Please refer to Docket ID NRC-2022-0181 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-2022-0181. Address questions about NRC dockets to Dawn Forder, telephone: 301-415-3407, email: Dawn.Forder@nrc.gov. For technical questions contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

• 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, 301-415-4737, or by email to PDR.Resource@nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• 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. eastern time, Monday through Friday, except Federal holidays.

Please include Docket ID NRC-2022-0181 in your comment submission. The NRC requests that you submit comments through the Federal rulemaking website at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, call or email the individual or individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

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

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

This rule is limited to the changes contained in Amendment No. 6 to Certificate of Compliance No. 1032 and does not include other aspects of the Holtec International Storage Multipurpose Flood/Wind (HI-STORM FW or Holtec International HI-STORM FW) Cask System design. The NRC is using the “direct final rule procedure” to issue this amendment because it represents a limited and routine change to an existing certificate of compliance that is expected to be non-controversial. Adequate protection of public health and safety continues to be reasonably assured. The amendment to the rule will become effective on March 22, 2023. However, if the NRC receives any significant adverse comment on this direct final rule by February 6, 2023, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register or as otherwise appropriate. In general, absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

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

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

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

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

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

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

(3) The comment causes the NRC to make a change (other than editorial) to the rule, certificate of compliance, or technical specifications.

Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended, states that “[t]he Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the Nuclear Waste Policy Act states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule that added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on March 28, 2011 (76 FR 17019), that approved the Holtec International HI-STORM FW System design and added it to the list of NRC approved cask designs in §  72.214, “List of approved spent fuel storage casks,” as Certificate of Compliance No. 1032.

By letter dated October 2, 2019, and supplemented on June 30, 2020, December 21, 2020, August 2, 2021, and November 29, 2021, Holtec International submitted a request to amend Certificate of Compliance No. 1032 for the HI-STORM Flood/Wind Multipurpose Canister Storage System. Amendment No. 6 revises the certificate and technical specifications as follows:

• add anchored configuration for the HI-STORM FW overpack;

• allow use of non-single failure proof lifting equipment during handling of heavy loads within the 10 CFR part 72 jurisdictional boundary;

• revise LCO 3.1.2, “SFSC Heat Removal System Operability,” to allow an engineering evaluation to be performed in lieu of transferring the multipurpose canister (MPC) into a transfer cask;

• revise the Radioactive Effluent Control Program to no longer require annual submittal of a separate radioactive effluent report [10 CFR 72.44(d)(3)] for the HI-STORM FW system;

• revise the allowable contents for the MPC-37, -89, and -32ML to clarify fuel debris requirements permitted for storage;

• revise the MPC-37, -89, and -32ML basket design features to clarify that the minimum cell ID and minimum cell wall thickness are nominal dimensions; and

• incorporate additional clarifications and editorial changes that do not substantively change the technical information of the certificate of compliance.

As documented in the preliminary safety evaluation report, the NRC performed a safety evaluation of the proposed certificate of compliance amendment request. The NRC determined that this amendment does not reflect a significant change in design or fabrication of the cask. Specifically, the NRC determined that the design of the cask would continue to maintain confinement, shielding, and criticality control in the event of each evaluated accident condition. In addition, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 6 would remain well within the limits specified by 10 CFR part 20, “Standards for Protection Against Radiation.” Thus, the NRC found there will be no significant change in the types or amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents.

The NRC staff determined that the amended HI-STORM FW Cask System design, when used under the conditions specified in the certificate of compliance, the technical specifications, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be reasonably assured. When this direct final rule becomes effective, persons who hold a general license under § 72.210 may, consistent with the license conditions under § 72.212, load spent nuclear fuel into HI-STORM FW Cask Systems that meet the criteria of Amendment No. 6 to Certificate of Compliance No. 1032.

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC revises the HI-STORM FW Cask System design listed in § 72.214, “List of approved spent fuel storage casks.” This action does not constitute the establishment of a standard that contains generally applicable requirements.

Under the “Agreement State Program Policy Statement” approved by the Commission on October 2, 2017, and published in the Federal Register on October 18, 2017 (82 FR 48535), this rule is classified as Compatibility Category NRC—Areas of Exclusive NRC Regulatory Authority. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR chapter I. Therefore, compatibility is not required for program elements in this category.

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

Under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the NRC has determined that this direct final rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has made a finding of no significant impact on the basis of this environmental assessment.

The action is to amend § 72.214 to revise the HI-STORM FW Cask System design listing within the “List of approved spent fuel storage casks” to include Amendment No. 6 to Certificate of Compliance No. 1032.

This direct final rule amends the certificate of compliance for the HI-STORM FW Cask System design within the list of approved spent fuel storage casks to allow power reactor licensees to store spent fuel at reactor sites in casks with the approved modifications under a general license. Specifically, Amendment No. 6 revises the certificate of compliance as described in Section IV, “Discussion of Changes,” of this document, for the use of the HI-STORM FW Cask System.

On July 18,1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was analyzed in the environmental assessment for the 1990 final rule. The environmental assessment for this Amendment No. 6 tiers off of the environmental assessment for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under the National Environmental Policy Act of 1969, as amended.

The HI-STORM FW Cask System is designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an independent spent fuel storage installation, the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, can include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

This amendment does not reflect a significant change in design or fabrication of the cask. Because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 6 would remain well within the 10 CFR part 20 limits. The NRC has also determined that the design of the cask as modified by this rule would maintain confinement, shielding, and criticality control in the event of an accident. Therefore, the proposed changes will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment supporting the July 18, 1990, final rule. There will be no significant change in the types or significant revisions in the amounts of any effluent released, no significant increase in the individual or cumulative radiation exposures, and no significant increase in the potential for, or consequences from, radiological accidents. The NRC documented its safety findings in the preliminary safety evaluation report.

The alternative to this action is to deny approval of Amendment No. 6 and not issue the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into the HI-STORM FW Cask System in accordance with the changes described in proposed Amendment No. 6 would have to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. The environmental impacts would be the same as the proposed action.

Approval of Amendment No. 6 to Certificate of Compliance No. 1032 would result in no irreversible commitment of resources.

No agencies or persons outside the NRC were contacted in connection with the preparation of this environmental assessment.

The environmental impacts of the action have been reviewed under the requirements in the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” Based on the foregoing environmental assessment, the NRC concludes that this direct final rule, “List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM Flood/Wind Multipurpose Canister Storage System, Certificate of Compliance No. 1032, Amendment No. 6,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing collections of information were approved by the Office of Management and Budget, approval number 3150-0132.

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

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and Holtec International. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810).

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if (1) it notifies the NRC in advance; (2) the spent fuel is stored under the conditions specified in the cask's certificate of compliance; and (3) the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On March 28, 2011 (76 FR 17019), the NRC issued an amendment to 10 CFR part 72 that approved the HI-STORM FW Cask System design by adding it to the list of NRC-approved cask designs in §  72.214.

By letter dated October 2, 2019, and supplemented on June 30, 2020, December 21, 2020, August 2, 2021, and November 29, 2021, Holtec International submitted a request to amend Certificate of Compliance No. 1032 for the HI-STORM FW Cask System as described in Section IV, “Discussion of Changes,” of this document.

The alternative to this action is to withhold approval of Amendment No. 6 and to require any 10 CFR part 72 general licensee seeking to load spent nuclear fuel into the HI-STORM FW Cask System under the changes described in Amendment No. 6 to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the preliminary safety evaluation report and environmental assessment, this direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of this direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory; therefore, this action is recommended.

The NRC has determined that the backfit rule (§ 72.62) does not apply to this direct final rule. Therefore, a backfit analysis is not required. This direct final rule revises Certificate of Compliance No. 1032 for the HI-STORM FW Cask System, as currently listed in § 72.214. The revision consists of the changes in Amendment No. 6 previously described, as set forth in the revised certificate of compliance and technical specifications.

Amendment No. 6 to Certificate of Compliance No. 1032 for the HI-STORM FW Cask System was initiated by Holtec International and was not submitted in response to new NRC requirements, or an NRC request for amendment. Amendment No. 6 applies only to new casks fabricated and used under Amendment No. 6. These changes do not affect existing users of the HI-STORM FW Cask System, and the current Amendments Nos. 0 to 5 and 8 continue to be effective for existing users. While current users of this storage system may comply with the new requirements in Amendment No. 6, this would be a voluntary decision on the part of current users.

For these reasons, Amendment No. 6 to Certificate of Compliance No. 1032 does not constitute backfitting under § 72.62 or § 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, the NRC has not prepared a backfit analysis for this rulemaking.

This direct final rule is not a rule as defined in the Congressional Review Act.

The documents identified in the following table are available to interested persons as indicated.

The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2022-0181. In addition, the Federal rulemaking website allows members of the public to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) navigate to the docket folder (NRC-2022-0181), (2) click the “Subscribe” link, and (3) enter an email address and click on the “Subscribe” link.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72:

The National Marine Sanctuaries Act (NMSA) authorizes the Secretary of Commerce (Secretary) to designate, manage, and protect as a national marine sanctuary (NMS) any area of the marine environment that is of special national significance due to its conservation, recreational, ecological, historical, scientific, cultural, archeological, educational, or esthetic qualities (16 U.S.C. 1431 et seq. ). Since the NMSA was enacted, fifteen (15) NMSs have been designated. Day-to-day management of the National Marine Sanctuaries System (System) is delegated from the Secretary to NOAA's Office of National Marine Sanctuaries (ONMS). Regulations implementing the NMSA are codified in Title 15, part 922 of the Code of Federal Regulations (CFR). Part 922 includes general regulations applicable to all sanctuaries (subparts A through E) and site-specific regulations that relate to each individual sanctuary (subparts F through T).

As the System evolved and new sanctuaries were designated, corresponding changes were made to the general and site-specific regulations. In certain instances, these changes produced redundant, inconsistent, outdated, or conflicting regulatory provisions. NOAA published a proposed rule on January 18, 2011 (78 FR 5998) to update and streamline the regulations, and subsequently published an interim final rule on May 13, 2022 adopting the proposed changes, establishing a delayed effective date, and providing an opportunity for additional public comment (87 FR 29606). This final rule withdraws the amendatory instructions and associated regulatory text of that interim final rule, but retains the preamble and responses to comments provided in that interim final rule. The effect of this final rule is to affirm much of that interim final rule, as this final rule is largely similar to the interim final rule. As such, this final rule updates both the general and site-specific regulations as contemplated in the original proposed rule, making the regulations more consistent, uniform, concise, organized, and understandable by:

• Reorganizing and consolidating existing general regulations published in subparts A (General), B (Sanctuary Nomination Process), C (Designation of National Marine Sanctuaries), D (Management Plan Development and Implementation, and E (Regulations of General Applicability) into a new subpart A (Regulations of General Applicability);

• Updating and consolidating sanctuary permitting procedures and requirements into a new subpart D (National Marine Sanctuary Permitting), which applies to all sanctuaries unless expressly stated in subpart D or the site-specific regulations;

• Reserving subparts B, C, and E; and

• Making non-substantive, administrative changes to the site-specific sanctuary regulations set forth in subparts F through T of 15 CFR part 922.

This final rule administratively withdraws the amendatory instructions and associated text from the interim final rule published on May 13, 2022, at 87 FR 29606, 1 and replaces them with the amendatory instructions and associated regulatory text herein, while retaining the interim final rule's preamble discussion and the interim final rule's responses to comments. The effect of this final rule is to largely affirm the interim final rule, while making minor amendments in certain provisions to respond to comments and make technical corrections to boundary coordinates.

As noted below in “III. Response to Comments on the interim final rule”, NOAA retains the existing regulatory language for the definition of the term “commercial fishing” and for third party appeals of sanctuary permitting decisions by interested persons in those sanctuaries that currently recognize such appeals ( i.e., Monitor, Channel Islands, Greater Farallones, Gray's Reef, Cordell Bank, Mallows Bay—Potomac River, Wisconsin Shipwreck Coast national marine sanctuaries, and National Marine Sanctuary of American Samoa). In addition, this final rule removes amendatory instructions for updating the boundary description and boundary coordinates for the Flower Garden Banks National Marine Sanctuary (NMS), which were inadvertently included in the interim final rule and did not reflect the boundary expansion that went into effect on March 22, 2021 (86 FR 15404). These changes from the interim final rule are discussed below in more detail.

In FR Doc. 2022-09626 appearing on page 29606 in the Federal Register of Friday, May 13, 2022, the following corrections are made:

A. Instruction 19 in the regulatory text of the interim final rule, appearing at 87 FR 29633, directed the Federal Register to revise paragraph (a) in 15 CFR 922.92. However, only the introductory text of the paragraph was set out and the remaining subparagraphs in the section were inadvertently omitted. The instruction should have said to revise the introductory text of paragraph (a), keeping the subparagraphs unchanged. In order to retain the subparagraphs to (a), NOAA publishes this final rule with this technical correction and makes the corresponding changes to the amendatory instructions below.

B. Instructions 29 and 33 in the regulatory text are removed. The boundary description for Flower Garden Banks NMS is set forth in 15 CFR 922.120, and Appendix A of 15 CFR 922 subpart L, includes the boundary coordinates for the Flower Garden Banks NMS. The sanctuary was expanded in 2021 to include several additional banks in the northwestern Gulf of Mexico (86 FR 4937; January 19, 2021). The amendatory instructions to revise the boundary description in 15 CFR 922.120 and the table of boundary coordinates are removed so the areas added to the sanctuary in 2021 will be retained.

In response to a public comment requesting that NOAA conduct additional analysis before modifying the definition of the term “commercial fishing,” NOAA has decided not to move forward with changing the definition. NOAA will further evaluate the issues before proposing to modify the definition of the term “commercial fishing.”

Based on the input we received through public comments, NOAA has decided not to finalize the proposal to limit third party appeals to only applicants and permittees in sites that allow any interested person to appeal. Instead, NOAA is retaining the existing language in the regulations that provides the opportunity for third party administrative appeals at Monitor NMS, Channel Islands NMS, Greater Farallones NMS, Gray's Reef, NMS of American Samoa, Cordell Bank NMS, Mallows Bay Potomac River NMS, and Wisconsin Shipwreck Coast NMS ( see subparts F through K and S and T). NOAA intends to continue evaluating the process for engaging with interested parties in sanctuary permitting decisions and may revisit this issue in a subsequent rulemaking process.

NOAA received eight public comments on the interim final rule, which are divided into ten topics. Each topic is summarized below and NOAA's responses follow.

1. Comment: NOAA received several comments that expressed general support for the housekeeping rulemaking effort, in which NOAA seeks to streamline and clarify important elements of ONMS regulations. There was also support for specific provisions, including the decision not to consolidate the definition of “traditional fishing” and the decision to extend the deadline from 120 days to 180 days for a Regional Fishery Management Council to respond to a request for draft fishing regulations pursuant to NMSA section 304(a)(5).

Response: NOAA appreciates the public support for those provisions.

2. Comment: NOAA received a comment that identified a correction that needs to be made regarding a web page on the ONMS website that should be updated to include the new expanded Flower Garden Banks NMS boundaries. The commenter also identified that Appendix A to subpart L of 15 CFR part 922 should be updated to include the new expanded Flower Garden Banks NMS boundaries.

Response: NOAA will update the web page accordingly and, as discussed above, this final rule corrects the interim final rule to accurately describe the Flower Garden Banks NMS boundaries in subpart L of 15 CFR part 922.

3. Comment: NOAA received a comment requesting that it reissue the rulemaking as a proposed rule to solicit additional public comment.

Response: NOAA declines to reissue the rulemaking as a proposed rule. Although several years have passed since the 2013 proposed rule was published, NOAA believes the organizational and clarifying changes contained in that proposed rule remain relevant and useful, and will make it easier for stakeholders and the public to understand and navigate the NMSA regulations. NOAA accepted public comment on the proposed rule for a period of sixty days from January 28, 2013 through March 28, 2013, and NOAA received 28 comments on the proposed rule. Recognizing the time that elapsed since the publication of the 2013 proposed rule, NOAA issued an interim final rule with a delayed effective date that provided an additional thirty-day public comment period, which opened on May 13, 2022 and closed on June 13, 2022. The purpose of this additional public comment period was to provide NOAA with further opportunity to consider the potential impact of this action, including any relevant new issues or concerns that may have arisen in the years since the rule was proposed. NOAA received only eight public comments on the interim final rule. In total, ninety days of public comment have been afforded for this Action. Given this, NOAA believes there has been sufficient opportunity for public engagement to identify the relevant views of the public related to this rulemaking.

4. Comment: One commenter questioned the proposed modification to the definition of the term “commercial fishing” and recommended that additional analysis be completed before the definition is changed. The commenter noted that commercial fishing includes specific permitting, reporting and operational requirements and that simply trying to sell fish does not make that person a commercial fisher. The commenter asked how the definition considers charter or for-hire captains that are permitted to sell their catch. Lastly, the commenter questioned how attempts to fish commercially would be enforced.

Response: NOAA reviewed the proposed modification to the definition of the term “commercial fishing” in light of the concerns raised by the commenter and has decided not to finalize the proposed modification to the definition. NOAA will continue to evaluate the proposed modification and may revisit this issue in a subsequent rulemaking.

5. Comment: One commenter questioned the modification of the term “conventional hook and line gear” and recommended that additional analysis be completed before the definition is changed. They indicated that the implications of removing the term “bottom” in the term “bottom longline” are uncertain and it is unclear why “bottom longline” is not considered “conventional hook and line gear.” The commenter also asked about the implications of the change for pelagic longline and buoy gear. The commenter further asked whether the length of the gear ( e.g., the mainline) or number of hooks deployed or the material of the mainline impact the applicability of the term “conventional hook and line gear.”

Response: In Flower Garden Banks NMS, “conventional hook and line gear” is an exception to various regulatory prohibitions relating to the discharge or deposit of material within the sanctuary, injuring fish, whale shark and other sanctuary resources identified in the site-specific regulations at 922.122(a)(3)(i)(A) and (a)(7)-(10). Related to this sanctuary's regulations, “conventional hook and line gear” is inclusive of any fishing gear composed of a single line terminated by a combination of sinkers and hooks or lures. The definition of “conventional hook and line gear” was first introduced with the designation Flower Garden Banks NMS, which is the only site that uses the term. Historically, longline, particularly bottom longline, has been excluded from the definition of “conventional hook and line gear” (56 FR 64634; Dec. 5, 1991). According to the 1991 Flower Garden Banks NMS Final Environmental Impact Statement (FGBNMS FMP/FEIS), handlines were the only commercial fishing method documented at Flower Garden Banks NMS at the time of the designation and were particularly used for reef fish (see p. 40, FGBNMS FMP/FEIS). The use of bottom longlines and similar gear (such as buoy gear) was and still remains prohibited at Flower Garden Banks NMS pursuant to regulations implementing the Gulf of Mexico Fishery Management Plan for Coral and Coral Reefs (see p. 40, FGBNMS FMP/FEIS; see e.g., 50 CFR 622.74(p), (q), and (r)). Sport fishermen also used handlines to fish for snappers and groupers (see p. 40-41, FGBNMS FMP/FEIS). Since longline (including pelagic and buoy gear) is a single line fitted with a series of offshoot lines (ganglions) and baited hooks along its entire length, it does not fit within the definition of “conventional hook and line gear,” which is a single line terminated by a combination of sinkers and hooks or lures. The purpose of this rulemaking is not to make substantive changes to the definition; rather, the purpose, as noted in the 2013 proposed rule, is to clarify that the fishing gear prohibition applies to all types of longlines in Flower Garden Banks NMS, and not just bottom longlines (78 FR 5998, 6001; Jan. 28, 2013). The length of the longline mainline, numbers of hooks along the offshoot lines, and material of the mainline does not impact the applicability of the term “conventional hook and line” as this term applies to the site-specific regulations for Flower Garden Banks NMS.

6. Comment: One commenter expressed concerns that the changes between the proposed rule and the interim final rule regarding the definition of the term “take (taking or taken)” limits its applicability to marine mammals, sea turtles and birds with protections under those laws identified (the Endangered Species Act (ESA), the Marine Mammal Protection Act (MMPA), and the Migratory Bird Treaty Act (MBTA)), and asserted that the final definition excludes animals that were proposed to be included. The commenter asked that NOAA provide additional information about the impacts of this rulemaking on ESA-listed species and suggested that the changes to the definition of “take (taking or taken)” may affect listed species and therefore may require consultation under Section 7 of the Endangered Species Act.

Response: The proposed rule sought to reformat and update the existing definition of “take or taking.” The proposed definition of “take or taking” also included a fourth provision intended to clarify that the definition did not only apply to marine mammals, sea turtles, or birds, but also applied to other sanctuary resources. In response to public comments concerned that the proposed definition of “take or taking” inadvertently expanded the scope of the existing regulatory prohibitions ( see interim final rule Comment 24 in Section IV. Responses to Comments), NOAA revised the proposed definition by eliminating the fourth provision. For site-specific regulations that prohibit take of other living or non-living sanctuary resources ( e.g., 15 CFR 922.112(a); 922.132(11)(i); 922.163(a)(2), (5); 922.164(d)(ii) ), the plain language reading of the term “take (taking or taken)” continues to apply. In this final rule (as in the interim final rule), NOAA neither expands nor narrows the scope of the term “take” which applies to species listed under the ESA, MMPA, or MBTA. This action makes no change to the current definition of the term “take” as it applies to ESA-listed marine mammals, sea turtles, and seabirds. Therefore, ONMS does not believe there is a substantive impact on ESA-listed species, or that the Section 7 ESA consultation requirement is triggered.

7. Comment: NOAA received comments that raised concerns regarding limiting administrative permit appeals to applicants and holders of permits. These comments asserted that all sanctuaries should allow third parties to have an opportunity for an administrative appeal of ONMS permit decisions. The commenters also noted that, eliminating third party permit appeals, would force third parties to litigate sanctuary permitting concerns in federal court.

Response: NOAA declines to extend third party appeals to all sites. However, in response to public comment on the interim final rule, NOAA will retain the existing opportunity for third party sanctuary permit appeals in sites in the System that currently afford such appeals. If NOAA chooses to propose changes to the appellant pool at some point in the future, NOAA would do so through a separate rulemaking. NOAA notes that interested third parties may also provide meaningful input to the permit process and the underlying sanctuary regulations, through a variety of other mechanisms, including public review and comment of associated environmental analyses as part of the National Environmental Policy Act (NEPA) process or other statutory processes, as applicable.

8. Comment: NOAA received comments that raised concerns about an existing ONMS permit approval authority referred to as ONMS authorization (found in the interim final rule and this final rule at new section 15 CFR 922.36), which allows the ONMS Director to allow an applicant to conduct an otherwise prohibited activity if the proposed activity is permitted by another valid federal, state, or local agency. Commenters asserted that another agency's permit authority should not override ONMS regulatory prohibitions that were established during sanctuary designation or subsequent regulatory revisions. They also asserted that a public review and comment process should be required before an ONMS authorization for the prohibited activity is issued.

Response: The ONMS authorization authority is an existing type of permit approval authority that the Director may rely upon to allow otherwise prohibited activities within certain National Marine Sanctuaries ( i.e., Flower Garden Banks, Monterey Bay, Stellwagen Bank, Olympic Coast, Florida Keys, Thunder Bay, Mallows Bay-Potomac River, and Wisconsin Shipwreck Coast), where such activities are permitted by another valid Federal, State, or local agency. The Director must consider a suite of review criteria to decide whether to issue an ONMS authorization and what terms and conditions should be applied to an ONMS authorization. Utilization of this long-standing ONMS authorization authority can function to minimize administrative burdens on the regulated community while retaining the Director's ability to safeguard sanctuary resources and effectively manage those sanctuaries. NOAA's revisions to the regulatory provisions on ONMS authorization (as found in new section 15 CFR 922.36) are intended to clarify—not substantively alter—the existing ONMS authorization authority, which was previously codified at 15 CFR 922.49. Through this action, NOAA is not expanding the existing ONMS authorization authority or creating a new authority. Therefore, this comment is beyond the scope of this action. We also note that, as with other ONMS permit approvals, the public may provide input to the permit process through other mechanisms, including public review and comment of associated environmental analyses as part of the NEPA process or other statutory processes, as applicable.

9. Comment: One commenter asked NOAA to further regulate primary threats to ESA-listed species in NMSs, including those threats that result from fishing activities. The commenter specifically raised concerns about language in 15 CFR 922.5 that states, “[t]he Director may only directly regulate fishing activities pursuant to the procedure set forth in section 304(a)(5) of the NMSA.” The commenter asserted that it is inconsistent with a provision in Section 2(c) of the ESA that establishes that it is “the policy of Congress that all Federal departments and agencies shall seek to conserve endangered species and threatened species and shall utilize their authorities in furtherance of the purposes of this Act.” They further stated that the ESA defines “conservation” to mean “the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to the [ESA] are no longer necessary.”

Response: This action is intended to promulgate administrative updates to the existing sanctuary regulations (15 CFR part 922) to make them more consistent, uniform, concise, organized, and understandable. The commenter's request for NOAA to promulgate additional regulatory protections to address primary threats to ESA-listed species in NMSs is a substantive change that is beyond the scope of this action. Thus, the commenter's request to promulgate additional regulatory protections is declined.

10. Comment: One commenter recommended that NOAA update 15 CFR 922.122(h) to include renewable energy leases. These regulations relate to the limitation on the ability of ONMS to issue permits for the exploration for, development of, or production of oil, gas, or minerals in a no-activity zone in the Flower Garden Banks NMS.

Response: This action is intended to promulgate administrative updates to the existing sanctuary regulations (15 CFR part 922) to make them more consistent, uniform, concise, organized, and understandable. Adding a new restriction on ONMS permitting authority for renewable energy leases would be a substantive revision to the regulations that is beyond the scope of this rulemaking. Accordingly, the commenter's request to update 15 CFR 922.122(h) to include renewable energy leases is declined.

NOAA Administrative Order (NAO) 216-6A and the Companion Manual for NAO 216-6A ( https://www.nepa.noaa.gov/docs/NOAA-NAO-216-6A-Companion-Manual-01132017.pdf ) establish NOAA's policy and procedures for compliance with NEPA and the associated Council on Environmental Quality's regulations. NAO 216-6A, Environmental Review Procedures, requires all proposed actions to be reviewed with respect to environmental consequences on the human environment.

In the proposed rule (78 FR 5998; January 28, 2013), NOAA stated that it was preparing a draft environmental assessment (EA) to analyze the potential environmental impacts of the proposed rulemaking and that the draft EA would be released for public comment. The analysis in the draft EA would have focused on analyzing the potential environmental impacts of the consolidated definition of motorized personal watercraft (MPWC). Based on public comment received on the proposed rule, NOAA decided to withdraw the proposal to consolidate the MPWC definition and it was not included in the interim final rule. As a result, NOAA determined that preparation of a draft EA was not necessary for this rule. NOAA determined that, because the interim final rule included only technical and administrative changes to regulatory text, it fell within the criteria of a categorical exclusion in Appendix E of the NOAA NEPA Companion Manual, specifically categorical exclusion reference number G7 (“Preparation of policy directives, rules, regulations, and guidelines of an administrative, financial, legal, technical, or procedural nature, or for which the environmental effects are too broad, speculative or conjectural to lend themselves to meaningful analysis and will be subject later to the NEPA process, either collectively or on a case-by-case basis.”) NOAA considered the list of extraordinary circumstances and determined that none would be triggered by this final rule. Therefore, NOAA determined that this final rule would not result in significant effects to the human environment and is categorically excluded from the need to prepare an EA.

This rule has been determined to be not significant within the meaning of Executive Order 12866. The rule is part of NOAA's effort to carry out the directive under Executive Order 13563 for retrospective regulatory review.

Pursuant to Executive Order 13175, NOAA consults with federally-recognized tribes on actions that may have tribal implications. NOAA determined that the amendments to the Olympic Coast NMS permitting regulations in the consolidation of permit procedures and review criteria into the new subpart D, although not resulting in a substantive change to permitting requirements, could be perceived as having tribal implications because some of the regulatory text is specific to the federally-recognized tribes along the Washington Coast (Coastal Treaty Tribes). Therefore, we have determined that this regulation has tribal implications as defined in Executive Order 13175. NOAA certifies that this final rule was developed after meaningful consultation and collaboration with tribal representatives in accordance with Executive Order 13175. NOAA engaged in government-to-government consultation with tribal representatives from the Makah, Hoh and Quileute Indian Tribes and the Quinault Indian Nation of the Olympic Coast Intergovernmental Policy Council (IPC). NOAA determined that this regulatory action did not have implications for any other federally-recognized tribes at other sites.

In January 2012, NOAA initiated a dialogue with the Coastal Treaty Tribes for a potential rulemaking action that would revise and consolidate program-wide and site-specific regulations. ONMS staff presented initial items for consideration by the IPC and its members at a February 8, 2012, meeting. In May 2012, NOAA addressed initial concerns that were raised at the February meeting, provided a summary of the proposed regulatory changes, and invited the IPC members to consult if there were concerns about the general proposals. In October 2012, NOAA provided more detailed information, including pre-release draft regulatory language for program-wide regulations and Olympic Coast NMS site-specific regulations that could be of interest to the tribes. After the proposed rule was published in the Federal Register , NOAA forwarded the notice to the Washington Coast treaty tribes on February 15, 2013.

The Makah Tribe provided comments on the proposed rule that raised three priority issues. In addition to the matter noted in the “IV Responses to Comments” section of the interim final rule, the Makah Tribe reiterated its long-standing position about the role of the Regional Fishery Management Councils (RFMCs) in fisheries management, which did not require action in this rulemaking. The Makah Tribe also expressed interest in improved tribal involvement in the consideration of Olympic Coast NMS permit applications. Since the publication of the 2013 proposed rule, Olympic Coast NMS and the Makah Tribe engaged in government-to-government consultation in the development of a joint “Protocol for Permit Consultation” (dated April 10, 2015) that specifies the procedures by which consultation and coordinated communication will occur between the Makah Tribe and Olympic Coast NMS staff. The sanctuary staff and tribal representatives meet periodically to engage in permit consultations on ONMS permit applications, and the results of these meetings are included in ONMS permit decision documents. In addition, the Makah Tribe and ONMS have developed a protocol to engage in consultation as part of the NMSA section 304(d) interagency consultation process and have implemented the protocol in two recent sanctuary consultations. Olympic Coast NMS staff regularly engages with the Washington Coast treaty tribes on various initiatives of mutual interest.

NOAA has concluded this regulatory action does not have federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 13132.

This rule does not create any new information collection requirements, nor does it change existing information collection requirements approved by the Office of Management and Budget (OMB Control Number 0648-0141) under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. (PRA). There are no changes to the reporting burden as a result of these regulatory changes. Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

The Regulatory Flexibility Act (RFA) requires Federal agencies to prepare an analysis of a rule's impact on small entities whenever the agency is required to publish a rule, unless the head of the agency can certify, pursuant to 5 U.S.C. 605(b), that the action will not have a significant economic impact on a substantial number of small entities.

Pursuant to section 605(b), the Chief Counsel for Regulations for the Department of Commerce, certified to the Office of Advocacy of the Small Business Administration during the 2013 proposed rule stage and the 2022 interim rule stage that the regulations would not have a significant economic impact on a substantial number of small entities. The factual basis for certification was published in the proposed rule (78 FR 5998, 6009; January 18, 2011) and in the interim final rule (87 FR 29606, 29625; May 13, 2022). No public comments were received regarding this certification. Therefore, a regulatory flexibility analysis was not required and none was prepared.

Accordingly, for the reasons set forth above, 15 CFR part 922 is amended as follows:

The Federal Employees' Compensation Act (FECA) provides compensation for wage loss, medical care, and vocational rehabilitation to Federal employees and certain other individuals who are injured in the performance of their duties, or who develop illnesses as a result of factors of their Federal employment.

Under Public Law 117-263, Congress directed OWCP to update 20 CFR 10.121 within 16 days of the law's enactment. Section 10.121 addresses situations when the evidence submitted by the claimant is insufficient to meet their burden of proof and OWCP needs additional information. Presently, it requires OWCP to give the claimant at least 30 days to submit the evidence required. At Congress' express direction, OWCP is changing this 30-day period to 60 days.

The Agency's implementation of this action without opportunity for public comment is based on the good cause exception in 5 U.S.C. 553(b)(B), in that seeking public comment is impracticable, unnecessary, and contrary to the public interest. Seeking public comment is unnecessary because the agency has no discretion to change the timeline for a claimant to submit additional evidence. In addition, given the 16-day deadline for amending the regulation that was prescribed by Congress, seeking prior public comment on this is impracticable and contrary to the public interest in the orderly promulgation and implementation of regulations.

This regulatory action does not constitute a “significant” rule within the meaning of Executive Order 12866 in that it only changes the timeline to submit additional evidence by 30 days.

An analysis under the Regulatory Flexibility Act of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (RFA), 5 U.S.C. 601-612, is not needed for this rule. The RFA imposes certain requirements on Federal agency rules that are subject to the notice and comment requirements of the APA, 5 U.S.C. 553(b). The Department is invoking the good cause exception to notice-and-comment procedures for this final rule. Accordingly, the Department is not required to either certify that the final rule would not have a significant economic impact on a substantial number of small entities or conduct a regulatory flexibility analysis.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the Department consider the impact of paperwork and other information collection burdens imposed on the public. The Department has determined that this final rule does not require any collection of information or alter any existing information collections.

The Department has reviewed this proposed rule in accordance with the requirements of Exec. Order No. 13132, 64 FR 43,225 (Aug. 10, 1999), and the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 et seq., and has found no potential or substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. As there is no Federal mandate contained herein that could result in increased expenditures by State, local, or tribal governments or by the private sector, the Department has not prepared a budgetary impact statement.

The Department has reviewed this proposed rule in accordance with Exec. Order 13,175, 65 FR 67249 (Nov. 9, 2000), and has determined that it does not have “tribal implications.” The proposed rule does not “have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

The Department has reviewed this proposed rule in accordance with Exec. Order 12630, 53 FR 8859 (Mar. 15, 1988), and has determined that it does not contain any “policies that have takings implications” in regard to the “licensing, permitting, or other condition requirements or limitations on private property use, or that require dedications or exactions from owners of private property.”

The Department has reviewed this proposed regulation and has determined that the provisions of Exec. Order 13211, 66 FR 28355 (May 18, 2001), are not applicable as there are no direct or implied effects on energy supply, distribution, or use.

Claims filed under this regulation are subject to the current Privacy Act System of Records, DOL/GOVT-1, Office of Workers' Compensation Programs, Federal Employees' Compensation Act File, 67 FR 16826 (April 8, 2002).

For the reasons discussed in the preamble, the Office of Workers' Compensation Programs amends 20 CFR part 10 as follows:

Upon request, FDA has classified the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment.

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

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

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

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

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

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

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

On June 12, 2020, FDA received ContinUse Biometrics Ltd.'s request for De Novo classification of the Gili Pro BioSensor. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on April 1, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 870.2786. 1 We have named the generic type of device hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate, and it is identified as a device that uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rates. This device is not intended to independently direct therapy.

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

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

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:

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

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

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

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

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

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

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

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

On December 18, 2019, FDA received iotaMotion, Inc.'s request for De Novo classification of the iotaSOFT Insertion System—Drive Unit, Controller and Accessories. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on October 1, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 874.4450. 1 We have named the generic type of device powered insertion system for a cochlear implant electrode array, and it is identified as a prescription device used to assist in placing an electrode array into the cochlea.

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

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

At the time of classification, powered insertion systems for a cochlear implant electrode array are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows:

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

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

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

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

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

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

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

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

On June 12, 2020, FDA received Ortho-Space, Ltd.'s request for De Novo classification of the InSpace Subacromial Tissue Spacer System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on July 12, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 888.3630. 1 We have named the generic type of device resorbable shoulder spacer, and it is identified as a device intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.

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

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:

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

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

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

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

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

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

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

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

On July 23, 2020, FDA received Neurolutions, Inc.'s request for De Novo classification of the Neurolutions IpsiHand Upper Extremity Rehabilitation System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on April 23, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 890.5420. 1 We have named the generic type of device electroencephalography (EEG)-driven upper extremity powered exerciser, and it is identified as a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.

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

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

At the time of classification, the electroencephalography (EEG)-driven upper extremity powered exerciser is for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 890 is amended as follows:

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

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

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

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

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

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

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

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

On March 30, 2021, FDA received AppliedVR Inc.'s request for De Novo classification of the EaseVRx. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on November 16, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 890.5800. 1 We have named the generic type of device virtual reality behavioral therapy device for pain relief, and it is identified as a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display that utilizes a software program containing the behavioral therapy content.

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

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

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 890 is amended as follows:

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act) (Pub. L. 114-74, sec. 701, 129 Stat. 584, 599-600), which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, sec. 5, 104 Stat. 890, 891-892), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The amended statute, codified in a note following 28 U.S.C. 2461, requires agencies to publish annual adjustments for inflation, based on the percentage change between the Consumer Price Index (defined in the statute as the Consumer Price Index for all-urban consumers (CPI-U) published by the Department of Labor) for the month of October preceding the date of the adjustment and the prior year's October CPI-U. 28 U.S.C. 2461 note, secs. 4(a) and (b) and 5(b)(1). This rule implements the 2023 calendar year inflation adjustment amounts.

Under 38 U.S.C. 3710(g)(4)(B), VA is authorized to levy civil monetary penalties against private lenders that originate VA-guaranteed loans if a lender falsely certifies that they have complied with certain credit information and loan processing standards, as set forth by chapter 37, title 38 U.S.C. and part 36, title 38 CFR. Under section 3710(g)(4)(B), any lender who knowingly and willfully makes such a false certification shall be liable to the United States Government for a civil penalty equal to two times the amount of the Secretary's loss on the loan involved or to another appropriate amount, not to exceed $10,000, whichever is greater. VA implemented the penalty amount in 38 CFR 36.4340(k)(1)(i) and (k)(3). On December 15, 2022, the Office of Management and Budget (OMB) issued Circular M-23-05. This circular reflects that the October 2021 CPI-U was 276.589 and the October 2022 CPI-U was 298.012, resulting in an inflation adjustment multiplier of 1.07745. Accordingly, the calendar year 2023 inflation revision imposes an adjustment from $25,076 to $27,018.

Under 31 U.S.C. 3802, VA can impose monetary penalties against any person who makes, presents, or submits a claim or written statement to VA that the person knows or has reason to know is false, fictitious, or fraudulent, or who engages in other covered conduct. The statute permits, in addition to any other remedy that may be prescribed by law, a civil penalty of not more than $5,000 for each claim. 31 U.S.C. 3802(a)(1) and (2). VA implemented the penalty amount in 38 CFR 42.3(a)(1)(iv) and (b)(1)(ii). As previously noted, OMB Circular M-23-05 reflects an inflation adjustment multiplier of 1.07745. Therefore, the calendar year 2023 inflation revision imposes an adjustment from $12,537 to $13,508.

Accordingly, VA is revising 38 CFR 36.4340(k)(1)(i) and (3) and 38 CFR 42.3(a)(1)(iv) and (b)(1)(ii) to reflect the 2023 inflationary adjustments for civil monetary penalties assessed or enforced by VA.

The Secretary of Veterans Affairs finds that there is good cause under 5 U.S.C. 553(b)(B) and (d)(3) to dispense with the opportunity for prior notice and public comment and to publish this rule with an immediate effective date. The statute requires agencies to make annual adjustments for inflation to the allowed amounts of civil monetary penalties “notwithstanding section 553 of title 5, United States Code.” 28 U.S.C. 2461 note, sec. 4(a) and (b). The penalty adjustments, and the methodology used to determine the adjustments, are set by the terms of the statute. VA has no discretion to make changes in those areas. Therefore, an opportunity for prior notice and public comment and a delayed effective date are unnecessary.

Executive Orders 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). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Regulatory Flexibility Act, 5 U.S.C. 601-612, is not applicable to this rulemaking because notice of proposed rulemaking is not required. 5 U.S.C. 601(2), 603(a), 604(a).

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

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

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

Signing Authority: Denis McDonough, Secretary of Veterans Affairs, approved this document on December 20, 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 stated in the preamble, the Department of Veterans Affairs amends 38 CFR parts 36 and 42 as set forth below:

The 2015 Act  1 requires each Federal agency to adjust the level of statutory civil monetary penalties under the laws implemented by that agency with annual adjustments to account for inflation. Section 4 of the 2015 Act requires each Federal agency to publish these adjustments by January 15 of each year. The purpose of the 2015 Act is to maintain the deterrent effect of civil monetary penalties by translating originally enacted statutory civil penalty amounts to today's dollars and rounding statutory civil penalties to the nearest dollar.

Since January 15, 2017, the EPA has made six annual adjustments: on January 12, 2017, effective on January 15, 2017 (82 FR 3633); on January 10, 2018, effective on January 15, 2018 (83 FR 1190); on February 6, 2019, effective the same day (84 FR 2056), with a subsequent correction on February 25, 2019 (84 FR 5955); on January 13, 2020, effective the same day (85 FR 1751); on December 23, 2020, effective the same day (85 FR 83818); and on January 12, 2022, effective the same day (87 FR 1676). This rule implements the seventh annual adjustment mandated by the 2015 Act.

The 2015 Act provides a formula for calculating the adjustments. Each statutory maximum and minimum  2 civil monetary penalty, as currently adjusted, is multiplied by the cost-of-living adjustment multiplier, which is the percentage by which the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October 2022 exceeds the CPI-U for the month of October 2021. 3

With this rule, the new statutory maximum and minimum penalty levels listed in the third column of Table 1 of 40 CFR 19.4 will apply to all civil monetary penalties assessed on or after January 6, 2023, for violations that occurred after November 2, 2015, the date the 2015 Act was enacted. The former maximum and minimum statutory civil monetary penalty levels, which are in the fourth column of Table 1 to 40 CFR 19.4, will now apply only to violations that occurred after November 2, 2015, where the penalties were assessed on or after January 12, 2022, but before January 6, 2023. The statutory civil monetary penalty levels that apply to violations that occurred on or before November 2, 2015, are codified at Table 2 to 40 CFR 19.4. The fifth column of Table 1 and the seventh column of Table 2 display the statutory civil monetary penalty levels as originally enacted.

The formula for determining the cost-of-living or inflation adjustment to statutory civil monetary penalties consists of the following steps:

Step 1: The cost-of-living adjustment multiplier for 2023 is the percentage by which the CPI-U of October 2022 (298.012) exceeds the CPI-U for the month of October 2021 (276.589), which is 1.07745. 4 Multiply 1.07745 by the current penalty amount. This is the raw adjusted penalty value.

Step 2: Round the raw adjusted penalty value. Section 5 of the 2015 Act states that any adjustment shall be rounded to the nearest multiple of $1. The result is the final penalty value for the year.

Pursuant to section 4 of the 2015 Act, each Federal agency is required to publish adjustments no later than January 15 each year. In accordance with section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register . However, section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments “notwithstanding section 553” of the APA. Consistent with the language of the 2015 Act, this rule is not subject to notice and an opportunity for public comment and will be effective on January 6, 2023.

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

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose an information collection burden under the PRA. This rule merely increases the level of statutory civil monetary penalties that can be imposed in the context of a Federal civil administrative enforcement action or civil judicial case for violations of EPA-administered statutes and their implementing regulations.

This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. Because the 2015 Act directs Federal agencies to publish this rule notwithstanding section 553 of the APA, this rule is not subject to notice and comment requirements or the RFA.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action is required by the 2015 Act, without the exercise of any policy discretion by the EPA. This action also imposes no enforceable duty on any state, local or tribal governments or the private sector. Because the calculation of any increase is formula-driven pursuant to the 2015 Act, the EPA has no policy discretion to vary the amount of the adjustment.

This action does not have federalism implications. It will not have a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. This rule merely reconciles the real value of current statutory civil monetary penalty levels to reflect and keep pace with the levels originally set by Congress when the statutes were enacted or amended. The calculation of the increases is formula-driven and prescribed by statute, and the EPA has no discretion to vary the amount of the adjustment to reflect any views or suggestions provided by commenters. Accordingly, this rule will not have a substantial direct effect on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

The rulemaking does not involve technical standards.

Executive Order 12898 (59 FR 7629, February 16, 1994) directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color) and low-income populations.

The EPA believes that this type of action does not concern human health or environmental conditions and therefore cannot be evaluated with respect to potentially disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples. Rather, this action is mandated by the 2015 Act, which prescribes a formula for adjusting statutory civil penalties on an annual basis to reflect inflation.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and comment rulemaking procedures are impracticable, unnecessary or contrary to the public interest (5 U.S.C. 808(2)). The EPA finds that the APA's notice and comment rulemaking procedures are unnecessary because the 2015 Act directs Federal agencies to publish their annual penalty inflation adjustments “notwithstanding section 553 [of the APA].”

For the reasons set out in the preamble, the EPA amends title 40, chapter I, part 19 of the Code of Federal Regulations as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2021-0209 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before March 7, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0209 by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

In the Federal Register of April 22, 2021 (86 FR 21317) (FRL-10022-59), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP0F8893) by Ag Chem Resources, LLC, 10120 Dutch Iris Drive, Bakersfield, CA 93311. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of extract of Caesalpinia spinosa in or on raw agricultural commodities and processed foods when used in accordance with good agricultural practices. That document referenced a summary of the petition prepared by the petitioner Ag Chem Resources, c/o Exponent, which is available in the docket, https://www.regulations.gov (EPA-HQ-OPP-2021-0209). There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . . ” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. If EPA is able to determine that a tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for extract of Caesalpinia spinosa including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with extract of Caesalpinia spinosa follows.

Extract of Caesalpinia spinosa is a tannin-rich extract from the seed pods of Peruvian tara trees ( Caesalpinia spinosa ). There is a long history of safe exposure to tannins as these compounds are a part of the human diet and are naturally present in coffee and tea and nearly all vegetation, including in leaves, twigs, bark, wood, or fruit (U.S. EPA, 2006). Tannin compounds are found throughout the plant kingdom in forms ranging from simple phenols to macromolecules. Tannic acid is the macromolecule tannin compound found in Caesalpinia spinosa extract.

In conducting its hazard assessment for extract of Caesalpinia spinosa, EPA relied on the following data/information to satisfy the data requirements: (1) guideline acute toxicity studies; (2) guideline for the 90-day oral toxicity, prenatal developmental toxicity, and genetic toxicity studies; and (3) data waivers supported by information from open scientific literature in lieu of guideline studies for the 90-day dermal and 90-day inhalation data requirements. No adverse effects have been identified in the available data.

Extract of Caesalpinia spinosa has a low acute toxicity profile as evident by its toxicity Category IV classification for acute inhalation, acute dermal, acute oral toxicity, primary eye irritation, and primary dermal irritation. extract of Caesalpinia spinosa is not a dermal sensitizer.

To address the subchronic 90-day dermal data requirement, EPA granted a waiver based upon a weight of the evidence (WOE) approach as follows: (1) Extract of Caesalpinia spinosa is considered non-irritating to the skin, is not a dermal sensitizer, and is classified as Toxicity Category IV for acute dermal toxicity; (2) tannic acid is naturally occuring with a long history of exposure without adverse reactions seen in cosmetics and foods approved for use by the FDA; (3) the non-water component of the extract, tannin acid, has physiochemical properties that suggest a low probability for dermal penetration.

In terms of the 90 day-inhalation toxicity data requirement, EPA also granted a waiver based on the following: (1) tannic acid is naturally occurring with a long history of exposure with no adverse reactions reported; (2) tannic acid is approved for use in food by the FDA; (3) the physical and chemical properties of tannic acid ( e.g., the vapor pressure was too low to be reliably quantified for extract of Caesalpinia spinosa or tannic acid); (4) tannic acid is approved for inert ingredient (dispersing agent) use in pesticide products.

To address subchronic 90-day oral toxicity, data from a 90-day oral gavage study and a 4-week oral gavage study on rats with extract of Caesalpinia spinosa were conducted and found there were no adverse effects. The no-observed-effect-level (NOAEL) for both sexes was 3,500 mg/kg-bw/day and 3,000 mg/kg-bw/day, respectively, which were the highest doses tested in the studies. In addition, a 12-week dietary study on rats was provided using up to 800 mg/kg/day of tannic acid. In this study there were no significant changes in body weight, food intake, liver and kidney weights, gross pathology and histopathology observed.

For prenatal developmental and genetic toxicity, no maternal or developmental adverse treatment-related effects were observed. The NOAEL was greater than 3,500 mg/kg-bw/day, the highest dose level tested. In terms of mutagenicity, the active ingredient was determined to be non-mutagenic, and not genotoxic.

It is also relevant to the toxicological profile that “tannin” is approved for use as a direct human food additive as a boiler water additive under 21 CFR 173.310 and “tannic acid” is considered Generally Recognized as Safe (GRAS) when used as a flavoring agent, adjuvant, and pH control agent in baked goods, alcoholic beverages, beverage bases, gelatins, and frozen dairy desserts per 21 CFR 184.1097. In terms of its use in pesticide formulations, tannin (including tannic acid) is exempt from the requirement of a tolerance as an inert ingredient in pesticide products when used as a dispersing agent applied to growing crops under 40 CFR 180.920. In addition to its widespread natural presence in foods, tannic acid is widely used in various cosmetic products such as soap, facial cleansers, masks, moisturizers, and serums. Further, tannic acid derived from plants is recognized as an animal feed additive for all species by the European Union of Feed Additives pursuant to Regulation EC No. 1831/2003.

Based on the toxicological profile, EPA did not identify any toxicological endpoints of concern for assessing risk for this chemical.

1. Dietary exposure from food, feed uses, and drinking water. Extract of Caesalpinia spinosa is a naturally occurring, tannin rich extract found in plants to which humans have been exposed through fruit, tea, coffee, feed grains, and vegetable consumption. As part of its qualitative risk assessment for extract of Caesalpinia spinosa, the Agency considered the potential for any additional dietary exposure to residues of extract of Caesalpinia spinosa from its proposed use as a nematicide on agricultural use sites. EPA concludes that such dietary (food and drinking water) exposures are likely to be negligible, as extract of Caesalpinia spinosa is readily biodegradable in the environment, potential residues of the substance are not anticipated on treated commodities at the time of consumption based on its physical chemical properties. Furthermore, residue data available for carrots and tomatoes show that when the proposed end-use product was applied according to labeled rates and methods, pesticide residues were indistinguishable from background levels. A quantitative dietary exposure assessment was not conducted because a toxicological endpoint for risk assessment was not identified.

2. Residential exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure. There are no anticipated residential uses and significant residential exposure is not expected; therefore, residential handler and post-application risks of concern are not expected. Residential exposure may occur from non-pesticidal uses such as use in food commodities. However, inhalation exposure is not expected since tannins do not easily volatize because of their physical and chemical properties. A quantitative dietary exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish a tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to extract of Caesalpinia spinosa and any other substances, and this biopesticide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, EPA has not assumed that this active ingredient has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

FFDCA section 408(b)(2)(C) provides that EPA shall retain an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) safety factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. An FQPA safety factor is not required at this time for extract of Caesalpinia spinosa because EPA is performing a qualitative dietary assessment based on negligible toxicological and exposure concerns.

Based on the available data and information, the Agency has concluded that a qualitative aggregate risk assessment is appropriate to support this action, and that risks of concern are not anticipated from aggregate exposure to the extract of Caesalpinia spinosa. This conclusion is based on the low toxicity of the active ingredient, expected ready biodegradation in the environment, and existing natural levels present in foodstuffs. Anticipated dietary (food and drinking water) and bystander exposures are expected to be negligible, and there are no residential uses for the active ingredient. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found in the Memorandum entitled “Product Chemistry Review and Human Health Risk Assessment for FIFRA Section 3 Registrations of the Manufacturing-Use Product, AgChem1, and the End-Use Product AgChem1-EP1, Containing extract of Caesalpinia spinosa (99.9%) as a New Active Ingredient”. This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES .

Based on the Agency's assessment, EPA concludes that there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of extract of Caesalpinia spinosa. Therefore, the establishment of an exemption from the requirement of a tolerance for residues of extract of Caesalpinia spinosa in or on all food commodities when used in accordance with good agricultural practices is safe under FFDCA section 408.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR part 180 for residues of extract of Caesalpinia spinosa in or on all food commodities when used in accordance with good agricultural practices.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

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

(a) The need for the regulatory action and how the action will meet that need: The purpose of this regulatory action is to finalize, with modification, the Interim Final Rule with Comment Period (IFC), Vaccine and Mask Requirements to Mitigate the Spread of COVID-19 in Head Start Programs, which ACF issued on November 30, 2021 (86 FR 68052). This final rule takes into consideration the more than 1,700 public comments received on masking during the comment period, the most up to date data available on COVID-19, and knowledge gained through research on the transmission and effects of SARS-CoV-2 to establish a policy that prioritizes the health and safety of children served by the federal Head Start program, their families, and the program's staff while also adapting to the realities of evolving COVID-19 conditions. In brief, this final rule:

(1) removes the requirement of universal masking for all individuals 2 years of age and older when they are with two or more individuals in a vehicle owned, leased, or arranged by the Head Start program; when they are indoors in a setting where Head Start services are provided; and, for those not fully vaccinated, outdoors in crowded settings or during activities that involve close contact with other people.

(2) requires Head Start programs to have an evidence-based COVID-19 mitigation policy developed in consultation with their Health Services Advisory Committee (HSAC).

During this rulemaking process alone, there have been considerable gains in what the scientific, medical, and public health communities know and understand about SARS-CoV-2. More tools are available to protect against SARS-CoV2 than when the IFC was issued, and the conditions around COVID-19 have changed. These new tools include improved accessibility to vaccines for adults and children over age 6 months, treatments, tests, and improved information about other tools like ventilation to maximize protection and minimize transmission. For these reasons, and those further outlined in the preamble, ACF has removed the specific universal masking requirement and replaced it with a requirement that programs establish an evidence based COVID-19 mitigation policy in consultation with their HSAC.

Throughout the development of the IFC and this final rule, ACF has considered the guidance of the U.S. Centers for Disease Control and Prevention (CDC) as our lead public health agency to ensure the latest science guides our policies. After consideration and review of the latest CDC guidance, ACF has concluded that the universal masking requirement established in the IFC no longer is warranted.

The IFC was published at a point in time when the CDC recommended universal masking for individuals 2 years and older. At that time, vaccines were not yet available for children between the ages of two and five. Additionally, citing CDC data, ACF noted that “although COVID-19 cases had begun to decline in parts of the country,” “data indicate[d] cases are beginning to rise in other parts,” and “the future trajectory of the pandemic [was] unclear.” 86 FR 68053. ACF also highlighted the acute risks of the highly transmissible Delta variant, which at the time was “the predominant variant in the United States and ha[d] resulted in greater rates of cases and hospitalizations among children than from other variants.” Ibid. At this stage of the COVID-19 response, CDC recommends universal masking based on COVID-19 Community Level.

This final rule instead requires Head Start programs to have an evidence-based COVID-19 mitigation policy developed in consultation with their HSAC. The HSAC is an advisory group usually composed of local health providers; they may include pediatricians, nurses, nurse practitioners, dentists, nutritionists, and mental health providers. Head Start staff and parents also serve on the HSAC. All Head Start and Early Head Start programs are required to establish and maintain a HSAC (45 CFR 1302.40(b)).

Removing the universal mask requirement and replacing it with the requirement of an evidence-based COVID-19 mitigation policy allows Head Start programs to adapt to changing circumstances, to consider the unique challenges and needs faced by individual programs, and still supports the safest environments for the workforce, and the children and families Head Start serves.

(b) Legal authority for the final rule: ACF publishes this final rule under the authority granted to the Secretary by sections 641A(a)(1)(C), (D) and (E) of the Head Start Act, 42 U.S.C. 9836a(a)(1)(C), (D) and (E), as amended by the Improving Head Start for School Readiness Act of 2007 (Pub. L. 110-134). Specifically, section 641A of the Head Start Act allows the Secretary to “modify, as necessary, program performance standards by regulation applicable to Head Start agencies and programs.” In developing this modification, the Secretary included relevant considerations pursuant to section 641A(a)(2) of the Head Start Act, 42 U.S.C. 9836a(a)(2). The Secretary finds it necessary and appropriate to set health and safety standards for Head Start programs to ensure they respond to the evolving COVID-19 pandemic to keep the environment where Head Start services are provided safe.

This final rule removes the universal masking requirement for all individuals 2 years of age and older, which had applied universally subject to some exceptions. 1 While this final rule removes the universal masking requirement, programs may opt to include such requirements in their COVID-19 mitigation policy.

The universal masking requirement in the IFC mirrored CDC's recommendations in fall 2021 and was predicated on then-current data about COVID-19 and expectations about the future trajectory of the disease. The CDC has moved away from a recommendation for universal indoor masking in schools and early care and education facilities. On February 25, 2022, the CDC issued new COVID-19 mitigation recommendations to help individuals and communities make choices on what precautions to take, based on the level of disease burden in their community and the capacity of their nearby hospitals. CDC calls these “COVID-19 Community Levels,” which include low, medium, and high Community Level classifications. At present, CDC only recommends universal masking indoors at the high COVID-19 Community Level. As a result, Head Start programs may be operating with a more stringent masking requirement than the CDC indicates is warranted currently, and specifically, a requirement that reflects a different stage of the COVID-19 response when the CDC recommended universal masking for individuals ages 2 and older.

To clarify, programs may still promote, encourage, and even require universal masking as part of their COVID-19 evidence-based policy given the proven benefits of masking as an effective layered mitigation strategy against COVID-19, particularly when communities are experiencing a high level of disease burden or are serving high-risk populations ( e.g., when COVID-19 Community Levels are high). 2 The effectiveness of masking is discussed further in Section III and programs may find the responses helpful when developing their COVID-19 mitigation policies.

The removal of the universal masking requirement and replacement with the evidence-based COVID-19 mitigation policy gives Head Start programs more flexibility to adapt to the changing circumstances of COVID-19 while still protecting the health of children and consequently will reduce burden on programs.

This final rule requires Head Start programs to have an evidence-based COVID-19 mitigation policy developed in consultation with the program's HSAC. This modification allows the rule to continue to be relevant and up to date as the level of COVID-19 impact in communities changes.

The evidence-based COVID-19 mitigation policy should consider multiple mitigation strategies such as access to vaccination, masking, ventilation, and testing. Per the CDC, Head Start programs should consider local conditions, including transmission levels as well as program characteristics such as the population of children and families served, when selecting mitigation strategies to prioritize for implementation.

Although the national vaccination requirement remains in place while the vaccination portion of the IFC is under review, Head Start programs may include additional considerations beyond the original IFC requirement to support vaccination efforts, including for example, requiring staff remain up to date on COVID-19 boosters, sharing information on COVID-19 vaccination with staff and families, and/or partnering with local agencies to increase vaccination access.

OHS will issue supplementary information at the time of publication of this rule to Head Start programs to provide information that may assist programs in developing an evidence-based policy. Specifically, this supplementary information will reference the latest research and science on layered mitigation strategies, including information from the CDC guidance for Early Childhood Education settings, CDC COVID-19 Community Levels guidance, and state and local guidance. OHS will update this guidance as appropriate.

This final rule requires programs to have established an evidence-based COVID-19 mitigation policy in consultation with their HSAC by March 7, 2023.

This final rule revises requirements established on November 30, 2021, through an Interim Final Rule with Comment (IFC), “Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in Head Start Programs.”  3 In our main analysis, we evaluate the likely impacts of the final rule in comparison to a baseline scenario of the IFC without modifications.

The final rule requires that Head Start programs have an evidence-based COVID-19 mitigation policy, developed in consultation with their HSAC. This requirement will result in a one-time cost for each program to develop its mitigation policy. Although the final rule is not prescriptive with respect to the elements of these mitigation policies, we identify and estimate ongoing costs to Head Start programs by modeling elements of a mitigation policy that are intended to be representative of a range of potential options.

This final rule also removes the requirement for universal masking for all individuals two years of age and older. While some programs may maintain masking for certain groups or under certain circumstances, removing this requirement will likely result in fewer masks worn. All else equal, if fewer masks are worn as a result of the rule, this may result in increased transmission risk of SARS-CoV-2; however, this could be offset by other elements of evidence based COVID-19 mitigation policies developed by Head Start programs.

Overall, we anticipate that the cost savings associated with removing the universal masking requirement will exceed the incremental costs of the mitigation policies. Thus, the final rule will result in net cost savings, which accrue primarily to Head Start programs. Over a 3-month time horizon, we estimate that the final rule may result in about $9.2 million in net benefits; in other words, this amount is our estimate of the net cost savings attributable to the final rule.

Since its inception in 1965, Head Start has been a leader in supporting children from low-income families in reaching kindergarten healthy and ready to thrive in school and life. The program was founded on research showing that health and wellbeing are pre-requisites to maximum learning and improved short- and long-term outcomes. In fact, OHS identifies health as the foundation of school readiness.

The Head Start Program Performance Standards (HSPPS) require programs to comply with state immunization enrollment and attendance requirements and to work with families to ensure children who are behind on immunizations or other care get on a schedule to catch up (45 CFR 1302.15(e) and1302.42(b)(1)). Additionally, education, family service, nutrition, and health staff help children learn healthy habits, monitor each child's growth and development, and help parents access needed health care.

All Head Start and Early Head Start programs are required to establish and maintain a HSAC (45 CFR 1302.40(b)). The HSAC is an advisory group usually composed of local health providers; they may include pediatricians, nurses, nurse practitioners, dentists, nutritionists, and mental health providers, among others. Head Start staff and parents also serve on the HSAC. As HSACs are usually comprised of local health care providers, they provide an existing framework that supports Head Start programs in accessing and leveraging expertise to promote child health. The HSPPS specifically requires the HSAC to provide expertise in determining whether children are up to date on age-appropriate preventive and primary medical and oral health care; support the program in identifying children's nutritional health needs; and consult on appropriate screenings for communicable diseases for regular volunteers in cases where there is an absence of state, tribal or local laws.

It is vitally important that the Head Start program itself is safe for all children, families, and staff. For this reason, the HSPPS specify that the program must ensure Head Start staff do not pose a significant risk of communicable disease (45 CFR 1302.93(a)). Ensuring that children and families can benefit from program services as safely as possible is ACF's highest priority. While this is always important, COVID-19 has highlighted the need to ensure staff and young children are also protected.

ACF published an IFC in the Federal Register on November 30, 2021 (86 FR 68052). ACF issued the IFC on the basis of its authority in Section 641A of the Head Start Act, which allows the Secretary to “modify, as necessary, program performance standards by regulation applicable to Head Start agencies and programs,” including “administrative and financial management standards,” “standards relating to the condition and location of facilities (including indoor air quality assessment standards, where appropriate) for such agencies, and programs,” and “such other standards as the Secretary finds to be appropriate,” 42 U.S.C. 9836a(a)(1)(C)), (D), and (E). In developing these modifications, the Secretary included relevant considerations pursuant to section 641A(a)(2) of the Head Start Act, 42 U.S.C. 9836a(a)(2). 4 The Secretary consulted with experts in child health, including pediatricians, a pediatric infectious disease specialist, and the recommendations of the CDC and the U.S. Food and Drug Administration (FDA). 5   6   7   8 The Secretary considered OHS's past experience with the longstanding health and safety requirements of the HSPPS that have sought to protect Head Start staff and participants from communicable and contagious diseases. The Secretary also considered the circumstances and challenges typically facing children and families served by Head Start agencies. Challenges considered included the disproportionate effect of COVID-19 on low-income communities served by Head Start agencies and the potential for devastating consequences for children and families of program closures and service interruptions due to SARS-CoV-2 exposures. Based on all these factors, the Secretary found it necessary and appropriate to set health and safety standards for the condition of Head Start facilities that address the transmission of the SARS-CoV-2 and avoid severe illness, hospitalization, and death among program participants.

As of January 1, 2022, 9   10 following decisions by the United States District Courts for the Northern District of Texas and the Western District of Louisiana, implementation and enforcement of the IFC was enjoined in the following 25 States: Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, and Wyoming. Head Start, Early Head Start, and Early Head Start-Child Care Partnership grant recipients in those 25 states were not required to comply with the IFC pending future developments in the litigation. The IFC remained in effect in all other states, the District of Columbia, and U.S. territories. In this final rule, discussion of the states not implementing the requirement relative to states that are implementing the requirements is in reference to these injunctions.

As of the date of publication of the IFC, children under the age of 5 were not eligible for the COVID-19 vaccine. On June 17, 2022, the FDA authorized the emergency use of the Moderna and Pfizer-BioNTech COVID-19 vaccines to include children 6 months through 5 years of age. Due to the extension of this mitigation strategy to this age cohort, Head Start children who are vaccinated are now less vulnerable to the effects of COVID-19. COVID-19 vaccines continue to provide crucial protections against severe disease, hospitalization, and death in children and adolescents.

The IFC generated many comments. We analyze and discuss those comments in Part IV, Public Comments Analysis.

The comment period for the IFC was open for 30 days and closed on December 30, 2021. OHS received more than 1,700 comments that expressed concerns with masking generally, and most of those comments focused on masking children. As noted, this final rule does not address the vaccination or testing requirements in the IFC and, therefore, does not include a summary of the comments that pertain to that requirement.

Most comments came from individuals, including Head Start directors, other Head Start staff members, Members of Congress, and parents. A smaller subset of comments came from associations on behalf of their membership.

The comments expressing concerns with masking, and particularly the masking policy for children, include, but are not limited to, concerns regarding the physical health of children, the potential impact on their social-emotional and speech development, the safety and efficacy of masks, and the violation of parental rights. Other areas of concern included: difficulties sustaining partnerships, mostly related to conflicting requirements with school districts; the requirements being a violation of individual rights and an overreach of the federal government; and the sentiment that a national versus local approach to COVID-19 results in what commenters often referred to as a “one-size-fits-all” approach. Other comments cited disagreement with the mask requirement due to factually inaccurate information, such as the masking of children leading to carbon dioxide poisoning. A small minority of the submissions expressed support for the IFC. Supportive commenters commended ACF for its efforts to ensure the safety of Head Start children, families, and staff, noted that the mandate made them feel safer about Head Start services and viewed the requirements as a prioritization of the needs of children and staff, using evidence-based practices. Many of the supportive commenters acknowledged the challenges associated with the mask requirement but agreed that the dynamic nature of SARS-CoV-2 warranted this requirement.

We respond to the comments we received on masking in response to the IFC in this section-by-section discussion. We also address public comments in more detail in Section V where we discuss how we have made changes to the IFC. Before discussing the requirements in the final rule, we respond to the general comments we received in response to the IFC related to the burden of the masking requirement, challenges around full enrollment, the implementation timeline, and the lack of a termination date of the masking requirement. Many comments we received reiterated the same or similar information that fell into these broad categories, and we believe it is clearer for us to respond to similarly grouped comments in this way.

Comment: Commenters shared concerns that it is too burdensome to implement and enforce the new policies and procedures related to the mask requirement given the day-to-day complexities that come with navigating the ongoing pandemic. A majority of commenters raised concerns about the increased burden and stress imposed on staff and families due to the mask mandate.

Response: ACF is aware that programs have universally experienced increased burden related to operating amidst SARS-CoV-2 transmission. The masking requirement outlined in the IFC necessitated additional effort to implement, and these efforts were warranted at an earlier time to address COVID-19, given the age of children served and the disproportionate impact of the pandemic on children and staff in Head Start programs. Thus, while the requirement required increased effort, it was a critical part of a layered mitigation strategy to provide the maximum possible protection against COVID-19 infection to Head Start children, staff, and families.

Head Start programs implementing this requirement were able to do so successfully while continuing to operate their programs. That said, the requirement in this final rule of a COVID-19 mitigation policy gives Head Start programs more flexibility to adapt to the changing circumstances of COVID-19 and to benefit from prevailing public health recommendations concerning the most effective COVID-19 mitigation strategies while still protecting the health of children and being responsive to the needs of their communities.

Comment: Comments highlighted that many programs are already struggling to meet full enrollment and suggested that the mask requirement is further hindering their efforts to enroll families, especially when the requirement contradicts local school district policies. Commenters discussed the consequence of families removing their children from the program due to the mask requirement because they disagree with the requirement, believed it should be the decision of parents, or are concerned about inappropriate developmental consequences.

Response: ACF recognizes that enrollment has been challenging for some Head Start programs, particularly as they work to reach more families and be fully enrolled. However, ACF has no evidence that the mask requirement specifically hindered enrollment efforts nationally. OHS center status data suggests that enrollment of children increased in the months following the publication of the IFC, and the ability to provide children with in-person services remained steady after the issuance of the IFC. In the 4 months after the rule was implemented (February 2022-May 2022  11 ), programs reported a percent change increase of 7 percent in the total average actual enrollment, as compared to the 4 months leading up to effective date of the final rule (September-December 2021). Additionally, in the 4 months leading up to the effective date of the IFC, programs reported an average of 91.25 percent of enrolled children who received full in-person services. Again 4 months after the rule was implemented, programs reported an average of 92.6 percent of enrolled children were receiving full in-person services. Notably, in May 2022, the data show our highest percentage of reported enrolled children receiving full in-person services since the start of the pandemic (93.4 percent). If we examine the 25 states not implementing the requirements, as compared to the states and territories that were implementing the requirements, both groups increased their reported percentage of children served fully in-person after publication of the IFC. From November 2021 to March 2022, both groups of states increased their reported percentage of children served fully in-person by 2 percent.

In sum, the data does not show an indication that the requirement hindered programs' ability to operate in-person services. 12 While center status data has limitations and cannot be used to prove causation from any provisions in the IFC, based on the data available, OHS has not seen significant impact on slot-level operating status at the regional or national level. OHS has not seen a decrease in actual enrollment levels in the months following the publication of the IFC. Despite many commenters' speculation that these requirements would result in families removing their children from Head Start programs on a large scale, and ultimately, leading to extensive classroom closures, there has been no indication that these predictions occurred.

While some individual families may have removed their children from Head Start, we have not seen a large-scale exodus from Head Start programs.

Compared to the provisions in the IFC, ACF anticipates the shift to an evidence based COVID-19 mitigation policy will result in families being less inclined to disenroll their children.

Comment: Commenters reported various concerns broadly related to the timeline for the implementation of this requirement. Commenters raised concerns about the immediate effective date of the masking requirement, stating they did not have enough notice to properly inform their staff and families and set up policies and procedures. Commenters also raised concerns about the IFC's publication relative to the pandemic. Comments included doubt that a required mitigation strategy for masking is necessary and effective if it was put into place almost two years into the pandemic.

Response: ACF understands that the effective date for the masking requirement was challenging. We value this input and have taken these comments into consideration in the development of the implementation timeline for this final rule. IFCs, or provisions within IFCs, are used when an agency has good cause to issue a final rule without first publishing a proposed rule. ACF issued an IFC to protect Head Start staff, children, and families in response to alarming trends in the data and inadequate vaccination coverage. The lengthier process associated with a notice of proposed rulemaking (NPRM) process would have impeded ACF's ability to put the necessary mitigation strategies in place to create the safest possible environment for staff, children, and families based on the information available at the time. The Secretary found it necessary and appropriate to set health and safety standards for the condition of Head Start facilities to ensure the reduction in transmission of the SARS-CoV-2, based on the science at the time, and to avoid severe illness, hospitalization, and death among program participants.

In this final rule, in consideration of public comment concerns relative to the implementation timeline, the requirement to have established an evidence-based COVID-19 mitigation policy in consultation with their HSAC is effective 60 days following publication of the final rule, March 7, 2023. This compliance date will allow programs to develop and implement the required policy.

Comment: Commenters raised concerns with the lack of the termination date for the universal mask requirement. ACF invited comment on the decision to leave an undetermined end date or set a finite end date, such as 6 months from the effective date of the rule. Programs reported concerns that the indefinite nature of the requirement impedes their ability to update their internal policies, inform staff of expectations, update parents and families, budget for next year and outline expectations for prospective staff and families.

Response: ACF's final rule addresses these concerns in two respects:

(1) ACF has removed the universal masking requirement in this final rule, which means that all individuals ages 2 and older no longer need to wear a mask indoors, when there are two or more individuals on transportation, and, if unvaccinated, when outside in crowded spaces and during activities that involve sustained close contact with others, unless their program opts to include such requirements under its COVID mitigation policy.

(2) ACF is now requiring Head Start programs to have an evidence-based COVID-19 mitigation policy developed in consultation with the HSAC. ACF believes this change will address concerns with the lack of a termination date that existed in the IFC for the universal masking requirement. A fuller discussion of this change is included in Section VI.

The majority of commenters expressed concerns regarding the universal mask requirement for children 2 years of age and older in Head Start programs. There were several topics raised within this broader area of concern.

Comment: Some commenters raised the concern that having staff masked might be particularly difficult for young children who lip-read. There was also concern that staff will have difficulty hearing children who are masked. More prevalent, many commenters raised concerns regarding the potential for children to experience delays due to mask use, including social and emotional delays and developmental delays. Specifically, commenters expressed concern that the prolonged use of masks among young children would result in social and emotional delays due to the lack of facial recognition of emotional cues. Other commenters feared masks may hinder children's acquisition of speech and language and consequently children will experience developmental delays.

Response: While studies show masks may reduce decibels, attenuate frequencies, and remove visual cues which is a risk for young children who are developing speech, language, and pre-reading/reading skills, no serious adverse events have been reported. 13   14 Guidance from the American Academy of Pediatrics notes that teachers and staff may need to use clear paneled masks to adequately serve students who are deaf or hard of hearing, students receiving speech/language services, young students in early education programs, and English language learners. 15 Further, staff use of clear paneled masks when communicating with students who are deaf or hard of hearing may also be required by federal disability rights laws, which mandate that such students have equal opportunity to participate in the program.

With respect to the more prevalent concern about social-emotional or developmental delays due to mask use, although there have been numerous opinion pieces, there are few scientific studies published on the risk/benefit of adults wearing masks on young children's social-emotional and language development. While some of the comments will not be applicable to the final rule, given the revised requirements, programs may find the responses helpful as they consider the appropriateness of various alternatives to the universal masking requirement for their COVID-19 mitigation policies.

ACF identified relevant studies, and in sum, there is not sufficient evidence of an impact on social-emotional development when adults are wearing masks. 16   17   18   19   20

There is only one study that suggests that wearing a mask impairs children's ability to read emotions, but there are more studies, as noted above, that show no impact. There are no published studies on the long-term effects of young children's development when adults wear masks. The CDC currently recommends universal mask use when the COVID-19 Community Level  21 is high and ACF recommends that Head Start programs develop a policy on masking that aligns with state, local, and national public health guidance.

Comment: Many of the same commenters were worried about the safety of children wearing masks and their efficacy in mitigating the spread of COVID-19, some of whom cited conflicting guidance on mask use among young children in World Health Organization (WHO) and United Nations International Children's Emergency Fund (UNICEF) reports. Commenters reported concerns that face masks can reduce oxygen intake, leading to carbon dioxide poisoning from re-breathing the air we normally breathe out. Some commenters were concerned specifically about the impact of mask wearing for children with special health care needs. Other concerns included: that masks quickly become unhygienic with young children and themselves spread germs, that wearing a face mask weakens one's immune system, or that mask use increases one's chances of getting sick if exposed to the COVID-19 virus.

Response: To be clear, there has been no evidence to substantiate the claim that mask use leads to reduced oxygen intake or carbon dioxide poisoning, weakens one's immune system, or increases one's chances of getting sick. The CDC Science Brief: Community Use of Masks to Control the Spread of SARS-CoV-2 (last updated December 2021 at the time of this publication) provides clear information on SARS-CoV-2 transmission and the efficacy of masks. SARS-CoV-2 infection is transmitted predominantly by inhalation of respiratory droplets generated when people cough, sneeze, sing, talk, or breathe. Well-fitting masks are primarily intended to reduce the emission of virus-laden droplets by the wearer (“source control”), which is especially relevant for asymptomatic or pre-symptomatic infected wearers who feel well and may be unaware of their infectiousness to others. 22   23 Studies demonstrate that wearing well-fitting masks also provides protection to the wearer by reducing wearers' exposure to infectious droplets through filtration, including filtration of fine droplets and particles less than 10 microns. 24 Improving fit and filtration—for example, through strategies such as using mask fitters or layering a cloth mask over a medical procedure mask—can improve wearer protection. The community benefit of wearing well-fitting masks for SARS-CoV-2 control is due to the combination of source control and filtration protection for the wearer; the individual prevention benefit of wearing masks increases with increasing numbers of people using masks consistently and correctly in a given setting. 25

With respect to the safety of children wearing masks and their efficacy in mitigating the spread of COVID-19, ACF points to several studies. First, in terms of safety, there is no evidence to suggest that wearing a mask makes it harder for individuals to breathe, impacts their lung development, or traps carbon dioxide. 26   27   28

Second, in terms of the efficacy of children wearing masks as a mitigation strategy, there have been a few studies about mask use in K-12 settings since 2020, as well as one study conducted in early childhood settings. In sum, the available research suggests that the required use of masks for children in schools and early childhood education settings results in lower incidence of SARS-CoV-2 transmission and fewer school closures. 29   30   31   32

Additionally, commenters have cited a joint UNICEF and WHO report  33 that recommended children aged up to 5 years should not wear masks as a general preventive strategy. This recommendation conflicts with the most current CDC guidance and ACF is choosing to rely on the lead U.S. public health agency over other organizations. The report also acknowledges that evidence is limited around the use of masks in children for COVID-19 and countries may ultimately choose to recommend a lower age cut-off for mask use. Having access to the same data, countries have come to different conclusions on the benefits and harms of children wearing masks, with the U.S. and Canada recommending masking for children ages 2 and up.

Additionally, ACF acknowledges that commenters had valid concerns regarding the hygienics of masking children and agree that children may need extra masks should theirs become soiled. ACF encourages programs to consider the use of COVID-19 response funds and ongoing operational funds to purchase extra masks for children in response to this concern.

In sum, consistent with the CDC recommendations and available research, masking children is an appropriate policy option and is recommended as one layered mitigation strategy against COVID-19 when local conditions necessitate. Despite commenters' concerns, ACF has not received reports following the publication of the IFC indicating that masks caused Head Start children significant health and safety consequences.

Comment: Parents and stakeholders reported concern that the mask requirement for children does not respect parental choice. They expressed an overarching concern that the universal mask requirement for young children is contrary to the belief that parents know what is best for their child—a pillar of the philosophy of Head Start. Comments suggested that some parents have elected to remove their child from Head Start because of this requirement.

Response Much like the HSPPS requirement that children remain up to date on age-appropriate immunizations, there are public health issues that warrant prioritizing the health of the broader Head Start community—particularly as early childhood education occurs in congregate settings—and ACF believes the mask requirement is one such example. However, the CDC's recommendations have changed as the circumstances of COVID-19 have evolved and the local context and disease burden in the local community are key considerations for the use of masks and other mitigation strategies, ACF's final rule reflects this change.

Comment: There was also a concern among commenters that the requirement for children to mask outdoors is unnecessary, especially in rural areas and/or settings where playgrounds are often used just by one classroom. Commenters were also concerned that masks are too difficult for young children to wear, and staff will have a challenging time continuously reminding children to wear them correctly. Commenters expressed concern that the time spent reminding children to wear masks would ultimately come at the expense of teaching and supporting children in other ways.

Response: ACF has modified the requirement in response to the evolving circumstances of COVID-19 and to points raised during the public comment period. We discuss the changes to this requirement fully in Section V, but in summary, the requirement that Head Start programs have an evidence-based COVID-19 mitigation policy supports programs in scaling up or down mask use in response to the prevalence of COVID-19 epidemiology in their community and determining, in consultation with the program's HSAC, what circumstances necessitate mask use.

We think this change will, in part, address concerns related to outdoor masking, as programs will have the ability to create their own individual evidence-based COVID-19 mitigation policy, including with respect to outdoor masking.

Comment: Many comments raised the issue of workforce attrition and loss of volunteers due to unwillingness to comply with the masking requirements. Commenters explained that the impact of staff attrition in the classroom will lead to classroom closure and the loss of services to children and families. Commenters reported that this requirement imposes yet another barrier to already difficult hiring conditions and exacerbates staff shortages. They also noted that this requirement will ultimately lead potential staff to choose to work at other local child care centers that do not have such COVID-related requirements.

Response: ACF acknowledges programs are facing unprecedented challenges recruiting and retaining qualified staff that existed before the onset of the pandemic. We also acknowledge that some commenters were concerned that the mask requirement in the IFC may exacerbate these challenges. At the same time, it is difficult to determine what share of recruitment and retainment challenges are attributable to this requirement as compared to other causes. ACF is aware that compensation has significantly affected the early childhood workforce shortage and is the number one reason for Head Start staff attrition. Research with the broader early care and education (ECE) field indicates higher compensation for ECE professionals can improve employment stability and reduce turnover (and vice versa, with lower wages linked to higher turnover).”  34

Additionally, while there are workforce challenges nationally that exist both in those states implementing the requirements and in those that are not, we have no evidence that the workforce challenges among Head Start programs are more pervasive in those states implementing the mask requirement.

As noted in the Background of this final rule in Section II, Head Start regulations have always prioritized the health and safety of the children and families we enroll. At the time of the IFC's publication the evidence of the efficacy of the use of masks in reducing transmission of SARS-CoV-2 was substantial. Masks are effective at reducing transmission of SARS-CoV-2, the virus that causes COVID-19, when worn consistently and correctly. ACF affirms in this final rule the importance of mask use as a key mitigation strategy and believes requiring programs to have an evidence-based COVID-19 policy that includes mask use in appropriate circumstances will support the safest environment possible for Head Start staff, children, and families.

OHS continues to support Head Start programs and provide training and technical assistance as programs navigate this workforce shortage.

For adoption of the COVID-19 mitigation policy, the compliance date is March 7, 2023, 60 days following the publication of the final rule. This means that Head Start programs must have established an evidence-based COVID-19 mitigation policy developed in consultation with their HSAC 60 days after the publication of the final rule. This requirement applies to all Head Start grant recipients, including those that have been under a court injunction and not subject to the vaccination and masking requirements in the IFC issued on November 30, 2021. The removal of the universal masking requirement occurs immediately upon publication.

In this section, we discuss two changes made in this final rule. The two changes include:

(1) removing the requirement of universal masking for all individuals 2 years of age and older when there are two or more individuals in a vehicle owned, leased, or arranged by the Head Start program; when they are indoors in a setting where Head Start services are provided; and, for those not fully vaccinated, outdoors in crowded settings or during activities that involve close contact with other people.

(2) requiring Head Start programs to have an evidence-based COVID-19 mitigation policy developed in consultation with their HSAC.

The modifications are based on current public health data and best practices, input from numerous stakeholders, and the continually evolving landscape of COVID-19 conditions. We specifically relied on the guidance from and consultation with the country's leading public health agency, the CDC. Additionally, ACF received letters from state and national Head Start associations, outlining their feedback and perspectives on the implications on these requirements. We also received input from the grant recipient community, some of whom contributed their feedback as part of the nearly 2,700 comments we received during the public comment period. OHS also hosted two webinars following the publication of the IFC, which provided another opportunity for grant recipients to provide input and raise questions from their respective vantage points as executive directors, program directors, fiscal officers, staff members, and parents. Finally, OHS regularly consulted experts internal to OHS, ACF, HHS, and OHS's National Center advisers, all of whom bring expertise in diverse areas of program operations, including administrative and fiscal, health and safety, infectious disease management, and child development. As such, the Secretary satisfied the relevant considerations pursuant to section 641A(a)(2)(A) of the Head Start Act, 42 U.S.C. 9836a(a)(2)(A). We believe the changes we make below ensure these sections are clear, updated, streamlined, and transparent to the public.

The masking requirement in the IFC mirrored the CDC's recommendations issued in the fall of 2021 that all individuals ages 2 and older wear a mask indoors, wear a mask when there are two or more individuals on transportation, and, if unvaccinated, wear a mask when outside in crowded spaces and during activities that involve sustained close contact with others. In this final rule, ACF is removing the masking requirement and requiring Head Start programs to have an evidence-based COVID-19 mitigation policy developed in consultation with their HSAC.

The rationale for this change is twofold. First, the CDC's guidance, and the science and data that established the basis for that guidance, has changed as the conditions surrounding COVID-19 have evolved. The IFC was published at a point in time when the CDC recommended universal masking for individuals 2 years and older. At that time, citing CDC data, ACF noted that “although COVID-19 cases had begun to decline in parts of the country,” “data indicate[d] cases are beginning to rise in other parts,” and “the future trajectory of the pandemic [was] unclear.” 86 FR 68053. ACF also highlighted the acute risks of the highly transmissible Delta variant, which at the time was “the predominant variant in the United States and ha[d] resulted in greater rates of cases and hospitalizations among children than from other variants.” Ibid. At this stage of COVID-19 response, the science and data point to an approach that takes into account the impact of COVID-19 in the community, as demonstrated by the CDC's COVID-19 Community Levels. On February 25, 2022, the CDC issued these new recommendations to help individuals and communities make choices on what precautions to take, based on the level of disease burden in their community. As a result, Head Start programs may be operating with a more stringent masking requirement than the CDC indicates is warranted currently, and specifically a requirement that reflects a different stage of the response to COVID-19 when the CDC recommended universal masking for individuals ages 2 and older.

Second, the public comments on the IFC emphasized that the masking requirement prescribed a “one-size-fits-all” approach and did not consider the variation in locations and local conditions. Many cited low transmission rates within their communities, mainly in rural parts of the country that are particularly struggling with other issues which were only compounded by the circumstances of COVID-19. The shift away from universal masking for individuals 2 years and older allows programs to adapt more quickly to changing circumstances. The focus on a COVID-19 mitigation policy, is consistent with the comments and more reflective of the CDC's emphasis on layered prevention strategies—like staying up to date on vaccines, staying home when sick, ventilation, wearing masks, and hand washing—all of which have a key role in minimizing the spread of COVID-19.

As mentioned, throughout the development of the IFC and the final rule, ACF has leaned on the CDC as our lead public health agency to guide our policies. The CDC's new recommendations shift their focus to mask use depending upon the COVID-19 Community Levels. For that reason, and those further outlined in the preamble, ACF has removed the universal masking requirement.

In place of the universal masking requirement, ACF is requiring Head Start programs to have an evidence-based COVID-19 mitigation policy developed in consultation with their HSAC. Evidence-based is an umbrella term that refers to using the best research evidence ( e.g., found in health sciences literature) and clinical expertise ( e.g., what health care providers know) in content development. 35 Integrating the best available science with the knowledge and considered judgements from stakeholders and experts benefits Head Start children, families, and staff. 36 In the context of COVID-19, mitigation refers to measures taken to reduce or lower SARS-CoV-2 transmission, infection, or disease severity. Other terms used for this same concept are “risk reduction strategies” or “prevention strategies.”

The evidence-based COVID-19 mitigation policy should consider multiple mitigation strategies such as vaccination, masking, ventilation, and testing. Note, the national vaccination requirement remains in place while under review for those Head Start programs in states that are not subject to the court injunctions. However, Head Start programs may include additional considerations beyond the original IFC requirement in their approach to vaccination as part of their COVID-19 mitigation policy, including for example, requiring staff remain up to date on COVID-19 boosters, sharing information on COVID-19 vaccination with staff and families, and/or partnering with local agencies to increase vaccination uptake. Where appropriate, policies should acknowledge that staff may request reasonable accommodations based on Federal law because of a disability, medical condition, or sincerely-held religious belief, practice, or observance regarding elements of the mitigation policy. When developing an COVID-19 mitigation policy Head Start programs should consider the risk factors for their staff and the families served, the available strategies, or combination of strategies, to be used when the impact of COVID-19 changes in the community (such as testing, improving indoor air quality, staying home when sick, etc.);.); and how the risk of exposure could change depending on the Head Start services provided. Head Start programs may also want to consider additional precautions regardless of the prevalence of impact from COVID-19 at that time. As noted in the CDC's guidance to K-12 schools and ECE settings, ECE program administrators should work with local health officials to consider other local conditions and factors when deciding to implement prevention measures. For example, ECE-specific indicators—such as vaccination rates among children, pediatric-specific healthcare capacity, pediatric hospitalizations, and pediatric emergency visits—can help with decision-making. Head Start programs may consider the extent to which children or staff are at increased risk for severe disease from COVID-19 or have family members at increased risk for severe disease. ECE programs may choose to implement universal indoor mask use to meet the needs of the families they serve, which could include people at risk for getting very sick with COVID-19. 37

Note that the universal masking requirement was included at § 1302.47(b)(5)(vi) in the IFC. The requirement that Head Start programs have a COVID-19 mitigation policy is included in this final rule at § 1302.47(b)(9).

To the extent a court may stay or enjoin any part of this final rule or the IFC, ACF intends that other provisions or parts of provisions of this final rule and the IFC should remain in effect. In particular, ACF intends this final rule to take effect notwithstanding any stay or injunction of the separate vaccine requirement imposed by the IFC, which remains under agency review, and vice versa. Any provision held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable and shall not affect the remainder thereof or the application of the provision to other persons or circumstances.

Section 654 of the Treasury and General Government Appropriations Act of 1999 requires federal agencies to determine whether a policy or regulation may negatively affect family well-being. If the agency determines a policy or regulation negatively affects family well-being, then the agency must prepare an impact assessment addressing seven criteria specified in the law. ACF believes it is not necessary to prepare a family policymaking assessment, see Public Law 105-277, because the action it takes in this final rule will not have any impact on the autonomy or integrity of the family as an institution.

Executive Order 13132 requires federal agencies to consult with state and local government officials if they develop regulatory policies with federalism implications. Federalism is rooted in the belief that issues that are not national in scope or significance are most appropriately addressed by the level of government close to the people. This rule will not have substantial direct impact on the states, on the relationship between the federal government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this action does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act or CRA) allows Congress to review “major” rules issued by federal agencies before the rules take effect, see 5 U.S.C. 801(a). The CRA defines a major rule as one that has resulted, or is likely to result, in (1) an annual effect on the economy of $100 million or more; (2) a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, or innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets, see 5 U.S.C. 804(2). Based on our estimates of the impact of this rule, the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) has designated this rule as “not major” under the CRA.

The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501 et seq., minimizes government-imposed burden on the public. In keeping with the notion that government information is a valuable asset, it also is intended to improve the practical utility, quality, and clarity of information collected, maintained, and disclosed.

The PRA requires that agencies obtain OMB approval, which includes issuing an OMB number and expiration date, before requesting most types of information from the public. Regulations at 5 CFR part 1320 implemented the provisions of the PRA and § 1320.3 of this part defines a “collection of information,” “information,” and “burden.” PRA defines “information” as any statement or estimate of fact or opinion, regardless of form or format, whether numerical, graphic, or narrative form, and whether oral or maintained on paper, electronic, or other media (5 CFR 1320.3(h)). This includes requests for information to be sent to the government, such as forms, written reports and surveys, recordkeeping requirements, and third-party or public disclosures (5 CFR 1320.3(c)). “Burden” means the total time, effort, or financial resources expended by persons to collect, maintain, or disclose information.

The IFC established new recordkeeping requirements and as required under the PRA, ACF submitted a request for approval of these recordkeeping requirements. The initial request was approved through an emergency clearance process, allowing for 6 months of approval under the PRA. This was followed by a full request, including two public comment periods, to extend approval of the recordkeeping requirements without changes. The OMB Control Number for this information collection request (ICR) is 0970-0583.

Under this final rule, Head Start grant recipients are required to update their program policies and procedures to include an evidence-based COVID-19 mitigation policy developed in consultation with their Health Services Advisory Committee. ACF will request a revision to OMB number 0970-0583 to add this recordkeeping requirement through an emergency clearance process. This will allow for 6 months of approval under the PRA to support the requirement going into effect 60 days following the publication of this rule. We will follow the initial emergency approval with a full request to extend approval of the recordkeeping requirement. The full request will include two public comment periods inviting comments on this new recordkeeping requirement and related burden. These public comment periods will be announced through separate notices published in the Federal Register . The first notice will invite comments within 60-days of publication and is expected to publish soon after the publication of this final rule. The second notice will publish when ACF submits the full extension request to OMB and will invite comments to be submitted to OMB within 30-days of publication.

The burden of updating program policies and procedures is estimated at a total of 8 hours per grant recipient. To promote flexibility for local programs, there is no standardized instrument associated with the recordkeeping requirement under this final rule. See the Regulatory Impact Analysis section for related cost estimations.

We have examined the impacts of this final rule under Executive Order 12866, Executive Order 13563, and the Regulatory Flexibility Act (5 U.S.C. 601-612). 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, and OIRA has determined, that this final rule is a significant regulatory action as defined by Executive Order 12866. Thus, this rule has been reviewed by the Office of Information and Regulatory Affairs.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the impacts to small entities attributable to the final rule are cost savings, this analysis concludes, and we certify that the final rule will not have a significant economic impact on a substantial number of small entities. These impacts are discussed in detail in the Final Small Entity Analysis.

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 issuing “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 $165 million, using the most current (2021) Implicit Price Deflator for the Gross Domestic Product. This final rule will not result in expenditures in any year that meet or exceed this amount.

This final rule revises requirements established on November 30, 2021, through an Interim Final Rule with Comment (IFC), “Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in Head Start Programs.”  38 In our main analysis, we evaluate the likely impacts of the final rule in comparison to a baseline scenario of the IFC without modifications.

The final rule requires that Head Start programs have an evidence-based COVID-19 mitigation policy, developed in consultation with their Health Services Advisory Committee. This requirement will result in a one-time cost for each program to develop its policy. Although the final rule is not prescriptive with respect to the elements of these mitigation policies, we identify and estimate ongoing costs to Head Start programs by modeling elements of a policy that are intended to be representative of a range of potential options. We address uncertainty in the representativeness of this mitigation policy in a scenario analysis that considers a range of more stringent and less stringent approaches to mitigation in the main analysis; and we address uncertainty in projecting COVID-19 over the time horizon of the analysis by considering a range of observed historic COVID-19 metrics in Section E. Uncertainty and Sensitivity Analyses. For our primary analysis, we adopt a baseline scenario of the IFC, and perform a sensitivity analysis to consider an alternative baseline that incorporates the impact of federal court injunctions affecting the IFC and a second alternative baseline of no IFC requirements.

This final rule also removes the requirement for universal masking for all individuals two years of age and older. Removing this requirement will likely result in fewer masks worn. All else equal, if fewer masks are worn as a result of the rule, this may result in increased transmission risk of SARS-CoV-2; however, this could be offset by other elements of evidence-based COVID-19 mitigation policies developed by Head Start programs.

Overall, we anticipate that the cost savings associated with removing the universal masking requirement will exceed the incremental costs of the mitigation policies. Thus, the final rule will result in net cost savings, which accrue primarily to Head Start programs. Over a 3-month time horizon, we estimate that the final rule may result in about $9.2 million in net benefits, which matches our estimate of the quantified net cost savings attributable to the final rule. Table 1 reports a range of estimates of the incremental impacts of the final rule that account for uncertainty in projecting COVID-19 over the time horizon of the analysis.

ACF considered many policy alternatives beyond the regulatory option of the final rule. In addition to assessing the impact of the final rule, this RIA analyzes and quantifies the impacts of several alternatives related to the masking requirement.