Comments Invited

The FAA invites you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0198; Project Identifier MCAI-2020-00950-E” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Kevin M. Clark, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2020-13-07, Amendment 39-21152 (85 FR 38312, June 26, 2020), (AD 2020-13-07), for all RRD Trent 1000-D2, Trent 1000-J2, and Trent 1000-K2 model turbofan engines with fuel pump, part number G5030FPU01, installed. AD 2020-13-07 was prompted by the manufacturer's investigation into an unexpected reduction in fuel pump performance in certain high life fuel pumps. AD 2020-13-07 requires removal and replacement of the affected fuel pump with a part eligible for installation. The FAA issued AD 2020-13-07 to reduce the risk of reduced thrust during engine operation.

Since the FAA issued AD 2020-13-07, The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2021-0006, dated January 7, 2021 (referred to after this as “the MCAI”), to address the unsafe condition on these products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket on https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0198.

This product has been approved by EASA and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information. The FAA is issuing this NPRM because the Agency evaluated all the relevant information provided by EASA and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

The FAA reviewed Rolls-Royce (RR) Alert Non-Modification Service Bulletin TRENT 1000-73-AK581, Revision 2, dated December 2, 2020 (RR Alert NMSB). The RR Alert NMSB introduces a reduced life limit for affected fuel pumps installed on certain RRD Trent 1000 model turbofan engines. The RR Alert NMSB also includes additional RRD Trent 1000 turbofan engine models that require implementation of the reduced life limits for affected fuel pumps. 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 retain all the requirements of AD 2020-13-07. This proposed AD would add an additional part-number fuel pump and additional RRD Trent 1000 model turbofan engines on which this fuel pump is installed to the applicability. This proposed AD would require new and reduced life limits for certain part-numbered fuel pumps, depending on the engine model the fuel pump is installed on.

EASA AD 2021-0006 identifies RRD Trent 1000-E and Trent 1000-E2 model turbofan engines in the Applicability section. This AD does not include RRD Trent 1000-E and Trent 1000-E2 model turbofan engines in the Applicability. These engine models have never been produced and RR Alert NMSB TRENT 1000 73-AK581, Revision 2, dated December 2, 2020, did not publish life limits for affected fuel pumps installed on these engine models.

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

The FAA estimates that this AD, if adopted as proposed, would affect 28 engines installed on airplanes of U.S. registry.

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

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

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

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

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

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

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

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

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-2021-0199; Project Identifier MCAI-2021-00016-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Katherine Venegas, Aviation Safety Engineer, Los Angeles ACO Branch, FAA, 3960 Paramount Blvd., Lakewood, California 90712; telephone (562) 627-5353; email katherine.venegas@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0284, dated December 20, 2018 (EASA AD 2018-0284), to correct an unsafe condition for Airbus Helicopters Deutschland GmbH (AHD) Model EC135 P1, EC135 P2, EC135 P2+, EC135 P3, EC135 T1, EC135 T2, EC135 T2+, EC135 T3, EC635 P2+, EC635 P3, EC635 T1, EC635 T2+, and EC635 T3 helicopters. Model EC635 P2+, EC635 P3, EC635 T1, and EC635 T3 helicopters are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this proposed AD therefore does not include those helicopters in the applicability.

This proposed AD was prompted by a report of a report of increased control force in the collective axis on an AHD Model EC135 helicopter. Subsequent inspections determined that a nut on a piston of the MRA had cracked and separated from the piston rod. The FAA is proposing this AD to prevent failure of the MRA and subsequent loss of control of the helicopter. See the EASA AD for additional background information.

EASA AD 2018-0284 describes procedures for a one-time visual inspection of the MRA and depending on the results, replacing the affected parts.

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.

These products have been approved by the aviation authority of another country, and are approved for operation in the United States. Pursuant to the bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the Mandatory Continuing Airworthiness Information (MCAI) referenced above. The FAA is proposing this AD after evaluating all the relevant information and determining the unsafe condition described previously is likely to exist or develop in other products of these same type designs.

This proposed AD would require accomplishing the actions specified in EASA AD 2018-0284 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 MCAI.”

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA initially worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has since coordinated with other manufacturers and civil aviation authorities (CAAs) to use this process. As a result, EASA AD 2018-0284 will be incorporated by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2018-0284 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 the EASA AD 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 the EASA AD. Service information specified in EASA AD 2018-0284 that is required for compliance with EASA AD 2018-0284 will be available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0199 after the FAA final rule is published.

The EASA AD requires contacting Airbus Helicopters or replacing an affected part, where as this proposed AD would require performing the corrective action in accordance with FAA-approved procedures or removing the affected parts from service instead. Where the EASA AD specifies a compliance time for the inspection in terms of calendar time or flight hours, this proposed AD would require a compliance time in terms of hours time-in-service instead. Where the EASA AD specifies a compliance time of 15 days for reporting the inspection results, this proposed AD would require that the findings be reported within 30 days.

The FAA considers this proposed AD interim action. If final action is later identified, the FAA might consider further rulemaking then.

The FAA estimates that this AD affects 331 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates that operators may incur the following costs in order to comply with this proposed AD.

Inspecting the nuts on the MRA pistons would take about 1 work-hour for an estimated cost of $85 per helicopter and $28,135 for the U.S. fleet.

Replacing the MRA would take about 7 work-hours and parts would cost $325,081 for an estimated cost of $325,676 per helicopter.

Repairing the MRA would take up to about 8 work-hours and parts would cost about $110 for an estimated cost of up to $790 per MRA.

Reporting information would take about 1 hour for an estimated cost of $85 per helicopter and $28,135 for the U.S. fleet.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to 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 control number for the collection of information required by this proposed AD is 2120-0056. The paperwork cost associated with this proposed AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this proposed AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed 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) Will not affect intrastate aviation in Alaska, and

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

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

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want to make it publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want to make it publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

DEA will generally make available in publicly redacted form comments containing personal identifying information and confidential business information identified as directed above. If a comment has so much confidential business information that it cannot be effectively redacted, DEA may not make available publicly all or part of that comment. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document and supplemental information to this proposed rule are available at http://www.regulations.gov for easy reference.

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act, 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. Interested persons may file requests for a hearing or notices of intent to participate in a hearing in conformity with the requirements of 21 CFR 1308.44(a) or (b), and they shall include a statement of interest in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. 21 CFR 1316.47(a). Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing together with a written statement regarding the interested person's position on the matters of fact and law involved in any hearing as set forth in 21 CFR 1308.44(c).

All requests for hearing and waivers of participation, together with a written statement of position on the matters of fact and law involved in such hearing, must be sent to DEA using the address information provided above.

The Controlled Substances Act (CSA) provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion. 21 U.S.C. 811(a). This proposed action is supported by a recommendation from the Acting Assistant Secretary for Health of the Department of Health and Human Services (HHS) and an evaluation of all other relevant data by DEA. If finalized, this action would make permanent the existing temporary regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144.

On April 16, 2019, pursuant to 21 U.S.C. 811(h)(1), DEA published an order in the Federal Register (84 FR 15505) temporarily placing ethyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N -(adamantan-1-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)); 1-(5-fluoropentyl)- N -(2-phenylpropan-2-yl)-1 H -indazole-3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1 H -indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name: FUB-144) in schedule I of the CSA upon finding that these five synthetic cannabinoids (SCs) pose an imminent hazard to the public safety. That temporary order was effective on the date of publication. Pursuant to 21 U.S.C. 811(h)(2), the temporary control of these substances is set to expire on April 16, 2021. However, this same subsection also provides that during the pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to a substance, the temporary scheduling of that substance may be extended for up to one year. Proceedings for the scheduling of a substance under 21 U.S.C. 811(a) may be initiated by the Attorney General (delegated to the Administrator of DEA pursuant to 28 CFR 0.100) on his own motion, at the request of the Secretary of HHS, 1 or on the petition of any interested party. An extension of the existing temporary order is being ordered by the Acting Administrator of DEA (Acting Administrator) in a separate action, and is being simultaneously published elsewhere in this issue of the Federal Register.

The Acting Administrator, on his own motion, is initiating proceedings under 21 U.S.C. 811(a)(1) to permanently schedule 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. DEA gathered the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for these five SCs. On December 4, 2019, the former Acting Administrator submitted this data to the Assistant Secretary for Health of HHS (Assistant Secretary), and requested that HHS provide DEA with a scientific and medical evaluation and a scheduling recommendation for 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, in accordance with 21 U.S.C. 811(b) and (c). Upon evaluating the scientific and medical evidence, on February 26, 2021, the Acting Assistant Secretary submitted HHS's scientific and medical evaluation and scheduling recommendation for these five substances to the Acting Administrator. Upon receipt of the scientific and medical evaluation and scheduling recommendation from HHS, DEA reviewed the documents and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, in accordance with 21 U.S.C. 811(c).

As discussed in the background section, the Acting Administrator is initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 permanently to schedule I of the CSA. DEA has reviewed the scientific and medical evaluation and scheduling recommendation received from HHS, and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, pursuant to 21 U.S.C. 811(c). Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in its proposed scheduling action. Please note that both DEA Eight-Factor and HHS Eight-Factor analyses and the Acting Assistant Secretary's February 26, 2021, letter are available in their entirety under the tab “Supporting Documents” of the public docket of this action at http://www.regulations.gov, under Docket Number “DEA-491.”

1. The Drug's Actual or Relative Potential for Abuse: The term “abuse” is not defined in the CSA. However, the legislative history of the CSA suggests that DEA consider the following criteria in determining whether a particular drug or substance has a potential for abuse:  2

In its recommendation, HHS noted that the abuse of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 is creating a hazard to the health and safety of both the individual users and others within the community. Adverse effects have been observed following the ingestion of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 (see factor 6). SCs, including 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, are easily accessible and difficult to detect in standard urine drug screens. These factors are contributing to their popularity and high rates of abuse, while resulting in serious harm to users. In addition, poison centers continue to report the abuse and harm of SCs in general and their associated products. SCs continue to remain a threat to both the short- and long-term public health and safety.

HHS stated in their letter to DEA dated September 6, 2018, and reiterated in their recommendation dated February 26, 2021, that there are no Food and Drug Administration (FDA)-approved drug products containing 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 in the United States and there appear to be no legitimate sources for these substances as marketed drugs. In their recommendation dated February 26, 2021, HHS stated that FDA is not aware of any diversion, from schedule I research or manufacturing activities, related to these five SCs for the purpose of legitimate drug research.

HHS stated that because 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 are not approved for medical use and are not formulated or available for clinical use, the human use of these substances is assumed to be on an individual's own initiative, rather than on the basis of medical advice from a practitioner licensed by law to administer drugs. Further, published scientific and medical literature and law enforcement reports indicate that individuals are taking these SCs on their own initiative, rather than on the basis of medical advice of a licensed practitioner.

HHS noted that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, similar to schedule I SCs ( e.g., JWH-018), bind to and activate the cannabinoid type 1 (CB1) receptors (see factor 2). In addition, drug discrimination studies conducted in rodents demonstrate that these five SCs, similar to other schedule I SCs ( e.g., JWH-018; AM2201; ADB-PINACA, AB-FUBINACA, etc.), fully substitute for delta-9-tetrahydrocannabinol (THC) in animals trained to discriminate THC from vehicle control (see factor 2).

2. Scientific Evidence of the Drug's Pharmacological Effects, if Known: In their recommendation, HHS described in vitro receptor binding and functional assays that were conducted using 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. These results indicate that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, similar to other schedule I SCs, bind to CB1 receptors and act as agonists at CB1 receptors. HHS also noted that drug discrimination studies were conducted in animals to evaluate whether the five SCs have cannabinoid characteristics similar to other substances in schedule I of the CSA. Each of the five SCs were shown to fully substitute for the discriminative stimulus effects produced by delta-9-THC. No human studies involving 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 have been reported.

3. The State of Current Scientific Knowledge Regarding the Drug or Other Substance: HHS stated that it is important to highlight the fact that the five SCs are structurally unrelated to THC, the principle psychoactive chemical in marijuana. Instead, they are potent cannabinoids that are reported to be smoked for recreational purposes. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 are all CB1 receptor agonists that are pharmacologically similar to THC.

As stated by HHS, when FDA approves a drug under the Federal Food, Drug, and Cosmetic Act for human or animal medical use, such drug is considered to have a currently accepted medical use in the United States. In the absence of such approval by FDA, a drug may be considered to have a currently accepted medical use in the United States if DEA concludes that the drug satisfies all of the following five elements:  3

According to the HHS recommendation, none of the five SCs has been approved by FDA as a human or animal drug product in the United States or, to FDA's knowledge, been approved for medical use in any other country. Moreover, there are no well-controlled clinical studies showing safety or efficacy for any of these cannabinoids. In addition, there is no evidence by qualified experts that any of the five cannabinoids are accepted as having therapeutic uses. Therefore, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 have no currently accepted medical use for treatment in the United States.

4. Its History and Current Pattern of Abuse: FUB-144 was first identified in seized drug evidence in January, 2014, followed by FUB-AKB48 (March 2014), 5F-MDMB-PICA (July 2014), 5F-EDMB-PINACA (October 2017) and 5F-CUMYL-PINACA (February 2018) (National Forensic Laboratory Information System [NFLIS], 2021). 4 Following their manufacture in China, SCs are often encountered in countries including New Zealand, Australia and Russia before appearing throughout Europe and eventually in the United States. 5F-CUMYL-PINACA was first reported in the German and Swiss illicit drug market in 2015 but did not appear in the United States until February 2018. 5F-EDMB-PINACA was reported in China in 2016 but didn't appear in the United States until October 2017. 5F-MDMB-PICA was first reported in the scientific literature in Germany and Belgium in late 2016. While two reports of 5F-MDMB-PICA were noted in NFLIS occurring in 2014 and 2016, it was not until 2017 and 2018 that there was a dramatic increase in 5F-MDMB-PICA reports in the United States. These data further support that based upon trends, SCs appear in the illicit drug markets of other countries including those in Europe often before being reported in the United States. Law enforcement has seized 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 and misuse of these SCs has been associated with overdoses requiring emergency medical intervention ( see Factor 6).

The powder form of SCs is typically dissolved in solvents ( e.g., acetone) before being applied to plant material, or dissolved in a propellant intended for use in electronic cigarette devices. In addition, 5F-EDMB-PINACA was identified as an adulterant on pieces of paper that were smuggled into a detention facility and later found partially burned (see Factor 6). 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, similar to other SCs, have been found in powder form or mixed with dried leaves or herbal blends that were marketed for human use.

5. The Scope, Duration, and Significance of Abuse: According to HHS, SCs continue to be encountered on the illicit market despite scheduling actions that attempt to safeguard the public from the adverse effects and safety issues associated with these substances. Novel SCs continue to be encountered that differ only by small chemical structural modifications intended to avoid prosecution, while maintaining the pharmacological effects. Law enforcement and health care professionals continue to report the abuse of these substances and their associated products. NFLIS detailed 8,207 reports from forensic laboratories for these five substances as follows: 667 reports of 5F-EDMB-PINACA, 6,014 reports of 5F-MDMB-PICA, 411 reports of FUB-AKB48, 117 reports of 5F-CUMYL-PINACA, and 998 reports of FUB-144 for a period from 2014 through 2020. 5 A full presentation of the NFLIS reports by substance and year are available in DEA's eight-factor analysis within the Supporting Documents section of the public docket available at http://www.regulations.gov.

6. What, if Any, Risk There is to the Public Health: HHS and DEA documented multiple cases where 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 have been identified in overdoses and/or cases involving death attributed to their abuse in the United States and abroad. Emergency medical intervention has been required as well as serious adverse health effects reported from these incidents involving 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. Adverse effects have included seizures, diaphoresis, hypertension, tachycardia, cerebral edema and/or death. By sharing pharmacological similarities with other schedule I substances (THC, JWH-018 and other temporarily and permanently controlled schedule I SCs), 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 pose serious risk to the abuser.

7. Its Psychic or Physiological Dependence Liability: There are no clinical studies evaluating dependence liabilities specific for 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. However, scientific data indicate that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 have pharmacological profiles that are similar to other schedule I SCs. HHS stated that based upon this similar pharmacological profile, it is reasonable to assume that these cannabinoids retain a physiological and psychological dependence liability that is similar to that of Δ9-THC (a schedule I drug) and to other schedule I synthetic cannabinoids, such as JWH-018, XLR11, and AKB-48.

8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled Under the CSA: As noted by HHS, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 are not immediate precursors of any controlled substance of the CSA as defined by 21 U.S.C 802(23).

Conclusion: After considering the scientific and medical evaluation conducted by HHS, HHS's recommendation, and DEA's own eight-factor analysis, DEA finds that the facts and all relevant data constitute substantial evidence of the potential for abuse of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. As such, DEA hereby proposes to permanently schedule 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 as controlled substances under the CSA.

The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Acting Assistant Secretary for Health of HHS and review of all other available data, the Acting Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds that:

1. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 have a high potential for abuse that is comparable to other schedule I substances such as THC and JWH-018;

2. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 have no currently accepted medical use in treatment in the United States; and

3. There is a lack of accepted safety for use of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 under medical supervision.

Based on these findings, the Acting Administrator of DEA concludes that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, including their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

If this rule is finalized as proposed, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 would continue  6 to be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, import, export, engagement in research, conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances, including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 is required to be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.

2. Security. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 are subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823 and in accordance with 21 CFR 1301.71-1301.76. Non-practitioners handling these five substances must also comply with the employee screening requirements of 21 CFR 1301.90-1301.93.

3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 must be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.

4. Quota. Only registered manufacturers are permitted to manufacture 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

5. Inventory. Any person registered with DEA to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 must have an initial inventory of all stocks of controlled substances (including 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144) on hand on the date the registrant first engages in the handling of controlled substances pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records and Reports. Every DEA registrant is required to maintain records and submit reports with respect to 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312, and 1317.

7. Order Forms. Every DEA registrant who distributes 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 is required to comply with the order form requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 1305.

8. Importation and Exportation. All importation and exportation of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

9. Liability. Any activity involving 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and could subject the person to administrative, civil, and/or criminal sanctions.

In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.

This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This proposed rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-602, has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On April 16, 2019, DEA published an order to temporarily place 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates that all entities handling or planning to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 have already established and implemented the systems and processes required to handle these substances. There are currently 28 unique registrations authorized to specifically handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. From a review of entity names, DEA estimates these 28 registrations represent 22 entities. Some of these entities are likely to be large entities. However, since DEA does not have information of registrant size and the majority of DEA registrants are small entities or are employed by small entities, DEA estimates a maximum of 22 entities are small entities. Therefore, DEA conservatively estimates as many as 22 small entities are affected by this proposed rule.

A review of the 28 registrations indicates that all entities that currently handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 also handle other schedule I controlled substances, and have established and implemented (or maintain) the systems and processes required to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. Therefore, DEA anticipates that this proposed rule will impose minimal or no economic impact on any affected entities; and thus, will not have a significant economic impact on any of the 22 affected small entities. Therefore, DEA has concluded that this proposed rule will not have a significant effect on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined and certifies that this action would not result in 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 million or more (adjusted annually for inflation) in any 1 year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

For the reasons set out above, DEA proposes to amend 21 CFR part 1308 as follows:

The additions to read as follows:

Posting of Public Comments

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this proposed rule is available at http://www.regulations.gov for easy reference.

The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, a chemical as a list I chemical. 21 U.S.C. 802(34). The term “list I chemical” means a chemical that is used in manufacturing a controlled substance in violation of the CSA and is important to the manufacture of the controlled substance. Id. Pursuant to 28 CFR 0.100(b), the Attorney General has delegated his authority to designate list I chemicals to the Administrator of DEA (Administrator).

The DEA regulations set forth the process by which DEA may add a chemical as a listed chemical. As set forth in 21 CFR 1310.02(c), the agency may do so by publishing a final rule in the Federal Register following a published notice of proposed rulemaking with at least 30 days for public comments. The current list of all list I chemicals is available in 21 CFR 1310.02(a).

In addition, the United States is a party to the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988 Convention), December 20, 1988, 1582 U.N.T.S. 95. Under Article 12 of the 1988 Convention, when the United States receives notification that a chemical has been added to Table I or Table II of the 1988 Convention, the United States is required to take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion. The 1988 Convention also requires the United States to take other specified measures related to that chemical, including measures related to its international trade.

By letter dated May 7, 2020, in accordance with Article 12, paragraph 6 of the 1988 Convention, the Secretary-General of the United Nations informed the United States Government that the chemical methyl alpha -phenylacetoacetate (MAPA), including its optical isomers, was added to Table I of the 1988 Convention. This letter was prompted by a March 4, 2020, decision at the 63rd Session of the United Nations Commission on Narcotic Drugs (CND) to add MAPA to Table I. As discussed above, the United States is a party to the 1988 Convention, and has certain obligations pursuant to Article 12. By designating MAPA as a list I chemical, the United States will fulfill its obligations under the 1988 Convention.

MAPA is used in, and is important to, the manufacture of the schedule II substances phenylacetone (also known as phenyl-2-propanone, P2P, or benzyl methyl ketone), methamphetamine, and amphetamine. Throughout the 1970s, methamphetamine was illicitly produced in the United States, primarily with the precursor chemical P2P. In response to the illicit use of P2P, DEA controlled P2P as a schedule II controlled substance in 1980 pursuant to the “immediate precursor” provisions of the CSA, specifically 21 U.S.C. 811(e). 1 Clandestine laboratory operators have circumvented this control by developing a variety of synthetic methods for producing P2P.

Congress and DEA responded by placing controls on precursor chemicals used in the illicit production of P2P, such as phenylacetic acid (and its salts and esters), acetic anhydride, benzyl cyanide, benzaldehyde, and nitroethane. 2 3 However, clandestine laboratory operators circumvented these controls by using alternative precursors that avoid the production of P2P: Ephedrine and pseudoephedrine for the production of methamphetamine; and phenylpropanolamine for the production of amphetamine. This led Congress and DEA to place stringent controls on the manufacture, distribution, importation, and exportation of ephedrine (its salts, optical isomers, and salts of optical isomers), pseudoephedrine, and phenylpropanolamine (controlled as list I chemicals), and pharmaceutical products containing these chemicals through the Combat Methamphetamine Epidemic Act of 2005 (Title VII of the USA PATRIOT Act Improvement and Reauthorization Act of 2005, Pub. L. 109-117), the Methamphetamine Production Prevention Act of 2008 (Pub. L. 110-415), and the Combat Methamphetamine Act of 2010 (Pub. L. 111-268). 4 The international community soon took similar measures.

With the growing problem of illicit drug production, the issue of precursor chemical control has gained global attention. International controls on precursors were first established under Article 12 of the 1988 Convention, which established two categories of controlled illicit drug precursor substances: Table I and Table II. 5 International efforts to prevent the illicit production of amphetamine-type stimulants (including amphetamine and methamphetamine), and international control of precursors, have since made significant progress. Two international entities have played a crucial role in this effort: The CND and the International Narcotics Control Board (INCB). The CND meets annually to consider and adopt a range of decisions and resolutions related to international drug control treaties, including the 1988 Convention. The INCB is an independent, quasi-judicial expert body for the implementation of the international drug control treaties, including the 1988 Convention.

In response to domestic and international controls on amphetamine and methamphetamine precursors, clandestine laboratory operators have continued to explore alternate methods of making these illicit drugs, including developing techniques to manufacture their own precursors and diverting other precursors to produce these precursors. The INCB reported the emergence of MAPA in late 2017, noting its use as a precursor for the production of P2P. 6 The emergence and increase in encounters of MAPA are linked to increased scrutiny over other P2P precursors, such as alpha -phenylacetoacetamide (APAA). 7 Although MAPA does not have any legitimate use and it has not been widely traded through legitimate channels, it is advertised by online suppliers. 8 Clandestine laboratory operators currently use MAPA to manufacture P2P, which they then convert to methamphetamine and amphetamine.

MAPA is known as methyl alpha -phenylacetoacetate; methyl 3-oxo-2-phenylbutanoate; methyl 2-phenylacetoacetate; α-acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5. MAPA first emerged in late 2017 with the Netherlands reporting seizures totaling nearly 490 kg on Form D. 9 Belgium followed in 2018 with reports through the Precursors Incident Communication System (PICS) of more than 550 kg of MAPA seized. 10 China was reported as the alleged origin for all of the incidents in the Netherlands or Belgium where the origin was provided. The INCB reported an increase in the frequency of seizures and amounts seized reported through PICS since November 2018. 11

MAPA is a close chemical relative of precursors controlled under the 1988 Convention ( e.g., APAAN and APAA) and the timing of its emergence suggests it is trafficked to circumvent these recent precursor controls. The INCB notes that MAPA does not have any legitimate use. 12 DEA has not identified any known legitimate use for MAPA, other than in small amounts for research, development, and laboratory analytical purposes. Due to the lack of industrial uses of MAPA, the chemical has not been widely available from legitimate chemical suppliers. Since late 2017, however, there have been large international seizures of MAPA, primarily in Europe, which suggest there is a ready supply of MAPA from international chemical manufacturers. The only use for a large quantity of MAPA of which DEA is aware is as a primary precursor for conversion to P2P, and subsequent conversion to amphetamine or methamphetamine.

Between late 2017, and May 7, 2019, the INCB noted 29 incidents from PICS where MAPA was seized. The amount of MAPA seized in individual incidents ranged from 500 grams to 2 metric tons, and totaled more than 10.5 metric tons. All incidents reported in PICS occurred in Europe, or involved shipments of MAPA destined for countries in Europe.

DEA has determined that MAPA is now readily available from commercial chemical suppliers and has identified seven potential suppliers in China, five potential suppliers in the United States, three potential suppliers in the United Kingdom, and one potential supplier each in France, Hong Kong, and Latvia.

DEA is concerned about the ease with which MAPA serves as a precursor chemical for illicit controlled substance production and with the international trafficking in this chemical. The international community shares this concern. The INCB found “that MAPA is frequently used in the illicit manufacture of amphetamine-type stimulants, namely amphetamine, and that the volume and extent of the illicit manufacture of amphetamine-type stimulants pose serious public health or social problems so as to warrant international action.”  13 Based in part on the findings of the INCB, and as noted above, the CND has added MAPA to Table I of the 1988 Convention. Therefore, DEA is proposing the designation of MAPA as a list I chemical.

For the reasons discussed above, the Acting Administrator of DEA finds that MAPA is used in the manufacture of controlled substances ( i.e., schedule II substances P2P, methamphetamine, and amphetamine) in violation of the CSA and is important to the manufacture of these controlled substances. Laboratory operators are using MAPA as the precursor material for the illicit manufacture of P2P, methamphetamine, and amphetamine. Therefore, the Acting Administrator proposes the designation of MAPA as a list I chemical.

If finalized, handlers of MAPA would become subject to the chemical regulatory provisions of the CSA, including 21 CFR parts 1309, 1310, 1313, and 1316. Since 1 gram of MAPA could make approximately 1 gram of methamphetamine hydrochloride, which is equivalent to approximately 200 tablets containing 5 milligrams of methamphetamine hydrochloride, this action does not propose the establishment of a threshold for domestic and import transactions of MAPA in accordance with the provisions of 21 CFR 1310.04(g). Therefore, DEA is proposing that all MAPA transactions, regardless of size, would be regulated transactions as defined in 21 CFR 1300.02(b). As such, if finalized, all MAPA transactions would be subject to recordkeeping, reporting, import and export controls, and other CSA chemical regulatory requirements. In addition, each regulated bulk manufacturer must submit manufacturing, inventory, and use data on an annual basis, in accordance with 21 CFR 1310.05(d).

This rulemaking also proposes that chemical mixtures containing MAPA would not be exempt from regulatory requirements at any concentration, unless a manufacturer submits to DEA an application for exemption of such chemical mixture, DEA accepts the application for filing, and DEA exempts the chemical mixture in accordance with 21 CFR 1310.13 (Exemption of chemical mixtures by application). Since 1 gram of MAPA could make approximately 1 gram of methamphetamine hydrochloride, which is equivalent to approximately 200 tablets containing 5 milligrams of methamphetamine hydrochloride, regulation of chemical mixtures containing any amount of MAPA is necessary to prevent the illicit extraction, isolation, and use of MAPA. Therefore, all chemical mixtures containing any quantity of MAPA would be subject to control under the CSA, unless a manufacturer of MAPA is granted an exemption by the application process in accordance with 21 CFR 1310.13. This rulemaking proposes the modification of the “Table of Concentration Limits” in 21 CFR 1310.12(c) to reflect the fact that chemical mixtures containing any amount of MAPA are subject to CSA chemical control provisions.

DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations. 14 Manufacturers may submit an application for exemption for those mixtures that do not meet the criteria set forth in 21 CFR 1310.12(d) for an automatic exemption. Pursuant to 21 CFR 1310.13(a), DEA may grant an exemption of a chemical mixture, by publishing a final rule in the Federal Register , if DEA determines that: (1) The mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance, and (2) the listed chemical or chemicals cannot be readily recovered.

If finalized as proposed, the designation of MAPA as a list I chemical would subject handlers (manufacturers, distributors, importers, and exporters) and proposed handlers to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of a list I chemical. Upon publication of a final rule, persons potentially handling MAPA, including regulated chemical mixtures containing MAPA, would be required to comply with the following list I chemical regulations:

1. Registration. Any person who handles (manufactures, distributes, imports, or exports), or proposes to engage in such handling of, MAPA or a chemical mixture containing MAPA must obtain a registration pursuant to 21 U.S.C. 822, 823, 957, and 958. Regulations describing registration for list I chemical handlers are set forth in 21 CFR part 1309. DEA regulations require separate registrations for manufacturing, distributing, importing, and exporting of MAPA. 15 Further, a separate registration is required for each principal place of business at one general physical location where list I chemicals are manufactured, distributed, imported, or exported by a person. 16

DEA notes that under the CSA, “warehousemen” are not required to register and may lawfully possess list I chemicals, if the possession of those chemicals is in the usual course of business or employment. 17 Under DEA implementing regulations, the warehouse in question must receive the list I chemical from a DEA registrant and shall only distribute the list I chemical back to the DEA registrant and registered location from which it was received. 18 A warehouse that distributes list I chemicals to persons other than the registrant and registered location from which they were obtained is conducting distribution activities and is required to register as such.

Upon publication of a final rule, any person manufacturing, distributing, importing, or exporting MAPA or a chemical mixture containing MAPA would become subject to the registration requirement under the CSA. DEA recognizes, however, that it is not possible for persons who are subject to the registration requirements to immediately complete and submit an application for registration and for DEA to immediately issue registrations for those activities. Therefore, to allow any continued legitimate commerce in MAPA, DEA is proposing to establish in 21 CFR 1310.09 a temporary exemption from the registration requirement for persons desiring to engage in activities with MAPA, provided that DEA receives a properly completed application for registration on or before 30 days after publication of a final rule implementing regulations regarding MAPA. The temporary exemption for such persons would remain in effect until DEA takes final action on their application for registration or application for exemption of a chemical mixture.

The temporary exemption would apply solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, would become effective on the effective date of the final rule. Therefore, all transactions of MAPA and chemical mixtures containing MAPA would be regulated while an application for registration or exemption is pending. This is necessary because a delay in regulating these transactions could result in increased diversion of chemicals desirable to drug traffickers.

Additionally, the temporary exemption for registration does not suspend applicable Federal criminal laws relating to MAPA, nor does it supersede State or local laws or regulations. All handlers of MAPA must comply with applicable State and local requirements in addition to the CSA regulatory controls.

2. Records and Reports. Every DEA registrant would be required to maintain records and submit reports to DEA with respect to MAPA pursuant to 21 U.S.C. 830(a) and (b)(1) and (2) and in accordance with 21 CFR 1310.04 and 1310.05. Pursuant to 21 CFR 1310.04, a record must be made and maintained for two years after the date of a transaction involving a listed chemical, provided the transaction is a regulated transaction.

Each regulated bulk manufacturer of a listed chemical would be required to submit manufacturing, inventory, and use data on an annual basis. 19 Existing standard industry reports containing the required information would be acceptable, provided the information is separate or readily retrievable from the report.

The CSA and its implementing regulations require that each regulated person must report to DEA any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of subchapter I of the CSA. In addition, regulated persons must report any proposed regulated transaction with a person whose description or other identifying characteristics DEA has previously furnished to the regulated person, any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person, and any in-transit loss in which the regulated person is the supplier. 20

3. Importation and Exportation. All importation and exportation of MAPA would need to be in compliance with 21 U.S.C. 957, 958, and 971 and in accordance with 21 CFR part 1313.

4. Security. All applicants and registrants would be required to provide effective controls against theft and diversion of list I chemicals in accordance with 21 CFR 1309.71-1309.73.

5. Administrative Inspection. Places, including factories, warehouses, or other establishments and conveyances, where registrants or other regulated persons may lawfully hold, manufacture, distribute, or otherwise dispose of a list I chemical or where records relating to those activities are maintained, are controlled premises as defined in 21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for administrative inspections of these controlled premises as provided in 21 CFR part 1316, subpart A. 21

6. Liability. Any activity involving MAPA not authorized by, or in violation of, the CSA would be unlawful, and would subject the person to administrative, civil, and/or criminal action.

This proposed rule was developed in accordance with the principles of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866. E.O. 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB) as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more 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, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O. DEA has determined that this proposed rule is not a “significant regulatory action” under E.O. 12866, section 3(f).

If finalized as proposed, MAPA would be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. MAPA is used in, and is important to, the illicit manufacture of the schedule II-controlled substances P2P, methamphetamine, and amphetamine.

DEA has searched information in the public domain for any legitimate uses of this chemical. Other than the small amounts for research, development, and laboratory analytical purposes, DEA has not documented any industrial use for MAPA except for it being a chemical intermediate in the production of the schedule II substances P2P, methamphetamine, and amphetamine. Based on the review of established aggregate production quota for P2P (40 grams for 2019), legal conversion of MAPA to P2P in the United States, if it takes place at all, is limited to small, gram quantities. Therefore, DEA concludes the vast majority of, if not all, MAPA is used for the manufacturing of illicit P2P, methamphetamine, and amphetamine.

DEA cannot rule out the possibility that minimal quantities of MAPA are used for the manufacturing of legitimate P2P. However, if there are any quantities of MAPA used for the manufacturing of legitimate P2P, the quantities are believed to be minimal. DEA welcomes any public comment on these quantities and their economic significance.

DEA evaluated the costs and benefits of this proposed action.

DEA believes the market for MAPA for the legitimate manufacturing of pharmaceutical amphetamine or methamphetamine is minimal. As stated above, the only use for MAPA of which DEA is aware is as a chemical intermediate for the manufacture of P2P, methamphetamine, and amphetamine. Any manufacturer, distributor, importer, or exporter of MAPA for the production of legitimate P2P, methamphetamine, and amphetamine, if they exist at all, would incur costs if this proposed rule were finalized. The primary costs associated with this proposed rule would be the annual registration fees for manufacturers ($3,699) and for distributors, importers, and exporters ($1,850). However, any manufacturer that uses MAPA for legitimate P2P, methamphetamine, and amphetamine production would already be registered with DEA and have all security and other handling processes established because of the controls already in place on P2P, methamphetamine, and amphetamine, resulting in minimal cost to those entities. As there are different forms of handling the scheduled substances versus the list I chemical (distribution of P2P, methamphetamine, and amphetamine versus exporting MAPA), this could require a separate registration for the different handling of the substances. If an entity is already registered to handle, manufacture, import, or export a scheduled substance, the entity would not need an additional registration for the list I chemical, provided it is handling the list I chemical in the same manner that it is registered for with the scheduled substance, or as a coincident activity permitted by § 1309.21. Even with the possibility of these additional registrations, DEA believes that the cost would be minimal.

DEA has identified five domestic suppliers of MAPA, only one of which is registered with DEA to handle list I chemicals. It is difficult to estimate the quantity of MAPA these suppliers distribute. Chemical distributors often have items in their catalog while not actually having any material level of sales. If this proposed rule is finalized, suppliers for the legitimate use of MAPA, if any, are expected to choose the least-cost option, and stop selling the minimal quantities of MAPA, rather than incur the registration cost. Because DEA believes the quantities of MAPA supplied for the legitimate manufacturing of P2P, methamphetamine, and amphetamine are minimal, DEA estimates that the cost of foregone sales is minimal; and thus, the cost of this proposed rule is minimal. DEA welcomes any public comment regarding this estimate.

This analysis excludes consideration of any economic impact to those businesses that facilitate the manufacture and distribution of MAPA for the production of manufacturing illicit P2P, methamphetamine, and amphetamine. As a law enforcement organization and as a matter of principle, DEA believes considering the economic utility of facilitating the manufacture of illicit P2P, methamphetamine, and amphetamine would be improper.

Controlling MAPA is expected to prevent, curtail, and limit the unlawful manufacture and distribution of the controlled substances P2P, methamphetamine, and amphetamine. As a list I chemical, handling of MAPA would require registration with DEA, various controls, and monitoring as required by the CSA. This proposed rule is also expected to assist in preventing the possible theft or diversion of MAPA from any legitimate firms. DEA also believes control is necessary to prevent unscrupulous chemists from synthesizing MAPA and selling it (as an unregulated material) through the internet and other channels, to individuals who may wish to acquire an unregulated chemical intermediate for the purpose of manufacturing illicit P2P, methamphetamine, and amphetamine.

In summary, DEA conducted a qualitative analysis of costs and benefits. DEA believes this proposed action, if finalized, will minimize the diversion of MAPA. DEA believes the market for MAPA for the legitimate manufacturing of P2P, methamphetamine, and amphetamine is minimal. Therefore, any potential cost as a result of this regulation is minimal.

This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This proposed rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Acting Administrator, in accordance with the Regulatory Flexibility Act (RFA), 22 has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. As discussed above, if finalized as proposed, MAPA would be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, and exportation of list I chemicals. MAPA is used in, and is important to, the illicit manufacture of the schedule II-controlled substances P2P, methamphetamine, and amphetamine. DEA has not identified any legitimate industrial use for MAPA, other than its role as a chemical intermediate in the production of P2P, methamphetamine, and amphetamine. Based on the review of established aggregate production quota for P2P, 40 grams for 2019, legal conversion of MAPA to P2P in the United States, if it takes place at all, is limited to small, gram quantities. Therefore, DEA believes the vast majority, if not all, of MAPA is used for the illicit manufacturing of P2P, methamphetamine, and amphetamine. The primary costs associated with this proposed rule are the annual registration fees ($3,699 for manufacturers and $1,850 for distributors, importers, and exporters). Additionally, any manufacturer that uses MAPA for legitimate P2P, methamphetamine, and amphetamine production would already be registered with DEA and have all security and other handling processes in place, resulting in minimal cost.

DEA has identified five domestic suppliers of MAPA, only one of which is registered with DEA to handle list I chemicals. Based on Small Business Administration (SBA) size standards for chemical distributors and Statistics of U.S. Business data, each of the five suppliers are small entities because their revenues are below SBA's $150 million threshold. It is difficult to estimate the quantity of MAPA these suppliers distribute. Chemical distributors often have items in their catalog while not actually having any material level of sales. Based on the review of established aggregate production quota for P2P (40 grams for 2019), legal conversion of MAPA to P2P in the United States is limited to small, gram quantities. DEA believes any quantity of sales of MAPA from these distributors for legitimate P2P manufacturing is minimal. Therefore, DEA estimates the cost of this proposed rule on any affected small entity is minimal. DEA welcomes any public comment regarding this estimate. Based on these factors, DEA projects that this proposed rule, if promulgated, will not result in a significant economic impact on a substantial number of small entities.

On the basis of information contained in the RFA section above, DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not result in 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 1 year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of UMRA.

This proposed action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This proposed action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Accordingly, for the reasons set forth in the preamble, DEA proposes to further amend 21 CFR part 1310, as proposed to be amended at 85 FR 82984 (December 21, 2020) as follows:

The addition reads as follows:

This is a summary of the Commission's Notice of Proposed Rulemaking and Notice of Inquiry, FCC 21-36, in PS Docket Nos. 15-94 and 15-91, adopted on March 17, 2021 and released on March 19, 2021. The full text of this document is available at https://docs.fcc.gov/public/attachments/FCC-21-36A1.pdf.

Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

• Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: http://apps.fcc.gov/ecfs/.

• Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing.

Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701. U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.

• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. See FCC Announces Closure of FCC Headquarters Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020). https://www.fcc.gov/document/fcc-closes-headquarters-open-window-and-changes-hand-delivery-policy .

People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

The proceeding this Notice initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules, 47 CFR 1.1200 et seq. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with rule 1.1206(b). In proceedings governed by rule 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format ( e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

In this document, the Federal Communications Commission (the FCC or Commission), takes actions implementing section 9201 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021, Public Law 116-283, 134 Stat. 3388, § 9201 (NDAA21), exploring opportunities to improve the way the public receives emergency alerts on their mobile phones, televisions, and radios. The nation's Emergency Alert System (EAS) and Wireless Emergency Alerts System (WEA) ensure that the public is quickly informed about emergency alerts issued by federal, state, local, Tribal, and territorial governments and delivered over the radio, television, and mobile wireless devices.

Consistent with congressional directive, the Commission proposes rules to ensure that more people receive relevant emergency alerts, to enable EAS and WEA participants to report false alerts when they occur, and to improve the way states plan for emergency alerts. In this notice of proposed rulemaking, the Commission proposes to implement sections 9201(a)-(d) of the NDAA21 by adopting rules to ensure that mobile devices cannot opt-out of receiving WEA alerts from the Administrator of the Federal Emergency Management Agency (FEMA). The Commission also proposes rules to encourage chief executives of states and territories to form State Emergency Communications Committees (SECC) if none exist in their states and to adopt additional requirements concerning their SECC's administration of State EAS Plans. For jurisdictions that already have a SECC, the Commission encourages chief executives to review its composition and governance. The Commission proposes to enable the Administrator of FEMA and state, local, Tribal, and territorial governments to report false EAS and WEA alerts when they occur. Also, the Commission proposes rules to permit repeating EAS alerts issued by the President, the Administrator of FEMA, and any other entity determined appropriate under the circumstances by the Commission. The rules the Commission proposes are intended to facilitate the further development of a robust and redundant system for distributing vital alert information to all Americans.

In addition, the Commission initiates an inquiry to implement section 9201(e) of the NDAA21. Section 9201(e) directs that the Commission “[n]ot later than 180 days after the date of enactment of [the] Act, and after providing public notice and opportunity for comment. . .complete an inquiry to examine the feasibility of updating the Emergency Alert System to enable or improve alerts to consumers provided through the internet, including through streaming services.” In this notice of inquiry, the Commission seeks comment on the definition of “streaming services” and whether it would be technically feasible for streaming services to complete each step that EAS Participants complete under the Commission's rules in ensuring the end-to-end transmission of EAS alerts, including monitoring for relevant EAS alerts, receiving and processing EAS alerts, retransmitting EAS alerts, presenting EAS alerts in an accessible manner to relevant consumers, and testing. The Commission also seeks comment on related matters including whether and how to leverage the capabilities of the internet and end-user devices to enhance the alerting capabilities of the radio and television stations, cable systems, satellite radio and television providers, and wireline video providers that currently participate in EAS, as well as which additional internet-based services, if any, should be examined. As directed by Congress, after the conclusion of this inquiry, the Commission will submit a report on its findings and conclusions to the Committee on Commerce, Science, and Transportation of the United States Senate and the Committee on Energy and Commerce of the United States House of Representatives.

This notice of proposed rulemaking may contain new or modified information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA). If the Commission adopts any new or modified information collection requirements, they will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other federal agencies will be invited to comment on the new or modified information collection requirements contained in this proceeding. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, we seek specific comment on how we might further reduce the information collection burden for small business concerns with fewer than 25 employees.

As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the notice of proposed rulemaking ( Notice ). Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the Notice.

In the Notice, the Commission proposes amending the rules governing Wireless Emergency Alerts (WEA) and the Emergency Alert System (EAS) in response to the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021. Specifically, the Commission seeks comment on proposed rules that would (i) replace WEA's existing Presidential Alert class with a National Alert class that would ensure that WEA-enabled mobile devices could not opt-out of receiving WEA alerts issued by the President (or the President's authorized designee) or by the Administrator of the Federal Emergency Management Agency (FEMA); (ii) require participating CMS providers that use WEA header displays that read “Presidential Alert” to change those alert headers to read “National Alert;” (iii) encourage chief executives of states to form State Emergency Communications Committees (SECC) if none exist in their states, or if they do, to review their composition and governance; (iv) incorporate certain processing actions concerning SECCs' and the FCC's administration of State EAS Plans; (v) enable false EAS and WEA alert reporting by the Administrator of FEMA as well as State, local, Tribal, and territorial governments; and (vi) provide for repeating EAS alerts issued by the President, the Administrator of FEMA and any other entity determined appropriate under the circumstances by the Commission, in consultation with the Administrator of FEMA. To the extent this proposed and contemplated action may result in greater participation by state, local, Tribal, and territorial governments in the administration of State EAS Plans, enhanced administration of EAS alerting, hasten corrective action of any false alerts issued, and better enable alert originators to repeat alerts, they would benefit the public by strengthening national, state, local, Tribal, and territorial alerting activities, minimizing confusion and disruption caused by false alerts, and increase the chances for the public to receive critical alert messages.

The proposed action is authorized pursuant to the National Defense Authorization Act for Fiscal Year 2021, Public Law 116-283, 134 Stat. 3388 (2021), sec. § 9201.

The RFA directs agencies to provide a description of and, where feasible, an estimate of, the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

Small Businesses, Small Organizations, and Small Governmental Jurisdictions. Our action may, over time, affect small entities that are not easily categorized at present. We therefore describe here, at the outset, three broad groups of small entities that could be directly affected herein. First, while there are industry specific size standards for small businesses that are used in the regulatory flexibility analysis, according to data from the SBA's Office of Advocacy, in general a small business is an independent business having fewer than 500 employees. These types of small businesses represent 99.9% of all businesses in the United States which translates to 30.7 million businesses.

Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements for small exempt organizations. Nationwide, for tax year 2018, there were approximately 571,709 small exempt organizations in the U.S. reporting revenues of $50,000 or less according to the registration and tax data for exempt organizations available from the IRS.

Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2017 Census of Governments indicate that there were 90,056 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 36,931 General purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,040 special purpose governments—independent school districts with enrollment of less than 50,000. Accordingly, based on the 2017 U.S. Census of Governments data, we estimate that at least 48,971 entities fall into the category of “small governmental jurisdictions.”

Radio Stations. This Economic Census category comprises establishments primarily engaged in broadcasting aural programs by radio to the public. Programming may originate in their own studio, from an affiliated network, or from external sources.” The SBA has established a small business size standard for this category as firms having $41.5 million or less in annual receipts. Economic Census data for 2012 show that 2,849 radio station firms operated during that year. Of that number, 2,806 firms operated with annual receipts of less than $25 million per year, 17 with annual receipts between $25 million and $49,999,999 million and 26 with annual receipts of $50 million or more. Therefore, based on the SBA's size standard the majority of such entities are small entities.

In addition to the U.S. Census Bureau's data, based on Commission data we estimate that there are 4,560 licensed AM radio stations, 6,704 commercial FM radio stations and 8,339 FM translator and booster stations. The Commission has also determined that there are 4,196 noncommercial educational (NCE) FM radio stations. The Commission however does not compile and does not otherwise have access to information on the revenue of NCE stations that would permit it to determine how many such stations would qualify as small entities under the SBA size standard.

We also note, that in assessing whether a business entity qualifies as small under the above definition, business control affiliations must be included. The Commission's estimate therefore likely overstates the number of small entities that might be affected by its action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, to be determined a “small business,” an entity may not be dominant in its field of operation. We further note, that it is difficult at times to assess these criteria in the context of media entities, and the estimate of small businesses to which these rules may apply does not exclude any radio station from the definition of a small business on these bases, thus our estimate of small businesses may therefore be over-inclusive. Also, as noted above, an additional element of the definition of “small business” is that the entity must be independently owned and operated. The Commission notes that it is difficult at times to assess these criteria in the context of media entities and the estimates of small businesses to which they apply may be over-inclusive to this extent.

FM Translator Stations and Low-Power FM Stations. FM translators and Low Power FM Stations are classified in the category of Radio Stations and are assigned the same NAICS Code as licensees of radio stations. This U.S. industry, Radio Stations, comprises establishments primarily engaged in broadcasting aural programs by radio to the public. Programming may originate in their own studio, from an affiliated network, or from external sources. The SBA has established a small business size standard which consists of all radio stations whose annual receipts are $38.5 million dollars or less. U.S. Census Bureau data for 2012 indicate that 2,849 radio station firms operated during that year. Of that number, 2,806 operated with annual receipts of less than $25 million per year, 17 with annual receipts between $25 million and $49,999,999 million and 26 with annual receipts of $50 million or more. Therefore, based on the SBA's size standard we conclude that the majority of FM Translator Stations and Low Power FM Stations are small.

We note again, however, that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations must be included. Because we do not include or aggregate revenues from affiliated companies in determining whether an entity meets the applicable revenue threshold, our estimate of the number of small radio broadcast stations affected is likely overstated. In addition, as noted above, one element of the definition of “small business” is that an entity would not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific radio broadcast station is dominant in its field of operation. Accordingly, our estimate of small radio stations potentially affected by the rule revisions discussed in the Notice includes those that could be dominant in their field of operation. For this reason, such estimate likely is over-inclusive.

Television Broadcasting. This Economic Census category “comprises establishments primarily engaged in broadcasting images together with sound.” These establishments operate television broadcast studios and facilities for the programming and transmission of programs to the public. These establishments also produce or transmit visual programming to affiliated broadcast television stations, which in turn broadcast the programs to the public on a predetermined schedule. Programming may originate in their own studio, from an affiliated network, or from external sources. The SBA has created the following small business size standard for such businesses: Those having $41.5 million or less in annual receipts. The 2012 Economic Census reports that 751 firms in this category operated in that year. Of that number, 656 had annual receipts of $25,000,000 or less, and 25 had annual receipts between $25,000,000 and $49,999,999. Based on this data we therefore estimate that the majority of commercial television broadcasters are small entities under the applicable SBA size standard.

The Commission has estimated the number of licensed commercial television stations to be 1,368. According to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) on November 16, 2017, 1,258 stations (or about 91 percent) had revenues of $38.5 million or less, and therefore these licensees qualified as small entities under the SBA definition. In addition, the Commission has estimated the number of licensed noncommercial educational television stations to be 390. Notwithstanding, the Commission does not compile and otherwise does not have access to information on the revenue of NCE stations that would permit it to determine how many such stations would qualify as small entities. There are also 2,246 low power television stations, including Class A stations (LPTV), and 3,543 TV translator stations. Given the nature of these services, we will presume that all of these entities qualify as small entities under the above SBA small business size standard.

We note, however, that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, another element of the definition of “small business” requires that an entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television broadcast station is dominant in its field of operation. Accordingly, the estimate of small businesses to which rules may apply does not exclude any television station from the definition of a small business on this basis and is therefore possibly over-inclusive. Also, as noted above, an additional element of the definition of “small business” is that the entity must be independently owned and operated. The Commission notes that it is difficult at times to assess these criteria in the context of media entities and its estimates of small businesses to which they apply may be over-inclusive to this extent.

Cable and Other Subscription Programming. The U.S. Census Bureau defines this industry as establishments primarily engaged in operating studios and facilities for the broadcasting of programs on a subscription or fee basis. The broadcast programming is typically narrowcast in nature ( e.g., limited format, such as news, sports, education, or youth-oriented). These establishments produce programming in their own facilities or acquire programming from external sources. The programming material is usually delivered to a third party, such as cable systems or direct-to-home satellite systems, for transmission to viewers. The SBA size standard for this industry establishes as small, any company in this category which receives annual receipts of $41.5 million or less. According to 2012 U.S. Census Bureau data, 367 firms operated for the entire year. Of that number, 319 operated with annual receipts of less than $25 million a year and 48 firms operated with annual receipts of $25 million or more. Based on this data, the Commission estimates that the majority of firms operating in this industry are small.

Cable System Operators (Rate Regulation Standard). The Commission has developed its own small business size standards for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers nationwide. Industry data indicate that there are 4,600 active cable systems in the United States. Of this total, all but five cable operators nationwide are small under the 400,000-subscriber size standard. In addition, under the Commission's rate regulation rules, a “small system” is a cable system serving 15,000 or fewer subscribers. Commission records show 4,600 cable systems nationwide. Of this total, 3,900 cable systems have fewer than 15,000 subscribers, and 700 systems have 15,000 or more subscribers, based on the same records. Thus, under this standard as well, we estimate that most cable systems are small entities.

Cable System Operators (Telecom Act Standard). The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than one percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” As of 2019, there were approximately 48,646,056 basic cable video subscribers in the United States. Accordingly, an operator serving fewer than 524,037 subscribers shall be deemed a small operator if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate. Based on available data, we find that all but nine incumbent cable operators are small entities under this size standard. We note that the Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million. Although it seems certain that some of these cable system operators are affiliated with entities whose gross annual revenues exceed $250 million, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.

Satellite Telecommunications. This category comprises firms “primarily engaged in providing telecommunications services to other establishments in the telecommunications and broadcasting industries by forwarding and receiving communications signals via a system of satellites or reselling satellite telecommunications.” Satellite telecommunications service providers include satellite and earth station operators. The category has a small business size standard of $35 million or less in average annual receipts, under SBA rules. For this category, U.S. Census Bureau data for 2012 show that there was a total of 333 firms that operated for the entire year. Of this total, 299 firms had annual receipts of less than $25 million. Consequently, we estimate that the majority of satellite telecommunications providers are small entities.

All Other Telecommunications. The “All Other Telecommunications” category is comprised of establishments that are primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation. This industry also includes establishments primarily engaged in providing satellite terminal stations and associated facilities connected with one or more terrestrial systems and capable of transmitting telecommunications to, and receiving telecommunications from, satellite systems. Establishments providing internet services or voice over internet protocol (VoIP) services via client-supplied telecommunications connections are also included in this industry. The SBA has developed a small business size standard for “All Other Telecommunications,” which consists of all such firms with gross annual receipts of $32.5 million or less. For this category, U.S. Census data for 2012 show that there were 1,442 firms that operated for the entire year. Of these firms, a total of 1,400 had gross annual receipts of less than $25 million. Thus, the Commission estimates that the majority of “All Other Telecommunications” firms potentially affected by our action can be considered small.

Broadband Radio Service and Educational Broadband Service. Broadband Radio Service systems, previously referred to as Multipoint Distribution Service (MDS) and Multichannel Multipoint Distribution Service (MMDS) systems, and “wireless cable,” transmit video programming to subscribers and provide two-way high speed data operations using the microwave frequencies of the Broadband Radio Service (BRS) and Educational Broadband Service (EBS) (previously referred to as the Instructional Television Fixed Service (ITFS)).

BRS —In connection with the 1996 BRS auction, the Commission established a small business size standard as an entity that had annual average gross revenues of no more than $40 million in the previous three calendar years. The BRS auctions resulted in 67 successful bidders obtaining licensing opportunities for 493 Basic Trading Areas (BTAs). Of the 67 auction winners, 61 met the definition of a small business. BRS also includes licensees of stations authorized prior to the auction. At this time, we estimate that of the 61 small business BRS auction winners, 48 remain small business licensees. In addition to the 48 small businesses that hold BTA authorizations, there are approximately 86 incumbent BRS licensees that are considered small entities (18 incumbent BRS licensees do not meet the small business size standard). After adding the number of small business auction licensees to the number of incumbent licensees not already counted, there are currently approximately 133 BRS licensees that are defined as small businesses under either the SBA or the Commission's rules.

In 2009, the Commission conducted Auction 86, the sale of 78 licenses in the BRS areas. The Commission offered three levels of bidding credits: (i) A bidder with attributed average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years (small business) received a 15 percent discount on its winning bid; (ii) a bidder with attributed average annual gross revenues that exceed $3 million and do not exceed $15 million for the preceding three years (very small business) received a 25 percent discount on its winning bid; and (iii) a bidder with attributed average annual gross revenues that do not exceed $3 million for the preceding three years (entrepreneur) received a 35 percent discount on its winning bid. Auction 86 concluded in 2009 with the sale of 61 licenses. Of the ten winning bidders, two bidders that claimed small business status won 4 licenses; one bidder that claimed very small business status won three licenses; and two bidders that claimed entrepreneur status won six licenses.

EBS —Educational Broadband Service has been included within the broad economic census category and SBA size standard for Wired Telecommunications Carriers since 2007. Wired Telecommunications Carriers are comprised of establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” The SBA's small business size standard for this category is all such firms having 1,500 or fewer employees. U.S. Census Bureau data for 2012 show that there were 3,117 firms that operated that year. Of this total, 3,083 operated with fewer than 1,000 employees. Thus, under this size standard, the majority of firms in this industry can be considered small. In addition to Census data, the Commission's Universal Licensing System indicates that as of October 2014, there are 2,206 active EBS licenses. The Commission estimates that of these 2,206 licenses, the majority are held by non-profit educational institutions and school districts, which are by statute defined as small businesses.

Direct Broadcast Satellite (“DBS”) Service. DBS service is a nationally distributed subscription service that delivers video and audio programming via satellite to a small parabolic “dish” antenna at the subscriber's location. DBS is included in the category of “Wired Telecommunications Carriers.” The Wired Telecommunications Carriers industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or combination of technologies. Establishments in this industry use the wired telecommunications network facilities that they operate to provide a variety of services, such as wired telephony services, including VoIP services, wired (cable) audio and video programming distribution; and wired broadband internet services. By exception, establishments providing satellite television distribution services using facilities and infrastructure that they operate are included in this industry. The SBA size standard considers a wireline business is small if it has fewer than 1,500 employees. U.S. Census Bureau data for 2012 indicates that 3,117 wireline companies were operational during that year. Of that number, 3,083 operated with fewer than 1,000 employees. Based on that data, we conclude that the majority of wireline firms are small under the applicable SBA standard. Currently, however, only two entities provide DBS service, which requires a great deal of capital for operation: DIRECTV (owned by AT&T) and DISH Network. DIRECTV and DISH Network each report annual revenues that are in excess of the threshold for a small business. Accordingly, we must conclude that internally developed FCC data are persuasive that, in general, DBS service is provided only by large firms.

Wireless Telecommunications Carriers (except Satellite). This industry comprises establishments engaged in operating and maintaining switching and transmission facilities to provide communications via the airwaves. Establishments in this industry have spectrum licenses and provide services using that spectrum, such as cellular services, paging services, wireless internet access, and wireless video services. The appropriate size standard under SBA rules is that such a business is small if it has 1,500 or fewer employees. For this industry, U.S. Census Bureau data for 2012 show that there were 967 firms that operated for the entire year. Of this total, 955 firms had employment of 999 or fewer employees, and 12 firms had employment of 1,000 employees or more. Thus under this category and the associated size standard, the Commission estimates that the majority of wireless telecommunications carriers (except satellite) are small entities.

AWS Services (1710-1755 MHz and 2110-2155 MHz bands (AWS-1); 1915-1920 MHz, 1995-2000 MHz, 2020-2025 MHz and 2175-2180 MHz bands (AWS-2); 2155-2175 MHz band (AWS-3)). For the AWS-1 bands, the Commission has defined a “small business” as an entity with average annual gross revenues for the preceding three years not exceeding $40 million, and a “very small business” as an entity with average annual gross revenues for the preceding three years not exceeding $15 million. For AWS-2 and AWS-3, although we do not know for certain which entities are likely to apply for these frequencies, we note that the AWS-1 bands are comparable to those used for cellular service and personal communications service. The Commission has not yet adopted size standards for the AWS-2 or AWS-3 bands but proposes to treat both AWS-2 and AWS-3 similarly to broadband PCS service and AWS-1 service due to the comparable capital requirements and other factors, such as issues involved in relocating incumbents and developing markets, technologies, and services.

Narrowband Personal Communications Services. Two auctions of narrowband personal communications services (PCS) licenses have been conducted. To ensure meaningful participation of small business entities in future auctions, the Commission has adopted a two-tiered small business size standard in the Narrowband PCS Second Report and Order. Through these auctions, the Commission has awarded a total of 41 licenses, out of which 11 were obtained by small businesses. A “small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $40 million. A “very small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $15 million. The SBA has approved these small business size standards.

Broadband Personal Communications Service. The broadband personal communications service (PCS) spectrum is divided into six frequency blocks designated A through F, and the Commission has held auctions for each block. The Commission initially defined a “small business” for C- and F-Block licenses as an entity that has average gross revenues of $40 million or less in the three previous calendar years. For F-Block licenses, an additional small business size standard for “very small business” was added and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. These standards defining “small entity,” in the context of broadband PCS auctions, have been approved by the SBA. No small businesses within the SBA-approved small business size standards bid successfully for licenses in Blocks A and B. There were 90 winning bidders that claimed small business status in the first two C-Block auctions. A total of 93 bidders that claimed small business status won approximately 40 percent of the 1,479 licenses in the first auction for the D-, E-, and F-Blocks. On April 15, 1999, the Commission completed the reauction of 347 C-, D-, E-, and F-Block licenses in Auction No. 22. Of the 57 winning bidders in that auction, 48 claimed small business status and won 277 licenses.

On January 26, 2001, the Commission completed the auction of 422 C- and F-Block Broadband PCS licenses in Auction No. 35. Of the 35 winning bidders in that auction, 29 claimed small business status. Subsequent events concerning Auction No. 35, including judicial and agency determinations, resulted in a total of 163 C- and F-Block licenses being available for grant. On February 15, 2005, the Commission completed an auction of 242 C-, D-, E-, and F-Block licenses in Auction No. 58. Of the 24 winning bidders in that auction, 16 claimed small business status and won 156 licenses. On May 21, 2007, the Commission completed an auction of 33 licenses in the A-, C-, and F-Blocks in Auction No. 71. Of the 12 winning bidders in that auction, five claimed small business status and won 18 licenses. On August 20, 2008, the Commission completed the auction of 20 C-, D-, E-, and F-Block Broadband PCS licenses in Auction No. 78. Of the eight winning bidders for Broadband PCS licenses in that auction, six claimed small business status and won 14 licenses.

Wireless Communications Services. This service can be used for fixed, mobile, radiolocation, and digital audio broadcasting satellite uses. The Commission defined “small business” for the wireless communications services (WCS) auction as an entity with average gross revenues of $40 million for each of the three preceding years, and a “very small business” as an entity with average gross revenues of $15 million for each of the three preceding years. The SBA has approved these small business size standards. In the Commission's auction for geographic area licenses in the WCS there were seven winning bidders that qualified as “very small business” entities, and one that qualified as a “small business” entity.

Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing. This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment. The SBA has established a small business size standard for this industry of 1,250 employees or less. U.S. Census Bureau data for 2012 shows that 841 establishments operated in this industry in that year. Of that number, 828 establishments operated with fewer than 1,000 employees, 7 establishments operated with between 1,000 and 2,499 employees, and 6 establishments operated with 2,500 or more employees. Based on this data, we conclude that a majority of manufacturers in this industry are small.

The action proposed in the Notice, if adopted, will impose additional reporting, recordkeeping and/or other compliance obligations on certain small, as well as other, entities that process WEA alerts and manufacture mobile devices that receive such alerts, and could impose additional reporting, recordkeeping and/or other compliance obligations on small, as well as other, entities that, administer State EAS Plans, process and transmit EAS alerts, and manufacture equipment designed to process EAS alerts.

More specifically, the Notice seeks comment on adding a national alert category of FEMA Administrator national alerts to WEA that WEA-enabled mobile devices could not opt-out of receiving, which, as proposed will require modifications to Commercial Mobile Service (CMS) providers' network and/or mobile device equipment. Our proposal would accomplish this required change by combining the existing Presidential Alert class of WEA alerts with the new FEMA Administrator class of alerts into a single new category of “National Alerts.” As proposed, our action would require certain CMS providers to update device WEA alert header displays and settings menus related to their network infrastructure, including mobile devices. We propose an implementation timeline of approximately one year for CMS providers to make these changes to device displays.

The Notice also seeks comment on requiring that each SECC, not less frequently than annually, shall meet to review and update its State EAS Plan, and certify as much in the updated plan it submits annually to the Commission. In response to NDAA21's requirement for the Commission to adopt regulations requiring SECCs to meet annually to review and update their State EAS Plan, and to certify that such meeting was completed, we propose to amend § 11.21 of our rules to include as a required element in the State EAS Plan, a certification by the SECC Chairperson or Vice-Chairperson that the SECC meet (in person, via teleconference, or via other methods of conducting virtual meetings) at least once in the twelve months prior to submitting the annual updated plan to review and update their State EAS Plan. We further propose that such certification, if adopted, would be incorporated into the ARS. Section 11.21 already includes a requirement that State EAS Plans be updated annually, and the ARS requires annual updating as well, however, we propose to add some clarifying language to § 11.21 to more closely reflect the legislation's requirements on this point. To the extent any SECC is not meeting annually, such meeting requirement may require greater coordination efforts on the part of such SECC. The Notice also seeks comment on the creation of a proposed State EAS Plan content checklist for SECCs to use when reviewing and updating a State EAS Plan for submission to the Commission that identifies the information requested to ensure more complete State EAS Plan reporting. Section 11.21 already includes a listing of information required in the State EAS Plan, and the Alert Reporting System (ARS) data entry menus mirror these informational requirements (and will not allow a State EAS Plan to be submitted unless all required fields are completed). In the Notice, we inquire whether there is other information that should be included as part of the checklist for reporting.

In addition, the Notice seeks comment on modifying the EAS rules to provide for repeating EAS alerts issued by the President, the Administrator of FEMA and any other entity determined appropriate under the circumstances by the Commission. To the extent the modifications adopted involve adding a new alert originator and/or event code, or other changes to the EAS Protocol or alert processing by the EAS device, such change(s) likely would entail modifying the existing deployed base of EAS devices via software updates, which would entail some installation-related costs.

The NDAA21 also requires the Commission to establish a voluntary reporting system to receive from the FEMA Administrator or State, local, Tribal, or territorial governments reports of false alerts under the Emergency Alert System or the Wireless Emergency Alerts System for the purpose of recording such false alerts and examining the causes of such false alerts. To address this requirement, we propose to revise our rules to specify that, if the Administrator of FEMA or a State, local, Tribal, or territorial government entity becomes aware of transmission of an EAS or WEA false alert to the public, they may send an email to the Commission to inform the Commission of the false alert event and of any details that they may have concerning the event. In addition, we propose a minor revision to the existing rule requiring false alert reports from EAS industry participants to clarify the required nature of those reports compared to the voluntary reporting system for the Administrator of FEMA or a State, local, Tribal, or territorial government entity.

To help the Commission more fully evaluate the cost of compliance should our proposals be adopted, in the Notice we request comments on the cost implications of our proposals and ask whether there are more efficient and less burdensome alternatives for the Commission to address our obligations under the NDAA21. Although the Commission cannot fully quantify the cost of compliance for all small entities impacted by the rules proposed in the Notice, we believe our proposed modifications to the WEA and EAS rules are the most efficient and least burdensome approach to codifying the requirements of the NDAA21. We expect the information we receive in comments including cost and benefit analyses, to help the Commission identify and evaluate relevant matters for small entities, including compliance costs and other burdens that may result from the proposals and inquiries we make in the Notice.

The RFA requires an agency to describe any significant, specifically small business alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) and exemption from coverage of the rule, or any part thereof, for small entities.”

The proposed action in the Notice are designed to be minimally burdensome to all affected entities, including small entities. While the Commission does not expect the proposals to have a significant economic impact on small entities, below we discuss actions that should minimize any significant impact on small entities and some alternatives we considered.

The Commission believes that its proposal to replace WEA's existing Presidential Alert class with a National Alert class is the appropriate approach because it would require few, if any, technical changes to be made to participating CMS provider networks or the mobile devices of their subscribers and impose fewer costs than available alternatives. This proposal allows all participating CMS providers' wireless systems currently receiving mandatory Presidential Alerts, to receive “National Alerts” the same way—distributed automatically as a non-optional alert to the same class of wireless customers that they currently receive Presidential Alerts. This can be effectuated by using the existing WEA handling code for Presidential Alerts along with the name change to “National Alerts,” which minimizes costs for participating CMS providers. With respect to our proposal to require participating CMS providers that use WEA header displays that read “Presidential Alert” to change those alert headers to read “National Alert,” the Commission's approach grants participating CMS providers flexibility in the approach they use to ensure compliance. Specifically, this proposed requirement could be satisfied by any approach that ensures that “Presidential Alert” is not displayed on a user's mobile device, whether by changing the displayed header or not displaying the header at all. The Commission further proposes to reduce the burden on participating CMS providers by exempting from the requirement any network infrastructure that is technically incapable of meeting this requirement, such as situations in which legacy devices or networks cannot be updated to support this functionality. In our efforts to minimize costs and explore other alternatives, we have requested comments on each of these WEA proposals as well as on costs implications and cost estimates for these proposals as well as any alternatives.

The proposals to require each SECC to meet not less frequently than annually to review and update its State EAS Plan and certify as much in the updated plan it submits annually to the Commission, should not impose burdens on SECCs. The proposal allows SECCs to meet virtually, thus to the extent any SECC is not already meeting regularly, the annual meeting requirement would only entail greater coordination efforts on the part of such SECC to arrange a mutually agreeable time and meeting platform. While we recognize that the requirement to certify that the SECC has meet by phone, IP-based meeting application, or in person at least once annually, may impose some costs for SECC members, it is likely that many if not most SECCs are already are meeting in some form on a regular basis, and therefore the proposed annual meeting certification likely will certify an activity already being undertaken and documented.

In adopting a voluntary reporting process for FEMA or a State, local, Tribal, or territorial government entity to report false EAS or WEA transmissions to the Commission, we believe that our proposal, which provides a reporting system for receipt of false alerts via email directed to the Commission's Operations Center, is the most efficient, least costly, and least onerous method to implement this system. We have also structured this voluntary reporting system to be similar in format to the existing reporting requirement the Commission adopted in the Alerting Reliability Order and FNPRM, requiring EAS industry participants to report false EAS alerts to the Commission via email sent to the FCC Operations Center, avoiding the need for duplicative structures.

The primary rule modification proposed to provide for repeating EAS alerts issued by the President, the Administrator of FEMA and any other entity determined appropriate under the circumstances by the Commission would not add any burdens to any entity. To the extent the modifications adopted involve adding a new alert originator and/or event code, or other changes to the EAS Protocol or alert processing by the EAS device, such change(s) likely would entail modifying the existing deployed base of EAS devices via software updates, which would entail some minimal installation-related costs.

Throughout the Notice, the Commission has requested comment on the relative costs and benefits of these various proposed alternatives to ensure it has input from small entities and others to minimize the economic impacts of whatever action it might take. Nevertheless, in addition to the steps taken by the Commission discussed herein, commenters have been invited to propose steps that the Commission may take to further minimize any economic impact on small entities. Commenters have also been invited to propose alternatives that facilitate the Commission's obligations to implement the NDAA21 provisions.

None.

Accordingly, it is ordered , pursuant to the NDAA21, Public Law 116-283, 134 Stat. 3388, sec. 9201, that this notice of proposed rulemaking and notice of inquiry in PS Docket Nos. 15-94 and 15-91 is hereby adopted.

It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this notice of proposed rulemaking, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

For the reasons stated in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 10 and 11 as follows: