Please refer to Docket ID NRC-2020-0031 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2020-0031.

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

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

The NRC encourages electronic submission of comments through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2020-0031 in your comment.

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

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

The NRC's fee regulations are primarily governed by two laws: (1) The Independent Offices Appropriation Act, 1952 (IOAA) (31 U.S.C. 9701), and (2) the Nuclear Energy Innovation and Modernization Act (NEIMA) (42 U.S.C. 2215). The IOAA authorizes and encourages Federal agencies to recover, to the fullest extent possible, costs attributable to services provided to identifiable recipients. Under NEIMA, the NRC must recover, to the maximum extent practicable, approximately 100 percent of its annual budget, less the budget authority for excluded activities. Under Section 102(b)(1)(B) of NEIMA, “excluded activities” include any fee-relief activity as identified by the Commission, generic homeland security activities, waste incidental to reprocessing activities, Nuclear Waste Fund activities, advanced reactor regulatory infrastructure activities, Inspector General services for the Defense Nuclear Facilities Safety Board, research and development at universities in areas relevant to the NRC's mission, and a nuclear science and engineering grant program.

In fiscal year (FY) 2022, the fee-relief activities identified by the Commission are consistent with prior fee rules and include Agreement State oversight, regulatory support to Agreement States, medical isotope production infrastructure, fee exemptions for non-profit educational institutions, costs not recovered from small entities under § 171.16(c) of title 10 of the Code of Federal Regulations (10 CFR), generic decommissioning/reclamation activities, the NRC's uranium recovery program and unregistered general licenses, potential U.S. Department of Defense Program Memorandum of Understanding activities (Military Radium-226), and non-military radium sites. In addition, the resources for import and export licensing are identified as a fee-relief activity to be excluded from the fee-recovery requirement.

Under NEIMA, the NRC must use its IOAA authority first to collect service fees for NRC work that provides specific benefits to identifiable recipients (such as licensing work, inspections, and special projects). The NRC's regulations in 10 CFR part 170, “Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended,” explain how the agency collects service fees from specific beneficiaries. Because the NRC's fee recovery under the IOAA (10 CFR part 170) will not equal 100 percent of the agency's total budget authority for the fiscal year (less the budget authority for excluded activities), the NRC also assesses “annual fees” under 10 CFR part 171, “Annual Fees for Reactor Licenses and Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by the NRC,” to recover the remaining amount necessary to comply with NEIMA.

The NRC is issuing this FY 2022 proposed fee rule based on the FY 2022 budget request as further described in the NRC's FY 2022 Congressional Budget Justification (CBJ) (NUREG-1100, Volume 37) because a full-year appropriation has not yet been enacted for FY 2022. The amount used for total budget authority in this proposed rule is $887.7 million, an increase of $43.3 million from FY 2021. As explained previously, certain portions of the NRC's total budget authority for the fiscal year are excluded from NEIMA's fee-recovery requirement under Section 102(b)(1)(B) of NEIMA. Based on the FY 2022 budget request, these exclusions total $131.0 million, an increase of $8.0 million from FY 2021. These excluded activities consist of $91.5 million for fee-relief activities, $23.1 million for advanced reactor regulatory infrastructure activities, $14.3 million for generic homeland security activities, $1.0 million for waste incidental to reprocessing activities, and $1.1 million for Inspector General services for the Defense Nuclear Facilities Safety Board. Table I summarizes the excluded activities for the FY 2022 proposed fee rule. The FY 2021 amounts are provided for comparison purposes.

After accounting for the exclusions from the fee-recovery requirement and net billing adjustments ( i.e., for FY 2022 invoices that the NRC estimates will not be paid during the fiscal year, less payments received in FY 2022 for prior year invoices), the NRC must recover approximately $752.2 million in fees in FY 2022. Of this amount, the NRC estimates that $188.9 million will be recovered through 10 CFR part 170 service fees and approximately $563.3 million will be recovered through 10 CFR part 171 annual fees. Table II summarizes the fee-recovery amounts for the FY 2022 proposed fee rule using the budget request and takes into account the budget authority for excluded activities and net billing adjustments. For all information presented in the following tables, individual values may not sum to totals due to rounding. Please see the work papers, available as indicated in the “Availability of Documents” section of this document, for actual amounts.

In FY 2021, the explanatory statement associated with the Consolidated Appropriations Act, 2021, included direction for the NRC to use $35.0 million in prior-year unobligated carryover funds, including $16.0 million for the University Nuclear Leadership Program. Since a full-year appropriation has not yet been enacted, the FY 2022 proposed fee rule is based on the FY 2022 budget request. Therefore, this proposed fee rule does not account for the utilization of carryover funds. The FY 2021 amounts are provided for comparison purposes.

The NRC uses a professional hourly rate to assess fees under 10 CFR part 170 for specific services it provides. The professional hourly rate also helps determine flat fees (which are used for the review of certain types of license applications). This rate is applicable to all activities for which fees are assessed under §§ 170.21 and 170.31.

The NRC's professional hourly rate is derived by adding budgeted resources for (1) mission-direct program salaries and benefits, (2) mission-indirect program support, and (3) agency support (corporate support and the Inspector General). The NRC then subtracts certain offsetting receipts and divides this total by the mission-direct full-time equivalent (FTE) converted to hours (the mission-direct FTE converted to hours is the product of the mission-direct FTE multiplied by the estimated annual mission-direct FTE productive hours). The only budgeted resources excluded from the professional hourly rate are those for mission-direct contract resources, which are generally billed to licensees separately. The following shows the professional hourly rate calculation:

For FY 2022, the NRC is proposing to increase the professional hourly rate from $288 to $291. The 0.9 percent increase in the professional hourly rate is primarily due to a 1.5 percent increase in budgetary resources of approximately $11.2 million. The increase in budgetary resources is, in turn, primarily due to an increase in salaries and benefits to support Federal pay raises for NRC employees. The anticipated increase in the number of mission-direct FTE compared to FY 2021 is an offset to the increase in the professional hourly rate. The number of mission-direct FTE is expected to increase by 10, primarily to support new reactor licensing activities, including the review of design certifications, pre-application activities, and the review of combined license (COL) applications.

The FY 2022 estimate for annual mission-direct FTE productive hours is 1,510 hours, which is unchanged from FY 2021. This estimate, also referred to as the productive hours assumption, reflects the average number of hours that a mission-direct employee spends on mission-direct work in a given year. This estimate, therefore, excludes hours charged to annual leave, sick leave, holidays, training, and general administrative tasks. Table III shows the professional hourly rate calculation methodology. The FY 2021 amounts are provided for comparison purposes.

The NRC proposes to amend the flat application fees it charges in its schedule of fees in §§ 170.21 and 170.31 to reflect the revised professional hourly rate of $291. The NRC charges these fees to applicants for materials licenses and other regulatory services, as well as to holders of materials licenses. The NRC calculates these flat fees by multiplying the average professional staff hours needed to process the licensing actions by the professional hourly rate for FY 2022. As part of its calculations, the NRC analyzes the actual hours spent performing licensing actions and estimates the five-year average of professional staff hours that are needed to process licensing actions as part of its biennial review of fees. These actions are required by Section 205(a) of the Chief Financial Officers Act of 1990 (31 U.S.C. 902(a)(8)). The NRC performed this review in FY 2021 and will perform this review again in FY 2023. The higher professional hourly rate of $291 is the primary reason for the increase in flat application fees (see the work papers).

In order to simplify billing, the NRC rounds these flat fees to a minimal degree. Specifically, the NRC rounds these flat fees (up or down) in such a way that ensures both convenience for its stakeholders and minimal effects due to rounding. Accordingly, fees under $1,000 are rounded to the nearest $10, fees between $1,000 and $100,000 are rounded to the nearest $100, and fees greater than $100,000 are rounded to the nearest $1,000.

The flat fees are applicable for certain materials licensing actions (see fee categories 1.C. through 1.D., 2.B. through 2.F., 3.A. through 3.S., 4.B. through 5.A., 6.A. through 9.D., 10.B., 15.A. through 15.L., 15.R., and 16 of § 170.31). Applications filed on or after the effective date of the FY 2022 final fee rule will be subject to the revised fees in the final rule.

In accordance with NEIMA, in FY 2022, the NRC identified international activities, including the resources for import and export licensing activities, as a fee-relief activity to be excluded from the fee-recoverable budget. The FY 2021 final fee rule, published in the Federal Register (86 FR 32146; June 16, 2021), provided for fees to be charged for import and export licensing actions, consistent with the FY 2021 budget request. However, charging fees under 10 CFR part 170 for import and export licensing actions during the effective dates of the FY 2021 final fee rule would be inconsistent with the Commission's substantive fee policy decision in the FY 2022 budget request and would result in the NRC imposing fees for import and export licensing actions for only one FY between FY 2018 and FY 2022. This would not be fair and equitable and could also lead to confusion for the affected import and export license applicants/licensees. Therefore, in light of the particular facts and unique history associated with this matter, on August 20, 2021, the Chief Financial Officer concluded that it would be in the public interest to grant an exemption from the provisions in the FY 2021 final fee rule (in §§ 170.21 and 170.31) that would require fees for import and export licensing actions in accordance with § 170.11(b). In accordance with the Commission's substantive fee policy decision for FY 2022, fees will not be assessed for import and exporting licensing activities (see fee categories K.1. through K.5. of § 170.21 and fee categories 15.A. through 15.R. of § 170.31) under this proposed rule.

As in prior years, the NRC proposes to assess a generic low-level waste (LLW) surcharge of $4.3 million. Disposal of LLW occurs at commercially operated LLW disposal facilities that are licensed by either the NRC or an Agreement State. Four existing LLW disposal facilities in the United States accept various types of LLW. All are located in Agreement States and, therefore, are regulated by an Agreement State, rather than the NRC. The NRC proposes to allocate this surcharge to its licensees based on data available in the U.S. Department of Energy's (DOE) Manifest Information Management System. This database contains information on total LLW volumes disposed of by four generator classes: Academic, industrial, medical, and utility. The ratio of waste volumes disposed of by these generator classes to total LLW volumes disposed over a period of time is used to estimate the portion of this surcharge that will be allocated to the power reactors, fuel facilities, and the materials users fee classes. The materials users fee class portion is adjusted to account for the large percentage of materials licensees that are licensed by the Agreement States rather than the NRC.

Table IV shows the allocation of the LLW surcharge and its allocation across the various fee classes.

In accordance with SECY-05-0164, “Annual Fee Calculation Method,” the NRC rebaselines its annual fees every year. “Rebaselining” entails analyzing the budget in detail and then allocating the FY 2022 budgeted resources to various classes or subclasses of licensees. It also includes updating the number of NRC licensees in its fee calculation methodology.

The NRC is proposing revisions to its annual fees in §§ 171.15 and 171.16 to recover approximately 100 percent of the NRC's FY 2022 budget request (less the budget authority for excluded activities and the estimated amount to be recovered through 10 CFR part 170 fees). The total estimated 10 CFR part 170 collections for this proposed rule are $188.9 million, which is a decrease of $1.6 million from the FY 2021 final rule. The NRC, therefore, must recover $563.3 million through annual fees from its licensees, which is an increase of $43.1 million from the FY 2021 final rule.

Table V shows the proposed rebaselined fees for FY 2022 for a sample of licensee categories. The FY 2021 amounts are provided for comparison purposes.

The work papers that support this proposed rule show in detail how the NRC allocates the budgeted resources for each class of licensees and calculates the fees.

Paragraphs a. through h. of this section describe the budgeted resources allocated to each class of licensees and the calculations of the rebaselined fees. For more information about detailed fee calculations for each class, please consult the accompanying work papers for this proposed rule.

The NRC proposes to collect $485.5 million in annual fees from the operating power reactors fee class in FY 2022, as shown in Table VI. The FY 2021 operating power reactors fees are shown for comparison purposes.

In comparison to FY 2021, the FY 2022 proposed annual fee for the operating power reactors fee class is increasing primarily due to the following: (1) An increase in budgeted resources; (2) a reduction of the 10 CFR part 171 billing adjustment; (3) the absence of the collection adjustment that was provided in FY 2021 due to the shutdown of Indian Point Generating, Unit 3; and (4) a decrease in 10 CFR part 170 estimated billings. The increase in the annual fee for the operating power reactors fee class is partially offset due to the increase in the total number of operating power reactors from 93 to 94. These components are discussed in the following paragraphs.

The budgeted resources for the operating power reactors fee class increased primarily due to the following: (1) An increase in contract funding in the information technology program to support the Mission Analytics Portal (a tool to enhance the agency's ability to leverage data to support mission activities), to develop infrastructure to increase analytics capabilities using artificial intelligence, and to develop mobile applications for resident inspectors; (2) an increase in certain contract costs in the areas of research, event response, and licensing due to the absence of authorized prior year unobligated carryover funding compared to FY 2021; (3) to support new reactor licensing activities for the review of the Westinghouse eVinci micro reactor design certification, the review of the NuScale Power, LLC standard design approval application, and pre-application activities for three non-light water reactors and COL applications; and (4) security-related pre-application activities for the Utah Associated Municipal Power Systems application. These new reactor resources are offset by a decrease in oversight resulting from the anticipated transition of Vogtle Electric Generating Plant, Units 3 and 4 (Vogtle Units 3 and 4), from construction into operation.

The proposed annual fee is also increasing due to the following contributing factors: (1) A lower 10 CFR part 171 billing adjustment credit than was included in the operating power reactors fee class calculation in FY 2021 from the deferral of annual fees and service fees due to the coronavirus disease (COVID-19) pandemic; and (2) the absence of the one-time current year collection adjustment that resulted in a credit of $2,700,000 due to the shutdown of Indian Point Nuclear Generating, Unit 3, in FY 2021.

Furthermore, the proposed annual fee for the operating power reactors fee class is increasing due to a decrease in the 10 CFR part 170 estimated billings as a result of the following: (1) The NRC's denial of the Oklo Power, LLC COL application to build and operate the Aurora compact fast reactor and (2) a decrease in hours associated with operator reactor licensing activities. The decrease in 10 CFR part 170 estimated billings is offset by an increase in work due to the following: (1) An anticipated rise in in-person inspections and travel as COVID-19 impacts become less prominent; (2) an increase in operating reactors license renewal applications; and (3) licensing activities to support the planned reviews of new power reactor designs.

The fee-recoverable budgeted resources are divided equally among the 94 licensed operating power reactors, an increase of one operating power reactor compared to FY 2021 due to the proposed assessment of annual fees for Vogtle Unit 3, resulting in an annual fee of $5,165,000 per reactor. Additionally, each licensed operating power reactor will be assessed the FY 2022 spent fuel storage/reactor decommissioning annual fee of $254,000 (see Table VII and the discussion that follows). The combined FY 2022 proposed annual fee for each operating power reactor is $5,419,000.

Section 102(b)(3)(B)(i) of NEIMA established a new cap for the annual fees charged to operating reactor licensees; under this provision, the annual fee for an operating reactor licensee, to the maximum extent practicable, shall not exceed the annual fee amount per operating reactor licensee established in the FY 2015 final fee rule (80 FR 37432; June 30, 2015), adjusted for inflation. The NRC included an estimate of the operating power reactors annual fee in Appendix C, “Estimated Operating Power Reactors Annual Fee,” of the FY 2022 budget request, with the intent to increase transparency with stakeholders. The NRC developed this estimate based on the staff's allocation of the FY 2022 budget request to fee classes under 10 CFR part 170, and allocations within the operating power reactors fee class under 10 CFR part 171. In addition, the estimated annual fee assumed 94 operating power reactors in FY 2022 and applied various data assumptions from the FY 2021 final fee rule (86 FR 32146; June 16, 2021). Based on these allocations and assumptions, the operating power reactor annual fee included in the FY 2022 budget request was estimated to be $4.8 million, approximately $0.6 million below the FY 2015 operating power reactors annual fee amount adjusted for inflation of $5.5 million. Although the FY 2022 budget request included the estimated operating power reactors annual fee, the assumptions made between budget formulation and the development of the FY 2022 proposed rule have changed; however, the FY 2022 proposed annual fee of $5,165,000 remains below the FY 2015 operating power reactors annual fee amount adjusted for inflation.

In FY 2016, the NRC amended its licensing, inspection, and annual fee regulations to establish a variable annual fee structure for light-water small modular reactors (SMRs) (81 FR 32617). Under the variable annual fee structure, an SMR annual fee would be assessed as a function of its bundled licensed thermal power rating. Currently, there are no operating SMRs; therefore, the NRC will not assess an annual fee in FY 2022 for this type of licensee.

The NRC proposes to collect $31.3 million in annual fees from 10 CFR part 50 power reactor licensees, and from 10 CFR part 72 licensees that do not hold a 10 CFR part 50 license, to recover the budgeted resources for the spent fuel storage/reactor decommissioning fee class in FY 2022, as shown in Table VII. The FY 2021 spent fuel storage/reactor decommissioning fees are shown for comparison purposes.

In comparison to FY 2021, the FY 2022 proposed annual fee for the spent fuel storage/reactor decommissioning fee class is increasing primarily due to the following: (1) The decline in the 10 CFR part 170 estimated billings and (2) a reduction of the 10 CFR part 171 billing adjustment. The increase in the proposed annual fee is partially offset by a decrease in the budgeted resources. These components are discussed in the following paragraphs.

The 10 CFR part 170 estimated billings for the spent fuel storage/reactor decommissioning fee class decreased primarily due to the following: (1) A reduction in hours and contract support associated with the staff's review of applications for renewals and amendments for independent spent fuel storage installation (ISFSI) licenses and dry cask storage certificates of compliance (CoCs); (2) the completion of the review of the Interim Storage Partners consolidated interim storage facility application and issuance of the license; and (3) the near completion of the staff's review of the Holtec HI-STORE consolidated interim storage facility application. This decrease in the 10 CFR part 170 estimated billings is partially offset by increased work, including the following: (1) Inspection activities, exemption requests, and financial assurance reviews for ISFSI licenses and dry cask storage CoCs; (2) the staff's review of a new fuel storage system; and (3) activities within the power reactor decommissioning program to support Indian Point Generating Unit 2's transition to decommissioning, the staff's review of a license transfer application for Kewaunee, and an increase in contract support for license termination plan activities, cooling tower demo surveys, and confirmatory surveys.

The increase in the annual fee is also due to a lower 10 CFR part 171 billing adjustment credit than was included in the spent fuel storage/reactor decommissioning fee class calculation in FY 2021 from the deferral of annual fees and service fees due to the COVID-19 pandemic.

The increase in the annual fee for the spent fuel storage/reactor decommissioning fee class is partially offset by a decline in budgeted resources with changes in workload primarily due to the completion of the license application reviews for the consolidated interim storage facilities and renewals for other ISFSIs. The decrease in the budgeted resources is offset by an increase in contract costs due to the absence of prior year unobligated carryover funding compared to FY 2021.

The required annual fee recovery amount is divided equally among 123 licensees, resulting in a FY 2022 annual fee of $254,000 per licensee.

The NRC proposes to collect $16.8 million in annual fees from the fuel facilities fee class in FY 2022, as shown in Table VIII. The FY 2021 fuel facilities fees are shown for comparison purposes.

In comparison to FY 2021, the FY 2022 proposed annual fee for the fuel facilities fee class is decreasing primarily due to the decrease in budgeted resources and the increase in 10 CFR part 170 estimated billings as discussed in the following paragraphs.

The budgeted resources for the fuel facilities fee class decreased primarily due to the following: (1) Efficiencies gained as a result of implemented enhancements to the licensing program and 2) enhancements made to the fuel facility oversight program through the implementation of the smarter inspection program.

The 10 CFR part 170 estimated billings increased as a result of the following: (1) The review of a new fuel facility license application, including the environmental review, for TRISO-X and (2) the staff's continued review of the Westinghouse Electric Company, LLC license renewal application.

The NRC will continue allocating annual fees to individual fuel facility licensees based on the effort/fee determination matrix developed in the FY 1999 final fee rule (64 FR 31447; June 10, 1999). To briefly recap, the matrix groups licensees within this fee class into various fee categories. The matrix lists processes that are conducted at licensed sites and assigns effort factors for the safety and safeguards activities associated with each process (these effort levels are reflected in Table IX). The annual fees are then distributed across the fee class based on the regulatory effort assigned by the matrix. The effort factors in the matrix represent regulatory effort that is not recovered through 10 CFR part 170 fees ( e.g., rulemaking, guidance). Regulatory effort for activities that are subject to 10 CFR part 170 fees, such as the number of inspections, is not applicable to the effort factor.

In FY 2022, the total remaining amount of the proposed annual fees to be recovered, $16.8 million, is attributable to safety activities, safeguards activities, and the LLW surcharge. For FY 2022, the total budgeted resources proposed to be recovered as annual fees for safety activities are $8.9 million. To calculate the annual fee, the NRC allocates this amount to each fee category based on its percentage of the total regulatory effort for safety activities. Similarly, the NRC allocates the budgeted resources to be recovered as annual fees for safeguards activities, $7.5 million, to each fee category based on its percentage of the total regulatory effort for safeguards activities. Finally, the fuel facilities fee class portion of the LLW surcharge—$0.4 million—is allocated to each fee category based on its percentage of the total regulatory effort for both safety and safeguards activities. The proposed annual fee per licensee is then calculated by dividing the total allocated budgeted resources for the fee category by the number of licensees in that fee category. The proposed annual fee for each facility is summarized in Table X.

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0145; Project Identifier MCAI-2021-00522-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Hal Jensen, Aerospace Engineer, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC 20024; phone: (202) 267-9167; email: hal.jensen@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2019-11-05, Amendment 39-19651 (84 FR 26546, June 7, 2019) (AD 2019-11-05), which applies to certain Bell Helicopter Textron Canada Limited Model 429 helicopters. AD 2019-11-05 requires inspecting the TR pitch link assemblies, and replacing certain pitch link bearings. The FAA issued AD 2019-11-05 to address a worn pitch link, which if not corrected, could result in pitch link failure and subsequent loss of control of the helicopter.

Since the FAA issued AD 2019-11-05, the FAA has determined that additional TR pitch link assemblies are affected by the unsafe condition. AD 2019-11-05 applies to helicopters with a pitch link assembly part number (P/N) 429-012-112-101, 429-012-112-103, 429-012-112-101FM, or 429-012-112-103FM installed. However, as specified in the corresponding TCCA AD, CF-2015-16R2, dated April 3, 2017 (TCCA AD CF-2015-16R2), all pitch link assemblies are part of the repetitive inspections.

The TCCA, which is the aviation authority for Canada, has issued TCCA AD CF-2015-16R3, dated April 30, 2021 (TCCA AD CF-2015-16R3) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain Bell Helicopter Textron Canada Limited Model 429 helicopters. TCCA AD CF-2015-16R3 retains the requirements of TCCA AD CF-2015-16R2 and revises the applicability by specifying certain helicopter serial numbers to account for new production helicopters which have already incorporated the new pitch link assemblies and corrected the unsafe condition. TCCA AD CF-2015-16R3 also specifies that installing a new pitch link assembly terminates the repetitive inspections.

This proposed AD was prompted by a report of a worn pitch link, and the FAA's determination that that all TR pitch link assemblies are affected by the unsafe condition. The FAA is proposing this AD to address a worn pitch link, which if not corrected, could result in pitch link failure and subsequent loss of control of the helicopter. See the MCAI for additional background information.

These products have been approved by the aviation authority of Canada, and are approved for operation in the United States. Pursuant to the bilateral agreement with Canada, TCCA, its technical representative, has notified the FAA of the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining the unsafe condition described previously is likely to exist or develop in other products of the same type design.

The FAA reviewed Bell Alert Service Bulletin No. 429-15-16, Revision C, dated October 16, 2020. This service information contains procedures for inspecting the TR pitch link assemblies, replacing certain pitch link bearings, and replacement of the pitch link assemblies. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This proposed AD would retain all of the requirements of AD 2019-11-05. This proposed AD would revise the applicability and require inspections of all TR pitch link assemblies.

The FAA estimates that this proposed AD affects 120 helicopters of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

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

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

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

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

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-1168; Project Identifier AD-2021-00825-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Chris Baker, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3552; email: christopher.r.baker@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA has received a report that, during production, a small number of fasteners common to upper wing panel stringers U-S1, U-S10, U-S12, U-S20, and U-S21 and lower wing panel stringer L-S14 were cap sealed on top of a black stripe of ink with a clear overcoat. The black stripe and clear overcoat were applied during airplane assembly to certain interior areas of the center fuel tank to ensure proper alignment of components, and this discrepancy was not identified by Boeing prior to the delivery of certain airplanes. The purpose of cap sealing is to provide a secondary layer of lightning protection to the metal-to-metal rivet installation bond, however, the clear overcoat is not an approved surface for sealing and can compromise sealant adhesion. Compromised sealant adhesion can, over time, affect the lightning-protection properties of the airplane. This condition, if not addressed, could result in ignition of fuel vapors and subsequent explosion of the fuel tank in the event of a lightning strike. The FAA expects, however, that the degree to which sealant adhesion is compromised under these circumstances, and therefore the risk, will initially be small, and increase gradually over a period of years as the adhesion begins to deteriorate. Additionally, the compliance time would allow operators to align this work with the typical schedule for maintenance into the airplane's fuel tank, which rarely exceeds once every ten years. Therefore, based on the evaluated risk, the FAA has determined that the related actions need to be completed within the timeframes identified in paragraph (g) of this proposed AD and in the manufacturer's service information.

The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

The FAA reviewed Boeing Special Attention Requirements Bulletin 737-57-1352 RB, dated February 1, 2021. This service information specifies procedures for preparing the surface and completely encapsulating the black stripe of ink, the clear overcoat, and the existing sealant with the approved production (BMS5-45) sealant at upper stringer U-S1, U-S10, U-S12, U-S20, and U-S21, and lower stringer L-S14. The affected areas are all located on the portion of the stringers just outboard of the wing box.

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

This proposed AD would require accomplishing the actions specified in the service information already described, except for any differences identified as exceptions in the regulatory text of this proposed AD. For information on the procedures and compliance times, see this service information at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-1168.

The FAA estimates that this AD, if adopted as proposed, would affect 11 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

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

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

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

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0143; Project Identifier MCAI-2021-01401-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Antariksh Shetty, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email 9-avs-nyaco-cos@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued TCCA AD CF-2009-29R4, dated October 1, 2021 (TCCA AD CF-2009-29R4) (also referred to after this as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain De Havilland Aircraft of Canada Limited Model DHC-8-401 and -402 airplanes. You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0143.

The FAA issued AD 2021-25-12, Amendment 39-21856 (86 FR 72174, December 21, 2021) (AD 2021-25-12), for certain De Havilland Aircraft of Canada Limited Model DHC-8-401 and -402 airplanes. AD 2021-25-12 requires repetitive lubrications of the trailing arm of the NLG, which include a general visual inspection of the NLG pivot pin mechanism for discrepancies and replacement of missing or damaged bolts. AD 2021-25-12 also requires revising the existing maintenance or inspection program to include new and revised airworthiness limitations (life limits for certain bolts). AD 2021-25-12 corresponds to TCCA AD CF-2009-29R4, except AD 2021-25-12 does not include the modification to the NLG shock strut assembly specified in Part I of TCCA AD CF-2009-29R4. AD 2021-25-12 explained that the FAA was considering further rulemaking to require the modification. The FAA has now determined that further rulemaking is necessary, and this proposed AD follows from that determination.

The FAA is proposing this AD to address failure of the pivot pin retention bolt, which could result in a loss of directional control or loss of an NLG tire during takeoff or landing, which could lead to runway excursions. See the MCAI for additional background information.

This NPRM does not propose to supersede AD 2021-25-12. Rather, the FAA has determined that a stand-alone AD would be more appropriate. This proposed AD would require the modification specified in Part I of TCCA AD CF-2009-29R4 that was not included in AD 2021-25-12.

De Havilland Aircraft of Canada Limited has issued Service Bulletin 84-32-161, Revision B, dated March 31, 2021, including UTC Aerospace Systems Service Bulletin 47100-32-145, Revision 3, dated March 26, 2021. This service information describes procedures for modifying the NLG shock strut assembly by replacing special bolt, part number (P/N) 47205-1 or 47205-3, with a new retention bolt, P/N NAS6204-14D (the modification includes a reverse orientation of the retention bolt and a rework of the weight on wheel (WOW) proximity sensor cover to provide clearance for the re-oriented retention bolt).

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.

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

This proposed AD would require accomplishing the actions specified in the service information already described.

This proposed AD would only require the modification specified in Part I of TCCA AD CF-2009-29R4. The other actions specified in TCCA AD CF-2009-29R4 are required by FAA AD 2021-25-12.

The FAA estimates that this AD, if adopted as proposed, would affect 54 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

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

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

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0146; Project Identifier AD-2021-00449-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Dorie Resnik, Aerospace Engineer, Aviation Safety Section, Boston ACO Branch, Compliance & Airworthiness Division, 1200 District Avenue, Burlington, MA 01803; telephone (781) 238-7693; email 9-AVS-AIR-BACO-COS@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2020-26-13, Amendment 39-21368 (85 FR 84201, December 28, 2020) (AD 2020-26-13) for Sikorsky Model S-92A helicopters with forward root fitting part number (P/N) 92209-07111-101 or 92070-20125-101; or stabilizer strut fitting P/N 92209-07404-041, 92209-07403-041, or 92070-20117-041 installed on horizontal stabilizer assembly (stabilizer assembly) P/N 92070-20117-045, 92070-20117-046, 92070-20125-041, 92070-20125-042, 92070-20125-043, 92070-20125-044, 92205-07400-043, or 92205-07400-045. AD 2020-26-13 was prompted by seven incidents of fatigue cracks in forward root fittings. Fatigue cracking in a forward root fitting degrades the load path and increases the load on other assembly parts, particularly at the aft horizontal stabilizer attachment points; therefore AD 2020-26-13 requires determining the total hours time-in-service (TIS) of the forward root fitting and the stabilizer strut fitting, establishing a life limit of 7,900 total hours TIS for certain part-numbered forward root fittings, and establishing a life limit of 19,100 total hours TIS for certain stabilizer strut fittings. For certain part-numbered stabilizer strut fittings, AD 2020-26-13 also requires repetitive inspections of certain parts of an affected stabilizer strut assembly. The FAA issued AD 2020-26-13 to prevent a forward root fitting from remaining in service beyond its life limit and to detect fatigue cracking in a forward root fitting and prevent increased load and stress cracking in the stabilizer root fitting aft.

Since the FAA issued AD 2020-26-13, Sikorsky notified the FAA that incorrect P/Ns are identified in the Applicability and the Required Actions paragraphs of AD 2020-26-13. This NPRM would expand the applicability of AD 2020-26-13 by adding an additional part-numbered stabilizer assembly. This NPRM would correct paragraph (g)(4) of the Required Actions so that the installation of the titanium stabilizer strut fitting P/N 92209-07404-041 is terminating action for the 50-hour TIS inspections of the aluminum stabilizer strut fitting P/N 92070-20117-04 or 92209-07403-041.

Sikorsky also notified the FAA that an additional repetitive inspection of certain parts of the stabilizer strut assembly is required to prevent the unsafe condition; this NPRM includes this repetitive inspection. Additionally, since AD 2020-26-13 was issued, Sikorsky requested and the FAA approved a global Alternative Method of Compliance (AMOC) to allow only removing parts from service that are cracked, corroded, or have fretting, deformation, or wear rather than require removing the upper and lower support strut rod ends, including lug and conical fitting and both upper and lower attachment fittings on the stabilizer from service. This NPRM incorporates that global AMOC into the proposed requirements.

The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would continue to require S-92 Maintenance Manual, SA S92A-AMM-000, Temporary Revision (TR) 55-33, dated March 24, 2020 (TR 55-33), which the Director of the Federal Register approved for incorporation by reference as of February 1, 2021 (85 FR 84201, December 28, 2020).

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

The FAA reviewed S-92 Maintenance Manual SA S92A-AWL-000, TR No. 4-58, dated October 2, 2017 (TR 4-58), and S-92 Maintenance Manual SA S92A-AWL-000, TR No. 4-66 dated November 20, 2019 (TR 4-66). This service information revises Task 4-00-00-200-000, Table 1 Replacement Schedule, dated November 30, 2015. Both TR 4-58 and 4-66 revise the Airworthiness Limitations Schedule by removing certain part-numbered components, introducing new part-numbered components, and establishing replacement intervals and recurring inspections for the forward root fitting and the horizontal stabilizer strut fitting. TR 4-58 also specifies inspecting the horizontal stabilizer and attaching hardware at a recurring interval of 250 hours TIS.

This proposed AD would require determining the total hours TIS of the forward root fitting and the stabilizer strut fitting. This proposed AD would also require establishing a life limit of 7,900 total hours TIS for certain part-numbered forward root fittings and establishing a life limit of 19,100 total hours TIS for stabilizer strut fitting P/N 92070-20117-041. Finally, this proposed AD would require for certain part-numbered stabilizer strut fittings installed, repetitively visually inspecting the following at intervals not to exceed 50 hours TIS:

• The hat bushing and both upper and lower fittings for a crack, corrosion, fretting, deformation, and wear.

• Both upper and lower support strut rod ends, including each lug and conical fitting, and both upper and lower attachment fittings on the stabilizer and pylon, including the bushings, for a crack, corrosion, fretting, deformation, and wear.

• The surface of each Mylar washer P/N 92070-20117-104 on certain stabilizer assemblies.

This proposed AD would also require repetitively inspecting the following at intervals not to exceed 250 hours TIS or one year, whichever occurs first:

• Each stabilizer attachment bolt and barrel nut set for corrosion, a crack, and damage to the threads indicated by uneven threads, missing threads, or cross-threading.

• Each forward root fitting and aft attachment fitting, including inspecting the bolt holes and fastener holes for a crack, wear, and corrosion; or as an alternative to detect any crack, fluorescent penetrant inspecting (FPI) the area.

• Each forward and aft attachment fitting mating surface for wear of the abrasion-resistant Teflon coating and degradation. For the purposes of this inspection, degradation may be indicated by fretting. If there is any wear of the coating or fretting, this proposed AD would require stripping the coating and performing a FPI or eddy current inspection to inspect for a crack. If there is no crack, this proposed AD would require recoating the surfaces.

Depending on the inspection results, this proposed AD would require removing parts from service before further flight.

Finally, this proposed AD would prohibit installing stabilizer assembly P/N 92205-07400-043, 92205-07400-045, and 92205-07400-047 on any helicopter.

The service information specifies that returning affected parts to a Sikorsky specialist is required; whereas this proposed AD would not include this requirement.

The FAA estimates that this proposed AD would affect 82 helicopters of U.S. registry. Labor costs are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.

Visually inspecting the stabilizer assembly and attached hardware would take about 3 work-hours for an estimated cost of $255 per helicopter and $20,910 for the U.S. fleet per inspection cycle.

If required, replacing a hat bushing and both upper fittings and lower fittings would take about 1 work-hour and parts would cost about $10,000 for an estimated cost of $10,085 per replacement.

If required, replacing the upper and lower support strut rod ends, including lug and conical fitting, would take about 1 work-hour and parts would cost about $10,000 for an estimated cost of $10,085 per replacement.

If required, replacing Mylar washers would take about 0.5 work-hour and parts would cost about $76 for an estimated cost of $119 per replacement.

If required, performing a fluorescent penetrant inspection would take about 3 work-hours for an estimated cost of $255 per inspection.

If required, replacing a stabilizer assembly would take about 6 work-hours and parts would cost about $312,000 for an estimated cost of $312,510 per replacement.

If required, replacing a forward root fitting would take about 10 work-hours and parts would cost about $25,000 for an estimated cost of $25,850 per replacement.

If required, replacing a stabilizer strut fitting would take about 10 work-hours and parts would cost about $10,000 for an estimated cost of $10,850 per replacement.

If required, replacing a forward root fitting and an aft attachment fitting would take about 20 work-hours and parts would cost about $50,000 for an estimated cost of $51,700 per replacement.

If required, removing wear or corrosion and applying corrosion preventative compound would take about 0.5 work-hour and parts would cost a nominal amount for an estimated cost of $43 per action.

If required, replacing a stabilizer attachment bolt and barrel nut set would take about 1 work-hour and parts would cost about $500 for an estimated cost of $585 per replacement.

If required, replacing a fastener would take about 0.1 work-hour and parts would cost a nominal amount for an estimated cost of $9 per fastener.

If required, removing the abrasion-resistant Teflon coating to inspect each forward and aft attachment fitting mating surface would take about 5 work-hours for an estimated cost of $425 per inspection.

If required, applying alodine or equivalent and applying abrasion-resistant Teflon coating would take about 5 work hours with minimal parts cost for an estimated cost of $425 per application.

According to Sikorsky, some of the costs of this proposed 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.

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

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

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the proposed regulation:

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

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

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

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

FDA has historically recognized the benefits of harmonization with other regulatory authorities and over time has taken a number of actions to promote consistency with its regulatory counterparts. As part of such activities, FDA is proposing to revise its device CGMP requirements as set forth in the QS regulation, codified in part 820 (21 CFR part 820). Through this proposed rulemaking, FDA intends to converge its requirements with quality management system requirements used by other regulatory authorities. FDA seeks to accomplish this primarily by incorporating by reference the 2016 edition of International Organization for Standardization (ISO) 13485 (ISO 13485). This rule, if finalized, would harmonize quality management system requirements for devices with requirements used by other regulatory authorities. Such harmonization should provide patients more efficient access to necessary devices, leading to improvement of life quality of the consumers.

We are proposing to amend the current part 820, primarily, through incorporating by reference the quality management system requirements of ISO 13485. We have determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the current part 820, providing a similar level of assurance in a firm's quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act. As such, we propose to withdraw the requirements in the current part 820, except that we propose to retain the scope of the current regulation and to retain and modify, as indicated below, a number of the definitions in the current part 820. We are also proposing to amend the title of the regulation and add FDA-specific requirements and provisions that clarify certain concepts used in ISO 13485. The result will be referred to as the Quality Management System Regulation (QMSR). These additions will ensure that the incorporation by reference of ISO 13485 does not create inconsistencies with other applicable FDA requirements. FDA is also proposing conforming edits to part 4 (21 CFR part 4) to clarify the device QMS requirements for combination products. These edits would not impact the CGMP requirements for combination products. The rule, if finalized, would converge QS regulation with the QMS requirements of ISO 13485, while continuing to provide the same level of assurance of safety and effectiveness under the FD&C Act and its implementing regulations. The Agency solicits comments on specific subject areas related to this proposed rule that FDA should consider in seeking to converge U.S. requirements with requirements used by other regulatory authorities in ways that are consistent with FDA's authority under the FD&C Act.

We are proposing to issue this rule under the same authority that FDA initially invoked to issue the current part 820 and combination product regulations, as well as the general administrative provisions of the FD&C Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360 l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264).

We estimate that the proposed rule will result in an annualized net cost savings (benefits) of approximately $439 million over 10 years at a discount rate of 3 percent. When we assume a discount rate of 7 percent, the annualized net cost savings are approximately $533 million. The benefit of the proposed rule is estimated in terms of reduction of compliance effort, and consequently cost savings, for medical device establishments that currently comply with both standards. The costs of the rule include initial training of personnel, and information technology and documentation update for the medical device industry and the FDA. There is also a one-time cost of reading and learning the rule for the medical device establishments.

If finalized, in addition to the cost savings to the medical device industry, the qualitative benefits of the proposed rule include quicker access to newly developed medical devices for patients, leading to improvement of life quality of the consumers. The proposed rule, if finalized, would also align the current part 820 with other related programs potentially contributing to additional cost savings.

QMSs specify requirements to help manufacturers ensure that their products consistently meet applicable customer and regulatory requirements and specifications (Ref. 1). In the United States, authority for the QS regulation for devices is found under section 520(f) of the FD&C Act (21 U.S.C. 360j(f)), which the FD&C Act refers to as CGMP requirements. FDA issued a final rule for CGMP requirements in the Federal Register of July 21, 1978 (43 FR 31508), which created part 820 (Ref. 2).

As described below, FDA significantly revised part 820 in a final rule published in the Federal Register of October 7, 1996 (61 FR 52602, effective June 1, 1997) (1996 Final Rule), establishing the current QS regulation. As revised, part 820 includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use. These requirements are intended to assure that devices are safe and effective and otherwise in compliance with the FD&C Act. FDA has not undertaken a significant revision of part 820 since the 1996 Final Rule. Part 820 has been an effective regulation, providing assurance that devices are safe and effective and otherwise in compliance with applicable sections of the FD&C Act.

Also in 1996, ISO issued the first version of ISO 13485, “Quality systems—Medical devices—Particular requirements for the application of ISO 9001,” as a voluntary consensus standard to specify, in conjunction with the application of ISO 9001, the QMS requirements for the design/development and, when relevant, installation and servicing of medical devices (Refs. 3 and 4). Over time, ISO 13485 has evolved into a stand-alone standard outlining QMS requirements for devices (Ref. 1). With each revision, ISO 13485 has become more closely aligned with, and similar to, the requirements in part 820. This alignment and similarity are particularly true for the 2016 version of ISO 13485. Recognizing this progression, FDA sees an opportunity for regulatory harmonization by proposing to amend the current part 820 regulation to explicitly incorporate the QMS requirements of ISO 13485. ISO 13485 is used internationally by many regulatory authorities either as a foundation for or as that country's QMS requirements for device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP), in which FDA and regulatory authorities from four other countries participate (Ref. 5).

The current part 820 applies to many different devices and thus does not prescribe in detail how a manufacturer must design and manufacture a specific device. Rather, the regulation was developed to be a mandatory and flexible framework, requiring manufacturers to develop and follow procedures and processes, as appropriate to a given device, according to the state-of-the-art for manufacturing and designing such device. Successful compliance with this regulation provides the manufacturer with a framework for achieving quality throughout the organization (Ref. 1).

While part 820 effectively addresses the requirements for a QMS, FDA has long recognized the value of, and has been exploring ways to effect, global harmonization for the regulation of devices. For example, FDA has actively participated in the development of internationally harmonized documents and standards on risk management since their inception, including the development of the Global Harmonization Task Force (GHTF) guidance document, “Implementation of Risk Management Principles and Activities Within a Quality Management System,” dated May 20, 2005, which outlines the integration of a risk management system into a QMS (Ref. 6). FDA also participated in the development of the various versions of ISO 14971 “Medical Devices—Application of Risk Management to Medical Devices” (Ref. 7).

In 2012, FDA developed a voluntary audit report submission pilot program, which is no longer operational, in which FDA accepted a manufacturer's ISO 13485:2003 audit report (Ref. 8). Through this program, FDA established the feasibility and use of ISO 13485 audit reports in lieu of FDA's routine inspections covering the QS regulation requirements. Additionally, FDA participates in the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world focused on regulatory harmonization and convergence (Ref. 9). IMDRF developed MDSAP in 2012. Under MDSAP, audits are conducted based on core ISO 13485 requirements with additional country-specific requirements. In determining whether to participate in MDSAP and which FDA-specific provisions were needed for the United States, FDA conducted a thorough review and comparison of ISO 13485 and part 820 and concluded that very few FDA-specific requirements needed to be added to this audit model, demonstrating not only the similarities between the current part 820 and ISO 13485, but the comprehensive QMS approach provided by ISO 13485. This has allowed FDA to participate in MDSAP and accept certain MDSAP audits as a substitute for its own routine surveillance of device quality systems (Ref. 5).

Through our participation in MDSAP, FDA has gained experience with ISO 13485 and determined that it provides a comprehensive and effective approach to establish a QMS for devices. As such, FDA is proposing to amend the device CGMP requirements of the QS regulation by incorporating by reference the 2016 edition of ISO 13485 as well as proposing additional regulations that help connect and align ISO 13485 with other FDA requirements. The 2016 version of ISO 13485 provides requirements for a QMS that allow a manufacturer to demonstrate its ability to provide devices and related services that consistently meet customer requirements and regulatory requirements applicable to such devices and services (Ref. 1). These requirements can be used by “an organization involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices” (Ref. 1).

FDA believes that globally harmonizing the regulation of devices will help provide consistent, safe, and effective devices, contributing to public health through timelier access for patients. Harmonizing differing regulations would remove unnecessary duplicative regulatory requirements and impediments to market access and remove barriers to patient access and costs. The more flexible approach to quality, based on risk management, found within ISO 13485 will meet the needs of patients to have access to quality devices in consonance with the progress of science and technology (Ref. 9).

Currently, device manufacturers registered with the FDA must comply with the current part 820. In addition to the current part 820, registered manufacturers in many other jurisdictions and domestic manufacturers that export devices must comply with ISO 13485, which is substantially similar to the current part 820. As a result, there is redundant effort for some manufacturers in complying with both the current part 820 and ISO 13485. The redundancy of effort to comply with two substantially similar requirements creates inefficiency. In order to address this inefficiency, we propose to incorporate by reference ISO 13485 requirements so that compliance with ISO 13485 would satisfy requirements of current part 820. Although the requirements under the current part 820 are effective and very similar to those in ISO 13485, incorporating ISO 13485 by reference would further the Agency's goals for regulatory simplicity and global harmonization and should reduce burdens on regulated industry, thereby providing patients more efficient access to necessary devices (Ref. 9).

The FD&C Act, as amended, and its implementing regulations establish a comprehensive system for the regulation of devices intended for human use. The device CGMP requirements in the current part 820 were authorized by section 520(f) of the FD&C Act, which was among the authorities added to the FD&C Act by the Medical Device Amendments of 1976 (Pub. L. 94-295). Under section 520(f) of the FD&C Act, FDA issued the current part 820 regulation, which was last revised in 1996.

In addition, section 520(f)(1)(B) of the FD&C Act directs the Agency to afford the Device Good Manufacturing Practice Advisory Committee (DGMP Advisory Committee) an opportunity to submit recommendations for proposed CGMP regulations, to afford an opportunity for an oral hearing, and to ensure that such regulations conform, to the extent practicable, with internationally recognized standards defining quality management systems, or parts of the standards, for devices (see 21 U.S.C. 360j(f)(1)(B)). The DGMP Advisory Committee reviews regulations proposed for promulgation regarding good manufacturing practices and makes recommendations to the Agency regarding the feasibility and reasonableness of the proposed regulations. The Agency will convene a DGMP Advisory Committee meeting and afford an opportunity for an oral hearing to discuss this proposal prior to FDA's finalization of this rule.

Further, the provisions of sections 501(a)(2)(B) and (h) of the FD&C Act (21 U.S.C. 351(a)(2)(B) and (h)) require the manufacture of drugs and devices to comply with CGMP requirements, and section 520(f) of the FD&C Act specifically authorizes the issuance of CGMP regulations for devices, including device constituent parts of products that constitute a combination of a drug, device, and/or biological product, as defined in § 3.2(e) (21 CFR 3.2(e)) (“combination products”). Combination products that include device constituent parts have a distinct regulatory framework for CGMP requirements because the product, by definition, also includes non-device constituent parts ( e.g., a drug or a biological product). In the Federal Register of January 22, 2013 (78 FR 4307), we issued a final rule codifying the CGMP requirements applicable to combination products at part 4. We issued the part 4 regulations, in part, under sections 501(a)(2)(B) and (h) and 520(f) of the FD&C Act and are proposing to amend part 4 under the same authorities.

In that final rule, we explained that the CGMP requirements specific to each constituent part of a combination product also apply to the combination product itself because, by definition, combination products consist of drugs, devices, and/or biological products (see 78 FR 4307 at 4320, citing § 3.2(e)). We also explained that, because the constituent parts of a combination product retain their regulatory status (as a drug or device, for example) after they are combined, all combination products are subject to at least two sets of CGMP requirements, but that those for drugs overlap considerably with the part 820 requirements for devices (see 78 FR 4307 at 4320). Part 4 clarifies the applicability of the various CGMP requirements to provide a streamlined option for practical implementation for co-packaged and single-entity combination products (see 78 FR 4307 at 4320 and § 4.4 (21 CFR 4.4)). Because of the similarity of the drug and device CGMP requirements, FDA considers demonstrating compliance with one of these two sets of regulations ( e.g., device CGMP requirements) along with demonstrating compliance with the specified provisions from the other set ( e.g., drug CGMP requirements) identified in part 4 as demonstrating compliance with all CGMP requirements from both sets (see 78 FR 4307 at 4320 and § 4.4).

This proposed rulemaking is the first revision of the current part 820 since 1996. As previously described, FDA has had a longstanding interest and history of participation in efforts to harmonize its regulatory requirements with the requirements used by other regulatory authorities from various jurisdictions ( i.e., other countries). This rulemaking is a continuation of these efforts and, if finalized, will harmonize FDA's quality management system regulation with requirements of the international standard ISO 13485, which is used by other regulatory authorities. Harmonizing the FDA standard with the ISO standard would have benefits for manufacturers because many firms producing devices for sale within the United States and abroad have to comply with both standards. If finalized, this rule would require compliance with an aligned set of requirements, instead of two different requirements.

On July 21, 1978, FDA issued a final rule in the Federal Register (43 FR 31508), establishing CGMP requirements for medical devices under section 520(f) of the FD&C Act. This rule became effective on December 18, 1978, and is codified under part 820.

The Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629) amended section 520(f) of the FD&C Act to provide FDA with the authority to add preproduction design controls to the CGMP regulation. This change in law was based on findings that a significant proportion of device recalls were attributable to faulty product design. The SMDA also added section 803 to the FD&C Act, which, among other things, authorizes the Agency to enter into agreements with foreign countries to facilitate commerce in devices, and in such agreements, FDA must encourage the mutual recognition of GMP regulations under section 520(f) of the FD&C Act (see 21 U.S.C. 383(b)(1)).

To implement the SMDA changes to section 520(f) of the FD&C Act, FDA revised part 820 by the 1996 Final Rule (61 FR 52602). This final rule revised the CGMP requirements for medical devices and promulgated the QS regulation under part 820 in its current form. As part of this revision, FDA added the design controls authorized by the SMDA in addition to other changes to achieve consistency with QMS requirements worldwide. At the time, the Agency sought to harmonize the CGMP regulations, to the extent possible, with the requirements for quality management systems contained in then-applicable international standards. In particular, FDA worked closely with the GHTF and ISO Technical Committee 210 (TC 210) to develop a regulation consistent with both ISO 9001:1994, Quality Systems—Model for Quality Assurance in Design, Development, Production, Installation, and Servicing; and the ISO committee draft (CD) revision of ISO/CD 13485 Quality Systems—Medical Devices—Supplementary Requirements to ISO 9001 (see 61 FR 52602 at 52604).

FDA is proposing to incorporate by reference ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes, Third Edition 2016-03-01. ISO is an independent, non-governmental international organization with a membership of national standards bodies. ISO 13485 specifies requirements for a QMS that can be used by a manufacturer involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, or provision of associated activities.

You may view the material at the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-420-7500. The material can also be found in a read-only format at the American National Standards Institute (ANSI) Incorporated by Reference (IBR) Portal, https://ibr.ansi.org/Standards/iso1.aspx, or you may purchase a copy of the material from the International Organization for Standardization, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; +41-22-749-01-11; customerservice@iso.org , https://www.iso.org/store.html . ISO 13485 provides a comprehensive approach to establish a QMS for medical devices.

FDA is proposing to incorporate by reference the current 2016 version of ISO 13485. Any future revisions to this standard would need to be evaluated to determine the impact of the changes and whether this rule, if finalized, should be amended. If deemed necessary and appropriate, FDA will update the final regulation in accordance with the Administrative Procedure Act (5 U.S.C. 553) and obtain approval of any changes to the incorporation by reference in accordance with 1 CFR part 51.

We are proposing to issue this rule under the same authority that FDA initially invoked to issue the current Quality System Regulation (part 820) and Regulation of Combination Products (part 4), as well as the general administrative provisions of the FD&C Act: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

We are proposing to amend the current part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes. While the current part 820 provides sufficient and effective requirements for the establishment and maintenance of a QMS, regulatory expectations for a QMS have evolved since the current part 820 was implemented over 20 years ago. By proposing to incorporate ISO 13485 by reference, we are seeking to explicitly require current internationally recognized regulatory expectations for QMS for devices subject to FDA's jurisdiction. The resulting regulation will be referred to as the QMSR.

The current part 820 requirements are, when taken in totality, substantially similar to the requirements of ISO 13485. Where ISO 13485 diverges from the current part 820, these differences are generally consistent with the overall intent and purposes behind FDA's regulation of QMSs. Almost all requirements in the current part 820 correspond to requirements within ISO 13485. Therefore, we are proposing to amend the current part 820 by withdrawing the majority of the requirements for establishing and maintaining a QS. Despite these changes, this proposal does not fundamentally alter the requirements for a QS that exist in the current part 820. The rule, if finalized, would converge QS regulation with the QMS requirements of ISO 13485, while continuing to provide the same level of assurance of safety and effectiveness under the FD&C Act and its implementing regulations.

However, we recognize that reliance on ISO 13485 without clarification or modification could create inconsistencies with FDA's statutory and regulatory framework. Therefore, as detailed in this rulemaking, we are proposing additional definitions, clarifying concepts, and additional requirements, all of which would require compliance within a manufacturer's QMS in addition to ISO 13485. The Agency solicits comments on specific subject areas related to this proposed rule that FDA should consider in seeking to converge U.S. requirements with requirements used by other regulatory authorities in ways that are consistent with FDA's authority under the FD&C Act.

Our approach to this rulemaking is to simplify and streamline the regulation. Where possible, we either are proposing to accept the incorporated requirement without modification or are proposing a requirement that will supersede the correlating requirement in ISO 13485. There are a few exceptions where we are proposing to clarify concepts or augment specific clauses in ISO 13485, but overall, we are not proposing to modify the clauses in ISO 13485. (see table 1). This philosophy also helps further regulatory convergence.

As discussed further in section VI., this rule is only proposing to amend the current part 820 and does not impact our inspectional authority under section 704 of the FD&C Act (21 U.S.C. 374). We are also proposing conforming edits to part 4 to clarify the device QMS requirements for combination products. These edits would not impact the CGMP requirements for combination products.

FDA is not proposing to modify which establishments or products are subject to part 820. As before, the requirements would apply to manufacturers of finished devices; however, FDA notes that the legal authority exists to cover manufacturers of components or parts of finished devices under this regulation should the need arise (see 61 FR 52602 at 52606).

The proposed modifications to the scope of the requirements are non-substantive, and include the following:

1. Clarify that conflicting regulations that are more specific are controlling only to the extent of the conflict.

The current § 820.1(b) states that when there is a conflict between regulations in part 820 and a specifically applicable regulation located in chapter I of title 21 of the CFR, the regulations that specifically apply to the device in question supersede other generally applicable requirements. A reader might interpret this provision to mean that the specifically applicable regulation renders the rest of the part 820 regulation completely inapplicable. The proposed amendment is intended to clarify that the generally applicable part 820 regulations apply to the extent they do not otherwise conflict with the specifically applicable regulation. Moreover, to the extent that any clauses of ISO 13485 conflict with any provisions of the FD&C Act and/or its implementing regulations, the FD&C Act and/or its implementing regulations will control.

2. Rearrange some of the content and add paragraph breaks for clarity and improved flow, for example, separating requirements for manufacturers of components or parts into a paragraph different from the one describing manufacturers of finished devices.

3. Remove the paragraph listing authority because the CFR already lists the legal authority for the regulation as a separate entry.

4. Relocate the enforcement provision to a new separate paragraph in § 820.10.

Definitions of key terms related to quality management systems appear in the current § 820.3 and in Clause 3 of ISO 13485. We have reviewed the definitions in ISO 13485 to determine their suitability for FDA's purposes. We find that most of the definitions in Clause 3 are acceptable; thus, unless identified in this section, we are not proposing any modifications to the terms and definitions in Clause 3 and are proposing to remove the correlating terms and definitions from the current part 820. In some cases, however, the current § 820.3 definitions include terms that ISO 13485 does not and vice versa. Further, there are some definitions in ISO 13485 that do not align with requirements in the FD&C Act and its implementing regulations.

To account for these differences and ensure consistency with such law and regulations, we are proposing to retain and/or revise certain definitions that are in the current part 820. We are also proposing to withdraw certain terms and definitions from the current part 820 that do not have a corollary in ISO 13485 because they are not needed to understand and implement the proposed part 820. Among the definitions being withdrawn from the current part 820 is the term “establish”. Though the term establish is not defined in the ISO standard, section 0.2 states that when a requirement is required to be “documented”, it is also required to be established, implemented, and maintained. We believe the clarification of this concept within the standard is sufficient to convey the current requirement for manufacturers to establish and maintain the regulatory requirements of a QMS.

1. Terms that do not appear in ISO 13485 but that are necessary for the purposes of part 820 (terms additional to ISO 13485) (Proposed § 820.3(a)).

For the terms that do not appear in ISO 13485, but are necessary to ensure alignment with the FD&C Act and its implementing regulations, we are proposing to retain the definitions of such terms with minor revisions, as indicated below.

We are proposing to retain the definition of Act (see § 820.3(a)) in current part 820, except we propose to expand the term to more precisely reflect the specific act to which the definition refers because FDA has the authority to promulgate regulations under other acts. The addition of “Federal Food, Drug, and Cosmetic” to this term will help avoid potential ambiguity if we amend part 820 in the future under a different authority.

We are also proposing to replace the term “management with executive responsibility” (see § 820.3(n)) in the current part 820 with the term “top management”, which is used in ISO 13485, but is defined in “Quality Management Systems—Fundamentals and Vocabulary,” ISO 9000:2015 (ISO 9000) (Ref. 10). We propose to accomplish this by revising the name of the term to “top management” but retaining the definition in the current part 820. This will maintain the principle and requirement that the most senior employees of a manufacturer are responsible for establishing and making changes to the quality policy and ensuring the manufacturer follows the policy. FDA expects medical device manufacturers, led by top management, to embrace a culture of quality as a key component in ensuring safe and effective medical devices that otherwise comply with the FD&C Act. A culture of quality meets regulatory requirements through a set of behaviors, attitudes, activities, and processes. Top management ensures that applicable regulatory requirements are met through the integration of QS processes.

We are retaining the majority of the definition of “rework”; however, we are proposing to remove the term “device master record (DMR)” (§ 820.3(j)) from the regulation. The device master record is not a term used in ISO 13485 and so this definition does not need to be retained. FDA believes the concept of a DMR is adequately covered under the requirements for a medical device file under Clause 4.2.3 of ISO 13485. We are retaining the definition of “process validation” (§ 820.3(z)(1)) and clarifying the concept. FDA recognizes the terms “process validation” and “validation of processes”, the term used in ISO 13485, as synonymous. We are also proposing to include a definition for the term “customer”, as it is important for interpretation of the proposed rule. Although FDA historically has not used the term “customer”, we find it is a useful term and can encompass many types of individuals and organizations throughout the device manufacturing process, such as component manufacturers, contract manufacturers, and end users. Requirements related to customers are generally consistent with the overall intent and purposes behind FDA's regulation of device QMSs, which is to assure that finished devices will be safe and effective and otherwise in compliance with the FD&C Act. When considering the requirements related to customer property in ISO 7.5.10, FDA expects that manufacturers comply with this provision to the extent necessary to assure the safety and effectiveness of the devices being manufactured. For example, a manufacturer is expected to ensure that the integrity of a component provided by a contract manufacturer is not compromised before it is incorporated into the device being manufactured. To the extent any customer property requirements may be interpreted to go beyond the safety and effectiveness of the devices being manufactured, FDA does not intend to enforce this provision for such activities.

We are retaining without change the terms and definitions for “component” (§ 820.3(c)); “finished device” (§ 820.3(l)); “human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device” (820.3(bb)); “design validation” (§ 820.3(z)(2)); “remanufacturer” (§ 820.3(w)); “nonconformity” (§ 820.3(q)); and “verification” (820.3(aa)) because these terms are necessary for implementing part 820.

2. Terms that are defined in ISO 13485, which we propose not to incorporate and are proposing definitions that supersede the definition of the similar term in the standard (Proposed § 820.3(b)).

There are a number of terms and definitions in ISO 13485 that would create inconsistencies with the FD&C Act and its implementing regulations. FDA cannot incorporate any definitions of terms that are inconsistent with how the FD&C Act defines such terms because FDA cannot, nor does it seek to, amend its statutory definitions by rulemaking. As such, we clarify that the definitions of terms in section 201 of the FD&C Act (21 U.S.C. 321) supersede the definitions in ISO 13485. In particular, the definitions of “device” and “labeling” in sections 201(h) and (m) of the FD&C Act, respectively, supersede the correlating definitions for “medical device” and “labelling” in ISO 13485.

In addition, we are proposing to retain the definition of “manufacturer” (§ 820.3(o)) and retain with modification the definition of “product” (§ 820.3(r)) from the current part 820 because the ISO 13485 definitions of these terms do not align with the established range of these terms by FDA. The definitions in proposed part 820 would supersede that of the correlating term in ISO 13485.

With regards to the definition of “manufacturer”, we are proposing to retain our current definition because it is more comprehensive than the definition in ISO 13485. For example, FDA's definition contains a list of functions that when performed meet the definition of manufacturer. The comparable ISO 13485 definition does not include this level of detail in its definition. This definition is expanded upon in the notes to the ISO definition, which are guidance—not requirements. By explicitly including the functions that a manufacturer performs in the proposed definition, the Agency intends to maintain its original interpretation of this term and to clarify the functions that continue to be subject to the requirements of part 820.

A similar logic has been applied to the definition of “product”. FDA's definition of product includes a list of items considered to be “product” for the purposes of part 820 that is not included in the definition in ISO 13485, but some of which are included in the notes to the ISO definition.

Additionally, we note that consistent with the clarification in clause 0.2, which specifies that “when the term ‘product’ is used, it can also mean ‘service’,” for the requirements of clause 7.4 Purchasing we expect that when ensuring purchased products conform to requirements, oversight for purchased services are also included.

As stated above, FDA is proposing to incorporate by reference the International Standard, ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes, Third Edition 2016-03-01. ISO 13485 provides a comprehensive approach to establish a quality management system for medical devices. If this proposed rule is finalized, it will provide most of the CGMP requirements for devices. We note that the definitions in ISO 9000 apply to ISO 13485; however, to the extent that there is any conflict between ISO 9000 and the FD&C Act and its implementing regulations, the FD&C Act and its implementing regulations would control.

While we recognize that adopting ISO 13485 could seem like a significant change, the current part 820 and ISO 13485 are substantially similar, and this effort promotes international harmonization. The substance of the ISO 13485 requirements and the activities and actions required for compliance are primarily the same as under the current part 820. ISO 13485 has a greater emphasis on risk management activities and risk-based decision making than the current part 820. Risk management for device manufacturers is the essential systematic practice of identifying, analyzing, evaluating, controlling, and monitoring risk throughout the product lifecycle to ensure that the devices they manufacture are safe and effective. The current part 820 explicitly addresses risk management activities only in the risk analysis requirement within design validation in § 820.30(g); whereas, risk management is more broadly integrated in ISO 13485. FDA, however, has expected that manufacturers, led by top management, integrate risk management activities throughout their QMS and across the total product lifecycle. FDA discussed risk management and risk-based decision making in several sections of the 1996 Final Rule establishing the current QS requirements. For example, while not specified in the requirements for Corrective and Preventive Action (§ 820.100), FDA states that it “expect[s] the manufacturer to develop procedures for assessing the risk, the actions that need to be taken for different levels of risk, and how to correct or prevent the problem from recurring, depending on that risk assessment” (61 FR 52602 at 52634). Additionally, FDA states that “[w]hen conducting a risk analysis, manufacturers are expected to identify possible hazards associated with the design in both normal and fault conditions. The risks associated with the hazards, including those resulting from user error, should then be calculated in both normal and fault conditions. If any risk is judged unacceptable, it should be reduced to acceptable levels by the appropriate means” (61 FR 52602 at 52620). FDA has, therefore, expected risk management throughout a QMS and the total product lifecycle.

Nonetheless, although the integration of risk management principles throughout ISO 13485 does not represent a shift in philosophy, the explicit integration of risk management throughout the clauses of ISO 13485 more explicitly establishes a requirement for risk management to occur throughout a QMS and should help industry develop more effective total product life-cycle risk management systems. Effective risk management systems provide the framework for sound decision making within a QMS and provide assurance that the devices will be safe and effective (see section 520(f) of the FD&C Act).

The current § 820.5 requires that manufacturers establish and maintain a quality management system that meets the requirements of part 820. We propose to relocate this requirement within the codified and to revise this provision to require that a quality management system that complies with ISO 13485, as modified by the proposed part 820, be documented. These requirements will serve as the minimum requirements for establishing a QMS that complies with the final version of this proposed rule. In general, when ISO 13485 refers to documenting evidence we recommend that manufacturers record quantitative data, as appropriate, because such information will assist manufacturers in monitoring the performance of their processes and effectiveness of their process controls.

In addition, there are many clauses throughout ISO 13485 that refer to “applicable regulatory requirements.” We propose to include the FDA requirements that must be completed when the listed term or clause is used, in order to assist manufacturers in understanding how ISO 13485 relates to other regulatory requirements for devices. We are only proposing to identify certain instances of the phrase “applicable regulatory requirements” and therefore the proposed list is not intended to be comprehensive. Regulated manufacturers are responsible for identifying and meeting all applicable requirements, even if such requirements are not specifically called out in the proposed § 820.10.

We also propose to clarify that Clause 7.3 Design and Development applies only to the manufacturers of the class I devices that are listed in this provision in addition to all manufacturers of class II and III devices. This retains the scope of current § 820.30(a). We are not proposing to modify which devices are subject to these requirements and are only revising this provision to reflect the location of similar requirements in ISO 13485. We also note that this is consistent with clause 1 of ISO 13485, which recognizes that there may be exclusions by the regulatory authority from the Design and Development requirement and directs the manufacturer to document such in its justification for exclusion.

Finally, we are proposing to add a requirement to ensure that devices that support or sustain life, the failure of which to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury, comply with the traceability requirements set forth in in Clause 7.5.9.2 for implantable medical devices. Such products currently are subject to similar requirements in § 820.65 for traceability; however, in ISO 13485 only implantable devices are subject to this requirement.

We are including clarifications for three concepts to explain how these concepts in ISO 13485 relate to our statutory and regulatory framework for medical devices.

Organization. ISO 13485 uses the term “organization” to describe the entity who is creating a QMS that conforms to the requirements in ISO 13485. Instead, we propose to clarify the term “organization” to also include the meaning of the term “manufacturer” as it is defined in proposed § 820.3.

Safety and performance. ISO 13485 often refers to “safety and performance” as a standard to measure medical devices. We propose that where the standard uses “safety and performance,” readers shall construe that phrase to mean the same as “safety and effectiveness” in section 520(f) of the FD&C Act. We understand that some people could disagree about how the two standards compare, whether one is more stringent than the other, or even equivalent. In proposing this clarification, we do not intend to take a position on the matter of comparison. Instead, we propose this clarification to avoid confusion and ensure that implementation of a QMS is aligned with the standard of safety and effectiveness in section 520(f) of the FD&C Act and otherwise established for devices in FD&C Act.

Validation of processes. ISO 13485 uses the term “validation of processes” and does not contain its own definition of the term. We propose to clarify the term “validation of processes” as used in ISO 13485 to refer to “process validation,” as that term is defined in part 820. We are retaining the definition of process validation (§ 820.3(z)(1)) because ISO 13485 does not define “validation of processes,” but the use is the same as that expected for process validation under part 820. This will also allow for alignment between ISO 13485 and other requirements in the FD&C Act and its implementing regulations.

As stated above, we are proposing additional requirements to ensure consistency and alignment with other requirements in the FD&C Act and its implementing regulations. FDA considers the following requirements necessary for implementation of a QMS that is consistent with applicable requirements but are not specified in ISO 13485. These requirements include control of records and device labeling and packaging controls.

FDA notes that the current part 820 contains requirements for record types that are not specifically identified in ISO 13485, such as, quality system record, device master record, design history file, and device history record. We are not proposing to retain separate requirements for these record types as we believe the elements that comprise those records are largely required to be documented by other ISO 13485 Clauses, such as Clause 4.2 and its subclauses.

We propose additional requirements to help ensure that records are established and maintained in a manner that is useful to FDA and manufacturers. First, we propose to include signature and date requirements for records subject to Clause 4.2.5 of ISO 13485. Such requirements provide clarity on the information FDA needs to ensure validity of records. Records are not necessarily limited to hardcopy documents that are physically signed. Manufacturers can choose to develop electronic records and electronic methods for signing and dating such records, if that best suits their business practices. Our focus is on whether the substance of the requirements is met and not the physicality of the record or signature methodology. Second, FDA is proposing specific requirements to ensure that the information required by part 803 (21 CFR part 803), Medical Device Reporting, is captured on certain records of complaints and servicing activities. Third, we propose to require that firms document the Unique Device Identification (UDI) for each medical device or batch of medical devices in accordance with 21 CFR part 830 in its records. Last, we are proposing to retain the clarification from the current part 820 (§ 820.180) about confidentiality of records FDA receives. This reminds firms that FDA protects such records in accordance with 21 CFR part 20. If this rule is finalized as proposed, manufacturers must meet the requirements in ISO 13485 Clause 4.2.5 and also meet the requirements of the eventual § 820.35.

We also note that ISO 13485 Clause 4.2.5 requires that records be “readily identifiable and retrievable.” FDA considers this phrase to be substantially similar to the requirement in current part 820 (§ 820.180) that records be “reasonably accessible” and “readily available.” In the 1996 Final Rule, the Agency explained that “FDA expects that such records will be made available during the course of an inspection. If the foreign manufacturer maintains records at remote locations, such records would be expected to be produced by the next working day or 2, at the latest. FDA has clarified that records can be kept at other than the inspected establishment, provided that they are made `readily available' for review and copying.” (61 FR 52602 at 52637). FDA will consider records that a manufacturer makes available in accordance with this statement to be “readily identifiable and retrievable.”

Each year, device recalls are initiated related to product labeling and packaging. Clause 7.5.1(e) of ISO 13485 states that “defined operations for labelling and packaging shall be implemented.” However, ISO 13485 fails to provide additional requirements for labeling and packaging and does not specifically address the inspection of labeling by the manufacturer. Therefore, FDA proposes to retain requirements from the current part 820 that would strengthen controls for labeling and packaging operations, given that many device recalls are related to labeling and packaging. FDA believes that these provisions will better assure the manufacture of safe and effective devices. If this rule is finalized as proposed, regulated industry must meet the requirements in ISO 13485 7.5.1 and the proposed § 820.45.

We are proposing to amend part 4 to reflect the amendments made to part 820 in incorporating ISO 13485 by reference. As explained above, part 4 provides a streamlined option to demonstrate compliance with the multiple, applicable sets of CGMP requirements for certain combination products ( i.e., single-entity and co-packaged combination products). To do so, one option part 4 presents for single-entity and co-packaged combination products with device constituent parts is to demonstrate compliance with the requirements of one other applicable set of requirements along with specified provisions of part 820 (rather than all provisions). We are not proposing to change the underlying activities required of manufacturers that pursue this streamlined option. Instead, we are proposing conforming amendments to the part 4 references to the corresponding clauses in ISO 13485. To that end, we are taking comment on the proposed conforming amendments and whether additional changes are necessary to assure compliance with part 4. The QS requirements outlined in part 4 are not fundamentally different than the corresponding requirements in ISO 13485.

FDA proposes that any final rule based on this proposal become effective 1 year after the date of publication of the final rule in the Federal Register . This approach is intended to provide adequate time for manufacturers to make any changes necessary to comply with the requirements of ISO 13485. We welcome comment on this approach.

Although this rule does not impact FDA's authority to conduct inspections under section 704 of the FD&C Act, FDA intends to replace its current inspection approach for medical devices, the Quality System Inspection Technique (QSIT), with an inspection approach that will be consistent with the requirements of the proposed part 820 as finalized. Similar to the current QSIT inspection approach, these inspections would involve the collection of information to support observations noted during the inspection and those included on a Form FDA 483, as appropriate and necessary. FDA inspections will not result in the issuance of certificates of conformance to ISO 13485, nor is FDA developing a certification program for ISO 13485. In addition, manufacturers with a certificate of conformance to ISO 13485 are not exempt from FDA inspections.

If this rule is finalized, FDA intends to engage in a variety of implementation activities including, among other activities, updating information technology systems, training of personnel, finalizing the inspection approach, and revising relevant regulations and other documents impacted by this rulemaking.

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us 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, and other advantages; distributive impacts; and equity). We believe that this proposed rule is an economically significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because of the burden of the proposed rule on very small medical device establishment (as defined in the analysis), we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

We estimated the benefits in terms of cost savings. These cost savings are primarily due to the potential reduction in redundant effort in compliance of similar regulations and standards by medical device establishments. The annualized costs savings of medical device establishments are estimated at approximately $533 million at a 7 percent discount rate, and approximately $439 million at a 3 percent discount rate. In addition, if finalized, we believe that there will be added benefits through quicker access to newly developed medical devices for patients, leading to improvement of life quality for the consumers. The cost of the proposed rule primarily consists of a one-time initial expenditure for updating systems and protocols, and training personnel for medical device establishments, which currently do not comply with ISO 13485. The cost estimate for these establishments is annualized at $7.0 million at a 7 percent discount rate, and approximately $5.8 million at a 3 percent discount rate.

Participation in virtual public hearing. Please note that because of current Centers for Disease Control and Prevention (CDC) recommendations, as well as state and local orders for social distancing to limit the spread of COVID-19, the EPA cannot hold in-person public meetings at this time.

To request a virtual public hearing, contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. If requested, the virtual hearing will be held on March 10, 2022. The hearing will convene at 10:00 a.m. Eastern Time (ET) and will conclude at 5:00 p.m. ET. The EPA may close a session 15 minutes after the last pre-registered speaker has testified if there are no additional speakers. The EPA will announce further details at https://www.epa.gov/stationary-sources-air-pollution/lead-acid-battery-manufacturing-area-sources-national-emission.

If a public hearing is requested, the EPA will begin pre-registering speakers for the hearing no later than 1 business day after a request has been received. To register to speak at the virtual hearing, please use the online registration form available at https://www.epa.gov/stationary-sources-air-pollution/lead-acid-battery-manufacturing-area-sources-national-emission or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. The last day to pre-register to speak at the hearing will be March 7, 2022. Prior to the hearing, the EPA will post a general agenda that will list pre-registered speakers in approximate order at: https://www.epa.gov/stationary-sources-air-pollution/lead-acid-battery-manufacturing-area-sources-national-emission.

The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearings to run either ahead of schedule or behind schedule.

Each commenter will have 5 minutes to provide oral testimony. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) by emailing it to hansen.amanda@epa.gov. The EPA also recommends submitting the text of your oral testimony as written comments to the rulemaking docket.

The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing.

Please note that any updates made to any aspect of the hearing will be posted online at https://www.epa.gov/stationary-sources-air-pollution/lead-acid-battery-manufacturing-area-sources-national-emission. While the EPA expects the hearing to go forward as set forth above, please monitor our website or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov to determine if there are any updates. The EPA does not intend to publish a document in the Federal Register announcing updates.

If you require the services of a translator or special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by March 2, 2022. The EPA may not be able to arrange accommodations without advanced notice.

Docket. The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2021-0619. All documents in the docket are listed in https://www.regulations.gov/. Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in Regulations.gov .

Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-2021-0619. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov/, including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit electronically to https://www.regulations.gov/ any information that you consider to be CBI or other information whose disclosure is restricted by statute. This type of information should be submitted as discussed below.

The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

The https://www.regulations.gov/ website allows you to submit your comment anonymously, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through https://www.regulations.gov/, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any digital storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should not include special characters or any form of encryption and be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.

Due to public health concerns related to COVID-19, the Docket Center and Reading Room are open to the public by appointment only. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/dockets.

The EPA continues to carefully and continuously monitor information from the CDC, local area health departments, and our federal partners so that we can respond rapidly as conditions change regarding COVID-19.

Submitting CBI. Do not submit information containing CBI to the EPA through https://www.regulations.gov/. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, note the docket ID, mark the outside of the digital storage media as CBI, and identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in Instructions above. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI and note the docket ID. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

Our preferred method to receive CBI is for it to be transmitted electronically using email attachments, File Transfer Protocol (FTP), or other online file sharing services ( e.g., Dropbox, OneDrive, Google Drive). Electronic submissions must be transmitted directly to the OAQPS CBI Office at the email address oaqpscbi@epa.gov, and as described above, should include clear CBI markings and note the docket ID. If assistance is needed with submitting large electronic files that exceed the file size limit for email attachments, and if you do not have your own file sharing service, please email oaqpscbi@epa.gov to request a file transfer link. If sending CBI information through the postal service, please send it to the following address: OAQPS Document Control Officer (C404-02), OAQPS, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2021-0619. The mailed CBI material should be double wrapped and clearly marked. Any CBI markings should not show through the outer envelope.

Preamble acronyms and abbreviations. Throughout this notice the use of “we,” “us,” or “our” is intended to refer to the EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

This rulemaking is issued under the authority of the Office of Federal Procurement Policy (OFPP) Act which provides the authority for an agency head to issue agency acquisition regulations that implement or supplement the FAR.

VA is proposing to revise the VAAR to add new policy or regulatory requirements and to remove any redundant guidance and guidance that is applicable only to VA's internal operating processes or procedures. Codified acquisition regulations may be amended and revised only through rulemaking. All amendments, revisions and removals have been reviewed and concurred with VA's Integrated Product Team of agency stakeholders.

The VAAR uses the regulatory structure and arrangement of the FAR and headings and subject areas are consistent with FAR content. The VAAR is divided into subchapters, parts (each of which covers a separate aspect of acquisition), subparts and sections.

The Office of Federal Procurement Policy Act, as codified in 41 U.S.C. 1707, provides the authority for the Federal Acquisition Regulation and for the issuance of agency acquisition regulations consistent with the FAR.

When Federal agencies acquire supplies and services using appropriated funds, the purchase is governed by the FAR, set forth at title 48 Code of Federal Regulations (CFR), chapter 1, parts 1 through 53, and the agency regulations that implement and supplement the FAR. The VAAR is set forth at 48 CFR, chapter 8, parts 801 to 873.

VA proposes to make the following changes to the VAAR in this phase of its revision and streamlining initiative. For procedural guidance cited below that is proposed to be deleted from the VAAR, each section cited for removal has been considered for inclusion in VA's internal agency operating procedures in accordance with FAR 1.301(a)(2). Similarly, delegations of authority that are removed from the VAAR will be included in the VAAM as internal agency guidance. The VAAM is being created in parallel with these revisions to the VAAR and is not subject to the rulemaking process as they are internal VA procedures and guidance. The VAAM will not be finalized until corresponding VAAR parts are finalized.

We propose to revise the authorities cited for this part. The authorities cited for this part are 38 U.S.C. 8123; 38 U.S.C. 8153; 38 U.S.C. 8303; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; 41 U.S.C. 1707; and 48 CFR 1.301-1.304. The Title 38 authorities are cited as they provide the statutory basis for the exclusions as outlined in 801.104-70. We have retained the authority from 48 CFR 1.301-1.304 as this is the FAR subpart outlining the guidance for agency acquisition regulations.

Under subpart 801.1, Purpose, Authority, Issuance, we propose to revise 801.103, Authority, to add 41 U.S.C. 1707 (the OFFP Act) as an authority to the publishing of this regulation. Under 801.104, Applicability, we propose to revise the text for clarity and to remove an unnecessary reference to the VA Canteen Service.

In 801.104-70, Exclusions, we propose to retain the first paragraph and redesignate it as paragraph (a) which explains that the FAR and VAAR do not apply to those purchases made using the General Post Fund when a donor specifies the exact item to be purchased. Under 801.104-70, we also propose to add paragraph (b) to address the statutory exception at 38 U.S.C. 8123, Procurement of prosthetic appliances, which states: “The VA may procure prosthetic appliances and necessary services required in the fitting, supplying, and training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as the VA may determine to be proper, without regard to any other provision of law.” Finally, under this section, we propose to add paragraph (c) to address the statutory exception at 38 U.S.C. 8153, Sharing of health-care resources, which allows the VA to secure health-care resources which otherwise might not be feasibly available, or to effectively utilize certain other health-care resources, by using simplified procedures which were codified in VAAR part 873, Simplified Acquisition Procedures For Health-Care Resources.

We propose to remove 801.105 (no text) and 801.105-2, Arrangement of regulations, as the location of this guidance has been revised to comport with the placement of the corresponding FAR guidance. The information that was covered here has been moved to 801.301, Policy.

In 801.106, OMB approval under the Paperwork Reduction Act, we propose to delete the chart that contains the OMB approval numbers. We propose to revise this section to add language directing the reader to the VAAM for the list of information collection and recordkeeping requirements associated with the control numbers. Given the constant updating of VA's information collection requirements and the OMB control numbers, it is more prudent to place this information in the VAAM which doesn't require rulemaking for updating.

VA proposes to remove subpart 801.2, Administration, as it explains the role of the Defense Acquisition Regulations Council and the Civilian Agency Acquisition Council, which is redundant to the FAR.

We propose to revise the name of subpart 801.3 from “Department Acquisition Regulations” to “Agency Acquisition Regulations” so that the title comports with the FAR heading. We propose to add 801.301, Policy, which states that the VA implementation and supplementation of the FAR is issued in the VAAR under authorization and subject to the authority, direction, and control of the Secretary of Veterans Affairs. This section also explains what the VAAR contains and introduces and explains the VAAM.

For 801.304, we propose to revise this section to change the title from “Department control and compliance procedures” to “Agency control and compliance procedures” to comport with the FAR title of this section. We also propose to revise the text to reflect the roles and titles currently in use in VA.

We propose to revise the title of subpart 801.4 from “Deviations from the FAR and VAAR” to “Deviations from the FAR.” This change was made to conform to the FAR title.

We propose to revise 801.403, Individual deviations, by adding language specifying that the Senior Procurement Executive (SPE) may authorize individual deviations from the FAR and VAAR when an individual deviation is in the best interest of the Government.

Under 801.404, Class deviations, we propose to revise the language to clarify that the SPE is the VA authority designated to comply with FAR 1.404.

Under subpart 801.6, Career Development, Contracting Authority and Responsibilities, we propose to revise 801.601, General, to reflect that that the SPE has authority to appoint contracting officers under FAR 1.603 and this authority is further delegated to the heads of the contracting activities (HCAs). This revision also removes the reference to VA's Contracting Officer Certification Program (COCP) which no longer exists. We also propose to revise the section to remove the material pertaining to purchase card holders and to add coverage that HCAs may authorize ordering officers to place orders against a contract or agreement under certain circumstances.

Under 801.602, Contracting officers, we propose to remove this section as the policy regarding bills of lading and the authorization to sell personal property is outdated and the coverage including the responsibilities delegated to contracting officers is not required in the regulation.

We propose to remove 801.602-2, Responsibilities, and move this internal guidance to the VA Acquisition Manual (VAAM).

We propose to revise 801.602-3, Ratification of unauthorized commitments, to update the authorities within the VA designated to ratify unauthorized commitments. This section incorporates the language from Class Deviation—VAAR 801.602-3, Ratification of Unauthorized Commitments, dated May 3, 2013. We propose to delete the procedural guidance from this section and move it to the VAAM.

We propose to remove 801.602-70, General review requirements, and add it to the VAAM as it contains VA's internal procedures.

We propose to remove 801.602-71, Basic review requirements, and add it to the VAAM as it contains VA's internal procedures.

We propose to remove the following three sections: 801.602-72, Exceptions and additional review requirements; 801.602-73, Review requirements for scarce medical specialist contracts and contracts for health care resources; and 801.602-74, Review requirements for an interagency agreement. The three sections contain policy requiring reviews at the Departmental level, inconsistent with current VA policy in this area.

We propose to remove 801.602-75, Review requirements—OGC, and the corresponding table and add it to the VAAM as it contains VA's internal procedures and review thresholds. A class deviation to update this policy was signed April 12, 2017.

We propose to delete the sections listed below as they contain policy requiring reviews at the Departmental level, inconsistent with current VA policy in this area. Various sections are also specific to only one administration/organization which is inconsistent with the objective to establish policies and procedures at the departmental level. The sections slated for removal as described above are as follows:

We also propose to remove section 801.603, Selection, appointment, and termination of appointment, as this information includes internal VA procedures and this information is more suitable for inclusion in the VAAM. The sections slated for removal under this section are as follows:

We propose to renumber and retitle the proposed for removal 801.603-70, to 801.604, and from “Representatives of contracting officers” to “Contracting Officer's Representatives (COR),” to comport with the FAR heading and location. We propose to revise the section to remove the text stating that contracting officers can name a Government employee as a representative as it is redundant to guidance at FAR 1.602-2(d). We have also removed obsolete guidance allowing contracting officers to delegate their authority to other Government contracting officers under centralized indefinite delivery type contracts. We also removed outdated guidance pertaining to centralized contracts for blood and other contract practices that are managed at the contracting office level. We propose to revise the text prescribing the clause to match the revised section heading. The clause has been renumbered from 852.270-1 to 852.201-70 to be consistent with the numbering convention for VA's clauses.

We propose to remove 801.670, Special and limited delegation, for not adding value to the regulation. It restates guidance that is provided elsewhere regarding the delegation of authority to award contracts.

We propose to remove 801.670-1, Issuing bills of lading, which rescinds the authority to issue bills of lading. This is redundant as the authority to issue bills of lading was removed from the VAAR at 801.602. We propose to remove section 801.670-3, as this policy is now obsolete.

We propose to remove 801.670-4, National Cemetery Administration, as it does not fit the criteria of being departmental level policy and it also includes information that is no longer current.

We propose to remove 801.670-5, Letters of agreement, as it states that the authority to utilize letters of agreement has been rescinded. This guidance is no longer relevant at this time.

We propose to remove 801.680, Contracting authority of the Inspector General, as this information is more appropriate for the VAAM.

We propose to remove 801.690, VA's COCP and the following sections: 801.690-1, Definitions; 801.690-2, General; 801.690-3, Responsibilities under the COCP; 801.690-4, Selection; 801.690-5, Requirements for contracting authority; 801.690-6, Appointment; 801.690-7, Termination; 801.690-8, Interim appointment provisions; and 801.690-9, Distribution of Certificates of Appointment. We propose to delete the sections listed above as they all describe a program, the Contracting Officer's Certification Program (COCP) that no longer exists. The guidance previously located in 801.690-9, Distribution of Certificates of Appointment, has been moved to 801.603-3.

We propose to remove 801.695, VA's Appointment of HCA's Program, and the supporting sections: 801.695-1, Policy; 801.695-2, Procedures for appointment of HCAs; and 801.695-3, Authority of the HCA. We propose to remove the sections listed above and move them to the VAAM as they include information that is internal to the VA.

VA proposes adding the definition of Ordering Officer to reflect the introduction and usage of the term in multiple parts of the VAAR. The authorities cited for this part are: 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301-1.304.

We propose adding a new section, 808.470, Ordering officers, under subpart 808.4, Federal Supply Schedules, to convey that ordering officers may be authorized to place orders under established orders and Blanket Purchase Agreements under a Federal Supply Schedule award with a single awardee. The authorities cited for this part are: 38 U.S.C. 8127-8128; 40 U.S.C. 121(c); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

VA proposes to add a new section, 816.570, Ordering officers, under subpart 816.5, Indefinite-Delivery Contracts, to convey that ordering officers may be authorized to place orders under established Indefinite-Delivery Contracts with a single awardee. The authorities cited for this part are: 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301-1.304.

We propose to add a new part 835, Research and Development. The authorities cited for this part are 38 U.S.C. 7303, 40 U.S.C. 121(c), 41 U.S.C. 1702 and 48 CFR 1.301-1.304. We propose to add 835.001-70, VA definitions, to provide four R&D definitions crafted for the VA. We propose to add 835.003-70, Policy, in which paragraph (a) cites the U.S. Code that authorizes VA to execute a medical research program to improve the medical treatment of our Veterans and paragraph (b) states that the Office of Research Oversight (ORO) serves as the primary VHA office that advises the Under Secretary for Health on all compliance matters related to: Human subject protections; laboratory animal welfare, research safety, research laboratory security, research information security, research misconduct, and other research improprieties. Also under part 835, we propose to add 835.003-71, Research misconduct, which requires the contracting officer to insert the research misconduct clause into all R&D solicitations and contracts and 835.003-72, Protection of human subjects, which requires the contracting officer to insert the “Protection of Human Subject” clause in all R&D solicitations and contracts.

In 835.003-73, Animal welfare, we propose to add a prescription requiring the contracting officer to insert the Animal Welfare clause, 852.235-72, in all R&D solicitations and contracts. Under 835.003-74, Facilities, we propose to add a prescription requiring contracting officers to insert clause 852.235-73, Facilities, into R&D solicitations and contracts when the facilities to be assigned to perform effort on an R&D contract are critical to the success of the R&D effort or are a critical factor in the award of the contract. Under 835.003-75, Acknowledgement of support and disclaimer, we propose to add a prescription requiring contracting officers to insert clause 852.235-74, Acknowledgement of Support and Disclaimer, into R&D solicitations and contracts. We propose to add 835.010, Scientific and technical reports, which includes a prescription requiring contracting officers to insert clause 852.235-75, Scientific and Technical Reports, into R&D solicitations and contracts.

In subpart 852.2, Text of Provisions and Clauses, we propose to add clause 852.201-70, Contracting Officer's Representative (COR). This clause replaces a clause previously numbered as 852.270-1 and entitled “Representatives of contracting officers.”

We propose to add clause 852.235-70, Research Misconduct. This clause requires contractors to notify the contracting officer if there are any allegations of research misconduct. The clause also provides procedures for contractors to follow if their initial inquiry into the allegations requires a full investigation. We propose to add clause 852.235-71, Protection of Human Subjects, which makes clear that research involving human subjects is not permitted under the award unless expressly authorized in writing by the contracting officer.

We propose to add clause 852.235-72, Animal Welfare, which should be used in all R&D solicitation and contracts and directs VA's contractors to comply with the United States Department of Agriculture (USDA) Animal Welfare Act and Animal Welfare Regulations at https://www.aphis.usda.gov/animal_welfare, and the Animal Welfare Information Center's (AWIC) information for improved animal care and use in research, testing, and teaching. This clause also directs the contractor to provide to the contracting officer a written plan of providing adequate veterinary care to laboratory animals, including the frequency of visits and provisions for after hours, weekend and holiday veterinary coverage. We propose to add clause 852.235-73, Facilities, which stipulates that the facilities specified in the contract proposal are considered essential to the work being performed under the contract and that prior to changing the facilities, the contractor must notify the contracting officer in writing of the intent to remove, replace, or divert any of the specified facilities and the contractor cannot make a change in facilities without the contracting officer's written consent.

Under subpart 852.2, we propose to add 852.235-74, Acknowledgement of Support and Disclaimer. This clause requires the contractor to acknowledge the Government's support in the publication of any material based on research developed under the contract and it also requires contractors to add a disclaimer (for all material published outside of scientific journals and papers), that “any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the VA.” We also propose to add clause 852.235-75, Scientific and Technical Reports, which requires contractors to submit an electronic copy of the approved scientific technical reports delivered under the contract to the National Technical Information Service (NTIS).

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

The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

This proposed 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 proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

This rulemaking does not change VA's policy regarding small businesses and does not have a significant economic impact to individual businesses. The overall impact of the proposed rule would be of benefit to small businesses owned by Veterans or service-disabled Veterans as the VAAR is being updated to provide needed guidance to ensure VA's contractors properly protect and safeguard VA sensitive information, which includes Veteran's sensitive personal information. This rulemaking adds a new VAAR part concerning Acquisition of Information Technology that codifies information collection burdens. VA's requirement to collect the information is the result of existing requirements to ensure compliance across the Federal government and specifically when VA contractors, subcontractors, business associates and their employees require access to VA information (including VA sensitive information) or information systems. VA is merely adding existing and current regulatory requirements to the VAAR and placing guidance that is applicable only to VA's internal operation processes or procedures into a VA Acquisition Manual. VA estimates no substantial cost impact to individual businesses will result from these rule updates already required to be considered by both large and small businesses to receive an award from VA or another Federal agency. There are costs associated with this rulemaking pertaining to the codification of an information collection request in order to comply with VA's responsibilities under the Federal Information Security Modernization Act of 2014. Each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. By statute, VA is required to ensure that its contractors, subcontractors, business associates, and their employees operating under contracts at VA shall be subject to the same Federal laws, regulations, policies or procedures as VA and VA personnel. While this requirement adds some burden in annual costs and hours to firms already awarded and performing contracts at VA, the overall cost is considered de minimis, for either large or small contractors, in relation to the potential impact and harm to Veterans and VA information and information systems should a contractor not comply. Properly setting forth the requirements will provide clarity to the public and ensure appropriate safeguards are in place to ensure protection of VA's information (in particular VA sensitive personal information) and information systems. In total, this rulemaking does not change VA's policy regarding small businesses, does not have a substantial economic impact to individual businesses, and does not significantly increase or decrease costs small business were already required to bear when performing contracts which required the access, maintenance, process, or utilization of VA sensitive information or information systems.

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

Denis McDonough, Secretary of Veterans Affairs, approved this document on February 3, 2022, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons set out in the preamble, VA is proposing to amend 48 CFR parts 801, 802, 808, 816, 835, and 852 as follows: