Table of Contents: I. Obtaining Information and Submitting Comments II. Rulemaking Procedure III. Background IV. Plain Writing V. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2023-0131, 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-2023-0131. 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: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. 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 a.m. and 4 p.m. eastern time, Monday through Friday, except Federal holidays.

Please include Docket ID NRC-2023-0131, 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 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.

Because the NRC considers this action to be non-controversial, the NRC is publishing this proposed rule concurrently with a direct final rule in the Rules and Regulations section of this issue of the Federal Register . The direct final rule will become effective on December 18, 2023. However, if the NRC receives any significant adverse comment by November 2, 2023, then the NRC will publish a document that withdraws the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments in a subsequent final rule. In general, absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action in the event the direct final rule is withdrawn.

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.

For a more detailed discussion of the proposed rule changes and associated analyses, see the direct final rule published in the Rules and Regulations section of this issue of the Federal Register .

Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended, requires 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 December 22, 1994 (59 FR 65897) that approved the Standardized NUHOMS® Horizontal Modular Storage System for Irradiated Nuclear Fuel System design and added it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1004.

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

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-2023-0131. 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-2023-0131); (2) click the “Subscribe” link; and (3) enter an email address and click on the “Subscribe” link.

Table of Contents I. Synopsis of the Proposed Determination II. Introduction A. Authority B. Background 1. Current Standards 2. History of Standards Rulemakings for Metal Halide Lamp Fixtures C. Deviation from Appendix A III. Rationale of Analysis and Discussion of Related Comments A. Scope of Coverage B. Technology Options and Screening Analysis C. Efficiency Levels D. Scaling Equipment Classes E. Shipments F. Manufacturer Impacts IV. Proposed Determination A. Technological Feasibility B. Cost Effectiveness C. Significant Conservation of Energy D. Summary V. Procedural Issues and Regulatory Review A. Review Under Executive Orders 12866, 13563, and 14094 B. Review Under the Regulatory Flexibility Act C. Review Under the Paperwork Reduction Act D. Review Under the National Environmental Policy Act of 1969 E. Review Under Executive Order 13132 F. Review Under Executive Order 12988 G. Review Under the Unfunded Mandates Reform Act of 1995 H. Review Under the Treasury and General Government Appropriations Act, 1999 I. Review Under Executive Order 12630 J. Review Under the Treasury and General Government Appropriations Act, 2001 K. Review Under Executive Order 13211 L. Review Under the Information Quality Bulletin for Peer Review VI. Public Participation A. Participation in the Webinar B. Procedure for Submitting Prepared General Statements for Distribution C. Conduct of the Webinar D. Submission of Comments E. Issues on Which DOE Seeks Comment VII. Approval of the Office of the Secretary I. Synopsis of the Proposed Determination

The Energy Policy and Conservation Act, Pub. L. 94-163, as amended (“EPCA”), 1 authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291-6317) Title III, Part B of EPCA  2 established the Energy Conservation Program for Consumer Products Other Than Automobiles. (42 U.S.C. 6291-6309) These products include metal halide lamp fixtures (“MHLFs”), the subject of this NOPD. (42 U.S.C. 6292(a)(19))  3

DOE is issuing this NOPD pursuant to the EPCA requirement that not later than 3 years after issuance of a determination that standards do not need to be amended, DOE must publish either a notification of determination that standards for the product do not need to be amended, or a notice of proposed rulemaking (“NOPR”) including new proposed energy conservation standards (proceeding to a final rule, as appropriate). (42 U.S.C. 6295(m))

For this proposed determination, DOE analyzed MHLFs that meet the definition of an MHLF in 10 CFR 431.322. DOE first analyzed the technological feasibility of more energy efficient MHLFs. For those MHLFs for which DOE determined higher standards to be technologically feasible, DOE evaluated whether higher standards would be cost effective. DOE has tentatively determined that the market and technology characteristics of MHLFs are largely similar to those analyzed in the previous rulemaking, which concluded with the publication of a final rule determining not to amend standards. 86 FR 58763 (October 25, 2021) (“October 2021 Final Determination”). Therefore, DOE has tentatively determined that the conclusions reached in the October 2021 Final Determination regarding the benefits and burdens of more stringent standards for MHLFs are still relevant to the MHLF market today. Hence, DOE has tentatively determined that the amended standards for MHLFs would not be cost effective.

The following section briefly discusses the statutory authority underlying this proposed determination, as well as some of the historical background relevant to the establishment of standards for MHLFs.

EPCA authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. Title III, Part B of EPCA established the Energy Conservation Program for Consumer Products Other Than Automobiles. These products include MHLFs, the subject of this document. (42 U.S.C. 6292(a)(19)) EPCA prescribed initial energy conservation standards for these products (42 U.S.C. 6295(hh)(1)) and directed DOE to conduct two cycles of rulemakings to determine whether to amend these standards (42 U.S.C. 6295(hh)(2)(A) and (3)(A)).

The energy conservation program under EPCA consists essentially of four parts: (1) testing, (2) labeling, (3) the establishment of Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA specifically include definitions (42 U.S.C. 6291), test procedures (42 U.S.C. 6293), labeling provisions (42 U.S.C. 6294), energy conservation standards (42 U.S.C. 6295), and the authority to require information and reports from manufacturers (42 U.S.C. 6296).

Subject to certain criteria and conditions, DOE is required to develop test procedures to measure the energy efficiency, energy use, or estimated annual operating cost of each covered product. (42 U.S.C. 6295(o)(3)(A) and 42 U.S.C. 6295(r)) Manufacturers of covered products must use the prescribed DOE test procedure as the basis for certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA and when making representations to the public regarding the energy use or efficiency of those products. (42 U.S.C. 6293(c) and 42 U.S.C. 6295(s)) Similarly, DOE must use these test procedures to determine whether the products comply with standards adopted pursuant to EPCA. (42 U.S.C. 6295(s)) The DOE test procedures for MHLFs appear at title 10 of the Code of Federal Regulations (“CFR”) part 431, subpart S at § 431.324.

Federal energy conservation requirements generally supersede State laws or regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6297(a)-(c)) DOE may, however, grant waivers of Federal preemption for particular State laws or regulations, in accordance with the procedures and other provisions set forth under EPCA. ( See 42 U.S.C. 6297(d))

Pursuant to the amendments contained in the Energy Independence and Security Act of 2007 (“EISA 2007”), Public Law 110-140, any final rule for new or amended energy conservation standards promulgated after July 1, 2010, is required to address standby mode and off mode energy use. (42 U.S.C. 6295(gg)(3)) Specifically, when DOE adopts a standard for a covered product after that date, it must, if justified by the criteria for adoption of standards under EPCA (42 U.S.C. 6295(o)), incorporate standby mode and off mode energy use into a single standard, or, if that is not feasible, adopt a separate standard for such energy use for that product. (42 U.S.C. 6295(gg)(3)(A)-(B)) In this analysis DOE considers only active mode energy consumption as standby and off mode energy use are not applicable to MHLFs at this time.

DOE must periodically review its already established energy conservation standards for a covered product no later than 6 years from the issuance of a final rule establishing or amending a standard for a covered product. (42 U.S.C. 6295(m)) This 6-year look-back provision requires that DOE publish either a determination that standards do not need to be amended or a NOPR, including new proposed standards (proceeding to a final rule, as appropriate). (42 U.S.C. 6295(m)(1)) EPCA further provides that, not later than 3 years after the issuance of a final determination not to amend standards, DOE must publish either a notification of determination that standards for the product do not need to be amended, or a NOPR including new proposed energy conservation standards (proceeding to a final rule, as appropriate). (42 U.S.C. 6295(m)(3)(B)) DOE must make the analysis on which a determination is based publicly available and provide an opportunity for written comment. (42 U.S.C. 6295(m)(2))

A determination that amended standards are not needed must be based on consideration of whether amended standards will result in significant conservation of energy, are technologically feasible, and are cost effective. (42 U.S.C. 6295(m)(1)(A) and 42 U.S.C. 6295(n)(2)) Additionally, any new or amended energy conservation standard prescribed by the Secretary for any type (or class) of covered product shall be designed to achieve the maximum improvement in energy efficiency which the Secretary determines is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Among the factors DOE considers in evaluating whether a proposed standard level is economically justified includes whether the proposed standard at that level is cost-effective, as defined under 42 U.S.C. 6295(o)(2)(B)(i)(II). Under 42 U.S.C. 6295(o)(2)(B)(i)(II), an evaluation of cost-effectiveness requires DOE to consider savings in operating costs throughout the estimated average life of the covered products in the type (or class) compared to any increase in the price, initial charges, or maintenance expenses for the covered products that are likely to result from the standard. (42 U.S.C. 6295(n)(2); 42 U.S.C. 6295(o)(2)(B)(i)(II)) DOE is publishing this NOPD in satisfaction of the 3-year review requirement in EPCA following a determination that standards need not be amended.

Current standards for MHLFs manufactured on or after February 10, 2017, are set forth in DOE's regulations at 10 CFR 431.326 and are specified in Table II.1. 10 CFR 431.326(c). Additionally, it is specified at 10 CFR 431.326 that MHLFs manufactured on or after February 10, 2017, that operate lamps with rated wattage >500 watts (“W”) to ≤1000W must not contain a probe-start metal halide ballast. 10 CFR 431.326(d). The following MHLFs are not subject to these regulations: (1) MHLFs with regulated-lag ballasts; (2) MHLFs that use electronic ballasts that operate at 480 volts; and (3) MHLFs that use high-frequency electronic ballasts. 10 CFR 431.326(e).

As noted in section II.A of this document, EPCA directed DOE to conduct two rulemaking cycles to determine whether to amend standards for MHLFs established by EPCA. (42 U.S.C. 6295(hh)(2)(A) and (3)(A)) DOE published a final rule amending the standards on February 10, 2014 (“February 2014 Final Rule”). 79 FR 7746. These current standards are set forth in DOE's regulations at 10 CFR 431.326 and are specified in section II.B.1 and Table II.1 of this document. DOE completed the second rulemaking by publishing a final rule on October 25, 2021, that determined not to amend current standards for MHLFs. 86 FR 58763.

In support of the present review of the MHLF energy conservation standards, on October 6, 2022, DOE published a request for information (“RFI”), which identified various issues on which DOE sought comment to inform its determination of whether the standards need to be amended. 87 FR 60555 (“October 2022 RFI”).

DOE received two comments in response to the October 2022 RFI from the interested parties listed in Table II.2.

Comments Invited

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2023-1894; Project Identifier MCAI-2022-00334-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Jared Hyman, Aviation Safety Engineer, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (781) 238-7799; email 9-AVS-AIR-BACO-COS@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0037, dated March 7, 2022, and corrected March 15, 2022 (EASA AD 2022-0037), to correct an unsafe condition for all Leonardo S.p.A Model A109E, A109LUH, A109S, AW109SP, A119, and AW119 MKII helicopters.

This proposed AD was prompted by multiple reports of excessive axial play on the ball bearing of the lower half of the MR rotating scissor assembly. In some cases, this resulted in dislodgement of the ball bearing from its seat. The FAA is proposing this AD to detect and address any excessive axial play of the MR rotating scissor assembly. See EASA AD 2022-0037 for additional background information.

For certain applicable model helicopters, EASA AD 2022-0037 requires accomplishing one-time MR rotating scissor coupling and axial play checks. Depending on the results, EASA AD 2022-0037 requires repetitively measuring the axial play or replacing certain parts. For all applicable model helicopters, EASA AD 2022-0037 requires accomplishing repetitive qualitative and quantitative axial play checks and, depending on the results, repetitively measuring the axial play or replacing certain parts. Furthermore, EASA AD 2022-0037 requires reporting certain information to the manufacturer and prohibits installing certain parts on any helicopter unless the part has passed required inspections.

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

The FAA also reviewed Leonardo Helicopters Alert Service Bulletin (ASB) No. 109EP-177, Leonardo Helicopters ASB No. 109S-105, Leonardo Helicopters ASB No. 109SP-149, and Leonardo Helicopters ASB No. 119-111, each Revision A and dated March 3, 2022. This service information specifies procedures for inspecting the MR rotating scissor coupling and axial play, measuring the axial play, inspecting the qualitative axial play, inspecting the quantitative axial play, and replacing components of the MR rotating scissor assembly (scissor bracket flange assembly, rotary scissor sleeve, lower scissor lever assembly, and upper scissor lever assembly) and bushings.

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

This proposed AD would require accomplishing the actions specified in EASA AD 2022-0037, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD and except as discussed under “Differences Between this Proposed AD and the EASA AD.”

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2022-0037 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2022-0037 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2022-0037 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0037. Service information referenced in EASA AD 2022-0037 for compliance will be available at regulations.gov under Docket No. FAA-2023-1894 after the FAA final rule is published.

EASA AD 2022-0037 applies to Model A109LUH helicopters, whereas this proposed AD would not because that model is not FAA-type certificated. EASA AD 2022-0037 refers to several actions as a “check,” whereas this proposed AD would refer to those actions as an “inspection” instead because those actions must be accomplished by persons authorized under 14 CFR 43.3. EASA AD 2022-0037 requires discarding certain parts, whereas this proposed AD would require removing those parts from service instead.

Service information referenced in EASA AD 2022-0037 specifies to contact Leonardo Helicopters for instructions as a result of certain M/R rotating scissor maximum torque force check (inspection) results, whereas this proposed AD would require accomplishing corrective action in accordance with a method approved by the FAA, EASA, or Leonardo S.p.a. Helicopters' EASA Design Organization Approval. EASA AD 2022-0037 requires interpreting the MR rotating scissor coupling and axial play inspection results (PASSED or FAILED) by using its required service information, whereas this proposed AD would require interpreting those results by using tables in the body of this proposed AD and recorded results of certain inspections. Furthermore, if the scissor coupling inspection result is an “UNCERTAIN RESULT,” the service information referenced in EASA AD 2022-0037 specifies contacting Leonardo Helicopters, whereas this proposed AD would consider an “UNCERTAIN RESULT” as “FAILED.”

EASA AD 2022-0037 requires accomplishing repetitive qualitative axial play checks, whereas this proposed AD would not. EASA AD 2022-0037 requires quantitative axial play checks within intervals not to exceed 200 flight hours, whereas this proposed AD would require quantitative axial play inspections within intervals not to exceed 55 hours time-in-service. The service information referenced in EASA AD 2022-0037 cautions that only approved personnel are permitted to perform the bushing replacement, whereas this proposed AD would not include that caution.

The FAA estimates that this AD, if adopted as proposed, would affect 204 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.

The one-time MR rotating scissor coupling and axial play inspections would take about 2 work-hours for an estimated cost of $170 per helicopter and up to $34,680 for the U.S. fleet.

A quantitative axial play inspection would take about 1 work-hour for an estimated cost of $85 per helicopter and $17,340 for the U.S. fleet per inspection cycle.

Measuring the axial play would take about 1 work-hour for an estimated cost of $85 per helicopter and $17,340 for the U.S. fleet per inspection cycle.

Certain corrective action that may be needed as a result of an inspection could vary significantly from helicopter to helicopter. The FAA has no data to determine the costs to accomplish the corrective action or the number of helicopters that may require corrective action.

Replacing the scissor bracket flange assembly would take about 4 work-hours and parts would cost about $8,099-11,574 (depending on part number) for an estimated cost of $8,439-11,914 per replacement. Alternatively, replacing its bushings would take about 2 work-hours and parts would cost about $225 for an estimated cost of $395 per replacement.

Replacing each rotary scissor sleeve would take about 2 work-hours and parts would cost about $565 for an estimated cost of $735 per replacement.

Replacing the lower scissor lever assembly (including the washer and retaining bolt) would take about 2 work-hours and parts would cost about $3,308-3,385 (depending on part number) for an estimated cost of $3,478-3,555 per replacement. Alternatively, replacing its bushings would take about 2 work-hours and parts would cost about $225 for an estimated cost of $395 per replacement.

Replacing the upper scissor lever assembly would take about 2 work-hours and parts would cost about $2,219-3,015 (depending on part number) for an estimated cost of $2,389-3,185 per replacement. Alternatively, replacing its bushings would take about 2 work-hours and parts would cost about $225 for an estimated cost of $395 per replacement.

Reporting the inspection results to the manufacturer would take about 1 work-hour for an estimated cost of $85 per report.

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

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

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

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

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

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

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

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

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

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

Comments Invited

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2023-1891; Project Identifier AD-2023-00612-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Jacob Fitch, Aviation Safety Engineer, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; phone: (817) 222-4130; email: jacob.fitch@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA proposes to adopt a new AD for all Centerpointe Model S-58BT, S-58DT, S-58ET, S-58FT, S-58HT, and S-58JT helicopters. During a preflight inspection, fatigue cracking was found on a Model S-58BT helicopter in the angle supports and cross-members forming the edges of the AGBM. Due to their similarity to the Model S-58BT helicopter, the FAA has determined that Centerpointe Model S-58DT, S-58ET, S-58FT, S-58HT, and S-58JT helicopters are also affected by the same unsafe condition. This condition, if not addressed, could result in loss of the angle gearbox, resulting in loss of main rotor drive and subsequent loss of control of the helicopter.

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

The FAA reviewed Centerpointe Aerospace Service Bulletin No. 58B75, dated April 26, 2023. This service information specifies procedures for repetitively performing an FPI and reporting the results to the manufacturer. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in ADDRESSES .

This proposed AD would require repetitive FPIs of the AGBM for a crack, as specified in the service information already described, except as discussed under “Differences Between this Proposed AD and the Service Information.” This proposed AD would also require removing any cracked AGBM from service before further flight.

Where the service information specifies that the initial FPI be performed within 120 days after receipt of the service information, this proposed AD would require the initial FPI to be performed within 250 hours time-in-service. The service information specifies reporting the results of the FPI to the manufacturer, whereas this proposed AD would not.

The FAA estimates that this AD, if adopted as proposed, would affect 14 helicopters of U.S. registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.

Performing an FPI of the AGBM would take about 5 work-hours and parts cost $150 for an estimated cost of $575 per helicopter, and $8,050 for the U.S. fleet, per inspection.

If necessary, replacing an AGBM would take about 41 work-hours and the parts cost would be $30,000 for an estimated cost of $33,485 per helicopter.

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

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

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

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

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

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

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the airway structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.

The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.

Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

An electronic copy of this document may be downloaded through the internet at www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see ADDRESSES section for address, phone number, and hours of operations). An informal docket may also be examined during normal business hours at the office of the Western Service Center, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.

Jet Routes are published in paragraph 2004 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. Canadian Area Navigation Routes are published in paragraph 2007 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the ADDRESSES section of this document.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L. 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.

In support of NextGen, this proposal is part of an ongoing, large, and comprehensive airway modernization project in the state of Alaska. Part of this project is to transition the Alaskan en route navigation structure away from dependency on Nondirectional Radio Beacons (NDB) and move to develop and improve the RNAV route structure. The FAA is planning to decommission the Orca Bay, Yakataga, and Sitka NDBs in the state of Alaska. As a result, portions of Jet Route J-133 will become unusable.

The FAA proposes to amend Jet Route J-133 by revoking the portion between the Anchorage, AK, Very High Frequency Omnidirectional Range/Distance Measuring Equipment (VOR/DME) and the Sitka, AK, NDB. This portion of J-133 would be replaced by the proposed RNAV route Q-801. Q-801 would extend between Anchorage, AK, VOR/DME and HARPR, OR, waypoint (WP).

The FAA is proposing an amendment to 14 CFR part 71 to amend Jet Route J-133 and to establish Canadian RNAV route Q-801 in United States airspace. NAV CANADA is amending RNAV route Q-801 in their airspace to ensure continuity and cross-border connectivity with the new RNAV route Q-801 proposed in this NPRM. The proposed Air Traffic Service (ATS) route actions are described below.

J-133: Jet route J-133 currently extends between Galena, AK, VOR/DME and Sitka, AK, NDB. The FAA proposes to revoke the portion between the Anchorage, AK, VOR/DME and the Sitka, AK, NDB. As amended, Jet route J-133 would extend between Galena, AK, VOR/DME and Anchorage, AK, VOR/DME.

Q-801: Q-801 would extend between the Anchorage, AK, VOR/DME and the HARPR, OR, WP. The new route would remain within United States airspace between the Anchorage VOR/DME and the EEVER, AK, Fix and between the CYVIC, WA, WP and the HARPR WP. The new EEVER route point is being established on the Alaska/Canada border north of the MOCHA, AK, Fix. The new CYVIC route point is being established on the United States/Canada border in Washington state replacing, the CFPXC computer navigation fix (CNF) currently charted. This action is part of an ongoing FAA initiative to replace CNF and unpronounceable border fix/waypoint names with standard, pronounceable, five-letter names. This proposed action would establish RNAV route Q-801 within the United States and exclude the airspace in Canada.

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

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

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

Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background A. Introduction B. Need for the Rule C. FDA's Current Regulatory Framework D. History of the Rulemaking IV. Legal Authority V. Description of the Proposed Amendment to the Definition of In Vitro Diagnostic Products A. Proposed Amendment B. Legal Basis for the Proposed Amendment VI. Description of the Proposed Enforcement Policy A. Scope B. Stages VII. Proposed Effective Date VIII. Preliminary Economic Analysis of Impacts IX. Analysis of Environmental Impact X. Paperwork Reduction Act of 1995 XI. Federalism XII. Consultation and Coordination With Indian Tribal Governments XIII. Other Issues for Consideration XIV. References I. Executive Summary A. Purpose of the Proposed Rule

FDA is proposing to amend its regulations to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory. This amendment would reflect that the device definition in the FD&C Act does not differentiate between entities manufacturing the device, and would provide further clarity, including for stakeholders affected by the accompanying changes to FDA's general enforcement discretion approach for LDTs. In connection with amending the regulation, FDA intends to phase out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. For purposes of this document, we use “manufacture” and related terms as a shorthand for the various activities that constitute manufacturing as described in FDA regulations ( e.g., design, preparation, propagation, assembly, and processing).

In 1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C Act to create a comprehensive system for the regulation of devices intended for human use. In implementing the MDA, FDA has generally exercised enforcement discretion such that it generally has not enforced applicable requirements with respect to most LDTs. Enforcement discretion for LDTs developed as a matter of general practice. However, the risks associated with LDTs are much greater today than they were at the time of enactment of the MDA. As discussed more fully in section III.B, today's LDTs are generally, among other things, used more widely, by a more diverse population, with an increasing reliance on high-tech instrumentation and software, and more frequently for the purpose of guiding critical healthcare decisions. In this regard, today's LDTs are similar to other IVDs that have not been under this general enforcement discretion approach. Given these changes, and for the additional reasons discussed in section III.B, phasing out the general enforcement discretion approach for LDTs is important to protect the public health. The phaseout of FDA's general enforcement discretion approach for LDTs is intended to help assure the safety and effectiveness of LDTs, and may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.

This rulemaking would amend the definition of “in vitro diagnostic products” in FDA regulations to state that IVDs are devices under the FD&C Act “including when the manufacturer of these products is a laboratory.” In conjunction with this amendment, FDA is also proposing a policy under which FDA intends to phase out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. Additional details regarding the proposed phaseout policy are discussed further in section VI.

FDA is proposing to issue this rule under the Agency's general rulemaking authorities and statutory authorities relating to devices. These authorities include sections 201(h)(1), 301, 501, 502, 510, 513, 514, 515, 518, 519, 520, 701, 702, 704, and 801 of the FD&C Act (21 U.S.C. 321(h)(1), 331, 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 371, 372, 374, and 381).

We quantify benefits to patients from averted health losses due to problematic IVDs offered as LDTs. 1 Due to limitations in the data, we quantify health benefits only with respect to IVDs for certain diseases and conditions; however, we would expect additional health benefits associated with averted health losses for other diseases and conditions. We estimate that the annualized benefits over 20 years would range from $2.67 billion to $86.01 billion at a 7 percent discount rate, with a primary estimate of $31.41 billion, and from $1.81 billion to $61.41 billion at a 3 percent discount rate, with a primary estimate of $22.33 billion. Additional benefits would include averted non-health losses from the quantified reduction in costs of problematic IVDs offered as LDTs and unquantified reduction in costs from lawsuits and costs to healthcare systems. We quantify costs to affected laboratories for complying with applicable statutory and regulatory requirements. Additional costs would include some costs to FDA, which we include in our estimates. The annualized costs would range from $2.52 billion to $19.45 billion at a 7 percent discount rate, with a primary estimate of $5.87 billion, and from $2.39 billion to $18.55 billion at a 3 percent discount rate, with a primary estimate of $5.60 billion. The annualized transfers  2 would range from $100 million to $452 million at a 7 percent discount rate, with a primary estimate of $226 million, and from $121 million to $538 million at a 3 percent discount rate, with a primary estimate of $269 million. The annualized costs to FDA would range from $265 million to $1.06 billion at a 7 percent discount rate, with a primary estimate of $530 million, and from $251 million to $1.00 billion at a 3 percent discount rate, with a primary estimate of $501 million. These estimates do not include anticipated offsets from user fees. Factoring in offsets from user fees at current levels, estimated costs to FDA are reduced to $165 million to $607 million at a 7 percent discount rate, with a primary estimate of $304 million, and to $103 million to $465 million at a 7 percent discount rate, with a primary estimate of $233 million, covering approximately half of the estimated costs to FDA.

FDA's regulations define IVDs as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, and intended for use in the collection, preparation, and examination of specimens taken from the human body. IVDs include test systems (also referred to in this preamble as “tests”) that are performed on samples taken from the human body, such as blood or tissue, for the purpose of detecting diseases or other conditions, monitoring a person's overall health, identifying patients who are likely to benefit from specific therapies, or otherwise helping to diagnose, cure, mitigate, treat, or prevent disease or its sequelae. Some IVDs are manufactured by conventional manufacturers for use by other entities such as laboratories, healthcare providers, or, in some cases, patients. Such IVDs may include “test kits,” containing packaged sets of components that are part of or comprise a test system. Other IVDs are manufactured by laboratories for use by the same or other laboratories. Such IVDs include LDTs. FDA has generally considered an LDT to be an IVD that is intended for clinical use and that is designed, manufactured, and used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing. Section V.B sets forth the legal reasoning for FDA's position that IVDs manufactured by laboratories, including LDTs, are devices.

However, in implementing the MDA, FDA generally has exercised enforcement discretion such that it generally has not enforced applicable requirements with respect to most LDTs. At the time of passage of the MDA, LDTs were mostly manufactured in small volumes by laboratories that served their local communities. They were typically intended for use in diagnosing rare diseases or for other uses to meet the needs of a local patient population, or were generally similar to well-characterized, standard tests. They also tended to employ manual techniques (and did not use automation) performed by laboratory personnel with specialized expertise; to be used and interpreted by physicians or pathologists in a single institution responsible for the patient (and who were actively involved in patient care); and to be manufactured using components legally marketed for clinical use, such as general purpose reagents or immunohistochemical stains marketed in compliance with FDA regulatory requirements. Due to these and other factors, FDA generally exercised enforcement discretion such that it generally has not enforced applicable requirements for most LDTs. 3

However, the LDT landscape has evolved significantly since 1976. Today, many LDTs rely on high-tech or complex instrumentation and software to generate results and clinical interpretations. They are often used in laboratories outside of the patient's healthcare setting and are often manufactured in high volume for large and diverse populations. Many LDTs are manufactured by laboratory corporations that market the tests nationwide, as they accept specimens from patients across the country and run their LDTs in very large volumes in a single laboratory. Today's LDTs are also more commonly manufactured with instruments or other components not legally marketed for clinical use and are more often used to inform or direct critical treatment decisions, to widely screen for common diseases, to predict personal risk of developing certain diseases, and to diagnose serious medical conditions such as cancer and heart disease. 4 The risks associated with most modern LDTs are therefore much greater today than they were at the time FDA began implementing the MDA, and most LDTs today are similar to other IVDs that have not been under FDA's general enforcement discretion approach. In addition, FDA is concerned that firms are offering IVDs as “LDTs” even when they are not LDTs, because they are not actually designed, manufactured, and used within a single laboratory ( see, e.g., Refs. 4 and 5).

As a result of this evolution in the testing landscape, FDA has long recognized the need for a change in the Agency's general enforcement discretion approach for LDTs. The history of FDA's efforts with respect to LDTs is set forth in the “History of the Rulemaking” section below (section III.D). Over the past few years, FDA has accumulated even more information supporting the need for a change, as discussed below. In light of these developments, FDA is proposing to amend FDA's regulations to make explicit that IVDs are devices under the FD&C Act including when the manufacturer is a laboratory. 5 FDA is also proposing a policy under which FDA intends to phase out FDA's general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.

FDA is proposing a policy under which FDA intends to phase out the general enforcement discretion approach for LDTs because that approach has led to an oversight scheme that does not best serve the public health. LDTs that are under the general enforcement discretion approach are treated differently from other IVDs. However, there is no longer a sound basis for this distinction. In FDA's experience, including with COVID-19 tests and IVDs that are offered as LDTs after FDA's approval of a comparable companion diagnostic, many test systems made by laboratories today are functionally the same as those made by other manufacturers of IVDs. They involve the same materials and technologies, are intended for the same or similar purposes, are developed by and for individuals with similar expertise, and are marketed to the same patients, sometimes on a national scale. For these reasons, tests made by laboratories are often used interchangeably by healthcare providers and patients with tests made by other manufacturers. In fact, today, the testing industry has come to view FDA's general enforcement discretion approach as an alternative pathway to market for test systems, such that test systems are often “launched as LDTs” with no assurance that they meet requirements under the FD&C Act and its implementing regulations (see, e.g., Refs. 6 and 7). 6 These tests lack the characteristics and institutional safeguards that originally justified FDA's general enforcement discretion approach, as discussed above, and may directly compete with FDA-authorized kit-based test systems. FDA views this bifurcated system of oversight as untenable and inconsistent with FDA's public health mission.

The proposed phaseout of FDA's general enforcement discretion approach is designed to redress the imbalance in oversight and protect the public health. Diagnostic testing is a cornerstone of modern medicine; CDC estimates that 70 percent of medical decisions are based on laboratory test results (Ref. 8). IVDs offered as LDTs are a growing sector of that market (Ref. 1). Moreover, these tests are proliferating in some of the most complicated and sensitive areas of medical practice, where the presence of a valid test can be most important.

As the testing landscape has evolved, information about these tests in the scientific literature, news articles, and anecdotal reports submitted to the Agency, among other sources, has exposed evidence of problems associated with these tests. This evidence is discussed in more detail below. Particularly over the last few years, this evidence has been growing and likely does not reflect the full scale of the problems. (Until FDA systematically collects information on these tests, such as adverse event reports, it will not be able to assess more fully the extent of the risks to patients in the manner it does for other devices.) Based on current safety signals, FDA is proposing to phase out the general enforcement discretion approach to help assure that patients are receiving accurate and reliable diagnostic test results regardless of where the tests are made.

Today, IVDs offered as LDTs are ubiquitous, and are intended to diagnose a broad range of diseases and conditions (see Ref. 2). In many cases, these IVDs are meant for use in complex areas of medicine involving life-threatening diseases, such as cancer, neurological diseases, cardiovascular illness, infectious diseases, and rare diseases. They can proliferate in areas where diagnosis is difficult, and the healthcare community has few points of reference for determining test validity. Sometimes, they use complex algorithms to calculate “scores” for diagnosis with little transparency to the user about the basis for these algorithms. Increasingly, these IVDs are intended to inform drug treatment, directing physicians to choose certain drugs based on a patient's genetic or other information. FDA has witnessed an explosion in the volume, complexity, and scope of IVDs offered as LDTs for use in determining cancer treatments, 7 and as discussed below, news coverage, including as recently as this year, has drawn attention to the use of IVDs offered as LDTs for non-invasive prenatal screening (NIPS), which evaluate fetal DNA circulating in a pregnant individual's blood. In general, IVDs offered as LDTs are occupying a growing share of the testing market and are used in some of the most complex areas of medicine ( see, e.g., Refs. 1 and 2).

Given the role these IVDs play in modern medical care, their validity has a significant impact on the public health. False positive test results, which erroneously indicate that a patient has a certain disease or condition, can delay diagnosis and treatment of the true disease or condition, lead to unwarranted interventions, and cause needless distress. Interventions may involve medication with serious side effects or risky medical procedures. False negative results can lead to progression of disease, in some cases without the opportunity for life-saving treatment, and the spread of infectious disease. The harms to patients from false positive and negative results can be significant. For example, the application of an ineffective oncology treatment due to a false positive for a patient already weakened from disease, or the failure to receive a life-saving medication due to a false negative, can be fatal. These false results can stem from an analytical error or from a lack of clinical validity where a measured result is incorrectly associated with a particular clinical state. Flaws in a test's algorithm can mean the difference in whether a patient with cancer receives a beneficial immunotherapy. Pregnant people may use screening tests to make decisions without obtaining appropriate confirmatory testing. In 2016, FDA learned of a false positive result from a genetic test for long QT syndrome (a heart signaling disorder) that led to the erroneous implantation of a defibrillator in a healthy individual. In addition to the risks associated with the implantation procedure, the defibrillator delivered inappropriate shocks to the patient, which posed the risk of sudden cardiac death (Refs. 9 and 10). These are just a few examples of how diagnostic tests can and do have significant long-term consequences for patients.

FDA has highlighted the risks associated with IVDs offered as LDTs for decades, and our concerns have grown in recent years. As described in the “History of the Rulemaking” section, we first took steps to address the issue in the late 1990s, followed by a series of different proposed strategies for increasing oversight. In 2015, the Agency published a report of 20 case studies involving inaccurate, unsafe, ineffective, or poor quality LDTs that caused or may have caused patient harm (“2015 Report”) (Ref. 11). More recent evidence suggests that the situation is getting worse. This evidence cuts across test types and laboratories and is from a variety of sources, including published studies in the scientific literature, allegations of problematic tests reported to FDA, FDA's own experience in reviewing IVDs offered as LDTs, news articles, and class-action lawsuits. Overall, the evidence points to fundamental uncertainty in the marketplace about whether IVDs offered as LDTs provide accurate and reliable results.

Scientific literature is one source of evidence. Over time, FDA has become aware of various publications that describe problems with IVDs offered as LDTs. In the past 3 years, four different studies have documented high variability in performance among these IVDs (Refs. 12 to 15). In one study, the same samples were sent to 19 laboratories for testing using their own manufactured test and only 7 of those laboratories correctly reported all results (Ref. 12). For almost half of the tests studied, analytical accuracy was significantly lower than that of the parallel test approved by FDA. In another study, researchers sent identical samples to two different laboratories to detect tumor mutations and found over 70 percent discordance in the results from their tests (Ref. 13). A study by Friends of Cancer Research found substantial variability among tumor mutational burden (TMB) tests manufactured by laboratories and used to identify patients with cancer most likely to benefit from immunotherapy (Ref. 14). A fourth study highlighted validity concerns specific to early cancer detection tests, including one IVD offered as an LDT that delivered nine false positive results for every true cancer diagnosis (Ref. 15). An article published earlier this year detailed an oncologist's experience with false results from an unapproved blood-based multi-cancer early detection IVD offered as an LDT and intended to screen for more than 50 types of cancer (Ref. 16). A 2016 study published in the New England Journal of Medicine reported false positive results from genetic IVDs offered as LDTs for hypertrophic cardiomyopathy in multiple patients of African American descent (Ref. 17). These studies do not mean that every laboratory is manufacturing bad tests or that no patient can rely on IVDs offered as LDTs. Instead, they reflect a level of variability, including the potential for inaccurate or incomplete results, that highlights the need for changes to the basic oversight scheme.

FDA's own experience has reinforced concerns regarding IVDs offered as LDTs. FDA has gathered information about IVDs offered as LDTs through its review of submissions. Although the Agency generally has not enforced requirements for LDTs, it has received premarket submissions from some laboratories seeking authorization for their tests. We have received numerous submissions for such tests, including premarket review submissions, 8 Q-submissions, 9 and investigational use submissions for IVDs offered as LDTs, as well as many emergency use authorization (EUA) requests from laboratories (which are discussed further below). FDA's review of these submissions has provided insight into laboratory test development and, in some cases, revealed significant concerns. For example, FDA has observed that many laboratories fail to perform appropriate or adequate validation studies, have data demonstrating their test does not work as intended but offer the test anyway, or use instruments and other components that are not adequately controlled for clinical use. The tests described in these submissions have been intended for a range of diseases or conditions, some of which are very serious. FDA has received submissions for IVDs offered as LDTs to diagnose Alzheimer's disease, predict heart disease risk, diagnose Fabry disease (a rare neurological disorder), and inform treatment considerations for a rare blood cancer, all of which lacked adequate validation to support authorization.

In addition, given that FDA's general enforcement discretion approach for LDTs has not applied to IVDs for emergency use (though FDA has issued enforcement policies for such IVDs during specific emergencies, as explained elsewhere in this preamble), FDA has received EUA requests for tests from laboratories, including many for COVID-19 diagnostics. Of the first 125 EUA requests for COVID-19 molecular diagnostic tests submitted from laboratories, 82 showed test design or validation problems (Ref. 18). In one case, the approach to validation was so poor that when redone correctly, there was a 400-fold difference in performance, leading the laboratory to take the test off the market. In another example, an academic medical center (AMC) laboratory purported to validate its test with only 12 positive samples, showing perfect performance. FDA requested evaluation of additional specimens to confirm. When an additional 12 samples were evaluated, the cumulative performance revealed an unacceptably high false negative rate, where the test identified only 71 percent of known positive specimens as positive and falsely identified 29 percent of known positive samples as negative, and the EUA request was withdrawn. In addition, multiple laboratories that offered their tests as described in FDA's COVID-19 test guidance (see discussion in Ref. 19) did not provide any analytical and/or clinical validation data in the EUA requests that they submitted after the tests were in use. This experience provided a window into the approach that many laboratories may take to test validation, and not only confirmed but increased FDA's concerns about the validation of IVDs offered as LDTs. The experience also showed that even tests involving relatively well-understood techniques (here, the polymerase chain reaction, or PCR, technique) may not perform well. In all, test performance seen in this subset of submissions from laboratories was far worse than we expected. To the extent that this sample represents larger trends in the performance of IVDs offered as LDTs, it underscores the need for greater FDA oversight.

FDA has also received multiple complaints, adverse event reports, and other allegations identifying problems with IVDs offered as LDTs. 10 One complaint alleged that an IVD offered as an LDT to diagnose autism had insufficient clinical validation to support this use. In another complaint, an informant alleged that a laboratory was forging results when its liquid biopsy test did not work. Additionally, FDA has received multiple voluntary medical device reports (primarily from patients) of inaccurate NIPS test results, as well as inaccurate results from an oncology IVD offered as an LDT that predicts risk of breast cancer recurrence and informs the decision to pursue chemotherapy, both of which can pose serious, irreversible harm to patients. Another report described a false negative result from a BRCA test marketed to predict one's risk of breast cancer. The patient was later diagnosed with breast cancer and found to be BRCA1 positive by another test. A separate report from a healthcare provider described a different patient that received discrepant results from testing with this BRCA test and with another IVD offered as an LDT for hereditary cancer risk prediction. In yet another report, a patient described a false positive breast cancer result from an oncology blood IVD offered as an LDT and that led to invasive followup procedures, emotional anguish, and unnecessary monetary expenses. FDA also received a report regarding a blood-based test for lung cancer that underestimated cancer in about 40 percent of patients. Additionally, FDA has received medical device reports regarding infectious disease genetic IVDs offered as LDTs without validation, from which inaccurate results could lead to limb loss or women's health issues, and regarding inaccurate results from an IVD offered as an LDT to assess medication adherence. As noted above, collectively, this information, though anecdotal, points to potential problems among IVDs offered as LDTs, the scope and scale of which FDA cannot fully assess or address without phasing out the general enforcement discretion approach for applicable requirements (such as adverse event reporting).

Aside from the scientific community and FDA, the general public is coming to recognize concerns with the current scheme, in which most LDTs are generally not overseen by FDA. General news sources and other outlets have reported on such concerns (see, e.g., Refs. 20 to 26). For example, the New York Times recently conducted an indepth investigation into NIPS tests and found that positive results from the tests are incorrect about 85 percent of the time (Ref. 22). NIPS tests are screening tests, so they should be followed up with confirmatory diagnostic testing, but the New York Times article reported that patients and healthcare providers are making healthcare decisions based on results from these screening tests alone due to manufacturers' marketing claims. A device whose labeling is false or misleading in any particular manner is misbranded under the FD&C Act; however, under the general enforcement discretion approach, FDA generally has not enforced this proscription for IVDs offered as LDTs. As another example, ProPublica reported on a COVID-19 test offered by a laboratory under contract with a university without EUA authorization from FDA, which, according to the report, missed 96 percent of the positive cases from the university campus, and routinely sent people infected with COVID-19 back into the community (Ref. 26). In addition, consumers, shareholders, and investors are filing lawsuits against laboratory manufacturers for false and misleading statements about test efficacy, including lawsuits related to pharmacogenetic tests (genetic tests intended to inform drug selection) and NIPS (see, e.g., Complaint, In re Myriad Genetics, Inc. Sec. Litig., No. 2:19-cv-00707-PMW (D. Utah 2019); Complaint, Hickok v. Capone, No. 2021-0686 (Del. Ch. 2021); Complaint, Davis v. Natera, Inc., No. 3:22-cv-00985 (N.D. Cal. 2022); Complaint, Carroll v. Myriad Genetics Inc., No. 4:22-CV-00739 (N.D. Cal. 2022); Biesterfeld v. Ariosa Diagnostics, Inc., No. 1:21-CV-03085, 2022 WL 972281 (N.D. Ill. 2022); and Complaint, Kogus v. Capone, No. 2022-0047-SG (Del. Ch. 2022)). The overall picture presented by this evidence indicates that a change in oversight is needed to better assure the safety and effectiveness of IVDs offered as LDTs.

As described above, the evidence FDA has collected points to flaws in laboratory manufacturing of tests that need to be addressed to protect the public. Greater oversight by FDA would help address these flaws.

In the past, FDA has communicated with the public when it is particularly concerned about a type of IVD offered as an LDT. For example, in addition to the 2015 Report, FDA has issued safety communications about pharmacogenetic tests, NIPS tests, ovarian cancer screening tests, nipple aspirate tests, and instruments used in the design of many different LDTs (Refs. 27 to 31). FDA has also taken compliance action in some circumstances, such as issuing a warning letter to a laboratory manufacturing a pharmacogenetic test in April 2019 (Ref. 32). However, more structural change is needed. FDA's general enforcement discretion approach emerged at a time when the typical IVD offered as an LDT looked very different from how it looks today. FDA has made a preliminary determination that this approach has become outdated, and the proposed steps to end this approach in this rulemaking would better protect the public health.

Increased oversight would help to ensure the safety and effectiveness of IVDs offered as LDTs. More accurate diagnoses would lead to better care, which would advance public health overall. Through increased oversight, the public, including patients and healthcare professionals, could have more confidence that the test results they rely on are accurate. Greater FDA oversight of IVDs offered as LDTs has become particularly important as more and more novel treatments require use of a specialized test to identify patients likely to benefit from them. This, in turn, has led to increased development of tests used as the primary driver for therapeutic decisions. These include tests to determine whether to administer a therapeutic, which therapeutic to administer, and at what dose to administer the therapeutic. For example, recent approvals of drug products to treat diseases in their early stages, such as for early-stage Alzheimer's patients, make accurate and early diagnosis of these diseases more critical today than ever before. As another example, gene therapy is an emerging field with incredible potential to treat many diseases or conditions. Testing is required to identify patients with the defective gene targeted by the treatment and, in some cases, to assess whether the patient has antibodies to the vector delivering the treatment that would prevent it from working. In these and other cases, accurate and reliable test results are essential for safe and effective use of a therapeutic.

Increased oversight would also address business strategies that take advantage of the current bifurcated system. For example, in a number of cases, laboratories that have submitted premarket submissions for their tests, but whose tests did not meet applicable requirements for authorization, have still offered these IVDs as “LDTs.” Some of these tests, such as a test intended to diagnose Alzheimer's disease, had inadequate validation data to support authorization (see Ref. 33). A genotyping test purported to predict heart disease risk, but FDA found that there was no association between the genetic information the test identified ( KIF6 ) and heart disease. A third test, intended to diagnose Fabry disease, showed a high level of false negatives. The public health is not served by a scheme in which tests that have these types of problems are still offered to patients simply because the manufacturer is a laboratory. FDA is also aware that some industry players have created business models that claim a connection to laboratories and offer IVDs as LDTs. The increase in firms using these business models, as well as their substantial magnitude of reach, underscores the need for more oversight.

In addition, FDA anticipates that consistent oversight would bring more stability to the testing market overall, which could help to encourage the manufacture of IVDs for which there is a reasonable assurance of safety and effectiveness. FDA is aware of arguments that better assuring the safety and effectiveness of LDTs would foster test innovation. FDA is also aware of arguments that IVD manufacturers that are not laboratories may currently be discouraged from investing time and resources into developing novel tests due to the concern that once the manufacturer receives marketing authorization for its test, laboratories will develop similar tests and market their tests without complying with FDA requirements. We anticipate that applying the same oversight approach to laboratories and non-laboratories that manufacture IVDs would better assure the safety and effectiveness of LDTs, and would remove a disincentive for non-laboratory manufacturers to develop novel tests, thereby spurring innovation and access to IVDs for which there is a reasonable assurance of safety and effectiveness. As a result, we anticipate that phasing out the general enforcement discretion approach for LDTs would advance responsible innovation by both laboratory and non-laboratory IVD manufacturers alike, rather than discouraging it.

FDA is aware of other arguments that ending the general enforcement discretion approach for LDTs would interfere with test innovation and patient access due to the potential need for premarket review of new tests. However, under FDA's device authorities, FDA premarket review is only required for certain tests (generally those classified into class II or class III), and FDA estimates that approximately 50 percent of IVDs offered as LDTs would not require premarket review (see section II.F.4 of the Preliminary Economic Analysis of Impacts (Ref. 34)). In addition, FDA review is only required for device modifications in certain circumstances. For devices that are subject to PMA requirements, a PMA supplement is required only for changes that affect the safety or effectiveness of the device, and in some cases the change may be made prior to FDA approval (see 21 CFR 814.39(d)); may be made 30 days after a supplement has been filed, unless FDA takes certain action (see 21 CFR 814.39(e)); or may be made 30 days after FDA receives a notice describing the change (in lieu of a supplement), unless FDA takes certain action (see 21 CFR 814.39(f)). For devices that are subject to 510(k) requirements, a new 510(k) is only required for a significant change or modification in design, components, method of manufacture, or intended use, where a significant change or modification is one that could significantly affect the safety or effectiveness of the device or that is a major change or modification in the device's intended use (21 CFR 807.81(a)). FDA has published several guidance documents to help stakeholders determine whether a certain change or modification may require a PMA supplement, new 510(k), or other submission to FDA, and FDA has several mechanisms available through which manufacturers may seek FDA assistance in making this determination. In addition, under section 515C of the FD&C Act (21 U.S.C. 360e-4), a PMA supplement or new 510(k) is not required for a change to a device that would otherwise require a supplement or new 510(k) if the change is consistent with a predetermined change control plan previously approved or cleared by FDA. We also note that as described in section VI.B, FDA is proposing to phase out the general enforcement discretion approach for LDTs with respect to premarket review requirements on a date that aligns with or follows the beginning of a new user fee cycle, such that FDA's review timelines and goals would be reflected in commitments newly negotiated with industry. For all of these reasons, FDA does not anticipate that ending the general enforcement discretion approach for LDTs would unduly impair test innovation and patient access.

Furthermore, FDA's approach was never intended to selectively foster laboratory innovation at a cost to public health. Rather, the approach arose based on certain test characteristics and institutional safeguards that at the time adequately protected patients. In general, those characteristics and safeguards are no longer present, putting public health at risk. Further, FDA is aware that this scheme is in some cases fostering unfounded claims of innovation rather than responsible innovation. These claims are concerning to FDA because they can mislead the public, undermine legitimate competition, and disincentivize responsible, science-based innovation.

Finally, increased oversight may help to advance health equity. FDA is aware of concerns that IVDs offered as LDTs may exacerbate health inequities due to higher rates of inaccurate results among underrepresented patient populations, particularly racial and ethnic minorities undergoing genetic testing (see, e.g., Refs. 17 and 35 to 38). Some IVDs offered as LDTs have not been validated for use in all patient populations within a disease state, meaning that it is unknown how well the test may perform across diverse patient populations expected to use the test and the test may be less accurate in underrepresented patient populations, potentially contributing to health disparities (see, e.g., Ref. 39). Increased FDA oversight may help to ensure that information is available pertaining to device safety and effectiveness for specific demographic characteristics if performance differs within the target population, through the enforcement of applicable labeling requirements. In addition, when FDA conducts premarket review of a device, FDA may ask that sponsors provide data for different intended patient populations, and with new authorities under the Food and Drug Omnibus Reform Act of 2022 (FDORA), sponsors generally are required to submit diversity action plans to FDA, including the sponsor's goals for enrollment in device clinical studies. In contrast, with limited oversight over these tests, FDA does not know whether diverse patient populations are being included in validation studies for these IVDs. FDA has made a preliminary determination that increased oversight for these IVDs would help ensure adequate representation of the intended use population in validation studies and transparency regarding potential differential performance, helping to advance health equity. FDA also recognizes that IVDs offered as LDTs may serve communities in rural, medically underserved areas with disparities in access to diagnostic tests. However, the benefits of test access directly depend on the ability of tests to work as intended. Thus, to the extent that access to IVDs offered as LDTs may benefit patients in rural, medically underserved communities, the harms of unsafe or ineffective IVDs offered as LDTs may also be realized among these underserved patient populations. By increasing its oversight, FDA may better prevent and mitigate such harms, thereby better protecting the health of these underserved populations.

We are aware of arguments that other mechanisms—such as the medical expertise of laboratorians or requirements under CLIA—already provide adequate oversight of IVDs offered as LDTs. However, our review of the evidence indicates otherwise. Evidence suggests that under the current scheme, the healthcare community lacks adequate assurances about the safety and effectiveness of IVDs offered as LDTs. Although laboratories that offer LDTs are also subject to CLIA, which is primarily administered by the Centers for Medicare & Medicaid Services (CMS), CLIA is not a substitute for FDA oversight. CLIA establishes requirements for laboratories and laboratory personnel pertaining to operations, inspections, and certification, with a focus on the proficiency with which laboratories perform clinical testing (see 42 U.S.C. 263a and 42 CFR part 493). Among other requirements, clinical laboratories generally must have a CLIA certificate that corresponds to the complexity of tests performed prior to accepting human samples for testing. However, under CLIA, CMS does not regulate critical aspects of laboratory test development; does not evaluate the performance of a test before it is offered to patients and healthcare providers; does not assess clinical validity ( i.e., the accuracy with which a test identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient); does not regulate certain manufacturing activities, such as design controls and acceptance activities; does not provide human subject protections for patients who participate in test clinical research trials; and does not require adverse event reporting. As such, CMS has described the FDA and CMS “regulatory schemes” as “different in focus, scope and purpose, but they are intended to be complementary” (Ref. 40). Where CLIA does play a role (as discussed further below, compliance with CLIA may provide certain assurances relating to quality system (QS) requirements), FDA has tailored its proposed phaseout policy accordingly. 11

We are also aware of arguments that any additional oversight of LDTs should be accomplished by granting new statutory authorities to CMS. However, this would cause a problematic split in oversight, with the same types of tests being reviewed by different Agencies depending on where the test was made. For example, a cancer diagnostic test developed by a conventional manufacturer would be reviewed by FDA while a similar cancer diagnostic test (using the same sample type and testing for the same analytes) developed by a laboratory would be reviewed by another Agency. Further, with that divided oversight, an IVD developed by a conventional manufacturer could even be reviewed and cleared by FDA and subsequently reviewed by another Agency if a laboratory made certain modifications to it. However, if those same modifications were made by the original manufacturer, they would be reviewed by FDA. This could lead to confusion and inconsistency.

FDA has both the authority and the expertise to perform the necessary oversight of IVDs offered as LDTs and is the only Agency for which that is the case. One of FDA's most basic and well-understood responsibilities is helping to ensure the safety and effectiveness of medical products. FDA employs staff across a wide range of disciplines, including physicians, statisticians, engineers, biologists, chemists, geneticists, and others, to evaluate the science behind medical products before they reach the market. Understanding the complex technical information in applications, such as clinical trial data, bench testing results, and product manufacturing and design characteristics—and putting that information in context to assess whether a product can be marketed—is within the unique expertise of FDA. This type of expertise is no less important for IVDs, which can have a wide variety of public-health consequences, as described elsewhere in this rule. During review of an application for an IVD, FDA reviewers closely examine data relevant to analytical validity, clinical validity, and safety, and draw on their expertise and experience to understand both the product and the science supporting the product.

Review of the underlying science behind an IVD is based on what the IVD does and is in no way related to where the IVD is made. Thus, FDA's experience and expertise with respect to oversight of other IVDs is directly applicable to oversight of LDTs. In fact, FDA has already applied its expertise to the review of some IVDs offered as LDTs—for example, during public health emergencies. As stated above, FDA has reviewed many EUA requests for tests from laboratories during the public health response to COVID-19.

Entities outside FDA have also recognized that FDA should oversee LDTs, and that greater oversight is needed. For example, the Secretary's Advisory Committee on Genetics, Health, and Society, in its April 2008 report entitled “U.S. System of Oversight of Genetic Testing,” stated that “FDA should address all laboratory tests, regardless of how they are produced ( i.e., as a commercial test kit or laboratory-developed test), in a manner that takes advantage of its current experience” (Ref. 41). The American Cancer Society Cancer Action Network has taken a similar position, noting in a November 2016 statement that “[c]urrent oversight of LDTs falls short of ensuring these tests produce accurate and meaningful results . . . [t]he FDA is the most appropriate agency to evaluate the analytical and clinical validity of diagnostic tests, along with their safety, to help ensure that cancer patients and their doctors are able to make appropriate treatment decisions based on accurate information” (Ref. 42). Likewise, the Advanced Medical Technology Association (AdvaMed) stated in November 2021 that the association has “long supported the idea that all diagnostic test developers . . . should be subject to the same FDA standards and processes” (Ref. 43).

As discussed throughout this section, increased oversight of IVDs offered as LDTs is needed. However, FDA has also made a preliminary determination that our general enforcement discretion approach should be phased out in a manner that accounts for the level of public health concern and the importance of avoiding undue disruption to the testing market, including undue disruption to the provision of care. Therefore, we are proposing a gradual phaseout to occur in stages over a total period of 4 years, as described in section VI.B. FDA anticipates that this phaseout policy should ultimately enable IVDs offered as LDTs that are supported by sound science to remain on the market. FDA also recognizes that some IVDs may need to come off the market, because, for example, the IVD cannot meet applicable requirements under the FD&C Act and its implementing regulations, or the laboratory chooses not to invest resources to meet those requirements. To the extent that withdrawal from the market of these IVDs implicates any reliance interests, FDA has made a preliminary determination that the public-health benefits associated with the reasonable assurance of safety and effectiveness of IVDs offered as LDTs outweigh any such interests. In addition, in the long run, it is possible that any reduction in the number of current IVDs offered as LDTs may be offset by the market entry of IVDs from other manufacturers who will have benefitted from a more consistent oversight approach and increased stability spurring innovation.

The FD&C Act, as amended by the MDA and subsequent statutes, establishes a comprehensive system for the regulation of devices, defined in section 201(h)(1) of the FD&C Act, that are intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness of the device; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act).

General controls include, but are not limited to, provisions that relate to establishment registration and device listing; premarket notification; prohibitions against adulteration and misbranding ( e.g., labeling that fails to bear adequate directions for use); recordkeeping and reporting, including adverse event reporting and reporting of corrections and removals initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act caused by the device which may present a risk to health; and current good manufacturing practice (CGMP) requirements. These controls apply to all devices unless an exemption applies.

Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, post-market surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act).

Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act).

Under section 513(d)(1) of the FD&C Act, devices that were introduced or delivered for introduction into interstate commerce for commercial distribution before the enactment of the MDA on May 28, 1976 (generally referred to as “preamendments devices”) are classified after FDA: (1) receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation, along with a proposed regulation classifying the device, and provides an opportunity for interested persons to submit comments; and (3) publishes a final regulation classifying the device. A preamendments device for which a classification regulation has not been promulgated is known as an “unclassified device.” Until an unclassified device type has been formally classified by regulation, the marketing of new devices within the device type requires FDA premarket review through a premarket notification (510(k)) under section 510(k) of the FD&C Act.

Devices that were not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976 (generally referred to as “postamendments devices”) are classified automatically by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require approval of a premarket approval application (PMA), unless and until: (1) FDA classifies or reclassifies the device into class I or II under section 513(f)(2) or (3) of the FD&C Act, or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act and part 807 of the regulations (21 CFR part 807).

In addition, under section 520(g) of the FD&C Act and part 812 of FDA's regulations (21 CFR part 812), a clinical investigation to determine the safety and effectiveness of certain devices must be the subject of an approved investigational device exemption (IDE) before such investigation may commence. If an IDE has been granted, a failure to comply with a requirement under which the device was exempted for investigational use renders the device adulterated (see section 501(i) of the FD&C Act).

Failure to comply with applicable requirements of the FD&C Act and FDA regulations may render the device adulterated and misbranded under sections 501 and 502 of the FD&C Act and may constitute a prohibited act under section 301 of the FD&C Act (21 U.S.C. 331).

IVDs, as defined in § 809.3 (21 CFR 809.3), are devices intended for human use and are subject to the FD&C Act. They include class I, class II, and class III devices, as well as both preamendments and postamendments devices. Like other devices, IVDs are subject to general controls, including premarket notification, reporting requirements regarding adverse events and corrections and removals, IDE requirements (though most investigations of IVDs are exempt from most provisions of the IDE regulation), and other applicable requirements under the FD&C Act and FDA's regulations. IVDs are also subject to specific labeling requirements in part 809 of the regulations (21 CFR part 809).

FDA has made clear, on many occasions and over many years, that LDTs are devices under the FD&C Act (for the legal reasoning for this conclusion, see section V.B). Over 25 years ago, FDA explained that clinical laboratories that develop tests are acting as manufacturers of medical devices (62 FR 62243 at 62249 (November 21, 1997)). FDA reiterated that position in a citizen petition response a year later (Ref. 44), and in the preamble to a final rule 3 years after that (65 FR 18230 at 18231 (April 7, 2000)). In 2006, FDA again cited its prior statement that clinical laboratories that develop tests are acting as manufacturers of medical devices (Ref. 45 (quoting 62 FR 62243 at 62249)). In 2014, FDA expressly considered and rejected arguments that LDTs are not devices under the FD&C Act, stating in a citizen petition response that “LDTs are devices within the plain language of the [statutory] definition” (Ref. 46). Five years later, FDA issued a warning letter stating that “FDA has not created a legal `carve-out' for LDTs such that they are not required to comply with the requirements under the Act that otherwise would apply. . . . Although FDA has generally exercised enforcement discretion for LDTs, the Agency always retains discretion to take action when appropriate, such as when it is appropriate to address significant public health concerns” (Ref. 47). A wide range of other FDA documents, including guidance documents, safety communications, compliance letters, and other public statements, have indicated or otherwise taken as their premise that IVDs are devices even when the manufacturer is a laboratory (see, e.g., Refs. 11, 18, 27, 28, and 48 to 56).

FDA has also taken regulatory actions consistent with these statements and documents. Since 2017, the Agency has reviewed over 40 PMAs, 510(k)s, and De Novo classification requests for tests identified by the manufacturer as LDTs, and has approved, cleared, or granted De Novo classification for roughly half of those tests under authorities in the FD&C Act specifically reserved for “devices.” FDA has also received many EUA requests from laboratories and has authorized over 150 such tests for emergency use, an authority that is also limited to “devices” or other FDA-regulated medical products.

In light of FDA's recognition that LDTs are devices and our increasing concerns about IVDs offered as LDTs (as detailed in the “Need for the Rule” section, section III.B of this document), over the years the Agency has considered various ways to address IVDs manufactured by laboratories that raise safety or effectiveness concerns. In 1997, FDA sought to address these concerns by establishing restrictions on the sale, distribution, and use of analyte specific reagents (ASRs), which the Agency described as the “primary ingredients” of most LDTs (62 FR 62243 at 62249). In 2006, FDA issued a draft guidance outlining a different enforcement approach for a type of LDT known as an in vitro diagnostic multivariate index assay (IVDMIA), 12 which raised particular safety and effectiveness concerns (Ref. 45). FDA later determined that it should engage in a more comprehensive effort to oversee LDTs, in part due to stakeholder feedback.

Consistent with this determination, in 2010, FDA announced plans to develop a broader approach to the oversight of LDTs. The Agency held a 2-day public meeting and opened a docket for public comment (75 FR 34463 (June 17, 2010)). Input received through those proceedings informed two draft guidance documents issued by FDA on October 3, 2014, entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (79 FR 59776) and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” (79 FR 59779) (Refs. 48 and 49). In those draft guidance documents, FDA proposed to implement a risk-based oversight framework for IVDs offered as LDTs, with a phased enforcement strategy. FDA solicited public feedback on the draft guidance documents and held a public workshop on January 8 and 9, 2015 (79 FR 69860 (November 24, 2014)).

From October 2014 through 2016, FDA analyzed more than 300 sets of comments on the draft guidance documents, as well as discussion from the public workshop, and engaged extensively with stakeholders in meetings and conferences. A number of interested parties provided feedback, including laboratories, healthcare providers, patients, conventional IVD manufacturers, government agencies, and Congress. The feedback ranged generally from strong opposition to strong support for FDA's proposed increased oversight of LDTs and addressed a wide range of topics, including FDA's authority to regulate LDTs, the risks posed by LDTs without increased FDA enforcement, the effect of a new enforcement approach on test access and innovation, the potential interplay between FDA regulation and CLIA, and the implications of increased FDA oversight for competition in the IVD market.

On January 13, 2017, FDA issued a discussion paper (2017 Discussion Paper) synthesizing the feedback that had been provided to the Agency, following a choice by FDA not to finalize the draft guidance documents to allow for further public discussion and to provide an opportunity for Congress to develop legislation for a new regulatory framework encompassing all IVDs that appropriately balances patient protection with continued access and innovation (Ref. 50).

In August 2020, HHS posted a statement on its website entitled “Rescission of Guidances and Other Informal Issuances,” which stated, among other things, that “the department has determined that the Food and Drug Administration (`FDA') will not require premarket review of laboratory developed tests (`LDT') absent notice-and-comment rulemaking” (Ref. 57). 13 This statement was informed by advice in a legal memorandum from the HHS Office of General Counsel (see Ref. 59). In November 2021, based on new advice from the HHS Office of General Counsel, HHS leadership determined that the August 2020 statement no longer represented the Department's policy or legal views (Ref. 59). HHS Secretary Xavier Becerra publicly announced the withdrawal of the statement on November 15, 2021 (Ref. 60). Various news outlets have reported on these events (Refs. 61 to 64).

FDA is proposing to issue this rule under the Agency's general rulemaking authorities and statutory authorities relating to devices. These authorities include sections 201(h)(1), 301, 501, 502, 510, 513, 514, 515, 518, 519, 520, 701, 702, 704, and 801 (21 U.S.C. 321(h)(1), 331, 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 371, 372, 374, and 381). In particular:

• Under section 201(h)(1) of the FD&C Act, a device is defined as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”

• Section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act.

For additional descriptions of some of the authorities referenced above, see “FDA's Current Regulatory Framework” section (section III.C.). For additional discussion of how these legal authorities apply to LDTs, see “Legal Basis for the Proposed Amendment” section (section V.B.).

We are proposing to amend part 809, subpart A, specifically § 809.3, by updating the definition of “in vitro diagnostic products” to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory. IVDs are defined as “those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body” (§ 809.3). This amendment would reflect FDA's longstanding view that LDTs are devices under the FD&C Act, and would reflect the fact that the device definition in the FD&C Act does not differentiate between entities manufacturing the device. In other words, whether an IVD is a device does not depend on where or by whom the IVD is manufactured.

FDA is also proposing to amend the statutory citation for the device definition included in § 809.3 to reflect amendments to section 201(h) of the FD&C Act as a result of the enactment of the Safeguarding Therapeutics Act (Pub. L. 116-304, 134 Stat. 4915). For many years, the definition of “device” had been codified at section 201(h) of the FD&C Act. Upon enactment of the Safeguarding Therapeutics Act, the definition of “device” was redesignated as paragraph (h)(1) and a new definition of “counterfeit device” was codified at paragraph (h)(2).

If amended as proposed, § 809.3 would express in plain terms that IVDs, including test systems, fall within the definition of a device in section 201(h)(1) of the FD&C Act when they have been manufactured by laboratories. In this subsection, FDA sets forth the legal reasoning for this position.

The FD&C Act defines a device as, in relevant part, “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” (see 21 U.S.C. 321(h)(1); see also 21 U.S.C. 360j(o) (identifying circumstances under which software is and is not within the device definition)). This definition includes IVD test systems. Test systems are sets of IVDs—for example, reagents, instruments, specimen collection devices, software, and other related materials—that function together to produce a test result. See, e.g., § 809.10(a)(9)(iii) (21 CFR 809.10(a)(9)(iii)) (discussing “multiple unit products which require the use of included units together as a system”); id. § 809.10(b) (referring to reagents and instruments within a system). According to a straightforward reading of the statutory text, these systems are “apparatus[es],” “contrivance[s],” and articles that are “similar or related” to “instrument[s]” and “in vitro reagent[s],” that are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease. They consist of individual parts that have their own regulatory identity, but, when combined, constitute a new device.

The device definition expressly contemplates this scenario because it provides that both an overall article and each of its “components” and “parts” are devices subject to regulation. (21 U.S.C. 321(h)(1); cf. Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 768 (3d Cir. 2018) (describing the distinct status of a “system that is itself a `device' but that is comprised of Class II [device] components in addition to one or more Class III [device] components”).) The word “apparatus,” which is defined as “a set of materials or equipment designed for a particular use,” encompasses test systems by its plain terms. (See Apparatus, Merriam-Webster.com (last accessed June 28, 2023); see also United States v. Bacto-Unidisk, 394 U.S. 784, 798 (1969) (“Congress fully intended that the [FD&C] Act's coverage be as broad as its literal language indicates”).) Consistent with this analysis, FDA's definition of an “in vitro diagnostic product,” which was first promulgated in 1973 and is still in effect today, identifies a “system” as a type of IVD and a device under the FD&C Act. (Section 809.3 (IVDs include “reagents, instruments, and systems”); see 38 FR 7096 at 7098 (March 15, 1973).)

The regulation of test systems is important because test systems are generally the IVDs that produce a result—a “positive” or “negative” (such as what patients receive in the context of COVID-19 diagnostic tests), a quantitative value (such as a concentration of glucose), or perhaps a more detailed report of results. The quality of test results is generally what defines both the risks and benefits of IVDs: the risks stem from inaccurate, unreliable, incomplete, or misleading test results, and the benefits stem from accurate, reliable, and complete test results. For that reason, test systems and their results are a key focus of FDA's regulation of IVDs. FDA has issued over 350 regulations classifying different types of test systems (see generally 21 CFR parts 862, 864, 866) and has evaluated the performance and results of innumerable test systems over the course of decades. Patients and healthcare professionals rely on FDA to help ensure the validity of test systems, and conventional IVD manufacturers have built their business around this premise.

The focus on test systems and their results is not new; it has been a consistent theme throughout the history of FDA's regulation of IVDs. Congress expressly granted FDA authority over diagnostic products in 1938. (Federal Food, Drug and Cosmetic Act (June 25, 1938), Pub. L. 75-717, 52 Stat. 1040 (defining “drug” and “device” with reference to an intended use in “diagnosis,” among other things).) Following the 1938 Act, FDA took action against diagnostic products, including against a system intended to diagnose illness based on human blood samples. (See Drown v. United States, 198 F.2d 999, 1001 (9th Cir. 1952).) And, in the early 1970s, FDA established a specific IVD regulatory program in response to “rapid growth in development of in vitro diagnostic products combined with the increasing use and reliance on the results by physicians, hospital personnel, and clinical laboratories.” (37 FR 819, January 19, 1972). This program addressed the “need [for] closer scrutiny because of the possibility that inaccurate and unreliable results may be obtained.” Id. FDA issued final regulations establishing controls over IVDs, including “systems,” in 1973 (38 FR 7096 at 7098) (creating, among other things, “product class standards” to set “performance requirements necessary to assure accuracy and reliability of results”). FDA's increasing concerns about these products was evident from the fact that—even before Congress expanded the Agency's device authorities in 1976—it applied the drug authorities to certain IVDs. The Supreme Court upheld that application in Bacto-Unidisk, 394 U.S. at 800-01.

In 1976, Congress enacted the MDA, sweeping legislation meant to broaden and strengthen FDA's authority over devices. (See, e.g., H.R. Rep. 94-853 at 11 (February 29, 1976).) The MDA included revisions to the definition of “device” to clarify that IVDs should be regulated under the new, more robust device authorities. (Medical Device Amendments of 1976, Pub. L. 94-295, 90 Stat. 539 (adding the term “in vitro reagent” to the definition of a device); S. Rep. No. 93-670 at 16 (January 29, 1974) (“The Committee recognizes that there is confusion at the present time about whether certain articles are to be treated as devices or drugs under the Food, Drug and Cosmetic Act. Therefore, the Committee reported bill has carefully defined `device' so as to specifically include implants, in vitro diagnostic products, and other similar or related articles.”). The legislative history shows that Congress had serious concerns about test systems and sought to empower FDA to address them. (See, e.g., S. Rep. No. 93-670 at 3-4 (January 29, 1974) (describing with concern “quack devices” such as a “diagnostic service” in which “[p]ractitioners . . . mailed in the blood spots taken from their patients,” “[t]he blood-spotted paper was put into a slot of the electrical device called the `Radioscope' while the operator stroked with a wand the abdomen of a person holding metal plates connected to the device,” and “the operator determined from this the identity, kind, location, and significance of any disease present”).) Congress also contemplated performance standards relevant to test systems, such as required labeling with “ranges of accuracy of diagnosis.” (H.R. Rep. 94-853 at 27.) Thus, in the MDA, Congress endorsed FDA's focus on test systems and their results.

The definition of “device” in the FD&C Act encompasses test systems regardless of where or by whom they are manufactured. (See 21 U.S.C. 321(h)(1).) In particular, the definition contains no exception or limitation for devices manufactured by laboratories. “Congress expresses its intentions through statutory text passed by both Houses and signed by the President (or passed over a Presidential veto).” ( Oklahoma v. Castro-Huerta, 142 S. Ct. 2486, 2496 (2022).) If Congress had intended such a limitation, it could have said so. Instead, Congress made clear that the definition does not turn on the type of entity manufacturing the device: for example, the statute expressly recognizes that even “practitioners licensed by law to prescribe or administer . . . devices” (the professionals most closely associated with traditional medical practice) can “manufacture . . . devices,” though they may be exempt from certain requirements when they do so “solely for use in the course of their professional practice.”  14 (See 21 U.S.C. 360(g)(2); see also 21 U.S.C. 360i(c)(1), 374(a)(2)(B).)

Courts have repeatedly recognized that articles manufactured by medical professionals fall within FDA's jurisdiction ( e.g., United States v. Regenerative Sciences, 741 F.3d 1314 (D.C. Cir. 2014) (holding that doctors “producing, as part of their medical practice,” a “drug” under the FD&C Act violated the FD&C Act); Drown v. United States, 198 F.2d 999, 1001 (9th Cir. 1952) (upholding FDA action against chiropractor who “manufacture[d] certain photographic, therapeutic and diagnostic instruments of her own design which she use[d] in her practice”)). As the D.C. Circuit in Regenerative Sciences observed, an approach that rejects “the [FD&C Act]'s regulation of doctors” would “create an enormous gap in the [FD&C Act]'s coverage.” (741 F.3d at 1320.)

The inclusion of articles in the FD&C Act's definition of a device without regard to the identity of their manufacturer makes particular sense in the context of test systems. Today, in FDA's experience, there is little distinction between the test systems manufactured by laboratories and other manufacturers. These systems generally consist of highly specialized components with complex functionality working in combination; they rarely resemble the “1976-type” tests discussed in this rule. For example, a modern-day next generation sequencing (NGS) test system for genetic testing typically consists of (among other things) a DNA extraction kit to extract nucleic acids from a human sample; an NGS instrument that analyzes the nucleic-acid output and (after days) generates gigabytes of sequencing raw data; and multiple pieces of computer software that translate that raw data into a test report. The systems look the same, and function the same way, regardless of who manufactures them. And although not all systems look exactly like an NGS system, they do typically involve sophisticated instruments with advanced software that, when used in conjunction with other test components, produce the system's results. Their manufacture generally requires knowledge of bioinformatics, software development, and an underlying specialty, such as medical genetics—knowledge that is neither traditionally associated with nor unique to laboratories. FDA understands that many test systems offered as LDTs are designed at Fortune 500 companies (see Ref. 65) by a “development team,” similar to how systems from conventional manufacturers are designed. And in FDA's experience, the individuals on these development teams generally have the same training and expertise regardless of whether they are employed by a “laboratory” organization or a conventional manufacturer. Even smaller laboratories use the same complex equipment for their systems, although they may purchase and use components that are labeled by other companies for “research use only.” In short, there is nothing inherent in the nature or design of laboratory developed test systems that would justify exclusion from FDA's jurisdiction.

That is not to say that laboratories and conventional IVD manufacturers are identical. Laboratories do occupy a distinct role in diagnostic testing because they are the entities that generally perform the tests. Like many devices, such as a magnetic resonance imaging unit used by a trained technician, test systems are usually used by trained professionals. Laboratories that are certified under CLIA and that meet the regulatory requirements under CLIA to perform high complexity testing employ trained laboratorians to “run” test systems, and CLIA is the statutory scheme that governs that work, as discussed in more detail in section III.B. However, a laboratory's role in performing test systems does not change its obligations under the FD&C Act when it is manufacturing test systems. As previously noted, the FD&C Act does not exclude medical professionals who manufacture devices from its scope, and the mere fact that a device is manufactured in connection with a medical service or procedure does not eliminate FDA's jurisdiction. (See United States v. Regenerative Sciences, 741 F.3d at 1319 (“Notwithstanding appellants' attempt to characterize this case as an effort by the FDA to `restrict[ ] the use of an autologous stem cell procedure, ' the focus of the FDA's regulation is on the Mixture [that is, the product that is created in connection with the procedure].”).)

Although some commentators have argued that laboratory manufacturing is immune from regulation because it is within the “practice of medicine,” that argument misconstrues the scope of the FD&C Act's “practice of medicine” provision. Section 1006 of the FD&C Act (21 U.S.C. 396) provides: “Nothing in this [Act] shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” Section 1006 carves out a specific zone of protected conduct that does not reach laboratory manufacturing of test systems. The purpose of the provision is to “ensure[ ] that once the FDA permits a device to be marketed for one use, health care practitioners have the flexibility to draw on their expertise to prescribe or administer the device” for other uses. ( Judge Rotenberg Educ. Ctr., Inc. v. United States, 3 F.4th at 395 (emphases added); see also Conf. Rep. 105-399 at 97 (November 9, 1997) (provision intended to cover “off-label use of a medical device by a physician using his or her best medical judgment in determining how and when to use the medical product for the care of a particular patient”).) The statutory provision applies only in the context of use of a “legally marketed device”—that is, a device that is already manufactured and lawfully on the market—and only applies to “prescrib[ing] or administer[ing] . . . within a legitimate health care practitioner-patient relationship.” It does not apply to the manufacture of new test systems. The manufacture of a new device falls squarely within FDA's realm. Cf. United States v. Regenerative Sciences, 741 F.3d at 1320 (“[W]hile the [FD&C Act] was not intended to regulate the practice of medicine, it was obviously intended to control the availability of drugs for prescribing by physicians.”) (quoting United States v. Evers, 643 F.2d 1043, 1048 (1981)). The fact that healthcare practitioners may prescribe a device, such as a test system, in the context of a healthcare practitioner-patient relationship does not mean that entities manufacturing that device can escape regulation. If that were the case, few devices would be regulated, because most are intended for use by healthcare practitioners in the context of a healthcare practitioner-patient relationship.

Furthermore, contrary to what some commentators have suggested, CLIA did not repeal FDA's authority over IVDs manufactured by laboratories, which dates back to at least 1938. CLIA does not expressly repeal FDA's authority, nor was FDA's authority repealed by implication. “An implied repeal will only be found where provisions in two statutes are in irreconcilable conflict, or where the latter Act covers the whole subject of the earlier one and is clearly intended as a substitute.” ( Branch v. Smith, 538 U.S. 254, 273 (2003) (cleaned up).) Here, as CMS itself has explained, “the regulatory schemes of the two agencies are different in focus, scope and purpose” and “are intended to be complementary” (Ref. 40). As explained in section III.B, CLIA puts a focus on the proficiency with which laboratories perform clinical testing, and the FD&C Act puts a focus on the manufacturing of test systems. CMS and FDA have different areas of expertise, and CLIA does not address a wide range of activities regulated under the FD&C Act, such as clinical validation and design activities. Thus, “CLIA does not preempt the FDA's authority to regulate facilities like [Clinical Reference Laboratory]. When two statutes are `capable of co-existence, it is the duty of the courts, absent a clearly expressed congressional intent to the contrary, to regard each as effective.' ” ( Clinical Reference Lab. v. Sullivan, 791 F. Supp. 1499, 1509 (D. Kan. 1992) (quoting Ruckelshaus v. Monsanto Co., 467 U.S. 986, 1018, (1984)), aff'd in part and rev'd in part on other grounds sub nom., United States v. Undetermined No. of Unlabeled Cases, 21 F.3d 1026 (10th Cir. 1994).)

In fact, Congress has affirmed that test systems manufactured by laboratories are devices under the FD&C Act. In the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), Congress listed 510(k) clearance or premarket approval under the FD&C Act as one of several bases for Medicare payment for an “advanced diagnostic laboratory test,” which is defined in part as a clinical diagnostic laboratory test “that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner)” (section 216(a) of PAMA). If such laboratory tests were not devices, the 510(k) clearance and premarket approval provisions would not apply to them and the inclusion of such provisions would be pointless and ineffectual. In addition, Congress indicated that clinical laboratory tests are devices in 2016 amendments to the FD&C Act. (21 U.S.C. 360j(o)(1)(D) (repeatedly referring to “clinical laboratory test or other device data”) (emphasis added).)

The FD&C Act confers jurisdiction on FDA to regulate test systems, a point that has been codified in FDA's regulations for more than half a century. And nothing in the text, history, or purpose of the statute suggests that test systems manufactured by laboratories are excluded from that jurisdiction. This interpretation is not only the most straightforward reading of the statute, it is also the most reasonable: any other interpretation would create a bifurcated scheme in which systems that are functionally identical are treated differently under the law.

Modern Commerce Clause jurisprudence holds that Congress has “authority to regulate even purely local activities that are part of an economic `class of activities' that have a substantial effect on interstate commerce.” ( United States v. Regenerative Sciences, 741 F.3d at 1320 (quoting Gonzales v. Raich, 545 U.S. 1, 17 (2005)).) Thus, few have disputed that Congress possesses the power to grant FDA authority to regulate even purely intrastate activities. However, some commentators have asserted that language in the FD&C Act referencing “interstate commerce” and “commercial distribution” precludes FDA from regulating IVDs that are designed, manufactured, and used in a single laboratory. As discussed below, these assertions lack merit.

a. Interstate commerce. There is no overarching requirement in the FD&C Act that FDA-regulated articles have a particular nexus with interstate commerce. Interstate commerce is not a prerequisite to FDA jurisdiction (beyond the constitutional minimum). Rather, under the FD&C Act, a limited number of provisions include specific interstate commerce “elements,” and thus require a particular connection with interstate commerce in order for those provisions to apply. For example, certain of the FD&C Act's “prohibited acts” contain an interstate commerce element that must be satisfied before the government can bring an enforcement action under those provisions ( e.g., 21 U.S.C. 331(a), (c), (d), and (k)). But relatively few of the FD&C Act's device provisions include a specific interstate commerce element, and most of the device-related prohibited acts do not. (See, e.g., 21 U.S.C. 331(e) (prohibiting the failure to establish or maintain any record, or make any report, required under the device adverse-event reporting requirements without reference to interstate commerce); id. 331(p) (prohibiting the failure to register a device establishment without reference to interstate commerce); id. 331(q)(1) (prohibiting the failure to comply with device investigational-use requirements without reference to interstate commerce); id. 331(fff)(3) (prohibiting the doing of any act which causes a device to be a counterfeit device, or the sale or dispensing, or holding for sale or dispensing, of a counterfeit device without reference to interstate commerce); see generally United States v. Walsh, 331 U.S. 432, 434-36 (1947) (finding no interstate commerce element to 21 U.S.C. 331(h), which prohibits false guaranties) (“[21 U.S.C. 331(a)] is directed to illegal interstate shipments, while [21 U.S.C. 331(h)] is directed to the giving of false guaranties”).) If an FD&C Act provision does not contain an interstate commerce element, “interstate commerce” imposes no limit on FDA's powers beyond the constitutional minimum. For devices, the FD&C Act imposes obligations even where there is no interstate commerce element and likewise gives FDA authority to take action when there is a violation of those obligations. Thus, FDA does not, for example, somehow lose jurisdiction if a particular device has not been “introduced” into interstate commerce.

In fact, Congress intentionally revised a provision of the FD&C Act to ensure that FDA could take action against devices without satisfying any particular interstate commerce element. In the MDA, Congress revised the seizure provisions in section 304 of the FD&C Act to “permit seizure of devices without reference to interstate commerce” because the previous interstate commerce requirement “ha[d] been a burden to the effective enforcement of existing authorities” and “whether or not a medical device actually crosses state lines has nothing to do with the principal intent of this proposal: to assure the safety and effectiveness of medical devices.” (H.R. Rep. 94-853 at 15; see 21 U.S.C. 334(a)(2).) In other words, Congress recognized that the interstate commerce element in this provision did not advance the goals of the MDA. Consistent with that view, the FD&C Act grants FDA wide-ranging authority over devices, including IVDs, and that general authority does not turn on a connection with interstate commerce above the constitutional minimum.

In addition, one of the key prohibited acts on which FDA relies, section 301(k) of the FD&C Act (21 U.S.C. 331(k)), contains an interstate commerce element, but applies even when a problematic device has not been introduced in interstate commerce. That provision prohibits “the doing of any . . . act with respect to[ ] a . . . device . . . if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.” Courts have held that even if a product is wholly manufactured and sold intrastate, the interstate commerce element is satisfied if the components used in manufacturing the product have traveled in interstate commerce. (See United States v. Regenerative Sciences, 741 F.3d at 1320-21 (upholding FDA enforcement action under 331(k) because a drug component had traveled in interstate commerce); Baker v. United States, 932 F.2d 813, 815 (9th Cir. 1991); United States v. Dianovin Pharm., Inc., 475 F.2d 100, 102 (1st Cir. 1973).) At least some components of test systems, such as general purpose reagents, ASRs, instruments, and collection devices, are usually shipped in interstate commerce even if the system itself is designed, manufactured, and used solely in the laboratory ( i.e., intrastate). And section 709 of the FD&C Act (21 U.S.C. 379a) establishes a presumption of interstate commerce in enforcement actions, meaning that the burden is on regulated parties to demonstrate, for example, that no component of a system traveled across State lines. (“In any action to enforce the requirements of this Act respecting a device . . . the connection with interstate commerce . . . shall be presumed to exist.”).

Some commentators have cited the interstate commerce element in section 510(k) of the FD&C Act to raise questions about FDA's authority over LDTs. Section 510(k) provides that a person who is required to register and “proposes to begin the introduction or delivery for introduction into interstate commerce” of a device “shall” submit a premarket notification. Under this line of argument, laboratories that design, manufacture, and use an IVD in a single laboratory are not proposing to introduce their IVD into interstate commerce, and therefore section 510(k) does not apply to them. That argument, however, does not lead to the conclusion that FDA lacks jurisdiction over LDTs or that none of the FD&C Act requirements apply to LDTs. It would mean only that section 510(k) does not apply. And if accepted, the only practical consequence of that assertion would be that affected laboratories are subject to more burdensome requirements under the FD&C Act.

In particular, if section 510(k) is construed to mean that such IVDs are not eligible for the premarket notification pathway, that would only mean that those IVDs (unless they are 510(k)-exempt, in which case section 510(k) would not apply anyway, or are for investigational use) would be forced into the more rigorous review pathways of premarket approval or authorization through the De Novo pathway. That is because under section 513(f)(l) of the FD&C Act, a postamendments device, i.e., a device that was “not introduced or delivered for introduction into interstate commerce for commercial distribution before [May 28, 1976],” is a class III device by operation of law (21 U.S.C. 360c(f)(1)). If such a device cannot be found to be substantially equivalent through the premarket notification pathway, it must either have an approved PMA (21 U.S.C. 360e(a)), or be reclassified and gain authorization through a pathway such as the De Novo process (21 U.S.C. 360c(f)(2)(A)(ii)). Thus, under this theory, laboratories would not escape FDA regulation—they would face heavier regulation. However, because section 510(k) does not, in fact, preclude regulated entities from submitting premarket notifications even assuming their devices are not introduced into interstate commerce, and because laboratories have every incentive to take the less burdensome path to market of 510(k) notification, the 510(k) pathway should play the same role in device reclassification (21 U.S.C. 360c(f)) for IVDs offered as LDTs as for any other device. Regardless, the inclusion of an interstate commerce element in section 510(k) in no way affects FDA's overall authority to regulate IVDs manufactured by laboratories.

b. Commercial distribution. The phrase “for commercial distribution” also appears in various device provisions of the FD&C Act, and some commentators have asserted that this phrase, too, signals that FDA lacks authority over LDTs. For example, they point to the 510(k) premarket notification requirement, which is triggered when a person who is required to register “proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use” (21 U.S.C. 360(k)). As with “interstate commerce,” the presence of this phrase in that provision and certain other specific device provisions does not bear on the Agency's overall jurisdiction. Furthermore, LDTs are for commercial distribution, so the presence of the phrase does not change the operation of those provisions with respect to these IVDs.

Under our longstanding, judicially endorsed interpretation, “commercial distribution” does not require the physical transfer of an object, as some commentators have argued. Instead, the legislative history, FDA's near-contemporaneous regulation, and at least one judicial decision reflect that the phrase “commercial distribution” means “on the market.” A House Report issued 3 months before enactment of the MDA contains an unusually clear statement of the intended meaning of the phrase: “`Commercial distribution' is the functional equivalent of the popular phrase `on the market.' ” (H.R. Rep. No. 94-853 at 36) FDA's regulations implementing the registration, listing, and 510(k) provisions, which were finalized in 1977 (soon after enactment of the MDA), similarly define commercial distribution as “any distribution of a device intended for human use which is held or offered for sale.” (21 CFR 807.3(b)) In the preambles to the proposed and final rule, FDA equated the term with the phrase “on the market” (41 FR 37458 at 37459 (September 3, 1976); 42 FR 42520 at 42524 (August 23, 1977)). A court has also endorsed this interpretation of the term ( United States v. An Article of Device Consisting of 1,217 Cardboard Boxes, 607 F. Supp. 990, 994-95 (W.D. Mich. 1985) (giving deference to FDA's reasonable interpretation of “commercial distribution” to mean, “in its popular sense, `on the market' ”)). These sources show that the term does not relate to physical movement, and because IVDs manufactured by laboratories (including LDTs) generally are “on the market,” they are for commercial distribution.

Based on the considerations set forth in this preamble, FDA is proposing to end the general enforcement discretion approach for LDTs. However, FDA also recognizes that many IVDs manufactured by laboratories are currently being marketed as LDTs, and that a sudden change could negatively affect the public, including patients and industry. In particular, FDA understands that the healthcare community and patients have been using these IVDs, and that coming into compliance will take time for manufacturers. FDA also recognizes that we should consider Agency resources. For additional information regarding the estimated costs associated with this rulemaking, see the Preliminary Economic Analysis of Impacts (Ref. 34).

To achieve greater oversight in a manner that accounts for the various considerations, FDA is proposing to gradually end its general enforcement discretion approach in stages, as described below (hereinafter “the phaseout policy”). FDA's intent is that, following a 4-year phaseout period, IVDs offered as LDTs generally would be expected to meet applicable requirements.

Although FDA is proposing to gradually end its current general enforcement discretion approach over a period of years, the phaseout policy does not in any way alter the fact that it is illegal to offer IVDs without complying with applicable requirements. Regardless of the phaseout timeline and continued enforcement discretion approach for certain IVDs discussed below, FDA retains discretion to pursue enforcement action at any time against violative IVDs when appropriate.

Moreover, FDA has adopted and intends to continue adopting enforcement discretion policies for certain types of IVDs in certain circumstances, as appropriate. For example, FDA issued guidance documents with enforcement discretion policies for certain COVID-19 and Mpox tests at the beginning of each declared emergency (as described further below), and intends to issue a draft guidance with an enforcement policy for IVDs for emerging outbreaks offered prior to FDA review to address the immediate public health need. FDA will seek public comment on such draft guidance in accordance with good guidance practices (see 21 CFR 10.115).

With this notice of proposed rulemaking, FDA seeks public comment on whether specific enforcement discretion policies would be appropriate for IVDs offered as LDTs for other public health scenarios. If so, please provide a description of those scenarios, an explanation of why enforcement discretion policies with respect to those scenarios would be appropriate, and any relevant evidence to support such policies. FDA would also appreciate public comment on what, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.) and what steps could be taken to mitigate those consequences.

FDA's proposed phaseout policy, including the scope and phaseout timeline, is set forth below.

While FDA's general enforcement discretion approach has been focused on LDTs, FDA is proposing a broader scope for the phaseout policy. Specifically, FDA is proposing to apply the phaseout policy to IVDs that are manufactured and offered as LDTs by laboratories that are certified under CLIA and that meet the regulatory requirements under CLIA to perform high complexity testing, 15 even if those IVDs do not fall within FDA's traditional understanding of an LDT because they are not designed, manufactured, and used within a single laboratory. 16 Throughout this preamble, these IVDs are referred to as “IVDs offered as LDTs.” FDA is proposing this scope because it recognizes that not all laboratories have understood the limited nature of FDA's general enforcement discretion approach and have been offering IVDs based on the approach even when they do not fit what FDA generally considers to be an LDT. As previously discussed, FDA has made a preliminary determination to structure the phaseout in a way that avoids undue disruption to the testing market. This is important even for certain IVDs currently on the market that do not fall within the scope of FDA's general enforcement discretion approach.

Although FDA is proposing this broader scope for the phaseout policy, it does not intend to sweep in certain tests that were excluded from the general enforcement discretion approach, as reflected in compliance patterns, multiple public FDA actions and communications, or both. These tests are:

1. Tests that are intended as blood donor screening or human cells, tissues, and cellular and tissue-based products (HCT/Ps) donor screening tests required for infectious disease testing under 21 CFR 610.40 and 1271.80(c), respectively, or for determination of blood group and Rh factors required under 21 CFR 640.5. Under the cited regulations, a blood or HCT/P establishment must not use a test for the purposes listed here unless the test is licensed, approved, or cleared by FDA for such use. Blood and HCT/P establishments must register with FDA and are subject to FDA inspection (see 21 CFR parts 207, 607, 807 and 1271). FDA's general enforcement discretion approach for LDTs has never applied to these tests because these tests are a critical part of the overall process of ensuring the safety of blood and blood components and HCT/Ps by preventing infectious disease transmission and incompatible blood transfusions which can have life-threatening consequences. Based on FDA experience, establishments have been generally complying with these requirements (see, e.g., Refs. 66 and 67).

2. Tests intended for emergencies, potential emergencies, or material threats declared under section 564 of the FD&C Act. After all previous declarations under section 564(b), FDA has generally expected LDTs to comply with applicable requirements in the FD&C Act and FDA regulations. FDA's general enforcement discretion approach has not applied to these tests because of the significant risk posed by the disease (as signified by the unusual step of issuing a declaration) and because false results can have serious implications for disease progression and public health decision-making, in addition to the individual patient's care. As it has done in other areas, FDA has adopted (and may continue to adopt) specific enforcement discretion policies for such tests (see, e.g., Refs. 51 and 52). In addition, consistent with the Government Accountability Office's 2022 recommendation that “FDA should develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies,” FDA intends to issue guidance on factors to consider in adopting such enforcement discretion policies (Ref. 68). FDA has communicated its expectations regarding tests for emergency use in guidance and elsewhere, including “It has come to our attention” letters posted on FDA's website and other public communications (see, e.g., Refs. 51 to 54, 69, and 70).

3. Direct-to-consumer tests. FDA's general enforcement discretion approach has not applied to tests intended for consumer use (without meaningful involvement by a licensed healthcare professional), given the greater risks to patients presented by these tests (see, e.g., Refs. 48, 55, and 71 to 75). FDA's enforcement discretion approach for LDTs was originally premised, in part, on the participation of medical professionals to help determine whether a particular test was appropriate, counsel patients on the significance and limitations of a test, assist in interpreting results, assess how the results fit in the overall clinical picture, and consider next steps. When patients order tests, receive results, and make decisions (such as a decision to stop medication) without this expert intermediary, there is a heightened need for FDA oversight.

For these categories of tests, FDA has generally expected applicable requirements to be met, and we are not proposing to change that approach.

FDA notes that the manufacturing of test components outside of a laboratory—for example, when the same entity owns both the laboratory and a manufacturing facility separate from the laboratory—does not fall within FDA's general enforcement discretion approach. FDA's approach has long been specific to laboratory development ( e.g., 61 FR 10484 (“ in-house developed tests have not been actively regulated by the Agency”) (emphasis added); Ref. 48 (describing an LDT as an IVD that is “designed, manufactured, and used within a single laboratory”). The proposed phaseout policy would not change FDA's longstanding expectation that IVD manufacturing activities occurring outside of a CLIA-certified laboratory comply with applicable device requirements.

In addition, for certain categories of tests manufactured by laboratories, FDA is proposing to continue to apply the current general enforcement discretion approach going forward. One such category of tests is referred to in this preamble as “1976-Type LDTs.” Such tests have the following characteristics common among LDTs offered in 1976: use of manual techniques (without automation) performed by laboratory personnel with specialized expertise; use of components legally marketed for clinical use; and design, manufacture, and use within a single CLIA-certified laboratory that meets the requirements under CLIA for high complexity testing. The characteristics associated with LDTs offered in 1976 resulted in the emergence of FDA's general enforcement discretion approach for LDTs, and the specific characteristics listed above provide the greatest risk mitigation among the characteristics that were commonly associated with LDTs offered in 1976 (discussed in section III.A). Based on changes to the LDT landscape since 1976, the risks associated with most modern LDTs are generally much greater today than they were in 1976; however, for tests that share the characteristics listed above, FDA has made a preliminary determination that the risks are sufficiently mitigated such that FDA's general enforcement discretion approach for LDTs should continue to apply. These tests might include, for example, immunohistochemistry tests that involve no automated preparation or interpretation, but would not include, for example, lateral flow tests, as they do not generally rely on laboratory personnel expertise.

FDA is also proposing to continue to apply the general enforcement discretion approach to Human Leukocyte Antigen (HLA) tests that are designed, manufactured, and used in a single laboratory certified under CLIA that meets the requirements to perform high-complexity histocompatibility testing when used in connection with organ, stem cell, and tissue transplantation to perform HLA allele typing, for HLA antibody screening and monitoring, or for conducting real and “virtual” HLA crossmatch tests. FDA has made a preliminary determination that HLA LDTs for transplantation used in histocompatibility laboratories that meet the regulatory requirements under CLIA to perform high complexity testing, when used in connection with organ, stem cell, and tissue transplantation for certain purposes as described in this paragraph, are unique in that they are generally developed, and the testing is generally performed, in urgent, life-saving situations for the patient. Physicians must often make prompt decisions about transplantation based on medical judgment regarding their patient's condition and degree of mismatch between the donor and patient should an organ, stem cells, or tissue become available. Further, these tests are often individualized within each medical facility, for example, they include reagents that reflect local HLA polymorphisms and patient demographics. Note that the general enforcement discretion approach does not apply to HLA tests used for blood transfusion as such tests are highly standardized across institutions; FDA intends to continue to enforce applicable requirements for HLA tests used for blood transfusion.

FDA also intends to maintain its longstanding enforcement discretion approach for tests intended solely for forensic (law enforcement) purposes. This approach has been in place for over 20 years and applies to such tests regardless of whether they are offered as an LDT. See, e.g., 65 FR 18230 (April 7, 2000). Tests used in the law enforcement setting are subject to protections and requirements associated with the judicial process that mitigate risk related to test accuracy and sample collection and that generally are not available in the home, workplace, insurance, and sports settings. These protections include the use of rules of evidence in judicial proceedings and legal representation of the accused ( i.e., the person being tested) through the judicial process during which the accuracy of the test may be raised during the adjudication. We seek comment on any implications of continued enforcement discretion with regard to LDTs used for law enforcement purposes and any factors that FDA should consider—particularly as it relates to civil rights and equity—related to the scientific validity and accuracy of these tests.

In addition, tests exclusively used for public health surveillance are distinct from other tests where: (1) they are intended solely for use on systematically collected samples for analysis and interpretation of health data in connection with disease prevention and control, and (2) test results are not reported to patients or their healthcare providers. These tests would not be affected by the phaseout policy. The results of these tests are generally used for trending on a population basis. Public health authorities also have access to test results from non-surveillance tests that are FDA approved, cleared, or authorized and that are reported under State reporting laws for infectious and other diseases. In addition, during a public health emergency, if there was a 564 declaration (as there was for past public health emergencies), FDA could require test result reporting to public health authorities under emergency use authorizations, as appropriate.

In 2017, FDA indicated support for less oversight of other categories of tests, such as low-risk tests (class I devices), tests currently on the market, and tests for rare diseases. However, FDA has accumulated information in the intervening years that suggests we should treat these categories of tests similarly to other FDA-regulated tests. For example, as discussed above in section III.B, FDA has gained additional information showing that there is a high variability in the performance of IVDs offered as LDTs that are currently on the market, including in circumstances where the test technology is relatively simple and well-understood, where the tests are for rare diseases, and where the tests are low risk. Among other things, FDA's recent experience with tests for COVID-19 suggests that many tests manufactured by laboratories are not appropriately validated. Compliance with premarket review requirements (when applicable), QS requirements, and registration and listing requirements would help assure that these IVDs work as intended, enable FDA to keep track of IVDs offered as LDTs (and, for example, help FDA locate IVDs that are raising concerns or independently evaluate the risk status of marketed IVDs), assist with FDA's inspection and planning efforts, and make information available to patients and healthcare providers that may inform the selection of particular IVDs for use. Therefore, FDA is now proposing to end the general enforcement discretion approach, via a phaseout approach, with respect to premarket review requirements (as applicable), QS requirements, and registration and listing requirements for these tests, in addition to medical device reporting (MDR) requirements ( i.e., reporting of adverse events), correction and removal reporting requirements, and other requirements applicable to such tests. Based on the information available at this time, FDA has made a preliminary determination that this proposal appropriately balances the relevant considerations with respect to these tests, including currently marketed IVDs offered as LDTs.

However, FDA expects that some stakeholders will suggest that FDA continue to maintain the current general enforcement discretion approach with respect to premarket review and some or all QS requirements for currently marketed LDTs or a subset of currently marketed LDTs ( i.e., what some previously referred to as “grandfathering”). To the extent commenters suggest such an approach for FDA's consideration, FDA requests information to support such an approach, including the following:

• Given the information in the “Need for the Rule” section of this preamble in particular, what would be the public health rationale for generally exercising enforcement discretion with respect to premarket review and some or all QS requirements, for LDTs that are being offered as of the date of issuance of this proposed rule and are not changed with respect to indications for use or performance after that date? Please provide data to support such an approach. Also, if you think there are steps that might help support such an approach, including ideas that might help to address the public health concerns discussed in the “Need for the Rule” section, please describe them, and include a rationale and any supporting evidence.

• If commenters suggest maintaining the general enforcement discretion approach with respect to premarket review and QS requirements for a subset of LDTs ( e.g., low and moderate risk LDTs) currently on the market that are being offered as of the date of issuance of this proposed rule and are not changed with respect to indications for use or performance after that date, what would be the public health rationale to support such an approach? Please provide any data supporting such an approach. Also, if you think there are steps that might help support such an approach, including ideas that might help to address the public health concerns discussed in the “Need for the Rule” section, please describe them and include a rationale and any supporting evidence.

FDA recognizes that the phaseout of the general enforcement discretion approach described in this section may have a relatively greater impact on small laboratories. Therefore, FDA seeks comment on the following:

• Is there a public health rationale to have a longer phaseout period for IVDs offered as LDTs by laboratories with annual receipts below a certain threshold ( e.g., $150,000) (see Table 43 in the Preliminary Economic Analysis of Impacts (Ref. 34))? If so, please provide relevant data and comment specifically on an alternative recommended timeline.

In addition, FDA is aware that some AMCs have claimed that their laboratories operate under unique circumstances (such as being integrated into direct patient care) and therefore their tests should be treated differently than tests manufactured by other laboratories. Although FDA is not aware of an established definition of an AMC laboratory, one possible description is: a laboratory for which a certificate is in effect under CLIA and that meets the requirements under CLIA to perform tests of high-complexity; that is part of an accredited public or nonprofit private AMC that has a medical residency training program or fellowship program related to test development, application, and interpretation; and that is integrated into the direct medical care for a patient, including specimen collection, testing, interaction with the treating provider, and, as appropriate, patient treatment based on the test, all at the same physical location. FDA seeks comments on the following:

• What are the characteristics of AMC laboratories? Do the characteristics included above accurately describe AMC laboratories and in fact distinguish them from other laboratories?

• Should FDA continue the general enforcement discretion approach with respect to any requirements, such as premarket review requirements, for tests manufactured by AMC laboratories?

• If FDA should continue the general enforcement discretion approach with respect to any requirements, such as premarket review requirements, for tests manufactured by AMC laboratories, are there any additional considerations that should be taken into account with respect to this approach, for example, whether an FDA cleared or approved test is available for the same intended use as the test manufactured by an AMC laboratory? Please provide a rationale and other information ( e.g., data) to support any additional considerations.

• If FDA should have a different policy for AMC laboratories, what would be the public health rationale to support such a policy? For example, if integration of an AMC laboratory into direct patient care is included as a basis for a different policy, please include a public health rationale when explaining why and how such integration supports the different policy, and how integration could ensure that there is a reasonable assurance of IVD safety and effectiveness.

• If FDA should have a different policy for AMC laboratories, is there evidence to support such a policy?

FDA also is interested in and seeks comment on leveraging programs such as the New York State Department of Health Clinical Laboratory Evaluation Program (NYSDOH CLEP) or those within the Veterans Health Administration (VHA), as appropriate. In particular, FDA requests comment on whether it may be appropriate to continue the general enforcement discretion approach, such that FDA generally would not enforce any applicable device requirements, where outside programs can be leveraged. If FDA should continue to exercise enforcement discretion under these circumstances:

• What specific characteristics of and activities within these programs justify such an approach?

• Should the scope of such a policy be more limited for each program in question? For example, should FDA continue enforcement discretion for premarket review requirements and intend to enforce other requirements, such as reporting adverse events?

• Are there any additional considerations that should be taken into account?

Please provide a rationale and other information ( e.g., data) to support any suggestions.

As previously discussed, FDA is proposing to gradually phase out its current general enforcement discretion approach so that most IVDs offered as LDTs would generally fall under the same enforcement approach as other IVDs. In developing the proposed phaseout policy, FDA has considered a number of factors, including the public health importance of better assuring the safety and effectiveness of IVDs offered as LDTs, the desire to avoid undue disruption to the testing market, the time it may take for laboratories to come into compliance with FDA requirements, the need for adequate resources to implement the phaseout policy in a manner that does not undermine reasonable expectations with regards to premarket review timing (per the Medical Device User Fee Amendments (MDUFA) V agreement), and the benefits of a relatively simple policy that can be easily understood and implemented. Keeping these factors in mind, FDA has structured the phaseout policy to contain five key stages:

• Stage 1: End the general enforcement discretion approach with respect to MDR requirements and correction and removal reporting requirements 1 year after FDA publishes a final phaseout policy, which FDA intends to issue in the preamble of the final rule.

• Stage 2: End the general enforcement discretion approach with respect to requirements other than MDR, correction and removal reporting, QS, and premarket review requirements 2 years after FDA publishes a final phaseout policy.

• Stage 3: End the general enforcement discretion approach with respect to QS requirements 3 years after FDA publishes a final phaseout policy.

• Stage 4: End the general enforcement discretion approach with respect to premarket review requirements for high-risk IVDs 3 1/2 years after FDA publishes a final phaseout policy, but not before October 1, 2027.

• Stage 5: End the general enforcement discretion approach with respect to premarket review requirements for moderate risk and low risk IVDs (that require premarket submissions) 4 years after FDA publishes a final phaseout policy, but not before April 1, 2028.

Each of these stages is discussed in further detail below. For each stage, FDA is proposing a period of time for laboratories to come into compliance before FDA intends to end the general enforcement discretion approach. FDA encourages laboratory manufacturers to begin early and work toward compliance with requirements sooner than the end of the specified timeframes. FDA also intends to consider providing more targeted guidance and/or making additional resources available on specific topics, such as compliance with applicable labeling requirements, over the course of the phaseout period.

1. Stage 1: End the general enforcement discretion approach with respect to MDR requirements and correction and removal reporting requirements 1 year after FDA publishes a final phaseout policy.

FDA has structured the phaseout policy to obtain information about potentially harmful IVDs offered as LDTs as soon as feasible. As detailed elsewhere in this preamble, FDA is concerned that some of the IVDs offered as LDTs may be posing risks to patients. Therefore, FDA is prioritizing the phaseout of the general enforcement discretion approach for requirements that would help FDA identify and monitor significant issues with IVDs offered as LDTs, consistent with other considerations described in this proposed policy.

Enforcement of the MDR requirements under 21 U.S.C. 360i(a) through (c) and 21 CFR part 803, in particular, would enable FDA to systematically monitor significant adverse events to identify problematic IVDs offered as LDTs, such as those with poor performance or other safety issues. FDA has made a preliminary determination that gathering this information is important for IVDs that do not have the safeguards associated with compliance with other FDA requirements, such as manufacturing under QS requirements or confirmation of analytical and clinical validity through premarket review.

For similar reasons, FDA is prioritizing the collection of information about when a manufacturer has initiated a correction or removal of its IVD to reduce a risk to health or to remedy a violation of the FD&C Act that may present a risk to health. Under 21 U.S.C. 360i(g) and part 806 (21 CFR part 806), manufacturers are required to report such corrections or removals to FDA, and FDA intends to phase out the general enforcement discretion approach for these requirements at the same time it does so for MDR requirements. Because FDA intends for the phaseout of the general enforcement discretion approach with respect to correction and removal reporting requirements to occur before phaseout of the general enforcement discretion approach with respect to registration and listing requirements, FDA intends to exercise enforcement discretion, such that it generally does not intend to enforce, the requirement to use the establishment registration number on such reports (21 CFR 806.10) when laboratories use their CLIA certificate number instead prior to registering.

FDA's proposal to phase out enforcement discretion for MDR requirements within 1 year after finalization of the policy is informed by comments FDA received in response to the draft guidance documents that FDA issued in 2014 proposing to implement an oversight framework for IVDs offered as LDTs. In 2014, FDA proposed a 6-month timeline for laboratory compliance with MDR requirements (Ref. 48), and we received comments suggesting that a longer period may be appropriate for the establishment of a system to identify, review, and report adverse events. Based in part on those comments, FDA is now proposing a 1-year time period for laboratories to come into compliance with the MDR requirements. In conjunction with the phaseout of the general enforcement discretion approach with respect to the MDR requirements, FDA is also proposing to end the general enforcement discretion approach with respect to the requirements of part 806, concerning reports of corrections and removals. Because MDRs frequently are a basis for corrections and removals, FDA views these requirements as working together to provide information to FDA about issues with device performance or quality. We anticipate that this 1-year time period is adequate, particularly given that laboratories should already have some processes in place for detecting problems with their IVDs to comply with CLIA regulations.

2. Stage 2: End the general enforcement discretion approach with respect to requirements not covered during other stages of the phaseout policy 2 years after FDA publishes a final phaseout policy.

FDA is proposing to end the general enforcement discretion approach for requirements besides MDR, correction and removal reporting, QS, and premarket review requirements 2 years after the final policy is published. These other requirements include registration and listing requirements under 21 U.S.C. 360 and part 807 (excluding subpart E); labeling requirements under 21 U.S.C. 352 and parts 801 and 809, subpart B; and investigational use requirements under 21 U.S.C. 360j(g) and part 812. We have included compliance with investigational use requirements at this stage, in recognition that there has been some confusion about our enforcement approach in this area. Our understanding is that laboratories often are not complying with investigational use requirements currently, even though FDA has generally expected compliance with these requirements. 17 We are therefore including these requirements in the phaseout policy.

FDA recognizes that this proposal is different from FDA's prior statements in the 2017 Discussion Paper regarding oversight of IVDs manufactured by laboratories with respect to certain requirements, for which the timing of FDA's expectations for compliance generally depended on the type of premarket review applicable to the device. However, upon review, FDA anticipates that it would better serve the public health and be simpler to phase out the general enforcement discretion approach for these requirements at the 2-year mark. For example, under this timeline, laboratories could work toward compliance with the stage 2 requirements without necessarily determining the risk category of their IVDs until later stages of the proposed phaseout policy. Another advantage of this timeline is that FDA would obtain registration and listing information before the enforcement discretion phaseout date for premarket review requirements, which could give the Agency an initial understanding of the universe of IVDs offered as LDTs to facilitate premarket review of those IVDs. Based on its experience, FDA anticipates that 2 years is adequate time to come into compliance with the various requirements.

3. Stage 3: End the general enforcement discretion approach with respect to QS requirements 3 years after FDA publishes a final phaseout policy.

At the 3-year mark, FDA would expect compliance with the device CGMP requirements of the QS requirements under 21 U.S.C. 360j(f) and part 820 (21 CFR part 820). However, for IVDs for which all manufacturing activities occur within a single CLIA-certified laboratory that meets the regulatory requirements to perform high complexity testing and for which distribution of the IVD does not occur outside that single laboratory, FDA would expect compliance at the 3-year mark with some, but not all, of the QS requirements. Although FDA and CMS regulation are different and complementary, compliance with CLIA requirements provides some quality assurances that may be relevant to laboratories' manufacturing practices. In particular, laboratories may in practice be able to apply concepts set forth under CLIA requirements for laboratory operations to manufacturing activities regulated by FDA. For FDA to effectively leverage the CLIA assurances, this proposed approach would apply only when all manufacturing activities occur within a single laboratory and the IVD is not distributed outside that laboratory. However, even in the context of this approach, there are certain QS requirements for which CLIA regulations do not provide the assurances that FDA requirements would provide. These requirements include design controls under 21 CFR 820.30; purchasing controls (including supplier controls) under 21 CFR 820.50; acceptance activities (receiving, in-process, and finished device acceptance) under 21 CFR 820.80 and 21 CFR 820.86; corrective and preventative actions (CAPA) under 21 CFR 820.100; and records requirements under part 820, subpart M. Because CLIA does not provide assurances relevant to these requirements, FDA is proposing to end the general enforcement discretion approach for these specific requirements for IVDs for which all manufacturing activities occur within a single CLIA-certified laboratory that meets the regulatory requirements to perform high complexity testing, and which are not distributed outside that laboratory, 3 years after finalizing this policy. For all other IVDs offered as LDTs and subject to this phaseout policy, FDA is proposing to end the general enforcement discretion approach for all QS requirements 3 years after finalizing this policy.

Based on its experience, FDA anticipates that 3 years is adequate time for laboratories to come into compliance with QS requirements. In addition, based on the discussion above regarding concerns with the quality and validation of IVDs offered as LDTs, FDA has made a preliminary determination that phasing out the general enforcement discretion approach for QS requirements later than 3 years would not be in the best interest of the public health. Compliance with QS requirements is critical to the quality and validity of IVDs offered as LDTs. For example, under the design controls of the QS requirements, laboratories would, among other things, generally have better procedures for validating the design of their tests, which would help to ensure that they are analytically and clinically valid (see Ref. 76).

FDA also notes that on February 23, 2022, FDA proposed to amend the device QS regulation, part 820, to align more closely with international consensus standards for devices (87 FR 10119). As stated in that proposed rule, the requirements, if finalized, would be substantially similar to the requirements of the current part 820, providing a similar level of assurance in a firm's quality management system, and FDA intends for this phaseout policy to apply with respect to any regulations promulgated through that rulemaking.

FDA intends to finalize amendments to the QS regulation expeditiously, such that the amended QS requirements would be in effect before the proposed beginning of stage 3. Upon the start of stage 3, or if the laboratory complies with QS requirements prior to the start of stage 3, FDA would expect compliance with the QS requirements that are in effect at that time. For further information on the QS requirements that would be established pursuant to the amendments to the QS regulation, if finalized as proposed, please refer to the proposed codified at 87 FR 10119 at 10133 and 10134. Notably, the requirements relating to design controls, purchasing controls, acceptance activities, CAPA, and records requirements are set forth in the following ISO 13485 clauses as modified by the proposed codified for part 820: Clause 4. Quality Management System, Subclause 4.2.5; Clause 6. Resource Management; Clause 7. Product Realization, Subclause 7.1, Subclause 7.3, Subclause 7.4, and Subclause 7.4.3; and Clause 8. Measurement, Analysis, & Improvement, Subclause 8.2.5, Subclause 8.2.6, and Subclause 8.3.

In addition, FDA notes that under section 515(d)(2) of the FD&C Act, the Agency may not approve a PMA if the applicant fails to demonstrate conformity with the QS requirements. Therefore, compliance with the QS requirements is needed to support approval of a PMA. As provided in section 520(f)(2) of the FD&C Act, any person subject to the QS requirements may petition for an exemption or variance from any QS requirement (see also 21 CFR 820.1).

4. Stage 4: End the general enforcement discretion approach with respect to premarket review requirements for high-risk IVDs 3 1/2 years after FDA publishes a final phaseout policy, but not before October 1, 2027.

FDA proposes that the phaseout date for the general enforcement discretion approach with respect to premarket review requirements for high-risk IVDs offered as LDTs (IVDs that may be eligible for classification into class III) should occur 3 1/2 years from the time that FDA issues a final phaseout policy. The premarket review requirements are set forth in 21 U.S.C. 360e and 21 CFR part 814. FDA is proposing this time period because it is mindful that phasing out the general enforcement discretion approach on a timeline that is too short could cause undue disruption in the testing market. Among other things, we anticipate that 3 1/2 years would provide sufficient notice and opportunity for laboratories manufacturing IVDs to plan for and prepare PMAs and would appropriately account for any reliance interests. We note that 3 1/2 years is a longer time period than was discussed in either the 2014 draft guidance documents or the 2017 Discussion Paper for the phaseout of the general enforcement discretion approach for premarket review requirements.

This timeline is also intended to align the phaseout date for the general enforcement discretion approach for premarket review requirements for high-risk IVDs offered as LDTs with the start of fiscal year 2028, which coincides with the beginning of a new user fee cycle. This alignment would provide an opportunity for industry participation in negotiations regarding the next user fee cycle with the knowledge that laboratory manufacturers would be expected to comply with premarket review requirements. (Although a trade association representing laboratories previously has participated in MDUFA negotiations, the prior negotiations have not incorporated similar expectations regarding laboratory compliance with premarket requirements.) Thus, we propose that this amount of time is appropriate to foster stability and consistency in the marketplace for the current MDUFA cycle, and would take into account the need for adequate FDA resources to implement the phaseout policy in a manner that does not compromise the capacity to achieve MDUFA V performance expectations. FDA anticipates that during this 3 1/2 -year period, laboratories would work with FDA to determine whether PMAs should be submitted for their IVDs.

Under FDA's proposed policy, FDA generally would not intend to enforce against IVDs offered as LDTs after a PMA has been submitted (within the 3 1/2 -year timeframe) until FDA completes its review of the application. Given that such IVDs may already be on the market and available to patients, FDA generally does not intend to interrupt access at the point when a submission is made.

Finally, FDA recognizes that the 2017 Discussion Paper described a possible premarket-review approach specific to LDTs for unmet needs. FDA has not included such an approach in this proposed policy because we anticipate that the 3 1/2 -year timeframe should be sufficient for laboratories to meet premarket review requirements for each of their marketed IVDs, as applicable, including IVDs for unmet needs. FDA also anticipates that programs currently in place may facilitate the development and premarket authorization of IVDs for unmet needs. These programs include the Humanitarian Use Devices (HUD)/Humanitarian Device Exemption (HDE) program, 18 which, among other things, provides an exemption from the requirement to establish a reasonable assurance of effectiveness for devices intended for use in the treatment or diagnosis of rare diseases or conditions (21 U.S.C. 360j(m); 21 CFR part 814, subpart H), and the Breakthrough Devices program, which is intended to help expedite the development and review of certain devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions (21 U.S.C. 360e-3).

FDA is proposing to end the general enforcement discretion approach with respect to premarket review requirements for moderate risk IVDs offered as LDTs (IVDs that may be eligible for classification into class II) and low risk IVDs offered as LDTs (IVDs that may be eligible for classification into class I) that require a premarket submission 4 years after FDA publishes the final phaseout policy. These premarket submissions include 510(k) submissions, the requirements for which are set forth at 21 U.S.C. 360(k), 360c(i), and part 807, subpart E. These submissions also include De Novo requests, which laboratories may submit for IVDs offered as LDTs for which there is no legally marketed device upon which to base a determination of substantial equivalence, and for which the laboratory seeks classification into class I or class II. These requirements are set forth at 21 U.S.C. 360c(f)(2) and 21 CFR part 860, subpart D.

FDA intends this stage to begin no earlier than April 1, 2028. FDA's reasons for proposing this time period to phase out the general enforcement discretion approach with respect to premarket review requirements for moderate risk and low risk IVDs offered as LDTs are similar to those for the “stage 4” time period, except that FDA has lengthened the time period by 6 months in order to prioritize the review of applications for high-risk IVDs offered as LDTs (subject to premarket approval requirements), so that FDA can focus first on IVDs for which the consequences of a false result are most significant. FDA also recognizes that a greater number of IVDs are subject to the 510(k) requirements, as compared with premarket approval requirements, so a longer period of time for laboratories to come into compliance with these requirements may be appropriate, particularly for laboratories with large test menus.

FDA generally would not intend to enforce against IVDs offered as LDTs after a 510(k) or De Novo request has been submitted (within the 4-year timeframe) until FDA completes its review of the submission.

FDA also anticipates that laboratories may seek to utilize FDA's Third Party review program. FDA currently operates a Third Party review program for medical devices, and multiple organizations are accredited to conduct reviews of 510(k) submissions for certain IVDs (see Ref. 77). We anticipate interest in the Third Party review program among test manufacturers, as well as potential new Third Party review organizations. In particular, FDA is aware of certain CLIA accreditation organizations that may be interested in potentially becoming Third Party reviewers under FDA's program, and to the extent laboratories are already familiar with these organizations, laboratories may be inclined to use the Third Party review program. In addition, under the MDUFA V agreement, FDA is currently working to enhance the Third Party review program, which may make it more attractive to manufacturers including laboratories.

The Agency proposes that any final rule based on this proposed rule will become effective 60 days after the date of publication of the final rule in the Federal Register .

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 14094, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866 Section 3(f)(1) (as amended by Executive Order 14094) if they “have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of [the Office of Information and Regulatory Affairs (OIRA)] for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” OIRA has determined that this proposed rule is a significant regulatory action under Executive Order 12866 Section 3(f)(1).

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because most facilities that will be affected by this rule are defined as small businesses and the proposed rule is likely to impose a substantial burden on the affected small entities, we find that the proposed rule will have a significant economic impact on a substantial number of small entities.

We prepared an analysis consistent with the Unfunded Mandates Reform Act of 1995 (section 202(a)), which requires us to prepare a written statement that includes estimates of anticipated impacts, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $177 million, using the most current (2022) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would result in an expenditure in at least one year that meets or exceeds this amount.

This proposed rule, if finalized, would amend FDA's regulations to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory. As discussed in section VI, FDA intends to phase out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.

We anticipate that the benefits of phasing out FDA's general enforcement discretion approach for LDTs would include a reduction in healthcare costs associated with unsafe or ineffective tests, including tests promoted with false or misleading claims, and from therapeutic decisions based on the results of those tests. Quantified benefits are the annualized sum of both health and non-health benefits. Unquantified benefits would include the reduction in costs from lawsuits and reduction in costs to healthcare systems.

Table 1 summarizes the annualized benefits, costs, and transfers of the proposed rule. At a 7 percent discount rate, 20-year annualized benefits range from $2.67 billion to $86.01 billion, with a primary estimate of $31.41 billion per year. At a 3 percent discount rate, 20-year annualized benefits range from $1.81 billion to $61.41 billion, with a primary estimate of $22.33 billion per year. At a 7 percent discount rate, 20-year annualized costs range from about $2.52 billion to $19.45 billion, with a primary estimate of $5.87 billion per year. At a 3 percent discount rate, annualized costs range from about $2.39 billion to $18.55 billion, with a primary estimate of $5.60 billion per year. At a 7 percent discount rate, 20-year annualized transfers range from $100 million to $452 million, with a primary estimate of $226 million per year. At a 3 percent discount rate, 20-year annualized transfers range from $121 million to $538 million, with a primary estimate of $269 million per year.

We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 34) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

We have determined under 21 CFR 25.30(h) 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.

FDA tentatively concludes that this proposed rule contains no new collections of information. However, FDA does assume that there will need to be corresponding adjustments to the burden estimates for relevant approved collections of information before the relevant phaseout stage begins and any such collection of information would not be as a result of the implementation of the proposed rule. FDA tentatively concludes that the following information collections will need adjustment before the relevant phaseout stage begins: Office of Management and Budget (OMB) control number 0910-0437, Medical Device Reporting; OMB control number 0910-0359, Corrections and Removals; OMB control number 0910-0625, Device Registration and Listing; OMB control number 0910-0485, Labeling; OMB control number 0910-0078, Investigational Device Exemption; OMB control number 0910-0073, Quality Systems; OMB control number 0910-0231, Premarket Approval; OMB control number 0910-0332, Humanitarian Device Exemption; OMB control number 0910-0756, Q-Submissions; OMB control number 0910-0120, Premarket Notification; and OMB control number 0910-0844 De Novo. Such adjustments will be submitted for review and clearance by OMB under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521).

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that this proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. Through publication of this proposed rule, we are providing notice and an opportunity for State and local officials to comment on this rulemaking.

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.

FDA anticipates that this proposed rule, if finalized, may require conforming amendments to other FDA regulations, including provisions regarding IVD labeling and ASRs in part 809. FDA intends to consider and propose conforming amendments, where appropriate, at a future date.

In addition, we note that various bills have been introduced in Congress that would change the legal status of IVDs as devices (under these bills, IVDs would generally be regulated as “in vitro clinical tests” and would be subject to new statutory authorities). 19 We recognize that the enactment of such legislation would directly impact this rule, given that it is being proposed under the statutory device authorities and other authorities under the FD&C Act.

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, FDA proposes to amend 21 CFR part 809 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register OMB Office of Management and Budget NPRM Notice of proposed rulemaking (advance, supplemental) § Section U.S.C. United States Code NYSDOT New York State Department of Transportation II. Background, Purpose, and Legal Basis

The Loop Parkway Bridge across Long Creek, mile 0.7, Nassau County, NY, has a vertical clearance of 21 feet at mean high water and a horizontal clearance of 75.5 feet at mean high water. Waterway users include recreational and commercial vessels, including fishing vessels.

The existing drawbridge operating regulations are listed at 33 CFR 117.799(f). NYSDOT is requesting a temporary rulemaking to operate under single leaf openings while they perform bridge deck replacements. NYSDOT has reached out to local mariners and notified them of the proposed temporary rulemaking as well as outlined an alternate route for larger vessels that may not be able to make passage under the bridge with single leaf openings.

The Loop Parkway Bridge will continue to operate under its regular operating schedule found in 33 CFR 117.799(f). However, this proposed rule will allow the bridge to operate under single leaf openings from September 15, 2023, through May 15, 2024. For vessels that are too large for single leaf openings, NYSDOT has set an alternate route. Vessels that can pass without requesting a bridge opening may do so. NYSDOT has reached phase 2 of the project which requires replacing the bridge deck. The reason for this request is to allow the project to progress while minimizing impact on mariners.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive orders.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This proposed rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the ability of vessels to still transit the bridge under singe leaf openings or may transit through an alternate route.

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

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

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rulemaking would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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

Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01, Rev.1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under paragraph L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.

Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this proposed rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2023-0530 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

Viewing material in docket. To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. Also, if you click on the “Dockets” tab and then the proposed rule, you should see a “Subscribe” option for email alerts. Selecting this option will enable notifications when comments are posted, or if/when a final rule is published.

We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

Personal information. We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:

The addition reads as follows:

I. Table of Abbreviations [Delete/Add Any Abbreviations Not Used/Used in This Document] CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register OMB Office of Management and Budget NPRM Notice of Proposed Rulemaking (Advance, Supplemental) § Section U.S.C. United States Code NYSDOT New York State Department of Transportation II. Background, Purpose and Legal Basis

The Meadowbrook State Parkway Bridge across Sloop Channel, mile 12.8, Nassau County, NY, has a vertical clearance of 21 feet at mean high water and a horizontal clearance of 75.5 feet at mean high water. Waterway users include recreational and commercial vessels, including fishing vessels.

The existing drawbridge operating regulations are listed at 33 CFR 117.799(h). NYSDOT is requesting a temporary rulemaking to operate under single leaf openings while they perform bridge deck replacements. NYSDOT has reached out to local mariners and notified them of the proposed temporary rulemaking as well as outlined an alternate route for larger vessels that may not be able to make passage under the bridge with single leaf openings.

The Meadowbrook State Parkway Bridge will continue to operate under its regular operating schedule found in 33 CFR 117.799(f). However, this proposed rule when made final would allow the bridge to operate under single leaf openings until May 15, 2024. For vessels that are too large for single leaf openings NYSDOT has set an alternate route. Vessels that can pass without requesting a bridge opening may do so. NYSDOT has reached phase 2 of the project which requires replacing the bridge deck. The reason for this request is to allow the project to progress while minimizing impact on mariners.

We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This proposed rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the ability of vessels to still transit the bridge under singe leaf openings or may transit through an alternate route.

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

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

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

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

Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01, Rev.1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f). The Coast Guard has determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under paragraph L49, of Chapter 3, Table3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.

Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision-Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2023-0532 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

Viewing material in docket. To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. Also, if you click on the” Dockets” tab and then the proposed rule, you should see a “Subscribe” option for email alerts. Selecting this option will enable notifications when comments are posted, or if/when a final rule is published.

We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

Personal information. We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:

The addition to read as follows:

Background and Need

This proposed rule would revise certain criminal prohibitions in 36 CFR part 261, subpart A, to enhance consistency of the Forest Service's law enforcement practices with those of State and other Federal land management law enforcement agencies. In addition, this proposed rule would streamline enforcement of some of the criminal prohibitions found in 36 CFR part 261, subpart B, which are enforceable only through issuance of an order, by moving them to 36 CFR part 261, subpart A, which contains criminal prohibitions that are enforceable without issuance of an order.

Forest Service law enforcement personnel continue to encounter a significant volume of violations for simple possession of controlled substances and drug paraphernalia. Agency personnel routinely deal with under-age alcohol possession on National Forest System (NFS) lands. These violations pose a threat to the safety of visitors to NFS lands as well as to Forest Service personnel. This proposed rule would enhance the Forest Service's authority to address public safety issues by adding prohibitions relating to controlled substances, drug paraphernalia, and alcoholic beverages. These proposed prohibitions would enable the Forest Service to enforce more effectively violations on NFS lands for simple possession of controlled substances, possession of alcoholic beverages in violation of State law (for open containers or under-age drinking), and furnishing alcoholic beverages to minors. The proposed rule also would authorize the Forest Service to enforce violations for the possession of drug paraphernalia if prohibited by State law. These proposed changes are intended to align the Forest Service's law enforcement practices more closely with those of State and local law enforcement agencies.

Additionally, the proposed rule would update the prohibitions to enhance protection of persons visiting and working on NFS lands from theft of personal property and from disorderly conduct by other visitors. The proposed rule would enhance enforcement of wildfire prevention prohibitions by moving them from 36 CFR part 261, subpart B, which requires issuance of an order, to 36 CFR part 261, subpart A, which does not, and by adding a prohibition banning exploding targets year-round. The proposed rule also would make other revisions such as updating the prohibitions relating to off-road vehicles and updating the penalty for violating the criminal prohibitions in 36 CFR part 261 consistent with current statutory law.

Proposed revisions to specific types of public safety prohibitions are discussed below.

It is a violation of Federal law for a person knowingly or intentionally to possess controlled substances (21 U.S.C. 844(a)). Forest Service law enforcement officers enforce 21 U.S.C. 844(a) on NFS lands, and in some circumstances off these lands, under the National Forest System Drug Control Act of 1986 (16 U.S.C. 559b-559g). A violation of 21 U.S.C. 844(a) without aggravating factors is classified as a Class A misdemeanor. With aggravating factors, this type of violation is classified as a felony (18 U.S.C. 3559(a)).

Violations of 21 U.S.C. 844(a) require referral to the appropriate United States Attorney's Office for the filing of a complaint or information and prosecution before a United States District Court judge. Guidelines established by the United States Attorney's Office for prosecutions under 21 U.S.C. 844(a) are based upon the amount of the controlled substance involved in the violation. In many instances, violations for simple possession of a controlled substance on NFS lands are not prosecuted under 21 U.S.C. 844(a) because they involve small amounts that are insufficient to meet these prosecutorial guidelines.

The Forest Service's criminal prohibitions at 36 CFR part 261, subpart A, do not expressly prohibit the possession of controlled substances on NFS lands. To provide an alternative to proceeding under 21 U.S.C. 844(a), the Forest Service is proposing to revise 36 CFR part 261, subpart A, to prohibit knowingly or intentionally possessing a controlled substance in violation of Federal law. The proposed rule also would add a definition for the term “controlled substance” that tracks the definition of that term in the Controlled Substances Act (21 U.S.C. 801 et seq. ).

With these changes, the possession of small amounts of a controlled substance could be handled through issuance of a notice of violation by a Forest Service law enforcement officer and prosecution before a United States magistrate judge and would be classified as a Class B misdemeanor. Forest Service law enforcement personnel would continue to refer cases involving larger amounts of controlled substances that meet prosecutorial guidelines to the appropriate United States Attorney's Office.

Possession of drug paraphernalia is not a violation of Federal law (see 21 U.S.C. 863(d)). Some States prohibit possession of drug paraphernalia only if it contains the residue of a controlled substance. Other States prohibit possession of drug paraphernalia even if it does not contain the residue of a controlled substance. The proposed rule would add a prohibition that would prohibit knowingly or intentionally possessing drug paraphernalia in either situation when it is in violation of State law.

The Forest Service has limited authority in 36 CFR part 261 to address underage drinking and other violations of State law relating to alcoholic beverages, such as State laws prohibiting open containers of alcoholic beverages and furnishing alcoholic beverages to minors. The current authority is contained in 36 CFR 261.58(bb), which prohibits possession of an alcoholic beverage as defined by State law when enforced through issuance of an order issued under 36 CFR part 261, subpart B. The proposed rule would add two prohibitions relating to alcoholic beverages (possessing an alcoholic beverage in violation of State law and providing an alcoholic beverage to a minor in violation of State law) to 36 CFR part 261, subpart A. These changes would make the prohibitions generally applicable to NFS lands and enforceable without issuance of an order. These proposed changes are intended to allow the Forest Service to address more effectively the use of NFS lands at gatherings where alcoholic beverages are consumed by giving Forest Service law enforcement officers the same enforcement options as their State and local counterparts.

The prohibition in 36 CFR 261.58(bb) would be retained to allow the Forest Service to prohibit consumption of alcoholic beverages temporarily in specific areas of NFS lands when appropriate to protect public safety, such as at a large event, regardless of whether consumption of alcoholic beverages is in violation of State law.

Both Federal and State laws apply to the national forests (16 U.S.C. 480). Generally, States enforce State laws, while Forest Service law enforcement personnel enforce Federal laws, including the criminal prohibitions in 36 CFR part 261, subparts A and C, and in orders issued under 36 CFR part 261, subpart B. In most cases, the Federal laws and prohibitions relate to the Agency's resource protection responsibilities. However, with the urbanization and development of areas near NFS lands, crimes against persons and personal property have become an increasing public safety concern.

The Forest Service cooperates with State and local law enforcement agencies in the execution of their responsibilities related to NFS lands. Under the Cooperative Law Enforcement Act of 1971 (16 U.S.C. 551a), the Forest Service has entered into reimbursable agreements with some State and local law enforcement agencies (usually a county sheriff's office) for the protection of persons and their property on NFS lands where these lands and facilities account for increased visitor use.

Over time, however, it has become evident that reimbursement through the cooperative law enforcement program alone cannot always provide for the appropriate level of protection. Many local law enforcement agencies find that their limited personnel, the remote location of NFS lands, and the seasonal nature of use those lands receive impede rapid response to crimes committed on NFS lands. When a person is victimized by theft of or damage to personal property on NFS lands—for example at a campsite or a trailhead parking lot—and State or local enforcement personnel are unable to respond, Forest Service law enforcement personnel have limited authority to assist. The proposed rule would add a prohibition that would allow Forest Service law enforcement personnel to take appropriate action in response to theft of or damage to personal property on NFS lands.

To protect persons on NFS lands, the proposed rule also would revise the prohibitions relating to disorderly conduct. A significant increase in visitation to national forests and grasslands has coincided with an increase in incidents of public behavior that threatens the safety of others. Forest Service law enforcement personnel frequently encounter situations in which a person makes lewd or obscene comments to another person; follows another person around, including into a restroom, with no legitimate purpose and in a threatening manner; or engages in indecent exposure. The proposed rule would revise the disorderly conduct prohibitions in 36 CFR 261.4 to address these situations.

The proposed rule would incorporate State traffic law in § 261.12 so that State traffic law is enforceable as Federal traffic law. Specifically, the proposed rule would incorporate two commonly cited violations of State traffic law: operating a motor vehicle without a valid license and operating a motor vehicle while under the influence of an alcoholic beverage or a controlled substance. The proposed rule also would incorporate a catch-all prohibition that would incorporate any other State traffic laws so that they are enforceable as Federal traffic law.

Wildland fires, including catastrophic wildfires, have increased in frequency and severity on NFS lands. An accumulation of hazardous fuels combined with severe drought have resulted in extreme fire conditions and very large fires. Forest Service estimates indicate that more than 460 million acres of all vegetated lands are at moderate to high risk from uncharacteristically large wildfires, encompassing many wildland-urban interfaces with high densities of structures that intermingle with undeveloped wildlands. In 2022, more than 7.5 million acres burned in the United States, and more than 2,700 structures were destroyed, including 1,294 residences. These fires have long-term and sometimes irreversible consequences, including damage to watersheds that supply drinking water and damage to critical habitat for endangered species. The Forest Service also incurs significant annual costs related to wildland fire suppression.

This proposed rule would allow the Forest Service to take additional enforcement actions to prevent wildfires on NFS lands. The possession and use of fireworks or other pyrotechnic devices are not generally prohibited on NFS lands. However, they may be prohibited in areas specified in an order issued under 36 CFR 261.52(f). Typically, the Forest Service issues orders under 36 CFR 261.52(f) on a seasonal basis when the threat of fire is high. However, given the higher risk and greater severity of wildland fires, the Agency has determined that a year-round ban is necessary to protect NFS lands and resources, persons using those lands, and surrounding communities from the threat of catastrophic wildfire. The proposed rule would move these prohibitions to 36 CFR part 261, subpart A, so that they are enforceable anywhere on NFS lands during any season without issuance of an order under 36 CFR part 261, subpart B.

Exploding targets—targets that explode when struck by a bullet—have become popular throughout the United States, and their use is increasing on NFS lands. Exploding targets can be purchased legally and are intended for use as a target for firearms practice. However, when detonated by a bullet, exploding targets often result in a fireball that can ignite vegetation and surrounding materials and spread to adjacent areas. A growing number of wildfires on NFS lands have been caused by exploding targets; from 2012 to 2022, multiple fires burned over 139,000 acres as result of exploding targets, costing taxpayers millions of dollars to suppress. Additionally, trash is often left behind after exploding targets are used, including undetonated targets, which present additional safety risks for visitors, employees, and firefighters.

Exploding targets are regulated by the Forest Service as explosives under the Agency's authority to issue orders banning the use of explosives in specified areas under 36 CFR 261.52(b). Because exploding targets present a significant fire hazard at any time of year, the Forest Service is proposing to add a generally applicable prohibition to 36 CFR 261.5 that does not require issuance of an order and that would ban possession as well as use of an exploding target on NFS lands.

Exploding targets generally consist of two separate chemical components (usually an oxidizer like ammonium nitrate and a fuel such as aluminum or another metal) that become a binary explosive when combined. The individual components, which often are pre-packaged together, are kept separate within individual containers for sale and transport. Kept separate, the components are not explosives. Combined, however, the components become explosive and thus are subject to Federal explosive laws and regulations. To avoid triggering Federal law until they are ready to be used and to minimize the risk of injury, the components are typically combined at the site where the exploding targets are going to be used. This proposed rule would ban the possession and use of an exploding target (the binary explosive that is created by combining the two components).

The Forest Service recognizes hunting and safe target shooting as valid uses of NFS lands. This proposed rule would not affect these valid uses.

A section-by-section description of the proposed rule follows.

The proposed rule would make a technical change to 36 CFR 261.1b, which governs penalties for violating a criminal prohibition in 36 CFR part 261, to make it consistent with current statutory law. The regulations at 36 CFR 261.1b refer to the penalty in 16 U.S.C. 551, which provides that a violation shall be punished by a fine of not more than $500, imprisonment for not more than six months, or both. Violations were classified as petty offenses.

The Comprehensive Crime Control Act of 1984 established categories of offenses based on the maximum amount of imprisonment for each offense (18 U.S.C. 3559). Offenses with a maximum term of six months of imprisonment, such as those offenses covered by 36 CFR part 261, are considered Class B misdemeanors. The Comprehensive Crime Control Act of 1984 also prescribes a range of fines for Class B misdemeanors, depending on specific circumstances associated with the violation, with a maximum fine of $5,000 for a person and $10,000 for an organization (18 U.S.C. 3571). The proposed revision reflects this statutory change and provides for exceptions when a statute establishing an offense expressly sets a different penalty.

The proposed rule would add six definitions to 36 CFR 261.2 for the terms “alcoholic beverage,” “controlled substance,” “exploding target,” “firework,” “pyrotechnic device,” and “recreation site.” The proposed rule also would revise the definition of “developed recreation site.”

The term “alcoholic beverage” would be defined to have the same meaning as under State law. This definition is consistent with the current use of the term in 36 CFR 261.58(bb).

The term “controlled substance” would be defined to have the same meaning as in the Controlled Substance Act (21 U.S.C. 801 et seq. ).

The term “exploding target” would be defined to mean a binary explosive that is designed to explode when struck by a bullet. Exploding targets consist of two components that are combined to create the explosive. Individually, the parts are inert. However, when combined, they become explosive.

The term “firework” would be defined to have the same meaning as in 27 CFR 555.11. As defined in those regulations, the term “firework” means any composition or device that is designed to produce a visible or an audible effect by combustion, deflagration, or detonation and that meets the definition of “consumer fireworks” or “display fireworks” as defined by 27 CFR 555.11. This definition is consistent with the Forest Service's current interpretation of what constitutes a firework.

The term “pyrotechnic device” would be defined to have the same meaning as the term “articles pyrotechnic” in 27 CFR 555.11. As currently defined in those regulations, the term “articles pyrotechnic” means devices for professional use that are similar to consumer fireworks in chemical composition and construction but are not intended for consumer use. This definition is consistent with the Forest Service's current interpretation of what constitutes a pyrotechnic device.

This proposed rule would amend 36 CFR 261.2 by revising the definition of “developed recreation site” and adding a definition of “recreation site” to be consistent with the definitions of those terms in Chapter 50 of the Forest Service's Recreation Site Handbook, Forest Service Handbook 2309.13. Chapter 50 of the Recreation Site Handbook defines the terms “developed recreation site” and “recreation site” based on the scale of development at a site. Chapter 50 of the Recreation Site Handbook also contains a recreation site development scale showing the characteristics of each scale of development.

The term “developed recreation site” is currently defined in 36 CFR 261.2 as “an area which has been improved or developed for recreation.” The proposed definition of “developed recreation site” would be more specific than the current definition and would match the definition of that term in Chapter 50 of the Recreation Site Handbook. As defined in Chapter 50 of the Recreation Site Handbook, a developed recreation site is “a recreation site that has a development scale of 3, 4, or 5 (sec. 50.5, ex. 01)”. Recreation sites with a development scale of 3, 4, or 5 range from moderate to extensive site development.

Additionally, the proposed rule would add a definition of “recreation site” to 36 CFR 261.2 that tracks the definition of that term in Chapter 50 of the Recreation Site Handbook. Chapter 50 of the Recreation Site Handbook defines the term “recreation site” as “an area that is improved, developed, or otherwise authorized by the Forest Service for recreation and that has a development scale of 0, 1, 2, 3, 4, or 5 (sec. 50.5, ex. 01).” Under this added definition, the term “recreation site” would cover a broader range of areas than the term “developed recreation site” and would include recreation sites with a development scale of 0, 1, or 2, which range from no to little site modification.

Currently, the term “developed recreation site” is used in the criminal prohibitions in 36 CFR part 261, subpart A, specifically, in 36 CFR 261.10(d)(1), (i), and (j) and 261.16. These prohibitions would continue to apply only to developed recreation sites, that is, to recreation sites that have a development scale of 3, 4, or 5. The prohibitions would not be broadened to apply to recreation sites with a development scale of 0, 1, or 2, which have little to no site modification, because the public may not have adequate notice that such a site exists, given the lack of development, and that a prohibition applies.

In contrast, the term “recreation site” would be substituted for “developed recreation site” each time the latter term appears in prohibitions designated by order in 36 CFR part 261, subpart B, specifically, in 36 CFR 261.52(d) and 261.58(b) and (d). Prohibitions designated by orders can be broader in scope and can cover recreation sites with a development scale of 0, 1, or 2 because orders specify the area to which they apply.

The prohibitions in 36 CFR 261.4 pertain to disorderly conduct. This proposed rule would add a criminal intent element, or mens rea, that the violator acted intentionally or recklessly in committing the offense. To be cited for a violation of disorderly conduct, a person must have committed one of the acts described in paragraphs (a) through (c) with the intent to cause, or recklessly to create a substantial risk of causing, public alarm, nuisance, jeopardy, or violence. The criminal intent standard would require a showing that the violator knowingly intended to cause public alarm, nuisance, jeopardy, or violence by the prohibited acts or words. Alternatively, the reckless standard, which has a lesser mens rea, would require a showing that the violator was aware of, but consciously disregarded, the substantial risk that the prohibited acts or words would cause public alarm, nuisance, jeopardy, or violence.

This proposed rule also would revise the types of conduct that would constitute disorderly conduct when committed with the requisite mens rea. The current paragraph (a) prohibits only fighting. This proposed rule would add threatening or other violent behavior. This proposed rule also would revise paragraph (b) and would substitute it for current paragraphs (b) and (c), which cover “fighting words,” such as utterances that are likely to provoke violence or unlawful acts. Fighting words are not protected speech under the First Amendment. Revised paragraph (b) would cover fighting words by prohibiting “making an utterance or performing an act . . . that is made or performed in a manner likely to inflict injury or to incite an immediate breach of peace.” Because revised paragraph (b) also would cover an utterance or act that is obscene or threatening when committed with the intent to cause public alarm, nuisance, jeopardy, or violence, or recklessly create a risk thereof, revised paragraph (b) would address situations when a person (1) makes lewd or obscene comments short of solicitation to another person; (2) follows another person around, including into a restroom, with no legitimate purpose if done in a threatening manner; and (3) commits indecent exposure. This proposed rule also would redesignate paragraph (d) as paragraph (c) and would provide further instruction as to what constitutes unreasonable noise in violation of the disorderly conduct prohibition.

The Forest Service proposes to add paragraphs (h), (i), and (j) to 36 CFR 261.5, which contains prohibitions relating to fire. The prohibitions in proposed paragraphs (h), (i), and (j) are currently enforceable only through issuance of an order under 36 CFR 261.52. Moving these prohibitions to § 261.5 would make them generally applicable to NFS lands year-round and enforceable without issuance of an order.

Specifically, proposed paragraph (h) would prohibit possessing or using an exploding target or any kind of firework or other pyrotechnic device. The prohibition banning the possession or use of fireworks or other pyrotechnic devices is currently enforced in areas specified by an order issued under 36 CFR 261.52(f). The proposed rule would move this prohibition to 36 CFR part 261, subpart A, which would make it generally applicable to NFS lands year-round and enforceable without issuance of an order. The proposed rule also would add a prohibition to paragraph (h) that would ban the possession and use of exploding targets.

Proposed paragraph (i) would prohibit violating any State law concerning burning or fires or any State law whose purpose is to prevent or restrict the spread of fire. This prohibition is currently enforced in areas specified by an order issued under 36 CFR 261.52(k). The Forest Service may incorporate State law concerning burning or fires or any State law which is for the purpose of preventing or restricting the spread of fire in an order issued under § 261.52(k). Violations of these orders constitute violations of Federal law. The proposed rule would move this prohibition to 36 CFR part 261, subpart A, which would make it generally applicable to NFS lands year-round and enforceable without issuance of an order.

Proposed paragraph (j) would prohibit operating or using any internal or external combustion engine without a properly installed and maintained spark-arresting device that meets specified requirements. This prohibition is currently enforced in areas specified by an order issued under 36 CFR 261.52(j). The proposed rule would move this prohibition to 36 CFR part 261, subpart A, which would make it generally applicable to NFS lands year-round and enforceable without issuance of an order.

This proposed rule would add paragraph (j) to 36 CFR 261.9 to provide enforcement authority for theft by prohibiting damaging or removing without authorization any personal property belonging to another person.

This proposed rule would revise paragraphs (a) and (e), would remove paragraph (o), and would add paragraphs (o) through (s) to 36 CFR 261.10 relating to occupancy and use of NFS lands.

Paragraph (a) currently prohibits constructing, placing, or maintaining certain improvements on NFS lands or facilities without an authorization. Signs are not listed as a type of improvement that is prohibited without an authorization. This proposed rule would revise paragraph (a) to prohibit constructing, placing, or maintaining a sign on NFS lands or facilities without an authorization.

Paragraph (e) prohibits abandoning any personal property. Forest Service law enforcement personnel have encountered a noticeable increase in personal property, such as camping and other recreational equipment, being stored on NFS lands. Because the term “abandon” connotes relinquishing property without an intent to reclaim possession, the Forest Service needs a better tool to manage illegally stored personal property on NFS lands. This proposed rule would prohibit leaving personal property unattended for longer than 24 hours, except in locations where longer periods have been designated.

Paragraph (o) prohibits discharging or igniting a firecracker, rocket or other firework, or explosive into or within any cave. This prohibition is no longer necessary because it is covered by proposed paragraph (h) that would be added to § 261.5. Paragraph (p) in 36 CFR 261.10 would become paragraph (o).

Proposed paragraphs (p) and (q) would add prohibitions for simple possession of controlled substances and drug paraphernalia, respectively.

Proposed paragraph (r) would add a prohibition for possessing an alcoholic beverage in violation of State law. Under this proposed prohibition, Forest Service law enforcement personnel could issue a notice of violation for possession of alcohol by a minor or for possession of an open container in a vehicle, where prohibited by State law. Proposed paragraph (s) would add a prohibition for providing an alcoholic beverage to a minor in violation of State law.

The proposed rule would move the prohibition in 36 CFR 261.54(f), which prohibits operating a vehicle or motor vehicle carelessly, recklessly, or in a manner or at a speed that would endanger or be likely to endanger any person or property, to proposed paragraph (e) of 36 CFR 261.12, which contains prohibitions relating to NFS roads and NFS trails. Moving this prohibition to § 261.12 would make it generally applicable to NFS lands year-round and enforceable without issuance of an order. The proposed rule also would add a prohibition for operating a motor vehicle in violation of a posted sign or traffic control device.

The proposed rule would amend 36 CFR 261.15, which pertains to off-road vehicle use on NFS lands. The proposed rule would revise paragraphs (e) and (g). Paragraph (e), which prohibits off-road vehicle use while under the influence of alcohol or another drug, would be updated to refer to the proposed defined terms in § 261.2, i.e., “alcoholic beverage” and “controlled substance.” The terminology in paragraph (g), which prohibits careless and reckless driving, also would be updated without altering the substance of the prohibition.

The United States Court of Appeals for the Ninth Circuit has interpreted 36 CFR 261.50 to allow only those persons holding the positions specified in 36 CFR 261.50(a) and (b), including persons acting in those positions, to issue orders under 36 CFR part 261, subpart B. United States v. True, 946 F.2d 682, 687 (9th Cir. 1991). The proposed rule would amend § 261.50(a) and (b) to expressly authorize the persons holding the positions specified in those paragraphs to delegate the authority to issue orders under 36 CFR part 261, subpart B, to officials acting in those positions or to their deputy. The proposed rule would amend § 261.50(a) and (b) to clarify that the authority of officials issuing an order is limited to areas over which those officials have delegated authority.

This proposed rule would move the prohibitions in paragraphs (f), (j), and (k) to § 261.5, which would make the prohibitions generally applicable to NFS lands year-round and enforceable without issuance of an order.

This proposed rule would amend 36 CFR 261.53 relating to special closures. The changes to the heading and introductory text of § 261.53 would clarify that this provision can be used to restrict use of an area, such as to close an area to a particular use, as well as to close an area in its entirety to all uses.

The proposed rule would move the prohibition in 36 CFR 261.54(f), which prohibits operating a vehicle or motor vehicle carelessly, recklessly, or in a manner or at a speed that would endanger or be likely to endanger any person or property, to proposed paragraph (e) of 36 CFR 261.12, which contains prohibitions relating to NFS roads and NFS trails. This revision would make the prohibition in 36 CFR 261.54(f) generally applicable to NFS lands year-round and enforceable without issuance of an order.

The authority to issue orders relating to occupancy and use of NFS lands is contained in 36 CFR 261.58. Paragraph (bb) prohibits possession of an alcoholic beverage as defined under State law, when enforced through issuance of an order. This proposed rule would revise paragraph (bb) to be consistent with the proposed definition of “alcoholic beverage” that would be added to § 261.2.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will determine whether a regulatory action is significant as defined by E.O. 12866 and will review significant regulatory actions. OIRA has determined that this proposed rule is not significant as defined by E.O. 12866. E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The Agency has developed the proposed rule consistent with E.O. 13563.

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 801 et seq. ), OIRA has designated this proposed rule as not a major rule as defined by 5 U.S.C. 804(2).

The proposed rule would streamline enforcement of criminal prohibitions in existing regulations by providing for enforcement without issuance of an order and enhance consistency of the Forest Service's law enforcement practices with those of State and other Federal land management agencies. Forest Service regulations at 36 CFR 220.6(d)(2) exclude from documentation in an environmental assessment or environmental impact statement “rules, regulations, or policies to establish servicewide administrative procedures, program processes, or instructions.” The Agency's preliminary assessment is that this proposed rule falls within this category of actions and that no extraordinary circumstances exist which would require preparation of an environmental assessment or environmental impact statement. A final determination will be made upon adoption of the final rule.

The Forest Service has considered this proposed rule under the Regulatory Flexibility Act (5 U.S.C. 602 et. seq. ). This proposed rule would not have any direct effect on small entities as defined by the Regulatory Flexibility Act. This proposed rule would not impose record-keeping requirements on small entities; would not affect their competitive position in relation to large entities; and would not affect their cash flow, liquidity, or ability to remain in the market. Therefore, the Forest Service has determined that this proposed rule would not have a significant economic impact on a substantial number of small entities pursuant to the Regulatory Flexibility Act.

The Agency has considered this proposed rule under the requirements of E.O. 13132, Federalism. The Agency has determined that the proposed rule conforms with the federalism principles set out in this executive order; would not impose any compliance costs on the States; and would not have substantial direct effects 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, the Agency has concluded that this proposed rule would not have federalism implications.

E.O. 13175, Consultation and Coordination with Indian Tribal Governments, requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that 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. This proposed rule would streamline enforcement of criminal prohibitions in existing regulations by providing for enforcement without issuance of an order and enhance consistency of the Forest Service's law enforcement practices with those of State and other Federal land management agencies. The Agency has reviewed this proposed rule in accordance with the requirements of E.O. 13175 and has determined that this proposed rule would not have substantial direct effects on 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. Therefore, consultation and coordination with Indian Tribal governments is not required for this proposed rule.

The Agency has analyzed this proposed rule in accordance with the principles and criteria in E.O. 12630, Governmental Actions and Interference with Constitutionally Protect Property Rights. The Agency has determined that the proposed rule would not pose the risk of a taking of private property.

The Agency has reviewed this proposed rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that this proposed rule would not constitute a significant energy action as defined in E.O. 13211.

The Forest Service has analyzed this proposed rule in accordance with the principles and criteria in E.O. 12988, Civil Justice Reform. After adoption of this proposed rule, (1) all State and local laws and regulations that conflict with this proposed rule or that impede its full implementation would be preempted; (2) no retroactive effect would be given to this proposed rule; and (3) it would not require administrative proceedings before parties may file suit in court challenging its provisions.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Agency has assessed the effects of this proposed rule on State, local, and Tribal governments and the private sector. This proposed rule would not compel the expenditure of $100 million or more by any State, local, or Tribal government or anyone in the private sector. Therefore, a statement under section 202 of the Act is not required.

This proposed rule does not contain any recordkeeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 that are not already required by law or not already approved for use and therefore would impose no additional paperwork burden on the public. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. seq. ) and its implementing regulations at 5 CFR part 1320 do not apply.

Therefore, for the reasons set forth in the preamble, the Forest Service proposes to amend chapter II of title 36 of the Code of Federal Regulations as follows:

The additions and revisions read as follows:

Table of Contents for Preamble I. Public Participation and Request for Comments II. Abbreviations III. Background IV. Legal Authority V. Discussion of Proposed Rule VI. Regulatory Analyses A. Regulatory Planning and Review B. Small Entities C. Assistance for Small Entities D. Collection of Information E. Federalism F. Unfunded Mandates G. Taking of Private Property H. Civil Justice Reform I. Protection of Children J. Indian Tribal Governments K. Energy Effects L. Technical Standards M. Environment I. Public Participation and Request for Comments

The Coast Guard views public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at www.regulations.gov. To do so, go to www.regulations.gov, type USCG-2021-0288 in the search box, and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.

Viewing material in docket. To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the www.regulations.gov Frequently Asked Questions web page. That FAQ page also explains how to subscribe for email alerts that will notify you when comments are posted or if a final rule is published. We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

Personal information. We accept anonymous comments. Comments we post to www.regulations.gov will include any personal information you have provided. For more about privacy and submissions to the docket in response to this document, see the DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

Public meeting. We do not plan to hold a public meeting, but we will consider doing so if we determine from public comments that a meeting would be helpful. We would issue a separate Federal Register notice to announce the date, time, and location of such a meeting.

As described in title 46 of the Code of Federal Regulations (CFR), section 10.107, a Coast Guard-issued Merchant Mariner Credential (MMC) serves as a mariner's qualification document and certificate of identification. Mariners employed aboard most U.S. merchant vessels are required to hold a valid MMC.

As mandated by title 46 of the United States Code (U.S.C.), section 2110, and in accordance with the Independent Offices Appropriations Act (31 U.S.C. 9701), the Coast Guard has established fees associated with MMC applications, which are codified in table 1 to 46 CFR 10.219(a). There are three types of credentialing fees: an evaluation fee, an examination fee, and an issuance fee. The fee amount varies based on the individual credential transaction that an applicant seeks.

Evaluation fees for MMCs range from $50 to $100, and the applicant must pay the fee at the time an application is submitted to the Coast Guard. Examination fees range from $45 to $140, depending on the endorsement sought, and must be paid before the professional examination for an endorsement is taken. 1 If an applicant applies for an MMC with both a rating and an officer endorsement, the higher evaluation fee is charged. Issuance fees are $45 and must be paid before an MMC is issued. 2

The original issuance of an MMC, as well as any subsequent credential transactions, such as increasing the scope of authority, raising the grade of authority, or renewing an MMC, all require a fee. 3 MMCs are valid for a period of 5 years and may be renewed at any time during the validity period of the credential and for 1 year after expiration.

Mariners typically seek additional endorsements after accruing the required sea service and completing required training. There are no fees associated with the issuance of mariner medical certificates or International Convention on Standards of Training, Certification and Watchkeeping for Seafarers (STCW) endorsements.

The Coast Guard does not require a fee for MMC transactions if one of the following three conditions is met:

(1) The application is for a Document of Continuity, as specified in 46 CFR 10.219(e)(3).

(2) The credential is a duplicate of a credential lost in a shipwreck or other casualty under 46 CFR 10.229(c) and reflected in table 1 to § 10.219(a).

(3) The applicant qualifies for a “no-fee” Merchant Mariner Credential under 46 CFR 10.219(h).

Currently, an applicant only qualifies for a “no-fee” MMC if they are a volunteer for or an employee of an organization that is youth-oriented, not-for-profit, and charitable, 46 CFR 10.219(j). The holder of a “no fee” MMC is restricted to using vessels owned or operated by the sponsoring organization, 46 CFR 10.219(k).

In March 2019, Executive Order 13860, “Supporting the Transition of Active-Duty Service Members and Military Veterans Into the Merchant Marine,” directed the Coast Guard to waive the fees associated with MMC applications “for active duty service members, if a waiver is authorized and appropriate.”  4 The Executive Order applied only to members of the armed forces.

Subsequently, in December 2019, Congress enacted the National Defense Authorization Act for Fiscal Year 2020 (NDAA 2020). 5 Building upon Executive Order 13860, section 3511(c)(1) of the NDAA 2020 directed the Coast Guard to waive evaluation, examination, and issuance fees associated with MMCs, if a waiver is authorized and appropriate, not just for the armed forces (Army, Navy, Air Force, Marine Corps, Space Force, and Coast Guard), but for all “members of the uniformed services on active duty.” The uniformed services include the Commissioned Corps of the National Oceanic and Atmospheric Administration (NOAA) and the Commissioned Corps of the U.S. Public Health Service (USPHS) in addition to the Army, Navy, Air Force, Marine Corps, Space Force, and Coast Guard. 6

In accordance with Executive Order 13860 and section 3511 of the NDAA 2020, on May 26, 2020, the Coast Guard's Office of Merchant Mariner Credentialing (CG-MMC) issued Policy Letter 02-20, “Waiver of Fees Associated with Merchant Mariner Credential Applications for Active Duty Members of the Uniformed Services.”  7 CG-MMC Policy Letter 02-20 provides guidance for the waiver of MMC fees for active duty members of the uniformed services. The policy provided a waiver of fees for mariners who provide documentation evidencing their eligibility for the fee waiver. This documentation may include active-duty orders or a letter from their command or personnel office on official letterhead that states the applicant is a current member of the uniformed services on active duty or a member of the Selected Reserve of the Ready Reserve of any of the armed forces or the Ready Reserve Corps of the USPHS.

Section 3511(c)(1) of the NDAA 2020 directed the Coast Guard to waive evaluation, examination, and issuance fees associated with MMCs for members of the uniformed services on active duty, if a waiver is authorized and appropriate. The Coast Guard has found that such a waiver is authorized and appropriate. Under 46 U.S.C. 2110(g), the Secretary of the Department of Homeland Security (DHS) may exempt a person from paying such a fee if the Secretary determines that it is in the public interest to do so. The Secretary has delegated this authority to the Coast Guard through article II, paragraph 92, subparagraph (a) of DHS Delegation No. 00170.1, Revision No. 01.3. The Coast Guard concludes that it is in the public interest to exempt members of the uniformed services (Army, Navy, Air Force, Marine Corps, Space Force, Coast Guard, Commissioned Corps of the NOAA, and Commissioned Corps of USPHS) on active duty; members of the Selected Reserve of the Ready Reserve of any of the armed forces (Army National Guard of the United States, Army Reserve, Navy Reserve, Marine Corps Reserve, Air National Guard of the United States, Air Force Reserve, and Coast Guard Reserve); and the Ready Reserve Corps of the USPHS from fees associated with obtaining an MMC. As discussed in Executive Order 13860, it is the policy of the United States to establish and maintain an effective merchant marine and to provide sufficient support and resources to active duty and separating service members who pursue or possess MMCs. The goals of not requiring these fees are to: (1) help attract active-duty service members with the appropriate skills and expertise to obtain an MMC for employment in the maritime industry; (2) support U.S. national security requirements; and (3) provide meaningful, well-paying jobs to U.S. veterans. 8

The Coast Guard is proposing to amend 46 CFR 10.219 and codify this MMC fee waiver in the regulations. Specifically, the Coast Guard proposes to exempt members of the uniformed services on active duty, members of the Selected Reserve of the Ready Reserve of any of the armed forces (Army National Guard of the United States, Army Reserve, Navy Reserve, Marine Corps Reserve, Air National Guard of the United States, Air Force Reserve and Coast Guard Reserve), and the Ready Reserve Corps of the USPHS from paying evaluation, examination, or issuance fees for an MMC.

For purposes of this rule, “uniformed services” would have the same meaning as defined at 10 U.S.C. 101(a)(5): the Army, Navy, Air Force, Marine Corps, Space Force, and Coast Guard, as well as members of the NOAA and USPHS Commissioned Corps. Members of the Selected Reserve of the Ready Reserve of a reserve component named in 10 U.S.C. 10101 and members of the Ready Reserve Corps of the USPHS would also be eligible for the exemption. (The NOAA Commissioned Corps does not have a reserve component.)

For members of the armed forces, “active duty” would have the same meaning as under 10 U.S.C. 101(d)(1). For members of the NOAA commissioned corps, “active duty” would have the same meaning as under 33 U.S.C. 3002(b)(1). For members of the USPHS Commissioned Corps, “active duty” would have the same meaning as “active service” under 42 U.S.C. 212(d). “Selected Reserve” would have the same meaning as under 10 U.S.C. 10143(a).

This fee exemption would be located in a new paragraph, paragraph (m), in 46 CFR 10.219.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. A summary of our analyses based on these statutes and Executive orders follows.

Executive Orders 12866 (Regulatory Planning and Review), as amended by Executive Order 14094 (Modernizing Regulatory Review), and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, OMB has not reviewed this rule.

The Coast Guard has developed an analysis of the costs and benefits of the proposed rule to assess its impacts. The regulatory analysis (RA) follows.

The rule is being proposed in response to two items. The first is section 3, paragraph (a)(ii) of Executive Order 13860, “Supporting the Transition of Active-Duty Service Members and Military Veterans Into the Merchant Marine,” signed March 4, 2019. 9 The second is section 3511(c)(1) of the NDAA 2020. 10

For purposes of the analysis, this RA is presented in two parts. Part I examines the impacts of CG-MMC Policy Letter 02-20, which was issued on May 26, 2020. 11 Part II examines the impacts of the proposed rulemaking post the issuance of the CG-MMC Policy Letter 02-20. The policy letter and the proposed rulemaking cover different populations. The difference between the two populations arises from which components of the reserves are eligible for a waiver of fees under the policy letter and which would be eligible under this proposed rule. The policy letter covers all reservists on active duty currently and in the past. The proposed rulemaking, however, would cover only those reservists who are currently members of the Selected Reserve, as described in 10 U.S.C. 10143(a), or a reserve component named in 10 U.S.C. 10101, or the Ready Reserve of the USPHS. The in-scope population of the proposed rulemaking is a subset of that of the policy letter.

The Coast Guard does not have data on the number of Selected Reservists or Ready Reservists who were granted fee exemptions under the policy letter, nor does it have data on the number of the reservists who were granted fee exemptions while on active-duty status. Due to this lack of data, it is not possible to estimate the differences in the affected populations between the policy letter and the proposed rulemaking. 12 Therefore, the Coast Guard is treating the estimated difference as an unquantified impact of the proposed rule, though the Coast Guard explores potential cost savings effects in its analysis. Further discussion can be found below.

Since the policy letter and proposed rulemakings are implemented at different time periods (the policy letter was implemented in 2020, and the proposed rulemaking is expected to be implemented in 2024), two different baselines need to be examined. The first is that associated with the pre-policy baseline (covering 2020-2033), and the second is that associated with the proposed rulemaking baseline (covering 2024-2033). The pre-policy baseline analyzes the effects of the Policy Letter 02-20 published in 2020 which allowed certain eligible applicants to receive an MMC fee exemption. The pre-policy baseline estimates the costs and savings that applicants and the Coast Guard received as a result of the policy letter as well as the costs and savings from this proposed rulemaking. The second baseline, the proposed rulemaking baseline, estimates the costs and savings that would occur as the result of this proposed rulemaking only. However, since we are unable to determine the change in population there are no additional costs or savings that can be attributed to the proposed rulemaking baseline.

Table 1, below, provides a summary of all impacts from Policy Letter 02-20 and the proposed rulemaking on a per-applicant basis. Section 1a of that table discusses the impacts of the policy letter, and section 1b discusses those of the proposed rulemaking. The dollar figures are presented in both nominal and discounted terms (7 percent on an annualized basis) for a 10-year period.

A policy letter was published to immediately implement Executive Order 13860, section 3511(c)(1) of the NDAA 2020. The implementation of the policy letter had three impacts. The first impact is the time that applicants are required to provide documentation to show eligibility for the MMC fee exemption. 13 Prior to the implementation of the policy letter, applicants did not need to provide such documentation. The second impact involves the labor costs to the Coast Guard to evaluate documentation for eligibility of the fee exemption. Prior to the policy letter, the Coast Guard did not have to evaluate such documentation, so there was no cost to the Government. The third impact of the policy letter was in the form of transfer payments, which are monetary payments from one group to another that do not affect the total resources available to society. Prior to the implementation of the policy letter, the affected population were required to pay the MMC fees. Following publication of the Policy Letter, the Federal Government incurs the cost of those fees. These three factors comprise the effects of the of Policy Letter 02-20.

The population will be discussed in greater detail below in the “Affected Population” section of this RA.

In accordance with Executive Order 13860 and section 3511 of the NDAA 2020, and the authority under 46 U.S.C. 2110(g), the Coast Guard waived MMC fees for members of the uniformed services (Army, Navy, Air Force, Marine Corps, Space Force, Coast Guard, and the Commissioned Corps of NOAA and the USPHS), including reservists and members of the National Guard, if they are currently on active duty at the time of application, or are a current member of the reserve forces and were previously on active duty. 14 The waiver was implemented through Policy Letter 02-20. This policy letter took effect on May 26, 2020. Data is available for all these categories of personnel except the Ready Reserve Corps of the USPHS. The Ready Reserve Corps of the USPHS was authorized and funded by the Coronavirus Aid, Relief and Economic Security Act and signed into law on March 27, 2020. It only began to accept applications in the fall of 2020. 15 With respect to the other groups mentioned above, the maximum potentially affected population is 2,145,035. This is the total number of personnel who may be eligible for an MMC fee exemption. A detailed breakdown of this population can be found below in Table 2.

Of the 2,145,035 eligible persons, only a small number applied for an MMC and received a fee waiver. Based on available data, 2020 through 2022 (inclusively), an average of 622 eligible persons were granted a waiver of MMC fees (per year). The Coast Guard assumes that, in the 10-year period following implementation of Policy Letter 02-20, an average of 622 persons will continue to annually request and receive a waiver of MMC fees.

Table 3 provides the MMC evaluation, examination, and issuance fees waived for qualifying individuals for the policy letter. 16 The column on the right side shows the aggregated evaluation, examination, and issuance fees for each type of credential transaction. The average fee for an MMC, as can be seen at the bottom of table 3, is $159.38.

As stated previously, there were three impacts of the policy letter. The first was that it resulted in a cost to applicants to provide the documentation needed to show eligibility for the MMC fee exemption. The second was the cost to the Coast Guard to process this documentation. The third was the transfer price associated with the costs of the fees being shifted from individual applicants to the Federal Government. The costs to applicants are discussed in detail in section (1), below. Costs to the Coast Guard are discussed in section (2). Section (3) discusses the combined costs to applicants and the Coast Guard, and section (4) details the transfer costs.

Applicants for an MMC fee waiver, under Policy Letter 02-20, need to provide documentation to show eligibility. Examples of documentation include, but are not limited to, active-duty orders citing Titles 10 or 14 of the United States Code, a letter from the command or personnel office on official letterhead stating that the applicant is currently serving under Titles 10 or 14, or similar documentation. The applicant should submit the documentation with their application for an MMC. 17

The National Maritime Center (NMC) estimates that it would take applicants 15 minutes to obtain eligibility documentation and include it with an MMC application. 18 19 The Coast Guard estimates the mean hourly rate of active duty uniformed service members at $39.48 per hour. 20 The Coast Guard estimates the mean monthly pay of active duty uniformed service members at $6,865.77. 21 That figure, $6,865.77, is multiplied by 12 to obtain an annual figure of $82,389.24 ($6,865.77 × 12). To estimate hourly rates, the Coast Guard divides $82,389.24 by 2,087, which the Office of Personnel and Management (OPM) uses as the number of working hours in a year, per 5 U.S.C. 5504(b)(1). Hence, the Coast Guard estimates the average hourly rate of active-duty uniformed service members at $39.48  22 ($82,389.24 ÷ 2,087) and estimates the cost to this population to provide documentation showing eligibility for the fee waiver at $9.87 ((15 minutes ÷ 60 minutes) × $39.48 = $9.87). As the Coast Guard forecasts 622 applicants per year, the total nominal cost is estimated at $6,139 per annum (622 × $9.87 = $6,139.14, rounded to $6,139). Table 4 shows the estimated nominal cost over a 14-year period, including discounted and annualized figures. As the policy letter became effective in 2020, table 4 shows the estimated costs for the 14-year period covering 2020 through 2033 (the 14-year period following the implementation of the policy letter). 23 Table 4 is showing the pre-policy letter baseline. All dollar figures in Table 4, and all other tables in this regulatory analysis, are in 2021 terms unless otherwise stated.