The ACEP interim rule was published in the Federal Register on January 6, 2020, (85 FR 558-590) to make changes to the ACEP policies and procedures in the ACEP regulations in 7 CFR part 1468. This correction is being published to address minor errors in the preamble portion of the ACEP interim rule. There are no changes to the ACEP regulations as published on January 6, 2020.

The Docket ID provided in the ADDRESSES section in the interim rule was incorrect as it should have matched the number provided in the document heading. The correct Docket ID is NRCS-2019-0006 and is correct throughout this document.

Additionally, in the ACEP wetland reserve easements (ACEP-WRE) Key-Changes preamble section on ACEP-WRE Wetland Restoration, on page 564 of the January 6, 2020, interim rule, the definition of “wetland restoration” from the previous ACEP regulation had been included for reference. NRCS recognizes that including the former definition may cause confusion. The interim rule revised the definition, and the new definition for the term “wetland restoration” can be found in § 1468.3 as revised.

At the time the interim rule was published, NRCS intended to request comment with respect to two additional matters.

In the discussion of § 1468.20(d) under the preamble heading “Summary of Changes to Subpart B, Agricultural Land Easements (ACEP-ALE)”, on page 565 of the interim rule, NRCS discussed the criteria by which land can be determined eligible and explains the reasons why land enrolled in ACEP-ALE cannot include forest land greater than two-thirds of the ACEP-ALE easement area. NRCS is requesting public comment about whether other NRCS conservation programs with an easement component, such as the Healthy Forest Reserve Program or the Regional Conservation Partnership Program, should be used to assist in the protection of agricultural lands on which nonindustrial private forest is the predominate use at levels beyond the scope of ACEP-ALE.

Additionally, NRCS requests public comment on recommendations to streamline access to ACEP and input on new or existing ranking criteria that would assist NRCS in selecting projects that best further ACEP purposes. Specifically, NRCS is considering whether there is anything that would fit under the language `other related conservation benefits' identified in § 1468.22(c)(3)(iv) that would not fit within the other criteria listed in § 1468.22(c)(3), in consideration of whether the criteria of `other related conservation benefits' should be kept (see page 580 of the interim rule). All comments received on or before the closing date for comments, March 20, 2020, will be considered. NRCS will review and respond to the public comments in the ACEP final rule.

The comment period for the ACEP interim rule was initially scheduled to close on March 6, 2020. This correction extends the comment period, which will now close on March 20, 2020. The public comment period for the EA and FONSI has also been extended until March 20, 2020. In addition, the URL in the January 6, 2020, interim rule for the EA and FONSI was in error. There have been no changes to either the EA or FONSI, the correction is that the URL was not going to the web page that contains the EA and FONSI. A copy of the EA and FONSI may be obtained at https://www.nrcs.usda.gov/wps/portal/nrcs/detailfull/national/programs/farmbill/?cid=stelprdb1263599 .

The regulations in 9 CFR subchapters B, C, and D pertain to the cooperative control and eradication of livestock or poultry diseases (subchapter B), the interstate transportation of animals (including poultry) and animal products (subchapter C), and the exportation and importation of animals (including poultry) and animal products (subchapter D).

In a proposed rule  1 published in the Federal Register on May 30, 2019 (84 FR 25013-25018, Docket No. APHIS-2016-0054), we proposed to consolidate the regulations governing diagnostic laboratory approval authorities for animal diseases covered by 9 CFR subchapters B through D into a single regulation and establish a set of standard procedures that we would use to conduct future diagnostic laboratory approvals. The consolidated regulations are intended to provide for consistent inspection protocols, proficiency testing methods, quality system guidelines, and definitions; facilitate the approval of additional laboratories in emergency situations; and simplify regulatory oversight and compliance.

We solicited comments for 60 days ending on July 29, 2019. We received six comments by that date, from private citizens and a State animal health commission. All the commenters generally supported the proposed rule. One commenter did raise a few questions, which are discussed below.

As part of the proposed rule, we proposed to remove the specific laboratory approval provisions found in our regulations regarding equine infectious anemia, Johne's disease, and contagious equine metritis. One commenter noted that the scope of the proposed regulations could appear to be limited to those three diseases, but stated they favored a more expansive interpretation that would include all the diseases cited in 9 CFR subchapters B, C, and D.

The commenter's more expansive interpretation is correct. As stated in proposed § 71.22(a), State, university, and private laboratories must obtain Animal and Plant Health Inspection Service (APHIS) approval to conduct official testing for those diseases covered by subchapters B, C, and D and must meet the requirements of § 71.22 in order to obtain and maintain that approval.

The same commenter stated that it should be clear that regulations also apply to laboratories that test for other communicable diseases of livestock or poultry that the Secretary may determine constitute an emergency and pose a threat to animal health. In that vein, the commenter also encouraged APHIS to continue to develop regulations for a national list of reportable animal diseases.

As anticipated by the commenter, the regulations will serve as the framework for the approval of laboratories that test for new or emerging communicable diseases of livestock or poultry for which tests are available should there be a need for those laboratories. We continue our work on developing regulations for a national list of reportable animal diseases.

Finally, the commenter asked for clarity as to whether or not there are any potential user fees for laboratory approvals and inspections by APHIS personnel.

User fees currently do apply with respect to some inspections conducted in connection with new or continuing approvals of laboratories, and those existing fees are not affected by this rule. Any new fees or adjustments to existing fees would be the subject of a separate regulatory action.

In the proposed rule, we proposed to define the term National Animal Health Laboratory Network (NAHLN) as “a nationally coordinated network and partnership of Federal, State, and university-associated animal health laboratories that provide animal health diagnostic testing, methods research and development, and expertise for education and extension to detect biological threats to the nation's animal agriculture, thus protecting animal health, public health, and the nation's food supply.” In this final rule, we are revising this proposed definition to indicate that the NAHLN is primarily composed of Federal, State, and university-associated animal health laboratories. This is because, on a case-by-case basis, private laboratories may be used in the NAHLN based on needed capabilities.

In the proposed rule, proposed paragraph (b) of § 71.22 provided that official testing would have to be performed in laboratory facilities with controlled conditions, instrumentation appropriate for the testing being conducted, and biosecurity measures commensurate with the disease of diagnostic concern, but neglected to specify that each of these facility requirements must be acceptable to APHIS. In this final rule, we are clarifying that the determinations that the requirements have been met must be made by APHIS, rather than the facility itself.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document. Executive Orders 12866 and 13771 and Regulatory Flexibility Act.

This rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. This rule is not an Executive Order 13771 regulatory action because it is not significant under Executive Order 12866.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov website (see footnote 1 above for a link to Regulations.gov ).

This rule consolidates existing diagnostic laboratory approval authorities for certain animal diseases into a single regulation and establishes a framework that we will use to conduct future diagnostic laboratory approvals. The consolidated regulations will serve to simplify regulatory oversight and compliance, saving time and resources. For both the laboratories and APHIS, consolidating and standardizing the process will create an easier-to-understand and more user-friendly approval process; improve efficiency in obtaining approvals to conduct testing for single or multiple diseases; reduce the administrative burden associated with obtaining and tracking laboratory approvals; and simplify the steps required to renew an existing approval.

There are over 400 APHIS-approved laboratories. The laboratories range widely in size, from one-person practices to large, State-wide systems. They are classified within the Veterinary Services industry, for which the Small Business Administration's small-entity standard is annual receipts of not more than $7.5 million. For the industry overall in 2012, there were 27,939 establishments that operated throughout the year. Ninety-nine percent (27,605 establishments) had receipts of less than $5 million. Thus, most of these entities are small.

Cost savings because of this rule would be realized mainly by approximately 50 larger laboratories due to the multiple tests they perform. In accordance with guidance on complying with Executive Order 13771, the single primary estimate of the yearly savings that would be provided by this proposed rule is $1.1 million, the mid-point estimate annualized in perpetuity using a 7 percent discount rate.

This rule will lessen the administrative burden for affected laboratories, benefiting rather than having any negative impact on them. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

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

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the reporting and recordkeeping requirements included in this final rule, which were filed under 0579-0472, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Mr. Joseph Moxey, APHIS' Information Collection Coordinator, at (301) 851-2483.

Accordingly, we are amending 9 CFR parts 71, 75, 80, and 93 as follows:

Discussion

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 382, 382B, 382E, 382F, and 382G airplanes, type certificated in any category; and Model C-130A, C-130B, C-130BL, C-130E, C-130H, C-130H-30, C-130J, C-130J-30, EC-130Q, HC-130H, KC-130H, NC-130B, NC-130, and WC-130H airplanes, type certificated in the restricted or amateur category. The NPRM published in the Federal Register on July 31, 2019 (84 FR 37165). The NPRM was prompted by a report indicating that two elevator booster assemblies experienced significant hydraulic fluid leaks, caused by fatigue cracks in the actuator cylinder. The NPRM proposed to require an inspection to determine the part number of the elevator booster actuator, repetitive ultrasonic inspections of the actuator to detect cracking, and replacement of cracked elevator booster assemblies.

The FAA is issuing this AD to address the possibility of a dual failure of the left and right actuator cylinders in the elevator booster assembly, which could lead to a significant reduction in controllability of the airplane.

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

Lynden Air Cargo, LLC stated that it concurred in concept and that the proposed AD would enhance safety.

Lynden Air Cargo, LLC requested clarification whether the ultrasonic inspection procedures in the proposed AD can also be accomplished for off-airplane spare elevator booster actuators. The commenter noted that the Accomplishment Instructions of Lockheed Martin Aeronautics Company Service Bulletin 382-27-51, Revision 1, dated January 17, 2018, state to do the inspection while the elevator booster actuators are installed on the airplane. The commenter asked that, if the inspection cannot be done off-airplane, alternative inspection procedures be provided.

The FAA agrees to clarify. Lockheed has issued Lockheed Martin Aeronautics Company Service Bulletin 382-27-51, Revision 2, dated October 3, 2019. This service information has been revised to clarify that the same inspection procedures can be accomplished with the elevator booster actuators either on or off the airplane. The FAA has revised this AD to refer to the latest service information and to provide credit for actions that were accomplished using Lockheed Martin Aeronautics Company Service Bulletin 382-27-51, Revision 1, dated January 17, 2018.

Lynden Air Cargo, LLC requested that paragraph (h) of the proposed AD be revised to refer to flight hours, rather than flight cycles. The commenter noted that all other references for compliance time in the proposed AD and the service information refer to flight hours.

The FAA agrees with the commenter's request. The NPRM inadvertently referred to flight cycles rather than flight hours in the location noted. Since paragraph (h) of this AD is a compliance time exception for certain airplanes, revising the language will not adversely affect safety, but will allow operators to use this exception. This final rule has been revised accordingly.

The affected airplane models were originally manufactured by Lockheed Martin Corporation/Lockheed Martin Aeronautics Company, but are currently operating as type certificated airplanes in any category, including restricted and amateur category airplanes with a variety of type certificate holders. The FAA has revised the SUMMARY , the Discussion section, and paragraph (c) of this AD to clarify that the affected airplanes are certificated in different categories. The FAA has also revised paragraph (c) of this AD to refer to the current type certificate holders.

The FAA has also revised the manufacturer contact information in the ADDRESSES section and paragraph (m)(3) of this AD. The website provided in the NPRM is no longer valid.

The proposed AD inadvertently referred to Lockheed Martin Aeronautics Company Service Bulletin 82-833, Revision 1, dated January 17, 2018. That service information is only applicable for airplanes operated by the U.S. military, and is not applicable for the airplanes identified in this AD. The FAA revised this AD to remove all references to Lockheed Martin Aeronautics Company Service Bulletin 82-833, Revision 1, dated January 17, 2018.

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

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

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

The FAA has also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

The FAA reviewed Lockheed Martin Aeronautics Company Service Bulletin 382-27-51, Revision 2, dated October 3, 2019. This service information describes procedures for an inspection to determine the part number of the elevator booster actuator, repetitive ultrasonic inspections of the elevator booster actuator at the forward-most end to detect cracking along the fluid transfer bore, left and right cylinders, and replacement of cracked elevator booster assemblies. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 7 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

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

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

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

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

Discussion

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0206, dated August 20, 2019 (“EASA AD 2019-0206”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A350-941 and -1041 airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A350-941 and -1041 airplanes. The NPRM published in the Federal Register on October 28, 2019 (84 FR 57655). The NPRM was prompted by reports of sealant bead damage caused by rotation of the attachment fitting bearing assembly of a THS. The NPRM proposed to require repetitive detailed inspections, and applicable corrective action(s) if necessary. In addition, as specified in the EASA AD, the NPRM provided an optional modification that would terminate the inspections.

The FAA is issuing this AD to address possible water ingress due to sealant bead damage, which could result in corrosion damage in the aluminum corner fitting. This condition, if not addressed, could lead to detachment and loss of the THS, possibly resulting in loss of control of the airplane and injury to persons on the ground. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule and has considered the comment received. Air Line Pilots Association, International (ALPA), indicated its support for the NPRM.

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

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

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

EASA AD 2019-0206 describes procedures for repetitive detailed inspections for damage of the fillet sealant and corrosion on aluminum in the lower and upper corner fittings and bearing assembly attachment interface at frame (FR) 102, left-hand and right-hand sides. EASA AD 2019-0206 also describes procedures for an optional modification (application of new corrosion protection in the THS upper and lower attachment fitting bearing assembly) that would eliminate the need for the repetitive inspections. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 11 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

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

The FAA has received no definitive data that would enable the agency to provide cost estimates for the repair specified in this AD.

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

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

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

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

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0190, dated July 31, 2019 (“EASA AD 2019-0190”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A300 series airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus SAS Model A300 series airplanes. The NPRM published in the Federal Register on October 28, 2019 (84 FR 57663). The NPRM was prompted by a report that indicated that bleed and air conditioning systems were contaminated by hydraulic fluid, and by an investigation that revealed that hydraulic fluid contaminations caused the failure of check valves installed on the hydraulic reservoir air pressurization system. The NPRM proposed to require repetitive functional tests of the hydraulic reservoir air pressurization lines, and repair or replacement if necessary.

The FAA is issuing this AD to address bleed and air conditioning systems contaminated by hydraulic fluid, which, if not detected and corrected, could lead to leakage of pressurization check valves, and, in case of pressurization line rupture, to loss of a hydraulic system, possibly resulting in reduced control of the airplane. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. We have considered the comment received. The Air Line Pilots Association, International (ALPA) stated that it supports NPRM.

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

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

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

EASA AD 2019-0190 describes procedures for repetitive functional tests of the hydraulic reservoir air pressurization lines, and repair or replacement if necessary. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 1 airplane of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates that it would take about 1 work-hour per product to comply with the reporting requirement in this AD. The average labor rate is $85 per hour. Based on these figures, the FAA estimates the cost of reporting the inspection results on U.S. operators to be $85.

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

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 AD is 2120-0056. The paperwork cost associated with this 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 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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

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

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

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

I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 2019, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

The sponsors of the following approved applications have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor:

Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661 has informed FDA that it has changed its address to 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092. Accordingly, we are amending § 510.600(c) to reflect this change.

Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234, has requested that FDA withdraw approval of NADA 010-005 for use of WAZINE (dipiperazine sulfate and piperazine hydrochloride) Soluble Powders because the product is no longer manufactured or marketed. Following this withdrawal of approval, Fleming Laboratories, Inc., is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c). In addition, Fleming Laboratories, Inc.'s product was the only piperazine product approved for use in food-producing animals. Accordingly, tolerances for piperazine will be removed from part 556.

Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092, has requested that FDA withdraw approval of ANADA 200-200 for use of Halothane USP (halothane) because the product is no longer manufactured or marketed.

Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103, has requested that FDA withdraw approval of ANADA 200-472 for use of Fomepizole Injection because the product is no longer manufactured or marketed.

Elsewhere in this issue of the Federal Register , FDA gave notice that approval of NADA 010-005 and ANADAs 200-200 and 200-472, and all supplements and amendments thereto, is withdrawn effective February 3, 2020. As provided in the regulatory text of this document, the animal drug regulations in parts 510, 520, 556, and 529 are amended to reflect these actions.

FDA is revising the regulations at 21 CFR 520.2520d to reflect the approved conditions of use of trichlorfon, phenothiazine, and piperazine soluble powder for oral administration to horses as an anthelmintic. This information was deleted in error during redesignation (79 FR 28833, May 20, 2014). FDA is also revising the regulations at 21 CFR 520.2612 to reflect the currently approved dosage for trimethoprim and sulfadiazine suspension for oral administration to horses as an antimicrobial. Lastly, FDA is revising the assay limits for nicarbazin medicated feeds at 21 CFR 558.4(d) in the “Category II” table. These actions are being taken to improve the accuracy of the regulations.

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.

Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 520, 522, 524, 529, 556, and 558 are amended as follows:

Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234, has requested that FDA withdraw approval of NADA 010-005 for use of WAZINE (dipiperazine sulfate and piperazine hydrochloride) Soluble Powders because the product is no longer manufactured or marketed.

Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092, has requested that FDA withdraw approval of ANADA 200-200 for use of Halothane USP (halothane) because the product is no longer manufactured or marketed.

Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103, has requested that FDA withdraw approval of ANADA 200-472 for use of Fomepizole Injection because the product is no longer manufactured or marketed.

Therefore, under authority delegated to the Commissioner of Food and Drugs and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADA 010-005 and ANADAs 200-200 and 200-472, and all supplements and amendments thereto, is hereby withdrawn, effective February 3, 2020.

Elsewhere in this issue of the Federal Register , FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.

Legal Authority

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; (2) at the request of the Secretary of the Department of Health and Human Services (HHS);  1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated on the Attorney General's own motion, as delegated to the Administrator of the DEA, and is supported by, inter alia, a recommendation from the Assistant Secretary for Health of HHS and an evaluation of all relevant data by the DEA. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA.

On April 10, 2017, DEA published an order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place the six synthetic cannabinoids (SCs) methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N -(adamantan-1-yl)-1-(5-fluoropentyl)-1 H -indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 82 FR 17119. That temporary scheduling order was effective on the date of publication, and was based on findings by the former Acting Administrator of the DEA (Acting Administrator) that the temporary scheduling of these six SCs was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), requires that the temporary control of these substances expire two years from the issuance date of the scheduling order, on or before April 9, 2019. However, the CSA also provides that during the pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, the temporary scheduling of that substance could be extended for up to one year. Accordingly, on April 8, 2019, DEA extended the temporary scheduling of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA by one year, or until April 9, 2020. 84 FR 13796. Also, on April 8, 2019, DEA published a notice of proposed rulemaking (NPRM) to permanently control 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA in schedule I of the CSA. 84 FR 13848. Specifically, DEA proposed to add these six SCs to the hallucinogenic substances list under 21 CFR 1308.11(d).

On March 21, 2019, HHS provided DEA with a scientific and medical evaluation document prepared by the Food and Drug Administration (FDA) entitled “Basis for the Recommendation to Place Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA], Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] and their Salts in Schedule I of the Controlled Substances Act.” After considering the eight factors in 21 U.S.C. 811(c), each substance's abuse potential, lack of legitimate medical use in the United States, and lack of accepted safety for use under medical supervision pursuant to 21 U.S.C. 812(b), the Assistant Secretary of HHS recommended that 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA be controlled in schedule I of the CSA. In response, DEA conducted its own eight factor analysis of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA. The DEA and HHS analyses are available in their entirety in the public docket for this rule (Docket Number DEA-446) at http://www.regulations.gov under “Supporting Documents.”

After a review of the available data, including the scientific and medical evaluation and the scheduling recommendations from HHS, DEA published a NPRM entitled “Schedules of Controlled Substances: Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA in Schedule I.” This NPRM proposed to control 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA, and their salts, isomers, and salts of isomers in schedule I of the CSA. 84 FR 13848, April 8, 2019. The proposed rule provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations on or before May 8, 2019. No requests for such a hearing were received by DEA. The NPRM also provided an opportunity for interested persons to submit comments on the proposed rule on or before May 8, 2019.

The DEA received three comments on the proposed rule to control 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA in schedule I of the CSA.

Support for rulemaking: Two commenters recognized the dangers and public health risks, and supported the rulemaking to permanently place these substances in schedule I.

DEA Response: The DEA appreciates the comments in support of this rulemaking.

Dissent for rulemaking: One commenter stated that while SCs, in general, could pose a public health risk, are more harmful than “traditional cannabis,” and have no known legitimate medical use, this individual disagreed with the permanent control of these specific six substances. This commenter also questioned the appropriateness and effectiveness of current drug control policy and mentioned use of alternative approaches such as investing in treatment of current SC users, education about harmful effects of SCs, removal of cannabis from schedule I, and additional research into the substances at issue in this rulemaking. In addition, the commenter discussed the increased cost associated with regulatory, administrative, and enforcement activities involving scheduled drugs and concern over potential tribal implications.

DEA response: DEA's mission is to enforce the controlled substance laws and regulations of the United States. The CSA contains specific mandates pertaining to the scheduling of controlled substances. DEA has followed all of those mandates regarding the scheduling of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA, including receiving from the Secretary of HHS a scientific and medical evaluation, and recommendation, regarding control (21 U.S.C. 811(b)); considering the factors enumerated in 21 U.S.C. 811(c); determining, based on the above, appropriate scheduling for these SCs (21 U.S.C. 812(b)); and conducting a formal rulemaking to schedule these SCs (21 U.S.C. 811(a)). These SCs satisfy the CSA's criteria for placement in schedule I by virtue of their high potential for abuse, the fact that these substances have no currently accepted medical use in treatment in the United States, and their lack of accepted safety for use of the substance under medical supervision. 21 U.S.C. 812(b)(1).

As per the commenter's views regarding the appropriateness and effectiveness of current drug control policy, use of alternative approaches such as investing in treatment, education about harmful effects of SCs, and removal of cannabis from schedule I, these are outside the scope of the current scheduling action.

Regarding the increased costs associated with regulatory, administrative, and enforcement activities involving scheduled drugs, these issues are not unique to the substances that are currently being controlled by this final rule.

Regarding the commenter's concern that the scheduling of these SCs will have tribal implications, DEA has analyzed the expected impact of this final rule, and has determined that it will 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. As evidence, the commenter cites the incarceration rates of Native Americans and native youths relative to the national average; however, does not explain how this data is relevant to the substances being permanently scheduled in this final rule.

As per the comment related to additional research into the substances at issue in this rulemaking, DEA has utilized funding of its own to conduct pharmacological research studies into all these six substances. The data generated from these studies have been utilized in evaluating these substances for control under the CSA. HHS, upon conducting scientific and medical evaluation of these and all available data, recommended schedule I controls for these substances. DEA conducted its own review of HHS scientific and medical evaluation and all other relevant data and determined that these substances warrant control as schedule I substances under the CSA. Additional information about these substances can be viewed in the public docket for this rule (Docket Number DEA-446) at http://www.regulations.gov under “Supporting Documents.”

After consideration of the relevant matter presented as a result of public comments, the scientific and medical evaluations and accompanying recommendation of HHS, and after its own eight-factor evaluation, DEA finds that these facts and all other relevant data constitute substantial evidence of potential for abuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA. As such, DEA is permanently scheduling 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA 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 Assistant Secretary for HHS and review of all other available data, the Acting Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:

(1) Methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N -(adamantan-1-yl)-1-(5-fluoropentyl)-1 H -indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] have a high potential for abuse that is comparable to other schedule I substances such as delta-9-tetrahydrocannabinol (Δ 9 -THC) and JWH-018;

(2) Methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N -(adamantan-1-yl)-1-(5-fluoropentyl)-1 H -indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] have no currently accepted medical use in treatment in the United States; and

(3) There is a lack of accepted safety for use of methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N -(adamantan-1-yl)-1-(5-fluoropentyl)-1 H -indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA] under medical supervision.

Based on these findings, the Acting Administrator of DEA concludes that methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N -(adamantan-1-yl)-1-(5-fluoropentyl)-1 H -indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], 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).

5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA will continue  2 to be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, research, and conduct of instructional activities, including the following:

1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA must 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-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA are subject to schedule I security requirements and must be handled in accordance with 21 CFR 1301.71-1301.93.

3. Labeling and Packaging. All labels and labeling for commercial containers of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA 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-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

5. Inventory. Every DEA registrant who possesses any quantity of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA was required to keep an inventory of all stocks of these substances on hand as of April 10, 2017, 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 must maintain records and submit reports with respect to 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and/or MDMB-FUBINACA, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312.

7. Order Forms. Every DEA registrant who distributes 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA must continue 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-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA must continue to 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-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

Executive Orders 12866, 13563, and 13771, Regulatory Planning and Review, Improving Regulation and Regulatory Review, and Reducing Regulation and Controlling Regulatory Costs

In accordance with 21 U.S.C. 811(a), this final 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 12866 and the principles reaffirmed in Executive Order 13563.

This final rule does not meet the definition of an Executive Order 13771 regulatory action. OMB has previously determined that formal rulemaking actions concerning the scheduling of controlled substances, such as this rule, are not significant regulatory actions under section 3(f) of Executive Order 12866.

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

This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The 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 rule does not have tribal implications warranting the application of Executive Order 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), 5 U.S.C. 601-602, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On April 10, 2017, DEA published an order to temporarily place these six substances 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 these substances have already established and implemented the systems and processes required to handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA. There are currently 33 registrations authorized to handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and/or MDMB-FUBINACA specifically, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. These 33 registrations represent 28 entities, of which 22 are small entities. Therefore, DEA estimates 22 small entities are affected by this rule.

A review of the 33 registrations indicates that all entities that currently handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA also handle other schedule I controlled substances, and have established and implemented (or maintain) the systems and processes required to handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, or MDMB-FUBINACA. Therefore, DEA anticipates that this 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 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 $100,000,000 or more (adjusted annually for inflation) in any 1 year. . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under 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.

This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. However, pursuant to the CRA, DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, 21 CFR part 1308 is amended as follows:

Under the Controlled Substances Act (CSA), each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c) and the current list of scheduled substances is published at 21 CFR part 1308.

Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule, “remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Acting Administrator of the Drug Enforcement Administration (DEA). 28 CFR 0.100.

The 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, (2) at the request of the Secretary of the Department of Health and Human Services (HHS), 1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated by two citizen petitions to remove 6β-naltrexol from the list of scheduled controlled substances of the CSA, and is supported by, inter alia, a recommendation from the Assistant Secretary of the HHS and an evaluation of all relevant data by the DEA. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle or propose to handle 6β-naltrexol.

6β-Naltrexol is the major metabolite of naltrexone. Naltrexone and 6β-naltrexol are reversible opioid receptor antagonists. Opioid receptor antagonists are commonly used in the treatment of opioid addiction and overdose. On December 24, 1974, naloxone, an opioid receptor antagonist that works similarly to naltrexone, was removed from all schedules for control under the CSA. Effective on March 6, 1975, title 21 of the Code of Federal Regulations was amended to remove naltrexone from all schedules for control under the CSA. The Administrator of the DEA found that both naltrexone and naloxone and their salts have an accepted medical use for treatment in the United States and that they do not have a potential for abuse to justify continued control in any schedule under the CSA. In June 2003 and April 2008, the DEA received two separate citizen petitions to initiate proceedings to amend 21 CFR 1308.12(b)(1) to decontrol 6β-naltrexol from schedule II of the CSA. These petitions complied with the requirements of 21 CFR 1308.44(b) and were accepted for filing. Both petitioners argue that 6β-naltrexol has been characterized as an opioid receptor antagonist, a class of drugs with no abuse potential.

Pursuant to 21 U.S.C. 811(b), the DEA gathered the necessary data on 6β-naltrexol and forwarded the data, the sponsors' petitions, and a request for scheduling recommendation on 6β-naltrexol to HHS on August 11, 2009.

On July 21, 2017, HHS provided to DEA a scientific and medical evaluation entitled “Basis for the Recommendation to Remove (5α,6β)-17-(cyclopro pylmethyl)-4,5-epoxymorphinan-3,6,14-triol (6β-naltrexol) and Its Salts from All Schedules of Control Under the Controlled Substances Act” and a scheduling recommendation. Following consideration of the eight factors and findings related to the substance's abuse potential, legitimate medical use, and dependence liability, HHS recommended that 6β-naltrexol and its salts be removed from all schedules of control of the CSA.

In response, DEA conducted its own eight factor analysis of 6β-naltrexol pursuant to 21 U.S.C. 811(c). Both the DEA and HHS analyses are available in their entirety in the public docket of this rule (Docket Number DEA-492) at http://www.regulations.gov under “Supporting and Related Material.”

After a review of the available data, including the scientific and medical evaluation and the recommendation to decontrol 6β-naltrexol from HHS, the Acting Administrator of DEA published in the Federal Register a notice of proposed rulemaking (NPRM) entitled “Schedules of Controlled Substances: Removal of 6β-naltrexol from Control” which proposed removal of 6β-naltrexol and its salts from the schedules of the CSA. 84 FR 43530, August 21, 2019. The proposed rule provided an opportunity for interested persons to file a request for a hearing in accordance with DEA regulations by September 20, 2019. No requests for such a hearing were received by DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before September 20, 2019.

DEA received four comments on the proposed rule to remove 6β-naltrexol from control. Two commenters supported decontrol of 6β-naltrexol. Two commenters submitted comments not related to the proposed action.

One commenter supported decontrolling 6β-naltrexol and expressed agreement with DEA's findings that 6β-naltrexol does not possess abuse or dependence potential. Another commenter was also in support of this decontrol action although the commenter mentioned the drug names as “6-naltrexol” and “naltrexone” and appears to have used these two names interchangeably. DEA assumes that the commenter's reference to “naltrexone” or “6-naltrexol” is actually in reference to 6β-naltrexol.

DEA Response: DEA appreciates the comments in support of this rulemaking.

One commenter stated that DEA should spend more time in combating drugs that are readily available to public and are highly prescribed by physicians rather than putting efforts on drugs with no abuse potential and are limited to research labs.

DEA Response: DEA's mission is to enforce the controlled substance laws and regulations. The CSA contains specific mandates pertaining to the scheduling of controlled substances. Pursuant to 21 U.S.C. 811(a)(2), the Attorney General through formal rulemaking may remove any drug or other substance from the schedules if it is found that the drug or other substance does not meet the requirement for inclusion in any schedule under the CSA. Proceedings for the issuance, amendment, or repeal of such rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary, or (3) on the petition of any interested party. DEA, under authority delegated by the Attorney General, has initiated the current scheduling action in response to two petitions requesting decontrol of 6β-naltrexol. Pursuant to CSA, DEA has followed all of those mandates regarding the current decontrol of 6β-naltrexol, including receiving from the Secretary of HHS a scientific and medical evaluation, and recommendation, regarding control (21 U.S.C. 811(b)); considering the factors enumerated in 21 U.S.C. 811(c); determining, based on the above, appropriate scheduling for 6β-naltrexol (21 U.S.C. 812(b)); and conducting a formal rulemaking to decontrol 6β-naltrexol (21 U.S.C. 811(a)(2)). 6β-Naltrexol satisfies the CSA's criteria for removal from controls.

Another commenter mentioned that a majority of states have legalized the use of cannabis for medical and recreational purposes and there are reports of medical benefits for cannabis. This commenter further stated that “removing cannabis from being Schedule I drug is long over due . . .”

DEA Response: Because the current rule involves 6β-naltrexol, but not cannabis, this comment is unrelated and is outside the scope of the current scheduling action.

Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of HHS, and based on DEA's consideration of its own eight-factor analysis, the Acting Administrator finds that these facts and all relevant data demonstrate that 6β-naltrexol does not meet the requirements for inclusion in any schedule, and will be removed from control under the CSA.

In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures done “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 12866 and the principles reaffirmed in Executive Order 13563.

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

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

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

The Acting Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this rule is to remove 6β-naltrexol from the list of schedules of the CSA. This action removes regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances for handlers and proposed handlers of 6β-naltrexol. Accordingly, it has the potential for some economic impact in the form of cost savings.

This rule will affect all persons who would handle, or propose to handle, 6β-naltrexol. 6β-Naltrexol is the major metabolite of naltrexone and is not currently available or marketed in any country. Due to the wide variety of unidentifiable and unquantifiable variables that potentially could influence the distribution and dispensing rates, if any, of 6β-naltrexol, DEA is unable to determine the number of entities and small entities which might handle 6β-naltrexol. In some instances where a controlled pharmaceutical drug is removed from the schedules of the CSA, DEA is able to quantify the estimated number of affected entities and small entities because the handling of the drug is expected to be limited to DEA registrants even after removal from the schedules. In such instances, DEA's knowledge of its registrant population forms the basis for estimating the number of affected entities and small entities. However, the DEA does not have a basis to estimate whether 6β-naltrexol is expected to be handled by persons who hold DEA registrations, by persons who are not currently registered with DEA to handle controlled substances, or both. Therefore, the DEA is unable to estimate the number of entities and small entities who plan to handle 6β-naltrexol.

Although DEA does not have a reliable basis to estimate the number of affected entities and quantify the economic impact of this final rule, a qualitative analysis indicates that this rule is likely to result in some cost savings. Any person planning to handle 6β-naltrexol will realize cost savings in the form of saved DEA registration fees, and the elimination of physical security, recordkeeping, and reporting requirements. Because of these factors, DEA projects that this rule will not result in a significant economic impact on a substantial number of small entities.

On the basis of information contained in the “Regulatory Flexibility Act” 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 for inflation) in any one year . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of UMRA.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act, 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.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. However, pursuant to the CRA, DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, 21 CFR part 1308 is amended to read as follows:

On June 17, 2019, the Drug Enforcement Administration (DEA) published an interim final rule to make brexanolone (including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible) a schedule IV controlled substance. 84 FR 27938. The interim final rule provided an opportunity for interested persons to submit comments, as well as file a request for hearing or waiver of hearing, on or before July 17, 2019.

The DEA received three comments in response to the interim final rule to control brexanolone as a schedule IV substance of the Controlled Substances Act (CSA). Two of the three commenters were in support of the interim final rule to place brexanolone in schedule IV of the CSA, and one commenter was opposed to the placement of brexanolone in schedule IV of the CSA. The DEA did not receive any requests for hearing or waiver of hearing.

Two commenters supported controlling brexanolone as a schedule IV controlled substance. These commenters indicated support for scheduling brexanolone under the CSA due to its similarity to other schedule IV sedatives including midazolam and alprazolam.

DEA Response. The DEA appreciates the support for this rulemaking.

A commenter opposed the interim final rule to control brexanolone as a schedule IV substance. Although the commenter did not state if or where brexanolone should be scheduled, the commenter expressed concerns about brexanolone's adverse health effects such as exposure of an antidepressant to infants through breastmilk, potential for “hidden side effects,” and drug-associated dizziness and somnolence affecting the maternal care of the infant.

DEA Response. The commenter's concerns about adverse health effects of brexanolone are related to the Food and Drug Administration's (FDA) approval process (such as weighing the benefits versus risks) and outside of the scope of this rulemaking. The FDA approved a new drug application (NDA) for Zulresso (brexanolone)—a substance identified as having abuse potential pursuant to 21 U.S.C. 811(f)—and provided the DEA with a scheduling recommendation for control of brexanolone in schedule IV of the CSA. As provided in 21 U.S.C. 811(j), the scheduling recommendation by the Department of Health and Human Services (HHS) and the FDA approval of the NDA necessitated the DEA review and scheduling action. The DEA made the findings required under 21 U.S.C. 812(b)(4) for the placement of brexanolone in schedule IV. The scheduling determination was based on a comprehensive evaluation of all available data as related to the eight-factor analysis pursuant to 21 U.S.C. 811(c), but not by a single metric such as adverse health effects as expressed by this commenter. As stated in the interim final rule, after careful consideration of data from preclinical and clinical studies, the DEA concurred with the HHS recommendation that brexanolone has abuse potential comparable to other schedule IV benzodiazepines such as midazolam and alprazolam, and therefore, supported and continues to support through the promulgation of this final rule placement of brexanolone in schedule IV under the CSA. None of the commenter's concerns about brexanolone's potential health effects undermine any aspect of the interim final rule's analysis.

Based on the rationale set forth in the interim final rule, the DEA adopts the interim final rule without change.

As indicated above, brexanolone has been a schedule IV substance by virtue of the interim final rule issued by DEA in June 2019. Therefore, this final rule does not alter the regulatory requirements applicable to handlers of brexanolone that have been in place since that time. Nonetheless, for informational purposes, we restate here those requirements. Brexanolone is subject to the CSA's schedule IV regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule IV substances, including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) brexanolone, or who desires to handle brexanolone, must be registered with the 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. Any person who intends to handle brexanolone and is not registered with the DEA must submit an application for registration and may not handle brexanolone, unless the DEA approves that application for registration, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.

2. Disposal of stocks. Any person who obtains a schedule IV registration to handle brexanolone, but who subsequently does not desire or is not able to maintain such registration, must surrender all quantities of brexanolone or may transfer all quantities of brexanolone to a person registered with the DEA in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws.

3. Security. Brexanolone is subject to schedule III-V security requirements and must be handled and stored in accordance with 21 CFR 1301.71-1301.93.

4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of brexanolone must comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.

5. Inventory. Every DEA registrant who possesses any quantity of brexanolone was required to keep an inventory of all stocks of brexanolone on hand, as of June 17, 2019, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records and Reports. DEA registrants must maintain records and submit reports for brexanolone, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317.

7. Prescriptions. All prescriptions for brexanolone or products containing brexanolone must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C.

8. Manufacturing and Distributing. In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule IV controlled substances, such registrants should be advised that (consistent with the foregoing considerations) any manufacturing or distribution of brexanolone may only be for the legitimate purposes consistent with the drug's labeling, or for research activities authorized by the Federal Food, Drug, and Cosmetic Act and the CSA.

9. Importation and Exportation. All importation and exportation of brexanolone must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

10. Liability. Any activity involving brexanolone not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

This final rule, without change, affirms the amendment made by the interim final rule that is already in effect. Section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553) generally requires notice and comment for rulemakings. However, 21 U.S.C. 811 provides that in cases where a new drug is (1) approved by the HHS and (2) HHS recommends control in CSA schedule II-V, the DEA shall issue an interim final rule scheduling the drug within 90 days. Additionally, the law specifies that the rulemaking shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause. The DEA issued an interim final rule on June 17, 2019 and solicited public comments on that rule. Section 811 further states that after giving interested persons the opportunity to comment and to request a hearing, “the Attorney General shall issue a final rule in accordance with the scheduling criteria of subsections (b), (c), and (d) of this section and section 812 (b) of” the CSA. 21 U.S.C. 811(j)(3). The DEA is now responding to the comments submitted by the public and issuing the final rule, in conformity with the APA and the procedure required by 21 U.S.C. 811.

In accordance with 21 U.S.C. 811(a) and (j), this 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 procedures and 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 12866 and the principles reaffirmed in Executive Order 13563.

This final rule is not an Executive Order 13771 regulatory action pursuant to Executive Order 12866 and OMB guidance. 1

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

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

This final rule does not have tribal implications warranting the application of Executive Order 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. Under 21 U.S.C. 811(j), the DEA was not required to publish a general notice of proposed rulemaking prior to this final rule. Consequently, the RFA does not apply.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined 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 for inflation) in any one 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 requirement 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.

This final rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets. However, pursuant to the CRA, the DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.

I. What changes to 22 CFR 41.31 does this rule make?

This rule makes certain changes to the Department's regulation on B nonimmigrant visas, but does not change Department of Homeland Security regulations regarding the admissibility of aliens, including Visa Waiver Program travelers, or otherwise modify the standards enforced by officials of the Department of Homeland Security. The Department is revising the definition of “pleasure” and subdividing 22 CFR 41.31(b)(2) into three paragraph levels. The Department is retaining its existing, and longstanding, general rule that pleasure, as referred to in Immigration and Nationality Act (INA) section 101(a)(15)(B), 8 U.S.C. 1101(a)(15)(B), for purposes of visa issuance, refers to legitimate activities of a recreational character, including tourism, amusement, visits with friends or relatives, rest, medical treatment, and activities of a fraternal, social, or services nature. The Department is also adding a provision that provides, for purposes of visa issuance, that the term pleasure, as used in INA 101(a)(15)(B), 8 U.S.C. 1101(a)(15)(B), does not include travel for the primary purpose of obtaining United States citizenship for a child by giving birth in the United States. The Department is renumbering this provision as paragraph (i).

The Department is adding a provision that provides that a nonimmigrant B visa applicant seeking medical treatment in the United States shall be denied a visa under INA section 214(b), 8 U.S.C. 1184, if unable to establish, to the satisfaction of a consular officer, a legitimate reason why he or she wishes to travel to the United States for medical treatment, and that a medical practitioner or facility in the United States has agreed to provide treatment. Additionally, the applicant must provide the projected duration and cost of treatment and any incidental expenses. The applicant must also establish to the satisfaction of the consular officer that he or she has the means and intent to pay for the medical treatment and all incidental expenses, including transportation and living expenses, either independently or with the pre-arranged assistance of others. If an applicant's responses to this line of questions are not credible, that may give consular officers reason to question whether the applicant qualifies for a visa in the B nonimmigrant classification, and could lead to additional questions as to whether the applicant intends to timely depart the United States, or intends to engage in other impermissible activity. The Department is renumbering this provision as paragraph (ii).

The Department is adding a new paragraph (iii), which establishes a rebuttable presumption that any B nonimmigrant visa applicant who a consular officer has reason to believe will give birth during her stay in the United States is traveling for the primary purpose of obtaining U.S. citizenship for a child.

Section 101(a)(15)(B) of the INA, 8 U.S.C. 1101(a)(15)(B), is ambiguous as to the scope of activities covered by the phrase “visiting the United States . . . temporarily for pleasure.” Birth tourism is not explicitly mentioned in INA 101(a)(15)(B), 8 U.S.C. 1101(a)(15)(B). The Department is aware that many foreign nationals have sought B nonimmigrant visas for the purpose of obtaining U.S. citizenship for a child by giving birth in the United States. The Department has concluded that a more reasonable interpretation of the statutory provision and a better policy is that the statutory provision authorizing the issuance of visas to temporary visitors for pleasure does not extend to individuals whose primary purpose of travel is to obtain U.S. citizenship for a child by giving birth in the United States. The Department considers birth tourism an inappropriate basis for the issuance of temporary visitor visas for the policy reasons discussed herein.

As discussed below, this rule reflects a better policy, as birth tourism poses risks to national security. The birth tourism industry is also rife with criminal activity, including international criminal schemes, as reflected in federal prosecutions of individuals and entities involved in that industry.

The Department recognizes that some aliens may wish to rely on U.S. medical facilities for birth because of specialized medical needs that can be met in the United States. Thus, given the Department's longstanding practice of considering receipt of medical treatment as legitimate activity for purposes of B nonimmigrant visa issuance, this rule seeks to balance the United States' strong interest in curtailing birth tourism with its interests in facilitating legitimate medical travel and other legitimate travel on a B nonimmigrant visa. In order to clarify when visa issuance for the purpose of travel to the United States for medical treatment while pregnant (and likely to give birth) might be acceptable, the Department is codifying in regulation the standards regarding B nonimmigrant visa issuance for travel for medical treatment. Nothing in this rule purports to affect the acquisition of U.S. citizenship by individuals born in the United States, under the Fourteenth Amendment to the U.S. Constitution or INA 301, 8 U.S.C. 1401.

This rule, which explicitly establishes that birth tourism is not a permissible purpose for issuance of a B visa, also reflects—for the first time in regulation—a longstanding Department doctrine of visa adjudication—namely, the primary purpose test. Under the primary purpose test, a consular officer must consider a visa applicant's primary (or principal) purpose of travel to evaluate the applicant's eligibility for the requested visa classification. All of a visa applicant's intended activities in the United States are considered in determining the applicant's eligibility for a visa under standards set out in INA 212 and 214(b), 8 U.S.C. 1182 and 1184, and other applicable visa eligibility standards. The Department's FAM guidance to consular officers on this point—that an “alien desiring to come to the United States for one principal, and one or more incidental, purposes should be classified in accordance with the principal purpose”—has remained unchanged for well over 30 years. Compare 9 FAM 41.11 N3.1 (August 30, 1987) with current 9 FAM 402.1-3 (last revised May 21, 2018). 1 For B nonimmigrant visa applicants, the primary purpose of travel must be for permissible B-1 or B-2 activity for business or pleasure. Under the primary purpose test, in the context of a B-1/B-2 visa application, a consular officer may not issue a visa to an applicant who: (1) Primarily intends to engage in activity properly classified in another nonimmigrant visa classification; or (2) primarily intends to engage in any other activity not permissible in the B nonimmigrant visa classification. In addition, no visa may be issued to an alien who intends to engage in any unlawful activity. An alien's “primary purpose” of travel would be determined by the consular officer based on what the consular officer concludes is the alien's principal objective for traveling to the United States, following careful consideration of information submitted by the applicant and the consular officer's evaluation of the credibility of the applicant.

For example, consider a minor applying for a B nonimmigrant visa to accompany his legal guardian, but not parent, in the United States on another nonimmigrant visa classification ( e.g., H-1B). The minor would not qualify for a derivative visa ( e.g., H-4), because he is not a child of the guardian. In that case, the minor's primary purpose of travel would be to accompany his guardian, which is permissible activity in the B visa classification. The Department's FAM guidance has long acknowledged a tension that arises with minors who are legally required under state or local law in the United States to attend school while residing, even if temporarily, in the United States, but whose primary purpose of travel is to accompany an adult to whose household they belong. The Department's FAM guidance has long provided that “when a family member's primary purpose to come to the United States is to accompany the principal, the classification of the accompanying [minor] family member is either of a derivative of the principal, if the classification provides, or as a B-2, if not.”

The burden is on the visa applicant to establish that he or she is entitled to nonimmigrant status under INA 101(a)(15) of the INA, 8 U.S.C. 1101(a)(15), based on his or her primary purpose of travel, to the satisfaction of the consular officer. See INA section 214(b), 291, 8 U.S.C. 1184(b), 1361.

The Department estimates that thousands of children are born in the United States to B-1/B-2 nonimmigrants annually. While the Department recognizes that precisely estimating the number of individuals who give birth in the United States, after traveling to the United States on a B1/B2 nonimmigrant visa, is challenging, reporting from U.S. embassies and consulates has documented trends showing an increasing number of B visa applicants whose stated primary purpose of travel is to give birth in the United States. Permitting short-term visitors with no demonstrable ties to the United States to obtain visas to travel to the United States primarily to obtain U.S. citizenship for a child creates a potential long-term vulnerability for national security. Foreign governments or entities, including entities of concern to the United States, may seek to benefit from birth tourism for purposes that would threaten the security of the United States. This rule would help close a potential vulnerability to national security that would be posed by any foreign government or entity that sought to exploit birth tourism to enhance access to the United States.

The Fourteenth Amendment to the U.S. Constitution provides that “[a]ll persons born or naturalized in the United States, and subject to the jurisdiction thereof, are citizens of the United States and of the state wherein they reside.” Section 301(a) of the INA, 8 U.S.C. 1401(a) states that “a person born in the United States, and subject to the jurisdiction thereof” shall be a national and citizen of the United States at birth. The INA provides a clear method for those who do not acquire U.S. citizenship at birth to acquire it later: Naturalization.

This is a stark difference between aliens using a temporary visitor visa for the purpose of obtaining U.S. citizenship for their children and the extensive requirements applicants must meet to naturalize to become U.S citizens. To naturalize, an alien must establish attachment to the principles of the Constitution of the United States and favorable disposition toward the “good order and happiness” of the United States, including a depth of conviction that would lead to active support of the Constitution, and not be hostile to the basic form of government of the United States, or disbelieve in the principles of the Constitution. See 8 U.S.C. 1427(a); 8 CFR 316.11(a). Adult citizens are entitled to numerous rights and benefits of citizenship, including the right to vote in federal elections, the ability to run for public office, the ability to serve on a jury, and the option to petition immediate family members to immigrate to the United States when they reach the age of twenty-one. Citizens have a right to enter the United States even without a U.S. passport. See Worthy v. United States, 328 F. 2d 386, 394 (5th Cir. 1964). The previous regulation failed to address the national security vulnerability that could allow foreign governments or entities to recruit or groom U.S. citizens who were born as the result of birth tourism and raised overseas, without attachment to the United States, in manners that threaten the security of the United States.

An entire “birth tourism” industry has evolved to assist pregnant women from other countries to come to the United States to obtain U.S. citizenship for their children by giving birth in the United States, and thereby entitle their children to the benefits of U.S. citizenship. 2 Birth tourism companies advertise their businesses abroad by promoting the citizenship-related benefits of giving birth in the United States. Companies tout a broad range of benefits for the U.S. citizen child and eventually its family, including, but not limited to, access to free education, less pollution, retirement benefits, the ability to compete for jobs in the U.S. government, and the ability for the whole family to eventually immigrate to the United States. 3

By obtaining a child's U.S. citizenship through birth tourism, foreign nationals are able to help that child avoid the scrutiny, standards, and procedures that he or she would normally undergo if he or she sought to become a U.S. citizen through naturalization. Under INA section 316, 8 U.S.C 1427, for example, such aliens generally are required to fulfill a residency requirement of at least five years, be a person of good moral character attached to the principles of the Constitution, and be well disposed to the “good order and happiness” of the United States. Additionally, they are required to take an Oath of Allegiance. See section 337(a) of the INA, 8 U.S.C. 1448(a). The steps for naturalization are rigorous and include national security-related inquiries, requiring applicants to meet stringent residency rules, complete multiple forms collecting detailed personal information, provide fingerprints, complete an in-person interview, and pass English and civics tests.

Foreign travelers have sought to gain the numerous benefits of U.S. citizenship for their children by obtaining visas to travel to the United States to give birth, while in some cases, passing along the costs to tax payers at the state and local level. Some of these benefits include ease of travel to countries that offer visa-free travel to U.S. citizens, the ability to study and work in the United States, and a legal path for the child's parents to immigrate to the United States once the child turns twenty-one. U.S. embassies and consulates have reported that visa applicants intending to give birth in the United States provide numerous reasons for their choice, including, but not limited to, obtaining a second citizenship for their child, the perceived low-cost medical services available to women in the United States, the lower cost of obtaining U.S. citizenship through birth tourism than through a U.S. investor visa, and the perceived guarantee of a better socioeconomic future for their child.

While this rule will not preclude visa issuance to all aliens who may give birth in the United States, it recognizes the risks posed by allowing the previous visa policy to continue; and addresses some of those national security threats that exist when aliens, who may have no ties to, or constructive interest in, the United States, easily are able to obtain U.S. citizenship for their children, through birth in the United States.

The birth tourism industry in the United States also is a source of fraud and other criminal activity, including international criminal schemes. A recent federal indictment of 19 individuals on immigration fraud charges shows that businesses in the lucrative birth tourism industry committed “widespread immigration fraud and engaged in international money laundering,” as well as defrauding “property owners when leasing the apartments and houses used in their birth tourism schemes.”  4 According to the recent federal indictment, in exchange for their services, birth tourism operators charged as much as $100,000 and one of the largest operators is alleged to have used “14 different bank accounts to receive more than $3.4 million in international wire transfers” in a two year period alone. 5

This rule explicitly establishes that birth tourism is not a permissible purpose of travel for issuance of a B visa. This rule will help eliminate the criminal activity associated with the birth tourism industry. The recent federal indictments describe birth tourism schemes in which foreign nationals applied for visitor visas to come to the United States and lied to consular officers about the duration of their trips, where they would stay, and their purpose of travel. According to the indictments that charge the operators of the birth tourism schemes, foreign women were coached on how to pass their U.S. visa interviews by lying on their visa application forms and providing false statements to consular officers. The applicants also provided false statements on their visa applications and in their interviews about the funds available to them to cover the costs of their proposed treatment and stay in the United States. 6 When foreign travelers lie about their true purpose of travel to the United States during their visa interviews, consular officers may not identify a true basis for visa ineligibility, including, for example, lack of intent or ability to pay for the costs of their stay. This rule, by limiting the circumstances in which an alien will be in a position to give birth in the United States on a “tourist” visa, will potentially decrease the number of birth tourism providers in the United States, thus discouraging aliens from applying for visas to travel to the United States for this purpose. By explicitly establishing that birth tourism is not a permissible purpose for issuance of a B visa, this rule will reduce the number of visa applicants who apply for B visas for the purpose of birth tourism.

This rule will help prevent operators in the birth tourism industry from profiting off treating U.S. citizenship as a commodity, sometimes through potentially criminal acts, as described above. The investigation into birth tourism operators in California uncovered a scheme where birth tourism operators enriched themselves “using cash, fabricated financial documents, and nominee names for the transfer of money”  7 from overseas to the United States. In some cases, birth tourism operators leased apartments by providing false information about the true occupants of the residences, making false statements about occupants' monthly income, and furnishing altered bank statements in order to be approved for leases. 8 The federal indictments highlight accounts of birth tourism customers failing to pay all the costs of giving birth in the United States, including hospital, doctor, and other bills, which would then be referred to collection. 9 In one example, a couple “paid only $4,600 of the $32,291 in hospital charges related to the birth of their baby.”  10 In another example, a couple paid a hospital the indigent rate of $4,080 for hospital bills that exceeded $28,000, despite having more than $225,000 in a U.S. bank account and making purchases at Rolex and Louis Vuitton stores during their time in the United States. 11 Meanwhile, birth tourism operators are earning millions of dollars through the scheme, evading taxes, money laundering, and engaging in fraud to enhance their profits.

Under previous Department guidance and under this rule, medical treatment, whether medically necessary or elective, generally continues to be permissible activity in the B nonimmigrant classification, subject to certain restrictions.

Under guidance to consular officers in the Department's Foreign Affairs Manual (FAM)  12 and this rule, an applicant who seeks a B nonimmigrant visa for medical treatment in the United States shall be denied a visa under INA section 214(b), 8 U.S.C. 1184(b), if unable to establish, to the satisfaction of a consular officer, a legitimate reason why he or she wishes to travel to the United States for medical treatment. Additionally, the applicant must satisfy the consular officer that a medical practitioner or facility in the United States has agreed to provide treatment. The applicant must also establish to the satisfaction of the consular officer that he or she has reasonably estimated the duration of the visit and has the means, derived from lawful sources, and intent to pay for the medical treatment and all incidental expenses. If an applicant's responses to this line of inquiry are not credible, that may give consular officers reason to question whether the applicant intends to timely depart the United States or intends to engage in other impermissible activity.

The two new sentences in § 41.31(b)(2)(ii) added by this rule track language about medical treatment and the B-2 nonimmigrant classification on the Department's public facing website. See https://travel.state.gov/content/travel/en/us-visas/tourism-visit/visitor.html.   13 The identified information often helps inform a consular officer's determination whether the applicant qualifies for a B visa, including whether the applicant overcomes the presumption in INA 214(b), 8 U.S.C. 1184(b), that he or she is an intending immigrant, and whether the applicant is “entitled to a nonimmigrant status under section 101(a)(15).” INA 214(b), 8 U.S.C. 1184(b).

The Department is adding this provision to § 41.31(b) now because application of these factors will have a direct bearing on implementation of this new policy that a primary purpose of obtaining United States citizenship for a child by giving birth in the United States (as opposed to travel for the primary purpose of obtaining medical treatment for reasons related to childbirth for maternal or infant health) is an impermissible basis for B visa issuance. For a B nonimmigrant visa applicant who seeks to travel to the United States to give birth, consular officers will evaluate whether the applicant has credibly articulated a permissible purpose of travel on a B visa, or whether the applicant's primary purpose of travel is birth tourism, i.e., to obtain U.S. citizenship for the child.

The Department believes including the new provisions in § 41.31 clarify the requirements for all B nonimmigrant applicants who seek medical treatment in the United States, by including the factors that a consular officer will weigh when determining whether the applicant qualifies for a B nonimmigrant visa. These regulatory refinements should be particularly helpful for applicants who are likely to give birth in the United States, to help them determine whether they are eligible to apply for a B nonimmigrant visa.

Under this rule, if a consular officer has reason to believe a B nonimmigrant visa applicant will give birth in the United States, the applicant is presumed to be seeking a visa for the primary purpose of obtaining U.S. citizenship for the child. To rebut this presumption, the visa applicant must establish, to the satisfaction of a consular officer, a legitimate primary purpose other than obtaining U.S. citizenship for a child by giving birth in the United States. The fact that an applicant has arranged an elective medical birth plan (as opposed to a birth requiring specialized medical treatment) in the United States is not, by itself, sufficient to establish that the primary purpose is not obtaining U.S. citizenship for the child. Take, for example, a visa applicant who identified several potential options in multiple countries that would satisfy her medical birth plan. If that visa applicant arranged a birth plan in the United States, instead of in another country, because the child would acquire U.S. citizenship, the presumption would likely not be rebutted, especially if she had ties to a geographically closer country that would meet her needs. But, for another example, consider an otherwise qualified B nonimmigrant visa applicant from a part of Mexico lacking appropriate medical facilities who arranged a birth plan in the United States based on proximity to her residence in Mexico. In that case, the presumption could be rebutted. A visa applicant who identified a birth plan in the United States based on specialized medical care for a complicated pregnancy could also potentially rebut the presumption. Medical care is not the only way the presumption can be rebutted. For example, if a consular officer determined an individual's primary purpose for travel to the United States is to visit her dying mother, and that during the visit she may give birth in the United States because her due date overlapped with her mother's last expected months of life, she could rebut the presumption. For another example, if a B nonimmigrant visa applicant satisfied the consular officer that her child would acquire U.S. citizenship if born outside the United States under section 301(g) of the INA, 8 U.S.C. 1401(g), based on the visa applicant's husband's U.S. citizenship and prior physical presence in the United States, the visa applicant would rebut the presumption that her primary purpose was to obtain U.S. citizenship for the child.

This rule is exempt from notice and comment under the foreign affairs exemption of the Administrative Procedure Act (APA), 5 U.S.C. 553(a).

Opening this pronouncement of foreign policy to public comment, including comment from foreign government entities themselves, and requiring the Department to respond publicly to pointed questions regarding foreign policy decisions would have definitely undesirable international consequences. See Yassini v. Crosland, 618 F.2d 1356, n.4 (9th Cir. 1980). The Department recognizes specifically that foreign governments or parts thereof may have interests in this rule as a matter of their foreign policy goals. The Department has concerns that birth tourism, and the birth tourism industry, pose a significant vulnerability for the security of the United States. Various public sources have identified specific countries that are the primary sources of birth tourists, some of which countries have very sensitive relationships with the United States. Some governments may support their citizens' desire to use U.S. temporary visitor visas as a mechanism to obtain U.S. citizenship for their children. Foreign governments or entities, including entities of concern to the United States, may seek to benefit directly or indirectly from birth tourism, including for purposes that would threaten the security of the United States. As a DOJ representative stated during hearings on the Administrative Procedure Act, “[a] requirement of public participation in . . . promulgation of rules to govern our relationships with other nations . . . would encourage public demonstrations by extremist factions which might embarrass foreign officials and seriously prejudice our conduct of foreign affairs.” Administrative Procedure Act: Hearings on S.1663 Before the Subcomm. on Admin. Practice & Procedure of the S. Comm. on the Judiciary, 88th Cong. at 363 (1964).

Recognizing that certain countries have been publicly identified as being principal sources of foreign nationals pursuing birth tourism, and certain of those countries raise particular national security concerns, this rule clearly and directly impacts foreign affairs functions of the United States and “implicat[es] matters of diplomacy directly.” City of N.Y. v. Permanent Mission of India to the U.N., 618 F.3d 172, 202 (2d Cir. 2010). This regulatory change reflects changes to U.S. foreign policy, specifically in the context of U.S. visas, that significantly narrow the ability of foreign nationals residing abroad to easily obtain U.S. citizenship for their children without complying with any of the rigorous requirements for permanent residence or naturalization. Publicly identifying birth tourism as a threat to the security of the United States, in a context where specific countries have been identified as the primary source of birth tourists, inherently affects U.S. bilateral relations with those countries, and signals a significant shift in U.S. policy towards those foreign governments and their populations. This modification of U.S. visa policy may also lead to reciprocal actions on the part of foreign governments, including some countries in which there are a significant number of U.S. citizens residing.

Because this final rule is exempt from notice and comment rulemaking under 5 U.S.C. 553, it is exempt from the regulatory flexibility analysis requirements set forth by the Regulatory Flexibility Act (5 U.S.C. 603 and 604).

The Unfunded Mandates Reform Act of 1995 (UMRA) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of UMRA requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may directly result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. This rule governs B nonimmigrant visa classification and does not mandate any direct expenditure by State, local, or tribal governments.

The Office of Information and Regulatory Affairs has determined that this rule is not a major rule as defined by 5 U.S.C. 804(2), for purposes of congressional review of agency rulemaking under the Small Business Regulatory Enforcement Fairness Act of 1996.

The Office of Information and Regulatory Affairs (OIRA) has determined that this rule is significant under Executive Order 12866, though not economically significant. Thus, it has been reviewed by OIRA. Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). The Department has reviewed this rule to ensure consistency with those requirements.

The Department has also considered this rule in light of Executive Order 13563 and affirms that this regulation is consistent with the guidance therein.

In crafting this rule, the Department considered alternate ways to address the national security concerns associated with birth tourism. The Department seeks to balance the United States' strong interest in curtailing birth tourism, based on national security and law enforcement concerns, with its commitment to facilitating legitimate medical travel and other legitimate bases for issuing B nonimmigrant visas.

The Department recognizes this rule may result in indirect costs to state and local entities and the private sector associated with loss of business from foreign national customers who seek to travel to the United States for the primary purpose of obtaining United States citizenship for a child by giving birth in the United States.

As detailed above, the rule aims to end a threat to national security and to mitigate criminal activity associated with the birth tourism industry. Birth tourism companies highlight the benefits of eligibility and priority for jobs in U.S. government, public companies and large corporations.

This rule represents the most narrowly tailored regulation to mitigate the threat. The Department considered whether all B-1/B-2 visa applicants, and applicants for visas in other nonimmigrant classifications, might be denied, in accordance with the INA, in any case where a consular officer reasonably expects the applicant will give birth in the United States to a child who would become a U.S. citizen solely because of the place of birth. The Department decided not to adopt such an interpretation, instead limiting this policy to B-1/B-2 nonimmigrant visa applicants and limiting it to applicants who have a primary purpose of obtaining U.S. citizenship for a child expected to be born in the United States. Notably, the B visa classification constitutes the vast majority of nonimmigrant visa applications and the one that is typically used for birth tourism.

With the understanding that some foreign nationals have historically applied for and obtained B nonimmigrant visas for the primary purpose of giving birth in the United States to obtain U.S. citizenship for the child, the Department crafted this rule narrowly to address core national security-related concerns.

The objective of E.O. 13132 is to guarantee the Constitution's division of governmental responsibilities between the federal government and the states. It furthers the policies of the Unfunded Mandates Reform Act. This rule does not have federalism implications within the meaning of E.O. 13132, because it does not impose any substantial direct compliance costs on State, local, or tribal governments or preempt State, local, or tribal law. Furthermore, this rule does not involve grants, other forms of financial assistance, and direct development that implicate concerns under E.O. 12372.

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

The Department has determined that this rulemaking will not have a substantial direct effect on one or more Indian tribes, will not impose substantial direct compliance costs on Indian tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, and will not pre-empt tribal law. Accordingly, the requirements of Section 5 of Executive Order 13175 do not apply to this rulemaking.

This rule is not subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017), because it is expected to be de minimis under E.O. 13771.

This rule does not impose any new information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C. Chapter 35. The Online Nonimmigrant Visa Application, DS-160, already allows visa applicants to identify medical treatment as a subset of B visa travel purpose. Consular officers would evaluate the application using existing forms and would not need new approved information collections.

Accordingly, for the reasons stated in the preamble, the Department is amending 22 CFR part 41 as follows:

I. Background

On December 10, 2018, HUD published a rule in the Federal Register, at 83 FR 63457, which proposed expanding HUD's ability to approve assistance for projects sited near propane storage tanks (otherwise known as “Liquified Petroleum Gas containers” or “LPG containers”). The rule proposed amending HUD regulations at 24 CFR part 51, subpart C, which establish the Acceptable Separation Distance (ASD) that must be kept between HUD-assisted projects and containers of hazardous substances, by creating an exception for aboveground propane storage tanks of a capacity of 250 gallons or less if the storage tank complies with NFPA 58 (2017), a voluntary consensus standard that establishes safety standards used by the propane industry and operators regarding storage, handling, transportation, and use of propane, as well as all underground storage tanks.

HUD's proposed rule was intended to modernize outdated codified safety standards. HUD's current standards, codified at 24 CFR part 51, subpart C, are based on the findings of studies conducted by the Department, in 1975 and 1982. 1 The effect of these standards is to prescribe the ASD of HUD-assisted projects from specific hazardous operations, unless appropriate mitigating measures are implemented. Substances deemed hazardous include petrochemical products, such as propane. HUD-assisted projects include the development, construction, rehabilitation, modernization, or conversion with HUD subsidy, grant assistance, loan, loan guarantee, or mortgage insurance of any project intended for residential, institutional, recreational, commercial, or industrial use.

Mitigation measures can be costly and limit choices for siting a HUD-assisted project. HUD's experience has been that there are significant practical and economic difficulties in mitigating off-site residential propane tanks located on adjacent properties. HUD has recently provided waivers for approval of HUD-assisted sites that have propane tanks in compliance with NFPA 58 (2017) on the basis that such compliance mitigated any danger to HUD-assisted projects sited adjacent to the hazard.

Based on HUD's experience, HUD issued its proposed rule to streamline and update its current rule.

This final rule follows publication of the December 10, 2018, proposed rule and takes into consideration the public comments received on the proposed rule. In response to public comment, a discussion of which is presented in the following section of this preamble, and in further consideration of issues addressed at the proposed rule stage, the Department is making changes, described below, in this final rule.

HUD received several comments requesting reconsideration of the 250-gallon limit for aboveground propane tanks exempted from HUD's ASD requirements. After performing further analysis on common residential tank sizes and potential risks posed by larger tanks, HUD has determined that exempting tanks up to 1,000 gallons would increase the rule's effectiveness without posing additional risk. As such, the definition of “hazard” in § 51.201 has been revised to exempt tanks up to 1,000 gallons. The justification for this change is described below.

Typical propane consumption and the range of typical tank sizes vary widely between warmer and cooler climates. An average-size modern home using high-efficiency propane heating equipment and other appliances in a warm climate region can expect to use 194 to 258 gallons per year, while the same home in a cold climate region would typically use 991 to 1,844 gallons per year. 2

The same variables that impact propane consumption naturally also impact the choice of propane tank sizing. In addition, the average customer, especially in a cold climate prefers to minimize the frequency of refueling to ensure that they don't run out given the high heating loads they experience in the winter. Propane prices also fluctuate with the market throughout the year and tend to be on the higher side during the heating season and lower in the summer. Larger tanks allow customers to buy larger quantities of propane during periods of lower prices resulting in better savings. They also save on delivery related fees by having fewer fill ups. The tank size thus becomes a cost controlling factor for the customer, and tank sizes up to 1,000 gallons are regularly used for residential purposes. 3

The reliability of propane tanks has increased significantly over the past 30 years and studies suggest that the evolution of industry safety practices has reduced the probability of propane tank failure. 4 Studies by the NFPA, documented in the rule's Regulatory Impact Analysis, show that propane is not a leading cause of fires or listed as a source of residential structure fires in the United States. Propane tanks are extremely durable. In a study performed by the U.S. Department of Defense and the Energy Research and Development Administration, these tanks sustained very little damage even from the energy of a simulated nuclear blast. 5 This experiment and others conducted in the propane industry demonstrate that propane tank explosions are difficult and rare.

Furthermore, this rule does not remove all safe distance requirements for LPG containers sited near HUD-assisted projects. All tanks exempted from HUD's ASD requirements under this rule must be fully compliant with NFPA (2017) standards, including NFPA separation distance requirements. Tanks locations must meet a separation distance between the container and important buildings  6 or line of adjoining property that can be built upon, in accordance with the NFPA 58. Tanks between 125 and 500 gallons must be at least 10 feet apart from important buildings or property lines of adjoining property that can be built upon, while tanks between 501 and 1,000 gallons must be at least 25 feet apart. Under NFPA 58 and this rule's revision of 24 CFR part 51, tanks under 125 gallons would not require a separation distance.

For the reasons described above, HUD has determined that LPG containers with capacities of up to 1,000 gallons that comply with NFPA 58 (2017) will no longer be subject to the hazard restrictions posed by 24 CFR part 51. Since the separation distance imposed by NFPA 58 compliance is sufficient to ensure the safety of HUD-assisted projects, increasing the size of tank covered by this exception will reduce regulatory and cost burden on even more projects and communities without any significant additional risk.

One commenter stated that it was unclear whether the tank size referenced in § 51.201 definition of “hazard” was to be measured in water gallon capacity or propane gallon capacity. As a result, HUD has amended the language of § 51.201 to clarify that tanks are measured in water gallon capacity. This language was clarified in order to align the rule with language in NFPA 58 (which uses water capacity to determine ASD standards). The American Society of Mechanical Engineers, which certifies propane tanks, also rates tanks in terms of their water capacity.

Additionally, a commenter found the language used to describe propane tanks (“Containers which are designed to hold liquefied propane gas . . .”) confusing. To increase clarity and accuracy, HUD is amending the phrase to read: “Containers which are used to hold liquefied petroleum gas.” First, replacing “designed” with “used” more accurately describes the scope of the definition, since some containers that are not designed to hold LPG are used to hold it nonetheless, while still complying with NFPA safety requirements. Second, HUD is replacing “liquified propane gas” with “liquefied petroleum gas” because the gas used in heating systems is sometimes comprised of not only propane, but butane as well. These changes will increase consistency between this final rule and NFPA 58 (2017).

The public comment period for the proposed rule closed on February 8, 2019. HUD received six public comments in response to the proposed rule. These comments were submitted by a nationally recognized fire safety codes and standards organization, the national trade group for the propane industry, a nonprofit affordable housing developer, and private citizens.

None of the commenters opposed conforming the ASD standards for residential propane tanks to industry standards. Commenters were generally supportive of the proposed rule, but, as provided in the following section of this Preamble, they also recommended changes or clarifications, several of which are discussed above.

Comment: How will this rule impact HUD-assisted projects sited near multiple propane tanks, or propane tanks stored near other gases.

HUD Response: Under this final rule, LPG tanks of 1,000 gallons or less are not subject to ASD requirements, regardless of how many tanks are present, if they comply with NFPA code 58 (2017). The exclusion from the ASD requirement applies only to LPG tanks. If there are other gases stored in stationary aboveground containers, the ASD must be calculated for those nonpropane containers.

Comment: HUD should not exempt all underground propane containers from hazard restrictions, but only those which comply with applicable Federal, State, or local safety standards, because improperly spaced underground containers can leak gas into underground structures.

HUD Response: HUD is declining to implement this change in this final rule, as this rule is amending safety standards relating to fire and blast hazards, which do not take into consideration other issues such as vapor contamination. HUD performs environmental review of most projects, including multifamily housing and new construction, which captures information related to vapor contamination to document compliance with the standards at 24 CFR 50.3(i) and 58.5(i)(2), using investigative techniques including but not limited to ASTM Phase I and Phase II Environmental Site Assessment. 7 Furthermore, this rule is conforming the relevant regulation with HUD's longstanding policy of considering underground tanks exempt from the ASD restrictions listed in 24 CFR 51 subpart C because they are shielded by the topography from posing fire or blast risks to HUD-assisted projects and, therefore, do not meet the definition of “hazard” at § 51.201. This is also consistent with HUD's treatment of LPG pipelines in existing regulations, in which LPG pipelines are excluded from the definition of “hazard” so long as they are either underground or comply with Federal, State, and local safety standards.

Comment: HUD should update the FHA Single Family Housing Policy Handbook to indicate that FHA can assist in the purchase of properties with underground propane tanks.

HUD Response: This final rule focuses on updates to the regulation at 24 CFR 51 subpart C, and updates to subregulatory guidance are beyond the scope of this rulemaking. Nevertheless, HUD agrees that the referenced guidance should reflect these revisions.

Comment: The rule only incorporates NFPA 58 by reference for LPG containers 250 gallons or less which are exempt from hazard restrictions. HUD should incorporate NFPA 58 by reference for all LPG containers regardless of size in order to maintain a consistent approach to handling LPG as a hazard.

HUD Response: As discussed above, in this final rule HUD is incorporating NFPA 58 (2017) by reference for LPG containers 1,000 gallons or less that are exempt from hazard restrictions. Containers larger than 1,000 gallons will still be defined as “hazards” and will still need to comply with HUD's safety standards at 24 CFR part 51, subpart C. This rulemaking is intended to mitigate regulatory and cost burden related to residential propane tanks (which typically hold 1,000 gallons or less)  8 and is not intended to address commercial, industrial, or agricultural propane tanks (which typically hold more than 1,000 gallons). 9

This rule incorporates the following voluntary consensus standard for siting of HUD-assisted projects near aboveground propane storage tanks that hold up to 1000 gallons: NFPA 58 Liquefied Petroleum Gas Code (2017). The NFPA develops building, fire, and electrical safety codes and standards. Federal agencies frequently use these codes and standards as the basis for developing Federal regulations concerning safety. NFPA 58 (2017) provides industry benchmark and operational information and standards for safe propane storage, handling, transportation, and use. NFPA 58 (2017) mitigates risks and ensures safe installations, to prevent failures, leaks, and tampering that could lead to fires and explosions. The regulation cannot account for future editions of NFPA that do not yet exist. Therefore, if HUD wishes to revise the standard in the future to incorporate newer editions of NFPA 58 this would require further rulemaking.

NFPA 58 (2017) is available online, via read-only access, at https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=58. Members of the public may visit the link and create a username and password to view the free-access edition. The standard may also be obtained from the National Fire Protection Association at 1 Batterymarch Park, Quincy, MA 02169, telephone number (800) 344-3555, fax number (800) 593-6372.

Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. HUD has examined the economic, budgetary, legal, and policy implications of this action and has determined that this final rule is a significant regulatory action under section 3(f) of Executive Order 12866 (but not an economically significant action). HUD has prepared a regulatory impact analysis that addresses the costs and benefits of the final rule. The analysis is available at Regulations.gov and is part of the docket file for this rule.

Executive Order 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017. This final rule is an Executive Order 13771 deregulatory action. Details on the estimated cost savings of this rule can be found in the rule's economic analysis.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small nonprofit organizations, and small governmental jurisdictions.

This rule updates a codified regulation to reduce regulatory and cost burden on communities that may be restricted in their ability to site HUD-assisted projects because of the presence of stationary aboveground propane storage tanks that may be nearby. Specifically, the rule allows the siting of HUD-assisted projects near stationary aboveground propane storage tanks with a capacity of 1,000 gallons or less if the storage tank complies with NFPA Code 58 (2017). HUD has determined that the rule would result in the reduction of costly mitigation measures.

Small entities affected by the rule include owner-occupied single family, small public housing authorities, and a limited number of multifamily projects. Notwithstanding, HUD has determined that the rule's impact will be to reduce administrative burdens and generate cost savings estimated to be from $200,000-$18,000,000 per year. Due to economies of scale and the cost of compliance with the existing rule, these reductions of administrative burden will provide relatively greater benefit to entities that are small. This rule would have minimal impact on small firms because they would not be required to modify current operational procedures. The rule will eliminate the need for costly waiver processes and mitigation costs on the part of these small entities. For example, as described in the Regulatory Impact Analysis, of 1200 small rental properties in Mississippi applying for disaster recovery assistance after Hurricane Katrina, 750 required additional compliance measures or a waiver under current 24 CFR part 51 subpart C in order to be eligible for assistance. Removing such obstacles to assistance would have particularly beneficial impact for similarly situated small rental properties, and other small entities, that are assisted going forward. Similarly, as discussed in the Regulatory Impact Analysis, HUD's 2017 waiver for certain Community Development Block Grant and Home Investment Partnerships programs in Vermont included both residences and small businesses; specifically, restaurants. In waiving the requirements of the existing regulation as to these small businesses, HUD noted that in 2011 there were 1,346 restaurants in Vermont using propane. These restaurants were affected by the cost or practicability of compliance with the existing rule, and these costs will be saved in future projects under this rule. Accordingly, the undersigned certifies that this rule will not have a significant economic impact on a substantial number of small entities.

A Finding of No Significant Impact with respect to the environment for this rule has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The Finding of No Significant Impact is available for public inspection between 8 a.m. and 5 p.m., weekdays in the Regulations Division, Office of General Counsel, U.S. Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20410-5000. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the Finding by calling the Regulations Division at (202) 708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at (800) 877-8339. The Finding of No Significant Impact will also be available for review in the docket for this rule on Regulations.gov .

Executive Order 13132 (entitled “Federalism”) prohibits, to the extent practicable and permitted by law, an agency from promulgating a regulation that has federalism implications and either imposes substantial direct compliance costs on State and local governments and is not required by statute, or preempts State law, unless the relevant requirements of section 6 of the Executive order are met. This rule does not have federalism implications and does not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and on the private sector. This rule would not impose any Federal mandates on any State, local, or tribal governments, or on the private sector, within the meaning of UMRA.

Accordingly, for the reasons stated in the foregoing preamble, HUD amends 24 CFR part 51 as follows:

Throughout this document “we,” “us,” and “our” refer to the EPA.

On December 3, 2019, the EPA proposed in the Federal Register approval of the SIP submission. See 84 FR 66096. The proposed revisions would amend the SIP by providing a more efficient way to perform emissions sampling on air pollution sources throughout Missouri. The State requested approval of incorporating by reference the federally defined methods for stack testing. The EPA solicited comments on the proposed revisions to Missouri's SIP and received no comments.

The EPA is approving revisions to the Missouri SIP submitted by the State of Missouri to the EPA on October 25, 2019. The revisions to the previously federally approved Missouri State rule 10 CSR 10-6.030 Sampling Methods for Air Pollution Sources are administrative in nature and do not affect the stringency of the SIP. The revisions will provide a more efficient way to perform emissions sampling by incorporating by reference federally promulgated methods.

A detailed discussion of the revision to Missouri's SIP and was provided in EPA's December 3, 2019, Federal Register document. See 84 FR 66096.

The State submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice on this SIP revision from May 15, 2018 to August 2, 2018 and received eight comments. Based on the comments received the State made revisions to rule text in sections (21) (22) and (23) that incorporated by reference specific appendices and subparts. The State provided a second public notice on this SIP revision from April 15, 2019 to June 6, 2019 and received no comments. In addition, as explained above, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

We are taking final action to approve revisions to Missouri's SIP by approving the State's request to revise 10 CSR 10-6.030, Sampling Methods for Air Pollution Sources .

In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Missouri Regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 7 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Therefore, these materials have been approved by the EPA for inclusion in the State Implementation Plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

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

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

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

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

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

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

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

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

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

• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 24, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as set forth below:

Throughout this document, whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

On October 1, 2015, EPA promulgated a revised 8-hour ozone NAAQS of 0.070 parts per million (ppm). See 80 FR 65292 (October 26, 2015). Effective August 3, 2018, EPA designated nonattainment areas for the 2015 ozone NAAQS. See 83 FR 25776 (June 4, 2018). The Chicago, IL-IN-WI and St. Louis, MO-IL areas were designated as marginal nonattainment areas for the 2015 ozone NAAQS.

Section 182(a)(3)(B) of the CAA requires states with ozone nonattainment areas classified as marginal and above to submit revisions to their SIPs to require the owner or operator of each stationary source of NO X or VOC to provide the state with an annual statement documenting the actual emissions of NO X and VOC from their source. Under section 182(a)(3)(B)(ii), a state may waive the emissions statement requirement for any class or category of stationary sources which emits less than 25 tons per year of VOC or NO X if the state, in its base year emissions inventory, provides an inventory of emissions from such class or category of sources. States and EPA have generally interpreted this waiver provision to apply to sources (without specification of a specific source class or source category) emitting less than 25 tons per year of VOC or NO X .

Many states, including Illinois, adopted emissions statement rules for stationary sources in nonattainment areas under the 1-hour ozone NAAQS, which EPA approved as part of each state's SIP. In cases where an existing emissions statement requirement is still adequate to meet the requirements under the 2015 ozone NAAQS, states may provide the rationale for that determination to EPA in a written statement for approval in the SIP to meet the requirements of section 182(a)(3)(B). See 83 FR 62998, 63001, 63023 (December 6, 2018) and 80 FR 12264, 12291 (March 6, 2015).

IEPA submitted a SIP revision on May 16, 2019 certifying that the previously SIP-approved emissions statement regulations meet the emissions statement requirement for areas designated as nonattainment for the 2015 ozone standard pursuant to sections 110 and 182 of the CAA. In its submission, IEPA stated that it has information collection authority under Section 4 of the Illinois Environmental Protection Act, and that IEPA collects NO X and VOC emissions statements under 35 IAC Part 254, titled “Annual Emissions Report,” which applies to any source located in an ozone nonattainment area that has the potential to emit 25 tons per year or more of VOC or NO X from all emission units during the reporting year. IEPA further stated that these regulations also apply to permitted smaller sources which are required to submit and certify source-wide totals of actual emissions from all regulated air pollutants emitted. Finally, IEPA confirmed, that in general, facilities subject to Part 254 must submit actual emissions data for NO X and VOC on an annual basis and must certify that the information provided is accurate to the best of the certifier's knowledge.

EPA approved the “Annual Emissions Report” rules into the Illinois SIP on May 15, 2002 (67 FR 34614). Based on this approval and IEPA's certification, the regulations at 35 IAC Part 254 are sufficient to meet the emissions statement requirements of CAA section 182(a)(3)(B) for the 2015 ozone NAAQS.

EPA is approving, as a SIP revision, IEPA's certification that Illinois' “Annual Emissions Report” rules at 35 IAC Part 254 meet the requirements of CAA section 182(a)(3)(B) under the 2015 ozone standard for the Illinois portions of the Chicago, IL-IN-WI and St. Louis, MO-IL ozone nonattainment areas.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective March 24, 2020 without further notice unless we receive relevant adverse written comments by February 24, 2020. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that, if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective March 24, 2020.

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

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

• Is not expected to be an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because this action is not significant under Executive Order 12866;

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 24, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this issue of the Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2) of the CAA.)

40 CFR part 52 is amended as follows:

Throughout this document, wherever “we,” “us,” or “our” is used, it means the EPA.

By statute, EFSEC has jurisdiction for managing the air program with respect to major energy facilities in the State of Washington. See Chapter 80.50 of the Revised Code of Washington (RCW). The EFSEC air quality regulations are contained in Chapter 463-78 Washington Administrative Code (WAC) General and Operating Permit Regulations for Air Pollution Sources. These EFSEC regulations rely primarily on the adoption by reference of the corresponding Ecology general air quality regulations contained in Chapter 173-400 WAC General Regulations for Air Pollution Sources. Many of the provisions of Chapter 173-400 WAC adopted by reference remain unchanged since the EPA's last approval of EFSEC's regulations and were not resubmitted as part of Washington's September 30, 2019, SIP revision. Other revised Chapter 173-400 WAC provisions were not submitted for approval as part of this current SIP revision, including certain subsections of WAC 173-400-030 and 173-400-040. Specifically, subsections WAC 173-400-030(30) [subsequently renumbered to (32)], WAC 173-400-030(36) [subsequently renumbered to (38)], and WAC 173-400-040(2) were not submitted by Ecology and EFSEC as part of this action. For those sections, the versions previously approved by the EPA in the Federal Register at 82 FR 24533 (May 30, 2017) remain in the SIP.

On October 29, 2019, we proposed approving EFSEC's updated adoption by reference to include certain changes to Ecology's general air quality regulations since EFSEC's last adoption by reference (84 FR 57836). The reasons for our proposed approval were stated in the proposed rule and will not be re-stated here. The public comment period for our proposed action ended on November 29, 2019. We received no adverse comments.

The EPA is approving and incorporating by reference into the Washington SIP the submitted changes to WAC 463-78-005, Adoption by Reference, State effective August 26, 2019, and the corresponding submitted updates to EFSEC's adoption by reference of the following sections of Chapter 173-400 WAC:

• 173-400-111, 173-400-116, 173-400-710, 173-400-720, 173-400-730, 173-400-810, 173-400-830, 173-400-840, 173-400-850, State effective July 01, 2016;

• 173-400-025, 173-400-030, 173-400-040, 173-400-050, 173-400-171, 173-400-740, State effective September 16, 2018; and

• 173-400-060 and 173-400-105, State effective November 25, 2018.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, we are finalizing the incorporation by reference as described in the amendments set forth to 40 CFR part 52 below. The EPA has made, and will continue to make, these materials generally available through https://www.regulations.gov and at the EPA Region 10 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

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

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

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

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

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

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

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

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

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

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not address technical standards; and

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

The SIP is not approved to apply on any Indian reservation land in Washington except as specifically noted in this preamble and is also not approved to apply in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Washington's SIP is approved to apply on non-trust land within the exterior boundaries of the Puyallup Indian Reservation, also known as the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement Act of 1989, 25 U.S.C. 1773, Congress explicitly provided state and local agencies in Washington authority over activities on non-trust lands within the 1873 Survey Area. Consistent with EPA policy, the EPA provided a consultation opportunity to the Puyallup Tribe in a letter dated May 16, 2019.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 24, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires the Secretary of Health and Human Services (HHS) to adopt standards for the electronic transmission of certain health care administrative transactions conducted between health care providers, health plans, health care clearinghouses, and others. In January 2009 (74 FR 3295), the Secretary adopted the National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard Implementation Guide, Version D, Release 0, August 2007 (hereinafter referred to as Version D.0) for the following retail pharmacy transactions: Health care claims or equivalent encounter information, referral certification and authorization, and coordination of benefits.

Schedule II drugs are defined, in part, by the Controlled Substances Act (CSA) as those with a high potential for abuse which may lead to severe psychological or physical dependence (21 U.S.C. 812(b)(2)). Regulators take particular interest in Schedule II drugs because of public health concerns associated with their potential for misuse. The CSA prohibits the refilling of Schedule II drugs, but permits partial fills of Schedule II drugs in limited circumstances where a pharmacist has less than the prescribed amount of a medication in stock, the prescription is for a patient in a long-term care (LTC) facility, or a patient has a terminal illness. 1

In September 2012, the HHS Office of the Inspector General (OIG) issued a report titled “Inappropriate Medicare Part D Payments for Schedule II Drugs Billed as Refills” that analyzed all of the 2009 program year prescription drug event (PDE) records for refills of Schedule II drugs. 2 PDE records are claim summary records that contain data elements from prescription drug claims, submitted by prescription drug plan sponsors to the Centers for Medicare & Medicaid Services (CMS) for every prescription a provider fills for a Medicare Part D beneficiary. One of those data element fields is titled “Fill Number (403-D3),”  3 which identifies refills. The Version D.0 implementation specifications require that a “0” be entered in the Fill Number (403-D3) field for a new prescription and that the number be sequentially increased by “1” for each refill. The OIG analyzed 20.1 million records for Schedule II drugs and, focusing on the Fill Number (403-D3) field, identified what it concluded were refills. The OIG concluded that the Medicare Part D program had inappropriately paid $25 million for 397,203 Schedule II drug refills and that LTC facility pharmacies billed for 75 percent of such refills. The OIG stated that the Medicare Part D plan sponsors should not have paid for those drugs because Federal law prohibits Schedule II drug refills, and concluded that “[p]aying for such drugs raises public health concerns and may contribute to the diverting of controlled substances and their being resold on the street.”  4

CMS took a different interpretation of the OIG's findings. In its written response to the OIG report, 5 CMS expressed concern that the OIG's strict interpretation of PDE data did not support the OIG's findings. CMS believed the OIG's findings were based, in part, on a misinterpretation of Schedule II drug partial fills dispensed to LTC facility residents as refills. This prompted CMS to make an inquiry to an NCPDP work group, the WG9 Government Programs Medicare Part D FAQ Task Group (“Task Group”), which is designed to guide Federal pharmacy programs on NCPDP standards. CMS noted to the Task Group that, while the OIG report appeared to misinterpret partial fills as refills dispensed to patients in LTC facility pharmacies, it was not aware of any means by which a pharmacy could distinguish partial fills of a controlled substance prescription for billing purposes without using the Fill Number (403-D3) field. The Task Group replied to CMS that the Version D.0 implementation specification did not support the OIG's findings regarding the use of the Fill Number (403-D3) field, 6 and that the industry used the Fill Number (403-D3) field to represent the fill number—the amount actually dispensed—and not necessarily the refill number.

As a result, the Task Group initiated Designated Standard Maintenance Organization (DSMO) change request #1182  7 to update the pharmacy standard to effect a clarification and avoid further misinterpretation. The Task Group advised CMS that NCPDP would recommend changes to the standard to allow Version D.0 to specify the conditional use of a field not then used in the claim billing transaction, the Quantity Prescribed (460-ET) field, to indicate the actual quantity prescribed in the transmission of the claim, which would make data available to validate whether there are inappropriate fills in excess of the quantity prescribed. NCPDP noted this change in its November 2012 publication of Version D.0, which required the use of the Quantity Prescribed (460-ET) field when claims for Schedule II drugs are submitted to Medicare Part D. However, HHS has not adopted the November 2012 publication of Version D.0, thus HIPAA covered entities may not use it for HIPAA transactions.

On June 21, 2013, the NCVHS wrote to the Secretary that it agreed with NCPDP's recommendation to allow Version D.0 to specify the conditional use of the Quantity Prescribed (460-ET) field in a republished Version D.0 with an explanation in the Editorial Corrections section, and a change to the Version D.0 Editorial Document. 8 The NCVHS indicated that, with this change, “data will be available to validate whether or not there are inappropriate fills in excess of the quantity prescribed, a concern raised in a September 2012 report from the HHS Office of the Inspector General.”

During the last decade, the nation has experienced worsening issues with opioid addiction and overdose deaths, prompting various Congressional and Administration actions. For example, the Comprehensive Addiction and Recovery Act (CARA) (Pub. L. 114-198) was enacted on July 22, 2016. CARA amended the CSA to allow a pharmacist to partially fill a prescription for a Schedule II controlled substance if (1) such partial fills are not prohibited by state law; (2) a partial fill is requested by the patient or prescribing practitioner; and (3) the total quantity dispensed in a partial fill does not exceed the quantity prescribed. We believe CARA's implementation will yield an upsurge in partial fills. That view is echoed in a May 31, 2017 letter NCPDP sent to the DEA, which stated “[w]ith implementation of the CARA partial Fill Provision, the potential exists for a significant increase in the number of occurrences of a prescription for a Schedule II controlled substance being partially filled.”

Pursuant to the President's direction to consider the declaration of the public health emergency, consistent with the requirements of the Public Health Service Act, the Acting Secretary declared a nationwide public health emergency to address the opioid crisis on October 26, 2017. 9 The President also directed the heads of executive departments and agencies to use all lawful means to exercise all appropriate emergency and other relevant authorities to reduce the number of deaths and minimize the devastation the drug demand and opioid crisis inflicts upon American communities. Even prior to the President's direction, HHS had been responsive to the opioid crisis. In April 2017, the Secretary announced a 5-Point Strategy to—

• Improve access to prevention, treatment, and recovery support services;

• Target the availability and distribution of overdose-reversing drugs;

• Strengthen public health data reporting and collection;

• Support cutting-edge research on addiction and pain; and

• Advance the practice of pain management. 10

The requirements finalized in this rule support one of our top opioid strategic priorities calling for better data, which may ultimately help in reducing the drug supply.

In the January 31, 2019 Federal Register (84 FR 633), we published the proposed rule titled “Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) D.0 Standard” (hereafter referred to as the January 2019 proposed rule). In response to the January 2019 proposed rule, we received 15 timely pieces of correspondence from a variety of commenters, including a pharmacy standards development organization, data content committees, health plans, health care companies, professional associations, technology companies, and individuals.

In this section of this final rule, we present our proposals, summation of the comments received, and our responses to the comments. Some of the public comments received in response to the January 2019 proposed rule were outside of the scope of the proposed rule, and are not addressed in this final rule.

We proposed to adopt a modification of the requirements for the use of the Quantity Prescribed (460-ET) field of the August 2007 publication of Version D.0, which is the currently adopted version. We indicated that the modification would require that covered entities treat that field as required where a transmission uses Version D.0, August 2007, for a Schedule II drug for these transactions: (1) Health care claims or equivalent encounter information; (2) referral certification and authorization; and (3) coordination of benefits. HHS believes that, by modifying the requirements for the use of the NCPDP Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, covered entities will be able to clearly distinguish whether a prescription is a “partial fill,” or a refill, in the HIPAA retail pharmacy transactions.

Comment: A number of commenters supported HHS's proposal, noting that its narrow approach would not increase administrative burden and would let all covered entities accurately reflect partial fills of Schedule II drugs. A commenter stated that, while the proposal would not itself solve the opioid crisis, it would represent a step in the right direction by yielding better data to allow researchers to understand opioid prescribing trends.

Response: We thank the commenters for their support.

Comment: Some commenters did not agree with the proposal and urged HHS to adopt the November 2012 publication of Version D.0, which commenters stated was balloted and approved by the NCPDP membership and subsequently approved by the American National Standards Institute. Some of these commenters noted that NCPDP's only modification in that November 2012 version was to alter use of the Quantity Prescribed (460-ET) field from “not used” to “situational.”

Response: We note that, regardless of whether NCPDP's only change in its November 2012 version of D.0 was with respect to the Quantity Prescribed (460-ET) field, NCPDP had made other changes in previous D.0 releases before that time, and that all of the modifications NCPDP made to Version D.0 subsequent to the currently adopted 2007 version are included in its November 2012 publication. Thus, were we to adopt the November 2012 version here, covered entities would be required to implement a number of changes in addition to the one associated with the Quantity Prescribed (460-ET) field. Moreover, as we noted in the January 2019 proposed rule (84 FR 635), the alterations NCPDP made with respect to the Quantity Prescribed (460-ET) field in its November 2012 publication applied only to Medicare Part D claims, which would not cover a huge swath of HIPAA covered entities. We continue to believe that the narrow, targeted approach we proposed best addresses the immediate need to yield better data and information regarding partial fills of Schedule II drugs, and is the least burdensome to the industry.

Comment: Some commenters stated that HHS's proposal to modify the requirements for the use of the Quantity Prescribed (460-ET) field in Version D.0 failed to follow the process for adopting a modification to an existing HIPAA standard as established in the Transactions and Code Sets Rule and codified at § 162.910.

Response: As we explained in the January 2019 proposed rule (84 FR 635), the proposal would not modify the currently adopted Version D.0. Rather, it would require covered entities to treat a field in Version D.0 differently than is required by the Version D.0 implementation specifications. While commenters rightly note that modifications to HIPAA standards would require HHS to use the standards modification process established through rulemaking, because we are not modifying a HIPAA standard, we are not required to follow that process.

Specifically, our regulations at § 162.923(a) require covered entities to comply with the adopted HIPAA standards, except as otherwise provided. Here, we are providing that in a narrow instance, covered entities must use the adopted HIPAA standard Version D.0 in a way other than that specified by Version D.0. This constitutes a modification to the use of the adopted standard, not a modification to the standard itself. The term “implementation specification” is defined broadly at 45 CFR 160.103 as “specific requirements or instructions for implementing a standard.” Under the HIPAA regulations, implementation specifications are not limited to just those developed by standard setting organizations, which we adopt as HIPAA standards and incorporate by reference in the CFR. Implementation specifications are also requirements we establish for covered entities to comply with a standard. Under § 162.923(a), which specifies that we may require covered entities to comply with the adopted HIPAA standards except as otherwise provided, we are providing an exception.

Comment: Some commenters, recognizing that NCPDP's November 2012 Version of D.0 was limited to just Medicare Part D, recommended, as a work-around, that HHS adopt the November 2012 publication of Version D.0 and include language in the final rule stating that “covered entities must designate the situational field, Quantity Prescribed (460-ET) field as required for Schedule II Drugs, within applicable trading partner materials.” To that end, the commenters suggested that NCPDP payer sheets, which are used to define required field submission, could be used as part of trading partner materials where payers could require the submission of the Quantity Prescribed (460-ET) field for all claims or equivalent encounter information, prior authorization, and coordination of benefits transactions where the drug dispensed is a Schedule II drug.

Response: We considered the commenters' suggestion, but continue to believe that our proposal to modify the requirements for the use of Version D.0 is the least burdensome approach for covered entities. As noted earlier in this final rule, that November 2012 publication includes modifications NCPDP made subsequent to the version we adopted as the HIPAA standard; if we were to adopt the November 2012 publication, covered entities would be required to implement a number of changes in addition to the one associated with the Quantity Prescribed (460-ET) field.

Comment: A commenter noted that the proposed change would make apparent the discrepancies between the prescribed and dispensed quantities, but would not help explain the discrepancies. The commenter illustrated this point with the following example. “[I]f the physician wrote the prescription for #60 and the pharmacy only dispenses #30, this does not mean it is a `partial fill,' the discrepancy could instead be due to insurance restricting the drug supply, or other insurance requirements. The Quantity Prescribed (460-ET) field does not specifically indicate if a partial fill happens. This could lead to erroneous conclusions about the fill event in certain instances, such as when the insurance plan may have limited how much was allowed for coverage, or if there was not enough quantity in stock, which would not provide the intended data surrounding actual partial fills.” The commenter recommended that HHS instead utilize the following combination of fields, which the commenter asserted would clarify a discrepancy between prescribed and dispensed quantities—Dispensing Status (343-HD) field; Quantity Intended To Be Dispensed (344-HF) field; and Day Supply Intended To Be Dispensed (345-HG) field. The commenter noted that these fields are not required, but are available and supported by Version D.0.

Response: The fields to which the commenter refers are presently and purposefully only intended for use in the case of a pharmacy inventory shortage. We believe the approach we proposed, and adopt here, is superior to the commenter's recommended approach, which would be significantly more burdensome to covered entities by requiring them to comply with different requirements for each type of partial fill and to implement more software systems updates.

Comment: A commenter suggested that it would be easier for many pharmacies to implement systems changes to effectuate HHS's proposal so that the modification to the requirements for the use of the Quantity Prescribed (460-ET) field could cover more than just Schedule II drugs. Therefore, the commenter suggested that HHS expand this proposal to include Schedule III through V drugs as well. Conversely, several commenters supported HHS's proposed approach, which limits the modification to just Schedule II drugs.

Response: As discussed earlier in this final rule, the need for regulatory action to modify the requirements for the use of the August 2007 version of the NCPDP D.0 standard and the concerns motivating our proposed modification stem partly from CARA's change to the partial fill requirements for Schedule II drugs. We believe that requiring the Quantity Prescribed (460-ET) field to apply to all drugs, not just Schedule II drugs, would increase the burden on pharmacies, nor would it further the goals discussed herein. Therefore, we are finalizing our proposal without modification, but appreciate the commenters' varied perspectives, and may in the future consider expanding this requirement to include prescribed drugs in Schedules III through V.

Comment: A commenter encouraged the Secretary to expedite a proposed rule seeking the adoption of the NCPDP Telecommunication Standard Implementation Guide Version F2, which the commenter asserts provides enhanced transparency and improves patient safety measures for all controlled substances. By contrast, another commenter was pleased that we did not propose to adopt Version F2 because the commenter believes the language of the relevant field to be “chilling” as it suggests penalties may apply when the field is misused.

Response: We appreciate that there are arguments for and against expedited rulemaking for the adoption of NCPDP Telecommunication Standard Implementation Guide Version F2. Were we to adopt Version F2, covered entities would need to make significant changes. While we continue to carefully evaluate the NCVHS's May 17, 2018 recommendation encouraging HHS to adopt the updated NCPDP pharmacy standards, we believe the public health emergency caused by the opioid crisis, and the urgent need for better data and information to help combat it, dictate that we now take this narrow, targeted approach as proposed.

Comment: A number of commenters supported HHS's proposal that the term “Schedule II drugs,” be included in the modifications to §§ 162.1102, 162.1302, and 162.1802, to mirror the Drug Enforcement Administration's definition of the term at 21 CFR 1308.12. Some of these commenters agreed with HHS that Schedule III through V drugs should not be included in this rule.

Response: We thank the commenters for their support. We note that in this final rule, we are making a technical change to the regulation text to remove the phrase “as updated” from each of the three provisions that define Schedule II drugs, that is, §§ 162.1102(d)(1), 162.1302(d)(1), and 162.1802(d)(1), because the phrase is superfluous.

After reviewing the public comments received, we are finalizing the modification of the requirements for the use of the Quantity Prescribed (460-ET) field for retail pharmacy transactions, which will be reflected in the regulations at §§ 162.1102, 162.1302, and 162.1802.

We proposed that the final rule would be effective 60 days after publication in the Federal Register and that the compliance date would be 180 days after the effective date, in accordance with section 1175(b)(2) of the Social Security Act.

Comment: A number of commenters supported HHS's proposed effective and compliance dates for the modification.

Response: We thank the commenters for their support.

Comment: Some commenters urged HHS to revise the implementation timeline of the proposed modification. These commenters suggested that HHS should not adopt a compliance date that would interfere with end-of-year industry processing requirements. Commenters explained that they estimated the compliance date for this final rule would be January 2020, which coincides with the 2020 Medicare Part D rule's implementation timeframe for the NCPDP SCRIPT Standard Version 2017071 as well as the normal annual benefit plan changes. Another commenter stated that a short compliance timeframe would cause beneficiaries to be unable to access their medications because payers would not have sufficient time to make the necessary systems changes. A commenter recommended that HHS implement a transitional period for this modification whereby payers may begin using the Quantity Prescribed (460-ET) field on the effective date of the final rule, but mandatory use of the field for all entities be no earlier than June 2020. Finally, some commenters stated their belief that the compliance date and effective date are the same, which they believed would result in a hard cut-over that could engender risks in patient access to care as well as burdensome administrative and operational challenges.

Response: In considering these comments, we recognize commenters' confusion with respect to the distinct concepts of compliance and effective dates, and we have clarified the regulation text in this final rule to be clear that the compliance date is 180 days after the effective date of the rule. As we noted previously in this document, this final rule will be effective 60 days after publication in the Federal Register . The compliance date, or the date on which covered entities must comply with the modification, follows that by 180 days. In the spring 2019 Unified Regulatory Agenda, we noted that, this final rule would be published in December 2019. Based on that, we anticipate that the effective date of this rule will be in February 2020 and the compliance date will be in August 2020. We believe this explanation ameliorates commenters' concerns. After consideration of the public comments received and the clarification offered here, we are finalizing the effective and compliance dates of this final rule without modification.

The incorporation by reference of the standards referenced in this rule (Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007 and equivalent Batch Standard Implementation Guide, Version 1, Release 2 (Version 1.2), National Council for Prescription Drug Programs) was previously approved for the amended sections. We are making no changes to the incorporation.

The Office of Management and Budget (OMB) has determined that the establishment of standards for electronic transactions under HIPAA (which mandate that the private sector disclose information and do so in a particular format) constitutes an agency-sponsored third-party disclosure as defined under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq. ). (See 65 FR 50350 (August 17, 2000).) With respect to the scope of its review under the PRA, however, OMB has concluded that its review would be limited to the review and approval of initial standards, and to changes in industry standards which would substantially reduce administrative costs. (See 65 FR 50350 (August 17, 2000).) This document, which requires the use of a data element that was not previously used and the disclosure of additional information in a particular location in the transaction, would usually constitute an information collection requirement because it requires third-party disclosures. However, because of OMB's determination, noted above, there is no need for OMB review under the PRA. But see 5 CFR 1320.3(b)(2) (time, effort, and financial resources necessary to comply with an information collection that would otherwise be incurred in the normal course of business can be excluded from PRA “burden” if the agency demonstrates that such activities needed to comply with the information collection are usual and customary).

We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

Executive Orders 12866 and 13563 direct 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). A Regulatory Impact Analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule. We did not receive any comments on the regulatory impact statement from the January 2019 proposed rule. Therefore, we are finalizing it in this rule with no modifications.

Covered entities inconsistently reflect partial fills and fill numbers for Schedule II drugs in retail pharmacy transactions that utilize Version D.0 because Version D.0 does not permit covered entities to use the Quantity Prescribed (460-ET) field. As a result, stakeholders cannot reliably discern from transactions data when a Schedule II drug has been partially filled or refilled. To help understand the economic burden of this issue, in the January 2019 proposed rule, HHS referred back to the previously mentioned 2012 OIG report, which estimated that pharmacies inaccurately billed $25 million worth of partial fills as refills in 2009 paid by the Medicare Part D program. The OIG also expressed concerns about the possibility of these inappropriately dispensed Schedule II drugs being resold on the street. 11 As previously stated, and discussed in the January 2019 proposed rule, CMS noted its concern that the OIG's strict interpretation of PDE data did not support the OIG's findings, instead believing that the OIG's findings were based in part on a misinterpretation that Schedule II drug partial fills dispensed to LTC facility residents were refills. However, these findings represent a helpful starting point for this estimate. The White House Council of Economic Advisers estimates that opioid abuse exacted a cost of $504 billion in 2015 and contributed to a significant number of prescription and illicit drug overdose deaths. 12 Furthermore, in the January 2019 proposed rule and in this final rule, HHS discussed that the Secretary declared a public health emergency to combat the opioid crisis.

For this analysis, HHS continues to leverage the historical cost and benefit data from the study conducted to support the Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards August 2008 proposed rule and the January 2009 final rule (73 FR 49742 and 74 FR 3295 and 3296, respectively) (hereinafter referenced as the study). The impact analysis for this final rule utilizes the historical cost estimates derived from the study across covered entities. The final estimate provided an overall cost of $38 million to fully implement the then-new requirements of the 2007 Version D.0 for chain pharmacies (73 FR 49772). Since this is a very narrow, targeted modification that is limited to requiring covered entities to use the Quantity Prescribed (460-ET) field of the currently adopted Version D.0 in certain specified situations, we anticipate the aggregate costs will be minimal. HHS expects minor system and implementation expenses, which consist of modifying software configurations, updating business processes, and minimal personnel training. We continue to believe the investments to adopt this modification and update existing systems have the same cost variables as the adoption of the current Version D.0. As discussed in the January 2019 proposed rule (84 FR 636), we used these same considerations from the January 16, 2009 final rule (74 FR 3296) to formulate our assumptions on implementing system upgrades, and staff training costs. While it is difficult to determine aggregate costs across the industry, we believe system costs for this modification to the requirements for use of Version D.0 to be limited IT resources, training, and business processes, and that this modification would cost between 1 to 5 percent of the original estimated cost, or between $380,000 and $1,900,000. The study also estimated a maximum upgrade fee cost of $1.08 million per year for independent pharmacies (73 FR 49772). This results in an estimated cost for this modification of $10,800 to $54,000 per year in service fees across all independent pharmacies.

Pharmacies will benefit from using the Quantity Prescribed (460-ET) field because it will facilitate better monitoring of Schedule II drugs for over- or inappropriate prescribing. By virtue of the more robust data that we believe can be used to help avoid audits and incorrect payments, HHS believes that large pharmacy chains can save up to $500,000 per year, while smaller chains can save approximately $100,000 per chain. Therefore, this can yield a total 10-year benefit of up to $10 million, and that does not account for the value of the time pharmacists and pharmacy technician staff who process these claims can save.

We believe health plans and their associated pharmacy benefit managers (PBMs) will also incur minimal cost since most have existing hardware and software platforms capable of using this field with their current technology and networks. Thus, we expect this change will have a similarly minimal cost impact of between 1 and 5 percent of the original implementation costs. The study originally estimated the total cost to implement the 2007 Version D.0 for plans and PBMs to be a maximum of $10.6 million for the industry (73 FR 49773). Thus, we continue to believe that the total cost for this change for health plans and PBMs to be between $106,000 and $530,000.

Executive Orders 12866 and 13563 direct 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). An RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule. We anticipate that the modification to the requirements for the use of the Quantity Prescribed (460-ET) field will yield more data and information with respect to the dispensing, facilitate better monitoring of Schedule II drugs, and reinforce the Administration's commitment to lowering overall health care costs by reducing administrative burden and improving the quality of health care.

The RFA requires agencies to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate the great majority of independent retail pharmacies are small businesses as defined by the Small Business Administration's (SBA) definition of having revenues of less than $7.5 million up to $38.5 million in any 1 year. The SBA defines a size threshold in terms of annual revenues for pharmacies as $27.5 million. Our proposed estimate stated that 95 percent of independent retail pharmacies have revenues below $27.5 million or are nonprofit organizations and are considered small entities. Individuals and states are not included in the definition of a small entity. As stated earlier, for this analysis HHS used the same considerations from the January 16, 2009 final rule to formulate our assumptions for this RFA, we the reader to refer to that analysis for additional information. We continue to believe that the modification to the requirements for the use of the Quantity Prescribed (460-ET) field will have a de minimis effect on that analysis; therefore, the Secretary has determined that this final rule will not have a significant economic impact on independent retail pharmacies and is not preparing an analysis under the RFA.

In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we continue to define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. This final rule will affect the operations of a substantial number of small rural hospitals because they are covered entities under HIPAA and must comply with the regulations; however, we do not believe the rule will have a significant impact on those entities, for the reasons stated above in reference to small businesses. Therefore, the Secretary has determined that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals and is not preparing an analysis under section 1102(b) of the Act.

Based on the information contained herein, including the 2009 analysis referenced above, the Secretary has determined and certifies that this final rule will not have a significant economic impact on a substantial number of small entities. Accordingly, HHS is not required to, and does not, prepare a regulatory impact analysis under the RFA.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2019, that threshold is approximately $154 million. We believe that this final rule will have no consequential effect on state, local, or tribal governments or on the private sector in excess of that threshold.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. We believe that since this final rule does not impose substantial costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017 and requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” OMB's interim guidance, issued on April 5, 2017, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/M-17-21-OMB.pdf, explains that the requirements (as previously discussed) only apply to each new “significant regulatory action that imposes costs.” We have determined that this final rule is not a “significant regulatory action” and thus does not trigger the previously discussed requirements of Executive Order 13771.

We have assessed the anticipated costs and benefits of this final rule and continue to believe that it will yield more data and information with respect to the dispensing of Schedule II drugs.

In accordance with the provisions of Executive Order 12866, this final rule was not reviewed by the Office of Management and Budget.

For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR part 162 as set forth below: