination. See 78 FR at 62385. The USPTO's first action pendency has been decreasing in recent years, and the USPTO expects that trend to continue. The USPTO will monitor the impact that delays in placing an application in condition for examination have on first action pendency and will adjust the time periods in § 1.704(c)(6) and (c)(13) as appropriate.

Comment (5): Several comments request clarification regarding § 1.704(c)(10) and the submission of drawings and other papers in response to a notice received from the USPTO. The comments suggest that the USPTO should make a distinction as to whether the papers are being voluntarily submitted or are being submitted in response to an Office action or notice from the USPTO.

Response: Section 1.704(c)(10), as adopted in this final rule, excludes “an amendment under § 1.312 or other paper expressly requested by the Office” from the amendments under § 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment. Thus, only an amendment under § 1.312 or other paper not expressly requested by the USPTO ( i.e., a “voluntary” amendment under § 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under § 1.704(c)(10), as adopted in this final rule. An amendment under § 1.312 or other paper expressly requested by the USPTO filed more than three months from the date of mailing or transmission of the USPTO communication notifying the applicant of such request, however, will result in a reduction of patent term adjustment under § 1.704(b). Thus, an amendment under § 1.312 or other paper expressly requested by the USPTO submitted within three months of the date of mailing or transmission of the Office action or notice requiring such an amendment under § 1.312 or other paper will not result in a reduction of patent term adjustment.

Comment (6): One comment asks whether the proposed change to § 1.704(c)(10) affects the list of other papers not considered to be a failure to engage in unreasonable efforts under this provision.

Response: The USPTO has previously indicated that the submission of the following papers after a notice of allowance will not result in a reduction of patent term adjustment under § 1.704(c)(10): (1) Fee(s) Transmittal (PTOL-85B); (2) power of attorney; (3) power to inspect; (4) change of address; (5) change of entity status (micro/small/not small entity status); (6) a response to the examiner's reasons for allowance or a request to correct an error or omission in the “Notice of Allowance” or “Notice of Allowability”; (7) status letters; (8) requests for a refund; (9) an inventor's oath or declaration; (10) an information disclosure statement with a statement in compliance with § 1.704(d); (11) the resubmission by the applicant of unlocatable paper(s) previously filed in the application (§ 1.251); (12) a request for acknowledgment of an information disclosure statement in compliance with §§ 1.97 and 1.98, provided that the applicant had requested that the examiner acknowledge the information disclosure statement prior to the notice of allowance, or the request for acknowledgement was the applicant's first opportunity to request that the examiner acknowledge the information disclosure statement; (13) comments on the substance of an interview where the applicant-initiated interview resulted in a notice of allowance; and (14) letters related to government interests ( e.g., those between NASA and the USPTO). See Changes to Patent Term Adjustment in View of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346, 1354 (Jan. 9, 2015); see also MPEP 2732. The USPTO is not changing this indication of papers submitted after a notice of allowance that will not result in a reduction of patent term adjustment under § 1.704(c)(10), except to also exclude “an amendment under § 1.312 or other paper expressly requested by the Office” from the amendments under § 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment under § 1.704(c)(10).

Comment (7): One comment suggests that the rule change be applied prospectively because it will alter patent prosecution. The comment also asks the USPTO to clarify what impact the rule changes would have on issued patents.

Response: The changes to § 1.704 in this final rule apply to applications and patents eligible for patent term adjustment in which a notice of allowance was mailed on or after July 16, 2020. The USPTO, however, will decide any timely request for reconsideration in compliance with § 1.705(b) of a patent term adjustment determination in applications and patents eligible for patent term adjustment in which a notice of allowance was mailed before July 16, 2020 consistent with the changes in this final rule if requested by the patentee.

The changes in this rulemaking involve rules of agency practice and procedure and/or interpretive rules. See Perez v. Mortg. Bankers Ass'n, 575 U.S. 92, 97 (2015) (Interpretive rules “advise the public of the agency's construction of the statutes and rules which it administers.” (citation and internal quotation marks omitted)); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (Rule that clarifies interpretation of a statute is interpretive.); Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (Rules governing an application process are procedural under the Administrative Procedure Act.); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (Rules for handling appeals were procedural where they did not change the substantive standard for reviewing claims.). Specifically, this rulemaking revises USPTO rules that interpret certain statutory provisions pertaining to patent term adjustment to specify a period of reduction corresponding to “the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution” (rather than to the consequences to the USPTO of the applicant's failure to engage in reasonable efforts to conclude prosecution) for consistency with the Federal Circuit's decision in Supernus. 913 F.3d at 1359.

Accordingly, prior notice and opportunity for public comment for the changes in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c) or any other law. See Perez, 575 U.S. at 101 (Notice-and-comment procedures are required neither when an agency “issue[s] an initial interpretive rule” nor “when it amends or repeals that interpretive rule.”); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))). However, the USPTO chose to seek public comment before implementing the rule to benefit from the public's input.

For the reasons set forth herein, the Senior Counsel for Regulatory and Legislative Affairs in the Office General Law of the USPTO has certified to the Chief Counsel for Advocacy of the Small Business Administration that the changes adopted in this notice will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b).

This rulemaking does not impose any additional requirements or fees on applicants. This rulemaking also does not change the circumstances defined as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application (35 U.S.C. 154(b)(2)(C)(iii)). This rulemaking implements the Federal Circuit's ruling on the provisions of 35 U.S.C. 154(b)(2)(C)(i) in Supernus to reflect the applicable period of reduction in the event that there is a failure of an applicant to engage in reasonable efforts to conclude processing or examination. This rulemaking specifically revises the period of reduction of patent term adjustment in the provisions of 37 CFR 1.704 pertaining to deferral of issuance of a patent (37 CFR 1.704(c)(2)), abandonment of an application (37 CFR 1.704(c)(3)), submission of a preliminary amendment (37 CFR 1.704(c)(6)), submission of papers after a decision by the Patent Trial and Appeal Board or by a Federal court (37 CFR 1.704(c)(9)), and submission of papers after a notice of allowance under 35 U.S.C. 151 (37 CFR 1.704(c)(10)) to specify a period of reduction corresponding to “the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution” (rather than to the consequences to the USPTO of the applicant's failure to engage in reasonable efforts to conclude prosecution) for consistency with the Federal Circuit's decision in Supernus. 913 F.3d at 1359. The changes in this rulemaking will not have a significant economic impact on a substantial number of small entities because applicants are not entitled to patent term adjustment that have not been reduced by a period equal to the period of the applicant's failure to engage in reasonable efforts to conclude processing or examination (35 U.S.C. 154(b)(2)(C)(i) and 37 CFR 1.704(a)), and because applicants may avoid adverse patent term adjustment consequences by refraining from actions or inactions defined as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination.

For the foregoing reasons, the changes in this notice will not have a significant economic impact on a substantial number of small entities.

This rulemaking has been determined to be not significant under Executive Order 12866 (Sept. 30, 1993).

The USPTO has complied with Executive Order 13563 (Jan. 18, 2011). Specifically, the USPTO has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided online access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across Government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

This rulemaking is not an Executive Order 13771 (Jan. 30, 2017) regulatory action because it is not significant under Executive Order 12866 (Sept. 30, 1993).

This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).

This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

This rulemaking does not potentially burden the development or use of domestically produced energy resources, with particular attention to oil, natural gas, coal, and nuclear energy resources under Executive Order 13783 (Mar. 28, 2017).

This rulemaking does not involve regulation of the United States financial system under Executive Order 13772 (Feb. 3, 2017).

This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden, as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

This rulemaking will not effect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801-808), the USPTO will submit a report containing the final rule resulting from this rulemaking and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the Government Accountability Office.

The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of $100 million (as adjusted) or more in any one year, or a Federal private-sector mandate that will result in the expenditure by the private sector of $100 million (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions that involve the use of technical standards.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) requires that the USPTO consider the impact of paperwork and other information collection burdens imposed on the public. The rules of practice pertaining to patent term adjustment and extension have been reviewed and approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) under OMB control number 0651-0020.

This rulemaking does not impose any additional requirements (including information collection requirements) or fees for patent applicants or patentees. Therefore, the USPTO is not resubmitting information collection packages to OMB for its review and approval because the changes in this rulemaking do not affect the information collection requirements associated with the information collections approved under OMB control number 0651-0020 or any other information collections.

Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.

For the reasons set forth in the preamble, 37 CFR part 1 is amended as follows:

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

On March 24, 2020, EPA proposed to approve the 1997 ozone NAAQS maintenance plans for the Door County, Kewaunee County, Manitowoc County, and Milwaukee-Racine areas (85 FR 16590). An explanation of the Clean Air Act (CAA) requirements, a detailed analysis of the revisions, and EPA's reasons for proposing approval were provided in the proposed rulemaking and will not be restated here. The public comment period for this proposed rule ended on April 23, 2020. EPA received no comments on the proposal.

EPA is approving the Kewaunee County, Door County and Manitowoc County, and the Milwaukee-Racine area second maintenance plans for the 1997 Ozone NAAQS, submitted by WDNR on December 13, 2019, as a revision to the Wisconsin SIP. These second maintenance plans are designed to keep the Kewaunee County area in attainment of the 1997 ozone NAAQS through 2028, Door County and Manitowoc County in attainment of the 1997 ozone NAAQS though 2030, and the Milwaukee-Racine area in attainment of the 1997 ozone NAAQS through 2032.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 17, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

Accordingly, 40 CFR part 52 is amended as follows:

On May 8, 2019 (84 FR 20070), EPA published a notice of proposed rulemaking (NPRM) for the State of Maryland. In the NPRM, EPA proposed approval of portions of Maryland's infrastructure SIP submittal for the 2010 SO 2 NAAQS. The formal SIP revision (16-11) was submitted by Maryland on August 17, 2016.

On August 17, 2016, Maryland, through the Maryland Department of the Environment (MDE) formally submitted a SIP revision to satisfy certain infrastructure requirements of section 110(a) of the CAA for the 2010 SO 2 NAAQS. The SIP submittal addressed the following infrastructure elements for the 2010 SO 2 NAAQS: CAA section 110(a)(2)(A), (B), (C), (D)(i)(I), (D)(i)(II), D(ii), (E), (F), (G), (H), (J), (K), (L), and (M). As explained in the NPRM, EPA is not taking action in this rulemaking related to Maryland's submittal for the interstate transport requirement of section 110(a)(2)(D)(i)(I). EPA is taking action on Maryland's 2010 1-hour SO 2 NAAQS infrastructure submission related to the section 110(a)(2)(D)(i)(I) requirements in a separate rulemaking.

The NPRM and the Technical Support Document (TSD) provided EPA's review and rationale for proposing approval of portions of Maryland's submittal and will not be restated here. The TSD is available online at www.regulations.gov, Docket ID Number EPA-R03-OAR-2018-0042.

One anonymous commenter provided comments in response to the May 8, 2019 proposed approval. EPA's responses to the comments are provided in this document. The full text of the comment is in the docket for this final rule.

Comment 1: The commenter questions the validity of EPA's statement in the TSD under CAA section 110(a)(2)(B) that Maryland maintains and operates a network of ambient monitors throughout the State to measure ambient air quality levels and to determine compliance with the NAAQS, in light of the requirements under the Data Requirements Rule (DRR) for SO 2. The commenter believes that section 110(a)(2)(B) should be disapproved until SO 2 monitors are installed at Brandon Shores, CP Crane, Chalk Point, Herbert Wagner, Luke Paper (Luke) and Morgantown, and that the data should be captured and reported to EPA and the public. The commenter also states that EPA has failed to take the DRR into consideration in its determination that section 110(a)(2)(G) is approvable, despite its finding that Maryland has shown under section 110(a)(2)(B) that it has the ability and authority to perform SO 2 air quality monitoring in accordance with EPA's requirements. The commenter believes that installation of monitors at the six sources in Maryland are required under the DRR so that ambient SO 2 levels near those sources can be evaluated for comparison to significant harm levels for SO 2 , and that EPA should not approve section 110(a)(2)(B) and (G) until Maryland installs more SO 2 monitors and reports the monitored data to EPA and the public.

Response 1: The commenter refers to the section 110(a)(2)(G) requirement in the context of SO 2 air quality monitoring and the DRR. Section 110(a)(2)(G) requires that state implementation plans have emergency authority comparable to that contained in section 303 of the CAA, and adequate contingency plans to implement such authority. In the proposed rule for this action, the technical support document lays out EPA's rationale for proposing approval of Maryland's submittal for section 110(a)(2)(G). The SIP-approved Maryland regulations COMAR 26.11.05.03 and 26.11.05.04 establish criteria for addressing emergency episodes of SO 2 in the State. However, because the comment pertains to air quality monitoring, EPA believes that the commenter mistakenly cited to section 110(a)(2)(G) and instead meant to cite to the monitoring requirements under section 110(a)(2)(F), which pertain to the installation, maintenance, and replacement of equipment, and the implementation of stationary source monitoring, periodic reports on emissions and emissions-related data from such sources, and correlation of the reports with any emissions limitations or standards. The section 110(a)(2)(F) requirement is discussed later in this response. EPA agrees that the six sources identified by the commenter were listed by the State under the DRR requirements, 40 CFR part 51, subpart BB, for characterization of SO 2 emissions, 1 2 but EPA disagrees that the DRR requires installation of SO 2 monitors at all six of the sources. Under the DRR, states were required to submit a list to EPA that identified all sources within the state having SO 2 emissions that exceeded a 2,000 tons per year (tpy) annual threshold during the most recent year for which emissions data for that source was available, plus any additional sources identified by the air agency or by EPA as also warranting air quality characterization. For each of the listed sources, a state was required to indicate by July 1, 2016, whether air quality around the source would be characterized through ambient monitoring or through air quality modeling. See 40 CFR 51.1203(b). Alternatively, the state could indicate that documentation would be provided by January 13, 2017, that the listed source was subject to federally-enforceable and in effect emission limit(s) below 2,000 tpy or a shutdown. If the state chose to install new SO 2 monitor(s), the state was required to include information about the new monitors in the annual monitoring network plan (AMNP) by July 1, 2016, and to ensure that the new monitor(s) were operational by January 1, 2017. If the state chose to model a source, the modeling protocol was required to be submitted by July 1, 2016.

On June 30, 2016, Maryland submitted a letter notifying EPA of the State's selected methods for characterizing the SO 2 emissions for the six sources named by the commenter. 3 The letter identified modeling as the method for characterizing five of the sources, and monitoring for characterizing the Luke facility. 4 Maryland's 2016 AMNP includes the following narrative of the chosen option to characterize SO 2 concentrations around each of these sources, as follows: “This final rule gives air agencies the flexibility to characterize air quality using either modeling of actual source emissions or using appropriately sited ambient air quality monitors. At the time of this publication, all sources except Verso Luke Mill are expected to model their emissions. Verso Luke Mill submitted a draft monitoring plan to MDE in March 2016. When Verso Luke Mill has submitted a complete package of material describing their proposed monitoring plan, an addendum to this Network Plan will be published and made available for a separate 30-day public comment period. The same July 2016 submission deadline to EPA will apply to this addendum.”  5 This language in the AMNP notes that the DRR provides Maryland the flexibility to choose between modeling and monitoring for each source subject to the requirements of the DRR, which Maryland exercised in its decision to use air quality modeling to characterize five sources' SO 2 emissions and monitoring to characterize Luke's SO 2 emissions. The DRR does not mandate installation of SO 2 monitors at the sources Maryland chose to characterize through air quality modeling. To meet the modeling pathway for Chalk Point and Morgantown Generating Stations, Maryland submitted a modeling analysis for the area surrounding each source on December 19, 2016, prior to the January 13, 2017 submission date required by the DRR. Before the modeling analysis was submitted to EPA, a modeling protocol was developed to outline the procedures to follow for the modeling analysis. To meet the monitoring pathway for Luke in Allegany County, Maryland installed three monitors to characterize the SO 2 emissions around Luke, including one monitor in West Virginia. The new monitors began operation on January 1, 2017.

EPA also disagrees with the comment that section 110(a)(2)(B) and 110(a)(2)(F) should be disapproved because of a lack of SO 2 monitors, which the commenter believes is required under the DRR. As discussed above, the DRR provides states the option to either model or monitor SO 2 emissions around listed DRR sources, and Maryland chose to model for certain sources. With this in mind, EPA found that for SO 2 , Maryland's monitoring network is sufficient under section 110(a)(2)(B) to monitor, compile and analyze data on SO 2 ambient data, and Maryland does provide monitored or modeled data to EPA upon request. The TSD for the NPRM provides EPA's analysis of how Maryland's submittal met the requirements for section 110(a)(2)(B) and 110(a)(2)(F). Maryland's authority to monitor and analyze ambient air quality is found in sections 2-103(b)(2) and 2-301(a)(1) of the Environment Article, Annotated Code of Maryland. The ambient air quality standards, definitions, reference conditions, and methods of measurement have been approved into the SIP and are found under COMAR 26.11.04.02. Regarding the validity of Maryland's SO 2 monitoring network under 110(a)(2)(B), EPA affirms that Maryland maintains and operates a network of ambient SO 2 monitors throughout the State meeting the requirements of the DRR and other applicable requirements, to measure ambient air quality levels and to determine compliance with the NAAQS. As required by 40 CFR 58.10, Maryland submits an AMNP annually to EPA that details any modifications to the sampling network. Maryland also submits a periodic network assessment to EPA every five years to determine if the network meets the monitoring objectives defined in 40 CFR part 58, appendix D, and to determine whether (1) new sites are needed, (2) existing sites are no longer needed and can be terminated, and (3) new technologies are appropriate for inclusion into the network. As required by 40 CFR 51.320, Maryland submits all ambient air quality data and associated quality assurance data for SO 2 to EPA's Air Quality System (AQS) in accordance with the schedule prescribed by EPA in 40 CFR 58.16. The 2016, 2017, and 2018 AMNP plans are provided in the docket for this rulemaking. 6 Therefore, the NPRM proposed to determine that Maryland met the requirements under section 110(a)(2)(B) of the CAA.

Regarding section 110(a)(2)(F), EPA finds that Maryland's SIP contains authority meeting the requirements to require sources to install, maintain and replace equipment necessary to monitor emissions from sources, the requirements to provide for periodic reports on the nature and amount of emissions from sources, and correlation of reports to the standard. Section 2-103 and 2-301 of the Environment Article, Annotated Code of Maryland, provides the authority for monitoring of air emissions for sources in the State and for adopting regulations to control air pollution, including testing, monitoring, record keeping, and emissions reporting requirements. Under this authority, Maryland has adopted, and EPA has approved into the Maryland SIP, provisions of Code of Maryland (COMAR) 26.11— Air Quality that require the installation, maintenance, and replacement of equipment, and the implementation of other necessary steps by stationary sources for testing, monitoring, recordkeeping, and reporting of emissions. This SIP-approved requirement of COMAR 26.11 also establishes the authority needed to require sources to provide for periodic reports on the nature and amount of emissions from such sources. Also relevant to the requirements of section 110(a)(2)(F) is section .04(B)(4) of Maryland regulation COMAR 26.11.01— Testing and Monitoring, which requires that all testing and monitoring reports submitted to MDE under this section be available for public inspection, and Maryland makes the monitoring data available to the public in real time at this site: https://mde.maryland.gov/programs/Air/AirQualityMonitoring/Pages/index.aspx. The TSD for the NPRM details EPA's analysis of Maryland's submission related to section 110(a)(2)(B) and 110(a)(2)(F), and EPA's determination that the Maryland's submittal meets the requirements for these sections.

Comment 2: The commenter stated that EPA should provide air quality data to the public so the public does not have to guess when facilities are polluting the air, and that monitoring network plans and modifications to the plans should be made public as well. The commenter also states that EPA should require monitoring network plans be made available to the public for comment so the public can litigate based on unbiased publicly available data.

Response 2: The quality-assured, certified monitoring data collected by the State is provided to the public. Maryland makes the monitoring data available to the public in real time at this site: https://mde.maryland.gov/programs/Air/AirQualityMonitoring/Pages/index.aspx. After Maryland submits the certified monitoring data to EPA, EPA reviews the data, then posts the emissions data to EPA's AQS. The AQS air monitoring data can be found at this site: https://www.epa.gov/aqs. EPA posts monitoring data and summary reports at this site: https://www.epa.gov/outdoor-air-quality-data.

Regarding public notice for the AMNP, EPA regulations at 40 CFR part 58, subpart B, require among other things that the state provide the AMNP for public inspection for at least 30 days prior to submission to EPA. 40 CFR 58.10(a)(1). Maryland did provide a 30-day public comment period on the 2016 AMNP, therefore, the public does have an opportunity to comment on Maryland's AMNP at the state level. The monitors installed to characterize SO 2 emissions around the Luke facility are required to continue in operation to report ambient data and may not be shut down unless the monitor meets specific criteria under § 51.1203(c)(3) and 40 CFR part 58. Under 40 CFR 58.10, AMNPs must go through Maryland's public process. Under 40 CFR 58.14, modifications to the SO 2 monitoring network outside of the AMNP require approval by the Regional Administrator of EPA.

Comment 3: The commenter questions why EPA has not yet taken action on section 110(a)(2)(D)(i)(I), and also questions EPA's policy of taking separate, later action on the portion of the Maryland submittal related to this section. In particular, the commenter notes that EPA has had the submittal since August 17, 2016, should have taken action by now, and should not be delaying action for a later date. The commenter notes that Maryland had until June 2, 2013 to submit this SIP and that EPA had 18 months after that to take final action on these SIPs, i.e. December 2, 2014. The commenter states that EPA must take action on this section as soon as possible to prevent harmful air pollution from negatively impacting neighboring states like Delaware, the District of Columbia, Pennsylvania, New Jersey, West Virginia, and Virginia. The commenter also states that this comment serves as a notice of intent to sue on EPA's failure to act on this section of the CAA within the statutory time frame.

Response 3: EPA's approach to reviewing and taking action on infrastructure SIPs is discussed in numerous past infrastructure rulemaking actions. 7 In these past actions, EPA explained an ambiguity in section 110(a)(1) and (2) with respect to infrastructure SIPs pertaining to whether states must meet all of the infrastructure SIP requirements in a single SIP submission, and whether EPA must act upon such SIP submission in a single action. Although section 110(a)(1) directs states to submit “a plan” to meet these requirements, EPA interprets the CAA to allow states to make multiple SIP submissions separately addressing infrastructure SIP elements for the same NAAQS. If states elect to make such multiple SIP submissions to meet the infrastructure SIP requirements, EPA can elect to act on such submissions either individually or in a larger combined action. Similarly, EPA interprets the CAA to allow it to take action on the individual parts of one larger, comprehensive infrastructure SIP submission for a given NAAQS without concurrent action on the entire submission. Therefore, EPA has sometimes elected to act at different times on various elements and sub-elements of the same infrastructure SIP submission.

This is discussed in the guidance issued on September 13, 2013 (2013 Infrastructure Guidance). 8 The 2013 Infrastructure Guidance explains that EPA has historically, when reviewing infrastructure SIP submissions, operated on the basis that the elements and sub-elements of section 110(a)(2) for a given NAAQS are, for the most part, severable. EPA intends to continue its practice of acting on infrastructure SIP elements together or separately, as appropriate, including in this instance, where EPA is taking separate action on the section 110(a)(2)(D)(i)(I) portion of Maryland's submittal. 9

EPA acknowledges that it has not met the statutory date for action on this Maryland submittal. However, this action will discharge EPA's statutory obligation related to section 110(a)(2)(A), (B), (C), (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M) of the CAA. With regard to this comment as a notice of intent to sue on the section 110(a)(2)(D)(i)(I) portion of the submittal, section 304(a) of CAA sets forth the circumstances under which a citizen can sue under the CAA. However, section 304(b) states that no action can be commenced “prior to 60 days after the plaintiff has given notice of such action to the Administrator.” Section 304(b)(2) stipulates that such notice “shall be given in such manner as the Administrator may prescribe by regulation.” The regulations at 40 CFR part 54 require that a notice of intent to sue be served on the Administrator by certified mail. 40 CFR 54.2(a). Title 40 CFR 54.3 specifies the content of such notice and requires, among other things, the full name and address of the person giving notice. So, a citizen intending to file a notice of intent to sue on EPA's mandatory duty to act on any portion of the Maryland submittal is required to do so via certified mail directly to Administrator, which would also need to meet the other requirements specified in 40 CFR part 54. EPA, therefore, does not consider this comment as meeting the requirements for notice of a mandatory duty suit.

Comment 4: The commenter questions EPA's proposed approval of section 110(a)(2)(E) based on Maryland's staff of 43 people, and that EPA needs to clarify whether these 43 individuals are working on only the SO 2 SIP or if they also have other work responsibilities. The commenter believes that EPA should show that these 43 people are able to handle all their assigned duties. The commenter also questions EPA's determination that MDE has adequate funding without an analysis of MDE's revenue and expenses and believes that EPA should perform a financial audit of MDE to ensure the State has adequate funding to perform their obligations under the CAA.

Response 4: As stated in the TSD for the NPRM, EPA's evaluation indicates that the State of Maryland has the staffing and funding resources to meet SIP obligations under section 110(a)(2)(E). Maryland's budget and staff level has been consistent over the past number of years and over these years, Maryland has been able to meet its statutory commitments, including submission of required air quality data and annual monitoring network plans. Maryland has an EPA-approved fee program under CAA title V which is used to support title V program elements such as permitting, monitoring, testing, inspections, and enforcement. EPA conducts periodic title V fee and program audits in accordance with generally accepted government auditing standards. Maryland regulation COMAR 26.11.02.19 provides fee schedules and other relevant fee information regarding title V permits and state permits to operate. Additionally, MDE receives grant funding annually from EPA through CAA section 105 to assist the State with the costs of implementing programs for the prevention and control of air pollution or implementation of national primary and secondary ambient air quality standards. The CAA section 105 grant funding MDE receives goes through an evaluation process under the requirements of 40 CFR part 35, subpart A, which call for the State and EPA to jointly evaluate and report progress and accomplishments under the work plan. Maryland also has various permit programs that are self-funded as they apply fees for permit applications. Most of these permit program fees can be adjusted if the State determines that the fee does not cover the reasonable costs of reviewing and acting upon the permit applications.

In addition to the EPA programs through which funding is received, MDE's infrastructure SIP submission identifies the organizations that participate in developing, implementing, and enforcing the EPA-approved SIP provisions related to a new or revised NAAQS and the associated resources. Maryland's Environmental Trust Fund, administered by the Maryland Department of Natural Resources (DNR), provides Maryland with annual funding that is used by the State to conduct air quality modeling, and also funds the Maryland Power Plan Research Program. Also, the Public Service Commission (PSC) collects application fees from power plants to fund its regulatory program. Based on a review of the existing resources, EPA has concluded that Maryland has met the funding requirements of section 110(a)(2)(E) and has adequate personnel to implement the SIP.

EPA is approving Maryland's August 17, 2016 infrastructure SIP submission which addresses the basic program elements, or portions thereof, specified in sections 110(a)(2)(A), (B), (C), (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M) of the CAA, necessary to implement, maintain, and enforce the 2010 SO 2 NAAQS. EPA is approving Maryland's infrastructure SIP submittal for the 2010 SO 2 NAAQS for these elements. As noted previously, EPA is taking separate action on the portion of the MDE submittal related to transport i.e., section 110(a)(2)(D)(i)(I). Maryland's submittal did not address section 110(a)(2)(I) or the nonattainment new source review (NNSR) permitting program requirements of section 110(a)(2)(C), which pertain to the nonattainment planning requirements of part D of the CAA. States are required to submit those nonattainment area requirements under a different timeline as statutorily required under part D of the CAA.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

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

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

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 17, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action approving portions of Maryland's infrastructure SIP submittal for the 2010 SO 2 NAAQS may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

Accordingly, 40 CFR part 52 is amended as follows:

On February 13, 2020, VA published a proposed rule in the Federal Register (85 FR 8242) which announced VA's intent to amend regulations for VAAR Case RIN 2900-AQ77 (parts 804, 805, 849, and 852). VA provided a 60-day comment period for the public to respond to the proposed rule and submit comments. The comment period for the proposed rule ended on April 13, 2020 and VA received no comments. This rule adopts as a final rule, without changes, the proposed rule published in the Federal Register on February 13, 2020.

This rule makes one non-substantive change to the proposed rule to ensure compliance with the FAR. A recent update in 84 FR 40220, dated Aug. 13, 2019, revised the FAR part 4 heading from “Administrative Matters” to “Administrative and Information Matters.” This final rule includes this technical non-substantive change to the heading under 804 to “Administrative and Information Matters.”

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). E.O. 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866.

VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.”

This final rule is not subject to the requirements of E.O. 13771 because this rule is not significant under E.O. 12866.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This rulemaking does not change VA's policy regarding small businesses, does not have an economic impact to individual businesses, and there are no increased or decreased costs to small business entities. On this basis, the final rule would not have an economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule would have no such effect on State, local, and tribal governments or on the private sector.

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

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Pamela Powers, Acting Deputy Secretary, Department of Veterans Affairs, approved this document on May 3, 2020, for publication.

For the reasons set out in the preamble, VA amends 48 CFR parts 804, 805, 849, and 852 as follows: