The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model DHC-8-102, -103, and -106 airplanes; Model DHC-8-200 series airplanes; and Model DHC-8-300 series airplanes. The NPRM published in the Federal Register on April 4, 2019 (84 FR 13148). The NPRM was prompted by the reported loss of an elevator spring tab balance weight prior to takeoff. The NPRM proposed to require inspecting the two balance weights and the two hinge arms on each elevator spring tab, and corrective actions if necessary.

The FAA is issuing this AD to address tolerance stack-up between the balance weight and the hinge arm that can allow the attachment bolts to fret with the hinge arm and result in wear, fracture, and loss of the spring tab balance weight. Loss of the spring tab balance weight can lead to unacceptable flutter margins and loss of the airplane.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2018-30, dated November 7, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model DHC-8-102, -103, and -106 airplanes; Model DHC-8-200 series airplanes; and Model DHC-8-300 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-0189.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA has considered the comment received. The Air Line Pilots Association, International stated that it agrees with the intent of 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.

Bombardier has issued Service Bulletin 8-55-27, Revision A, dated August 15, 2018. This service information describes procedures for inspecting the two balance weights and the two hinge arms on each elevator spring tab, and corrective actions including inspecting the holes in the hinge arm, inspecting the hinge arm for corrosion and chafing, installing bushings and a solid shim, replacing the hinge arm, repairing damage to the hinge arm, and permanently securing the mass balance.

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 47 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:

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 2019-0065, dated March 27, 2019 (“EASA AD 2019-0065”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A350-941 airplanes. The MCAI states:

EASA AD 2019-0065 describes procedures for replacing the original diagonal struts at frame 102 with new, improved parts. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

This AD requires accomplishing the actions specified in EASA AD 2019-0065 described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. As a result, EASA AD 2019-0065 is incorporated by reference in the FAA final rule. This AD, therefore, requires compliance with the provisions specified in EASA AD 2019-0065, except for any differences identified as exceptions in the regulatory text of this AD. Service information specified in EASA AD 2019-0065 that is required for compliance with EASA AD 2019-0065 is available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-0496.

Since there are currently no domestic operators of this product, notice and opportunity for public comment before issuing this AD are unnecessary. In addition, for the reasons stated above, the FAA finds that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and the FAA did not precede it by notice and opportunity for public comment. The FAA invites you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2019-0496; Product Identifier 2019-NM-055-AD” at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this AD. The FAA will consider all comments received by the closing date and may amend this AD based on those comments.

The FAA will post all comments the agency receives, without change, to http://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact the agency receives about this AD.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, the FAA provides the following cost estimates to comply with this AD:

The FAA was notified that a conflict may occur between the TCAS primary cockpit display indications and the aural alerts during an RA scenario on specific part-numbered Rockwell Collins FDSA-6500 flight display system applications. These applications may be installed on, but not limited to, Bombardier Inc. Model CL-600-2B16 (604 variant) airplanes and Textron Aviation Inc. Models 525B, B200, B200C, B200CGT, B200GT, B300, B300C, and C90GTi airplanes.

During testing of a full flight simulator on a development program, the TCAS fly-to/avoidance cue indication on the primary cockpit displays conflicted with other TCAS system information, such as aural cues, during an RA scenario. While the aural alert will provide the pilot with accurate information to resolve the RA, that information is not accurately represented by the TCAS fly-to/avoidance cue display. Specifically, the TCAS fly-to/avoidance cue is displayed relative to the aircraft horizon line instead of the aircraft symbol. Rockwell Collins determined that the data from the TCAS is being translated incorrectly by the FDSA-6500 software prior to display of the RA pitch indications.

This condition, if not addressed, could lead to the pilot over-correcting or under-correcting for aircraft separation and may result in a mid-air collision. The manufacturer is developing a software update to correct this condition. The actions required by this AD are intended to prevent conflicting TCAS information by prohibiting flight operation with RA functionality enabled. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA reviewed Rockwell Collins Operator Bulletin OPSB 0193-19R1, Revision 1, dated April 3, 2019. The service information describes the unsafe condition and provides examples of different scenarios that could occur with the TCAS indication conflicts. The service information also contains instructions for determining the part number of the FDSA-6500 installation.

The FAA is issuing this AD because it evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD prohibits operation with the TCAS in TA/RA mode by requiring a revision to the Limitations section of the AFM or AFMS and by fabricating and installing a placard on each aircraft primary flight display. An owner/operator (pilot) may revise the AFM or the AFMS and fabricate and install the required placard, and the owner/operator must enter compliance with the applicable paragraphs of the AD into the aircraft records in accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). A pilot may perform these actions because they can be performed equally well by a pilot or a mechanic. This is an exception to our standard maintenance regulations.

The FAA considers this AD interim action. The operating limitation required by this AD will immediately address the unsafe condition. However, Rockwell Collins is developing a software upgrade to correct the unsafe condition and eliminate the need for the operating limitation required by this AD action. Because the operating limitation required by this AD addresses the unsafe condition, any rulemaking with a software upgrade would allow for public notice and comment. Thus, the FAA will consider future rulemaking when the software upgrade becomes available.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because a conflict between the displayed indications and the TCAS aural alert could lead to the pilot over-correcting or under-correcting for aircraft separation and result in a mid-air collision. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, the FAA finds that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the Docket Number FAA-2019-0469 and Product Identifier 2019-CE-028-AD at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

The FAA will post all comments it receives, without change, to http://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact it receives about this final rule.

The FAA estimates that this AD affects 932 FDSA-6500 flight display system applications installed on 311 airplanes worldwide. The number of FDSA-6500 applications installed on airplanes on the U.S. Registry is unknown.

The FAA estimates the following costs to comply with 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.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

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 affect intrastate aviation in Alaska.

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. The NPRM published in the Federal Register on February 22, 2019 (84 FR 5609). The NPRM was prompted by reports of low clearance between the VFG power feeder cables and adjacent hydraulic lines and/or fuel lines in the aft equipment bay, which could cause chafing damage. The NPRM proposed to require modifying the routing of the VFG power feeder cables and harnesses in the aft equipment bay.

The FAA is issuing this AD to address chafing damage in the aft equipment bay, which could result in a hydraulic/fuel leak and electrical arcing as an ignition source, and could cause an in-flight fire.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2018-22, dated August 2, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-0019.

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

Flexjet stated that the routing modification in the proposed AD refers to “outdated Service Bulletins SB 700-24-089 R1, SB 700-24-6014 R1, 700-1A11-24-028 R1 [and] 700-24-5014 R1.” Flexjet added that on September 27, 2018, all service information referenced in the NPRM was updated to Revision 2. Flexjet noted that Revision 2 of the service information merely clarifies certain procedures.

The FAA infers that the commenter is asking that this AD refer to the following Bombardier service information as the appropriate source for accomplishing the required actions:

• Service Bulletin 700-24-089, Revision 02, dated September 27, 2018.

• Service Bulletin 700-24-6014, Revision 02, dated September 27, 2018.

• Service Bulletin 700-1A11-24-028, Revision 02, dated September 27, 2018.

• Service Bulletin 700-24-5014, Revision 02, dated September 27, 2018.

The FAA agrees with the commenter's request. The FAA has included the Bombardier service information listed above as the appropriate source of service information for accomplishing the required actions. The FAA has determined that no additional work is required for airplanes that have accomplished the actions specified in Revision 01 of the referenced service information. Revision 02 of the referenced service information clarifies the language in certain steps and adds notes to certain steps. The FAA has added Revision 01 of the referenced service information to paragraphs (h)(1) and (h)(2) of this AD to provide credit for actions done before the effective date of this AD.

The FAA reviewed the relevant data, considered the comment 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 also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

Bombardier has issued the following service information for Bombardier, Inc. Model BD-700-1A10 airplanes.

• Service Bulletin 700-24-089, Revision 02, dated September 27, 2018.

• Service Bulletin 700-24-6014, Revision 02, dated September 27, 2018.

Bombardier has issued the following service information for Bombardier, Inc. Model BD-700-1A11 airplanes.

• Service Bulletin 700-1A11-24-028, Revision 02, dated September 27, 2018.

• Service Bulletin 700-24-5014, Revision 02, dated September 27, 2018.

This service information describes procedures for modifying the routing of the VFG power feeder cables and harnesses in the aft equipment bay to ensure the required clearance between the cables and the hydraulic lines and/or fuel lines. These documents are distinct since they apply to different airplane models and configurations.

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 112 airplanes of U.S. registry. The FAA estimates the following costs to comply with 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 FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. The NPRM published in the Federal Register on March 12, 2019 (84 FR 8832). The NPRM was prompted by reports that certain aft fuselage fittings are susceptible to cracking because they were not manufactured correctly. The NPRM proposed to require replacement of those fittings with correctly manufactured parts, an eddy current inspection of certain fastener holes for cracking, and corrective actions if necessary.

The FAA is issuing this AD to address the possibility of undetected cracks developing in the aft fuselage fittings due to the absence of heat treatment, which could lead to aircraft structural failure.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2018-25, dated October 3, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-0119.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA has considered the comment received. The commenter indicated 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.

Bombardier has issued Service Bulletin 670BA-53-056, dated February 11, 2016. This service information describes, among other actions, procedures for removal and replacement of the aft fuselage fittings, and an eddy current inspection of certain fastener holes for cracking.

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

The FAA has received no definitive data that would enable us to provide cost estimates for the on-condition actions 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:

FDA is announcing the availability of an immediately in effect guidance for industry entitled “Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency.” This guidance describes FDA's policy concerning the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan to compound oral drug products for patients with BH4 deficiency.

Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician to qualify for exemptions from certain requirements of the FD&C Act related to FDA approval prior to marketing, current good manufacturing practice requirements, and labeling with adequate directions for use (see sections 505, 501(a)(2)(B), and 502(f)(1) of the FD&C Act (21 U.S.C. 355, 351(a)(2)(B), and 352(f)(1))). One of the conditions that must be met for a compounded drug product to qualify for these exemptions is that a licensed pharmacist or licensed physician compounds the drug product using bulk drug substances that: (1) Comply with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if such a monograph does not exist, are drug substances that are components of drugs approved by FDA; or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by FDA, appear on a list of bulk drug substances developed by FDA through regulation. (See section 503A(b)(1)(A)(i) of the FD&C Act.)

On February 19, 2019, FDA issued a final rule (84 FR 4696) (“February 19, 2019, final rule”), which established the list of bulk drug substances that can be used to compound drug products under section 503A of the FD&C Act even though they are not the subject of an applicable USP or NF monograph or a component of an FDA approved drug product (the 503A Bulks List). (See section 503A(b)(1)(A) of the FD&C Act.) The final rule, codified at § 216.23 (21 CFR 216.23), placed six bulk drug substances on the 503A Bulks List (§ 216.23(a)), and identified four others, including oxitriptan, that cannot be used to compound drug products under section 503A of the FD&C Act (§ 216.23(b)). Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future rulemaking.

FDA developed this guidance in response to communications from pharmacists and caregivers regarding the use of oxitriptan to treat patients with BH4 deficiency following issuance of the February 19, 2019, final rule, which placed oxitriptan on the list of bulk drug substances that cannot be used to compound drug products under section 503A of the FD&C Act. According to those communications and other information available to the Agency, oxitriptan is the standard of care for the treatment of BH4 deficiency, which is caused by several different rare enzyme defects that result from gene mutations. BH4 deficiency is also known as: Primary tetrahydrobiopterin deficiency, atypical phenylketonuria (PKU), GTP cyclohydrolase (GTPCH) deficiency, 6-pyruvoyl-tetrahydropterin synthase (6-PTPS) deficiency, and dihydropteridine reductase (DHPR) deficiency. FDA did not consider BH4 deficiency during its initial review of this substance for the 503A Bulks List. Thus, this guidance addresses the conditions under which FDA does not intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician for the use of bulk oxitriptan to compound oral drug products for the treatment of identified individual patients with BH4 deficiency provided certain conditions are met. In light of the new information regarding use of oral oxitriptan to treat BH4 deficiency, FDA is considering whether to reevaluate the exclusion of oxitriptan from the 503A Bulks List.

FDA is issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate due to the public health need for patients with BH4 deficiency to access compounded oxitriptan oral drug products (21 CFR 10.115(g)(2)). This guidance does not establish any rights for any person and is not binding on FDA or the public. Although this guidance is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation. This guidance is not subject to Executive Order 12866.

Persons with access to the internet may obtain the document at either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm or https://www.regulations.gov . Use the FDA website listed in the previous sentence to find the most current version of the guidance.

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NOAA National Oceanic and Atmospheric Administration NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

In March 2016, the harbormaster submitted a draft proposal to the Belfast City Council and subsequently the town began talks with Coast Guard Sector Northern New England regarding establishment of a special anchorage area in Belfast. Subsequently, the Town of Belfast, ME Harbor Committee and the Belfast harbormaster petitioned Coast Guard Sector Northern New England to designate a special anchorage area in the Passagassawakeag River, in the vicinity of Belfast, ME. In response, on October 3, 2017, the Coast Guard published a NPRM titled “Special Anchorage Areas; Passagassawakeag River, Belfast Bay, Belfast, Maine” (82 FR 46004). There, we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to establishing two special anchorages in the Passagassawakeag River. During the comment period that ended December 4, 2017, we received one comment. For the reasons discussed below, the Coast Guard is making no changes to this rule from the proposed rule.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 471, 2071; 46 U.S.C. 70034 (previously 33 U.S.C. 1231). Commander, First Coast Guard District has determined that this rule will reduce the risk of vessel collisions by creating two special anchorage areas in the Passagassawakeag River in the vicinity of the northeastern portion of Belfast, ME. The purpose of this rule is to increase the safety of life and property in the Passagassawakeag River in the vicinity of Belfast, improve the safety of anchored vessels, and provide for the overall safe and efficient flow of vessel traffic and commerce.

This rule establishes two special anchorage areas, referred to as special anchorage areas A and B, in the Passagassawakeag River in the vicinity of Belfast, ME. Special anchorage area A is approximately 554,800 sq. yards and is on the north side of the river located between the mouth of the Goose River and Patterson Pt, downstream of the US RT 1 Bridge. Special anchorage area B is approximately 693,889 sq. yards and located along the southern shores of the river located between the Belfast Town docks to Belfast City Park.

Vessels less than 65 feet in length, when at anchor in these special anchorage areas, will not be required to sound signals or display anchorage lights or shapes when at anchor. Additionally, mariners using these anchorage areas are encouraged to contact local and state authorities, such as the local harbormaster, to ensure compliance with any additional applicable state and local laws. Such laws may involve, for example, compliance with direction from the local harbormaster when placing or using moorings within the anchorage.

The Coast Guard received one comment on our NPRM published on October 3, 2017. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

The one comment was authored by a NOAA cartographer who wanted to make the Coast Guard aware of charted features within the proposed special anchorage areas. Specifically, a charted obstruction (Obstn) feature within special anchorage area A and a charted pier (jetty) in ruins within special anchorage area B.

The Coast Guard and Belfast harbormaster are aware of the charted obstructions. The town of Belfast has operated these areas as managed mooring fields for decades and places the moorings around the charted obstructions. The regulatory text appears at the end of this document. In our note to § 110.4(d), we state that all coordinates referenced use datum NAD 83 and that all anchoring in the areas is under the supervision of the town of Belfast harbormaster or other such authority as may be designated by the authorities of the Town of Belfast, Maine. Mariners using these special anchorage areas are encouraged to contact local and state authorities, such as the local harbormaster, to ensure compliance with any additional applicable state and local laws.

Additionally during the environmental review process the Coast Guard received comments from the NOAA Habitat Conservation Division. The comments, authored by a NOAA Marine Habitat Resource Specialist, recommended an eelgrass survey be conducted to determine the presence of eelgrass beds. Additionally, the Marine Habitat Resource Specialist recommended the moorings be converted to conservation moorings that use a floating pendant in lieu of chains to prevent damage to eelgrass beds.

An eelgrass study was conducted by the City of Belfast in October, 2018. The study concluded there was no eelgrass within the proposed area. The City of Belfast expressed their intention to continuously monitor the area for potential eelgrass growth.

We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analysis based on those statutes and Executive Orders, and we discuss First Amendment rights of protestors.

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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the fact that vessel movement in the area will not be affected. Additionally, those using the waterway will see no adverse changes to how the waterway presently operates.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the Passagassawakeag River in Belfast, ME may be small entities, for the reasons stated above in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of two special anchorage areas in the Passagassawakeag River in the vicinity of northeastern Belfast, ME. It is categorically excluded from further review under paragraph L59 (a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest to do so. There is insufficient time to allow for a reasonable comment period prior to the date of the event. We are taking immediate action to ensure the safety of participants and the general public from hazards associated with non-participant vessel movement near the swim event. It is impracticable and contrary to the public interest to publish an NPRM because we must establish this safety zone by July 14, 2019.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because the rule must be in effect by July 14, 2019, to mitigate the potential safety hazards associated with the swim event.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). Green Whales Inc. notified the Coast Guard that it will host the inaugural Jim Whelan Open Water Festival on July 14, 2019. The event will include a 400-meter swim with up to 50 participants and a 2-kilometer swim with up to 150 participants. The swim courses are on the waters of the New Jersey Intracoastal Waterway in Atlantic City, NJ. The Captain of the Port Delaware Bay (COTP) has determined that potential hazards associated with this swim event scheduled for July 14, 2019, will be a safety concern for participants and for vessels operating within the specified waters of the New Jersey Intracoastal Waterway. The purpose of this rulemaking is to protect participants, spectators, and transiting vessels on certain waters of the New Jersey Intracoastal Waterway before, during, and after the scheduled event.

This rule establishes a safety zone from 5 p.m. until 9 p.m. on July 14, 2019. The safety zone will cover navigable waters of the New Jersey Intracoastal Waterway between the Albany Avenue (Highway 40) bridge in the southwest and New Jersey Intracoastal Waterway Daybeacon 204 in the northeast. Paragraph (a) of the regulation text below provides a detailed description of the location. The duration of the zone is intended to ensure the safety of participants and vessels on these navigable waters before, during, and after the swim event scheduled from 6 p.m. to 8 p.m. on July 14, 2019. No person or vessel will be permitted to enter, transit through, anchor in, or remain within the safety zone without obtaining permission from the COTP Delaware Bay or a designated representative. If the COTP Delaware Bay or a designated representative grants authorization to enter, transit through, anchor in, or remain within the safety zone, all persons and vessels receiving such authorization must comply with the instructions of the COTP Delaware Bay or a designated representative. The Coast Guard will provide public notice of the safety zone by Local Notice to Mariners and Broadcast Notice to Mariners.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

The impact of this rule is not significant for the following reasons: (1) The enforcement period will last four hours when vessel traffic is usually low; (2) although non-participant persons and vessels may not enter, transit through, anchor in, or remain with the safety zone without authorization from the COTP Delaware Bay or a designated representative, surrounding channels within the New Jersey Intracoastal Waterways will remain unaffected. Persons and vessels will be able to operate in the surrounding area during the enforcement period; (3) persons and vessels will still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the COTP Delaware Bay or a designated representative; and (4) the Coast Guard will provide advance notification of the safety zone to the local maritime community by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene actual notice from designated representatives.

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

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only 4 hours that will prohibit entry within certain navigable waters during a swim event. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

On October 11, 2018, the Orrin G. Hatch-Bob Goodlatte Music Modernization Act (the “MMA”) was signed into law. 1 Title I of the MMA addresses the efficiency and fairness of the section 115 “mechanical” license for the reproduction and distribution of musical works embodied in digital phonorecord deliveries, including permanent downloads, limited downloads, and interactive streams. 2 In relevant part, it eliminates the song-by-song notice of intention process for such uses and creates a new blanket compulsory licensing system for digital music providers engaged in digital phonorecord deliveries. 3 The blanket licensing structure is designed to reduce the transaction costs associated with song-by-song licensing by commercial services that strive to offer “as much music as possible,” while “ensuring fair and timely payment to all creators” of the musical works used on these digital services. 4

The MMA directs the Register of Copyrights to designate a nonprofit entity operated by copyright owners, referred to by statute as the mechanical licensing collective (“MLC”), to administer this new blanket-licensing system beginning on the “license availability date,” that is, January 1, 2021. 5 As detailed further below, the MLC, through its board of directors and task-specific committees, will be responsible for a variety of duties, including receiving usage reports from digital music providers, collecting and distributing royalties associated with those uses, identifying musical works embodied in particular sound recordings, administering a process by which copyright owners can claim ownership of musical works (and shares of such works), and establishing a musical works database relevant to these activities. 6

By statute, digital music providers will bear the reasonable costs of establishing and operating the MLC through an administrative assessment, to be determined if necessary by the Copyright Royalty Judges (“CRJs”) in a separate proceeding. 7 The MMA also allows, but does not require, the Register to designate a digital licensee coordinator (“DLC”) to represent licensees in this proceeding, to serve as a non-voting member of the MLC, and to carry out other functions. 8

The entity designated as the MLC must be:

• A single nonprofit entity that is created by copyright owners to carry out its statutory responsibilities;

• “endorsed by, and enjoy[ ] substantial support from, musical work copyright owners that together represent the greatest percentage of the licensor market for uses of such works in covered activities, as measured over the preceding 3 full calendar years;”  9

• able to demonstrate to the Copyright Office that, by the license availability date, it will have the administrative and technological capabilities to perform the required functions; and

• governed by a board of directors and include committees that are composed of a mix of voting and non-voting members as directed by the statute. 10

If no single entity meets each of these statutory criteria, the Register must designate as the MLC the entity that most nearly fits these qualifications. 11 After five years, the Register will commence a periodic review of this designation. 12

The MMA enumerates a number of required functions for the MLC. 13 A core aspect of the MLC's responsibilities includes identifying musical works and copyright owners, matching them to sound recordings (and addressing disputes), and ensuring that a copyright owner gets paid as he or she should. To that end, the MLC will create and maintain a free, public database of musical work and sound recording ownership information. The MLC will administer processes by which copyright owners can claim ownership of musical works (and shares of such works), and by which royalties for works for which the owner is not identified or located are equitably distributed to known copyright owners on a market share basis after a required holding period. 14 The MLC will participate in proceedings before the CRJs to establish the administrative assessment that will fund the MLC's activities, as well as proceedings before the Copyright Office with respect to the foregoing activities. 15

The board of the MLC shall consist of fourteen voting members and three nonvoting members. 16 Ten voting members shall be representatives of music publishers that have been assigned exclusive rights of reproduction and distribution of musical works with respect to covered activities, and four other voting members shall be professional songwriters who have retained and exercise exclusive rights of reproduction and distribution for musical works they have authored. There are also three nonvoting members that will represent the interests of songwriters, music publishers, and digital licensees via representatives of relevant trade associations or, in the case of licensees, the DLC, if one has been designated. 17 Within one year of designation, the MLC must establish publicly available bylaws relating to the governance of the collective, following statutory criteria. 18

By statute, the MLC board must establish three committees. First, an operations advisory committee will make recommendations concerning the operations of the collective, “including the efficient investment in and deployment of information technology and data resources.”  19 Second, an unclaimed royalties oversight committee will establish policies and procedures necessary to undertake a fair distribution of unclaimed royalties. 20 Third, a dispute resolution committee will establish policies and procedures for copyright owners to address disputes relating to ownership interests in musical works, including a mechanism to hold disputed funds pending the resolution of the dispute. 21

Similar to the MLC, the DLC must:

• Be a single nonprofit entity created to carry out certain statutory responsibilities;

• be endorsed by digital music service providers and significant nonblanket licensees that together represent the greatest percentage of the licensee market for uses of musical works in covered activities, as measured over the preceding 3 calendar years; and

• possess the administrative and technological capabilities necessary to carry out a wide array of authorities and functions. 22

The Register is directed to designate the DLC following substantially the same procedure described for designation of the MLC. 23 Unlike the MLC, in the event the Register is unable to identify an entity that fulfills the criteria for the DLC, the Register may decline to designate a DLC; in that event, the statutory references to the DLC go without effect unless or until a DLC is designated. 24

The DLC is tasked with coordinating the activities of the licensees. 25 The DLC shall make reasonable, good faith efforts to assist the MLC in its efforts to locate and identify copyright owners of unmatched musical works (and shares of such works) by encouraging digital music providers to publicize the existence of the collective and the ability of copyright owners to claim unclaimed accrued royalties, including by posting contact information for the collective at reasonably prominent locations on digital music provider websites and applications, and conducting in-person outreach activities with songwriters. The DLC is authorized to participate in proceedings before the CRJs to determine the administrative assessment to be paid by digital music providers, and before the Copyright Office with respect to the blanket mechanical license.

The Register is to designate the MLC, along with the DLC (as applicable), by publishing a notice in the Federal Register that sets forth “the identity of and contact information for the . . . collective,” and “the reasons for the designation.”  26 These designations are subject to the approval of the Librarian of Congress pursuant to section 702 of title 17. 27 The legislative history states that “the Register is expected to allow the public to submit comments on whether the individuals and their affiliations meet the criteria specified in the legislation; make some effort of its own as it deems appropriate to verify that the individuals and their affiliations actually meet the criteria specified in the legislation; and allow the public to submit comments on whether they support such individuals being appointed for these positions.”  28

On December 21, 2018, the Office issued a Notice of Inquiry (“NOI”) setting forth the functions of the MLC and DLC and the statutory criteria for designation, and solicited proposals from entities meeting such criteria and seeking to be designated as the MLC or DLC, as well as relevant public comments. 29 The name and affiliation of each proposed board and committee member established by the MLC were solicited as part of the designation process. 30

The Office received one proposal for designation as the DLC and two proposals for designation as the MLC, which, in accordance with the NOI, the public was invited to comment upon. The response was considerable; the Office received over 600 comments addressing these proposals, including, but not limited to, musical work copyright owners endorsing one or more of the entities seeking designation. As noticed in the NOI, the Office also considered whether to utilize information meetings subject to established guidelines for such ex parte communications. 31 Determining that follow-up with each of the three candidates would be valuable, the Office issued such guidelines, and on May 28 and 29, the Office met with the three proponents seeking designation as the DLC or MLC, allowing the proponents to supplement their written submissions, but not to address matters wholly outside the record; summaries of those meetings were posted on the Office's website. 32

Beyond the Office's role in designating the MLC and DLC, Congress intended to invest the Register with “broad regulatory authority” to create policies and conduct proceedings as necessary to effectuate the MMA. 33 The statute enumerates several regulations that the Register is specifically directed to promulgate, including regulations regarding the form of the notices of license and notices of nonblanket activity, 34 usage reports and adjustments, 35 information to be included in the musical works database, 36 requirements for the usability, interoperability, and usage restrictions of that database, 37 and the disclosure and use of confidential information. 38 The legislative history contemplates that the Register will both “thoroughly review[ ]” policies and procedures established by the MLC, and promulgate regulations that balance “the need to protect the public's interest with the need to let the new collective operate without over-regulation.”  39

The Office received proposals from two entities seeking to be designated as the MLC: (1) The “Mechanical Licensing Collective, Inc.” referred to here as “MLCI”; and (2) the “American Music Licensing Collective,” referred to here as “AMLC.”  40 The candidates' respective submissions take differing approaches to demonstrating compliance with the statutory criteria. MLCI provides a detailed outline of its proposed organizational structure, business plan, and overall activities. It provided flowcharts and other illustrative materials setting forth in-depth plans for executing the MLC's administrative and technological responsibilities, including managing compulsory and voluntary licenses, matching songwriters to musical works, and collecting and distributing royalties. It describes its submission as the “music industry consensus proposal” and contends that its selection would facilitate valuable cooperative efforts across the industry. 41 AMLC focuses more specifically on matching unidentified songwriters to their compositions for payment purposes. It argues that the expertise of its proposed board and vendors makes it best positioned to advance that goal, 42 which the Conference Report describes as “the highest responsibility of the collective” beyond efficient and accurate collection and distribution of royalties. 43

The Copyright Office assessed the extent to which each candidate satisfies the statutory requirements for designation, which can be grouped into three categories: (1) Organization, board and committee composition, and governance; (2) endorsement and substantial support from musical work copyright owners; and (3) administrative and technological capabilities. As detailed below, the Office concludes that while both candidates meet the statutory criteria to be a nonprofit created to carry out its statutory responsibilities, only MLCI satisfies the endorsement criteria, and MLCI also has made a better showing as to its prospective administrative and technological capabilities. The Register is thus designating MLCI, including its individual board members, with the Librarian's approval.

As both proposals demonstrate, the new collective must undertake formidable responsibilities expeditiously and conscientiously to establish a number of operational functions critical to implementation of the new blanket licensing system. While the comprehensive MLCI proposal signals its understanding of the full scope of this project and its importance to songwriters and others in the music community, a successful collective will undoubtedly benefit from input from that broader community much in the way the MMA itself was enacted in a spirit of consensus and compromise. 44 The Register welcomes the prospect of MLCI working with the broader community of musical work copyright owners and other songwriters, as well as the DLC and individual digital music providers, to realize the promise of the MLC as envisioned by Congress.

As the statute requires, both MLCI and AMLC are constructed as nonprofit entities created by copyright owners to carry out the MLC's statutory responsibilities. 45 The analysis below will focus on relevant board and committee composition and governance issues.

In accordance with the statute, MLCI's proposed board includes four professional songwriters: Kara DioGuardi, Oak Fielder, Kevin Kadish, and Tim Nichols. 46 MLCI notes that these members were selected by a songwriter advisory panel consisting of two professional songwriters from each of the Nashville Songwriters Association International (“NSAI”), Songwriters of North America (“SONA”), Songwriters Guild of America (“SGA”), American Society of Composers, Authors and Publishers (“ASCAP”), and Broadcast Music, Inc. (“BMI”). 47 No members of the advisory panel were themselves candidates for the board or any committee. 48 NSAI reports that the panel considered nearly 300 songwriter applicants as part of this selection process. 49

To satisfy the requirement of ten music publisher representatives, MLCI's proposed board includes the following members: Jeff Brabec (BMG); Peter Brodsky (Sony/ATV Music Publishing); Bob Bruderman (Kobalt); Tim Cohan (peermusic); Alisa Coleman (ABKCO); Scott Cutler (Pulse Music Group); Paul Kahn (Warner/Chappell Music Publishing); David Kokakis (Universal Music Publishing Group); Mike Molinar (Big Machine Music); and Evelyn Paglinawan (Concord Music). MLCI notes that these members were selected by an advisory panel comprised of professionals associated with independent music publishers. 50 The panel “carefully vetted candidates to ensure that the representatives selected to serve on the Board (a) have the requisite expertise and experience to govern MLC; (b) individually and together faithfully reflect the entire music publisher community; and (c) are motivated to serve on the Board and understand and do not underestimate the serious responsibilities entrusted to them.”  51 As described by MLCI, the publisher board members represent a broad range of publishing interests—from a “thirty-employee company established and run by creatives with a catalog of approximately 10,000 songs” to the largest global publishers. 52

MLCI's required nonvoting board members are Danielle Aguirre (NMPA), as a representative of the nonprofit trade association of music publishers that represents the greatest percentage of the licensor market for uses of musical works in covered activities;  53 and Bart Herbison (NSAI), as a representative of a nationally recognized nonprofit trade association whose mission is advocacy on behalf of songwriters. 54 The third non-voting board member will be a representative of the DLC. 55

MLCI also submits proposed members for each of the three statutorily required committees. For the operations advisory committee, MLCI has selected copyright owners who have substantial experience with license administration, rights management operations, and the relevant technology. 56 For the unclaimed royalties oversight committee, the proposed members likewise have extensive experience relevant to that committee's task of “establish[ing] policies and procedures for the distribution of unclaimed accrued royalties and accrued interest.”  57 Each publisher representative on the unclaimed royalties committee is affiliated with an independent music publisher, as opposed to a major music publisher, which will help to ensure that smaller rightsholders have a voice in MLC functions. 58 Finally, consistent with the statute, MLCI proposes a dispute resolution committee made of five professional songwriters and five musical work copyright owners. 59

Based on the biographies and other information submitted regarding these proposed board and committee members, the Copyright Office determines that the proposed composition of MLCI's board and committees satisfies the statutory requirements, and moreover, that each of its proposed directors possesses the qualifications necessary for appointment to the board. 60 In addition, MLCI's submission indicates that its selection procedures were carefully designed to ensure transparency and input from a broad range of industry sectors, as well as to avoid any likelihood of self-selection. MLCI also designed its committee selection process such that committee members do not also serve on the board, helping guard against potential conflicts of interest or undue influence.

AMLC's submission provides less information on the mechanics of its board and committee selection processes. For its professional songwriter members, AMLC's board includes Rick Carnes, Imogen Heap, Zoe Keating, and Maria Schneider. 61 For its music publisher members, AMLC's board includes Maximo Aguirre (Maximo Aguirre Music Publishing, Inc.), Wally Badarou (ISHE sarl Music), John Barker (ClearBox Rights, LLC), Marti Cuevas (Mayimba Music), Joerg Evers (Eversongs), Brownlee Ferguson (Bluewater Music Corp.), Henry Gradstein (listed as an attorney and independent publisher), Lisa Klein Moberly (Optic Noise), Ricardo Ordonez (Union Music Group), and Jeff Price (Audiam, Inc.). 62 AMLC reports that these members were selected following an “active recruitment campaign” and that each selected member was required to have “proven skill sets and practical hands-on work experience” in various industry sectors, as well as “first-hand work experience and knowledge of music rights organizations and how they operate.”  63

On March 13, 2019, the Copyright Royalty Judges (Judges) published proposed regulations governing proceedings to determine the reasonableness of, and allocate responsibility to fund, the operating budget of the Mechanical Licensing Collective authorized by the Music Modernization Act (MMA). The Judges also proposed amendments to extant rules as required by the MMA. 84 FR 9053. The Judges received comments from the Digital Music Association (DiMA), The National Music Publishers Association (NMPA), and SoundExchange, Inc. 1 The commenters generally support the Judges' proposal while recommending certain adjustments, many of which the Judges accept as improvements to the rules as originally proposed. The Judges hereby adopt the proposed rules as amended.

The MMA amended title 17 of the United States Code (Copyright Act) to authorize, among other things, designation by the Register of Copyrights (with the approval of the Librarian of Congress) of a Mechanical Licensing Collective (MLC). 17 U.S.C. 115(d)(3)(A)(iv) and 17 U.S.C. 115(d)(3)(B)(i). The MLC is to be a nonprofit entity created by copyright owners to carry out responsibilities set forth in sec. 115 of the Copyright Act. 17 U.S.C. 115(d)(3)(A)(i). The Copyright Act sets forth the governance of the MLC, which shall include representatives of songwriters and music publishers (with nonvoting members representing licensees of musical works and trade associations). 17 U.S.C. 115(d)(3)(D). The MLC is authorized expressly to carry out several functions under the Copyright Act, including offering and administering blanket licenses and collecting and distributing royalties. 17 U.S.C. 115(d)(3)(C)(i) and (iii).

Section 115(d)(5)(A) of the MMA defines a second entity, the Digital Licensee Coordinator (“DLC”), a single nonprofit entity not owned by any other entity, created to carry out responsibilities under the MMA. The DLC must be endorsed by and enjoy substantial support from digital music providers and significant nonblanket licensees that together represent the greatest percentage of the licensee market for uses of musical works in covered activities, as measured over the preceding three calendar years. 17 U.S.C. 115(d)(5)(A). The DLC will be designated by the Register, with the approval of the Librarian, and is authorized to perform certain functions under the Copyright Act, including establishing a governance structure, criteria for membership, and dues to be paid by its members. 2 The DLC is also authorized to engage in efforts to enforce notice and payment obligations with respect to the administrative assessment, including by receiving information from and coordinating with the MLC. The DLC is also authorized to initiate and participate in proceedings before the Judges to establish the administrative assessment. 17 U.S.C. 115(d)(5)(B)-(C).

The MMA provides that the Judges must, within 270 days of the effective date of the MMA, commence a proceeding to determine an initial administrative assessment that digital music providers and any significant nonblanket licensees shall pay to fund the operations of the MLC. 17 U.S.C. 115(d)(7)(D)(iii)(I). 3 The Judges may also conduct periodic proceedings to adjust the administrative assessment. 17 U.S.C. 115(d)(7)(D)(iv). In the proceedings to determine the initial and adjusted administrative assessments, the Judges must determine an assessment “in an amount that is calculated to defray the reasonable collective total costs.” 17 U.S.C. 115(d)(7)(D)(ii)(II).

Creation of the MLC and the other statutory changes in the MMA require or authorize modification of the Judges' regulations relating to sec. 115. For example, sec. 102(d) of the MMA requires the Judges, not later than 270 days after enactment of the MMA, to amend 37 CFR part 385, “to conform the definitions used in such part to the definitions of the same terms described in sec. 115(e) of title 17, United States Code, as added by” sec. 102(a) of the MMA. That provision also directs the Judges to “make adjustments to the language of the regulations as necessary to achieve the same purpose and effect as the original regulations with respect to the rates and terms previously adopted by the [Judges].”

In that regard, the MMA also adds a new sec. 801(b)(8) to the Copyright Act, which authorizes the Judges “to determine the administrative assessment to be paid by digital music providers under section 115(d)” and states that “[t]he provisions of section 115(d) shall apply to the conduct of proceedings by the [Judges] under section 115(d) and not the procedures in this section, or section 803, 804, or 805.” 17 U.S.C. 801(b)(8). To discharge this duty, the MMA authorizes the Judges to adopt regulations concerning proceedings to set the administrative assessment established by the statute to fund the MLC. 17 U.S.C. 115(d)(7)(D)(viii) and 115(d)(12)(A).

As noted above, the three sets of comments the Judges received were generally supportive of the Judges' proposal, much of which responded to comments that the Judges had received in response to their Notice of Inquiry (NOI). Some comments, however, raised issues with particular aspects of the proposal, which the Judges address below. The comments of DiMA and NMPA overlapped on many issues. Therefore, the Judges discuss the respective comments of these two commenters in a single section. SoundExchange's comments are addressed in a separate section.

According to DiMA, Congressional intent in adopting the MMA is that the MLC and the DLC are to be created, designated, and approved to serve as proxies for the interests of their respective constituencies, with the MLC serving as the voice of musical work copyright owners/licensors and the DLC serving as the voice of digital music licensees. DiMA Comment at 3. DiMA believes, however, that as currently drafted, certain of the proposed rules put the DLC in an inferior position as compared to the MLC, creating inequities that ultimately may undermine the perceived goal of the assessment proceedings to establish the amount and terms of the administrative assessment based on a comprehensive, transparent record or to allow for the negotiation of a voluntary agreement among the MLC and DLC, which DiMA asserts, represent the vast majority of their respective stakeholders. Id. at 4. DiMA points out perceived disparities between the MLC and the DLC in three areas, discussed below.

DiMA notes that proposed § 355.3(e) would authorize the MLC to notice and take up to five depositions during its discovery period and would authorize the DLC, together with “interested copyright owners, interested Digital Music Providers, and interested Significant Nonblanket Licensees,” to notice and take up to five depositions “collectively” during their discovery period.

According to DiMA, the proposed rules thus permit the MLC to review whatever discovery it deems relevant, determine the five individuals it believes would be most advantageous to depose and the order in which it wishes to depose these individuals, and set the timing of those depositions within the discovery period, unencumbered by the other parties. DiMA Comment at 4.

In contrast, DiMA notes, the DLC would be required to share its five depositions with the other proceeding participants. As a result, DiMA believes that the proposed rules would constrain the DLC in its efforts to take depositions, requiring that it negotiate and compromise on the deposition process with other participants, making the development of a coherent and efficient strategy for this process incredibly difficult.

DiMA asserts that under the proposed rules, any proceeding participant other than the MLC could essentially “hijack” the first discovery period deposition process by noticing all five depositions on the very first day of that discovery period, thereby blocking the DLC's ability to take depositions of potentially far more relevant individuals. DiMA believes that the perceived open-ended nature of the deposition process in the proposed rules would create disputes that the CRJs would be required to resolve over areas such as the individuals who would be deposed, the time allocations for examination of those witnesses, and the timing of the depositions, resulting in significant inefficiencies within the discovery timeline. DiMA Comment at 5.

DiMA believes that the DLC should be provided with access to the deposition process equal to that of the MLC, and the proposed rules should be amended to permit the DLC to take up to five depositions under the same conditions as those provided to the MLC.

DiMA acknowledges the need to ensure that the discovery process is also fair to other proceeding participants. To that end, DiMA recommends that the proposed rules be modified to mandate a duty requiring these other parties to cooperate with DiMA and each other in good faith in discovery and to attempt to resolve disputes amongst themselves before availing themselves of the discovery disputes process outlined in proposed § 355.3(h). DiMA also suggests that the Judges modify the proposed rules to make clear that proceeding participants whose interests may not be fully represented by either the MLC or the DLC are permitted to take advantage of the discovery disputes process set forth in proposed § 355.3(h), to request authorization from the CRJs to take any depositions they deem necessary and, upon a showing of good cause, be permitted to take those depositions. DiMA Comment at 6.

DiMA believes that the deposition process outlined above would place the DLC on equal footing with the MLC, while at the same time providing meaningful opportunities to other proceeding participants to partake in the deposition process as well. Id.

The Judges believe that DiMA's proposed modifications to § 355.3(e) and (h) are reasonable and appropriate and therefore adopt DiMA's recommended modifications. 4

In the Joint Proposal that DiMA and the NMPA submitted in response to the Judges' Notice of Inquiry, NMPA/DiMA recommended that administrative assessment proceedings have two discovery periods. According to DiMA, the first discovery period would be reserved for the DLC and other participants in the proceeding, other than the MLC, to allow those parties to examine the MLC's submission and probe its constituent parts in preparation for the DLC's and other participants' responsive submissions. The second discovery period would be reserved for the MLC to allow it to examine the responsive submissions and to probe their constituent parts in preparation for the MLC's reply submission, which, under the Joint Proposal, the MLC would have the option to file after the second discovery period. DiMA Comment at 7.

DiMA contends that the proposed rules contain several ambiguities and inconsistencies that require clarification to ensure that discovery during administrative assessment proceedings is efficient, logical, and equitable. Id. For example, DiMA notes that § 355.2(g)(1)(iii) of the proposed rules reserves the first discovery period “for the [DLC] and any other participant in the proceeding, other than the [MLC], to serve discovery requests and complete discovery pursuant to § 355.3(d).” DiMA further notes that § 355.3(d) states that “the [DLC], interested copyright owners, interested Digital Music Providers, and interested Significant Nonblanket Licensees . . . and any other participant in the proceeding may serve requests for additional documents” (emphasis added by DiMA).

According to DiMA, the italicized language in § 355.3(d) is problematic in that there are no statutorily authorized “other participant[s] in the proceeding” other than the DLC, interested copyright owners, interested Digital Music Providers, and interested Significant Nonblanket Licensees, all of which are already enumerated within the same sentence, making this language redundant at best and potentially opening the door to discovery by the MLC during the first discovery period at worst, which, DiMA contends, is directly contrary to the language of proposed § 355.2(g)(1)(iii). DiMA Comment at 8. DiMA therefore recommends that the Judges clarify § 355.3(d) to remove the “interested copyright owners, interested Digital Music Providers, and interested Significant Nonblanket Licensees” language and instead conform this language with the language from § 355.2(g)(1)(iii) ( i.e., “the Digital Licensee Coordinator and any other participant in the proceeding, other than the Mechanical Licensing Collective”) to resolve this internal inconsistency and potential ambiguity. For the same reasons, DiMA also suggests that identical language in § 355.3(f)(1) likewise be modified accordingly. DiMA Comment at 8. The Judges believe DiMA's proposed modifications are reasonable and appropriate and therefore adopt them.

DiMA further notes that as presently drafted, proposed §§ 355.2(g)(1)(iii) and 355.3(d) fail to set forth the right of the DLC and other proceeding participants to take depositions during the first discovery period, which, DiMA contends, appears to be an inadvertent oversight, since those depositions are clearly contemplated by, and discussed in, § 355.3(e). DiMA recommends that § 355.3(d) be amended to add a subsection (2) that substantively mirrors § 355.3(g)(2) (but with the reference to “note” corrected to “notice”), which addresses the MLC's ability to take depositions during the second discovery period ( i.e., “The [DLC] (or if no [DLC] has been designated, interested Digital Music Providers and Significant Nonblanket Licensees representing more than half of the market for uses of musical works in Covered Activities, acting collectively) and any other participant in the proceeding, other than the [MLC], may notice and take depositions as provided in paragraph (e) of this section.”). DiMA Comment at 8.

DiMA also asserts that § 355.3(e) requires the correction of what appears to be a typographical error. According to DiMA, the first sentence of that section authorizes the noticing and taking of depositions during the first discovery period by the DLC and other proceeding participants. The second sentence then authorizes the noticing and taking of depositions by the MLC but inadvertently states that these depositions are to be taken during the “first” rather than the “second” discovery period. Yet § 355.2(g)(1)(v) discusses the second discovery period in the proceeding, which provides for the MLC “to serve discovery requests and complete discovery of the [DLC] and any other participant in the proceeding pursuant to § 355.3(g).” Section 355.3(g), in turn, is titled “ Second discovery period .” According to DiMA, the general framework of discovery and other sections of the proposed rules confirm that the second sentence of this subsection should instead read (proposed amendment in italics): “The [MLC] may give notice of and take up to five depositions during the second discovery period.” DiMA Comment at 9.

DiMA notes that the Judges requested specific comments with regard to reply submissions of the MLC, voicing the concern that the proposed rules as currently written “would authorize the MLC to respond to submissions of the DLC and other opposing parties but the proposal would not authorize the MLC to seek discovery from those parties to support its submission.” DiMA Comment at 9, quoting 84 FR at 9057.

DiMA posits that this reading of the proposed rules was perhaps the result of the inconsistencies discussed above that, when resolved, make clear that the second discovery period, the discovery period specifically set aside for the MLC in both the proposed rules and in the Joint Proposal, occurs after the DLC and other participants provide their responsive submissions and concurrent document productions and written disclosures. According to DiMA, the proposed rules already authorize the MLC to conduct discovery subsequent to the filing of responsive submissions by the DLC and other participants and prior to the filing of any reply submission by the MLC. DiMA Comment at 9.

For its part, NMPA “observes that the Proposed Rule could be read as unfairly limiting the scope of discovery in the second discovery period for the MLC as compared to the scope of discovery in the first period applicable to the DLC and additional parties.” NMPA Comment at 8. NMPA notes that proposed § 355.3(d) states that in the first discovery period, “[a]ny document request shall be limited to documents that are Discoverable” whereas proposed § 355.3(g)(1) states, with respect to the second discovery period, “requests shall be limited to documents that are Discoverable and relevant to consideration of whether any counterproposal fulfills the requirements of 17 U.S.C. 115(d)(7) or one or more of the elements of this part.” NMPA Comment at 8. 5 NMPA also requests that the Judges change paragraph (2) in the definition of Discoverable in proposed § 355.7 to read “(2) Relevant to consideration of whether a proposal or response thereto fulfills the requirements in 17 U.S.C. 115(d)(7).” According to NMPA, these requested changes should eliminate confusion concerning the MLC's ability to take discovery of the DLC and other parties regarding their respective responses to the MLC's proposal. NMPA Comment at 9.

The Judges find that DiMA's and NMPA's respective recommended modifications to the proposed rules in this area are reasonable and appropriate and therefore adopt them.

DiMA avers that §§ 355.4 and 355.6(d) of the proposed rules may not be consistent with the MMA because they include participants other than the MLC and the DLC in the negotiation periods and in any voluntary agreement that ultimately may result from those negotiations. According to DiMA, inclusion of such other participants is not mandated by the MMA and should be obviated by the MLC's and the DLC's roles as statutorily-designated representatives of their respective stakeholders. DiMA Comment at 10.

DiMA notes that § 355.4 of the proposed rules requires the participation of not only “[t]he [MLC] [and] the [DLC],” but also the participation of “ interested copyright owners, interested Digital Music Providers, and interested Significant Nonblanket Licensees ” (emphasis added by DiMA) in both negotiation periods within an administrative assessment proceeding, and sets the commencement of the first negotiation period for “the day after the [Judges] give notice of all participants in the proceeding.” DiMA notes that in explaining this provision and its timing, the Judges stated that they “are loathe to encourage the MLC and the DLC, or other significant participants, to engage in negotiations for up to a month (or up to half the suggested negotiating period) before the [Judges] identify and give notice of the full roster of participants.” DiMA Comment at 10, quoting the Judges' Rule Proposal, 84 FR at 9057.

DiMA notes that § 355.6(d) of the proposed rules likewise references voluntary agreements “negotiated and agreed to by the [MLC] and the [DLC], interested copyright owners, interested Digital Music Providers, and interested Significant Nonblanket Licensees ” (emphasis added by DiMA).

DiMA contends, however, that the MMA does not require or encourage such broad participation. According to DiMA, under the MMA only the MLC and the DLC must agree to any negotiated voluntary agreement. DiMA consequently requests that the Judges modify the proposed rules to remove “interested copyright owners, interested Digital Music Providers, and interested Significant Nonblanket Licensees” from proposed §§ 355.4 and 355.6(d). 6 DiMA also requests that the Judges modify the proposed rules such that the first negotiation period will begin on the date of commencement of the proceeding to determine or adjust the administrative assessment. DiMA Comment at 12. 7

The Judges believe that involvement in the settlement discussions between the MLC and DLC by other participants is appropriate and permitted—though not mandated—under the statute. At the same time, the Judges agree with DiMA's interpretation of the statute that only the MLC and DLC must agree to a voluntary settlement. Nevertheless, the Judges believe that the views of other participants may be helpful, and perhaps essential, for the Judges to determine whether good cause exists to exercise their discretion to reject a settlement. The Judges, therefore, have modified section 355.4 to clarify that participants other than the MLC and DLC may participate in settlement negotiations and may comment on any resulting settlement. In keeping with the accelerated timeline for administrative assessment proceedings, the Judges have imposed tight space limitations for comments, and abbreviated deadlines for comments and any reply by the settling parties. These limitations are subject to the general rules governing requests for enlargement in sections 303.3(c) and 303.7(b). The Judges have made a conforming change to section 303.3(c) to ensure that the rule governing requests for enlargement of space applies to space limitations set in section 355.4 and other provisions of subchapter B.

DiMA's set of comments also addressed six areas regarding the fact finding process: (1) Flexibility in scheduling of the proceedings and related timing; (2) concurrent expert testimony; (3) necessity of hearings; (4) admissibility of deposition transcripts; (5) witness attendance at the hearing and review of transcripts; and (6) scope of mandatory document productions. NMPA's comment also addressed some of these areas. The Judges address each area is turn.

DiMA agrees that the Judges' scheduling proposal, which DiMA views as more flexible than that DiMA and the NMPA proposed in their Joint Comment on the NOI, will allow the Judges to adopt a tailored schedule for each proceeding based on the circumstances of that proceeding and still retain the structural framework of the proceeding. DiMA Comment at 12. Likewise, NMPA states that it understands the Judges' desire for flexibility and agrees that a less structured schedule can still allow the Judges to conduct proceedings in a timely and efficient manner. NMPA believes that the Judges can establish the schedule in each particular proceeding with an eye toward commencing and completing the proceeding in accordance with the overall timetable set forth in the MMA. NMPA Comment at 3.

DiMA requests, however, that the Judges allot sufficient time after the close of the first and second discovery periods for the parties to incorporate relevant facts obtained through discovery into those submissions and to resolve discovery disputes that may arise. Id. at 13. DiMA also requests that the Judges consider incorporating a period of 3-5 days between the due date for opening and responsive submissions and the start of the first and second discovery periods to provide proceeding participants a few days to review the submissions and document productions and disclosures before commencing discovery activities. Id.

DiMA also notes that the Judges propose 60 days for the first discovery rather than the 75 days that the DiMA/NMPA Joint Comment had proposed. See proposed § 355.2(g)(1)(iii). The second discovery period would also be 60 days. DiMA asserts that there is justification for a longer first discovery period because the DLC will have to coordinate and negotiate with other parties involved in the first discovery period, whereas the MLC will be the lone party directing the second discovery period and will not be hindered by competing interests regarding noticing and taking depositions and deciding the number and extent of document requests. DiMA Comment at 13-14. DiMA contends that a longer discovery period is necessary and requests that the Judges reconsider a 75-day period for the first discovery period.

After careful consideration, the Judges decline to adopt DiMA's requests to lengthen the first discovery period and delay the commencement of the discovery periods. The timing provisions in the MMA for determining the Administrative Assessment are particularly compressed. The Judges believe that 60 days is a reasonable amount of time for discovery and that a longer period would only serve to restrict further an already short time frame for determining an Administrative Assessment.

DiMA and NMPA each responded to the Judges' proposal regarding concurrent expert testimony. DiMA supports the Judges' inclusion of the concurrent testimony option and believes that this approach could assist the Judges in creating a more comprehensive record upon which they can base their determination and in answering questions the Judges may have. DiMA also believes that a concurrent testimony approach could allow the Judges more latitude to address any concerns they may have with regard to the proposals then at issue. According to DiMA, engaging in concurrent expert testimony may lead to efficiencies by allowing the experts to focus on the heart of the issues that remain in dispute, to explain their differing viewpoints on those issues, and to have the ability to examine those viewpoints in real time by the experts themselves, the Judges, and counsel.

Additionally, DiMA avers that concurrent expert testimony may be particularly useful where, as here, the proceeding will be very subject-matter specific and the issues addressed at the hearing will be fairly complex, technical, and nuanced. To the extent the Judges or the parties elect to use the concurrent evidence approach in a particular proceeding, DiMA recommends that the Judges consider how best to direct and focus such testimony to ensure that the process is efficient and orderly at the hearing. DiMA also supports inclusion of concurrent expert testimony as an option for testimony at the hearing either in addition to or in lieu of “traditional” expert testimony, as the circumstances may dictate, while at the same time making clear that, in the absence of a specific ruling to the contrary, “traditional” ( i.e. non-concurrent) expert testimony will remain the default process and structure in administrative assessment proceedings. DiMA Comment at 13-14.

NMPA believes a concurrent evidence approach could help to narrow and clarify issues and permit immediate correction of testimony by one expert when another expert identifies mistakes in the first expert's testimony. Accordingly, NMPA does not object to the inclusion of language within proposed rule § 355.5(d) to permit a concurrent evidence procedure.

In light of uncertainties concerning the equities in particular proceedings, however, should the Judges adopt this approach, NMPA believes it would be helpful if, in any given proceeding, the Judges would solicit the views of the parties before requiring participation in a concurrent evidence procedure. NMPA Comment at 12-13.

The Judges adopt the concurrent evidence provision as proposed, but, consistent with NMPA's recommendation, will consider the views of any party regarding the implementation of a concurrent evidence approach in any particular Administrative Assessment proceeding. The Judges also confirm, consistent with DiMA's comment, that “traditional” expert testimony will remain the default process and structure in administrative assessment proceedings, i.e., absent any ruling by the Judges establishing a concurrent form of receiving expert testimony.

DiMA notes that current proposed § 355.5(a) allows the Judges to issue a determination for the administrative assessment without a hearing. DiMA Comment at 15. DiMA believes that this option is inconsistent with the MMA. In particular, DiMA references sec. 115(d)(7)(D)(iii)(III), which, DiMA contends, mandates a hearing. DiMA Comment at 15. As a result, DiMA contends that the proposed rules should be modified to clarify that a hearing is a required phase of the administrative assessment proceeding unless a voluntary agreement is reached between the MLC and the DLC. In addition to what DiMA believes is a statutory mandate, DiMA also believes that a hearing would afford the Judges the opportunity to examine whatever portions of the proposed assessment they found to be deficient or otherwise inconsistent with the MMA and to make a determination consistent with 17 U.S.C. 115(d)(7). DiMA Comment at 16.

As a practical matter, the Judges agree that, absent a settlement, a hearing will be beneficial for developing a record as a foundation for an Administrative Assessment determination. Therefore, the Judges accept DiMA's recommendation to amend proposed § 355.5(a) to remove references to the Judges' consideration of filings submitted for a determination without a hearing.

As DiMA notes, the Judges' proposed rules allow the introduction of deposition transcripts pursuant to the rules and limitations of Federal Rule of Civil Procedure 32. 84 FR at 9058; proposed § 355.5(c). DiMA agrees with the Judges' position on this issue because, according to DiMA, submission of only the deposition testimony that is permitted under FRCP 32 will ensure that the Judges receive these materials in a way that does not require them to wade through many exploratory lines of questioning in discovery depositions and does not duplicate the live testimony of any hearing witnesses. DiMA Comment at 16. NMPA noted that “the Joint Comments proposed that complete transcripts be admitted so relevant portions would be available as needed during the hearing without undue burden or delay. At the same time, NMPA understands the concerns articulated by the [Judges]. What is critical is that pertinent deposition testimony be available for use by the parties as necessary during a hearing.” NMPA Comment at 13. The Judges acknowledge NMPA's desire to have pertinent deposition testimony available during a hearing and believe that the current proposal will permit such access. As a practical matter, the Judges note that during an Administrative Assessment proceeding parties may submit deposition transcripts (and other exhibits) to the Judges. Once they are marked for identification, the entire transcript or a subset of it thereafter may be offered for admission into evidence during the hearing. Such submission is consistent with the current proposal. Therefore, the Judges adopt the rules in this area as proposed.

As DiMA notes, proposed § 355.5(d) generally prohibits a witness, other than a party representative, from listening to or reviewing a transcript of another witness prior to testifying. DiMA Comment at 17. DiMA does not object to this provision with respect to fact witnesses but recommends a carve-out for expert witnesses “as the testimony of expert witnesses is inherently different in nature and often benefits from learning additional facts from which expert opinions can be formed or adjusted.” Id. DiMA believes such a carve-out is particularly useful where the Judges contemplate the possibility of concurrent expert testimony.

The Judges believe that a carve-out for expert witnesses is reasonable and appropriate and therefore adopt it.

DiMA notes that proposed § 355.3(b), which deals with the initial Administrative Assessment proceeding, is inconsistent with proposed § 355.3(c), which deals with proceedings to adjust the Administrative Assessment, in that the latter requires the MLC to produce a three-year projection of costs, collections, and contributions whereas the former does not. DiMA recommends that the Judges modify the proposed rules to add the three-year projection requirement, beginning as of the license availability date, to § 355.3(b) both for the sake of consistency between proceedings and to provide the Judges with “robust, relevant information that will be useful in making their ultimate determination.” DiMA Comment at 18. DiMA believes that “mandating projections for at least three years will provide more accurate long-term cost information and will thus more likely result in an administrative assessment that will not require as much adjustment in future years.” Id. The Judges accept DiMA's request as appropriate and reasonable and adopt the modification as suggested.

DiMA also notes that the Judges have included in §§ 355.3(b)(2)(iii) and 355.3(c)(2)(v) a new, specific category of documents for mandatory production by the MLC ( i.e., processes for requesting proposals, inviting bids, ranking and selecting the proposals and bids of potential contracting and sub-contracting parties competitively (or by another method), including processes for ensuring the absence of overlapping ownership or other overlapping economic interests between the MLC or its members and any selected contracting or sub-contracting party). Id. at 18-19. DiMA supports this inclusion “as these documents are directly relevant to the core question of `reasonable' costs and are vital to a determination that is fair, accurate, and consistent with 17 U.S.C. 115(d)(7).” Id. at 19.

NMPA, on the contrary, believes that the proposed provision seems unnecessary and potentially onerous. NMPA Comment at 10. NMPA believes that the proposed provision, which was not included in the Joint Comments of NMPA and DiMA, could be interpreted to require production of materials concerning virtually every contract of the MLC no matter how small. Id. NMPA also suggests that some of the proposed language concerning “overlapping economic interests” could be read to suggest an expansion of the Judges' role beyond what is contemplated under the MMA. NMPA requests that the Judges modify the proposed language ( i.e., first clause of proposed §§ 355.3(b)(2)(iii) and (c)(2)(v) concerning the MLC's choice of vendors) at the very least to include a materiality threshold of ten percent of the MLC's annual budget. NMPA Comment at 10-11. As currently proposed, NMPA fears that the provisions could be read as requiring that the MLC would need to produce every contract, proposal and bid—no matter how trivial or immaterial. NMPA Comment at 10. NMPA maintains that such a requirement would be enormously burdensome and could threaten timely completion of the proceeding. NMPA Comment at 10-11.

NMPA is also concerned about the second clause of proposed § 355.3(b)(2)(iii) and (c)(2)(v), which is addressed to “ensuring the absence of overlapping ownership or other overlapping economic interests . . .”. NMPA Comment at 11. NMPA believes that this proposed language could be interpreted as suggesting that the Judges “are somehow responsible for policing the policies and practices of the MLC with respect to conflicts of interest.” Id. NMPA believes that the policies and practices of the MLC are adequately addressed in the MMA ( e.g., requirements of an annual report detailing the MLC's operations and expenditures and periodic audits to guard against “fraud, abuse, waste, and the unreasonable use of funds”). NMPA Comment at 11 and n.9. NMPA notes that the MMA does not confer authority or responsibility to the Judges to enforce these provisions. NMPA contends that the Judges' authority under the MMA is limited to establishing the Administrative Assessment for the MLC in accordance with the criteria set forth in 17 U.S.C. 115(d)(7). NMPA Comment at 11. As a result, NMPA requests that the Judges eliminate the second clause of proposed § 355.3(b)(2)(iii) and (c)(2)(v).

As a preliminary matter, the Judges acknowledge NMPA's concerns regarding the costs of gathering and providing information with respect to the MLC's operations, but the Judges believe that the NMPA is reading the proposal's requirement with respect to vendors too broadly. The Judges do not seek the type of granular information that NMPA's broad reading of proposed § 355.3(b)(2)(iii) and (c)(2)(v) implies. Rather, the proposal should be read more literally as requiring the MLC to produce information about the processes it employs in requesting proposals, inviting bids, ranking and selecting the proposals and bids of potential contracting and sub-contracting parties competitively (or by another method), and the processes for ensuring the absence of overlapping ownership or other overlapping economic interests between the MLC or its members and any selected contracting or sub-contracting party. In other words, when the MLC is seeking to employ a vendor, will it submit requests for proposals and choose the lowest bid? Will the MLC create a list of preferred vendors and employ one or more of them on an as-needed basis? Or will the MLC use another process for conducting its operations? The Judges believe that such information is well within the Judges' authority to carry out its obligations under the MMA to determine whether the MLC's costs are reasonable. Additionally, even if such information will be contained in the MLC's annual report, that document will not necessarily be completed and available for the Judges to consider. Going forward, in future assessment adjustment proceedings, if the required information is fully set forth in the most recent annual report, the MLC could submit the relevant pages from that document and confirm they remain applicable, in an attempt to satisfy this required document production. Accordingly, the Judges decline to adopt NMPA's proposed revisions.

DiMA correctly pointed out that the Judges erred in the numbering of the subparagraphs of the definition of Purchased Content Locker Service in § 385.2. DiMA Comment at 19-20. The Judges modify the definition to revert the numbering of this definition to the numbering in the extant definition.

DiMA also noted an inconsistency in the proposal regarding the duration of the first negotiation period ( i.e., 45 days in proposed § 355.2(g)(1)(i) versus 60 days in proposed § 355.4(a)). DiMA supports a 60-day period. 8 In its comment NMPA noted the same discrepancy, and speculated that it might relate to the Judges' belief that the negotiation period should commence after the parties to the proceeding have been determined, rather than at the commencement of the proceeding as NMPA and DiMA had recommend in their Joint Proposal. NMPA Comment at 7.

The Judges are sympathetic to DiMA's concerns that there be adequate time to negotiate and therefore expand the first negotiation period to 60 days, but the Judges note their desire that all parties have the opportunity to play a meaningful role in the negotiation process and therefore will direct the MLC and the DLC, if any, to monitor the list of parties filing petitions to participate  9 and to include all petitioners in any ongoing negotiations.

DiMA notes what it believes is an internal inconsistency in the beginning of the first discovery period set forth in proposed § 355.2(g)(1)(iii) and the second discovery period set forth in proposed § 355.2(g)(1)(v) and the procedure for calculating due dates generally, set forth in proposed § 303.7(a). DiMA recommends a modification to § 355.2(g)(1)(iii). DiMA Comment at 21. The Judges believe that this recommendation is reasonable and appropriate and modify proposed § 355.2(g)(1) to enhance its clarity.

DiMA also highlights three parallel provisions in the proposed rules regarding the production of documents by the MLC concurrent with its opening submission in the initial administrative assessment proceeding (proposed § 355.3(b)(2)), in proceedings to adjust the assessment (proposed § 355.3(c)(2)) and by the DLC and other participants concurrent with their responsive submissions (proposed § 355.3(f)(2)). The first provision would require that the documents be filed with the Judges, while the second and third provision would not require such filing. DiMA believes that none of the provisions should require filing with the Judges and therefore recommends that the Judges modify proposed § 355.3(b)(2) to remove the filing requirement, which DiMA contends would help to promote efficiency in Administrative Assessment proceedings since the participants are likely to produce a broader scope of documents than the narrower subset of documents they ultimately will attach as exhibits to their submissions or use at the hearing. DiMA Comment at 21-22. In the interests of promoting such efficiency, the Judges accept DiMA's recommendation and modify proposed § 355.3(b)(2) to mirror the related provisions that DiMA references.

DiMA also highlights two parallel provisions in proposed §§ 355.3(b)(2)(iii) and 355.3(c)(2)(v) regarding documents the MLC must provide concurrently with its opening submission in the initial Administrative Assessment proceeding and in proceedings to adjust the Administrative Assessment. DiMA opines that the language in the two sections should be identical but that it currently varies and that such variation creates ambiguity and inconsistency. DiMA believes that the applicable language in proposed § 355.3(c)(2)(v) is clearer and should apply to proposed § 355.3(b)(2)(iii) also. DiMA Comment at 22-23. The Judges agree and accept DiMA's recommended modification. 10

DiMA also highlights a phrase in proposed § 355.3(c)(2)(i) relating to the MLC's obligation to produce documents that identify and demonstrate “costs, collections, and contributions as required by 17 U.S.C. 115(d)(7) . . . including Collective Total Costs ”. DiMA Comment at 23 (emphasis added by DiMA). DiMA asserts that the addition of the italicized phrase is inconsistent with an equivalent provision in proposed § 355.3(b)(2)(i) and creates an “unnecessary ambiguity” because it suggests that there may be other costs that are relevant to the determination of the Administrative Assessment in addition to Collective Total Costs as that term is defined by the MMA. DiMA contends that there are no such other costs. As a result, DiMA recommends that the Judges strike the italicized language from proposed § 355.3(c)(2)(i). In the interests of avoiding ambiguity, the Judges accept the recommended change.

DiMA also highlights three sections of the rule proposal that address the mandatory written disclosures that the MLC, DLC, and other proceeding participants must provide concurrently with their submissions in the Administrative Assessment proceeding ( i.e., proposed §§ 355.3(b)(3), 355.3(c)(3), and 355.3(f)(3)). DiMA points out that although the substance of the written disclosures is generally consistent among the three subsections, the specific language of the proposed rules differs. DiMA recommends that the language of the three sections be harmonized and believes that the language of § 355.3(b)(3) is the clearest and therefore should be the model for each of the sections. DiMA Comment at 23-24. The Judges support the goal of harmonization of comparable provisions and therefore accept DiMA's recommended modifications.

DiMA also recommended that proposed § 355.3(e) addressing deposition notices be clarified by removing an ambiguity. DiMA Comment at 24. The Judges believe the recommended modification is appropriate and reasonable and therefore accept DiMA's recommended modification. 11

DiMA also recommends that proposed § 350.1 be modified to clarify that Administrative Assessment proceedings are proceedings pursuant to 17 U.S.C. 801(b). The Judges believe that DiMA's recommended modification is appropriate and reasonable and therefore they accept DiMA's recommended modification. 12

DiMA comments that the Judges declined in the proposal to adopt certain changes to extant § 385.21(d), which DiMA contends would mitigate the need for future updates to part 385 which DiMA believes will likely be required after the Copyright Office adopts new regulations with respect to statements of account and the content and format of usage data that will be required to be reported to the MLC after the license availability date (as defined in the MMA) ( e.g., while the per-play calculation is currently performed by the service providers, DiMA anticipates that that responsibility will shift to the MLC (based on data reported by the service providers) once the blanket license becomes available). DiMA Comment at 25. The Judges believe that the proposed changes to extant rule 385.21(d) are reasonable and appropriate and therefore adopt them.

DiMA also recommended certain technical updates to proposed § 303.5 and related provisions that the Judges believe are appropriate and therefore adopt them.

NMPA correctly noted that the Judges proposed, incorrectly, to omit 385.31(d) regarding “unauthorized use.” NMPA Comment at 17. This provision will be unchanged from the extant provision.

NMPA also cautioned the Judges that an observation that the Judges made in the notice of proposed rulemaking regarding retaining the extant assessment if the Judges found that the MLC's proposal did not fulfill the requirements of 17 U.S.C. 115(d)(7) “would seem to be inconsistent with the responsibilities entrusted to the [Judges] by Congress in relation to the administrative assessment.” NMPA Comment at 3. NMPA states that the Judges must establish the Administrative Assessment in an amount that meets the requirements set forth in 17 U.S.C. 115(d)(7). According to NMPA, “[i]f the correct amount happens to be the extant assessment, then retaining that assessment would be appropriate if it fulfills the requisite statutory criteria—but if it does not fulfill such criteria, then retaining the extant amount would be erroneous.” NMPA Comment at 4. The Judges recognize that no matter what amount they choose as the Administrative Assessment, that choice must be consistent with the Judges' obligations under the Copyright Act as amended by the MMA and supported by evidence in the record.

In the Notice, the Judges also asked whether the DLC should be required (rather than permitted) to submit and support a counterproposal. 84 FR at 9057. NMPA believes that such a provision “is not only unnecessary, but would be counterproductive.” NMPA Comment at 5. NMPA contends that the DLC should comment on and respond to the MLC's proposal rather than submit a wholly separate one. Id. NMPA states that under the MMA, it is the MLC and not the DLC or any other party that is charged with the responsibility of ensuring that it fulfills its statutory duties. Id. NMPA contends that “any legitimate proposal has to be based on the needs and budget of the MLC as reasonably determined by the MLC and supported by evidence offered in the administrative assessment proceeding.” NMPA Comment at 6, emphasis by NMPA. 13

As a result, NMPA supports proposed § 355.3(f) in its current form, which, according to NMPA, reflects the approach in the Joint Comments of NMPA and DiMA by requiring the DLC and other parties to respond to the MLC's proposal rather than submit competing proposals. NMPA Comment at 6. NMPA requests, however, that the Judges modify the proposed definition of “Discoverable” in proposed § 355.7 “to ensure that it permits discovery of information relevant to both a proposal or response thereto.” NMPA Comment at 6, emphasis original. NMPA also asks that the Judges eliminate the restriction in proposed § 355.3(g) that limits the scope of discovery taken by the MLC to discovery regarding counterproposals. NMPA states the “[i]n order to reply to concerns raised by the DLC or others, the MLC must be permitted to take discovery on their responsive submissions, regardless of the precise nature or characterization of those responses.” NMPA Comment at 6, emphasis original.

The Judges believe NMPA's proposed modifications are reasonable and appropriate and therefore adopt them. However, although the NMPA correctly notes that it is the MLC that has a responsibility under the MMA to identify its “needs and budget,” the DLC and the users of the musical works have a commensurate obligation under the MMA to bear the costs associated with operating the MLC. Nothing in the rules adopted herein prohibits the DLC (or any other participant that would bear any or all of the costs assessed) from proposing in its (or their) submissions, on an itemized basis corresponding with the items in the MLC's proposal, a rejection of, or substitution for, one or more of the provisions in the MLC proposal.

NMPA also suggests that the Judges add the word “relevant” to the current definitions of “end user” and “stream” in § 385.2 to avoid confusion regarding the usage of those terms in the regulation versus how those terms are used in the MMA, which, according to NMPA are used differently and in a less specific manner in the MMA than they are in part 385. NMPA Comment at 15-16. 14 The Judges believe that the current proposed regulations are sufficiently clear and therefore decline to adopt NMPA's suggested modifications to the definitions of end user and stream.

SoundExchange generally supports the proposed rules as they relate to pre-1972 recordings under secs. 112 and 114 of the Copyright Act and believes that the Judges should adopt these provisions substantially as proposed. SoundExchange Comment at 2. 16 Most of SoundExchange's comment addressed the definition of copyright owner and the SDARS Pre-1972 royalty deduction, which are discussed in turn below. 17

With respect to the definition of copyright owner in the proposed rules, SoundExchange addresses a concern that the Judges raised about potential unintended consequences that could occur by including “rights owner” as defined in sec. 1401(l)(2) of the Copyright Act in the definition of “copyright owners.” SoundExchange states that sec. 1401 is “quite clear about what rights do, and do not, come with being a rights owner under sec. 1401(l)(2).” Moreover, SoundExchange “does not believe that anyone could reasonably see the references to both copyright owners and rights owners within [the proposed definitions] and infer that those two concepts are redundant and mean the same thing for all purposes under the Copyright Act.” SoundExchange Comment at 4. Nevertheless, SoundExchange suggests a proposed modification to the definition of Copyright Owners in § 370.1 to distinguish between copyright owners under 17 U.S.C. 101 and rights owners under 17 U.S.C. 1401(l)(2). 18 The Judges believe the modification SoundExchange suggests addresses the concern of unintended consequences or confusion over the use of the term copyright owners to refer to copyright owners and rights owners. Therefore the Judges adopt the suggested modification.

SoundExchange also addressed the proposed amendments to part 382, subpart C, concerning adjustment of statutory royalty payment for SDARS to reflect use of sound recordings fixed before February 15, 1972, which SoundExchange contended in its comment to the NOI “have become inoperative by their terms.” 84 FR at 9060, quoting SoundExchange Comment on Notice of Inquiry at 6. Although the Judges proposed the amendments as SoundExchange had recommended, the Judges requested comment on the effect, if any, the proposed modifications would have on computation of royalties when an SDARS plays pre-1972 sound recordings that have fallen into the public domain. 84 FR at 9060. SoundExchange acknowledges that beginning in 2022, there will be sound recordings in the public domain. Nevertheless, SoundExchange believes that because these sound recordings will be roughly a century or more old when that occurs that the possibility of Sirius XM using public domain recordings seems more theoretical than real. SoundExchange Comment at 6. SoundExchange tried to identify such recordings used by Sirius XM in a recent month and found that of the million sound recording plays during the month, only a “handful of plays” seemed potentially to involve recordings originally released before 1923. Id. at 8. By contrast, the extant pre-1972 deduction addressed 10-15% of Sirius XM's actual usage when the Judges adopted it in 2013. SoundExchange Comment at 9, citing SDARS II, 78 FR 23054, 23071 (Apr. 17, 2013). SoundExchange notes that the pre-1972 deduction is inoperative today and will have no material effect during the current rate period. SoundExchange Comment at 9. Moreover, SoundExchange is concerned that Sirius XM could misapply any permissible deduction and that the extant regulations could be misread as allowing a royalty deduction for recordings “fixed before February 15, 1972” when no such deduction is available through 2021, and in 2022 and 2023 a deduction would only apply to original recordings published before 1923. Id.

The Judges believe that SoundExchange has adequately addressed concerns over an SDARS use of recordings that will enter the public domain and therefore adopt the regulations related to pre-1972 sound recordings as proposed.

SoundExchange also recommended two technical corrections, both of which the Judges find reasonable and appropriate and adopt. In particular, SoundExchange correctly noted that the authority citation for part 370 should reference sec. 114(f)(3)(A) rather than 114(f)(4)(A) to reflect the renumbering of the paragraphs of sec. 114(f) in the MMA. SoundExchange also noted that the definition of “Copyright Owner” in § 383.2(b) should refer to a copyright owner or (as opposed to and in the current proposal) a rights owner under sec. 1401(l)(2). SoundExchange Comment at 10.

For the reasons stated in the preamble, the Copyright Royalty Judges amend 37 CFR chapter III as set forth below:

On May 8, 2019, the Commission proposed changes to 39 CFR 3020.111(a) to include the requirement that the Postal Service describe how a proposed update to a size or weight limitation would impact competitors and users of the product(s). The Commission also proposed a requirement that the Postal Service explain how a size and weight limitation change is in accordance with the policies and applicable criteria of chapter 36 of title 39 of the United States Code. After consideration of the comments submitted, the Commission adopts final rules.

The Commission initiated this proceeding to evaluate whether changes to Mail Classification Schedule provisions that, in effect, add products to, remove products from, or transfer products between product lists are changes that implicate the requirements of 39 U.S.C. 3642. The Commission sought comments from interested parties on whether it should update its regulations to require information pursuant to section 3642 when changes to the size and weight limitations appear to modify the product lists.

After consideration of the comments submitted, the Commission finds that the amendments to 39 CFR 3020.111(a) strike the appropriate balance between requiring additional information to adequately assess the potential effects of a size and weight limitation change, without being unduly burdensome to the Postal Service. Moreover, the Commission finds that the proposed amendments are sufficient for the Commission to analyze whether a proposed size and weight limitation change would involve unreasonable price increases, unreasonable discrimination, or any other material harm to users and competitors. Although both the Greeting Card Association and the Association for Postal Commerce expressed concern regarding the scope of the rules and possible impacts on volume, both commenters noted that the Commission could address those concerns via proposed sections 3020.111(a)(2) and (3). Accordingly, the Commission adopts the revisions to 39 CFR 3020.111(a).

The Commission amends the rules for updating size and weight limitations in 39 CFR part 3020.

For the reasons stated in the preamble, the Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:

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

On June 22, 2010 (75 FR 35520), EPA published a revised primary SO 2 NAAQS of 75 parts per billion (ppb), which is met at a monitoring site when the 3-year average of the annual 99th percentile of daily maximum 1-hour concentrations does not exceed 75 ppb. This NAAQS was codified at 40 CFR 50.4. On July 25, 2013 (78 FR 47191), EPA published its initial air quality designations for the SO 2 NAAQS based upon air quality monitoring data for calendar years 2009-2011. In that action, the Terre Haute area, comprised of Fayette and Harrison Townships, was designated nonattainment for the SO 2 NAAQS.

Indiana was required to submit an attainment demonstration that meets the requirements of sections 172(c) and 191-192 of the CAA and provide for attainment of the SO 2 NAAQS as expeditiously as practicable, but no later than October 4, 2018, which represents five years after the area was originally designated as nonattainment under the 2010 SO 2 NAAQS. Indiana submitted its attainment demonstration on October 2, 2015. EPA approved the Terre Haute attainment demonstration on March 22, 2019 (84 FR 10692).

Under CAA section 107(d)(3)(E), there are five criteria which must be met before a nonattainment area may be redesignated to attainment. The relevant NAAQS must be attained in the area; the applicable implementation plan must be fully approved by EPA under section 110(k); the improvement in air quality must be determined to be due to permanent and enforceable reductions in emissions; the State must meet all applicable requirements for the area under section 110 and part D; and EPA must fully approve a maintenance plan and contingency plan for the area under section 175A of the CAA. On May 3, 2019 (84 FR 19007), EPA proposed to find that these five criteria have been met for the Terre Haute nonattainment area, and thus, EPA proposed to redesignate Terre Haute from nonattainment to attainment of the 2010 SO 2 NAAQS.

EPA published its proposed approval of the redesignation request and maintenance plan on May 3, 2019 (84 FR 19007). The public comment period for this proposal closed on June 3, 2019. EPA received one supportive comment.

EPA is redesignating the Terre Haute nonattainment area from nonattainment to attainment of the 2010 SO 2 NAAQS. Indiana has demonstrated that the area is attaining the SO 2 standard, and that the improvement in air quality is due to permanent and enforceable SO 2 emission reductions in the nonattainment area. EPA is also approving, as a revision to the Indiana SIP, Indiana's maintenance plan, which is designed to ensure that the area will continue to maintain the SO 2 standard through the year 2030.

In accordance with 5 U.S.C. 553(d), EPA finds there is good cause for these actions to become effective immediately upon publication. This is because a delayed effective date is unnecessary due to the nature of a redesignation to attainment, which relieves the area from certain CAA requirements that would otherwise apply to it. The immediate effective date for this action is authorized under both 5 U.S.C. 553(d)(1), which provides that rulemaking actions may become effective less than 30 days after publication if the rule “grants or recognizes an exemption or relieves a restriction,” and section 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's rule relieves the state of planning requirements for this SO 2 nonattainment area. For these reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for these actions to become effective on the date of publication of these actions.

Under the CAA, redesignation of an area to attainment and the accompanying approval of the maintenance plan under CAA section 107(d)(3)(E) are actions that affect the status of the geographical area and do not impose any additional regulatory requirements on sources beyond those required by state law. A redesignation to attainment does not in and of itself impose any new requirements, but rather results in the application of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, 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 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 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 September 6, 2019. 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).)

40 CFR parts 52 and 81 are amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2019-0096 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 6, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2019-0096, by one of the following methods.

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of May 13, 2019 (84 FR 20843) (FRL-9991-91), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11251) filed by Keller and Heckman LLP. on behalf of Kuraray America, INC., 1001 G Street NW—Suite 500 West, Washington, DC 20001. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of acetic acid ethenyl ester, polymer with ethene and ethenol (CAS Reg. No. 26221-27-2). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” and specifies factors EPA is to consider in establishing an exemption.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). acetic acid ethenyl ester, polymer with ethene and ethenol conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6). Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

The polymer's number average MW of 20,000 daltons is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.

Thus, acetic acid ethenyl ester, polymer with ethene and ethenol meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to acetic acid ethenyl ester, polymer with ethene and ethenol.

For the purposes of assessing potential exposure under this exemption, EPA considered that acetic acid ethenyl ester, polymer with ethene and ethenol could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of acetic acid ethenyl ester, polymer with ethene and ethenol is 20,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since acetic acid ethenyl ester, polymer with ethene and ethenol conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found acetic acid ethenyl ester, polymer with ethene and ethenol to share a common mechanism of toxicity with any other substances, and acetic acid ethenyl ester, polymer with ethene and ethenol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acetic acid ethenyl ester, polymer with ethene and ethenol does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of acetic acid ethenyl ester, polymer with ethene and ethenol, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of acetic acid ethenyl ester, polymer with ethene and ethenol.

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for acetic acid ethenyl ester, polymer with ethene and ethenol.

Accordingly, EPA finds that exempting residues of acetic acid ethenyl ester, polymer with ethene and ethenol from the requirement of a tolerance will be safe.

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

For access to docket FMCSA-2018-0165 to read background documents and comments received, go to http://www.regulations.gov at any time, or to Docket Services at U.S. Department of Transportation, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

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

This rulemaking updates an incorporation by reference found at 49 CFR 385.4 and referenced at 49 CFR 385.415(b). Section 385.4(b) currently references the April 1, 2016, edition of CVSA's “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403.” The Out-of-Service Criteria, while not regulations, provide uniform enforcement tolerances for roadside inspections to enforcement personnel nationwide, including FMCSA's State partners. In this final rule, FMCSA incorporates by reference the April 1, 2018, edition, which includes changes adopted in the April 1, 2017 edition.

Congress has enacted several statutory provisions to ensure the safe transportation of hazardous materials in interstate commerce. Specifically, in provisions codified at 49 U.S.C. 5105(d), relating to inspections of motor vehicles carrying certain hazardous material, and 49 U.S.C. 5109, relating to motor carrier safety permits, the Secretary of Transportation is required to promulgate regulations as part of a comprehensive safety program on hazardous materials safety permits. The FMCSA Administrator has been delegated authority under 49 CFR 1.87(d)(2) to carry out the rulemaking functions vested in the Secretary of Transportation. Consistent with that authority, FMCSA has promulgated regulations to address the congressional mandate on hazardous materials. Those regulations on hazardous materials are the underlying provisions to which the material incorporated by reference discussed in this final rule is applicable.

In 1986, the U.S. Department of Energy (DOE) and CVSA entered into a cooperative agreement to develop a higher level of inspection procedures, out-of-service conditions and/or criteria, an inspection decal, and a training and certification program for inspectors to conduct inspections on shipments of transuranic waste and highway route controlled quantities of radioactive material. CVSA developed the North American Standard Level VI Inspection Program for Transuranic Waste and Highway Route Controlled Quantities of Radioactive Material. This inspection program for select radiological shipments includes inspection procedures, enhancements to the North American Standard Level I Inspection, radiological surveys, CVSA Level VI decal requirements, and the “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403.” As of January 1, 2005, all vehicles and carriers transporting highway route controlled quantities of radioactive material are regulated by the U.S. Department of Transportation. All highway route controlled quantities of radioactive material must pass the North American Standard Level VI Inspection prior to the shipment being allowed to travel in the U.S. All highway route controlled quantities of radioactive material shipments entering the U.S. must also pass the North American Standard Level VI Inspection either at the shipment's point of origin or when the shipment enters the U.S.

Section 385.415 of title 49, Code of Federal Regulations, prescribes operational requirements for motor carriers transporting hazardous materials for which a hazardous materials safety permit is required. Section 385.415(b)(1) requires that motor carriers must ensure a pre-trip inspection is performed on each motor vehicle to be used to transport a highway route controlled quantity of a Class 7 (radioactive) material, in accordance with the requirements of CVSA's “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403.” It is necessary to update the reference to ensure that motor carriers and enforcement officials have convenient access to the correctly identified inspection criteria that are referenced in the rules. Copies of the reference are available to the public from CVSA either through its website, or by contacting CVSA at the address, and phone number provided, and from additional sources of information associated with future incorporations by reference.

According to 2012-2017 data from FMCSA's Motor Carrier Management Information System (MCMIS), approximately 3.5 million Level I-Level VI roadside inspections were performed annually. Nearly 97 percent of these were Level I, 1 Level II, 2 and Level III  3 inspections. During the same period, an average of 842 Level VI inspections were performed annually, comprising only 0.024 percent of all roadside inspections. On average, out-of-service violations were cited in only 10 Level VI inspections annually (1.19 percent), whereas on average, out-of-service violations were cited in 269,024 Level I inspections (25.3 percent), 266,122 Level II inspections (22.2 percent), and 66,489 Level III inspections (6.2 percent) annually. Based on these statistics, CMVs transporting transuranics and highway route controlled quantities of radioactive materials are clearly among the best maintained and safest CMVs on the highways today, due largely to the enhanced oversight and inspection of these vehicles because of the sensitive nature of the cargo being transported.

FMCSA published a notice of proposed rulemaking (NPRM) on December 31, 2018 (83 FR 67705). Whereas the incorporation by reference found at 49 CFR 385.4 and referenced at 49 CFR 385.415(b) references the April 1, 2016, edition of CVSA's “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403,” the NPRM proposed to incorporate by reference the April 1, 2018, edition, which also captures changes adopted in the April 1, 2017 edition. Cumulatively, 15 updates distinguish the April 1, 2018, edition from the 2016 edition. Each of the changes was described and discussed in detail in the NPRM. Generally, the changes serve to clarify or provide additional guidance to inspectors regarding uniform implementation and application of the out-of-service criteria, and none is expected to affect the number of out-of-service violations cited during Level VI inspections. The incorporation by reference of the 2018 edition did not change what constitutes a violation of FMCSA regulations.

FMCSA received one comment to the NPRM. The Commercial Vehicle Safety Alliance (CVSA) commended FMCSA for publishing the NPRM, and encouraged FMCSA to finalize the rule and update the incorporation by reference because “the current reference of the April 1, 2016 edition is outdated and does not reflect the most up to date standard.” In addition, CVSA noted that the “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403” is updated annually, and encouraged FMCSA to take the necessary action to update the regulations accordingly at that time.

FMCSA revises §§ 385.4 (a) and 385.415 (b) to conform to formatting requirements of the Office of the Federal Register; to update the reference in § 385.4(b) from the April 1, 2016, edition to the April 1, 2018, edition of the “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403;” and to clarify that copies are available to the public from CVSA either through its website, or by contacting CVSA at the address, and phone number provided, and from additional sources of information associated with future incorporations by reference.

The FMCSRs, and any exceptions to the FMCSRs, apply only within the United States (and, in some cases, United States territories). Motor carriers and drivers are subject to the laws and regulations of the countries in which they operate, unless an international agreement states otherwise. Drivers and carriers should be aware of the regulatory differences among nations.

The CVSA is an organization representing Federal, State and Provincial motor carrier safety enforcement agencies in United States, Canada and Mexico. The Out-of-Service Criteria provide uniform enforcement tolerances for roadside inspections conducted in all three countries.

FMCSA has determined that this action is not a significant regulatory action under section 3(f) of E.O. 12866, Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011), Improving Regulation and Regulatory Review. Accordingly, the Office of Management and Budget (OMB) has not reviewed it under that Order. It is also not significant within the meaning of DOT regulatory policies and procedures (DOT Order 2100.6 dated Dec. 20, 2018).

E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs,” does not apply to this action because it is a nonsignificant regulatory action, as defined in section 3(f) of E.O. 12866, and has zero costs; therefore, it is not subject to the “2 for 1” and budgeting requirements.

The Regulatory Flexibility Act of 1980 (RFA), Public Law 96-354, 94 Stat. 864 (1980), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et seq. ), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. 4 In compliance with the RFA, FMCSA evaluated the effects of the proposed rule on small entities. The rule incorporates by reference the April 1, 2018, edition of CVSA's “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403.” DOT policy requires an analysis of the impact of all regulations on small entities, and mandates that agencies strive to lessen any adverse effects on these entities.

When an Agency issues a rulemaking proposal, the RFA requires the Agency to “prepare and make available an initial regulatory flexibility analysis” that will describe the impact of the proposed rule on small entities (5 U.S.C 603(a)). Section 605 of the RFA allows an agency to certify a rule, instead of preparing an analysis, if the final rule is not expected to impact a substantial number of small entities. The final rule is largely editorial and provides guidance to inspectors and motor carriers transporting transuranics in interstate commerce. Accordingly, I hereby certify that this final rule will not have a significant economic impact on a substantial number of small entities.

In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, FMCSA wants to assist small entities in understanding this rule so that they can better evaluate its effects. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions, please consult the FMCSA point of contact, Michael Huntley, listed in the FOR FURTHER INFORMATION CONTACT section of this rule.

Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business Administration's Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of FMCSA, call 1-888-REG-FAIR (1-888-734-3247). DOT has a policy regarding the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights. 5

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. The Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector, of $161 million (which is the value equivalent to $100,000,000 in 1995, adjusted for inflation to 2017 levels) or more in any one year. This final rule will not result in such an expenditure.

Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), Federal agencies must obtain approval from the OMB for each collection of information they conduct, sponsor, or require through regulations. FMCSA determined that no new information collection requirements are associated with this final rule.

A rule has implications for federalism under section 1(a) of Executive Order 13132 if it has “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.” FMCSA has determined that this rule will not have substantial direct costs on or for States, nor will it limit the policymaking discretion of States. Nothing in this document preempts any State law or regulation. Therefore, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Impact Statement.

This final rule meets applicable standards in sections 3(a) and 3(b) (2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks, requires agencies issuing “economically significant” rules, if the regulation also concerns an environmental health or safety risk that an agency has reason to believe may disproportionately affect children, to include an evaluation of the regulation's environmental health and safety effects on children. The Agency determined this final rule is not economically significant. Therefore, no analysis of the impacts on children is required. In any event, the Agency does not anticipate that this regulatory action could in any respect present an environmental or safety risk that could disproportionately affect children.

FMCSA reviewed this final rule in accordance with E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and has determined it will not effect a taking of private property or otherwise have taking implications.

Section 522 of title I of division H of the Consolidated Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a privacy impact assessment (PIA) of a regulation that will affect the privacy of individuals. This rule does not require the collection of personally identifiable information (PII).

The Privacy Act (5 U.S.C. 552a) applies only to Federal agencies and any non-Federal agency which receives records contained in a system of records from a Federal agency for use in a matching program.

The E-Government Act of 2002, Public Law 107-347, section 208, 116 Stat. 2899, 2921 (Dec. 17, 2002), requires Federal agencies to conduct a PIA for new or substantially changed technology that collects, maintains, or disseminates information in an identifiable form. No new or substantially changed technology will collect, maintain, or disseminate information as a result of this rule. Therefore, FMCSA has not conducted a PIA.

The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.

FMCSA has analyzed this final rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, it does not require a Statement of Energy Effects under E.O. 13211.

This final rule does not have Tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) are standards that are developed or adopted by voluntary consensus standards bodies. FMCSA does not intend to adopt its own technical standard, thus there is no need to submit a separate statement to OMB on this matter. The standard being incorporated in this final rule is discussed in greater detail in sections IV, V and VII above, and is reasonably available at FMCSA and through the CVSA website.

FMCSA analyzed this rule consistent with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ) and determined this action is categorically excluded from further analysis and documentation in an environmental assessment or environmental impact statement under FMCSA Order 5610.1 (69 FR 9680, March 1, 2004), Appendix 2, paragraph (6)(b). The Categorical Exclusion (CE) in paragraph 6.t.(2) includes regulations to ensure that the States comply with the provisions of the Commercial Motor Vehicle Safety Act of 1986. The content in this rule is covered by this CE, there are no extraordinary circumstances present, and the final action does not have any effect on the quality of the environment. The CE determination is available for inspection or copying in the Regulations.gov website listed under ADDRESSES .

In consideration of the foregoing, FMCSA amends 49 CFR chapter III, part 385, as set forth below: