The EMP is authorized by Section 203 of the Agricultural Trade Act of 1978 (7 U.S.C. 5623), as amended. The EMP regulations appear at 7 CFR part 1486. The Agriculture Improvement Act of 2018 (Pub. L. 115-334), which reauthorized the program for fiscal years 2019-2023, introduced legislative changes to the program that improve the program's flexibility and usefulness to stakeholders, such as the delinking of proposed technical assistance activities from an assessment and an expansion of permitted travel activities. In addition, this rule updates the regulations to bring the operation of the program into conformance with the requirements in the Uniform Guidance. Additional changes are desirable to bring the administration of the program into line with the current best practices in Federal grantmaking.

This rule is being issued as a final rule without prior notice and opportunity for comment. The Administrative Procedure Act (5 U.S.C. 553) exempts rules “relating . . . to public property, loans, grants, benefits, or contracts” from the statutory requirements for prior notice and opportunity for comment and publication of the rule not less than 30 days before its effective date (5 U.S.C. 553(a)(2)). Accordingly, this final rule is effective when published in the Federal Register.

The program covered by this regulation is listed in the Catalog of Federal Domestic Assistance (CFDA) under the following FAS CFDA number: 10.603, Emerging Markets Program.

The Foreign Agricultural Service (FAS) is committed to complying with the E-Government Act of 2002 (44 U.S.C. chapter 36), to promote the use of the internet and other information technologies to provide increased opportunities for citizens' access to Government information and services, and for other purposes.

This rule has been reviewed in accordance with Executive Order 12988, “Civil Justice Reform.” This rule does not preempt State or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. This rule will not be retroactive.

Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with officials of State and local governments that would be directly affected by the proposed Federal financial assistance. The objectives of the Executive order are to foster an intergovernmental partnership and a strengthened federalism by relying on State and local processes for the State and local government coordination and review of proposed Federal financial assistance and direct Federal development. This rule will not directly affect State or local governments, and, for this reason, it is excluded from the scope of Executive Order 12372.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been determined to be not significant and was not reviewed by the Office of Management and Budget (OMB) in conformance with Executive Order 12866.

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

This rule has been reviewed for compliance with Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments, proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes. FAS has assessed the impact of this rule on Indian tribes and determined that this rule does not, to the knowledge of FAS, have tribal implications that require tribal consultation under Executive Order 13175. If a tribe requests consultation, FAS will work with USDA Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress.

Executive Order 13771 directs agencies to reduce regulation and control regulatory costs and provides that for every new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

I. Background

The Home Mortgage Disclosure Act of 1975 (HMDA) 1 requires most mortgage lenders located in metropolitan areas to collect data about their housing related lending activity. Annually, lenders must report their data to the appropriate Federal agencies and make the data available to the public. The Bureau's Regulation C 2 implements HMDA.

Prior to 1997, HMDA exempted certain depository institutions as defined in HMDA (i.e., banks, savings associations, and credit unions) with assets totaling $10 million or less as of the preceding year-end. In 1996, HMDA was amended to expand the asset-size exemption for these depository institutions.3 The amendment increased the dollar amount of the asset-size exemption threshold by requiring a one-time adjustment of the $10 million figure based on the percentage by which the CPI-W for 1996 exceeded the CPI-W for 1975, and it provided for annual adjustments thereafter based on the annual percentage increase in the CPI-W, rounded to the nearest multiple of $1 million.

The definition of “financial institution” in § 1003.2(g) provides that the Bureau will adjust the asset threshold based on the year-to-year change in the average of the CPI-W, not seasonally adjusted, for each 12-month period ending in November, rounded to the nearest $1 million. For 2019, the threshold was $46 million. During the 12-month period ending in November 2019, the average of the CPI-W increased by 1.6 percent. As a result, the exemption threshold is increased to $47 million for 2020. Thus, banks, savings associations, and credit unions with assets of $47 million or less as of December 31, 2019, are exempt from collecting data in 2020. An institution's exemption from collecting data in 2020 does not affect its responsibility to report data it was required to collect in 2019.

Under the Administrative Procedure Act (APA), notice and opportunity for public comment are not required if the Bureau finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest.4 Pursuant to this final rule, comment 2(g)-2 in Regulation C, supplement I, is amended to update the exemption threshold. The amendment in this final rule is technical and non-discretionary, and it merely applies the formula established by Regulation C for determining any adjustments to the exemption threshold. For these reasons, the Bureau has determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary. Therefore, the amendment is adopted in final form.

Section 553(d) of the APA generally requires publication of a final rule not less than 30 days before its effective date, except (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule.5 At a minimum, the Bureau believes the amendments fall under the third exception to section 553(d). The Bureau finds that there is good cause to make the amendments effective on January 1, 2020. The amendment in this final rule is technical and non-discretionary, and it applies the method previously established in the agency's regulations for determining adjustments to the threshold.

Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.6

The Bureau has determined that this final rule does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring approval by the Office of Management and Budget under the Paperwork Reduction Act.7

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Bureau will submit a report containing this rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to the rule taking effect. The Office of Information and Regulatory Affairs (OIRA) has designated this rule as not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons set forth above, the Bureau amends Regulation C, 12 CFR part 1003, as set forth below:

Discussion

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0183, dated July 26, 2019 (“EASA AD 2019-0183”) (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 FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A350-941 airplanes. The NPRM published in the Federal Register on September 25, 2019 (84 FR 50339). The NPRM was prompted by an investigation that identified the cargo lining gutter assembly would be unable to drain a certain quantity of water in case of leakage or rupture of certain water pipes. The NPRM proposed to require modification of the cargo lining gutter assemblies.

The FAA is issuing this AD to address this condition, which, if not corrected, could lead to fluid contamination of certain electrical equipment and connectors, possibly resulting in the loss of several flight control functions, with consequent reduced control of the airplane. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA has considered the comments received. The commenter John Motzel and two anonymous commenters stated support for the NPRM.

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

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

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

EASA AD 2019-0183 describes procedures for modifying the cargo lining gutter assemblies. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 5 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in the cost estimate.

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:

Discussion

The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0133, dated June 11, 2019 (“EASA AD 2019-0133”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Dassault Aviation Model FALCON 900EX airplanes. You may examine the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-0698.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2014-16-26, Amendment 39-17950 (79 FR 51077, August 27, 2014) (“AD 2014-16-26”); and AD 2017-19-04, Amendment 39-19034 (82 FR 43163, September 14, 2017) (“AD 2017-19-04”). AD 2014-16-26 and AD 2017-19-04 applied to certain Dassault Aviation Model FALCON 900EX airplanes. The NPRM published in the Federal Register on September 16, 2019 (84 FR 48569). The NPRM was prompted by the FAA's determination that new or more restrictive airworthiness limitations are necessary. The NPRM proposed to continue to require revising the existing maintenance or inspection program, as applicable; and to require additional revision of the existing maintenance or inspection program, as applicable; to incorporate new or more restrictive airworthiness limitations. The FAA is issuing this AD to address reduced structural integrity of the airplane. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA received no comments on the NPRM or on the determination of the cost to the public.

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

Dassault Aviation has issued Chapter 5-40, Airworthiness Limitations, Revision 16, dated September 2018, of the Dassault FALCON 900EX Maintenance Manual. This service information describes procedures, maintenance tasks, and airworthiness limitations specified in the Airworthiness Limitations section of the Airplane Maintenance Manual.

This AD also requires Chapter 5-40, Airworthiness Limitations, Revision 14, dated November 2015, of the FALCON 900EX Maintenance Manual, which the Director of the Federal Register approved for incorporation by reference as of October 19, 2017 (82 FR 43163, September 14, 2017).

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 100 airplanes of U.S. registry.

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

The FAA estimates the total cost per operator for the retained actions from AD 2017-19-04 to be $7,650 (90 work-hours × $85 per work-hour).

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. In the past, the FAA has estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. The FAA estimates the total cost per operator for the new actions to be $7,650 (90 work-hours × $85 per work-hour).

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.

The FAA determined that 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:

Discussion

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model MD-90-30 airplanes. The NPRM published in the Federal Register on June 21, 2019 (84 FR 29105). The NPRM was prompted by reports indicating that based on Model MD-80 airplane service experience, certain center wing stringers and skins are potentially susceptible to fatigue-related cracking on Model MD-90 airplanes. The Model MD-80 and Model MD-90 wings share the same basic design and experience similar stresses, but no such cracking has been found on Model MD-90 airplanes. Cracks on Model MD-80 airplanes were found in the center wing lower stringers, at the inboard end where they are joined to the airplane centerline by end fittings; in the lower stringer end fittings, at the outboard end where they attach to stringers; and in the lower forward and aft skins, underneath cracked stringers. If not addressed, this cracking could result in the inability of the structure to sustain limit loads, and adversely affect the structural integrity of the airplane. The NPRM proposed to require repetitive ETLF inspections of the left and right side fastener holes for any crack; repetitive ETHF inspections of the lower skin for any crack; and repair if any crack is found.

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

Boeing requested clarification regarding the number of cracking occurrences reported in areas outside of those addressed by AD 2016-07-28, Amendment 39-18473 (81 FR 21253, April 11, 2016) (“AD 2016-07-28”), or Boeing Alert Service Bulletin MD80-57A244, dated March 3, 2016. Boeing noted that in the NPRM, the Other Relevant Rulemaking section stated that since AD 2016-07-28 was issued, cracking was found at fastener holes common to stringers (S) S-11 through S-22, and around the external bracket angle at S-18 and S-19. Boeing emphasized that there was only one case of cracking, at S-13.

In addition, Boeing requested that the Other Relevant Rulemaking section in the NPRM be revised to explain that the new service information that Boeing is developing for Model MD-80 airplanes is to address potential cracking in new stringer locations and is not in response to actual in-service reports of cracking.

The FAA agrees with the commenter's assessment of crack findings. Of the cracks found since issuance of AD 2016-07-28, only one was found at S-13—the only area not addressed by AD 2016-07-28. All remaining crack findings were within the scope of the requirements of AD 2016-07-28. As a result of these cracks, Boeing made the determination to expand the inspection to stringers S-11 through S-22. This AD addresses those stringers on Model MD-90-30 airplanes.

The FAA acknowledges that the service information for the Model MD-80 airplanes, Boeing Service Bulletin MD80-57A244, dated March 3, 2016, which is mandated by AD 2016-07-28, has been revised. Boeing Service Bulletin MD80-57A244, Revision 1, dated October 1, 2019, updates the inspection method and expands the inspection area. The FAA may consider further rulemaking in the future to mandate these changes for Model MD-80 airplanes.

Because the Other Relevant Rulemaking section in SUPPLEMENTARY INFORMATION is not retained in final rules, the FAA has not revised this final rule in regard to these issues.

Delta Air Lines (DAL) requested clarification regarding the number of airplanes on the U.S. registry that would be affected by the NPRM. DAL stated that the Costs of Compliance paragraph indicated that an estimated 43 airplanes would be affected. However, DAL is the only U.S. operator of the affected airplanes, and DAL reports that there are 65 airplanes in their operations specification.

The FAA agrees with the commenter and has revised the Costs of Compliance paragraph in this final rule accordingly.

DAL requested that better quality copies of certain sheets of Boeing Drawing SN09570007 be provided to operators. The commenter stated that the poor quality of these sheets renders them useless in terms of doing inspections and is concerned about showing compliance with the requirements specified in the proposed AD.

The FAA acknowledges the commenter's concern regarding the legibility of certain sheets of Boeing Drawing SN09570007. Since Boeing Alert Service Bulletin MD90-57A031, dated March 19, 2019, does not include Boeing Drawing SN09570007 in the “Required for Compliance (RC)” section, the drawing is not required to comply with this AD. The drawing is referenced in Paragraph 1.J.2., Planning Information, References, Data Supplied with the Service Bulletin, in Boeing Alert Service Bulletin MD90-57A031, dated March 19, 2019. Operators notified Boeing about the illegible drawing sheets, and in response, Boeing issued Boeing Multi Operator Message MOM-MOM-19-0549-01B, dated October 4, 2019, which provides clearer images of Boeing Drawing SN09570007. The FAA recognizes that Boeing Drawing SN09570007 may provide helpful information to operators. Therefore, the FAA has added Note 1 to paragraph (g) of this AD to notify operators that if they have illegible pages of Boeing Drawing SN09570007, additional guidance can be found in Boeing Multi Operator Message MOM-MOM-19-0549-01B, dated October 4, 2019.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. The FAA 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 (other than the estimated number of affected airplanes as explained under the “Request to Revise Cost Information” section of this final rule) or increase the scope of this final rule.

The FAA reviewed Boeing Alert Service Bulletin MD90-57A031, dated March 19, 2019. This service information describes procedures for repetitive ETLF inspections of the left and right side fastener holes for any crack, repetitive ETHF inspections of the lower skin for any crack, and repair if any crack is found. 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 65 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 the agency 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:

Table of Contents I. Table of Abbreviations/Commonly Used Acronyms in This Document II. Background A. Reclassification B. Requirement for Premarket Approval C. Valid Scientific Evidence III. Public Comments in Response to the Proposed Order IV. The Final Order V. Implementation Strategy A. Date To File a PMA B. Compliance With Special Controls VI. Codification of Orders VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. References I. Table of Abbreviations/Commonly Used Acronyms in This Document   Abbreviation or acronym What it means 2012 Panel 2012 Neurological Devices Panel. 510(k) Premarket Notification. AC Alternating Current. CES Cranial Electrotherapy Stimulator Device. CFR Code of Federal Regulations. CNS Central Nervous System. DC Direct Current. DSM-5 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. ECT Electroconvulsive Therapy Device. FDA Food and Drug Administration. FDASIA Food and Drug Administration Safety and Innovation Act. FD&C Act Federal Food, Drug, and Cosmetic Act. FR Federal Register. IDE Investigational Device Exemption. MAUDE Manufacturer and User Facility Device Experience. MDR Medical Device Reporting. OMB Office of Management and Budget. PDP Product Development Protocol. PMA Premarket Approval Application. PRA Paperwork Reduction Act of 1995. RCT Randomized Controlled Trial. Ref. Reference. RWD Real-World Data. RWE Real-World Evidence. U.S.C. United States Code. VSE Valid Scientific Evidence. II. Background

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976, (generally referred to as preamendments devices) are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed classification regulation classifying the device; and (3) published a final classification regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976, (generally referred to as postamendments devices) are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process.1 Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.

Under section 515(i)(2) of the FD&C Act, following publication of a proposed order, a meeting of a device classification panel, and consideration of the comments of a proposed order, FDA has the authority to issue an administrative order revising the classification of a device that FDA has classified as a class III device and for which no administrative order has been issued calling for PMAs under section 515(b) of the FD&C Act, so that the device is classified into class I or II. In determining whether to revise the classification of a device or to require a device to remain in class III, FDA applies the criteria set forth in section 513(a) of the FD&C Act. Section 513(a)(1)(B) of the FD&C Act defines class II devices as those devices for which the general controls in section 513(a)(1)(A) by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls that, together with general controls, provide a reasonable assurance of safety and effectiveness of a device.

FDA published a proposed order in the Federal Register of January 22, 2016 (81 FR 3751) and held a meeting of the Neurological Devices Panel for a discussion of the CES device classification on February 10, 2012 (the 2012 Panel), as described in section 513(b) of the FD&C Act with respect to CES devices (Ref. 1). FDA also published an order in the Federal Register of September 10, 2009 (74 FR 16214), that was issued under section 515(i) of the FD&C Act that required submission of safety and effectiveness information on CES devices. FDA has considered the information available to the Agency, including the deliberations of the 2012 Panel meeting, the reclassification petitions submitted for these devices, and comments from the public docket to determine that there is sufficient information to establish special controls to effectively mitigate the risks to health identified in section III, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness when applied to CES devices intended to treat anxiety and/or insomnia.

Therefore, in accordance with sections 513(e)(1) and 515(i) of the FD&C Act, based on information with respect to the CES device and taking into account the public health benefit of the use of the CES device and the nature and known incidence of the risk of the device, FDA, on its own initiative, is issuing this final order to reclassify CES devices intended for treatment of anxiety and/or insomnia from class III to class II (special controls).2

Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order requiring PMAs. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments from all affected stakeholders, including patients, payers, and providers. As noted above, FDA published a proposed order that would require PMAs for CES devices intended to treat depression in the Federal Register of January 22, 2016. FDA held a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to CES devices (Ref. 2). Finally, FDA received and considered over 300 comments on the proposed order, as discussed in section III. Therefore, FDA has met the requirements under section 515(b)(1) of the FD&C Act.

On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) was enacted. Section 608(a) and (b) of FDASIA amended sections 513(e) and 515(b) of the FD&C Act, amended sections 513(e) and 515(b) of the FD&C Act, changing the mechanism for, respectively, reclassifying a device and requiring premarket approval for a preamendments device from rulemaking to an administrative order. In the Federal Register of December 17, 2018 (83 FR 64443), FDA published a final rule entitled “Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures,” which codified those sections of FDASIA (Medical Device Classification Procedures Final Rule).

Although under the FD&C Act a manufacturer of a class III preamendments device may respond to the call for PMAs by filing a PMA or a notice of completion of a PDP, in practice, the option of filing a notice of completion of a PDP has not been used. While corresponding requirements for PDPs remain available to manufacturers in response to a final order under section 515(b) of the FD&C Act, for simplicity this document will refer only to the requirement for the filing and receiving approval of a PMA.

Under section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B)), a preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order (or a final rule issued under section 515(b) of the FD&C Act prior to the enactment of FDASIA) requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act, whichever is later. Because CES devices that are the subject of this final order were classified in 1979 (44 FR 51770, September 4, 1979), the 30-month period has expired and, thus, the later of these two time periods is the 90-day period. However, for currently legally marketed CES devices intended to treat depression, FDA does not intend to enforce compliance with this 90-day requirement for an additional 90 days (i.e., 180 days after the effective date of this final order), as long as a notice of intent to file a PMA is submitted within 90 days of the effective date of this final order. The notification of the intent to file a PMA should include a list of all model numbers for which a manufacturer plans to seek marketing approval through a PMA. FDA does not intend to enforce compliance with the PMA requirements with respect to an applicant of a currently legally marketed CES device intended to treat depression during FDA's review of the PMA. FDA intends to review any PMA for the device within 180 days of the date of filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “the continued availability of the device is necessary for the public health.”

Also, a preamendments device subject to the order process under section 515(b) of the FD&C Act is not required to have an approved investigational device exemption (IDE) (see 21 CFR part 812) contemporaneous with its interstate distribution until the date identified by FDA in the final order requiring the filing of a PMA for the device. At that time, an IDE is required only if a PMA has not been filed and it has been determined that the device is a “significant risk” under § 812.3(m). If the manufacturer, importer, or other sponsor of the device submits an IDE application and FDA approves it, the device may be distributed for investigational use. If a PMA is not filed within 90 days after the issuance of a final order, and the device is not distributed for investigational use under an IDE, the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if its distribution continues. As stated above, FDA does not intend to enforce the requirement that a PMA be filed or that it has an approved IDE, if applicable, within 90 days, if a notice of intent to file a PMA is filed within 90 days of the effective date of this order. Other enforcement actions include, but are not limited to, the following: shipment of devices in interstate commerce will be subject to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and the individuals responsible for such shipment will be subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 333). FDA requests that manufacturers take action to prevent the further use of devices for which no PMA has been filed.

The evidentiary standard FDA relies on to determine the safety and effectiveness of a device is valid scientific evidence. Section 860.7(c)(2) (21 CFR 860.7(c)(2)) defines valid scientific evidence. As described in section III, in finalizing this order, FDA has assessed the totality of the valid scientific evidence available to FDA. This evidence includes the literature discussed in the proposed order and the information provided in response to the proposed order, including several comments that referenced additional clinical studies. FDA also considered randomized controlled clinical studies, single arm studies, and systematic literature reviews that were submitted in the comments. Single case reports or opinion-based commentary were also submitted to the dockets for consideration; however, without well controlled empirical experimentation, these types of information are generally not considered valid scientific evidence and were not relied upon to support this reclassification.

Section 860.7(c)(2) also explains that although random experience and reports lacking sufficient details to permit scientific evaluation are not regarded as valid scientific evidence to show safety or effectiveness, such information may be considered in identifying a device, the safety and effectiveness of which is questionable (§ 860.7(c)(2)). Such random experience and reports lacking sufficient details to permit scientific evaluation may be early and, sometimes, informal indications that the device is unsafe and/or ineffective (43 FR 32988 at 32990, July 28, 1978). Where FDA is considering the classification of a device, such random experience and reports are not considered valid scientific evidence (§ 860.7(c)(2)).

FDA received many comments from healthcare professionals describing their practices, the length of time they have been practicing, and the utilization of CES devices in treating patients with certain conditions. While FDA acknowledges receiving comments in providing information for recommending the reclassification of CES devices for treatment of certain conditions including anxiety, insomnia, and depression, statements by individual healthcare professionals that they have used CES devices to treat individual patients do not constitute valid scientific evidence to demonstrate reasonable assurance of safety and effectiveness (see Valid Scientific Evidence (VSE) discussion in 48 FR 56778 at 56787-56788, comments 16-21, December 23, 1983 (Ref. 3)). Such comments do not contain sufficient detail to capture the use of the device, exposures, and outcomes in the appropriate population and are not interpretable using informed clinical and scientific judgment.

FDA also received many comments from patients, or friends and family of patients, in support of and against reclassification of CES devices for specific indications for use. These comments described the experience of the patient that received treatment from a CES device. FDA acknowledges receiving comments from patients and other individuals about their positive experiences with CES devices being considered for reclassification; however, FDA does not consider such comments to be valid scientific evidence. Because these comments did not contain sufficient data sources to capture the use of the device, exposures, and outcomes in the appropriate population and are not interpretable using informed clinical and scientific judgment, such comments are not considered valid scientific evidence.

For medical devices, available evidence traditionally consists of clinical and non-clinical studies conducted and provided to FDA by the device manufacturer or sponsor. However, FDA recognizes that a wealth of data covering medical device experience is routinely collected in the course of treatment and management of patients. Under certain circumstances, these real-world data (RWD) may constitute real-world evidence (RWE), or clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD, that may be of sufficient quality to help inform or augment FDA's understanding of the benefit-risk profile of devices at various points in their life cycle, and could potentially be valid scientific evidence used to aid FDA in regulatory decision making. See FDA's guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” (82 FR 41418, August 31, 2017) (Ref. 4), which clarifies how FDA evaluates RWD to determine whether it may be sufficiently relevant and reliable to generate the types of RWE that can be used in FDA regulatory decision making for medical devices, including potentially generating valid scientific evidence.

In order to determine the suitability of RWD for regulatory decision making, FDA will assess the relevance and reliability of the source and its specific elements. This assessment will be used to determine whether the RWD source(s) and the proposed analysis can generate evidence that is sufficiently robust to be used for a given regulatory purpose. Whether evidence is sufficiently relevant and reliable for use will, in part, depend on the level of quality necessary to make a particular regulatory decision (Ref. 4). Although FDA received numerous comments to the proposed order of patient and healthcare professionals' experiences with CES devices, many of the comments did not include sufficient data sources as evidence for consideration of reclassification of CES devices intended for treatment of depression in finalizing this order.

On January 22, 2016, FDA published in the Federal Register a proposed order to reclassify from class III to class II, subject to premarket notification, the CES devices intended to treat anxiety and/or insomnia and to require filing of a PMA for CES devices intended to treat depression. The comment period on the proposed order closed on April 21, 2016.

In response to the January 22, 2016, proposed order, FDA received over 300 comments from industry, professional societies, trade organizations, and individual consumers by the close of the comment period, each containing one or more comments on one or more issues.

We describe and respond to the comments in this section of the document. The comments are grouped based on common themes; we grouped similar comments together under the same number and listed them numerically. The number assigned to each group is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received. Please note that in some cases we separated different issues discussed by the same commenter and designated them as distinct comments for purposes of our responses.

(Comment 1) FDA received numerous comments in favor of the proposed reclassification of CES for treatment of anxiety and/or insomnia into class II with special controls.

(Response 1) Based on the consideration of the deliberation at the 2012 Panel meeting, valid scientific evidence, and review of relevant scientific articles and comments received in response to the 2016 proposed order, FDA continues to believe that CES devices intended to treat anxiety and/or insomnia should be reclassified from class III to class II (Refs. 1, 5, and 6), as initially specified in the proposed order. FDA has made this determination based upon an assessment (or, in some cases, reassessment) of the following sources of information: (1) Published literature referenced in the Executive Summary to the 2012 Panel; (2) comments and literature received in public dockets including the call for safety and effectiveness information for all preamendments class III devices (74 FR 16214), the 2012 Panel (76 FR 6625, February 7, 2011), and the proposed order (81 FR 3751); and (3) review of medical device reports (MDRs) in the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The reevaluation of the scientific evidence presented to and discussed at the 2012 Panel meeting, and the review of additional post-2012 scientific information, further supports this finding. Based on the totality of this available evidence, FDA has determined that the designated special controls, together with general controls, mitigate the risks to health associated with use of CES for the specific indications of treating anxiety and/or insomnia and provide a reasonable assurance of safety and effectiveness, as initially specified in the proposed order. Table 1 identifies the risks associated with CES for treatment of anxiety and/or insomnia and the necessary mitigation measures by the required special controls. In this final order, FDA has included a non-substantive, clarifying edit in table 1 for the mitigation measures for skin irritation by changing “biocompatibility testing” to “biocompatibility evaluation” in table 1. As a result, FDA is adopting the special controls identified in the proposed order for CES devices for the treatment of anxiety and/or insomnia. Therefore, FDA has determined that the proposed special controls identified in this final order, in combination with general controls, provide a reasonable assurance of safety and effectiveness of CES for treatment of anxiety and/or insomnia.

FDA will also create a new product code for CES devices intended for the treatment of anxiety and/or insomnia.

(Comment 2) Several comments opposed maintaining the classification of CES for the treatment of depression in class III and the call for PMAs for the following reasons: (1) There are little to no safety or effectiveness concerns; (2) maintaining the classification of CES for treatment of depression as class III is inconsistent with the statutory definition of class III because, among other things, it does not “present a potential unreasonable risk of illness or injury” based on valid scientific evidence available at the time of premarket clearance; (3) CES for treatment of depression may be addressed by requiring clinical performance data to support a premarket notification (510(k)); and (4) there is prevalence of comorbidity of anxiety disorders and depression that supports the reclassification of CES for treatment of depression to class II.

(Response 2) Based on the totality of evidence, including consideration of the deliberation at the 2012 Panel meeting, recent review of relevant scientific articles, and comments received in response to the 2016 proposed order (81 FR 3751), FDA continues to disagree with reclassification of CES for treatment of depression into class II. FDA has identified the following reasons for maintaining CES for the treatment of depression in class III and the call for PMAs:

(Response 2A) FDA disagrees that there are no safety or effectiveness concerns with reclassifying CES devices for treatment of depression into class II. As noted previously, the evidentiary standard FDA relies on to determine the safety and effectiveness of a device is valid scientific evidence as defined in § 860.7(c)(2). In finalizing this order, FDA has assessed the totality of the valid scientific evidence for treatment of depression that was discussed at the 2012 Panel meeting and provided in comments to the 2016 proposed order, including several comments that referenced additional clinical studies. In addition, this assessment also included an updated analysis of the publicly available safety data in FDA's MAUDE database and an updated review of the literature.

For the treatment of depression, FDA concluded in the 2016 proposed order that there was insufficient information to establish special controls that, in addition to general controls, would provide reasonable assurance of safety and effectiveness of CES devices for treating depression (81 FR 3751 at 3760).

The Agency's previous literature assessment identified 12 papers that examined the effect of CES on measures of depression (6 Randomized Controlled Trials (RCT) and 6 observational studies). In most RCTs, depression levels did not differ significantly between patients who were treated with active CES compared to those treated with placebo (Refs. 7-11), although one randomized trial by Hearst et al. reported fewer depression symptoms in the active CES treatment versus placebo groups (Ref. 12). Of the six observational studies that were reviewed, four studies reported improvement in depression symptoms after treatment with CES (Refs. 13-16). Moore et al. also reported improvement in depression post- (versus pre-) CES treatment, but the findings were not statistically significant (Ref. 17). The observational study by Marshall et al. reported no difference in depressive symptoms between the CES and placebo arms (Ref. 18). Moreover, the observational study Marshall et al. reported no difference in depressive symptoms between the CES and placebo arms (Ref. 18).

Among the intended uses of insomnia, anxiety, and depression, the evidence supporting the effectiveness of CES for treating depression was the weakest. As established in section 513(a)(1)(C) of the FD&C Act and § 860.3(c)(3), a device is in class III if insufficient information exists to determine that general controls and/or special controls are sufficient to provide reasonable assurance of its safety and effectiveness and the device is purported or represented to be for a use that is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury. FDA believes that the risks to health, identified earlier in this section, for the use of CES devices for treating depression, in the absence of an established positive benefit-risk profile, presents a potential unreasonable risk of illness or injury. FDA therefore concluded that there was insufficient information regarding the risks and benefits of the device for FDA to establish special controls that, in combination with general controls, would provide reasonable assurance of the safety and effectiveness of CES for treating depression.

As of the date of this final order, there is still insufficient information to establish special controls that, in addition to general controls, will provide reasonable assurance of safety and effectiveness of CES devices for treating depression. FDA has reviewed all the scientific literature that was cited in comments submitted to the docket of the 2016 proposed order. While these articles had not been discussed specifically in the proposed order, FDA is clarifying that they are not-supportive to the reclassification of CES for treatment of depression. Specifically, these articles have significant shortcomings, such as lacking a well-controlled design (Ref. 19), lacking a diagnosis for eligibility (Ref. 20), having uncertain correlation with diagnostic criteria used in the United States (Ref. 21), containing an exclusion for unipolar depression (Ref. 22), lacking an appropriately matched control group (Ref. 23), and/or including studies that did not focus specifically on CES (Refs. 24 and 25). In one case, while FDA considered a reference supportive of reclassification for anxiety, there was insufficient information to support reclassification for depression because the two groups were not matched with respect to the diagnosis (Ref. 26). Thus, these articles do not justify FDA changing the classification of CES devices intended for treatment of depression. Following the closure of the comment period for the 2016 proposed order, as part of the assessment of the current state of scientific evidence for CES devices, FDA also conducted an updated review of scientific literature. The search used a similar methodology as previous searches conducted in support of the preceding Federal Register orders, and the 2012 Panel meeting. As part of FDA's systematic identification of literature, FDA did not identify studies regarding the use of CES to treat depression as the primary diagnosis. However, FDA did identify four studies either where symptoms of depression were studied in populations of subjects where the primary diagnosis was not a psychiatric condition (Refs. 27 to 29), or where there was one single session administered to examine acute physiological changes only (Ref. 30). FDA evaluated these studies to determine whether they were designed to assess the use of CES to treat depressive disorders that are recognized by the clinical community as identified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5, published 2013) (Ref. 31). FDA concluded that the four studies published after January 1, 2016, through November 1, 2019, did not contribute sufficient information in the form of valid scientific evidence to demonstrate that the subjects met the criteria for any recognized depressive disorder, as defined in DSM-5 (Ref. 31).

In addition, FDA conducted a review of adverse event reporting for CES devices since the publication of the proposed order. The FDA's MAUDE database search resulted in a total of three additional CES-related medical device reporting (MDRs) and one possibly pertinent to CES between January 1, 2016, and September 1, 2019. Two MDRs were injury reports submitted by voluntary reporters for a CES device manufacturer. A third MDR was a malfunction report submitted by a device manufacturer for an implanted intestinal stimulator and noted concomitant use of an unspecified CES device and a fourth MDR report was used to “improve brain functioning” with a report of a third-degree burn. Although there are a low number of MDRs related to CES devices, the adverse reports for treatment of depression are only one factor (e.g., other factors may include the patient population targeted, alternative therapies) for FDA to consider in concluding that there is insufficient information to establish special controls that, in combination with general controls, will provide a reasonable assurance of safety and effectiveness of CES for the treatment of depression. FDA continues to believe that the risks to health identified for the use of CES devices for treating depression, in the absence of an established positive benefit-risk profile, presents a potential unreasonable risk of illness or injury. Thus, following the review of all the evidence presented, FDA has concluded that there is insufficient evidence to establish special controls that, in addition to general controls, will provide a reasonable assurance of safety and effectiveness for CES in treating depression. Accordingly, it is appropriate to maintain CES for treatment of depression in class III.

(Response 2B) FDA disagrees that maintaining the classification of CES for treatment of depression in class III is inconsistent with the statutory definition of class III. Section 513(a)(1)(C) of the FD&C Act (21 U.S.C. 360c(a)(l)(C)) defines class III, premarket approval as the following:

Both class II and class III devices may present a potential unreasonable risk of illness or injury; however, the distinction is that devices in class II have sufficient evidence from which special controls can be established, in combination with general controls, that will provide a reasonable assurance of safety and effectiveness. As stated above, the CES proposed order indicated that there was insufficient evidence that would allow FDA to develop special controls that, in combination with general controls, would provide a reasonable assurance of safety and effectiveness of CES devices intended for treatment of depression, and FDA has determined that there is not sufficient new information that would satisfy that requirement to mitigate a potential unreasonable risk of illness or injury.

(Response 2C) Some comments stated that CES for treatment of depression can be addressed by requiring clinical performance data to support a premarket notification (510(k)). However, in order to classify CES into class II for the treatment of depression, it is necessary for the evidence to first exist that permits the establishment of special controls to provide a reasonable assurance of safety and effectiveness. As mentioned above, FDA has conducted an extensive review of scientific literature and such evidence was not available at the time of the proposed order, and there continues to be a lack of effectiveness data to mitigate a potential unreasonable risk of illness or injury for CES devices for treatment of depression. Furthermore, there is lack of sufficient evidence to support development of special controls that would provide a reasonable assurance of safety and effectiveness for CES devices in treating depression.

(Response 2D) A comment also stated that there is a prevalence of comorbidity of anxiety disorders and depression that supports the reclassification of CES for treatment of depression to class II. While the articles by Jansson-Frojmark et al. and Coplan et al. (Refs. 24 and 25) discuss this connection, they are not studies of CES (as mentioned above) (Refs. 24 and 25). The available evidence where CES was investigated in an anxiety population where depression was a comorbidity is Barclay et al. (Ref. 6). This study, which investigated the use of CES to treat primary anxiety, also included subjects with “comorbid depression” provided that a subject's anxiety was more severe than the depression (Ref. 6). However, the study does not clearly demonstrate that these subjects met the DSM 5 criteria for a recognized depressive disorder (Ref. 31). Therefore, the evidence is insufficient to enable FDA to establish a reasonable assurance of safety and effectiveness to support reclassifying CES devices intended for treatment of depression from class III to II.

(Comment 3) A few comments supported the proposal for a call for PMAs for treatment of depression because they believed there was a lack of valid scientific evidence to support the effectiveness of CES devices for treatment of depression.

(Response 3) FDA agrees with the comments to maintain the classification of CES for treatment of depression as class III. As stated in the preceding response, FDA has determined that there is a lack of sufficient evidence that would satisfy the requirement to mitigate “a potential unreasonable risk of illness or injury” to warrant the reclassification for depression into class II with special controls. As a result, there is insufficient evidence to establish special controls to provide a reasonable assurance of safety and effectiveness of CES devices for treatment of depression.

(Comment 4) One comment compared the reclassification of CES with that of Electroconvulsive Therapy (ECT) devices. Specifically, the commenter states that FDA's reclassification of ECT devices, which provide the largest amount of electricity, to class II should equate to reclassification of CES devices, which provide less electricity, as class I.

(Response 4) FDA disagrees with this commenter's comparison of ECT and CES devices. The safety and effectiveness evidence in support of reclassifying ECT for specific uses was substantial and demonstrated benefits more consistently, in comparison to the evidence evaluated for reclassifying CES intended for treatment of depression from class III to II, although sufficient information exists to establish special controls that, in addition to general controls, will provide reasonable assurance of safety and effectiveness of the CES devices intended for treatment of anxiety and/or insomnia, as discussed above. FDA assessed the totality of the valid scientific evidence that was provided in response to the proposed ECT order, including several comments that referenced new clinical studies. Several of these studies included safety and effectiveness data for adult as well as adolescent patients as well as randomized controlled clinical studies, open-label observational trials, case series reports, systematic literature reviews, and practice guidelines that were submitted in the comments. Additionally, the final order for the reclassification of ECT devices published in the Federal Register (December 26, 2018, 83 FR 66103) identifies ECT devices as applying a brief electrical stimulation of the brain to produce a seizure, while CES devices provide lower stimulation current that is not intended to result in seizure in patients. FDA also believes that general controls alone are insufficient to mitigate the risks to health of CES devices; therefore, the special controls are also needed to provide reasonable assurance of safety and effectiveness for CES devices intended for treating anxiety and/or insomnia.

(Comment 5) Several comments oppose the proposal to identify CES devices as prescription devices. Also, one comment opposes a prescription for treatment of depression and suggests that Federal and State laws mandate that physicians advise patients about CES before prescribing psychiatric, sleeping and/or pain medications so that patients can make a reasonable decision and possibly reduce medication-induced mental health issues.

(Response 5) As stated in the proposed order, the CES device is a prescription only device for all three intended uses, i.e., anxiety, insomnia, and depression, and may not be safe for use except under the authorization of a healthcare professional licensed by law to administer the use of the device. As such, the device identification in § 882.5800(a) (21 CFR 882.5800(a)) has been revised to clarify that CES is a prescription device in accordance with 21 CFR 801.109. Per § 801.109(c), a prescription device must include labeling that describes the indications and other information for use, such as methods, frequency and duration of administration, any relevant hazards, contraindications, side effects, and precautions under which the healthcare professionals can use the device safely (see § 882.5800(b)). Accordingly, healthcare professionals will have access to and be aware of the warnings and precautions in the labeling, and as such, healthcare professionals should be adequately informed of the risks associated with these devices. The healthcare professional can inform the patients of the relevant risks. The warning and precaution statements are an appropriate mitigation for CES intended for the treatment of anxiety and insomnia.

(Comment 6) Several comments expressed the desire for insurance coverage to reduce the cost of the device.

(Response 6) FDA understands the concerns with cost and insurance coverage. However, FDA has no authority over commercial health insurance carriers. Under sections 513(e) and 515(i) of the FD&C Act, FDA has no authority to consider as part of a classification decision whether an indication or a device is covered by commercial health insurance companies. FDA recommends that patients check with their insurance company regarding coverage before receiving CES treatment.

(Comment 7) One comment stated that a manufacturer's website of a currently marketed CES device includes misleading marketing material that may persuade consumers to use this device. The comment also claims that the marketed CES device is not effective.

(Response 7) FDA takes seriously any alleged claims of false or misleading claims by a device manufacturer. Several complaints have been received by the agency claiming that CES devices have not demonstrated effectiveness for treating anxiety and/or insomnia. FDA reviews all complaints and follows the appropriate steps to address complaints received. As a result, FDA continues to believe that the special controls proposed and finalized in this final order should include clinical performance data that demonstrates, among other things, that a CES device, when used as directed, will provide clinically meaningful results in the indicated patient population and provide a reasonable assurance of effectiveness for the intended use of CES devices for treating anxiety and/or insomnia. FDA also believes that a call for PMAs is appropriate for CES devices for treatment of depression to mitigate the potential unreasonable risk of illness or injury.

(Comment 8) One comment suggested FDA should not rely on the recommendations of the 2012 Panel because the meeting was not conducted properly due to the following alleged errors by FDA: (1) Failure to include any panel members with the knowledge of or experience with CES devices; (2) failure to allow all interested parties ample time to present at the 2012 Panel; and (3) failure to provide adequate information by not presenting to the 2012 Panel for consideration the comments received from the proposed rule published in the Federal Register on August 8, 2011 (76 FR 48062), or articles of valid scientific evidence.

(Response 8) FDA believes the 2012 Panel was properly conducted based on the requirements under the FD&C Act. FDA also disagrees with the alleged errors stated for the following reasons.

First, FDA has specific procedures and protocols for all panel meetings that are followed to provide an objective outcome of the panel meetings. For more information, please refer to the FDA's Guidance, “Procedures for Meetings of the Medical Devices Advisory Committee” (Ref. 32). Also, FDA may exclude a healthcare professional from participating on an advisory committee if the person has a conflict of interest. Although a healthcare professional was excluded from the 2012 Panel, there was adequate representation of professionals with experience in using CES devices on the 2012 Panel. For more information on conflicts of interest as it relates to FDA advisory committees, please refer to the relevant FDA guidance entitled, “Public Availability of Advisory Committee Members' Financial Interest Information and Waivers” (Ref. 33).

Second, under section 513(b)(6)(A)(iii) of the FD&C Act, any person whose device is specifically the subject of review by a panel shall have the same opportunity as the Secretary to participate in meetings of the panel, including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information, and permitting the person or representative to call on experts within the person's organization to address such specific issues in the time provided. Furthermore, section 513(b)(6)(B) of the FD&C Act, before and after the enactment of the 21st Century Cures Act (Pub. L. 114-255), requires that meetings shall provide adequate time for initial presentations; and encourage free and open participation by all interested persons. FDA provided the appropriate allocated time for all interested parties to speak or present at the 2012 Panel and for the 2012 Panel to consider their concerns with CES devices (Ref. 32).

Third, during the 2012 Panel, FDA's presentation included a listing of scientific articles (Refs. 1 and 2) and the 2011 proposed rule (76 FR 48062) with a summary of the comments received to the docket for the proposed rule. Therefore, the 2012 Panel members received sufficient information on the 2011 proposed rule and other information to make an informed decision on the classification of CES devices.

(Comment 9) Some comments questioned FDA's effectiveness claims for reclassification and suggested that more research is needed on CES before the device should be reclassified. One comment stated that the proposed order did not provide sufficient valid scientific evidence through tests to prove the effectiveness of CES for reclassification into class II because most of the studies conducted were inconclusive.

(Response 9) FDA disagrees with these comments. The proposed order acknowledged that no individual published study on CES provides definitive evidence of effectiveness of CES for the treatment of anxiety and/or insomnia. FDA noted, however, that in 18 of the 24 small published studies (those that enrolled fewer than 50 patients) that included assessments of anxiety and/or insomnia, each study had a main finding that indicated a greater benefit of CES versus control for at least 1 of the outcome measures evaluated. Furthermore, CES treatment group outcomes improved in all large published studies (although not all studies demonstrated improvement compared with control patients), including two studies identified after the 2012 Panel (Refs. 5 and 6). Based on the available information, the proposed order concluded that there is valid scientific evidence of effectiveness for CES in the treatment of anxiety and/or insomnia. Since the proposed order was published, FDA has not become aware of new information that changes this position.

Importantly, however, FDA acknowledges that because different CES devices were evaluated and the methodology of CES delivery (e.g., electrode placement, stimulation parameters, duration and frequency of treatment sessions) varied, the data are insufficient to determine the technical performance parameters, adequate directions for use, and warnings for unsafe use for specific devices, and whether the devices, when used in accordance with such directions, will provide clinically meaningful results. As explained in the proposed order, although the evidence available to FDA collectively demonstrates a class effect of CES devices for treating anxiety and/or insomnia, it cannot be concluded, based on available information alone, that specific CES devices will be effective for treating anxiety and/or insomnia. As a result, FDA believes that the special controls must include clinical performance data that demonstrates that a device, when used as directed (including instructions for electrode placement, stimulation parameters, duration and frequency of treatment sessions, and other relevant characteristics), will provide clinically meaningful results in the indicated patient population and provide a reasonable assurance of safety and effectiveness for the intended use of CES devices for treating anxiety and/or insomnia.

(Comment 10) One comment recommended that FDA should obtain valid scientific evidence which supports that Central Nervous System (CNS) disorders are treatable with the use of CES.

(Response 10) The category of “CNS disorders” is very broad, while the classification of CES devices is only based on the treatment of anxiety, insomnia and/or depression, as they are the only indications that have been currently allowed for marketing authorization; therefore, valid scientific evidence for all CNS disorders are not relevant for this reclassification. This final order does not address the treatment of broader CNS disorders as they are outside the scope of this final order. Manufacturers seeking to indicate a device for a specific CNS disorder would be responsible for the collection of any valid scientific evidence that may be necessary to support a new indication for marketing CES devices.

(Comment 11) One comment suggests that FDA should correctly categorize CES as either Direct Current (DC) or Alternating Current (AC) stimulation and not whether it is the same waveform as the predicate CES devices used. Comment also suggests that clinical trials are necessary to determine regions of influence by current.

(Response 11) Based on our interpretation of this comment, FDA believes that CES devices could use AC or DC stimulation and that clinical trials conducted to comply with the special controls could be used to characterize the degree of activation in different brain regions.

Based on the information discussed in the preamble to the proposed order (81 FR 3751), the comments received for the proposed order, a review of medical device reports in the FDA MAUDE database, a review of current scientific literature, and 2012 Panel deliberations (Ref. 1), FDA concludes that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of CES devices intended for treatment of anxiety and/or insomnia. Under sections 513(e), 515(b), and 515(i) of the FD&C Act, FDA is adopting its findings, as published in the preamble to the proposed order. For the reasons described in section III, FDA is issuing this final order to reclassify CES devices intended for treatment of anxiety and/or insomnia from class III to class II (special controls). CES devices intended to treat anxiety and/or insomnia must comply with the special controls following the effective date of the final order. However, FDA does not intend to enforce compliance with the special controls for currently legally marketed CES devices intended to treat anxiety and/or insomnia until 1 year after the effective date of the final order.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For the CES devices classified as class II (i.e., for treatment of anxiety and/or insomnia), FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the device they intend to market.

FDA is also requiring the filing of a PMA for CES devices intended for the treatment of depression under section 515(b) of the FD&C Act. Under section 515(b)(1)(A) of the FD&C Act, PMAs for CES devices are required to be filed on or before 90 days after the effective date of a final order.

In accordance with section 515(b) of the FD&C Act, CES devices intended to treat depression must have a PMA or a notice of completion of PDP filed with the Agency by March 19, 2020. An applicant whose device was legally in commercial distribution before May 28, 1976, or whose device has been found to be substantially equivalent to such a device, will be permitted to continue marketing such class III devices during FDA's review of the PMA provided that the PMA is timely filed. For currently legally marketed CES devices intended to treat depression, FDA does not intend to enforce compliance with this 90-day requirement for an additional 90 days (i.e., 180 days after the effective date of any final order), as long as notice of intent to file a PMA is submitted within 90 days of the effective date of the final order. The notification of the intent to file a PMA submission should include a list of all model numbers for which a manufacturer plans to seek marketing approval through a PMA. FDA does not intend to enforce compliance with the PMA requirements with respect to an applicant of a currently legally marketed CES device intended to treat depression during FDA's review of the PMA. FDA intends to review any PMA for the device within 180 days of the date of filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “the continued availability of the device is necessary for the public health.” If a PMA for a class III device is not filed with FDA by March 19, 2020, the device will be deemed adulterated under section 501(f) of the FD&C Act. Table 2 shows the regulatory timetable for currently legally marketed CES devices intended to treat depression.

Under § 812.2(d), the exemption from the requirements of the IDE regulations for preamendments class III devices in § 812.2(c)(1) and (2) will cease to apply to CES devices indicated for depression that are: (1) Not legally on the market on or before March 19, 2020 or (2) legally on the market on or before March 19, 2020 but for which a PMA or notice of completion of a PDP is not filed by March 19, 2020, or for which PMA approval has been denied or withdrawn.

The device may be distributed for investigational use only if the requirements of the IDE regulations are met. The requirements for significant risk devices include submitting an IDE application to FDA for its review and approval. An approved IDE is required to be in effect before an investigation of the device may be initiated or continued under § 812.30. FDA, therefore, cautions that IDE applications should be submitted to FDA at least 30 days before March 19, 2020 to avoid interrupting investigations. There will be no extended period for filing an IDE nor exemption from IDE requirements, and studies may not be initiated without appropriate IDE approvals, where necessary.

Following the effective date of this final order, CES devices intended to treat anxiety and/or insomnia must comply with the special controls. FDA notes that a firm whose CES device was legally in commercial distribution before May 28, 1976, or whose device was found to be substantially equivalent to such a device and who does not intend to market such device for uses other than to treat insomnia and/or anxiety, may remove such intended uses from the device's labeling.

The special controls identified in this final order are effective as of the date of publication of this order, December 20, 2019. CES devices intended to treat anxiety and/or insomnia must comply with the special controls following the effective date of this order. However, FDA does not intend to enforce compliance with the special controls for currently legally marketed CES devices intended to treat anxiety and/or insomnia until 1 year after the effective date of the final order. Manufacturers who wish to continue to legally market a CES device for treatment of anxiety and/or insomnia must submit an amendment to their previously cleared 510(k) that demonstrates compliance with the special controls by December 21, 2020. Such amendment will be added to the 510(k) file but will not serve as a basis for a new substantial equivalence review. A submitted 510(k) amendment in this context will be used solely to demonstrate to FDA that a CES device is in compliance with the special controls. If a 510(k) amendment is not submitted by December 21, 2020 or if FDA determines that the amendment does not demonstrate compliance with the special controls, then this compliance policy would not apply, and FDA would intend to enforce compliance with these requirements. In that case, the device is deemed adulterated under section 501(f)(1)(B) of the FD&C Act as of the date of FDA's determination of noncompliance or 1 year after the effective date of the final order, whichever is sooner.

For models of CES devices intended to treat anxiety and/or insomnia that have not been legally marketed prior to December 20, 2019, or models that have been legally marketed but are required to submit a new 510(k) under § 807.81(a)(3) because the device is about to be significantly changed or modified, manufacturers must obtain 510(k) clearance, among other relevant requirements, and demonstrate compliance with the special controls included in the final order, before marketing the new or changed device.

Sections 513(e) and 515(b), as amended by FDASIA, and 515(i) of the FD&C Act require FDA to issue final orders rather than regulations to reclassify devices. Therefore, FDA will continue to codify reclassifications and requirements for approval of an application for premarket approval, resulting from changes issued in final orders, in the Code of Federal Regulations. Accordingly, under sections 513(e)(1)(A)(i) and 515(b) of the FD&C Act, as amended by FDASIA and FDA's Medical Device Classification Procedures final rule (83 FR 64443), in this final order, we are codifying the amendment of § 882.5800 by: (1) Revoking the requirements in § 882.5800(b) and (c) related to the classification of CES devices intended to treat anxiety and/or insomnia as class III devices and codifying the reclassification of CES devices intended to treat anxiety and/or insomnia to class II (special controls); (2) retaining the requirements in § 882.5800(b) and (c) related to the classification of CES devices intended to treat depression as class III devices subject to the requirement of approval of an application for premarket approval, as described in section IV; and (3) clarifying the device identification of CES devices to include it as a prescription device.

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

This final order refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E, have been approved under OMB control number 0910-0120. The collections of information in part 812 have been approved under OMB control number 0910-0078. The collections of information in 21 CFR part 814, subparts A through E have been approved under OMB control number 0910-0231. The collections of information in part 801 have been approved under OMB control number 0910-0485. The collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

Since early 2004, the United States Parole Commission has been conducting some parole proceedings by videoconference to cut down on delays in scheduling in-person hearings and conserve Commission resources. The Commission originally initiated the use of videoconference in parole release hearings as a pilot project in 2004 and then extended the use of videoconferencing to institutional revocation hearings in 2005, followed by probable cause hearings in 2007. Using videoconference for termination hearings is a natural progression in the use of this technology.

Conducted pursuant to 28 CFR 2.43(c) and 2.95(c), the primary objective of a termination hearing is to obtain information which assists the Commission in determining whether or not early termination of parole is appropriate. The subject is usually represented by an attorney, and the community supervision officer or the U.S. Probation officer provides a recommendation based on the subject's compliance with parole requirements. Given the limited purpose of the hearing, other witnesses are usually not present, and the hearing does not typically last long. The amendment will save travel time and expense, allowing the Commission to conduct termination hearings in a more expeditious manner.

In the interim rule with request for comments (83 FR 58500 (Nov. 20, 2018)), we encouraged the public to comment on our changes. We received written comments from the Public Defender Service for the District of Columbia (PDS) and one anonymous comment. We discuss those public comments below.

PDS objects to amending § 2.25 to include parole termination hearings, and renews its prior objections to the use of videoconference for probable cause hearings. PDS's comments, both past and present, characterize videoconference as a barrier to due process which unjustifiably denies a subject the opportunity to appear in person before the Commission. The Commission does not agree with this proposition. Termination hearings are limited in scope. Unlike revocation hearings, when all facets of the case are explored, witnesses testify, and the status of the offender is finally determined, the purpose of a termination hearing is to obtain information regarding the parolee's conduct in the community. The liberty interest implicated in a revocation hearing is not implicated in a termination hearing. At a termination hearing, the subject does not face the possibility of a loss of freedom as a result of termination being denied. See Henderson v. Sims, 223 F.3d 267, 274 (4th Cir. 2000); Little v. Thomas, 719 F.2d 50, 52 (3d Cir. 1982). Further, there is no constitutional or statutory entitlement to early termination of parole supervision. See Myers v. U.S. Parole Comm'n, 813 F.2d 957, 960 (9th Cir. 1987). Thus, the fact that the parolee's appearance for the termination hearing will be by videoconference does not violate due process.

PDS recommends that termination hearings only be conducted by videoconference in circumstances where either distance or physical hardship renders the subject unable to appear in person. While the Commission agrees that videoconferencing may be appropriate in the circumstances described by PDS, the Commission does not agree that the rule should be so narrow. It is within the Commission's discretion to determine when conducting a termination hearing by videoconference is appropriate.

PDS also raises concerns about technological issues, stating that experiencing technical difficulties during a hearing would completely undermine the value of having a hearing at all. Over the years, the Commission's experience has been that the quality of the transmission has improved and the personal interactions among the hearing participants does not appreciably decline with the use of videoconferencing.

The Commission also received an anonymous comment in support the use of videoconferencing for parole termination hearings. The comment, while acknowledging the issue of losing face-to-face contact, described the amendment as a logical practice that will increase the efficiency of the termination process.

This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulation Planning and Review,” section 1(b), Principles of Regulation, and in accordance with Executive Order 13565, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation. The Commission has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has not been reviewed by the Office of Management and Budget.

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Under Executive Order 13132, this rule does not have sufficient federalism implications requiring a Federalism Assessment.

The rule will not have a significant economic impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 605(b).

The rule will not cause State, local, or tribal governments, or the private sector, to spend $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. No action under the Unfunded Mandates Reform Act of 1995 is necessary.

These rule is not a “major rule” as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 Subtitle E—Congressional Review Act, now codified at 5 U.S.C. 804(2). The rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on the ability of United States-based companies to compete with foreign-based companies. Moreover, this is a rule of agency practice or procedure that does not substantially affect the rights or obligations of non-agency parties, and does not come within the meaning of the term “rule” as used in Section 804(3)(C), now codified at 5 U.S.C. 804(3)(C). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.

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 the Coast Guard did not receive notice of the marine event from involved parties with sufficient time to publish a NPRM and to receive public comments prior to the event. It is impracticable to publish an NPRM because the Coast Guard did not receive notice of the boat parade until December 4, 2019, and the special local regulation is needed for December 20, 2019. This action is necessary for the protection of life and property on the navigable waters of the United States. Therefore, it would be contrary to the public interest to postpone establishing this temporary special local regulation.

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 for the same reason discussed above.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The purpose of this rule is to ensure safety of the event participants, vessels and the navigable waters of Crown Bay, Haulover Clay and St. Thomas Harbor, St. Thomas, U.S. Virgin Islands (USVI), during the St. Thomas Lighted Boat Parade. The Captain of the Port (COTP) has determined that potential hazards associated with the marine parade event will pose a safety concern for any persons and vessels within the regulated area.

This rule establishes a temporary special local regulation on certain navigable waters of the Crown Bay, Haulover Cay, and St. Thomas Harbor, St. Thomas, USVI during the St. Thomas Lighted Boat Parade from 6:30 p.m. until 9:00 p.m. on December 20, 2019. The regulated area will encompass all waters within a 100-foot radius of participating vessels, beginning with the lead vessel, ending with the last participating vessel, and at all times extending 100-feet on either side of the parade vessels. The parade route consist of a course that starts at Crown Bay Marina in potion 18°19′986″ N, 64°57′088″ W; proceeds thence east through Haulover Cut, thence northeast throu Cay Bay, thence east towards the Coast Guard Base in Kings Wharf and thence back through the same route to the beginning position. All coordinates are North American Datum 1983.

The special local regulation is intended to protect personnel, vessels, and the marine environment in these navigable waters during the power boat races. All persons and non-participating vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the COTP San Juan or a designated representative. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the COTP San Juan or a designated representative. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP San Juan or a designated representative. The Coast Guard will provide notice of the regulated area by Local Notice to Mariners, Broadcast Notice to Mariners, and/or by on-scene designated representatives.

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.

This regulatory action determination is based on the size, location, and duration of the regulated area. The regulated area will impact a small designated area of Crown Bay, Haulover Cay, and St. Thomas Harbor, St. Thomas, USVI, during the event and thus is limited in scope. The special local regulation will be enforced for only a total period of 2.5 hours and thus is limited in time. Although persons and vessels will not be able to enter, transit through, anchor in, or remain within the zone without authorization from the Captain of the Port San Juan or a designated representative, they may operate in the surrounding area during the enforcement period. The rule will allow vessels to seek permission to enter the regulated area. Persons and vessels may still enter, transit through, anchor in, or remain within the regulated area during the enforcement period if authorized by the Captain of the Port San Juan or a designated representative. The Coast Guard will issue a Local Notice to Mariners and a Broadcast Notice to Mariners, allowing mariners to make alternative plans or seek permission to transit the regulated area.

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 enter, transit through, anchor in, or remain witin the regulated area may be small entities, for the reason stated in section V. A. above, this rule will not have a significate 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 call or email 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 call or email 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, Rev. 1, associated implementing instructions, 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 creation of a regulated area in conjunction with a regatta or marine parade to ensure the safety of vessels, spectators, and the public during the event. It is categorically excluded from further review under paragraph L61 in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email 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 100 as follows:

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

On August 15, 2019, the City of Valdez notified the Coast Guard that from 10 to 10:30 p.m. on December 31, 2019, it will be conducting a fireworks display launched from Sea Otter Park located next to the entrance of the Small Boat Harbor in the Port of Valdez, AK. In response, on November 13, 2019, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Port Valdez, Valdez, AK (84 FR 61583). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended December 13, 2019, we received one comment.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port of Valdez (COTP) has determined that potential hazards associated with the fireworks to be used in this December 31, 2019 display will be a safety concern for anyone within a 150-yard radius of the fireworks launching site. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.

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 because the fireworks event is scheduled to take place in celebration of the New Year, on December 31, 2019. Accordingly, this fireworks event will take place before thirty days from the date this final rule is published. It is, therefore, necessary for public safety to make this rule effective less than 30 days after publication in the Federal Register.

As noted above, we received one comment on our NPRM published November 13, 2019. The comment was in support of this regulation and no issues were raised. In this temporary final rule, we are making one change from the NPRM. Due to an administrative error, the proposed regulation in the NPRM did not include the enforcement period for the safety zone. We are correcting that error in this final rule by adding the following enforcement period in the regulation: 9:30 p.m. to 11:00 p.m. local time on December 31, 2019.

This rule establishes a safety zone from 9:30 to 11:00 p.m. on December 31, 2019. The safety zone will cover all navigable waters within 150 yards of the launching site at Sea Otter Park, located near the entrance of the Small Boat Harbor in the Port of Valdez, AK. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 10 to 10:30 p.m. fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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.

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic is rare and normally low for this time of year at the Port of Valdez. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

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 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 call or email 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 call or email 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, Rev. 1, associated implementing instructions, 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 150 yards of the launching site at Sea Otter Park, located near the entrance of the Small Boat Harbor in the Port of Valdez, AK. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email 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:

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Upper Mississippi River DHS Department of Homeland Security FR Federal Register MM Mile Marker NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

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 of the very short notification of when the diving work on the Illinois River is due to take place. It is impracticable to publish an NPRM because we must establish this safety zone by December 16, 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 contrary to public interest because immediate action is necessary to respond to the potential safety hazards associated with the diving work to take place in the Illinois River.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Upper Mississippi River (COTP) has determined that potential hazards associated with dive operations starting December 16, 2019, will be a safety concern for anyone seeking to transit at MM 91.5 and MM 28.3 on the Illinois River. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the diving takes place.

This rule establishes a safety zone which will be enforced for two days within the effective period from 7 a.m. through 1 p.m. or until dive operations are completed, whichever occurs sooner. The duration of the effective period is from December 16, 2019 to December 30, 2019 to allow for any potentially unsafe weather condtions that could delay the diving and salvage operations. The safety zone will cover all navigable waters of the Illinois River within one tenth of a mile up and down river of MM 91.5 and MM 28.3 extending the entire width of the river. This is necessary for divers and salvage equipment being used to complete work required to cut off old pilings below the water to recover the destroyed Coast Guard Aids to Navigation. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the work is taking place. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The COTP or designated representative will notify the public of the actual enforcement dates by Broadcast Notice to Mariners, Locan Notice to Mariners and or Marine Safety Information Bulletin, as approtiate.

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.

This regulatory action determination is based on the size, location, and duration of the safety zone. This safety zone impacts two small sections totaling less than a one mile stretch of the Illinois River for up to six hours over two days. Additionally, this rule allows vessels to seek permission to enter the zone.

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 call or email 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 call or email 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, Rev. 1, associated implementing instructions, 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 6 hours on two days that will prohibit entry within the dive operations locations at MM 91.5 and MM 28.3 on the Illinois River. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email 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:

I. General Information A. Does this action apply to me?

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 Publishing 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(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0526 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 February 18, 2020. 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-2017-0526, 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 December 15, 2017 (82 FR 59604) (FRL-9970-50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F8547) by Bayer CropScience, LP, 2 TW Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.1257 be amended by changing the name of the microbial from Paecilomyces lilacinus strain 251 to Purpureocillium lilacinum strain 251. That document referenced a summary of the petition prepared by the petitioner Bayer CropScience LP, which is available in the docket via http://www.regulations.gov. Although comments submitted to the docket for this notice of filing, none were relevant to this tolerance rulemaking.

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

The species lilacinus, formerly considered within the genus Paecilomyces, has been moved to the genus Purpureocillium and renamed lilacinum. The new taxonomy is presented in a 2011 scientific paper discussed and referenced in EPA's supporting document mentioned later in this paragraph. The strain-specific features and properties, including toxicological aspects of Paecilomyces lilacinus strain 251, have not changed due to the name change. Therefore, the risk assessments and tolerance exemption rationale for Paecilomyces lilacinus strain 251 apply to the new taxonomic classification, Purpureocillium lilacinum strain 251.

EPA evaluated the available toxicity and exposure data on Purpureocillium lilacinum strain 251 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Purpureocillium lilacinum strain 251.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Purpureocillium lilacinum strain 251. Therefore, the existing tolerance exemption for Paecilomyces lilacinus strain 251 is amended by updating the name of the exempt substance from Paecilomyces lilacinus strain 251 to Purpureocillium lilacinum strain 251.

An analytical method is not required for Purpureocillium lilacinum strain 251 because EPA is amending an exemption from the requirement of a tolerance without any numerical limitation.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (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:

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 EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing 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-2019-0205 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 February 18, 2020. 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-2019-0205, 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 June 7, 2019 (84 FR 26630) (FRL-9993-93), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8E8730) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested to amend 40 CFR 180.697 by removing the established tolerances for residues of flutianil, (2Z)-2-[2-fluoro-5-(trifluoromethyl)phenyl]sulfanyl-2-[3-(2-methoxyphenyl)thiazolidin-2-ylidene] acetonitrile, including its metabolites and degradates, in or on the raw agricultural commodities cantaloupe at 0.07 ppm; cherry at 0.40 ppm; cucumber at 0.20 ppm; grape at 0.70 ppm; squash at 0.05 ppm; and strawberry at 0.50 ppm.

In the Federal Register of October 3, 2019 (84 FR 52850) (FRL-9999-89), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8E8730) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested to amend 40 CFR 180.697 by establishing tolerances for residues of flutianil, (2Z)-2-[2-fluoro-5-(trifluoromethyl)phenyl]sulfanyl-2-[3-(2-methoxyphenyl)thiazolidin-2-ylidene] acetonitrile, including its metabolites and degradates in or on berry, low growing, subgroup 13-07G at 0.50 ppm; cherry subgroup 12-12A at 0.40 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.70 ppm; hop, dried cones at 2.0 ppm; and vegetable, cucurbit, group 9 at 0.20 ppm.

The documents referenced a summary of the petition prepared by OAT Agrio Co., Ltd., c/o Landis International, Inc., the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notices of filing. EPA's response to this comment is discussed in Unit IV.C.

For reasons discussed in Unit IV.D., EPA is establishing tolerances that vary slightly from what was requested, consistent with its authority in FFDCA section 408(d)(4)(A)(i).

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

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies 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.

No single or repeated dose study performed by any route of exposure produced an adverse effect following flutianil exposure below, at, or above the limit dose (1,000 mg/kg/day). The only toxic effect of flutianil exposure in the rat 28-day, 90-day, or 104-day oral toxicity studies was associated with hyaline droplet formation in the renal proximal tubular cells of males. No toxicity was observed in the female rats dosed up to the limit dose for comparable time periods. An immunohistochemical staining demonstrated that the hyaline droplets in the proximal tubular cells were related to the presence of alpha-2µ-globulin, which is not relevant for human toxicity. Based on the link to alpha-2µ-globulin and the lack of any degenerative or other associated effects, the hyaline droplet was not considered biologically relevant to humans.

No toxicity was seen in the developmental, reproductive, neurotoxic, or immunotoxic studies for flutianil. No dermal or systemic toxicity was observed at the limit dose in the rat 28-day dermal toxicity study. Nevertheless, in the rat 28-day inhalation toxicity study, increased lung weights in females and histopathological findings of minimal nasal mucous cell hypertrophy/hyperplasia and minimal lung centriacinar inflammation in males and females were observed at the highest dose tested. These observations were consistent with response to aerosol exposure to an airway irritant. The nasal mucous cell hypertrophy/hyperplasia is considered the physiological response of these cells to an irritant; however, the increased lung weights and cellular inflammation reflect some degree of edema in air spaces, and inflammation in the lung could affect airway responsiveness and pulmonary function. Therefore, the increased lung weights in females and lung lesions in both sexes were considered adverse effects. Flutianil is classified as “Not Likely to be Carcinogenic to Humans” based on lack of evidence of carcinogenicity in rats and mice and no evidence of mutagenicity. Flutianil produced no genotoxicity.

Specific information on the studies received and the nature of the adverse effects caused by flutianil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov on pages 24-28 of the document titled “Flutianil. Human Risk Assessment to Support New Uses for a New Active Ingredient, Flutianil on Apple, Cantaloupe, Cherry, Cucumber, Grape, Summer Squash, and Strawberry” in docket ID number EPA-HQ-OPP-2019-0205.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.

Based on the analysis of the available flutianil toxicological studies, there is no adverse toxicity from oral exposures seen in any of the required submitted toxicology studies. No toxicity endpoint and point of departure for regulating dietary exposure are established for the human health risk assessment. There are no registered or proposed residential uses at this time for flutianil; therefore, residential handler and post-application exposure and risk were not assessed.

Flutianil is used on a variety of crops. Humans could potentially be exposed to flutianil residues in food because flutianil may be applied directly to growing crops. These applications can also result in flutianil reaching surface and ground water, both of which can serve as sources of drinking water. There are no proposed uses in residential settings; therefore, there are no anticipated residential exposures.

Based on the toxicological profile of flutianil, EPA has concluded that the FFDCA requirements to retain an additional safety factor for protection of infants and children and to consider cumulative effects do not apply. Section 408(b)(2)(C) of the FFDCA (21 U.S.C. 346a) requires an additional tenfold margin of safety in the case of threshold risks, which are not present in this case. Section 408(b)(2)(D)(v) of the FFDCA requires consideration of information concerning cumulative effects of substances that have a common mechanism of toxicity, which flutianil does not have.

Based on the available data indicating a lack of adverse effects from exposure to flutianil, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to flutianil.

Adequate enforcement methodology—gas chromatography-mass spectrometry detector (GC/MSD) and high-performance liquid chromatography with tandem mass spectral detection (LC/MS/MS) for grapes only—is available to enforce the tolerance expression. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

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 any MRLs for these crops for flutianil.

One comment generally asserting that flutianil is toxic and should not be allowed on vegetables was received in response to the notice of filing. Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that these flutianil tolerances are safe. The commenter has provided no information to indicate that flutianil is not safe.

The petitioner seeks a vegetable, cucurbit, group 9 tolerance of 0.20 ppm. Previously, separate tolerances were established for cucumber, cantaloupe, and squash for harmonization purposes with Japan. The available data support establishing subgroup tolerances, so EPA is establishing two subgroup tolerances as follows: Melon subgroup 9A at 0.07 ppm and squash/cucumber subgroup 9B at 0.2 ppm. There are no Codex MRLs.

EPA is establishing the remaining tolerances as requested, except for modifications to be consistent with the rounding class practices of the Organisation for Economic Co-operation and Development (OECD).

Although the lack of toxicity supports a safety finding for an exemption from the requirement of tolerance for all crops, EPA is establishing numerical tolerances for residues resulting from direct applications to commodities for international trade purposes. Therefore, tolerances are established for residues of flutianil, (2Z)-2-[2-fluoro-5-(trifluoromethy)phenyl]sulfanyl-2-[3-(2-methoxyphenyl)thiazolidin-2-ylidene]acetonitrile, in or on berry, low growing, subgroup 13-07G at 0.5 ppm; cherry subgroup 12-12A at 0.4 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.7 ppm; hop, dried cones at 2 ppm; melon subgroup 9A at 0.07 ppm; and squash/cucumber subgroup 9B at 0.2 ppm.

Additionally, the following tolerances are removed as unnecessary due to the establishment of the above tolerances: Cantaloupe; cherry; cucumber; grape; squash; and strawberry.

This action establishes and modifies tolerances 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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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 tolerances 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:

This is a summary of the Commission's Report and Order (Order) in WC Docket No. 13-184; FCC 19-117, adopted on November 20, 2019 and released on December 3, 2019. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 12th Street SW, Washington, DC 20554 or at the following internet address: https://docs.fcc.gov/public/attachments/FCC-19-117A1.pdf.

1. The Commission's E-Rate program is a vital source of support for connectivity to—and within—schools and libraries. In particular, the E-Rate program provides funding for internal connections, which are primarily used for Wi-Fi, a technology that has enabled schools and libraries to transition from computer labs to one-to-one digital learning. In this document, the Commission makes permanent the “category two budget” approach that the Commission adopted in 2014 to fund these internal connections. The category two budget approach consists of five-year budgets for schools and libraries that provide a set amount of funding to support internal connections. In adopting this approach, the Commission also established a five-year test period (from funding year 2015 to funding year 2019), to consider whether this approach would be effective in ensuring greater and more equitable access to E-Rate discounts.

2. Based on the overwhelming record support for the category two budget approach from the E-Rate community, coupled with the Commission's own experience during the five-year test period, the Commission concludes that the category two budget approach has provided broader, more equitable, and more predictable funding for schools and libraries than under the prior rules. The budget amount provided to schools and libraries during the test period proved to be successful, and, moving forward, the Commission intends to generally remain within those parameters of support. Building on the success of the category two budget approach, the Commission takes important steps to (1) streamline processes to ensure more equitable, consistent distribution of support for small, rural schools and libraries within the existing E-Rate program budget for category two services, (2) simplify the category two budgets, and (3) decrease the administrative burden of applying for category two services. As a result of the measures the Commission takes in this document, the category two budget approach will become more streamlined, furthering the program's overall effectiveness and the deployment of Wi-Fi in schools and libraries across the country.

3. To ensure that our nation's students and library patrons have access to high-speed broadband and to further the Commission's goal of bridging the digital divide for all Americans, it permanently extends the category two budget approach, which has provided certainty and more equitable funding to schools and libraries for the last five funding years. Doing so avoids a return to the two-in-five rules. Furthermore, informed by the Commission's experience with administering the category two budgets during the five-year test period, it simplifies and streamlines the category two budget approach to allow applicants to make more effective use of category two funding and to reduce administrative burdens. As part of these improvements, the Commission also provides more equitable, consistent support for small, rural schools and libraries within the existing category two services budget and make permanent the eligibility of managed internal broadband services, caching, and basic maintenance of internal connections.

4. As detailed in the following, to ensure a smooth transition to the new rules, the Commission establishes rules for funding year 2020 that extend the five-year test period for an additional year and provide a prorated amount of category two support to all applicants. In this way, the Commission balances the desire to meaningfully improve the category two budget approach while minimizing the impact associated with such changes for the upcoming funding year. Thus, the new rules the Commission adopts for the category two budget approach will apply beginning in funding year 2021, at which time the budgets will reset for all applicants as the Commission moves to fixed five-year funding cycles, the first of which will run from funding years 2021 to 2025.

5. Based on a review of the record, the Commission first adopts its proposal to make the category two budget approach permanent, thus ensuring that the two-in-five rules will not come back into effect for any applicants following funding year 2019. Doing so is supported by the record and consistent with the findings of the Bureau's Category Two Budget Report. Commenters unanimously support the category two budget approach, and no commenter expressed a desire to return to the problematic two-in-five rules. In particular, commenters state that the benefits of the category two budget approach far outweigh any benefits of the alternative two-in-five rules approach. This view is consistent with the Bureau's finding that, since funding year 2015, funding has gone to all fifty states and all discount levels in a manner that more closely approximates the composition of participating schools and libraries in the E-Rate program overall.

6. Moreover, there is agreement that the category two budget approach “has led to wider, more robust deployment of broadband services within schools and libraries.” Likewise, the category two budget approach has “enabled all applicants, regardless of their place on the E-Rate discount matrix, to receive funding for broadband equipment and services inside their school and library buildings.” With respect to libraries, ALA observed that “for the first time in over fifteen years our libraries are assured of receiving C2 funding. The result is that all libraries, whether in rural remote areas or urban centers, have access to much needed funding for their in-building network requirements.” Commenters also note that extending the category two budget approach permanently will give “both applicants and service providers confidence that category two funding will continue in a reliable and predictable manner.”

7. Finally, the record contains no evidence of any significant economic costs associated with a transition to a permanent category two budget approach. Accordingly, the economic benefits of transitioning to a permanent category two budget are expected to outweigh the costs. For all of these reasons, the Commission makes the category two budget approach permanent.

8. Recognizing that the category two budget approach, while successful during the five-year test period, can be improved upon, the Commission takes this opportunity to simplify the budgets and make category two funding even more effective than during the last five funding years. Specifically, beginning in funding year 2021, the Commission resets all applicant budgets and begin fixed five-year budget cycles. As part of this modification, the Commission also adopts district-wide and library system-wide budget calculations, which will relieve applicants of some of the most significant administrative burdens associated with the category two application process and management of the budgets. Furthermore, to ensure the needs of schools with low student counts and small libraries, particularly those in rural areas, are met and to promote their increased participation, the Commission increases the category two funding floor to $25,000. The Commission maintains the per-student budget multipliers that served schools well during the five-year test period and adopt a single budget multiplier for libraries, all of which will be adjusted for inflation every five years. Additionally, the Commission makes managed internal broadband services, caching, and basic maintenance of internal connections permanently eligible, and confirm their eligibility for all applicants in funding year 2020.

9. First, to facilitate the transition to the new rules, the Commission will reset all budgets to the full amount eligible under the new rules, which will provide applicants the opportunity to deploy internal connections and make it easier for them to track their category two budgets in the new funding cycle. All applicants will start with a new five-year budget cycle beginning in funding year 2021, regardless of whether they completed their previous five-year budget cycle during the test period.1 The Commission agrees with commenters that resetting the budgets at the end of the test period will alleviate confusion, whereas rolling over remaining funds from the test period would be difficult to track given the changes to the rules and the budget calculations.

10. Next, as part of the improvements to the category two budget approach the Commission makes in this document, and to ease the administration of the budgets, the Commission adopts fixed five-year budget cycles, with the first such cycle running from funding year 2021 through funding year 2025. Applicants may submit applications in any funding year during this five-year cycle. In the 2019 Category Two Notice, 84 FR 34107, July 17, 2019, the Commission sought comment on using rolling budgets, or setting fixed five-year budget cycles, as part of the permanent category two budget rules, and asked if fixed five-year cycles would be easier to administer. Commenters largely support fixed five-year cycles, noting that fixed budgets present the “clearest and cleanest approach,” and that a “simplified, fixed timeframe for budget expenditure for all applicants will alleviate much of the confusion” created by rolling budgets. The Commission agrees and now adopts fixed five-year budget cycles to simplify the administration of the budgets and eliminate a source of confusion for applicants. Fixed cycles also present natural beginning and ending points for budgets, making it easier to make changes and updates to the budgets in future funding years should the need to do so arise. These changes will allow for the smoothest transition to the new rules, and the Commission agrees with commenters who stated that the risks associated with a fresh start and fixed budgets are minimal.

11. The Commission notes that no commenter supported rolling budgets that begin the first year a school or library requests category two funding and look back four years, as described in the 2019 Category Two Notice. Some commenters, however, supported rolling over unused funds from the five-year test period into new, fixed five-year cycles. The Commission concludes, however, that the administrative burden of carrying unused funds from one budget period to another far outweigh the benefits of doing so, and the program would be easier to administer with clear starting and ending points to budget periods. Other commenters support rolling budgets to the extent that fixed budgets will present challenges with schools opening or closing during a five-year period. The Commission disagrees and finds instead that fixed five-year cycles present the simplest rules to administer, and in fact minimize the confusion caused by a school opening or closing mid-cycle. Under a rolling scenario, that school district's budget would need to reflect changes caused by a school opening or closing for an extended period of time, while fixed budget cycles reset at the conclusion of the five-year cycle, giving the district an opportunity to start fresh calculating its budget. Overall, the benefits some applicants may receive from carrying over a portion of unused funding, or from being able to start calculating budgets on a rolling basis, are outweighed by the ability of all applicants to calculate budgets on a clear, predictable basis, with established beginning and ending points that also present clear opportunities for future modifications, should the need arise.

12. Next, as part of the permanent rules that will go into effect in funding year 2021, the Commission adopts district-wide and library system-wide category two budgets—a change that nearly all commenters support. Specifically, school districts and library systems will now have a single budget to administer, and the district or library system will have the flexibility to allocate category two funding among its schools and libraries as it sees fit, vastly simplifying the planning and application process for category two services. This change will simplify some of the more complicated aspects of administering the budgets and applying for funding (such as dividing the costs of shared services among multiple entities, estimating student counts at new schools, and counting part-time students), without eliminating protections against waste, fraud, and abuse, which continue to apply with respect to each individual school and library included in the school district-wide and library system-wide budgets. In particular, calculating the budgets in this way will largely eliminate the need for applicants to maintain and administer separate budgets for each school or library in a district or library system and minimize instances where funding requests are delayed or denied because they exceeded the budget for a particular school or library. Further, as commenters noted, different schools have different technological needs, and a single district-level or system-level budget will allow the school district or library system to determine how best to account for these differences. By affording applicants the flexibility to determine how best to allocate funding within their districts and library systems, the Commission ensures a more effective use of E-Rate funds.

13. In adopting district-wide budgets, the Commission provides general guidance on what constitutes a “school district.” Given that applicants are likely to be in the best position to apply this guidance to their particular circumstances, the Commission does not strictly define the term for the purposes of applying for and calculating a district-wide budget. In response to the Commission's request for comment on how applicants and USAC should determine which entities are part of a school district for calculating category two budgets, the Commission received several comments, but no clear consensus. To provide administrative ease and flexibility to account for differing scenarios and consistent with the manner in which applicants currently calculate district-wide discount rates, applicants should consider all schools that fall under the control of a central administrative agency as a district for the purpose of calculating a shared, district-wide budget.

14. Under this approach, private schools and charter schools that operate independently of a public school district or a central administrative agency, and are individually responsible for their finances and administration, should separately calculate their category two budgets and apply for funding. Independent charter schools, private schools, and other eligible educational facilities that seek support for more than one school building should factor all students in facilities under the control of their central administrative agency or entity into the category two budget calculation. For example, if a group of parochial schools shares administration and finances, they should calculate a single, “district-wide” category two budget for all students under the central administrative entity or agency.

15. To address issues that may arise regarding changes to school districts and library systems during a five-year budget cycle, as well as issues that may arise in accommodating states' varied definitions of school or library districts, the Commission directs the Bureau to provide clarifying guidance consistent with the terms of the Order, and publish clarifications or additional guidance with respect to the implementation and administration of district-wide and library system-wide category two budgets to the extent necessary.

16. Full-Time Enrollment. In another effort to streamline both the application filing and review process, going forward the Commission will base student counts on full-time enrollment only and eliminate the need for schools or school districts to count part-time students in their enrollment numbers. Commenters support this change as a simplification that stems from district-wide budgets. More specifically, because the district-wide budgets will allow school districts greater flexibility in allocating category two support, it is no longer necessary for schools with lower full-time enrollment, but high part-time enrollment to take the often difficult and time-consuming steps to count and verify their part-time enrollment numbers in order to obtain category two funding. Using district-wide budgets, the Commission believes that all schools in a district will have adequate support to ensure appropriate deployment of local area networks.

17. The Commission also will no longer permit school districts to estimate the number of students for buildings under construction because those students will otherwise be accounted for by the district enrollment numbers. However, an independent school with its own entity-level budget will still be allowed to estimate its enrollment numbers in order to be able to request category two support while construction is underway. As presently required by the Commission's rules, if an applicant overestimates the number of students who enroll in that school, it must return to USAC any funding in excess of that which it was entitled based on the actual enrollment by the end of the next funding year.

18. To ensure that all E-Rate applicants, including small schools and libraries in rural areas, have the funding they need to deploy their internal connections networks within the existing E-Rate program budget for category two services, the Commission takes several steps to make access to category two funding more equitable and, in turn, result in a more consistent distribution of support for small, rural schools and libraries. First, the Commission raises the category two budget funding floor from $9,200 to $25,000. Second, the Commission eliminates the funding disparity between urban and rural libraries inherent in the current bifurcated approach that disadvantages rural libraries and adopt a unified budget multiplier for all libraries.

19. Funding Floor. To ensure that small schools and libraries have sufficient funding to deploy their internal connections, the Commission increases the funding floor to a pre-discount level of $25,000 over the five-year funding cycle beginning in funding year 2021. In the 2019 Category Two Notice, the Commission sought comment on whether the funding floor should be increased to $25,000. The Commission agrees with commenters that the existing funding floor level of $9,200, combined with the overall administrative burden of requesting category two support, resulted in a low participation rate by small and rural entities with low student enrollment or small square footage. For instance, from funding year 2015 through funding year 2019, school sites nationwide, on average, used 60% of their category two funding support, but small sites that only qualify for the funding floor, on average, used only 33% of their category two funding support, in large part because so little funding was available to them or because the benefits of the funding at the floor were often lower than the costs associated with the application process.

20. To illustrate why few entities at the funding floor (which include many rural schools and libraries) took advantage of category two funding during the five-year test period, the Commission considers a small school at an 85% discount rate with 61 students. During that period, which set the budget floor at $9,200, such a school would have been eligible to receive category two support of just $7,820 despite having many of the same technical needs for its Wi-Fi networks as larger schools. In fact, one commenter estimates that it would cost $24,350 to deploy switches, wireless access points, wireless access point controllers, routers, and cabling to a small school with 61 students. The Commission agrees with those commenters that argue that a budget floor of $25,000 is sufficient to ensure that those small sites that previously did not participate can deploy internal connections networks. With a $25,000 funding floor, that same small school at an 85% discount rate will receive $21,250 in E-Rate support. The Commission expects that this additional funding, in addition to the increased flexibility of district-wide and library system-wide budgeting generally, will make it attractive and beneficial for small schools and libraries to take advantage of category two funding support. And the Commission finds that this increase in the funding floor can be done within the existing E-Rate program budget for category two services in combination with its other reforms to the category two budget approach.

21. School Multiplier. Consistent with the findings in the Category Two Budget Report, the Commission continues to believe that the existing category two budget mechanism is generally sufficient for schools, and thus the Commission adopts its proposal to maintain the $150 per student school budget multiplier adjusted for inflation from the five-year test period, and—for administrative simplicity—adjust that amount ($166.44) up to $167 per student for the new five-year funding cycle beginning in funding year 2021. The Commission finds that maintaining the same per-student level of support as was available in the previous category two budget cycle is sufficient to meet schools' internal connections needs. This level of support enabled 85% of school sites to receive category two funding support during the funding year 2015 through funding year 2019 budget cycle. Many schools required less funding than the $167 per student budget multiplier the Commission adopts in this document—in fact, 50% of schools used less than $131 per student over those five years.

22. Some commenters argue that a higher budget multiplier is needed for schools to build their Wi-Fi networks. The Commission disagrees. The Commission finds that increasing per-student budgets beyond the rate of inflation is not necessary at this juncture, particularly given the other changes the Commission makes to the category two budget approach in the Order. In fact, the Commission believes that the changes made in this document will lead to additional category two funding support being available for those schools that need it.

23. The streamlined district-wide budget approach the Commission adopts in this document empowers school districts to allocate category two funding support to the sites that need it most. Entity-specific budgets have constrained category two funding support to be directed to specific sites based on enrollment numbers or square footage without the ability to make adjustments for level of need. If there was a school in a district that required less than the per-site budget allocation to deploy a Wi-Fi network and another school in the district that required more than the per-site allocation, the district could not re-direct the unused funding to complete the more expensive network, which meant that part of the category two budget support for the district went unspent and an identified need went unmet. Implementing district-wide budgets lifts this restriction and allows applicants to allocate category two funding to the sites that most need it, which, in turn, permits them to take advantage of a greater portion of their category two budgets. For example, Funds For Learning estimates that adopting school district and library system-wide budgets will make an additional $94.1 million per year in category two funding available to applicants. Further, by increasing the funding floor, the Commission is providing additional category two funds to some of the smallest schools in the country. As a result, under the Commission's new approach, these small schools do not need an increase in the per-student allocation to receive an increase in the category two funding available to them.

24. Library Multiplier. To eliminate the funding disparity between rural and urban libraries inherent in the existing bifurcated approach to calculating budgets for libraries and to ease administration, the Commission establishes a single pre-discount budget multiplier for all libraries of $4.50 per square foot over the five-year funding cycle beginning in funding year 2021. Currently, the library multipliers differ based on geography. Specifically, libraries located in cities and urbanized areas with a population of 250,000 or more, as identified by the Institute of Museum and Library Services (IMLS) locale codes of 11, 12, and 21, receive $5.00 per square foot, adjusted annually for inflation, and libraries in all other locations receive $2.30 per square foot, adjusted annually for inflation.

25. As demonstrated by the record, the cost to deploy a Wi-Fi network does not vary significantly based on geography. As internal connections are provided within school and library buildings, which are similar regardless of location, the Commission is now persuaded by experience from the test period that the costs to install the equipment and the type of equipment needed to provide connections within these buildings should also be comparable regardless of location. Indeed, some commenters contend that internal connections deployment costs are higher in rural areas than urban areas, and even those commenters that favor a higher budget multiplier for libraries in highly-concentrated urban areas recognize that an increase in the budget multiplier for rural libraries is needed. Accordingly, the Commission finds that experience has not borne out the prediction that costs would be higher and the need for support would be greater in highly concentrated urban areas than for libraries in the rest of the country.

26. Moreover, the Commission's experience during the five-year test period shows that a lower budget multiplier for rural applicants creates a considerable disparity in access to the amount of category two funding support available for rural libraries. As the Bureau's Category Two Budget Report found, rural libraries seek category two funding support at a much lower rate than urban libraries. Commenters attributed rural libraries' lack of participation to insufficient budgets and recommended an increase to the multiplier for rural libraries. Raising the budget multiplier for libraries outside of highly-concentrated urban areas, therefore, is a necessary step towards ensuring that they have sufficient funding to deploy their internal connections.

27. Finally, setting a single budget multiplier for all libraries simplifies the library budget calculations for applicants and will reduce the application review burden for USAC. Without the need to determine the IMLS locale code for each E-Rate supported library and the overall budget multiplier for a library system, applicants and USAC should be able to increase the efficiency and pace of the filing and processing of applications.

28. To provide a single budget multiplier for all libraries within the existing budget, the Commission adopts a pre-discount multiplier of $4.50 per square foot for all libraries. The Commission calculated this number, first, by estimating the potential total of all pre-discount library budgets from funding year 2015 to funding year 2019 using all public libraries. The Commission then divided this potential total of all pre-discount library budgets by the total square footage of all public libraries. The Commission provided a slight upward adjustment to $4.50 per square foot to reflect the anticipated participation rates of libraries requesting category two funding under the E-Rate program. This new budget multiplier, coupled with the increased funding floor, will make additional category two support available for those small and rural libraries that did not participate during the five-year test period.

29. The Commission's experience indicates that a pre-discount multiplier of $4.50 per square foot will minimally impact libraries in highly concentrated urban areas while providing sufficient additional funding to enable other libraries to deploy internal connections networks. Given that 91% of libraries in highly concentrated urban areas used less than $3.99 per square foot from funding years 2015 through 2019, the Commission expects that this reduction will affect only a small proportion of libraries in those areas. Indeed, those applicants will still be under budget, even with a budget of $4.50 per square foot. Moreover, as with schools, introducing library system-wide budgets will give library systems enhanced flexibility to allocate funding throughout their sites as they see fit, and raising the funding floor will provide greater funding for small libraries, even if their per square foot allocations are reduced slightly.

30. Calculating District-Wide and Library System-Wide Budgets. Based on the changes to the budget multipliers and funding floor the Commission makes in this document, the Commission details how applicants will calculate their budgets under the district-wide and library system-wide budget methodology. Specifically, to ease administration and to recognize that school and library systems are in fact systems with generally unified budgets that have the ability to direct support to whatever school or library in the system needs it most, the Commission requires school districts and library systems to calculate total budgets using their aggregate student count or square footage and the “aggregate funding floor” (i.e., the aggregate number of schools or libraries times the funding floor).2 Therefore, a school district or library system need only determine the aggregate number of students or square footage throughout the system as well as the total number of eligible schools and libraries in the system, without detailing the precise number of students or square footage attributable to any individual school or library. The Commission expects most school districts and library systems to receive funding significantly above the aggregate funding floor and to appropriately allocate funds to those that need it most. In addition, the Commission recognizes that smaller school districts and library systems have less access to shared resources and are more likely to be located in rural areas where funding is scarce. As such, the Commission creates an exception for small school districts and library systems. Specifically, the Commission gives school districts and library systems with 10 or fewer sites the option to calculate their budgets on a per-site basis by adding together the budgets of each eligible site within the district or library system.

31. To illustrate how the calculation would work, the Commission considers a school district with five schools, three of which have 200 students each and two of which have 100 students each. Using the $167 budget multiplier for schools and the $25,000 funding floor for funding year 2021, the school district would have a total pre-discount budget of $150,200, to spend across the five schools over the five-year period.3 Giving small systems this option will ensure that small, rural school districts and library systems can take full advantage of the increased funding floor, with only minimal increases to administrative complexity for applicants and for USAC.4

32. Inflation Adjustment. For both budget multipliers and the funding floor, the Commission amends its rules to make a one-time adjustment for inflation before the start of the filing window for each five-year funding cycle. Commenters generally agree that a one-time inflation adjustment over a five-year cycle will reduce confusion surrounding the category two budget calculations, although commenters suggested different approaches for calculating inflation. The Commission rejects suggestions that use either predictions or other inflation indicators as too complex. Instead, the Commission finds that the simplest, most effective, and most accurate approach is to adjust for inflation before the start of the filing window for each five-year funding cycle, providing notice to applicants about the upcoming budget multipliers and funding floor. Adjusting for inflation in this way will simplify the budget calculation, and will ensure that subsequent five-year funding cycles accurately reflect historical inflation rates. To ensure that applicants know their budgets well in advance of funding year 2021, the Commission announces the budget multipliers and the funding floor in the Order. The Commission's calculations of the budget multipliers and funding floor account for future inflation through funding year 2021 using estimated inflation adjustments. Accordingly, these figures will not be further adjusted for inflation between now and the funding year 2021 filing window, or again during this initial five-year funding cycle.5

33. For future funding years, before the start of every five-year funding cycle, the Commission directs the Bureau to calculate and announce the inflation adjustments. Specifically, the Bureau will announce the budget multipliers and funding floor as adjusted for inflation at least 60 days before the start of the filing window for the next five-year funding cycle. For funding year 2026 and beyond, the Commission shall use the last four quarters of available data on the Gross Domestic Product Chain-type Price Index (GDP-CPI) compared with the equivalent quarters from the beginning of the five-year funding cycle. The increase shall be rounded to the nearest 0.1% and shall be used to calculate the category two budget multipliers and funding floor for that five-year funding cycle. The budget multipliers and funding floor will also be rounded to the nearest cent to eliminate confusion surrounding the calculation, as supported by commenters.

34. Student Counts and Square Footage. To further reduce administrative burdens, and consistent with the record, the Commission will require applicants to provide student counts and library square footage for schools and libraries only once (calculated at the time that the discount is calculated that funding year) during a five-year funding cycle beginning with the first such cycle that starts in funding year 2021. Specifically, under the fixed, five-year budgets the Commission adopts in this document, the Commission will require applicants to validate their student counts or library square footage for each school and library in the district or library system in the first year an applicant applies for category two support during the relevant five-year cycle. Applicants, if they choose to do so, can update their student counts or square footage information in subsequent funding years to reflect, for example, an increased budget due to increased student enrollment. Applicants, however, are not required to do so, and can instead keep the student count and square footage information for the entire five years of the budget cycle. The Commission notes, contrary to what was suggested in the record, that the requirement that the category two budget enrollment numbers only be validated once every five years has no impact on the requirement that schools update their enrollment and National School Lunch Program or Community Eligibility Provision numbers for purposes of calculating discount rates each year.

35. In the 2019 Category Two Notice, the Commission proposed to permanently extend the eligibility of managed internal broadband services, caching, and basic maintenance of internal connections under a category two budget approach consistent with the Commission's determination in 2014 to make these services eligible for support through funding year 2019. Commenters expressed broad support for retaining the eligibility of these three services. Consistent with the Commission's determinations in the 2014 First E-Rate Order, 79 FR 49160, August 19, 2014, it finds that category two budgets allay concerns about wasteful spending on these three services, and the Commission therefore sees continued benefit for the functionality of networks within schools and libraries in making these services eligible for category two support. Accordingly, the Commission adopts the proposal to make these services eligible for category two support under the permanent category two budget approach.

36. The 2019 Category Two Notice sought comment on whether additional services should be made eligible for category two funding. In response, commenters urged the Commission to make eligible several additional services. For example, several commenters requested that the Commission makes eligible under category two the filtering technology necessary for compliance with the Children's Internet Protection Act. But the Commission has previously explained that the Children's Internet Protection Act prohibits recipients from obtaining discounts under the universal service support mechanism for the purchase or acquisition of technology protection measures necessary for compliance with the Children's Internet Protection Act. Others requested that the Commission makes eligible services that it has either previously made ineligible or that the Commission has previously declined to make eligible. The Commission declines to make additional services eligible under category two so that E-Rate eligible entities continue to focus requests for category two funding on the internal connections that are truly necessary to deliver high-speed broadband to students and library patrons via local area networks and wireless local area networks, consistent with the Commission's reasoning in the 2014 First E-Rate Order. And the Commission finds that the requests of still other commenters to make additional services eligible for category one support are beyond the scope of this proceeding.

37. At the request of several commenters, the Commission directs the Bureau to address ongoing issues related to the application of its eligible services rules with respect to category two services by providing clarifications in instances where the terminology used in the Commission's rules does not align with the terminology used by service providers in the context of bid responses and invoicing or has otherwise caused applicant uncertainty or confusion about how to request category two services.

38. Equipment Transfer Rule. Consistent with the Commission's efforts to streamline the process for requesting support for category two services, it now eases the Commission's equipment transfer rule to lessen the paperwork burden on school districts and library systems. As the Commission stated in the 2019 Category Two Notice, and supported by the record, the original concerns that led to the adoption of a prohibition on equipment transfers for a period of three years after purchase—namely, that applicants might replace or upgrade their equipment more often than necessary or to circumvent the then-existent two-in-five rules—are no longer relevant under a district-wide and library system-wide category two budget approach. Under the district-wide and library system-wide category two budget approach, the category two purchases for all individual schools within the district fall under the same budget, so there will no longer be the incentive to purchase a piece of equipment for one site and move it to another. This incentive existed under the two-in-five rules because there were limits on the internal connections funding that each individual school could receive. Under those rules, if an individual school did not request equipment when it had the opportunity to do so, another school in the same district could circumvent the two-in-five rule by requesting that equipment and moving it to the facility where it was needed. As the two-in-five rules no longer apply, the provisions of the equipment transfer rules that prevent its circumvention are no longer needed.

39. The Commission therefore modifies section 54.513(d) of the Commission's rules, effective for funding year 2021, to allow districts and library systems to transfer equipment between schools within a district and libraries within a system. Importantly, transferors no longer must notify USAC of the transfer, but both the transferor and recipient must maintain detailed records documenting the transfer and the reason for the transfer for a period of five years as required by the Commission's rules. Additionally, as a reminder to all applicants, under section 54.516(a) of the Commission's rules, schools, libraries, and consortia are required to maintain asset and inventory records of equipment purchased and the actual locations of such equipment for a period of 10 years after purchase.

40. Non-Instructional Facilities. In the 2019 Category Two Notice, the Commission noted that the cost allocation of the shared costs of a piece of equipment located in a non-instructional facility could be more easily handled in a district-wide category two budget because the district-wide approach relieves the burden of allocating costs among the budgets of eligible entities. Under the per-entity budget rules, district-wide applicants requesting funding for equipment that would be shared district-wide but housed in a non-instructional facility determined each school's use of the shared equipment as well as the non-instructional building's use of the shared equipment, deducted the cost of the non-instructional building's use of the shared equipment, and submitted funding requests from each school for each portion of eligible funding. USAC then reviewed each funding request to ensure that funding is only provided for equipment used by eligible entities. Under the district-wide budget approach adopted in this document, applicants will only need to deduct the cost of the non-instructional facility's use of the shared network equipment.

41. In response to the 2019 Category Two Notice, commenters agreed that cost allocation of the use of shared equipment is burdensome, and requested that the Commission allow all buildings associated within a district or library system, including non-instructional facilities, to qualify for category two funding support because the category two budget places a ceiling on the amount that can be spent on category two services. The Commission declines to modify its rules regarding whether non-instructional facilities or the administrative buildings of libraries qualify for category two funding support. The district-wide budgets the Commission adopts in this document will reduce the administrative burden on applicants that use non-instructional facilities or other administrative buildings to house network equipment shared district-wide and will make it easier for USAC to review such requests by eliminating the need to allocate among eligible entities in a district. However, the Commission is not persuaded that the administrative burden associated with deducting the cost of the non-instructional building's use of shared network equipment warrants eliminating a rule designed to ensure that E-Rate support is only provided to eligible entities for eligible purposes. The relatively simple task of subtracting the cost of the non-instructional facility's use of the shared network element is unlikely to significantly burden either applicants or USAC. Accordingly, the Commission will continue to require applicants to deduct the cost of non-instructional facilities' use of shared equipment from their requests for E-Rate support, as required by the current rules.

42. In this document, the Commission extends the five-year test period for the category two budget approach through funding year 2020 and provide a prorated portion of category two funding for each applicant for that additional year. This approach ensures a smooth transition to the permanent rules effective in 2021 while providing applicants with sufficient funding to deploy internal connections in funding year 2020.

43. In the 2019 Category Two Notice, the Commission sought comment on using funding year 2020 as a bridge year between the five-year test period and the permanent extension of the category two budget approach. The Commission has weighed the costs and benefits of attempting to allow applicants to begin requesting E-Rate program support for category two services under these permanent rules—including the district-wide approach it adopts in this document—in funding year 2020 and finds that the costs of doing so far outweigh the benefits. In particular, implementing new rules for funding year 2020 would likely cause delays in funding commitments, and USAC would likely need to conduct manual application reviews to accommodate any rule changes. The Commission therefore adopts rules extending the five-year test period by one additional year and provide prorated E-Rate support for funding year 2020 while the Bureau and USAC take the necessary steps to ensure effective implementation of the permanent rules beginning funding year 2021. By extending the test period into funding year 2020, and making additional category two support available during that funding year, the Commission provides needed certainty and predictability to E-Rate participants while allowing the Commission and USAC adequate time to implement and ensure a smooth transition to the permanent rules the Commission adopts in this document.

44. First, to implement the permanent rules, the Commission recognizes that they and USAC will need time to update (1) E-Rate program forms in compliance with the Paperwork Reduction Act; (2) USAC's IT systems, including the E-Rate Productivity Center (EPC), to track the district-wide and library system-wide budgets and ensure funding requests that are over budget are reduced; and (3) administrative processes, such as Program Integrity Assurance procedures, to ensure consistent review for all five years of the funding cycle. Implementing the Commission's new rules as quickly as possible will, at best, take them into next year before completion. While SECA and SHLB suggest that USAC perform manual workarounds, including performing manual calculations of district-wide and library-wide budgets, the Commission disagrees. Doing so would require USAC to make such calculations for approximately 50,000 schools. Moreover, manual review of applications in the first year of a five-year funding cycle introduces risks of improper payments and the potential inability for USAC to properly track the category two budgets until the end of the funding cycle. Because these are fixed five-year budgets, any error that occurs in the first funding year has the potential to impact multiple funding years. Such an outcome would introduce further complexity and thus directly contradict the Commission's overall goal to simplify and streamline the category two budget approach.

45. Moreover, implementation of new rules has a strong potential to significantly delay the application filing window for funding year 2020. Despite the statements from some commenters that this months-long delay would be preferable to the community, the Commission finds that the potential harms, including delaying commitments for category one funding requests—which, this funding year, represented nearly $2 billion's worth of high-speed broadband service and equipment—are unacceptable. A delay in funding commitments would create delays in the deployment of E-Rate supported services, to the detriment of schools and libraries.

46. The Commission also is unpersuaded by arguments that extending the five-year test period will cause more confusion than rushing the implementation of the permanent rules with insufficient outreach to stakeholders. Instead, to give certainty to applicants in advance of the expected opening of the filing window for funding year 2020 and to smooth the transition to new, permanent rules, the Commission finds that the public interest would be served by an extension of the test period through funding year 2020. Since funding year 2015, over 90,000 schools and 4,900 libraries have used category two support to deploy Wi-Fi networks for the benefit of students and library patrons. The Commission largely makes no changes to how applicants should apply for support for category two services in funding year 2020, allowing applicants to move forward using their existing knowledge of the category two budget approach and providing an amount of funding equivalent to a single funding year's budget to aid applicants whose budgets would have ended in funding year 2019. The Commission also sets its clear guidance on the budget calculations for funding year 2021, allowing applicants to begin much-needed technology planning.

47. The Commission finds that the benefits of clear rules for funding year 2021 strongly outweigh the costs and risks associated with new rules implemented without adequate outreach to applicants and subsequent delays in funding commitments. By using funding year 2020 as a bridge to a permanent set of rules for category two services, the Commission will be able to ensure that the permanent rule changes are carefully and thoroughly implemented and administered, and that applicants are given a smooth transition period and notice for planning technology changes or upgrades. As a result of the Commission's extension of the test period, all applicants will continue to be able to request category two support under the existing category two budget approach in funding year 2020, and the Commission will not revert back to the two-in-five rules for any applicants.

48. The Commission provides a prorated portion of category two funding to all applicants in funding year 2020, which it will treat as a sixth year of the test period. In the 2014 First E-Rate Order, the Commission established a pre-discount category two budget for schools of $150 per student over five funding years, or 20% of the total funding per student annually. Accordingly, in extending the five-year test period by an additional year, the Commission provides an additional 20% in funding to schools and libraries, as well as to the funding floor. The Commission directs the Bureau to release updates to the category two budget multipliers and funding floor for the test period, adjusted for inflation and proration and rounded to the nearest cent, consistent with the Order, within 15 days of publication of the Order in the Federal Register. As in previous years of the test period, the available category two funding that will be available to applicants in funding year 2020 will be the updated budget multipliers and funding floor that the Bureau calculates minus the category two funding that applicants spent earlier in the test period.6

49. This action will ensure that all applicants, including those who have exhausted their category two budgets or completed their five-year budget cycles, can request category two support in funding year 2020. While ALA argued against making additional funds available during a bridge year, the Commission finds providing support for this one funding year more equitable and appropriate than denying funding to applicants that in good faith managed their five-year budgets over a five-year period (and did not anticipate a sixth year).

50. Moreover, this approach is consistent with the Commission's intent in the 2014 First E-Rate Order to provide approximately $1 billion per year in category two support to ensure applicants had access to funding for internal connections on a predictable, consistent, and equitable basis. Demand for category two services has tracked closely to this initial target. By providing a prorated portion of funding for funding year 2020, the Commission can make available approximately $1 billion for category two services, providing applicants with funding that may be needed to maintain their local area networks while the Commission transitions to permanent category two rules. The Commission also finds that providing a prorated portion of category two funding to all applicants treats all entities equitably because every entity will be eligible for the same amount of category two support during the six-year test period. Finally, this approach provides both applicants and USAC with a single calculation for all entities, which simplifies the administration in funding year 2020 for requesting and reviewing category two funding requests and reduces the chances of overpayments.

51. The Commission finds that good cause exists here to make those portions of the Order that codify the permanent eligibility of managed internal broadband services, caching, and basic maintenance of internal connections for support in funding year 2020 and beyond and the proration of budget multipliers and the funding floor for funding year 2020 effective upon publication in the Federal Register. A rule may be made effective prior to thirty days from publication in the Federal Register for good cause found and published with the rule. Here, to ensure that applicants have sufficient notice of the services that will be eligible and the prorated funding that will be available to them before they file their funding year 2020 applications, it is necessary to implement those portions of the Order as soon as possible following release of the Order. The filing window for E-Rate funding applications typically opens in mid-January each year to ensure adequate time for USAC to process such applications and issue funding commitments or denials. Therefore, in light of the need to enable the release of the Eligible Services List and notification of budget multipliers and the funding floor with sufficient time to make applicants aware of what services are eligible and the amount of support available before the opening of the filing window, the Commission finds that good cause exists to make the portions of the Order addressing eligible services and proration of budget multipliers and the funding floor for funding year 2020 effective upon publication in the Federal Register. Moreover, making the eligibility of managed internal broadband service, caching, and basic maintenance of internal connections and the budget multipliers and a funding floor for funding year 2020 effective immediately will not impose any implementation burden on applicants given that these services were eligible and budget multipliers and a funding floor were used during the initial five-year test period.

52. In addition, to ensure that the application filing window for funding year 2020 is not unduly delayed by implementation of the Commission's decisions herein, it waives the requirement in section 54.502(d) of the Commission's rules that the Eligible Services List be released at least 60 days prior to the opening of the application filing window. Section 1.3 of the Commission's rules allows the Commission to waive a rule on its own motion for good cause shown. The Bureau may find it necessary to release the Eligible Services List less than 60 days before the opening of the application filing window to ensure that the filing window opens with enough time to allow USAC to process applications for funding year 2020. Applicants will benefit from this waiver because it will help to ensure that their applications are processed in a timely manner. The Commission finds that the adoption of the Order at this time and its impact on a number of eligible services constitute special circumstances that warrant waiver of the 60-day requirement, and that doing so is in the public interest.

53. This document contains new and modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other Federal agencies will be invited to comment on the new and modified information collection requirements contained in the proceeding. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, it previously sought specific comment on how the Commission might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

54. The Commission has determined, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs that this rule is “non-major” under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of the Order to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).

55. As required by the Regulatory Flexibility Act of 1980 (RFA), as amended, the Federal Communications Commission (Commission) included an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the 2019 Category Two Notice in WC Docket No. 13-184. The Commission sought written public comment on the proposals in the 2019 Category Two Notice, including comment on the IRFA. The Commission did not receive any relevant comments in response to the IRFA. The Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

56. The Commission is required by Section 254 of the Communications Act of 1934, as amended, to promulgate rules to implement the universal service provisions of Section 254. On May 8, 1997, the Commission adopted rules to reform its system of universal service support mechanisms so that universal service is preserved and advanced as markets move toward competition. Specifically, under the schools and libraries universal service support mechanism, also known as the E-Rate program, eligible schools, libraries, and consortia that include eligible schools and libraries may receive discounts for eligible telecommunications services, internet access, and internal connections.

57. Taking steps to close the digital divide is a top priority for the Commission. The E-Rate program provides a vital source of support to schools and libraries, ensuring that students and library patrons across the nation have access to high-speed broadband and essential communications services. In the Order, the Commission permanently extends the category two budget approach and adopts several proposals that will reduce the burden on small entities, such as a move to district-wide or library-system wide budgets and fixed budget cycles to allow careful planning from E-Rate applicants. The Commission also extends the five-year test period for the category two budget approach for a sixth year to include funding year 2020 to provide funding for applicants in funding year 2020 while the Commission and USAC implement permanent rules for funding year 2021. During this funding year, with limited exceptions, the existing category two budget rules will continue to be in effect. Permanent rules for the category two budget approach to go into effect in funding year 2021.

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

59. Small Businesses, Small Organizations, Small Governmental Jurisdictions. The Commission's actions, over time, may affect small entities that are not easily categorized at present. The Commission therefore describes here, at the outset, three broad groups of small entities that could be directly affected herein. First, while there are industry specific size standards for small businesses that are used in the regulatory flexibility analysis, according to data from the SBA's Office of Advocacy, in general a small business is an independent business having fewer than 500 employees. These types of small businesses represent 99.9% of all businesses in the United States which translates to 28.8 million businesses.

60. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of August 2016, there were approximately 356,494 small organizations based on registration and tax data filed by nonprofits with the Internal Revenue Service (IRS).

61. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2012 Census of Governments indicate that there were 90,056 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 37,132 General purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,184 Special purpose governments (independent school districts and special districts) with populations of less than 50,000. The 2012 U.S. Census Bureau data for most types of governments in the local government category show that the majority of these governments have populations of less than 50,000. Based on this data the Commission estimates that at least 49,316 local government jurisdictions fall in the category of “small governmental jurisdictions.”

62. The small entities that may be affected are Schools and Libraries, Telecommunications Service Providers, internet Service Providers (ISPs), and Vendors of Internal Connections.

63. The Commission expects that the rules adopted in the Order will result in modified reporting, recordkeeping, or other compliance requirements for small or large entities. The Order takes two major actions. First, it permanently extends the existing category two budget approach for all entities, while adopting a number of steps to simplify how applications for category two services are filed, reviewed, and ultimately invoiced beginning in funding year 2021. These changes will result in modifications to information collections that decrease the compliance costs for small entities. And, second, it adopts rules extending the current five-year funding cycle for one additional year into for funding year 2020 to ensure that support for category two services is available and funding for other services are not delayed. For the funding year 2020 rules, both small and large entities will apply for category two funding in the same manner as in previous years with no changes to reporting, recordkeeping, or other compliance requirements. The Commission does not believe that small entities will have to hire attorneys, engineers, consultants, or other professionals to comply.

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

65. In the Order, the Commission has taken steps to minimize the economic impact on small entities with the rule changes that it has adopted by permanently extending the category two budget approach and working to simplify the administration of the budgets. In the following, the Commission outlines many of the adopted simplifications that will aid small entities in compliance.

66. District-Wide or Library System-Wide Budgets. The Commission adopts a rule providing that school districts and library systems shall calculate their budgets for the entire district or system, allowing applicants to use funds efficiently at the schools and libraries that need the funding. This dramatically reduces the requirements for the application review process, including, but not limited to, eliminating reporting of part-time students, eliminating complicated cost allocations for equipment that is shared by members of a district or system, and overall simplification of the application process from start to finish.

67. Modification of the Equipment Transfer Rule. In addition to the district- and system-wide budgets, the Commission amends its rule allowing districts and systems to transfer equipment among their own schools and libraries and eliminating the need to report such transfers to USAC. This removes a reporting requirement for all applicants, but keeps rules in place that requires schools and libraries to maintain asset inventories of all E-Rate supported equipment.

68. Modification of the Library Budget Multiplier. The Commission amends its rules to have a single library budget multiplier. Currently, there are two multipliers, depending on the urban status of the library. A single multiplier allows for a simpler calculation of the library budgets, streamlining the application and its review.

69. Increase of the Funding Floor. The Commission adopts an increase in the funding floor, which is aimed at encouraging participation by small entities. Many commenters argued that the burden of program compliance outweighed the benefit of receiving the current funding floor, which was also inadequate to meet their needs. Increasing the funding floor and simplifying the category two budget approach will allow more small entities to participate.

70. Simplification of the Budget Calculation. The Commission adopts fixed, five-year budgets that refresh every five years, eliminating the need for applicants and USAC to calculate the budgets annually with a series of different variables including inflation, changing student counts, and funding years at issue. This dramatically decreases the burden on applicants to calculate the budget and apply for E-Rate support.

71. The Order also extends the five-year test period for the category two budget approach into a sixth year and sets out the budget calculation in the Order to simplify how to calculate the amount of funding available to applicants in advance of the funding year 2020 filing window. While stakeholders advocated for a faster transition to the new rules as an alternative to rules for one funding year, the Commission finds that this approach causes the least disruption to the overall program and provides it and USAC with sufficient time and resources to successfully implement the many permanent changes the Commission adopts for funding year 2021. The Commission takes steps to minimize the burden of the funding year 2020 rules by simplifying the budget calculation slightly and otherwise maintaining current category two budget rules. As a result, there is no additional burden or cost to small entities because the program rules that are familiar to them are unchanged. Further, absent the rule changes in the Order, the category two budget rules would begin to sunset in funding year 2020, meaning that small entities would have to navigate two sets of rules. The rule changes in the Order prevent this sunsetting from taking place, thus preventing a potential source of burden and cost to small entities.

72. Accordingly, it is ordered that, pursuant to the authority contained in sections 1 through 4, 201 through 202, 254, 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151-154, 201-202, 254, 303(r), and 403, the Order is adopted, and § 54.502(c) of the Commission's rules, 47 CFR 54.502(c), is amended as set forth in the following, and such rule amendments shall be effective thirty (30) days after the publication of the Order in the Federal Register, except amendments to the budget multipliers and funding floor, which shall be effective immediately and except to the extent expressly addressed in the following.

73. It is further ordered, that pursuant to the authority contained in sections 1 through 4, 201 through 202, 254, 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151-154, 201-202, 254, 303(r), and 403, §§ 54.502(d)-(e) and 54.513(d) of the Commission's rules, 47 CFR 54.502(d)-(e) and 54.513(d), are amended as set forth in the following, effective upon announcement of approval by OMB under the Paperwork Reduction Act. The Commission directs the Bureau to announce the effective date for these information collections in a document published in the Federal Register announcing OMB approval.

74. It is further ordered that, pursuant to the authority contained in sections 1 through 4, 201 through 202, 254, 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151-154, 201-202, 254, 303(r), and 403, sections of the Order addressing eligible services and proration of budgets for funding year 2020 in paragraphs 35, 36, and 48 shall become effective immediately upon publication of the Order in the Federal Register, pursuant to 5 U.S.C. 553(d)(3); and 47 CFR 1.427(b).

75. It is further ordered, that pursuant to the authority contained in sections 1 through 4 and 254 of the Communications Act of 1934, as amended, 47 U.S.C. 151-154 and 254, and pursuant to the authority in § 1.3 of the Commission's rules, 47 CFR 1.3, that § 54.502(d), 47 CFR 54.502(d) is waived, and such waiver shall become effective upon release.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 54 as follows:

This document announces that OMB approved the information collection requirements in §§ 73.671(c)(5) and (7) and (e)(1) and (2), 73.673, and 73.3526(e)(11)(ii) and (iii) on December 3, 2019 and December 5, 2019. These rules were modified in the Report and Order in MB Docket Nos. 18-202 and 17-105, FCC 19-67, In the Matter of Children's Television Programming Rules; Modernization of Media Regulation Initiative, published 84 FR 41917, August 16, 2019. The Commission publishes this document as an announcement of the compliance date of the rules. The other rule amendments adopted in the Report and Order, which did not require OMB approval, became effective on September 16, 2019.

If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW, Washington, DC 20554, regarding OMB Control Numbers 3060-0214, 3060-0316, 3060-0750, and 3060-1065. Please include the applicable OMB Control Number(s) in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov.

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

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on December 3, 2019 and December 5, 2019, for the information collection requirements contained in §§ 73.671(c)(5) and (7) and (e)(1) and (2), 73.673, and 73.3526(e)(11)(ii) and (iii). Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Numbers for the information collection requirements in these rules are 3060-0214, 3060-0316, 3060-0750, and 3060-1065.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-0214.

OMB Approval Date: December 3, 2019.

OMB Expiration Date: December 31, 2022.

Title: Sections 73.3526 and 73.3527, Local Public Inspection Files; Sections 73.1212, 76.1701 and 73.1943, Political Files.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities; Not for profit institutions; State, Local or Tribal government; Individuals or households.

Number of Respondents: 23,984 respondents; 62,839 responses.

Estimated Time per Response: 1-52 hours.

Frequency of Response: On occasion reporting requirement, Recordkeeping requirement, Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections is contained in Sections 151, 152, 154(i), 303, 307 and 308 of the Communications Act of 1934, as amended.

Total Annual Burden: 2,043,805 hours.

Total Annual Cost: None.

Privacy Impact Assessment: The Commission prepared a system of records notice (SORN), FCC/MB-2, “Broadcast Station Public Inspection Files,” that covers the PII contained in the broadcast station public inspection files located on the Commission's website. The Commission will revise appropriate privacy requirements as necessary to include any entities and information added to the online public file in this proceeding.

Nature and Extent of Confidentiality: Most of the documents comprising the public file consist of materials that are not of a confidential nature. Respondents complying with the information collection requirements may request that the information they submit be withheld from disclosure. If confidentiality is requested, such requests will be processed in accordance with the Commission's rules, 47 CFR 0.459.

In addition, the Commission has adopted provisions that permit respondents subject to the information collection requirement for Shared Service Agreements to redact confidential or proprietary information from their disclosures

Needs and Uses: On July 10, 2019, the Commission adopted a Report and Order in MB Docket Nos. 18-202 and 17-105, FCC 19-67, In the Matter of Children's Television Programming Rules; Modernization of Media Regulation Initiative, which modernizes the children's television programming rules in light of changes to the media landscape that have occurred since the rules were first adopted. The Report and Order revises the following information collection requirements:

Pursuant to 47 CFR 73.3526(e)(11)(ii), commercial TV and Class A TV broadcast stations must maintain records sufficient to permit substantiation of the station's certification, in its license renewal application, of compliance with the commercial limits on children's programming established in 47 U.S.C. Section 303a and 47 CFR 73.670. In the Report and Order, the Commission revises this rule to permit these stations to place such records in their public files annually rather than quarterly and to permit the filing of these records within 30 days after the end of the calendar year. The Commission also revises 47 CFR 73.3526(e)(11)(iii) to require commercial television stations to place in their public files the Children's Television Programming Report (Report) (FCC Form 2100 Schedule H) on an annual rather than quarterly basis, within 30 days after the end of the calendar year and to eliminate the requirement to publicize the existence and location of the Report.

All other information collection requirements contained under 47 CFR 73.1212, 73.3526, 73.3527, 73.1943, and 76.1701 are still a part of the information collection and remain unchanged since last approved by OMB.

OMB Control Number: 3060-0316.

OMB Approval Date: December 3, 2019.

OMB Expiration Date: December 31, 2022.

Title: 47 CFR 76.5, Definitions, 76.1700, Records to Be Maintained Locally by Cable System Operators; 76.1702, Equal Employment Opportunity; 76.1703, Commercial Records on Children's Programs; 76.1707, Leased Access; 76.1711, Emergency Alert System (EAS) Tests and Activation.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 3,000 respondents/3,000 responses.

Estimated Time per Response: 14 hours.

Frequency of Response: Recordkeeping requirements.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in sections 151, 152, 153, 154, 301, 302, 302a, 303, 303a, 307, 308, 309, 312, 315, 317, 325, 339, 340, 341, 503, 521, 522, 531, 532, 534, 535, 536, 537, 543, 544, 544a, 545, 548, 549, 552, 554, 556, 558, 560, 561, 571, 572, 573 of the Communications Act of 1934, as amended.

Total Annual Burden: 42,000 hours.

Total Annual Cost: None.

Privacy Impact Assessment: No impacts.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: On July 10, 2019, the Commission adopted a Report and Order in MB Docket Nos. 18-202 and 17-105, FCC 19-67, In the Matter of Children's Television Programming Rules; Modernization of Media Regulation Initiative, which modernizes the children's television programming rules in light of changes to the media landscape that have occurred since the rules were first adopted. The Report and Order revises the following information collection requirements:

Pursuant to 47 CFR 76.1703, cable operators that air children's programming must maintain records sufficient to verify compliance with 47 CFR 76.225 and make such records available to the public. Such records must be maintained for a period sufficient to cover the limitations period specified in 47 U.S.C. Section 503(b)(6)(B). In the Report and Order, the Commission revises the rules to permit cable television operators to file their certifications of compliance with the commercial limits in children's programming annually rather than quarterly and to permit the filing of these certifications within 30 days after the end of the calendar year.

All other information collection requirements contained under 47 CFR 76.5, 76.1700, 76.1702, 76.1703, 76.1707, and 76.1711 are still a part of the information collection and remain unchanged since last approved by OMB.

OMB Control Number: 3060-0750.

OMB Approval Date: December 5, 2019.

OMB Expiration Date: December 31, 2022.

Title: 47 CFR 73.671, Educational and Informational Programming for Children; 47 CFR 73.673, Public Information Initiatives Regarding Educational and informational Programming for Children.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 1,770 respondents/1,125,720 responses.

Estimated Time per Response: 0.017-0.084 hours.

Frequency of Response: Third-party disclosure requirements.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Sections 154(i), 303, and 336 of the Communications Act of 1934, as amended.

Total Annual Burden: 57,560 hours.

Total Annual Cost: None.

Privacy Impact Assessment: No impacts.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: On July 10, 2019, the Commission adopted a Report and Order in MB Docket Nos. 18-202 and 17-105, FCC 19-67, In the Matter of Children's Television Programming Rules; Modernization of Media Regulation Initiative, which modernizes the children's television programming rules in light of changes to the media landscape that have occurred since the rules were first adopted. The Report and Order revises the following information collection requirements:

Pursuant to 47 CFR 73.671(c)(5), each commercial television broadcast station must identify programming as specifically designed to educate and inform children by the display on the television screen throughout the program of the symbol E/I. This requirement is intended to assist parents in identifying educational and informational programming for their children. Noncommercial television broadcast stations are no longer be required to identify Core Programming by displaying the E/I symbol throughout the program.

Pursuant to 47 CFR 73.671(e), each television broadcast station that preempts an episode of a regularly scheduled weekly Core Program on its primary stream will be permitted to count the episode toward the Core Programming processing guidelines if it reschedules the episode on its primary stream in accordance with the requirements of 47 CFR 73.671(e). Similarly, each television broadcast station that preempts an episode of a regularly scheduled weekly Core Program on a multicast stream will be permitted to count the episode toward the Core Programming processing guidelines if it reschedules the episode on the multicast stream in accordance with the requirements of 47 CFR 73.671(e). Among other requirements, the station must make an on-air notification of the schedule change during the same time slot as the preempted episode. The on-air notification must include the alternate date and time when the program will air. This requirement will help to ensure that parents and children are able to locate the rescheduled program.

Pursuant to 47 CFR 73.673, each commercial television broadcast station licensee must provide information identifying programming specifically designed to educate and inform children to publishers of program guides. This requirement is intended to improve the information available to parents regarding programming specifically designed for children's educational and informational needs. Commercial television broadcast station licensees are no longer be required to provide program guide publishers an indication of the age group for which the programming is intended. The Report and Order finds that very few program guides include this information.

OMB Control Number: 3060-1065.

OMB Approval Date: December 3, 2019.

OMB Expiration Date: December 31, 2022.

Title: Section 25.701 of the Commission's Rules, Direct Broadcast Satellite Public Interest Obligations.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 2 respondents; 2 responses.

Estimated Time per Response: 1-10 hours.

Frequency of Response: Recordkeeping requirement; on occasion reporting requirement; one-time reporting requirement; annual reporting requirement; Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority which covers this information collection is contained in Section 335 of the Communications Act of 1934, as amended.

Total Annual Burden: 48 hours.

Total Annual Cost: None.

Privacy Impact Assessment: No impacts.

Nature and Extent of Confidentiality: Although the Commission does not believe that any confidential information will need to be disclosed in order to comply with the information collection requirements, applicants are free to request that materials or information submitted to the Commission be withheld from public inspection. (See 47 CFR 0.459).

Needs and Uses: On July 10, 2019, the Commission adopted a Report and Order in MB Docket Nos. 18-202 and 17-105, FCC 19-67, In the Matter of Children's Television Programming Rules; Modernization of Media Regulation Initiative, which modernizes the children's television programming rules in light of changes to the media landscape that have occurred since the rules were first adopted. The Report and Order revises the following information collection requirements:

Pursuant to 47 CFR 25.701(e)(3), DBS providers that air children's programming must maintain records sufficient to verify compliance with this rule and make such records available to the public. Such records must be maintained for a period sufficient to cover the limitations period specified in 47 U.S.C. Section 503(b)(6)(B). In the Report and Order, the Commission revises the rules to permit DBS operators to file their certifications of compliance with the commercial limits in children's programming annually rather than quarterly and to permit the filing of these certifications within 30 days after the end of the calendar year.

All other information collection requirements contained under 47 CFR 25.701 are still a part of the information collection and remain unchanged since last approved by OMB.

Background

On April 16, 2019, NMFS published a proposed rule in the Federal Register (84 FR 15556) to implement IMO requirements in IATTC Resolution C-18-06, amendments to existing regulations related to the Vessel Register, and prohibition and incidental catch provisions for purse seine vessels fishing in the EPO. The 30-day public comment period for the proposed rule closed on May 16, 2019. Two comments were received and are addressed below. NMFS is finalizing the rule as proposed, except for minor revisions in response to comments, as described below. The preamble to the proposed rule contains additional background information, including information on the IATTC, the international obligations of the United States as an IATTC member, and the need for regulations.

This final rule is implemented under authority of the TCA (16 U.S.C. 951 et seq.) and MMPA (16 U.S.C. 1361 et seq). The authority of the Secretary of Commerce to promulgate such regulations has been delegated to NMFS. This rule implements IMO requirements of IATTC Resolution C-18-06 and amends several regulations that govern listing of U.S. commercial fishing vessels on the IATTC Vessel Register for vessels that fish for tuna or tuna-like species in the IATTC Convention Area (Convention Area). The Convention Area is defined as waters of the EPO within the area bounded by the west coast of the Americas and by 50° N latitude, 150° W longitude, and 50° S latitude. NMFS notes that some of the requirements described below that include new or revised information collections (i.e., those contained in amendatory sections 2 and 6) will become effective upon further publication of an effective date in the Federal Register.

This final rule requires that the owner of a fishing vessel of the United States engaging in fishing activities for tuna or tuna-like species in the Convention Area, and for which a high seas fishing permit under 50 CFR 300.333 is required, shall ensure that an IMO number has been issued for the vessel if the vessel's total internal volume is less than 100 gross registered tons (GRT) or less than 100 gross tons (GT) but equal to or greater than 12 meters in overall length. Vessel measurements are based on the vessel's Certificate of Documentation issued under 46 CFR part 67, or State documentation. Currently, IMO numbers are issued on behalf of the IMO by IHS Markit, formerly known as IHS Maritime, at no cost to the vessel owner (https://imonumbers.lrfairplay.com/). The instructions for requesting an exemption at 50 CFR 300.22(b)(3)(iv) also apply to the vessels subject to this requirement.

This final rule makes a technical correction to the vessel capacity limit for the U.S. tuna purse seine fishery operating in the EPO, to ensure the limit is consistent with the amount authorized by the IATTC. This adds 91 cubic meters to the current U.S. fleet capacity limit of 31,775 cubic meters, bringing the limit to 31,866 cubic meters. The additional 91 cubic meters of capacity is a result of an IATTC revision to the historical U.S. fleet capacity.

This final rule updates the regulations to clarify that purse seine vessels listed as inactive or sunk on the Vessel Register count towards the United States' 31,866 cubic meter fleet-wide capacity limit.

Additionally, this final rule sets a time limit of 2 consecutive calendar years for vessels holding inactive or sunk status, after which a request by such a vessel to be listed on the Vessel Register would be subject to the prioritization hierarchy at 50 CFR 300.22(b)(4)(v) as added by this rule. Requests for listing on the Vessel Register for the following year received between August 1 and November 30 will be prioritized in the following order: Currently active, currently inactive, first-come first-served, and, lastly, those who made a frivolous request, as described below, or were listed as inactive or sunk for more than two consecutive calendar years. This revision is consistent with the intent of the inactive status provision (i.e., to allow for vessel replacement or repair while not paying a full active vessel assessment fee), while preventing an indefinite hold on capacity.

This final rule allows an owner or managing owner of a purse seine vessel that has sunk but is listed as active on the Vessel Register to request the vessel be listed as sunk and categorized as inactive on the Vessel Register within 30 days of its sinking. Previous regulations required sunken vessels to be immediately removed from the Vessel Register. Under this final rule, if a request is not made to list the vessel as sunk within 30 days of its sinking, the vessel may be removed from the Vessel Register by the NMFS West Coast Regional Administrator.

A request for a small purse seine vessel (i.e., vessel with a carrying capacity of 400 short tons (362.8 metric tons) or less) to be listed as active on the Vessel Register for the following year will be considered frivolous if both of the following conditions apply: (1) The vessel has been listed as active during current and previous calendar years; and (2) the vessel has not landed tuna caught in the Convention Area in the calendar year prior to the request through November 15th of the year in which the request is made. For example, a request for active status made in 2019 to fish in 2020 for a small purse seine vessel that has already been on the active list of the Vessel Register for two calendar years or more would require one landing of tuna between January 1, 2018, and November 15, 2019, or the request would be considered frivolous. If a small purse seine vessel meets the two conditions described above and requests active status on the Vessel Register, the request is considered frivolous and subject to the prioritization hierarchy of requests under 50 CFR 300.22(b)(4)(v). This will prioritize inclusion on the Vessel Register of vessels that are actively fishing and landing tuna. The frivolous request provision for small purse seine vessels allows considerations of force majeure or other extraordinary circumstances that may have prevented a vessel from making a landing during the two year time period. Extraordinary circumstances may include lack of tuna availability, or other unique situations as determined by the Regional Administrator. If the Regional Administrator determines that extraordinary circumstances prevented a vessel from making a landing, the frivolous request provision would not apply and the vessel may be listed on the Vessel Register.

This final rule revises the regulatory text at 50 CFR 300.24(f) and (g) and 300.27(b) to be more consistent with IATTC Resolution C-04-05. For example, in 50 CFR 300.24(f) and 300.27(b), this final rule amends the release requirements so that they no longer apply to tuna-like species. Exempting tuna-like species from the release requirement allows purse seine vessels to retain tuna-like species, such as Pacific bonito and black skipjack, while remaining consistent with the goal of the Resolution to conserve non-target species. The prohibition on landing non-tuna species is also removed from 50 CFR 300.24(g) to allow for the landing of tuna-like species. Purse seine vessels are still prohibited from landing non-tuna species, other than tuna-like species, because the prohibition on failing to release any non-tuna species other than tuna-like species remains in 50 CFR 300.24(f) and 50 CFR 300.27(b). The continued requirement to release fish other than tuna and tuna-like species, and those retained for consumption on board the vessel, is necessary to comply with the Resolution and to promote the conservation of such species.

This final rule amends the 5-day advance notice of vessel departure requirement under 50 CFR 216.24(b)(8)(iv)(A) for purposes of facilitating use of the EPO tuna fleet capacity. If a vessel would like to use an IATTC and Western and Central Pacific Fisheries Commission (WCPFC) cross-endorsed observer when fishing in the IATTC Convention Area, the notification must also include a request for the placement of a cross-endorsed observer pursuant to the Memorandum of Cooperation between the IATTC and WCPFC.

This final rule amends regulatory text at 50 CFR 300.22(b)(4)(i), 300.22(b)(4)(iii), 216.24(b)(6)(iii) and 216.24(b)(8) to clarify that vessel owners must coordinate with NMFS to pay the vessel assessment fee directly to the IATTC, and not to NMFS. As established by the IATTC and implemented in existing regulations, the vessel assessment fee supports maintenance of the observer program and the placement of observers on tuna purse seine vessels.

This final rule also amends notification requirements to facilitate requests for active and inactive status on the Vessel Register. A business email address is now required, to assist in communications between NMFS and vessel owners. NMFS does not specify which notification method to use in sending requests for active status, or requests under the aging fleet provision, to the NMFS West Coast Regional Administrator. Written notifications not related to payment of the vessel assessment fee or permit applications are directed to the Highly Migratory Species (HMS) Branch of the NMFS West Coast Region to facilitate communication. The HMS Branch definition in 50 CFR 300.21 is amended to include the branch email address, wcr.hms@noaa.gov.

Regulations at 50 CFR 216.24(b)(4) will now specify that applicants have the option of submitting eastern tropical Pacific Ocean (ETP) vessel permit applications to NMFS by either fax, email, or via an online application including online payment by credit card as described below.

This final rule amends text in 50 CFR 300.22(b)(7) to clarify that the carrying capacity of inactive purse seine vessels is counted towards the U.S. fleet capacity limit, for reasons explained above. Text in 50 CFR 300.22(b)(1) is also amended to clarify that the vessel carrying capacity of a purse seine vessel that is permitted and authorized under an alternative international tuna purse seine fisheries management regime in the Pacific Ocean and authorized to exercise an option to fish with purse seine gear to target tuna in the Convention Area is not counted towards the U.S. carrying capacity limit. This rule further clarifies that any vessel exercising this single trip exception must follow the procedures described in 50 CFR 300.22(b)(4), where applicable.

The regulatory text of the proposed rule included a revision to the definition of tuna at 50 CFR 300.21, which is currently defined as any fish of the genus Thunnus and the species Euthynnus (Katsuwonus) pelamis. NMFS did not explain this proposed revision in the preamble to the proposed rule, which was an oversight. NMFS is revising the definition of tuna to any fish of the genus Thunnus and the species Katsuwonus pelamis, removing the reference to Euthynnus because Euthynnus is no longer commonly used by taxonomers. The revision to the definition is a technical correction, and has no effect on the regulated community or fishery resources.

This final rule also removes the phrase “Eastern Pacific Fisheries” from the section headings for 50 CFR 300.22 and 50 CFR 300.23, because the heading for 50 CFR part 300, subpart C, clearly identifies that the entire subpart deals with “Eastern Pacific Tuna Fisheries.”

This final rule also reorganizes, and amends, 50 CFR 300.22(b)(4) and 50 CFR 300.22(b)(7) to implement changes to purse seine Vessel Register listings and procedures for replacing purse seine vessels removed from the Vessel Register, as described above.

NMFS received comments from two entities during the 30-day comment period of the proposed rule. The summarized comments from both entities and NMFS' responses are below. Changes made to the proposed regulatory text in response to these comments may be found in the following section.

Comment 1: One commenter expressed concern that the aging fleet provision does not address a situation where the replacement vessel has a greater carrying capacity than the vessel it is replacing, and noted that vessel owners may wish to replace with a larger vessel. The commenter suggested that the replacement vessel should be granted priority for the same capacity that the existing vessel had on the Vessel Register, but noted that if there was available capacity, the replacement vessel should be eligible to request the use of this capacity. The commenter further noted that a replacement vessel could seal off wells to reduce the carrying capacity of the vessel, as permitted by the IATTC, until there was enough carrying capacity available to accommodate opening of those wells.

Response: NMFS understands that vessel owners may wish to purchase larger replacement vessels and agrees that any replacement vessels should only be granted priority use of the capacity that the existing vessel previously held. NMFS has changed the proposed regulatory text such that the regulatory text would now state that replacement vessels may have a carrying capacity greater than the vessel being replaced, but that the replacement vessel must have wells sealed in accordance with the protocol adopted by the IATTC, prior to being granted active status, such that the carrying capacity is equal to or less than that granted to the vessel it is replacing. The current IATTC protocol for sealing wells is described in IATTC Resolution C-12-08 (Protocol for sealing wells on purse-seine vessels). If additional carrying capacity becomes available, the replacement vessel may request additional carrying capacity subject to the prioritization hierarchy of requests as described in 50 CFR 300.22(b)(4)(v). NMFS notes that the vessel assessment required for listing a vessel as active or inactive on the Vessel Register may be based on the volume of both sealed and non-sealed vessel wells.

Comment 2: The second commenter suggested that vessel owners should not have to commit to fishing in the Convention Area before leaving port in response to the advanced notice of vessel departure requirement revision.

Response: An advanced notice of a vessel's departure to fish in the Convention Area has been a requirement since 2004 (69 FR 55288, September 13, 2004) and the rationale for this notice remains unchanged. Large purse seine vessels (i.e., vessels with a carrying capacity of more than 400 short tons (362.8 metric tons)), and certain other vessels fishing in the Convention Area are obligated to carry an approved observer, and the advanced notice of departure facilitates the placement of an approved observer onboard the vessel. If an advanced notice of departure is not received, then the placement of an IATTC-approved observer could not occur. The new requirement to supplement the vessel departure notification with the request for a cross-endorsed observer if the vessel intends to also fish in both the IATTC and Western and Central Pacific Fisheries Commission (WCPFC) Convention Areas during the same trip further facilitates the placement of such an approved observer. There are a limited number of cross-endorsed observers (those approved to observe in both the IATTC and WCPFC Convention Areas) and it benefits the fleet to coordinate placement of such observers on vessels fully authorized and intending to fish in both Convention areas, so as not to require the placement of two approved observers (i.e., one for each Convention Area).

Comment 3: The second commenter also requested the ability to apply for an eastern tropical Pacific Ocean (ETP) vessel permit online and for the ability to pay for the permit with a credit card.

Response: NMFS agrees and has modified the regulatory text at 216.24(b)(4) to allow applicants the option of submitting ETP vessel permit applications to NMFS by either fax, email, or via an online application including online payment by credit card. To apply for an ETP vessel permit online, the applicant must first email a request to wcr.hms@noaa.gov. Depending on the availability of permits, detailed instructions for applying online will then be supplied to the applicant.

NMFS agrees with comment 1, above, that the proposed aging fleet provision did not address a situation in which a vessel is to be replaced by one with a greater carrying capacity, therefore NMFS has changed the text from the proposed rule to take into account such a situation. In instances where the replacement vessel has a greater carrying capacity than that of the vessel being replaced, the replacement vessel will be eligible to be listed as active on the Vessel Register at the same or lesser carrying capacity as that of the vessel it is replacing. If the replacement vessel has a carrying capacity greater than the vessel being replaced, the vessel owner or managing owner may request additional carrying capacity be allocated to the vessel in accordance with the listing hierarchy for vessels on a first-come, first-served basis, under 50 CFR 300.22(b)(4)(v)(D). If additional carrying capacity is not available at the time the request to be listed as active on the Vessel Register is received by the Regional Administrator, the replacement vessel must reduce its carrying capacity to no more than the previously authorized carrying capacity of the vessel being replaced, by complying with the protocol for sealing wells adopted by the IATTC, prior to it being listed as active on the Vessel Register. Such a vessel may apply for additional carrying capacity as it becomes available, under the procedures described in 50 CFR 300.22(b)(4)(v)(D). Other processes of the aging fleet provision described in the preamble of the proposed rule remain unchanged.

As described above, in response to comment 3, through this final rule NMFS is modifying the regulatory text at 216.24(b)(4) to allow ETP vessel permit applications to be submitted by email to NMFS at wcr.hms@noaa.gov, or through an online permit system. Previously, only faxed applications were allowed. The online application option would require payment of permit fees by credit card. Applications by fax or email require payment by check or money order. To apply for an ETP vessel permit online, the applicant must first email a request to wcr.hms@noaa.gov. Directions for applying online will then be supplied to the applicant. First contacting NMFS to request application online is necessary to ensure that there is enough capacity to accommodate the vessel on the Vessel Register prior to processing of a credit card payment for a permit.

The NMFS Assistant Administrator, in consultation with the Department of State and the U.S. Coast Guard, has determined that this final rule is consistent with the TCA and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

This final rule contains revised collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) under control number 0648-0387. A request for revision to account for the additional information and updated notification requirements that would be required pursuant to this rule is under OMB review. Public reporting burden for obtaining an IMO number (50 CFR 300.22(b)(3)(iii)), for making an IMO exemption request (50 CFR 300.22(b)(3)(iv)), for making a sunk status request (50 CFR 300.22(b)(4)(iii)(D)), and for making an aging fleet provision request (50 CFR 300.22(b)(9)(iii)), are each estimated to average 30 minutes per response. This includes time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Public reporting burden for requesting utilization of a cross-endorsed observer at 50 CFR 216.24(b)(8)(iv)(A) is estimated to add 2 minutes to the vessel departure notification requirement, which is estimated to average 10 minutes per response. Additionally, revisions to 50 CFR 216.24(b)(4) requiring an email notification to NMFS to request an online ETP vessel permit application is expected to add 1 minute per response. Revisions made to the vessel register annual notification and vessel permit application fees at 50 CFR 216.24(b)(6)(iii) and 216.24(b)(6)(8)(iv) are not expected to change the public reporting burden.

Comments regarding these burden estimates, or any other aspects of the collection of information should be sent to the NMFS West Coast Region Long Beach office at the addresses above, by email to OIRA_Submission@omb.eop.gov, or by fax to (202) 395-5806. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that, for purposes of the Regulatory Flexibility Act, this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received about the certification. As such, no information received during the public comment period changes NMFS' analysis. Therefore, the initial certification published with the proposed rule—that this rule is not expected to have a significant economic impact on a substantial number of small entities—remains unchanged. As a result, a regulatory flexibility analysis was not required and none was prepared.

For the reasons set out in the preamble, 50 CFR parts 216 and 300 are amended as follows:

Background

Under the Endangered Species Act (ESA) and its implementing regulations, taking (e.g., harassing, injuring or killing) sea turtles is prohibited, except as identified in 50 CFR 223.206 in compliance with the terms and conditions of a biological opinion issued under section 7 of the ESA, or in accordance with an incidental take permit issued under section 10 of the ESA. Incidental takes of threatened and endangered sea turtles during shrimp trawling are exempt from the taking prohibition of section 9 of the ESA so long as the conservation measures specified in the sea turtle conservation regulations (50 CFR 223.206; 50 CFR 224.104) are followed.

On March 15, 2016 (81 FR 13772), we published a notice of intent to prepare an environmental impact statement to analyze potential revisions to the sea turtle conservation regulations, and conducted five scoping meetings in April 2016. We then incorporated the information and public comments gathered during that process into a draft environmental impact statement (DEIS), the notice of availability of which was published on December 16, 2016 (EIS No. 20160294; 81 FR 91169). The analysis included in this DEIS demonstrated that withdrawing the alternative tow time restriction and requiring TEDs in all skimmer trawls, pusher-head trawls, and wing nets (butterfly trawls) rigged for fishing, with the exception of vessels participating in the Biscayne Bay wing net fishery prosecuted in Miami-Dade County, Florida, would reduce the incidental bycatch and mortality of sea turtles in the southeastern U.S. shrimp fisheries. Therefore, it may be a necessary and advisable action to conserve threatened and endangered sea turtle species. Accordingly, we published a proposed rule (81 FR 91097; December 16, 2016) to withdraw the tow time restriction and include the required TED specifications for these gear types, as well as amend the tow time definition and clarify the names of the allowable TED openings and webbing flaps to improve understanding.

Based on public comment raising performance and safety issues with TED use on smaller vessels and regarding the economic impacts of the proposed rule, and new information indicating significantly lower levels of sea turtle mortality in the offshore fleet, we have revised the regulation to limit the TED requirements to skimmer trawl vessels 40 feet and greater in length. After reviewing concerns about applying TED testing data from skimmer trawl operations to pusher-head trawls and wing nets, coupled with a lack of observer data for these vessels, we have decided to maintain the tow time-requirement option for these other types of vessels. This final rule only requires TEDs on skimmer trawl vessels 40 feet and greater in length. This rule will achieve a significant conservation benefit for listed sea turtles, while affecting significantly fewer vessels and imposing far fewer costs upon industry. Because fewer TEDS will need to be manufactured to supply the vessels covered under the final rule, this rule can be implemented in far less time than the proposed rule, allowing for more focused and expedient sea turtle conservation. For purposes of this rule, vessel length is the length specified on the vessel's state vessel registration or U.S. Coast Guard vessel documentation required to be onboard the vessel while fishing.

The proposed rule also included a revision to the tow time definition that would have required vessels to remove their entire net and rigging from the water at specific intervals, instead of just the tail bag as is often done by skimmer trawl vessel operators. For small vessels that lack hydraulics, this process takes significant time and potentially makes the vessel unstable while raising the nets, which could introduce safety issues. Therefore, we revised our proposed tow time definition to avoid these potential scenarios while allowing for a more complete inspection of the net for captured sea turtles and clarifying what is required to end a tow under the regulations. For vessels using pusher-head trawls or wing nets, vessels less than 40 feet in length using skimmer trawls, or vessels considered as live bait shrimpers operating under the allowable tow time exemption, we are requiring the net to be emptied of catch on the deck within the specified time. This prevents vessels from lifting the tail bag clear of the water and potentially lowering it quickly back in due to concerns about the sufficiency of the shrimp catch. We believe this will result in the intended identification and safe release of any sea turtle captured in a net while minimizing issues to trawling operations, and more clearly identifies what is required of vessels to comply with tow time limits.

The proposed rule anticipated a six-month delay in effectiveness and solicited public input on different options for the phased implementation of the final rule. The revisions between the proposed and final rule have reduced the number of affected fishers by 82 percent, reduced the total economic effect by 73 percent, and are expected to result in a conservation benefit of 801-1,168 sea turtles annually in the Southeastern U.S. shrimp fisheries. The complete analysis for this alternative is included in a final environmental impact statement (FEIS), the notice of availability of which was published on November 15, 2019 (EIS No. 20190270; 84 FR 62530). We believe delaying the effectiveness of the rule until April 1, 2021 is warranted, as that will be an adequate period to allow for the manufacture of the necessary number of TEDs and for fishers, particularly lower income fishers, to financially prepare for the regulation.

We held 6 public hearings on the proposed rule in January 2017. Approximately 70 individuals attended the January 9 Larose, Louisiana meeting; 80 attended the January 10 Gretna, Louisiana meeting; 50 attended the January 10 Belle Chasse, Louisiana meeting; 50 attended the January 11 Biloxi, Mississippi meeting; 15 attended the January 12 Bayou La Batre, Alabama meeting; and 15 attended the January 18 Morehead City, North Carolina meeting. We conducted additional presentations on February 8 in Houma, Louisiana for the Louisiana Shrimp Task Force meeting and on February 16 for the Gulf of Mexico Fishery Management Council's Shrimp Advisory Panel. During the comment periods on the DEIS and proposed rule, we received approximately 38,500 comments encompassed in 1,200 submissions (e.g., one submission was a petition with 33,807 signatures; one submission consisted of 3,408 individual comments; other submissions summarized comments from multiple individuals). Below we summarize these comments, as well as comments received during the six public hearings and two additional presentations. We received additional comments advocating sea turtle conservation measures not related to the southeastern U.S. shrimp fisheries. Given the lack of relevance to this regulatory action, they are not addressed in the following responses. The public comment period on the DEIS officially ended on January 30, 2017, and the public comment period on the proposed rule officially ended on February 14, 2017.

Comment 1: Numerous comments support the required use of TEDs designed to exclude small turtles in skimmer trawls, pusher-head trawls, and wing nets.

Response: We agree that use of TEDs in skimmer trawls will benefit sea turtle populations and that use of TEDs on pusher heads and wing nets might benefit sea turtle populations, but due to a lack of data further study is required. At this time, there is a need to further explore efficacy and safety issues related to TED use on pusher-head trawls and wing nets, as well as small skimmer trawl vessels. Therefore, this final rule will only require TEDs on skimmer trawl vessels 40 feet and greater in length. Existing tow time requirements are maintained for pusher-head trawls, wing nets, and smaller skimmer trawl vessels.

Comment 2: All bottom trawls operating in the southeast region should be required to have TEDs, not just selected gear in the shrimp fisheries; NOAA should expand the TED requirement to all trawls; NOAA should require TEDs in try nets; NOAA should consider narrower TED bar spacing.

Response: We are continually evaluating fisheries that have the potential to impact sea turtle populations to assess if there are practical ways to minimize bycatch and mortality to the maximum extent practicable. Trawl fisheries in the Atlantic and the Gulf of Mexico have been documented to frequently interact with sea turtles due to the spatial and temporal overlap of the fisheries with sea turtle habitat. As a result, we are currently testing TEDs for try nets in the shrimp fisheries, as well as TEDs in other trawl fisheries (e.g., mid-Atlantic croaker fisheries). We have also conducted testing of narrower TED bar spacing in the past. In some fishing conditions, however, narrower bar spacing results in excessive catch loss and reduced gear performance. The TED bar spacing requirements in this rule and existing regulations are based on the segment of sea turtle populations that may be encountered by these particular fisheries and their respective fishing conditions.

Comment 3: Numerous comments support the status quo and oppose the required use of TEDs designed to exclude small turtles in skimmer trawls, pusher-head trawls, and wing nets. Similar comments suggest current tow times are sufficient to avoid sea turtle bycatch mortality, as evidenced by the growing number of Kemp's ridley nests.

Response: We have observer data that document sea turtle mortality resulting from incidental capture in skimmer trawls during tows that were compliant with tow time limits, as well as during tows that exceeded tow time limits. Incidentally-captured sea turtles are often released alive, which is one reason tow time restrictions were previously accepted as a mitigation measure. However, best available information and expert opinion (discussed in detail in the FEIS) indicate that persistent or delayed effects can lead to mortality (post-interaction mortality), including deaths of some turtles that appear to be in good health at the time of release (Stacy, et al., 2015 as referenced in the FEIS). Analysis of the behavioral condition of the turtles caught by skimmer trawls, using current criteria for estimating post-interaction mortality for trawl fisheries (as described in NMFS Procedural Directive 02-110-21), indicated that mortality could be more than triple the number estimated based on dead and comatose turtles alone. This indicates tow time limits may not be as effective in reducing sea turtle bycatch and mortality as previously thought. Furthermore, as sea turtle populations increase, interactions between skimmer trawl vessels and sea turtles are expected to likewise increase. While Kemp's ridley sea turtle nesting numbers have increased significantly in the past several decades, the trend has leveled off in recent years.

We believe the most effective protective measure for threatened and endangered sea turtle populations is to reduce the total time sea turtles are entrained in a skimmer trawl by using TEDs. TEDs are an effective tool in reducing this mortality, as demonstrated in other sectors of the shrimp fisheries. Gear research has shown that they reduce sea turtle bycatch with only minor reductions in target catch. At this time, TEDs will not be required on skimmer trawl vessels less than 40 feet in length, or in any pusher-head trawl or wing net.

Comment 4: NOAA should invest in sea turtle hatcheries to rebuild sea turtle populations (instead of requiring TEDs).

Response: In situ nests, or nests in their original place, are preferred over hatcheries whenever the natural beach can support successful nest incubation. Hatcheries are not a preferred alternative because of their limited conservation value when conditions are favorable for in situ incubation. Hatcheries can alter the physical environment of the nest, which can affect nest success and hatchling sex ratios. Predation rates are increased when releases of hatchlings from hatcheries are concentrated in limited areas. Regardless, hatchlings released from hatcheries must still survive to reproduce and, without TEDs, would remain subjected to increased mortality in trawls operating without TEDs. In the southeast U.S., nest success is high and is not a limiting factor that supports the use of hatcheries. Furthermore, sea turtle hatchlings (first year of life) have lower survival rates than older life stages. TEDs provide a greater conservation benefit to sea turtles than hatcheries as they reduce bycatch and mortality of older life stages that have already survived past the most vulnerable years.

Comment 5: The regulation may have significant adverse economic effects for an industry that has been struggling due to many other issues.

Response: We acknowledge the regulation may have significant adverse economic effects on the shrimp industry, as documented in the DEIS and FEIS. We believe the need to reduce mortalities of threatened and endangered sea turtles observed in vessels using skimmer trawls, however, warrants the required use of TEDs as specified in this final rule. This final rule has been modified from the proposed rule, and achieves a significant conservation benefit but has substantially reduced adverse economic effects on industry. Specifically, the revisions between the proposed and final rule have reduced the number of affected fishers by 82 percent, reduced the total economic effect by 73 percent, and are expected to result in a conservation benefit of 801-1,168 sea turtles annually in the Southeastern U.S. shrimp fisheries.

Comment 6: Sea turtles are not observed (i.e., do not occur) in areas where many skimmer trawls operate.

Response: Observer effort on skimmer trawl vessels indicates sea turtles occur in most areas where skimmer trawl vessels operate. At this time, we do not have sufficient information to confidently identify areas where sea turtle interactions would not occur, and where we could exempt TED use based on the possible absence of sea turtles. Therefore, at this time, TED exemptions by discrete area are not considered necessary and advisable.

Comment 7: TEDs will not work in skimmer trawls due to shallow water, due to a change in TED angle if running in shallow water and where the top of grid (and the escape opening) is exposed. Further, there can be excessive debris, particularly crab traps and after storm events.

Response: Based on TED testing conducted aboard commercial skimmer trawl vessels, we expect TEDs will work in the majority of areas and under the majority of fishing conditions. Greater than one-third of the vessels participating in TED testing from 2013 through 2015 operated in depths of 3 feet or less under the vessel with skimmer frames reaching out to shallower water (Gearhart in press). TEDs continued to perform effectively under these conditions. We expect TEDs installed at 55 degrees to operate as intended in water depths as shallow as 2.18 feet of water; TEDs installed at less steep angles would be able to operate in shallower water (e.g., TEDs installed at 45 degrees could operate in water as shallow as 1.89 feet).

We acknowledge skimmer trawl vessels with and without TEDs may encounter debris such as lost and abandoned crab traps and vegetative debris in the shallow, coastal waters where they operate. A common practice in the fishery is to install zippers, when TEDs are not installed, to help with removing crab traps. Zippers can still be installed with TEDs. Further, TEDs may offer some benefits, such as those discussed below, over zippers, since zippers can be difficult to open because of sand and sedimentation, where the potential benefits of TEDs occur regardless of sedimentation.

Our TED testing found that the diameter of the trawl ahead of the TED when properly installed is approximately 24 inches or less. This does not allow crab traps to make it to the TED and cause blockage. For skimmer trawl vessels with and without TEDs, once the blockage is removed the catch can be washed down to the tailbag where it can be dumped easily.

Crab traps and other debris can damage nets with or without TEDs. In areas where crab traps are abundant, fishers may have to inspect their nets more often to remove entrained crab traps.

Comment 8: The proposed regulations are subject to Executive Order 13771, which would require the elimination of two existing regulations.

Response: The Memorandum: Implementing Executive Order 13771, Titled “Reducing Regulation and Controlling Regulatory Costs” states that a significant regulatory action as defined in Section 3(f) of Executive Order 12866 is an Executive Order 13771 regulatory action and, therefore, must be offset according to the requirements of the executive order. This action was determined to be significant for purposes of Executive Order 12866 following publication of the proposed rule, and will be offset as appropriate and as soon as practicable after publication to comply with Executive Order 13771.

Comment 9: NOAA should provide translated materials for Vietnamese American fishers (per Executive Order 13166 and Title VI of the Civil Rights Act), who comprise a significant portion of the skimmer trawl fisheries.

Response: We acknowledge a significant portion of affected skimmer trawl fishers may not rely on English as their primary language. However, we are not required under Executive Order 13166 or Title VI of the Civil Rights Act of 1964, which deal with Federal financial assistance programs, to translate these regulatory materials to other languages. However, we are translating our Fishery Bulletin, compliance guide, and other outreach materials to assist the Vietnamese fishing community.

Comment 10: With increasing sea turtle populations, sea turtle bycatch will increase—bycatch will never be zero—how much bycatch reduction is enough?

Response: While nesting data indicate many sea turtle populations may be increasing, all species of sea turtles in U.S. waters are threatened or endangered under the ESA. In order to promote the continued conservation of these populations, we must continue to implement programs that provide adequate protection for sea turtle populations, including efforts to reduce sea turtle bycatch and mortality. The ESA requires us to issue regulations deemed necessary and advisable to provide for the conservation of any species listed as threatened and broadly authorizes the promulgation of regulations as may be appropriate to enforce the Act. Therefore, while these species remain threatened or endangered under the ESA, we are required to pursue efforts to recover them. Specific recovery metrics that would result in downlisting or delisting from the ESA are in the recovery plans for each sea turtle species.

Comment 11: The descriptions of the alternatives starting with Alternative 3 in the third column on page 91102 of the proposed rule do not match the alternative numbers in parentheses and do not match the descriptions in the DEIS.

Response: We acknowledge the summary text of the IRFA starting on page 91102 may have introduced some confusion. The summary compares the preferred alternative to the other six alternatives considered in the DEIS, which resulted in an apparent inconsistency in labeling the alternatives (Alternative 3 (the Preferred Alternative in the DEIS) is the basis, resulting in Alternative 4 becoming the “third alternative to the action”). The language in the classification section of the proposed rule diverged from standard protocol, which would have avoided this confusion. We remedy this issue in this rule.

Comment 12: NOAA's economic analysis does not take into consideration loss of other bycatch species (e.g., drum, crabs, flounder, etc.) and resulting income due to TED use.

Response: To date, TED testing studies have not collected sufficient data to generate scientifically acceptable estimates of the reduction in marketable incidental (i.e., non-shrimp) catch. In addition, although the states collect landings and revenue data for incidentally harvested species when the catch is sold, most states do not collect landings data when the harvests are retained for personal use (e.g., consumption). Thus, the landings and value of harvests retained for personal use are unknown. As a result, the economic analysis focuses on the economic effects caused by the reduction in harvest of the primary target species (i.e., shrimp) due to TED use. Revenue resulting from the harvest and sale of incidentally harvested non-shrimp species by vessels participating in the southeast shrimp fisheries are accounted for in the economic analysis as illustrated in the description of the economic environment (see Section 3.4 of the FEIS).

Comment 13: The economic analysis underestimates the adverse effects on processors. The assertion that processors can substitute imports for domestic product if landings are reduced because of the regulations is inaccurate because imports are not a good substitute or cannot be substituted for domestic product.

Response: We disagree that the adverse economic effects on processors in the FEIS are underestimated. We consider those estimates to represent the best available data. Further, the claims that imports are not a good substitute for domestic product and that the processing sector cannot substitute imports in place of reduced domestic landings are not supported by the available data and research (Keithly et al., 2015 as referenced in the FEIS). All research conducted to date, as well as the industry's statements, support the conclusion that imports compete with and are, therefore, substitutes for domestic product, as reflected by the fact that increases in imports have historically caused reductions in domestic shrimp prices. The data also indicate that the processing sector has increased its use of imports when domestic production has declined, and thus imports are used as a substitute for domestic product. However, we agree that the processing sector has become more dependent on domestic production in recent years. Larger processors are also better able to substitute imports for domestic production. We also agree it may be difficult for small processors to substitute imports for lost domestic production or otherwise mitigate the adverse effects from such reductions, particularly if some vessels cease operations because of this regulatory action. We discuss these conclusions in Sections 4.3 and 5.4 of the FEIS.

Comment 14: The proposed regulations would reduce public access to domestic shrimp, particularly from smaller vessels that market shrimp directly.

Response: Based on the economic analysis in the FEIS, we expect landings by vessels directly affected by this rule to decrease. To the extent the affected vessels act as their own dealers and sell shrimp directly to the public, a reduction in public access to domestic shrimp is expected. Many of these vessels are relatively small within the context of the fleets in the southeast shrimp fisheries. However, this final rule affects nearly 82 percent fewer vessels and the total expected loss in domestic landings is about 66 percent less relative to the preferred alternative in the DEIS. Thus, these adverse effects have been reduced as a result of the change to the preferred alternative.

Comment 15: NOAA's economic analysis underestimates shrimp loss.

Response: The economic analysis uses estimates of shrimp loss resulting from extensive testing of TEDs in skimmer trawls. We discuss these results in Sections 3.1 and 4.3.8 of the FEIS. The analysis of economic effects resulting from shrimp loss presented in the FEIS represents the best available information on the subject. Therefore, we believe the current estimates of shrimp loss in the FEIS to be accurate given the availability of current information. These results are also discussed below in the classification section of this rule.

Comment 16: NOAA fails to analyze the broader economic effects of the proposed TED requirements on coastal communities, including loss of jobs.

Response: The expected economic impacts of the proposed TED requirements in terms of expected reductions in employment (jobs), income, total value added, and output for the Gulf of Mexico and South Atlantic are provided in the Regulatory Impact Review (RIR) (see Section 5.5 of the DEIS and Section 5.7 of the FEIS). We revised these estimates in the FEIS to reflect the new preferred alternative. A national economic impacts model or state models can generate these estimates. If economic impacts are estimated state by state using the state models, the total economic impacts from the rule would be underestimated because potentially significant relationships between businesses across states would not be taken into account, unlike the national model which does account for those relationships. We chose to use the national model so as not to underestimate the total economic impacts of the rule. Our economic impacts models do not generate these estimates at the community level, as we do not have the necessary business relationship and activity data at that level. Section 3.5 of the FEIS describes communities that are the most likely to experience effects through the identification of top communities by regional quotient, licenses, and active fishers and through the identification of communities with processors. In addition, we added qualitative text on the loss of jobs at the community level to Section 4.4 of the FEIS in response to this comment.

Comment 17: NOAA's economic analysis does not take into account the long-term economic effect of vessels ceasing operations.

Response: We discuss the expected long-term economic effects if some vessels cease operations under all considered alternatives in Section 4.3.11 of both the DEIS and FEIS. The analyses consider direct effects on the harvesting sector (vessels) and indirect effects on the onshore sector (dealers, processors, and TED manufacturers). We discuss additional information regarding the expected long-term economic effects of the rule if certain vessels cease operations in the RIR, which we update in the FEIS to reflect the new preferred alternative.

Comment 18: NOAA's economic analysis does not take into consideration vessel devaluation due to the proposed TED requirements.

Response: We acknowledge that the new TED requirements in this rule can reduce the profitability of the adversely affected vessels and, thus, their market value. However, we do not have models that would allow us to project the potential magnitude of such decreases, particularly as most of the affected vessels do not have Federal permits and we only have one year of recent data regarding the market value of such vessels in the Gulf of Mexico. The reductions could be significant if some vessels shut down due to this regulatory action. On the other hand, the TED requirement would also eliminate the competitive advantage the affected vessels have had over otter trawl vessels, which have been required to use TEDs for many years. Thus, this change is not necessarily a cost to society. Nevertheless, we have included qualitative statements regarding these expected effects in the FEIS where applicable. Additionally, the change to the preferred alternative is expected to result in significantly fewer vessels being devalued compared to the proposed rule.

Comment 19: A six percent loss in shrimp is not trivial given the margins of the inshore skimmer trawl fisheries.

Response: We agree that a six percent loss in shrimp catch due to the new TED requirements is not trivial. The expected adverse economic effects resulting from shrimp loss are discussed in Section 4.4 of the FEIS, in the RIR (Section 5 of the DEIS and FEIS), and the Initial and Final Regulatory Flexibility Act Analyses (Section 6 of the DEIS and FEIS). The significance of these effects is discussed in absolute terms as well as in relative terms (i.e., given the different profit margins for various types of vessels in the shrimp fisheries, as discussed in Section 3.4 of the DEIS and FEIS). The magnitude of these adverse economic effects is further reflected by our expectation that about 32 percent of the affected part-time vessels could cease operations due to this rule, generating even greater reductions in landings and gross revenue to the industry. The change in the preferred alternative, however, has significantly reduced the total adverse economic effects expected to result from shrimp loss.

Comment 20: An independent cost estimate of the proposed regulations determined the average initial TED acquisition cost of $32,648 per vessel. Another comment estimated $20,000 to outfit TEDs in their nets. Yet another states many skimmer vessels use Dyneema and a single net can cost $5,000 for materials alone; to have 4-6 nets ready to fish could cost over $30,000 for just one vessel.

Response: Without specific information on these referenced estimates, we cannot provide a detailed response. However, it appears that these cost estimates may include vessel rigging modification and/or the purchase of new nets, which would not be necessary under the proposed regulation. TEDs can be easily installed into existing trawls between the trawl body and tail bag. Based on TED testing aboard commercial vessels, modifications to vessel rigging to accommodate TED use are unnecessary or minor and rarely occur. The estimates in the DEIS were based on the cost to purchase TEDs for actively fished nets and one set of spare nets for each vessel (i.e., four total TEDs if a vessel uses two nets). The prices ranged based on vessel size (i.e., smaller vessels assumed to fish with smaller, less expensive TEDs than larger vessels). We based the cost estimates on “average” TEDs constructed of conventional materials that are currently available to fishers. TEDs can vary in price based on design (e.g., flat bar TED). Vessels that desire to purchase additional TEDs beyond the minimum needed to continue fishing under this rule would incur additional costs.

Comment 21: NOAA's economic analysis overestimates shrimp loss (i.e., NOAA should include catch loss rates from 4-inch TED testing).

Response: As previously stated, we believe the economic effects resulting from shrimp loss presented in the DEIS represents the best available information on the subject. We disagree with the assertion that we should include catch loss rates from previous four-inch bar spacing TED testing. This action would require skimmer trawl vessels 40 feet and greater in length to use TEDs with 3-inch bar spacing instead of tow times. Research results on designs not authorized under this action are not appropriate for this analysis.

Comment 22: NOAA fails to take into consideration (i.e., benefit) the lack of tow times could offset shrimp loss.

Response: We do not expect the removal of a tow time limit to offset shrimp loss. Fishers can attempt to make up shrimp loss stemming from the use of TEDs by increasing the number and duration of tows, and thereby increasing their total catch and revenue, however, this could increase costs, such as fuel and labor. In addition, catch rates (i.e., catch per unit of effort) tend to decrease as towing time (effort) increases in the same area and, in turn, revenue per unit of effort is expected to decrease as towing time increases. Neither economic theory nor the available economic data can help us to determine whether the additional revenues from towing longer will exceed the additional costs.

Comment 23: NOAA overestimates the number of vessels affected by the proposed TED requirements; NOAA should exclude vessels anticipated to cease operations because of the TED requirements from the economic analysis.

Response: Although there are consistency issues between some data sources, we have determined the estimates of the number of affected vessels under the alternatives considered in the DEIS and FEIS are the best available estimates. We disagree that we should exclude vessels anticipated to cease operations from the economic analysis. If vessels cease operations as a result of the action, that is an effect of the action which needs to be considered per the requirements of Executive Order 12866, the Regulatory Flexibility Act, and the National Environmental Policy Act. To exclude and ignore this effect would distort the analysis and misinform managers and the public.

Comment 24: NOAA inconsistently estimates the per-vessel costs of TEDs and does not clearly explain how many TEDs each vessel will need.

Response: The explanation of how many TEDs each vessel will need and how the estimates of per-vessel TED costs were generated is provided in both the DEIS (pp. 156-157) and the proposed rule. Specifically, the analysis assumes each affected vessel would be required to acquire TEDs for each net fished plus one spare for each net. TED costs vary by vessel size and type. Practically all vessels affected under this rule fish with two nets, which would result in each vessel acquiring four TEDs in total. Thus, the average cost of TEDs per vessel is approximately $1,300 under this rule. Larger vessels would likely use larger TEDs, which cost more, and larger vessels typically use more nets (four). More large otter trawl vessels are affected under Alternatives 6 and 7, resulting in a higher average TED cost per vessel (approximately $1,700) compared to the other considered alternatives.

Comment 25: NOAA should analyze the economic effects of full-time and part-time vessels separately versus averaging across all vessels.

Response: The analysis of economic effects for all alternatives considered in the DEIS and FEIS looks at average effects across all vessels as well as average effects separately for different types of vessels, including part-time vessels (those in the Q1, Q2, and Q3 categories) and full-time vessels (all other categories).

Comment 26: NOAA should expand the economic analysis to include the benefits of TEDs (e.g., improved fuel efficiency due to reduced drag from excluding debris and bycatch; increased price due to improved condition of catch; reduced sorting time) and value of sea turtles beyond simple “conservation value” of the species (e.g., tourism).

Response: We agree that there are other potential benefits from the use of TEDs such as improved fuel efficiency, reduced sorting time, and increased value of product. For example, we anticipate some ancillary benefits from TED use in high debris areas, as the reduction of debris trapped in the tailbag would prevent damage to the catch, thereby increasing the quality (e.g., promoting harvest of whole shrimp rather than pieces) and potentially increasing the price per pound. We also acknowledge that sea turtles are a source of demand for ecotourism in the region. However, based on the existing peer-reviewed literature, there is no theoretical or empirical basis for asserting that the expected reductions in sea turtle mortalities under this rule will result in increased ecotourism and concomitant economic benefits. In addition, we currently lack data and models to quantitatively estimate these ancillary benefits. We have summarized these issues qualitatively and have addressed this comment in Section 5 (RIR) of the FEIS.

Comment 27: The use of TEDs by skimmer trawls would remove the Monterey Bay Aquarium Seafood Watch's Red Listing of Gulf of Mexico shrimp harvested by skimmer trawls and expand industry markets, and likely increase profits.

Response: Monterey Bay Aquarium and several environmental groups provided comments on the proposed rule, which stated that sea turtle bycatch is a serious concern in the fisheries and contributed to the current red list rating of the skimmer trawl fisheries. We agree that the use of TEDs by skimmer trawl vessels could result in a different listing by the Monterey Bay Aquarium Seafood Watch program. However, this regulatory action does not guarantee a change in the rating. Monterey Bay Aquarium has committed to promptly update their scientific assessment, but has not committed to the outcome of that assessment. Therefore, we cannot assume what the Monterey Bay Aquarium's rating for the skimmer trawl fisheries will be after implementing the final rule, nor the resulting economic benefits to the fisheries.

Comment 28: The use of TEDs by skimmer trawls would reduce additional bycatch aside from sea turtles, in turn benefitting other commercial and recreational fisheries.

Response: We agree that the use of TEDs by skimmer trawls would reduce additional bycatch other than sea turtles. Numerous studies indicate TEDs reduce finfish bycatch, crustaceans, and debris, resulting in benefits to the local ecosystem (see Section 4.2 of the FEIS).

Comment 29: NOAA should expand its environmental justice analysis by including additional analyses on how the proposed regulations may have high and disproportionate impacts on lower-income generating small fishing operations, expanding the analysis of effects to vessels that cease fishing operations as a result of the regulations, and summarizing the outreach efforts to foster public participation by minority and low income populations.

Response: The environmental justice analysis in the FEIS has been expanded. Specifically, new text has been added including a summary of the public participation process, a qualitative discussion of impacts to lower-income generating small fishing operations, and a qualitative discussion of the effects to vessels that cease fishing operations because of this action. As noted above, by limiting the TED requirement to vessels 40 feet and greater in length, the economic impact to industry is significantly reduced from the proposed rule to the final rule.

Comment 30: The DEIS and proposed rule did not demonstrate whether or how the expected mortality reduction of “small” sea turtles will contribute to population recovery of the sea turtle species and DPSs that occur within the southeastern U.S. The proposed rule and DEIS did not define “small” for each sea turtle species. In addition, the DEIS and proposed rule lacked analyses based on stock assessment models showing how abundance trends respond to the projected reduction in sea turtle mortality attributable to the new regulations, and evaluations of relative reproductive values or adult equivalents of “small” female sea turtles documented to have been incidentally captured and killed in skimmer trawls, pusher-head trawls, and wing nets within the southeastern U.S. shrimp fisheries.

Response: At present, we do not have stock assessment models for all sea turtle species impacted by this regulation. The conservation need for TEDs to reduce the bycatch of Kemp's ridley sea turtles in the skimmer trawl fisheries was identified in the Kemp's Ridley Recovery Plan (NOAA and USFWS 2011). A formal threats assessment identified skimmer trawls, among the trawl types not currently required to use TEDs, as a significant mortality threat, collectively resulting in an estimated annual mortality, adjusted for reproductive value, of 1,218 adult females annually (NOAA and USFWS 2011, Table A1-7). At the November 2014 meeting of the Kemp's Ridley Recovery Team (https://www.fws.gov/kempsridley/pdfs/KempsRidley_BiNationalTeam_Nov2014.pdf), the team identified requiring TEDs in the skimmer trawl fisheries (i.e., the largest component of the trawl fisheries not currently required to use TEDs) as one of the four most critical recovery actions that needed to be completed.

With regard to size, observer data from skimmer trawl vessels show interactions with green sea turtles ranging from 21.0 cm to 33.5 cm curved carapace length (CCL) and Kemp's ridley sea turtles ranging from 19.3 cm to 45.6 cm CCL (Stokes and Gearhart 2016). We did not explicitly define “small” because the size range varies across species and can change over time. In general, the term “small” refers to the small juvenile stage.

Comment 31: NOAA's data is insufficient to support this regulation.

Response: While we disagree and believe sufficient information has been gathered and presented to the public, all of which warrants measures to reduce sea turtle bycatch and mortality in the skimmer trawl fisheries, we do note this final rule differs from the proposed rule due to further data analysis. We have presented four years of observer data that demonstrates skimmer trawls capture sea turtles in their nets, some of which resulted in mortalities. Likewise, we have included information indicating that post-interaction mortality may occur to trawl-caught sea turtles that are released alive and in seemingly otherwise normal condition. We have also conducted extensive TED testing on skimmer trawl vessels using a variety of configurations and fishing under a variety of different conditions to determine the resultant catch loss under each scenario. Additional economic and social data are included and discussed in the FEIS and these have been determined to be the best available data. A new analysis of sea turtle bycatch and bycatch mortality in the otter trawl shrimp fisheries (Babcock et al. 2018 as referenced in the FEIS) indicates bycatch by otter trawlers is significantly lower than previously estimated, and further supports the need for sea turtle conservation in the skimmer trawl fisheries; this information is discussed further in the FEIS. While more data is always beneficial and desired, we believe sufficient data has been gathered, analyzed, and presented to support this action. Where data was lacking or the efficacy of TEDs merited further evaluation, as was the case with requiring the use of TEDs in pusher-head trawls, wing-nets, and smaller skimmer trawls, we narrowed the scope of the final rule accordingly.

Comment 32: New regulations are unnecessary, as NOAA's own data indicates sea turtle populations are recovering under the status quo.

Response: While there have been improvements in nesting numbers of several species of sea turtles, we still have recovery goals to meet for all ESA-listed sea turtle species. As mentioned in our response to Comment 10, in order to promote the continued conservation of these populations, we must continue to consider and implement conservation measures that will provide adequate protection for sea turtle populations and help us achieve our ESA recovery goals and objectives. The ESA requires us to issue regulations deemed necessary and advisable to provide for the conservation of any species listed as threatened and broadly authorizes the promulgation of regulations as may be appropriate to enforce the Act. Therefore, while these species remain listed under the ESA, we are required to continue our efforts to recover these species. Specific recovery metrics that would result in downlisting or delisting from the ESA are in the recovery plans for each sea turtle species. In addition, as noted in our response to Comment 30, the Kemp's Ridley Recovery Team identified requiring TEDs in skimmer trawls as one of the four most critical recovery actions that needed to be completed. Therefore, implementing this requirement is consistent with our statutory duty to implement the recovery plan under section 4(f) of the ESA.

Comment 33: NOAA does not have sufficient evidence of tow time violations; most fishers abide by tow times for reasons other than possibility of sea turtle bycatch.

Response: We disagree, as there have been cited violations of tow time limits by skimmer trawl fishers. While we are unable to quantify the extent to which tow time violations occur, we do have evidence that it is an issue that needs to be addressed. Moreover, we have observer data that document sea turtle mortality has resulted from capture in skimmer trawl nets occurring within the tow time limits, as well as information indicating post-interaction mortality is at a significant level, even though captured sea turtles are released alive and may seem in healthy condition when released. Therefore, we believe tow time limits are not as effective in reducing sea turtle bycatch and mortality as previously thought.

Comment 34: NOAA's catch loss rates based on TED use are manipulated and vastly under-estimated. NOAA conducted TED testing at times that are not representative of peak fishing activity, which results in an underestimate of catch loss.

Response: We conducted extensive fishery-independent and fishery-dependent testing during the 2013, 2014, 2015, and 2016 fishing seasons using a variety of TED configurations and under a variety of fishery conditions off Louisiana, Mississippi, Alabama, and North Carolina. We used an established protocol to conduct this testing. Prior to analysis, data were reviewed and unsuccessful tows were removed from the dataset. Unsuccessful tows were comprised of bogged gear, bag untied, torn nets, hung gear, bags dumped together, and fouled tickler chain. Successful tows were defined as tows in which the gear worked properly and the trawl was hauled in perfect condition. Tows with TED obstructions such as debris or crab pots were not removed from the data set and were included for analysis. However, tows in which the TED was twisted were considered captain related gear handling errors and were removed prior to analysis. In addition, tows with less than 2 kg of shrimp per net for both nets were removed prior to analysis.

We also attempted to conduct fishery-dependent work during the opening of shrimp season where catch rates would be expected to be highest, but were unable to find vessels willing to participate; fishers desired to focus on the season opener to maximize fishing time and catch. We attempted several times to address this issue with industry. Therefore, the resulting data from this research represents the best available science, and we believe it adequately reflects average fishing conditions. We document these findings in the FEIS and the primary study (Gearhart in press).

Comment 35: NOAA has not provided any data on wing nets or anchored vessels; TEDs will not work in vessels anchored and fishing tidal current.

Response: To date, we have not conducted TED testing on wing nets or anchored vessels. This gear fishes very differently from trawl vessels. This lack of research, among other reasons, has led us to change the preferred alternative in the FEIS and adjust our final rule accordingly.

Comment 36: Averaging observer catch data to all vessels, including small vessels that work in shallow water where sea turtles may not be as abundant, and extrapolating the skimmer trawl observer data to the wing net and pusher-head trawl fisheries is inappropriate.

Response: In order to determine the effects the shrimp fisheries have on threatened and endangered sea turtles, we must consider the entirety of the fisheries instead of just limited, observed vessels. Averaging limited data across an entire fishery is an acceptable practice, and has been conducted for numerous fisheries for several decades. We maintain the skimmer trawl observer data gathered over several years and in numerous states is the best available information on the skimmer trawl fisheries. Averaging these data helps to avoid overestimating or underestimating, which may occur when using data from a single year. We do not have discrete sea turtle abundance data that would lend itself to further refining catch rates by water depth or area to support or refute the commenter's assertion that sea turtles are not as abundant in shallow water. Therefore, we disagree with the first portion of this comment. We do agree, however, that applying observer data from skimmer trawls to wing nets and pusher-head trawls is problematic. In addition, comments raising safety and other practical concerns about using TEDs on small skimmer trawls factored into the decision to change the preferred alternative and modify the final rule to focus solely on skimmer trawl vessels 40 feet and greater in length.

Comment 37: NOAA grossly overestimates sea turtle mortality attributable to the skimmer trawl fisheries; the commenter asserts the average skimmer trawl vessel would experience one sea turtle mortality every eight years by only considering sea turtles released dead (n=3).

Response: We disagree with the commenter's assertion that sea turtle mortality is overestimated, and note the commenter fails to take into consideration post-interaction mortality in their estimate. We went to considerable lengths in the DEIS and FEIS to describe the process by which we estimated bycatch mortality using the best available information. Based on that information, we believe the combined skimmer trawl, pusher-head trawl, and wing net fisheries (i.e., 5,837 total vessels) may result in 2,165-2,942 sea turtle mortalities per year. Averaged across the whole fleet evenly, this would result in one sea turtle mortality per vessel every 1.98-2.7 years. Annual fishing effort, however, is not evenly distributed among vessels in the fleet, so this rate is of limited utility. The majority of the skimmer trawl, pusher-head trawl, and wing net fleet consists of part-time vessels that do not fish as often as full-time vessels. Therefore, we expect the rate to be significantly higher among the smaller population of full-time skimmer trawl, pusher-head trawl, and wing net vessels, many of which are 40 feet and greater in length.

Comment 38: NOAA's observer data demonstrates otter trawls with installed TEDs resulted in higher sea turtle mortality than skimmer trawls without TEDs.

Response: We disagree with this comment. As noted previously, we take into consideration post-interaction mortality when considering the effect of the skimmer trawl fleet (i.e., on vessels not using TEDs) on sea turtle populations. The period and sample sizes (i.e., hours of fishing effort observed) differ between the otter and skimmer trawl fleets for calculating mortality rates by gear type. From 2011-2015, we observed 13 sea turtles released dead from otter trawls fishing with TED-equipped nets (https://www.fisheries.noaa.gov/webdam/download/93552747), while during 2012-2015 we observed 3 sea turtles released dead from skimmer trawl vessels fishing without TEDs. During the respective periods, however, we observed 86,658 hours of effort on otter trawlers (E. Scott-Denton, NMFS, pers. comm.), while only 2,699 hours of effort were observed on skimmer trawl vessels. That equates to one observed dead turtle released every 6,666 hours on otter trawlers versus one observed dead turtle released every 900 hours on skimmer trawl vessels. This indicates considerably more observed lethal sea turtle interactions with skimmer trawl vessels than otter trawlers.

A new analysis of sea turtle bycatch and bycatch mortality in the otter trawl shrimp fisheries (Babcock et al. 2018) indicates bycatch by otter trawlers is significantly lower than previously estimated in past biological opinions. Furthermore, the results suggest that skimmer trawlers working without TEDs may result in more sea turtle mortalities than otter trawlers working with TEDs, even with lower total annual effort. This information is discussed in more detail in the FEIS.

Comment 39: A six-month delay in effectiveness is unrealistic given NOAA's own data indicates it would take more than two years to fabricate enough TEDs for vessels to use.

Response: We agree, and while the estimates are based on the best available information, we acknowledge that there is considerable uncertainty associated with estimating how many new TEDs will actually be installed, as well as how quickly the necessary TEDs will be constructed. TED production time was one of the factors considered when we decided to change the preferred alternative to one that will affect nearly 82 percent fewer vessels and require much less production time for the necessary number of TEDs. We also have extended the delay in effectiveness until April 1, 2021.

Comment 40: NOAA must maintain oversight over the electronic logbook data program.

Response: Electronic logbooks (ELBs) are required under a fishery management plan developed by the Gulf of Mexico Fishery Management Council, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act, only on selected vessels with a Federal Gulf of Mexico shrimp moratorium permit. The vast majority of vessels that use skimmer trawls do not have Federal permits and, thus, are not required to use ELBs. While we do maintain effective oversight over the ELB program, the program itself is not associated with this final rule.

Comment 41: NOAA's proposed regulation is discriminatory against certain fishers since it maintains tow times for bait shrimpers.

Response: The proposed regulation, as well as the final rule, focuses on the segments of the shrimp fisheries that are documented to have levels of bycatch mortality that can be reduced using TEDs. The bait shrimp fishery operates with tow times shorter than the alternative tow-time requirements per 50 CFR 223.206(d)(2)(ii)(A), to ensure shrimp are captured and transferred to a live well alive and in good condition. Based on this information, we determined the bait shrimp fishery presents a low risk of sea turtle bycatch and mortality and does not warrant additional restrictions at this time.

Comment 42: Biscayne Bay wing net vessels should be restricted to a maximum tow time of 10 minutes with observers to evaluate potential bycatch issues.

Response: Biscayne Bay wing nets are limited by state law to a frame size much smaller than frames of wing nets in other states. They also fish by sight in surface waters, and use nets constructed of light monofilament webbing. We have initially concluded this fishery may not present a threat to sea turtles. However, further investigation is needed to make a final determination.

Comment 43: Beam trawl vessels operating in the Corpus Christi Bay, Texas bait shrimp fishery should be exempt from the proposed TED requirements, similar to the Biscayne Bay wing net fishery exemption.

Response: Beam trawl vessels are exempt from existing TED requirements if they comply with provisions at 50 CFR 223.206(d)(2)(ii)(B)(1). The proposed and final regulations do not change the requirements for beam trawlers, which are currently required to fish with TEDs, excluding those that comply with the aforementioned exception.

Comment 44: TED requirements present safety issues when used on small vessels (e.g., walking out on frames to remove debris snagged in TEDs, extension can result in net getting entangled in the propeller, etc.).

Response: The TED is installed just in front of where the tail bag is brought alongside or onboard the vessel for dumping, so walking out on frames to remove debris from the TED is unnecessary. Further, this rule exempts skimmer trawl vessels less than 40 feet in length to allow us additional time to examine issues related to TED use on these smaller vessels, including potential safety issues, which may be more significant for them. Skimmer trawl vessels less than 40 feet in length will continue to be required to comply with the existing tow time requirements.

Comment 45: An installed TED on a small vessel may introduce issues with dumping the catch, as the TED extension may prevent the net from fully clearing the surface and complicate hauling it on deck. If the vessel is moving during the process, the TED may cause the net to twist tight, further complicating the situation.

Response: Skimmer trawl vessels less than 40 feet in length are exempt from the TED requirement in this final rule, but must continue to comply with the existing tow time requirements. We intend to examine issues that may be unique to these vessels to determine methods to mitigate those issues in the future. With respect to a twisting net, we found during TED testing this can be alleviated by either changing the location of the lazy line attachment on the trawl or changing the lifting point in the rigging to allow the TED to clear the water during haul back.

Comment 46: TEDs installed in skimmer nets exhibit a rolling action that twists the net and closes it, making it ineffective at catching anything.

Response: This rule will only authorize top-opening TEDs. Top-opening TEDs often begin with a half twist in the net when deployed. During active fishing with skimmer frames lowered and nets and bullets deployed, water flow opens the trawl and causes the TED to untwist and adjust into the proper fishing position. We anticipate that fishers will have to become familiar with how TEDs function and behave in their nets or under their specific fishing conditions, and adjust their activities to ensure their nets with installed TEDs are fishing correctly.

Comment 47: Excessive debris such as crab traps and tree limbs will accumulate on the TED grid and result in excessive catch loss.

Response: We acknowledge that the inshore/nearshore skimmer trawl fisheries encounter more debris while fishing compared to the offshore shrimp fisheries. Abandoned crab traps and debris, particularly debris after storms, currently present issues for skimmer trawl vessels. TEDs may actually help exclude some of this debris. In situations where there are numerous abandoned crab traps or excessive debris, fishers regularly check their nets to ensure entrained traps and debris are not negatively affecting their catch rates. We expect fishers to continue this practice with TEDs installed in their nets. Depending on the net and TED size, the diameter of the trawl just ahead of the TED is not large enough to allow crab traps or large debris to reach the TED. The use of TEDs facilitates crab trap and debris removal, alleviating the need for zippers that typically are used in skimmer trawls for debris removal, as discussed in response to Comment 7.

Comment 48: The proposed tow time definition presents issues for vessels without hydraulics (i.e., time to raise/lower gear) or for small vessels due to safety (e.g., raising and lowering rig constantly presents stability issues).

Response: We agree the proposed tow time definition may present issues for small vessels or vessels rigged without hydraulics. As a result, we have amended the tow time definition in this final rule to avoid issues related to constantly raising and lowering the skimmer trawl rig.

Comment 49: Small vessels cannot use a standard TED grid and need a smaller grid to fit in the nets.

Response: In response to comments relating to the feasibility of using TEDs on small vessels, and because we have not comprehensively tested TEDs on small vessels, we have changed our preferred alternative. As a result, skimmer trawl vessels less than 40 feet in length will have to continue to follow the tow time requirements. We will examine this and other issues related to TED use on small vessels and present solutions or adaptations to these potential issues so that TEDs could be effectively used on these smaller vessels in the future.

Comment 50: In some skimmer vessels, the entire net would have to be specially made to fit effective TEDs in the net.

Response: Nets used on skimmer trawl vessels 40 feet and greater in length can accommodate a standard TED, and as discussed in response to Comment 20, necessary modifications to rigging, if any, are expected to be minor.

Comment 51: Some skimmer vessels use A-frame rigging designed for short nets. The use of TEDs would require lengthening the net, and modifications to the A-frame rigging to pick up the nets, which could cost anywhere from $1,000-$10,000, depending on the size of vessel, extent of change, and costs of material and labor.

Response: The installation of a TED into a skimmer trawl adds four to five feet of length to the trawl. It may be necessary to install the TED farther forward in the trawl to partially compensate for the added length. Adjusting the lazy line attachment point on the tailbag may also be necessary to compensate for the added length. Each of these adjustments alleviates the need to change rigging configurations to compensate for TED installation.

Comment 52: The use of TEDs by small vessels with limited horsepower would slow the boat down to the point it would be ineffective.

Response: We do not expect skimmer trawl vessels to have difficulty pushing nets with TEDs installed due to limited horsepower. These vessels are typically powered to move trawls that contain significant amounts of catch. This catch increases the drag on the vessel. The addition of a TED is inconsequential with respect to the drag in the net relative to the catch. Instead, drag is reduced through TED use by reducing the amount of bycatch entrained in the net.

Comment 53: Fishers have serious concerns that TEDs would not work on their type or size of vessel and result in them having to convert to otter trawls, which would cost $20,000-$30,000.

Response: Results of TED testing indicates that TEDs will work effectively on vessels encompassed by this final rule (i.e., skimmer trawl vessels 40 feet and greater in length). We do not believe the associated economic effects of TED use in skimmer trawls are sufficient to make switching gears necessary, particularly considering TEDs are already required in the otter trawl fisheries.

Comment 54: NOAA needs to prepare a detailed enforcement plan, including the number of officers and vessels needed; minimum/maximum enforcement levels by time and area; the use of partner agencies, observers, and trained volunteer patrols; use of onboard cameras; implementation of emergency closures if enforcement (compliance) is not adequate; and other approaches to achieve a 94 percent TED compliance level.

Response: Our Office of Law Enforcement (OLE) is committed to enforcing the laws and regulations associated with TEDs. On a continuing basis, OLE management is evaluating how it can best use its resources in meeting OLE's overall mission of protecting the marine resources of the United States. OLE meets this mission through formal and informal relationships with other enforcement partners. TED compliance is but one regulatory requirement OLE and its partners are responsible for enforcing. We have had extensive discussions on this subject with our enforcement partners, and have developed a TED Compliance Policy that we also intend to integrate for the skimmer trawl fisheries. The TED Compliance Policy (https://www.fisheries.noaa.gov/webdam/download/93552419) outlines what data will be used, the time periods for calculating compliance, and discusses measures that would be taken if TED effectiveness falls below the TED compliance thresholds designated in the April 18, 2014, biological opinion on the southeastern shrimp fisheries.

Comment 55: NOAA should conduct a detailed analysis of sea turtle abundance, fishing effort, and stranding patterns to determine hotspots of sea turtle mortality in the fishery.

Response: A detailed analysis of sea turtle mortality hot spots would be a valuable exercise. But given the annual variability in sea turtle distribution, population size, and seasonal influences such as water temperature, wind speed and direction, and prey availability, as well as numerous other factors, the recommended analysis would not likely change how this rule is implemented. The use of TEDs can significantly reduce fishery-related bycatch and mortality on a regular basis, regardless of variability in sea turtle distribution, hence it is our preferred action over other alternatives considered in the DEIS and FEIS.

Comment 56: NOAA should investigate and promptly enact appropriate time and area closures for the fishery to protect important sea turtle habitat and populations.

Response: We regularly investigate all significant events in an attempt to learn the causative factor(s) for sea turtle mortality. In some cases, these factors are not readily identifiable, even after several years of investigation. If we determine an activity or source of mortality and habitat impacts can be prevented or mitigated by time/area closures, we would explore that option at the appropriate time based on available information.

Comment 57: TED use should be based on inside/outside waters as defined by the Louisiana Statutes 45:495, and only required in outside waters.

Response: Fisheries observer data from skimmer trawl vessels demonstrate that sea turtles occur within areas defined as inside waters by the Louisiana Statutes. The inside/outside waters definition also does not correlate with bathymetric or other sea turtle habitat preferences in a manner that lends itself to practical consideration. This recommendation would not effectively achieve our recovery goals and objectives of reducing bycatch and mortality of sea turtles in the shrimp fisheries.

Comment 58: Maintain existing tow times and enforce them through mandatory use of electronic vessel monitoring.

Response: The use of electronic vessel monitoring systems (VMS) is a potential management option, but one that was not considered due to the inherent difficulties in requiring such a system on thousands of vessels of differing sizes and configurations. Whereas VMS could be more effective on a more homogenous fleet of larger vessels, we determined it was not viable for the skimmer trawl fisheries. We have also looked at other options, such as a data logger to monitor tow times. However, since the revised tow time definition included in this final rule allows the frame to continually fish, it is impractical to configure a data logger to monitor tow times. We have documented that sea turtle bycatch and mortality, including post-interaction mortality, can occur within the allowable tow time limits. Therefore, TEDs represent the most effective measure to reduce sea turtle bycatch and mortality in these fisheries.

Comment 59: NOAA should provide TEDs to all fishers and allow a one-year trial period before making the requirement effective.

Response: We are currently exploring avenues for financial support that could provide TEDs to affected fishers. We do expect that affected fishers could receive assistance from the Fishery Finance Program, which could provide low-interest loans for fishers to purchase the required TEDs, although the program has not been used for this type of gear purchase in the past. Given the number of fishers affected and number of TEDs required, we are delaying effectiveness of this final rule until April 1, 2021. While this delay in effectiveness is not considered a trial period, it does provide fishers additional time to adapt to fishing with TEDs in their specific fishing conditions.

Comment 60: NOAA should have mitigation measures for the loss of shrimp due to TED use, as well as economic assistance to purchase TEDs. NOAA should explore opportunities to provide fishers TED training or TEDs with funding allocated to one or more of the Trustee Implementation Groups under the DEEPWATER HORIZON oil spill program.

Response: As previously mentioned in Comment 59, we are exploring measures to provide financial support for affected fishers to acquire TEDs. We have also considered the need for outreach and training efforts to assist fishers with the installation and maintenance of TEDs in their nets. We will be scheduling and announcing future TED training workshops to be conducted during the phase-in period.

Comment 61: NOAA needs to conduct a sea turtle stock assessment to determine population levels to determine if additional regulations are necessary.

Response: We disagree with this comment. While stock assessments for all sea turtle species would be beneficial for management purposes, we are mandated to implement management measures deemed necessary and advisable to recover threatened and endangered species under our purview. Given that fisheries observer data indicates sea turtle bycatch and mortality is occurring in the skimmer trawl fisheries, delaying management action to conduct stock assessments is not warranted.

Comment 62: If TEDs are required, implementation should be phased in over two to three years by breaking vessels into size classes or based on landings.

Response: We considered public comments such as this when determining how to implement the final rule. Since the revised final rule affects approximately 82 percent fewer fishers than the preferred alternative in the DEIS, we determined a single delayed implementation date would be most appropriate for fishers, management, and enforcement since this alternative requires much less production time for the necessary number of TEDs.

Comment 63: Due to issues with debris clogging in shallow water and the assumption a TED would lose angle, thereby increasing catch loss, NOAA should exempt TED use in waters 2-4 feet in depth.

Response: As mentioned in our response to Comment 7, TED testing aboard commercial vessels indicates that TEDs operate effectively in depths as shallow as 2 feet. Therefore, an exemption based on water depth is not warranted.

Comment 64: NOAA should exempt all skimmer trawls less than 40 feet in length from the TED requirements.

Response: Based on public comment and further deliberation, we revised our final rule to exempt skimmer trawl vessels less than 40 feet in length.

Comment 65: NOAA should look at other sea turtle issues such as vessel impacts, pollution, explosive demolition of oil rigs, and other fisheries including recreational fisheries, etc.

Response: Sea turtles face a variety of threats including vessel impacts, pollution, and bycatch in other fisheries. We address the impacts of various threats to sea turtles, and several other management actions that mitigate these impacts on sea turtle populations are discussed in Section 3 of the DEIS and FEIS.

Comment 66: Ban trawlers.

Response: We believe the use of TEDs in trawl nets reduces sea turtle bycatch in these fisheries to acceptable levels, which meets our goals and objectives for sea turtle conservation. A ban on all trawl gear is an extreme measure not warranted to support sea turtle conservation.

Comment 67: The TED implementation strategy should be based on what provides the greatest conservation benefit, and a phased approach may be necessary.

Response: Based on public comments raising performance and safety issues with TED use on smaller vessels and regarding the economic impacts of the proposed rule, and new information indicating significantly lower levels of sea turtle mortality in the offshore fleet, we have revised the regulation to now limit the TED requirements to skimmer trawl vessels 40 feet and greater in length. The more focused scope of the final rule will allow for faster implementation of the TED requirement and is expected to result in a significant conservation benefit of 801-1,168 sea turtles annually in the Southeastern U.S. shrimp fisheries. We may address other trawls, such as pusher-head trawls, wing nets, and try nets, as well as small skimmer trawl vessels, in future rulemaking.

Comment 68: Double rig trawlers should be banned in the lakes and inside waters.

Response: Double rig (otter) trawlers are currently required to use TEDs in their nets. As state shrimp fishery management issues unrelated to sea turtle bycatch and mortality are outside the purview of this action, we do not have any additional response to this comment.

This final rule has been determined to be significant for purposes of Executive Order 12866 because it may raise novel legal or policy issues out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. This significant regulation is considered regulatory under Executive Order 13771. Depending on the assumptions used, the estimated cost of this rule in 2016 dollars is between 3.24 and 3.85 million. A discussion on the basis for these estimates is in the FEIS.

We prepared a FRFA, as required by Section 603 of the Regulatory Flexibility Act (RFA), for this final rule. The FRFA describes the economic effects this final rule would have on small entities. A description of the action, why it is being considered, the objectives of, and legal basis for this final rule are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A copy of the full analysis is available from us (see ADDRESSES). A summary of the FRFA follows.

The ESA provides the statutory basis for this final rule. We did not receive any comments from the U.S. Small Business Administration's Office of Advocacy on the IRFA in the proposed rule. We received 18 comments from the public regarding the IRFA in the proposed rule and the economic effects analysis in the DEIS; see comments 11-28 in the preamble of this rule. Comment 39 regarding the delay in the effectiveness of this rule is also germane. These comments and our responses are incorporated here by reference. The preferred alternative and the tow time definition in this final rule were changed from the proposed rule, based in part on these comments. The reasons for these changes are discussed in the preamble and also incorporated here by reference.

No duplicative, overlapping, or conflicting Federal rules have been identified. This final rule would not establish any new reporting, record-keeping, or other compliance requirements beyond the requirement to use a TED when vessels 40 feet and greater in length use skimmer trawls to harvest shrimp in the southeastern United States. The net manufacturer typically installs TEDs, so fishers are not expected to have special skills. Some learning will likely be necessary for the maintenance and routine use of TEDs by fishers who have not historically had to use these devices. TEDs have been required in otter trawls for many years. A majority of the vessels directly regulated by this rule also used otter trawls between 2011 and 2014. Thus, many if not most vessel owners and captains are expected to be knowledgeable of how to maintain and use TEDs. As a result, the skills required for TED use are thought to be consistent with the skillset and capabilities of commercial shrimp fishers in general and special professional skills would not be expected to be necessary. Further, we plan to engage in significant outreach efforts (e.g., TED workshops and complimentary inspections by our Gear Monitoring Team) to educate owners and captains of affected skimmer vessels regarding how to use and maintain TEDs.

This final rule is expected to directly regulate businesses that operate vessels 40 feet and greater in length using skimmer trawls in the southeastern U.S. shrimp fisheries (North Carolina through Texas). An estimated 1,062 vessels use this gear (1,047 vessels in the Gulf of Mexico and 15 vessels in the South Atlantic). Although some vessels are known to be owned by businesses with the same, or substantially the same, individual owners and, thus, would be considered affiliated, ownership data is incomplete. It is not currently feasible to accurately determine the number of individual businesses these 1,062 vessels represent. While it will result in an overestimate of the actual number of businesses directly regulated by this rule, for the purposes of this analysis, we assume that each vessel is independently owned by a single business and, thus, the terms vessels and businesses are used interchangeably. Therefore, we expect this rule to directly regulate 1,062 businesses.

The average annual gross revenue (2014 dollars) over the period 2011-2014 for vessels 40 feet and greater in length that harvested shrimp using skimmer trawls was approximately $76,529 for vessels in the Gulf of Mexico (1,047 vessels) and $258,756 for vessels in the South Atlantic (15 vessels). The largest average annual gross revenue earned by a single business over this period was approximately $1.85 million. We have not identified any other small entities that might be directly affected by this regulatory action.

On December 29, 2015, we issued a final rule establishing a small business size standard of $11 million in annual gross receipts (revenue) for all businesses primarily engaged in the commercial fishing industry (NAICS code 11411) for RFA compliance purposes only (80 FR 81194, December 29, 2015). The $11 million standard became effective on July 1, 2016, and replaces the prior Small Business Administration standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors of the U.S. commercial fishing industry in all our rules subject to the RFA after July 1, 2016 (Id. at 81194). In addition to this gross revenue standard, a business primarily involved in commercial fishing is classified as a small business if it is independently owned and operated, and is not dominant in its field of operations (including its affiliates). Based on the information above, all businesses directly regulated by this rule are determined to be small businesses for the purpose of this analysis.

This final rule is expected to directly regulate all commercial fishing entities operating vessels 40 feet and greater in length that use skimmer trawls in the southeastern U.S. shrimp fisheries, or an estimated 1,062 businesses. Data from 2011 through 2014 indicate that 9,711 vessels (8,401 in the Gulf of Mexico and 1,310 in the South Atlantic) participated in the southeastern U.S. shrimp fisheries during this time. Thus, this rule would directly regulate about 11 percent of the vessels in these fisheries, which is considered a substantial number based on existing guidance. As previously discussed, all of these affected entities have been determined, for the purpose of this analysis, to be small entities. Therefore, we determine that this rule would affect a substantial number of small entities.

This final rule would require all commercial fishing businesses that operate vessels 40 feet and greater in length using skimmer trawls in the southeastern U.S. shrimp fisheries (North Carolina through Texas) to use TEDs designed to exclude small sea turtles when shrimping. These TEDs successfully result in the reduced bycatch of small sea turtles, but they also result in shrimp loss and, thus, reduced shrimp harvest per tow. Although it may be theoretically possible to compensate for this reduction in harvest with additional effort (i.e., more tows or trips), increasing effort will also increase operating costs. With the exceptions of 2013 and 2014, the differential between shrimp and fuel prices has generally been very small in the past several years and, therefore, vessels are already operating on small positive or negative economic margins. Increasing effort is therefore likely to be economically risky in the short term, particularly for vessels that only or primarily harvest after season openings because catch per unit of effort steadily declines over the course of a trip and a season and thus the additional revenue from each tow or trip steadily declines as well. Further, if additional effort was cost-effective or profitable, this effort would already be occurring and part of baseline fishing behavior. Therefore, we do not expect that individual vessels would or could compensate for lost shrimp and the associated gross revenues by increasing effort.

Vessels affected by this final rule would likely experience economic losses from two sources: Reduced shrimp revenue resulting from loss of shrimp catch caused by the use of TEDs and increased gear costs associated with the purchase, installation, maintenance, and replacement of newly required TEDs. Revenue loss from reduced shrimp harvest is expected to be recurring, barring changes in fishing practices, and the increased gear costs due to the purchase and installation of TEDs are expected to occur in the first year (i.e., prior to the effective date of this rule). Under normal use and proper maintenance, a TED would last more than three years and likely much longer for many vessels. In addition, TEDs can often be repaired by the owner or operator if they have or can easily obtain the proper knowledge. TEDs have been required in otter trawls for many years and a majority of the vessels directly regulated by this regulatory action also used otter trawls between 2011 and 2014. Thus, many if not most vessel owners and captains are expected to be knowledgeable of how to maintain and use TEDs. Further, we plan to engage in significant outreach efforts to educate the owners and captains of affected skimmer vessels regarding how to use and properly maintain TEDs. Therefore, TED costs are not assumed to recur on an annual basis.

In this analysis, we assume the average shrimp loss to be 6.21 percent (estimated range of 3.07-10.61 percent), the estimated cost per TED is $325 for small vessels (vessels less than 60 feet) and $550 for large vessels (vessels 60 feet or longer), and vessels are assumed to purchase/carry enough TEDs for the nets towed plus one spare set. Therefore, the actual effects of this final rule on individual vessels will vary based on gear purchase decisions (e.g., how many nets are used, how many spares are kept, and how many TEDs are purchased) and individual performance. Individual vessels may experience higher or lower shrimp loss than the average given their experience with TEDs. For example, fishers that have not traditionally had to use TEDs may initially experience shrimp loss greater than the average, which could persist until they become more familiar with the equipment, while shrimp loss for those who have experience with TEDs may be below the average.

Further, in this analysis, we expect neither the ex-vessel price per pound of shrimp nor the cost per TED to change in response to supply and demand conditions. Specifically, the estimated decrease in the harvest of domestic shrimp from catch loss due to the use of TEDs is not expected to result in an increase in the ex-vessel price of domestically-harvested shrimp, nor do we expect an increase in the average price (cost) of a TED. The maximum estimated number of TEDs necessary to outfit all of the vessels regulated by this regulatory action is 4,242. The assumed stability in shrimp ex-vessel prices is based on the fact that imported shrimp dominate the U.S. market and available evidence suggests the demand for shrimp is highly elastic. Whether the price of TEDs increases and the magnitude of that increase will be determined by the number of available producers (there are currently six), their capacity to meet demand (each can currently produce 20 TEDs per week), the timeframe for compliance, and the total number of TEDs needed. The total number of TEDs needed will be affected by vessel owners' purchase decisions and the number of vessels that can successfully remain in operation in the face of the higher operating costs and reduced revenue. Though not expected, if the ex-vessel price of shrimp increases due to reduced supply, this analysis will overstate the adverse economic effects of lost shrimp revenue. Conversely, if the price of a TED increases, the adverse economic effects associated with TED costs will be understated.

Because the increased gear costs associated with purchasing TEDs would be incurred in the first year but only periodically thereafter, whereas shrimp loss would recur on each trip in every year, the following analysis focuses on first-year results (i.e., results that include both TED purchase costs and shrimp revenue reduction). The adverse effects in subsequent years will be less than those in the first year. As previously stated, effects in subsequent years would be expected to vary with fishing adaptations (e.g., fishers may become more skilled in how the nets with TEDs are fished, thereby reducing shrimp loss), as well as unpredictable and unknown TED replacement schedules. In this analysis, all of the monetary effects provided are in 2014 dollars.

Over all of the businesses expected to be affected (1,062 vessels), this final rule would be expected to result in a reduction in gross revenue of approximately $2.29 million, TED costs of approximately $1.38 million, and thus a total adverse effect of approximately $3.67 million in the first year, assuming no vessels cease operations as a result of this rule. The average adverse effects per vessel in the first year would be $2,159 lost gross revenue and $1,298 in TED costs, and, thus, the average total adverse effect per vessel would be $3,457. These effects are not expected to be uniform across Gulf of Mexico and South Atlantic vessels. The 1,047 vessels in the Gulf of Mexico are expected to experience average adverse effects of $2,184, $1,298, and $3,482 in the first year with respect to lost gross revenue, TED costs, and total adverse effects, respectively. In general, the comparable values for the 15 South Atlantic vessels are much less at $429, $1,300, and $1,729, respectively.

However, these values insufficiently capture the range of differences in the economic performance of vessels across the fisheries. To examine these differences, we placed vessels in a category based on their average annual gross (total) revenue from 2011-2014. These categories are based on vessel categories developed for or derived from the annual economic reports for Federally-permitted vessels in the Gulf of Mexico and the South Atlantic, and a 2014 economic report for non-Federally-permitted vessels in the Gulf of Mexico. Vessels were placed in the category that their average annual gross revenue most closely approximated. In the South Atlantic, the distribution of gross revenue between shrimp and non-shrimp species was also taken into account.

In the Gulf of Mexico, vessels were placed into one of six categories: Average Federally-permitted vessel (Federal Gulf of Mexico), Q5, Q4, Q3, Q2, and Q1. Specifically, in the Gulf of Mexico, the average annual gross revenue ranges for the Federal Gulf, Q5, Q4, Q3, Q2, and Q1 categories are as follows: >/=$255,000, <$255,000 and >/=$119,000, <$119,000 and >/=$52,000, <$52,000 and >/=$29,000, <$29,000 and >/=$17,000, and <$17,000. In the South Atlantic, vessels were placed into nine categories: Rock shrimp (RSLA), primary penaeid (SPA Primary), secondary penaeid (SPA Secondary), average Federally-permitted South Atlantic penaeid vessel (AS), Q5, Q4, Q3, Q2, and Q1. A vessel was placed in the RSLA category if 50 percent or more of its gross revenue came from shrimp and its average annual gross revenue was >/=$456,000. A vessel was placed in the AS category if 50 percent or more of its gross revenue came from shrimp and its average annual gross revenue was <$456,000 and >/=$216,000. A vessel was placed in the SPA Primary category if 50 percent or more of its gross revenue came from shrimp and its average annual gross revenue was <$216,000 and >/=$119,000. Finally, a vessel was placed in the SPA Secondary category if <50 percent of its gross revenue came from shrimp and its average annual gross revenue was >/= $119,000. The ranges are the same as in the Gulf of Mexico for the Q5, Q4, Q3, Q2, and Q1 categories.

These categories should not be presumed to imply that every vessel in a particular category has a particular permit associated with the category name, as that is not always the case. Among these vessel categories for vessels in both areas, vessels in the Q1, Q2, and Q3 categories are considered, for the purpose of this analysis, as part-time commercial shrimp vessels (i.e., vessels that are only engaged in commercial fishing part-time) and vessels in each of the other categories are considered full-time vessels.

For Gulf of Mexico vessels, the number of vessels expected to be directly regulated by this final rule and their average annual gross revenue for 2011-2014 by category are as follows: 265 vessels and $6,661 (Q1), followed by 116 vessels and $23,060 (Q2), 169 vessels and $39,947 (Q3), 303 vessels and $80,411 (Q4), 139 vessels and $163,311 (Q5), and 55 vessels and $397,640 (Federal Gulf of Mexico). The expected average adverse effect (reduced shrimp revenue and TED cost) of this regulatory action in the first year for these vessels by category is $1,615, $2,175, $2,697, $4,677, $6,450, and $3,558 for vessels in each category, Q1-Q5 and Federal Gulf of Mexico, respectively.

Although the average adverse effects of this final rule could be compared to the average gross revenue to generate an estimate of the average relative (percent) effect of the rule by category, this “average to average” approach (average adverse effect/average gross revenue for each category) would provide a distorted perspective of the actual expected effects of this rule at the vessel level. For example, using this “average to average” approach for category Q1, the average estimated adverse effect of this rule would be approximately 24 percent ($1,615/$6,661), and thus the projected average adverse effect of this rule per vessel in the Q1 category would be 24 percent of average annual gross revenue). Although this outcome would not likely be considered insignificant, examination of the adverse effect by vessel (adverse effect/average gross revenue for that vessel), then averaged across all vessels, provides a much clearer picture of the expected economic burden of this regulatory action because it accounts for the heterogeneity of vessels within categories. Using this approach, the relative adverse effect of this rule as a percentage of average annual gross revenue increases to 85 percent for vessels in the Q1 category. This result demonstrates that most of these vessels generate minimal fishing revenue year-to-year, and the costs of the TEDs alone are likely to be financially unbearable even before factoring in the loss of shrimp revenue. Applying this approach (analysis at the vessel level, then averaging across all vessels) to all revenue categories for Gulf of Mexico vessels, the percent loss relative to gross revenue would be expected to be 85 percent (Q1), 9.5 percent (Q2), 6.9 percent (Q3), 5.9 percent (Q4), 4.2 percent (Q5), and 1.1 percent (Federal Gulf of Mexico). These results demonstrate that, although the expected effects in absolute monetary terms are greater for the vessels that generate the highest average annual gross revenues and are considered full-time vessels (i.e., Q4, Q5 and Federal Gulf of Mexico vessels), the relative effect of this rule would be greater on part-time vessels with the lowest average annual gross revenues (i.e., Q1, Q2, and Q3 vessels).

The number of South Atlantic vessels expected to be directly regulated by this final rule and, where disclosable, their average annual gross revenue for 2011-2014 by category are as follows: 4 vessels and $5,832 (Q1) vessels, 5 vessels and $70,860 (Q4), and 3 vessels and $835,270 (RSLA). In addition, 1 vessel in the SPA Secondary category and 2 vessels in the Q2 category are expected to be affected. Because the expected number of businesses affected by this regulatory action in the SPA Secondary and Q2 categories is so small, neither baseline economic information nor expected economic effects directly derived from that baseline economic information can be reported for these entities due to confidentiality restrictions. The expected average adverse effect (reduced shrimp revenue and TED cost) of this regulatory action in the first year for these vessels is $1,378, $2,180, and $1,308 for vessels in the Q1, Q4 and RSLA categories, respectively. Using the same vessel-level analytical approach discussed above for Gulf of Mexico vessels, the percent loss relative to gross revenue expected for South Atlantic vessels by category is 77.5 percent (Q1), 7.9 percent (Q2), 3.4 percent (Q4), 0.2 percent (RSLA), and 0.1 percent (SPA Secondary). Using the same vessel-level analytical approach discussed above for Gulf of Mexico vessels, the percent loss relative to gross revenue expected for South Atlantic vessels by category would be 69.1 percent (Q1), 7.6 percent (Q2), 4.9 percent (Q3), 2.8 percent (Q4), and 0.2 percent (RSLA). Although the expected effects in absolute monetary terms for the South Atlantic vessels do not follow as markedly the same pattern as those for Gulf of Mexico vessels, full-time vessels in the South Atlantic would generally be expected to experience greater average adverse effects than part-time vessels. However, the range of the difference is only several hundred dollars for South Atlantic vessels and not thousands of dollars as expected in the Gulf of Mexico. Further, although the relative effects in general are not expected to be as great for South Atlantic vessels, the relative effects on the part-time vessels in the South Atlantic still exceed those of full-time vessels. Although the effects on some South Atlantic part-time vessels may be so great as to render continued operation as a commercial fishing vessel economically infeasible, as with some part-time vessels in the Gulf of Mexico, only 6 part-time vessels are affected in the South Atlantic.

The average lifespan of a TED is inversely related to how often it is used for harvesting shrimp (i.e., the more it is used in a particular period of time, the shorter its lifespan will be). At some point over the 10-year time period considered in the analysis, there will be recurring TED costs for the Q2, Q3, Q4, and Q5 vessels, the frequency of which will vary with the average number of days they shrimp in each year level. Because the Q4 and Q5 vessels spend more days shrimping in a year on average, they will experience recurring TED costs more often than the Q2 and Q3 vessels. The Q1 vessels are not expected to experience recurring TED costs in this analysis because TEDs are expected to last about 15 years due to the relatively small number of days they spend shrimping on average in any given year.

In spite of the results presented above, the preceding analysis does not assume nor conclude that any specific individual or total number of vessels would be expected to stop operating in the southeastern U.S. shrimp fisheries because of this final rule. However, the vessels most likely to shut down because of these adverse effects are the part-time vessels (i.e., Q1, Q2, and Q3 vessels). These vessels have the lowest average annual gross revenues per vessel, are thought to earn relatively high negative net revenues (losses) on average, and are, therefore, the least able to absorb revenue reductions and cost increases. On the other hand, at least some of these vessels continued to commercially harvest shrimp in 2013 and 2014 after experiencing relatively high losses in 2012. This suggests either available data incompletely captures the “economics” of these operations (e.g., the value of shrimp retained for personal consumption or bartering purposes is not considered), or the decision to harvest shrimp is based on criteria other than, or in addition to, considerations of economic profit and loss, such as personal consumption of harvested shrimp and associated value and lifestyle bonus (i.e., the value of the commercial fishing lifestyle).

Nonetheless, in theory, vessels and businesses in general are expected to shut down when they cannot cover their variable costs. However, data on variable costs is not available for all vessels affected by this final rule. Estimates of average variable costs for a relatively small sample of the affected vessels are available, as are estimates of net revenues, but those estimates are insufficient with respect to determining how many and which vessel owners may choose to stop operating. Thus, the most appropriate measure to use for projecting how many and which vessels may stop operating is the percentage loss in average annual gross revenue, estimates of which are available for all of the affected vessels.

There is no single “hard and fast” decision rule for determining what percentage loss in gross revenue will definitively cause a vessel or any other business to stop operating. However, given the characteristics of the part-time vessels as noted above, it is reasonable to assume that an adverse effect (i.e., the combination of additional costs and revenue reductions) in the first year that represents more than 20 percent of their average annual gross revenue would be sufficient to cause them to shut down. Applying this assumption to the vessels affected by this rule results in the following findings.

The number of part-time skimmer trawl vessels 40 feet and greater in length projected to potentially shut down in the Gulf of Mexico is 178, or approximately 2 percent of the 8,401 shrimp vessels in the Gulf of Mexico, 17 percent of the 1,047 affected shrimp vessels in the Gulf of Mexico, and about 32 percent of the 550 part-time shrimp vessels affected in the Gulf of Mexico. The number of part-time vessels projected to shut down in the South Atlantic is only 2, or approximately 0.1 percent of the 1,310 shrimp vessels in the South Atlantic, 13 percent of the 15 affected vessels in the South Atlantic, and one-third of the 6 part-time shrimp vessels affected in the South Atlantic. As some uncertainty exists with respect to how business owners will respond, these estimates should be viewed with some caution.

In general, if vessels shut down, they will no longer be landing shrimp or other species, nor will they be generating gross revenues or net revenues associated with those landings (i.e., their loss in landings and gross revenue is 100 percent). Further, the average percentage loss in annual gross revenue per vessel will in turn increase, particularly in the long term because shutting down causes a long-term reduction in landings and gross revenue for the vessels that shut down. In theory, the loss of net revenues may improve or worsen average economic performance within the affected group of vessels depending on whether the economic performance (as measured by net revenues) of the vessels that shut down is better or worse than the average affected vessel. Because the vessels shutting down are thought to experience relatively high losses, average net revenues for those that continue operating would be expected to improve. On the other hand, because vessels that shut down will no longer require TEDs, the number of TEDs needed, the total costs of purchasing those TEDs, and the average cost of TEDs per affected vessel will decrease. The decrease in TED costs will help to mitigate the adverse effects across all vessels, but the losses in gross revenue would generally be expected to far outweigh the reductions in TED costs and thus the average adverse effect per affected vessel would be expected to increase. Further, the reductions in total TED costs would not reduce such costs for the vessels that continue operating as those would be expected to remain unchanged.

Seven alternatives, including no action, were considered for this final rule. The first alternative (no action) to the rule would not expand the required use of TEDs. The “no action” alternative would not achieve the objective of reducing the incidental bycatch and mortality of ESA-listed sea turtles, particularly small sea turtles, in the southeastern U.S. shrimp fisheries in order to aid in protection and recovery.

The second alternative to the final rule would have expanded the required use of TEDs to vessels 26 feet and greater in length using skimmer trawls, pusher-head trawls, and wing nets (butterfly trawls) to harvest shrimp in the southeastern U.S. This alternative was not selected as it would have been expected to affect more vessels (3,103) and increase the total expected TED costs and shrimp revenue loss compared to this rule. In addition, this alternative would have potentially caused an additional 680 part-time vessels to cease operations, and it would have taken almost 1.5 additional years to produce the number of TEDs necessary for all vessels to comply compared to this rule. This alternative was also not selected because, to date, we have no fishery observer data or TED testing information on any vessels using pusher-head trawls or wing nets in the southeastern U.S. shrimp fisheries. Concerns were expressed about applying data regarding the use of TEDs in skimmer trawl operations to pusher-head trawls and wing nets. New information indicated significant differences in the manner pusher-head trawls and wing nets operate compared to skimmer trawls, and therefore we determined additional gear testing is needed for those types.

The third alternative to the final rule would have expanded the required use of TEDs to vessels that use skimmer trawls, pusher-head trawls, and wing nets (butterfly trawls) in the southeastern U.S. shrimp fisheries (North Carolina through Texas), with the exception of vessels that use wing nets in Biscayne Bay in Miami-Dade County, Florida. This alternative was the preferred alternative in the proposed rule. This alternative was not selected because it would have been expected to affect significantly more vessels (5,847) and significantly increase the total expected TED costs and the shrimp revenue loss compared to this rule. This alternative was also not selected would have potentially caused an additional 2,630 part-time vessels to cease operations, and it would have taken almost 3.5 additional years to produce the number of TEDs necessary for all vessels to comply compared to this rule. In addition, to date, we have no fishery observer data on skimmer trawl vessels less than 26 feet in length or TED testing information on skimmer trawl vessels less than 25 feet in length in the southeastern U.S. shrimp fisheries. Thus, we do not have adequate information to determine the effectiveness and practicability of TEDs on skimmer trawl vessels less than 26 feet in length. Some of our concerns included the ability to adequately install TEDs in the nets of these vessels without significant modifications to vessel rigging. Other identified issues included the potential lack of deck space to accommodate TEDs. On very small vessels, such as skiffs 18 feet in length for example, there is limited space to sort catch and handle gear. These types of issues have complicated TED testing, as there is little space for observers, and would likely complicate enforcement and compliance checks at sea. Further, there were potential navigational concerns with TEDs installed on vessels less than 26 feet in length. For example, there were concerns the TED extension could interfere with the engine while maneuvering a small vessel. A net lengthened to accommodate a TED on a small vessel could potentially foul the engine and immobilize a vessel, presenting a potential safety issue. We are conducting additional testing before requiring TEDs on vessels less than 26 feet in length.

The fourth alternative to the final rule would have expanded the required use of TEDs to vessels 26 feet and greater in length using skimmer trawls. This alternative would have been expected to affect significantly more vessels (2,913) and lead to higher TED costs and greater shrimp revenue losses compared to this rule. This alternative would have also potentially caused an additional 623 part-time vessels to cease operations, and it would have taken almost 1.5 additional years to produce the number of TEDs necessary for all vessels to comply compared to this rule.

The fifth alternative to the final rule would have expanded the required use of TEDs to all vessels using skimmer trawls regardless of vessel length. Similar to the third alternative, this alternative would have been expected to affect significantly more vessels (5,432) and significantly increase the total expected TED costs and shrimp revenue loss compared to the rule. This alternative was also not selected would have potentially caused an additional 2,417 part-time vessels to cease operations, and it would have taken almost 3.5 additional years to produce the number of TEDs necessary for all vessels to comply compared to this rule. In addition, this alternative was also not selected for the reasons noted above with respect to why the TED requirement was not expanded to vessels less than 26 feet in length.

The sixth and seventh alternatives to the final rule would have expanded the required use of TEDs to all shrimp vessels regardless of trawl type but varying by fishing location (i.e., state waters only or all waters). These alternatives were not selected for the same reasons the second, third, and fourth alternatives were not selected. These alternatives were also not selected because they would have been expected to affect significantly more vessels (9,711 for both alternatives) and result in significantly greater expected increases in TED costs and shrimp revenue loss, with a relatively minor increase in the expected protection of small sea turtles, compared to the rule. These alternatives were also not selected because they would have potentially caused an additional 3,972 part-time vessels to cease operations, and it would have taken more than 7 additional years to produce the number of TEDs necessary for all vessels to comply compared to this rule.

Based on the above information, the alternative chosen in this final rule has minimized the expected adverse effects on small entities compared to the other significant alternatives considered that would achieve the objectives of this rule and the ESA.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a small entity compliance guide was prepared. The compliance guide will be distributed to affected entities by sending copies of the guide to fishing industry and interest groups (e.g., Louisiana Shrimp Association, Audubon Nature Institute—G.U.L.F., Vietnamese-American Fisher Folk and Families, and Coastal Communities Consulting, Inc., etc.) and to state fish and wildlife agencies in Louisiana, Mississippi, Alabama, Florida, and North Carolina. In addition, copies of this final rule and the compliance guide are available from the Regional Administrator (see ADDRESSES) and at the following website: https://www.fisheries.noaa.gov/southeast/bycatch/turtle-excluder-device-regulations.

As noted in the response to comment 8, we intend to offset this action as soon as practicable after publication to comply with Executive Order 13771.

For the reasons set out in the preamble, 50 CFR part 223 is amended as follows:

This final rule implements Amendment 120 BSAI FMP and Amendment 108 to the GOA FMP, collectively referred to as Amendments 120/108. The Council submitted Amendments 120/108 for review by the Secretary of Commerce (Secretary), and a Notice of Availability of Amendments 120/108 was published in the Federal Register on August 21, 2019 with comments invited through October 21, 2019 (84 FR 43576). The Secretary approved Amendments 120/108 on November 19, 2019. The proposed rule to implement Amendments 120/108 published in the Federal Register on September 27, 2019 (84 FR 51092) with comments invited through October 28, 2019. NMFS received six comment letters containing nine individual comments from six unique individuals during the comment periods for Amendments 120/108 and the proposed rule. The six commenters consisted of one association representing shoreside processors, one individual representing five communities in one Alaskan Borough, and four companies representing C/Ps. A summary of these comments and the responses by NMFS are provided under the heading “Comments and Responses” below.

A detailed review of the provisions of Amendments 120/108, the proposed regulations to implement Amendments 120/108 (84 FR 51092, September 27, 2019), and the rationale for this action is provided in the preamble to the proposed rule and is briefly summarized in this final rule. This preamble uses specific terms (e.g., Amendment 80 sector, directed fishing) that are described in regulation and in the preamble to the proposed rule. We refer the reader to the preamble to the proposed rule for additional detail.

NMFS manages the BSAI Pacific cod fishery under a total allowable catch (TAC) limit with portions of the TAC allocated to the Western Alaska Community Development Quota (CDQ) Program, the Amendment 80 sector, and the BSAI trawl limited access sector, which, in part, includes the American Fisheries Act (AFA) and the BSAI trawl catcher vessel sectors. CVs directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery deliver to shoreside processors and motherships offshore. A “mothership” is defined as a vessel that receives and processes groundfish from other vessels (see definition at 50 CFR 679.2).

The BSAI Pacific cod trawl CV fishery has seen rapid increases in CV and mothership participation from 2016 through 2018 as compared to fishery participation patterns prior to 2016 (i.e., from 2003 through 2015, as described in Section 2.7.1 of the Analysis). This increase in trawl CVs delivering Pacific cod to an increased number of C/Ps operating as motherships has resulted in a corresponding decrease in Pacific cod landings at BSAI shoreside processing facilities. Also since 2016, the BSAI Pacific cod TAC has been more fully harvested and the fishing season has grown shorter as the TAC has been reached earlier. Section 2.7.1 of the Analysis prepared for this action notes that the potential exists for up to 40 additional Amendment 80 C/Ps and AFA C/Ps to participate as motherships in the fishery, providing processing capacity for additional CVs, which would put greater fishing pressure on the fishery.

The Council determined, and NMFS agrees, that limiting access to the BSAI Pacific cod fishery by motherships receiving and processing Pacific cod from CVs directed fishing using trawl gear is needed, given the expectation of additional capacity entering the fishery. The Council adopted its preferred alternative for Amendments 120/108 at its April 2019 meeting.

This final rule balances the need to limit the number of C/Ps operating as motherships in the fishery with the need to provide continued access and benefits from the fishery for long-time participants with sustained activity, given the increasing number of participants in the fishery and shorter fishing seasons. This final rule promotes stability in the fishery by reducing the risk of a race for fish, stabilizing the length of the fishing season, and creating a safer, more predictable fishery. That stability will also minimize the potential for increased prohibited species catch (PSC) rates, particularly for halibut. Regulations at § 679.21(b)(4)(i)(B) require NMFS to close BSAI trawl limited access fisheries when halibut PSC limits are reached. Regulations at § 679.7(o)(7) prohibit Amendment 80 cooperatives from exceeding PSC halibut caps. These closures and caps could limit the ability of harvesters to fully harvest the TAC.

This final rule establishes the requirement that a C/P used to receive and process Pacific cod harvested and delivered by CVs directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery must be designated on a groundfish License Limitation Program (LLP) license with a BSAI Pacific cod trawl mothership endorsement. This final rule also establishes the eligibility criteria and issuance process for this new endorsement. C/Ps not designated on groundfish LLP licenses that receive the endorsement are prohibited from receiving and processing Pacific cod delivered by a CV directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery. This final rule does not preclude any vessel from delivering BSAI Pacific cod to a shoreside processor. This final rule also does not preclude a C/P without a BSAI Pacific cod trawl fishery mothership endorsement from receiving and processing incidental catch of Pacific cod that is caught by a CV while directed fishing for other species. This final rule does not preclude a vessel from participating as a C/P and processing its own catch in the BSAI non-CDQ Pacific cod fishery. Finally, true motherships (i.e., vessels that only receive catch from other vessels and that do not operate as C/Ps), other at-sea processors, and shoreside processors are not restricted by this action.

Under this action, NMFS will issue a BSAI Pacific cod trawl mothership endorsement to a groundfish LLP license with Bering Sea or Aleutian Islands area and C/P operation endorsements if the groundfish LLP license is credited with receiving and processing at least one legal mothership trip target landing of Pacific cod in the BSAI non-CDQ Pacific cod trawl CV fishery in each year of the qualifying period (2015 through 2017). NMFS anticipates that a total of two groundfish LLP licenses will receive a BSAI Pacific cod trawl fishery mothership endorsement under this final rule, resulting in up to two vessels that have also operated as C/Ps being eligible to receive and process Pacific cod delivered by a CV directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery. Under this action, NMFS will also prohibit Amendment 80 sector C/Ps not designated on an Amendment 80 Quota Share (QS) permit and an Amendment 80 LLP license, or not designated on an Amendment 80 LLP/QS license, from receiving and processing Pacific cod harvested by vessels directed fishing for Pacific cod in the BSAI and GOA.

This final rule limits access to the BSAI non-CDQ Pacific cod trawl CV fishery by motherships receiving and processing Pacific cod harvested and delivered by CVs directed fishing in that fishery to those C/Ps designated on a groundfish LLP license with a BSAI Pacific cod trawl mothership endorsement.

In order to implement Amendment 120, this final rule—

In order to implement Amendment 108, this final rule—

Additional detail about the rationale for and effect of the regulatory changes in this rule is provided in the preamble to the proposed rule (84 FR 51092, September 27, 2019) and in the Analysis for this action.

The following provides a brief summary of the regulatory changes made by this final rule.

This final rule adds § 679.4(k)(15) to include the provisions that are necessary to qualify for and receive a BSAI Pacific cod trawl mothership endorsement. Section 679.4(k)(15) establishes a notification process for holders of groundfish LLP licenses eligible and ineligible for a BSAI Pacific cod trawl mothership endorsement. This section also establishes an administrative adjudicative process to challenge NMFS's determinations on eligibility for a BSAI Pacific cod trawl mothership endorsement.

This final rule adds § 679.7(i)(12) to prohibit the receiving and processing by a C/P operating as a mothership of Pacific cod harvested and delivered by a CV directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery unless that C/P has a legible copy on board of a valid groundfish LLP license with endorsements for (1) the Bering Sea or Aleutian Islands area, (2) C/P operation type, and (3) BSAI Pacific cod trawl mothership operation.

This final rule also adds § 679.7(o)(3)(v) to prohibit the use of an Amendment 80 C/P to receive and process Pacific cod harvested by vessels directed fishing for Pacific cod in the BSAI or GOA, if that C/P is not designated on an Amendment 80 QS permit and an Amendment 80 LLP license or on an Amendment 80 LLP/QS license.

This final rule adds Table 57 to part 679 to list those groundfish LLP licenses that NMFS has determined are eligible, will be credited with qualifying receipts of legal mothership trip targets, and will receive a BSAI Pacific cod trawl mothership endorsement under this final rule.

NMFS received six comment letters containing nine individual comments from six unique commenters during the comment periods for Amendments120/108 and the proposed rule. The six commenters consisted of one association representing shoreside processors, one individual representing five communities in one Alaskan Borough, and four companies representing C/Ps. Seven of the nine individual comments supported this action. One comment did not support the action. One comment from three separate commenters suggested a clarification to the proposed regulatory language to support the intent of the action as described in the preamble to the proposed rule.

In the following responses to these comments, reference to the phrase “Amendment 120 or 108”, unless otherwise noted, means Amendment 120 or 108 and this final rule implementing Amendments 120/108.

Comment 1: NMFS received five comment letters that supported this action. Commenters noted that the action is consistent with the Council's purpose and need statement, which recognized that the negative impacts on historical participants arising from a management problem that has been building for several years warrants action. During the development of the Amendment 80 Program, the Council was silent on the ability of Amendment 80 C/Ps to act as motherships in limited access fisheries. However, there has been substantial growth in BSAI offshore Pacific cod deliveries by CVs to Amendment 80 C/Ps utilizing excess offshore processing capacity realized through the rationalized fishery. This has resulted in shifting processing effort away from historical, predominantly shoreside processors. The ability of motherships to operate close to the fishing grounds and provide quick turnaround for CVs, the decline in Pacific cod TAC, and the increased effort and catch per unit effort in the CV trawl fishery have led to an intensified race for fish, shorter fishing seasons, greater instability for historic participants and Alaska communities, and diminished ability to promote conservation. As the race for fish intensifies, Pacific cod flood the docks and are rushed through the factory to facilitate quick turnaround, and thus the race for fish negatively impacts vessel safety and fish quality, and global markets are flooded by large volumes of lower quality cod oversaturating the market.

The commenters state that the Council weighed all relevant information before recommending this action. The commenters state that this action addresses the need to limit the offshore processing capacity (specifically C/Ps acting as motherships) in the BSAI trawl CV Pacific cod fishery, while reducing the negative impacts on the two C/Ps with long-term participation as motherships by accommodating their continued participation. The commenters state that this action is an important step toward providing stability in the fishery and will provide conservation and management benefits to the fishery by slowing the pace of the fishery, ensuring the wise use of the resource, and improving safety-at-sea. Adoption of this rule will promote the goals and objectives of the Magnuson-Stevens Act.

Response: NMFS acknowledges the comment in support of Amendments 120/108. As noted in the Analysis (Section 2.8.1), this action has the potential to address impacts from C/Ps that have recently changed their fishing practices as a benefit of previously implemented rationalization programs. This action is intended to limit the offshore processing capacity in the BSAI non-CDQ Pacific cod trawl CV fishery in order to avoid further negative impacts on long-term participants in the fishery, including C/Ps operating as motherships, shoreside processors, and communities with local economies dependent on shoreside processing of Pacific cod. This action is also intended to allow more flexibility in fishing operations by ensuring predictable levels of competition. That flexibility may help reduce prohibited species catch in the fishery and improve vessel safety, by allowing vessels to implement fishing practices known to reduce PSC and improve vessel safety.

Comment 2: One commenter stated that many fishing communities across the state depend on tax revenue from raw fish delivered across the dock to shoreside plants. The recent escalation of C/Ps acting as motherships has resulted in a dramatic increase in the amount of deliveries to motherships offshore in recent BSAI Pacific cod seasons, at the expense of shore-based processing plants and communities who have historically processed a majority of the Pacific cod. This loss of shore-based processed cod is exacerbated by the recent lower Pacific cod TACs. The commenters state that this action will help our Pacific cod-dependent communities, and will have meaningful impacts for shoreside processors and coastal communities, that have relied heavily on volume fisheries like pollock and cod for decades. Though Alaska's shoreside processors rely on a diverse portfolio of species, high volume fisheries like pollock and Pacific cod are the foundation of the sector's economic success. Larger volumes of Pacific cod delivered shoreside allows for longer fishing seasons, a near year-round processing workforce, and increased economic activity. Significant investments have been made to expand markets, increase value, and increase capacity to serve the fishing fleets. Closing this regulatory loophole, which currently allows C/Ps to use the excess processing capacity realized through the benefits of their rationalization programs in order to act as motherships in the unrationalized trawl CV fishery, is critically important to Bering Sea shoreside processors historically dependent on Pacific cod and to the communities in which the shoreside processors operate. The increase in this mothership activity, starting in 2016 and increasing each year since, severely erodes shoreside Pacific cod landings, which have historically comprised almost the entire fishery, and erodes tax and other support service benefits from this fishery on which coastal Alaska communities depend.

Response: NMFS acknowledges this comment, and as noted in the response to Comment 1, the Analysis (Section 2.8.1) concluded that this action has the potential to prevent increased participation by C/Ps operating as motherships from reducing the benefits that the fishery provides to long-term, consistent participants in the BSAI non-CDQ Pacific cod trawl CV fishery, including shoreside processors and communities with local economies dependent on shoreside processing of Pacific cod.

Comment 3: This action is consistent with the Council's purpose and need statement and final action to reduce the excess processing capacity resulting from rationalization under Amendment 80 and corresponding Amendment 80 vessel replacement. The proposed rule for this action noted that the final rule implementing Amendment 80 had anticipated that a future regulatory amendment may be needed, depending on whether the use of C/Ps as motherships would increase due to the Amendment 80 Program and result in adverse impacts on existing shoreside processors. This action addresses those issues directly by including a prohibition on using replaced Amendment 80 vessels as motherships to receive and process Pacific cod harvested by vessels directed fishing for Pacific cod in the BSAI or GOA. (Current regulations already prevent this for AFA CPs.)

Response: This action prohibits replaced Amendment 80 C/Ps from acting as a mothership in the BSAI or GOA fisheries. Section 2.8.1 of the Analysis notes that there is no indication to date that this has occurred, but implementing a prohibition in this action eliminates the opportunity for this to occur in the future. The intent of the vessel replacement provision in Amendment 80 was to allow older, less efficient vessels to be replaced by more efficient vessels. The intent of the regulations was not to provide new opportunities for the replaced vessel in fisheries that are already fully utilized.

Comment 4: This action is consistent with the Council's intent for how the qualification for a BSAI Pacific cod trawl mothership endorsement should be calculated and applied. This calculation includes using targeted Pacific cod landings because the action is intended to only regulate C/Ps that receive and process Pacific cod harvested by CVs engaged in directed fishing, and not regulate the receiving and processing of incidental catch of Pacific cod. In addition, this action uses weekly production reports to determine which C/Ps received deliveries of targeted Pacific cod during the qualifying period, similar to the Council's approach in other actions, and was a range of qualifying years that honors the control date previously set by the Council and that encompasses years directly before and after significant new entry. This action does not prevent any Amendment 80 C/Ps acting as motherships from retaining incidental catch of Pacific cod delivered by CVs in their target flatfish fisheries, as is currently the practice. This action will not place any additional limit on incidental catch, beyond the maximum retainable amounts already in place, which are applied at the trip level. In addition, Amendment 80 C/Ps have full access to their exclusive, rationalized C/P allocations of BSAI Pacific cod, yellowfin sole, flathead sole, rock sole, Atka mackerel, and Aleutian Islands Pacific ocean perch fisheries. Similarly, AFA C/Ps that target pollock fisheries remain unaffected. This action only limits the ability of Amendment 80 and AFA C/Ps to act as motherships that receive and process Pacific cod delivered by CVs directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery, unless they have documented mothership processing history in this fishery as required by the Council's preferred alternative.

Response: NMFS concurs that this action, as noted in the preamble to the proposed rule, limits Amendment 80 and AFA C/Ps' ability to operate as a mothership in the BSAI non-CDQ Pacific cod trawl CV fishery based on qualification for an endorsement to participate. This action also prohibits Amendment 80 vessels not designated on an Amendment 80 QS permit and an Amendment 80 LLP license or an Amendment 80 LLP/QS license from operating as a mothership by receiving and processing Pacific cod harvested by vessels directed fishing in the GOA and BSAI. It does not impose additional limits on incidental catch of Pacific cod in other fisheries beyond existing regulatory requirements. This action does not change Amendment 80 C/Ps' access to their allocations of BSAI Pacific cod, yellowfin sole, flathead sole, rock sole, Atka mackerel, and Aleutian Islands POP fisheries. This action does not affect AFA C/P pollock fisheries.

Comment 5: If the two C/Ps that have history prior to Amendment 80 and are allowed to continue offshore processing under this action choose to expand their capacity in the future, the Council could consider a sideboard in the future.

Response: As noted in Section 2.8.1 of the Analysis, the Council and NMFS considered setting harvesting limits (commonly known as sideboards) on the C/Ps eligible for a BSAI Pacific cod trawl mothership endorsement. The Council and NMFS did not include a sideboard limitation due to the consistent trends in delivery patterns to these two C/Ps, the relatively limited amount of catch processed by these vessels, and the challenges in effectively monitoring and managing a sideboard. (See Sections 2.7.3.2 and 2.10 of the Analysis for additional detail.) The Council and NMFS may consider sideboard limitations under a future action, if appropriate.

Comment 6: Three commenters requested that NMFS review its proposed regulatory language in both the permit section (50 CFR 679.4) and the prohibitions section (50 CFR 679.7) to ensure that it does not exclude processing operations, such as operations of true motherships, floating processors, or shoreside processors which were not intended to be restricted under this action. The commenters expressed concern that the regulatory language could be interpreted as unintentionally precluding true motherships, floating processors, or shoreside processors from receiving and processing Pacific cod harvested by CVs directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery.

Response: NMFS concurs that the proposed regulatory text might be interpreted to be overly broad and exclude some processors, such as floating processors and true motherships, which were never intended to be precluded from receiving and processing Pacific cod harvested by CVs directed fishing in the BSAI non-CDQ trawl CV fishery. The preamble to the proposed rule, and Section 2.4.2 of the Analysis clearly state that floating processors and true motherships are not intended to be precluded from receiving and processing Pacific cod in the BSAI under this rule. Therefore, the regulatory text has been revised in this final rule to clarify that floating processors and true motherships are not precluded from receiving and processing Pacific cod in the BSAI under this rule. This revision is discussed further in the Changes from the Proposed Rule section of this final rule.

Comment 7: We understand the rationale for NMFS and the Council curtailing the recent increase in offshore deliveries to entering Amendment 80 and AFA C/Ps. We also appreciate their decision to allow the fishing vessel (F/V) Seafreeze Alaska to continue to operate as a mothership in the fishery in recognition of its long-term participation and dependence on this fishery. We note that the preamble to the proposed rule identified a single Amendment 80 C/P, the F/V Seafreeze Alaska, as taking mothership deliveries prior to the final rule for Amendment 80 in 2008. The preamble suggests that the history of the F/V Seafreeze Alaska was one reason for the final rule allowing Amendment 80 C/Ps to operate as motherships. The proposed rule recognizes that history and dependence by allowing the F/V Seafreeze Alaska to continue to participate in the fishery. Our business depends on the ability of our CVs to continue to deliver Pacific cod offshore. The proposed rule limits the continued participation of some of our C/Ps in the Pacific cod fishery. We understand the rationale for those limitations. We are thankful that the rule also recognizes the unique long-term dependence of the F/V Seafreeze Alaska on the offshore fishery, and we support implementation of a rule allowing that activity to continue.

Response: NMFS acknowledges this comment. However, NMFS also clarifies that the data analyzed for this action include data from 2003 forward. While there may have been other Amendment 80 C/Ps that received and processed Pacific cod delivered by CVs prior to 2003, NMFS determined the eligibility of the LLP license on which the F/V Seafreeze Alaska is designated based on criteria established by the Council, consistent with its intent to recognize sustained participation in the fishery.

Comment 8: Three commenters who support this proposed rule urged swift implementation prior to the upcoming 2020 BSAI Pacific cod trawl CV fishery A season in January. The commenters state that the purpose and need statement and the analysis identified that further delays to this action will undoubtedly lead to increased growth in offshore deliveries of Pacific cod. The commenters urged no further delays in action, since additional delays will result in a continued exponential shift away from historic Pacific cod processing efforts.

Response: NMFS appreciates the desire for timely implementation of this rulemaking.

Comment 9: We do not support the proposed rule for this action. Our company operates two Amendment 80 trawl C/Ps that took deliveries of BSAI non-CDQ trawl CV Pacific cod in two of the three years in the Council's selected qualifying period of 2015 through 2017. These C/Ps will not be eligible to mothership under these proposed regulations because they did not take qualifying deliveries in all three of the years in the qualifying period. The proposed rule states that the Council's rationale for not choosing the suboptions for one- or two-year participation requirements was that either option would have allowed participation in a manner that is not reflective of the historical harvest patterns in the fishery prior to the recent increase in Amendment 80 C/Ps acting as motherships. We disagree. Qualifying our vessels would be reflective of the historical harvest patterns in the fishery. Our history clearly shows participation of these two C/Ps as cod motherships prior to any privileges being received in the multi-species groundfish fishery through the Amendment 80 rationalization program. Our C/Ps have history operating as motherships for CVs delivering BSAI non-CDQ Pacific cod during the Amendment 80 qualifying years in addition to our recent participation in the fishery. However, these previous years of participation were not included in the Council's analysis, because that analysis included only data beginning with 2003. The Amendment 80 qualifying years of 1998 through 2004 are critical to understanding the historical modes of operation and harvest patterns of our fleet, including the dynamics of mothership activity pre- and post-rationalization. Without the inclusion of these years in the Analysis, the Council does not have a comprehensive understanding of the historical harvest patterns in the fishery and cannot justify the exclusion of these two vessels.

Response: NMFS disagrees. The Council expressed its intent, and Section 2.6.10 of the Analysis specifies, that qualification for a C/P to operate as a mothership should be based on the history of that vessel receiving deliveries of targeted non-CDQ BSAI Pacific cod harvested by CVs using trawl gear during each year in the three-year qualifying period (2015 through 2017). The qualifying period used in this final rule places emphasis on the years directly before, including, and after 2016, which was the year that five additional Amendment 80 C/Ps entered the fishery as motherships, more than doubling the number of participating C/Ps operating as motherships in the fishery. The increase in Amendment 80 C/Ps operating as motherships resulted in the Council expressing concern about the increased amount of BSAI non-CDQ Pacific cod delivered offshore in the fishery, and the corresponding decrease in the amount delivered to shoreside processors.

The Council considered including participation in the fishery prior to 2015, but determined that participation for the years prior to 2015 was stable and represented sustained effort. Further, the Council and NMFS considered the proposed action's consistency with the relatively stable conditions of the fishery under the Amendment 80 Program. The establishment of the Amendment 80 Program fundamentally changed the dynamics of the BSAI non-pollock trawl fisheries by establishing a framework under which exclusive rights to non-pollock target species allocations, including Pacific cod, were granted in part to improve stability in those fisheries. The post-Amendment 80 stability in the BSAI Pacific cod trawl fishery was maintained until 2016, when additional Amendment 80 C/Ps began receiving and processing Pacific cod. The Council's intent in recommending this action is to regain the stability in the fishery seen during the post-Amendment 80 and pre-2016 period, particularly in light of the dramatic decline in Pacific cod TACs. The preamble to the proposed rule provides additional details on the rationale for selecting the qualifying years.

Further, for reasons explained in Section 2.5.1 of the Analysis, NMFS is not able to reliably compare historical data prior to 2003 to the current catch accounting system that includes data from 2003 forward. NMFS believes that consideration of fishing patterns up to twelve years prior to the first year of the qualifying period (2015) is sufficient to establish sustained participation in the fishery. Catch history prior to 2003 is not likely to be representative of current fishing patterns or demonstrative of sustained participation in a fishery.

In response to public comment, NMFS has modified the regulatory text at §§ 679.4(k)(15)(i), (k)(15)(ii)(B), and (k)(15)(iii)(B) and 679.7(i)(12) to clarify that true motherships and floating processors are not excluded from receiving and processing Pacific cod in the BSAI non-CDQ Pacific cod CV trawl directed fishery. Regulatory language in the proposed rule was ambiguous and these clarifying changes are intended to ensure that the language cannot be misinterpreted to exclude those entities from processing Pacific cod in the fishery.

At the proposed § 679.4(k)(15)(i) the sentence that indicates that a vessel must be designated on a groundfish LLP license with a BSAI Pacific cod trawl mothership endorsement in order to receive and process Pacific cod delivered by CVs directed fishing using trawl in the BSAI non-CDQ Pacific cod fishery as specified in § 679.20(a)(7)(ii)(A) is revised to indicate that a C/P must be designated on a groundfish LLP license with a BSAI mothership Pacific cod trawl mothership endorsement in order to receive and process Pacific cod delivered by a CV directed fishing using trawl gear in that fishery.

At the proposed § 679.4(k)(15)(ii)(B) the sentence that indicates that a groundfish LLP license that had a vessel designated on it that received and processed at least one legal mothership trip target of Pacific cod delivered by a CV directed fishing using trawl gear in the BSAI non-CDQ Pacific cod fishery as specified in § 679.20(a)(7)(ii)(A) in each of the three years of the qualifying period of 2015 through 2017 is eligible to receive a BSAI Pacific cod trawl mothership endorsement has been revised to indicate that a groundfish LLP license that had a C/P designated on it that received and processed at least one legal mothership trip target of Pacific cod delivered by a CV directed fishing using trawl gear in the BSAI non-CDQ Pacific cod fishery as specified in § 679.20(a)(7)(ii)(A) in each of the three years of the qualifying period of 2015 through 2017 is eligible to receive a BSAI Pacific cod trawl mothership endorsement.

At the proposed § 679.4(k)(15)(iii)(B) the sentence that indicates that NMFS will credit a groundfish LLP license with a legal mothership trip target of Pacific cod if that groundfish LLP license was the only one on which the vessel that received and processed legal mothership trip targets was designated from 2015 through 2017 has been revised to replace the word “vessel” with the term “catcher/processor”.

At the proposed § 679.7(i)(12) in the Prohibitions section, the sentence that stipulates that it is prohibited to receive and process Pacific cod harvested and delivered by a CV directed fishing using trawl gear in the BSAI non-CDQ Pacific cod fishery without a legible copy on board of a valid groundfish LLP license with the appropriate endorsements, including a BSAI Pacific cod trawl mothership endorsement, has been revised to stipulate that it is prohibited to use a C/P to receive and process Pacific cod harvested and delivered by a CV directed fishing using trawl gear in that fishery without a legible copy on board of a valid groundfish LLP license with the appropriate endorsements.

In addition, the name of the fishery has been edited for consistency at §§ 679.4(k)(15)(i), (k)(15)(ii)(B), and (k)(15)(v)(B) and 679.7(i)(12).

The Administrator, Alaska Region, NMFS, determined that BSAI FMP Amendment 120 and GOA FMP Amendment 108 are necessary for the conservation and management of the BSAI and GOA Pacific cod fisheries and that they are consistent with the Magnuson-Stevens Act and other applicable laws.

This final rule has been determined to be not significant for the purposes of Executive Order 12866.

This final rule is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. The preambles to the proposed rule and this final rule include a detailed description of the actions necessary to comply with this rule, and as part of this rulemaking process NMFS included on its website a summary of compliance requirements that serves as the small entity compliance guide: https://www.fisheries.noaa.gov/action/amendment-120-fmp-groundfish-bering-sea-and-aleutian-islands-and-amendment-108-fmp. This action does not require any additional compliance from small entities that is not described in the preambles to the proposed rule and this final rule. Copies of the proposed rule and this final rule are available from the NMFS website at http://alaskafisheries.noaa.gov.

This FRFA incorporates the initial regulatory flexibility analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA, NMFS' responses to those comments, and a summary of the analyses completed to support this action.

Section 604 of the Regulatory Flexibility Act (RFA) requires that, when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code, after being required by that section or any other law to publish a general notice of proposed rulemaking, the agency shall prepare a FRFA. Section 604 describes the required contents of a FRFA: (1) A statement of the need for and objectives of the rule; (2) a statement of the significant issues raised by the public comments in response to the IRFA, a statement of the assessment of the agency of such issues, and a statement of any changes made to the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in this final rule, and why each of the other significant alternatives considered by the agency was rejected.

A description of this final rule and the need for and objectives of this rule are contained in the preamble to this final rule and the preamble to the proposed rule (84 FR 51092, September 27, 2019), and are not repeated here.

NMFS published the proposed rule on September 27, 2019 (84 FR 51092). An IRFA was prepared and summarized in the Classification section of the preamble to the proposed rule. The comment period for the proposed rule closed on October 28, 2019. The comment period for the notice of availability for Amendments 120/108 closed on October 21, 2019. NMFS received six letters of public comment on the proposed rule and Amendments 120/108. The Chief Counsel for Advocacy of the SBA did not file any comments on the proposed rule. NMFS received no public comments specifically on the IRFA.

This final rule directly regulates the owners and operators of certain Amendment 80 and AFA C/Ps operating as motherships when receiving Pacific cod in the BSAI non-CDQ Pacific cod trawl CV directed fishery. This final rule also directly regulates the owners of current Amendment 80 C/Ps and Amendment 80 C/Ps that have been replaced under BSAI Amendment 97 (77 FR 59852, October 1, 2012) and that are not designated on an Amendment 80 QS permit and an Amendment 80 LLP license, or are not designated on an Amendment 80 LLP/QS license, by prohibiting replaced Amendment 80 vessels from operating as a mothership in the BSAI or GOA Pacific cod fisheries. Based on the best available and most recent complete data from 2003 through 2018, 40 groundfish LLP license holders will be directly regulated by this action.

For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.

The RFA requires consideration of affiliations between entities for the purpose of assessing whether an entity is classified as small. The AFA pollock and Amendment 80 cooperatives are types of affiliation between entities. All of the AFA and Amendment 80 cooperatives have gross annual revenues that are substantially greater than $11 million. Therefore, NMFS considers members in these cooperatives affiliated large (i.e., they are not small) entities for RFA purposes.

Of the 40 groundfish LLP license holders directly regulated by this action, 21 were members of an AFA cooperative and 19 were members of an Amendment 80 cooperative in 2018. All of the groundfish LLP licenses with designated C/Ps that received and processed Pacific cod delivered by a CV directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery from 2003 through 2018 were affiliated with either an AFA or an Amendment 80 cooperative in 2018. NMFS therefore considers these LLP license holders to be affiliated large (i.e., they are not small) entities for RFA purposes.

Therefore, this final rule does not directly regulate any small entities.

This final rule does not add additional reporting or recordkeeping requirements for the vessels that choose to submit an appeal. An appeal process exists for LLP license endorsement issuance. No small entity is subject to reporting requirements that are in addition to or different from the requirements that already apply to all directly regulated entities. No unique professional skills are needed for the LLP license or vessel owners or operators to comply with the reporting and recordkeeping requirements associated with this final rule. This final rule does not implement or increase any fees that NMFS collects from directly regulated entities. The Analysis identifies no operational costs of the endorsement (see ADDRESSES).

Under this final rule, C/Ps acting as motherships that receive and process Pacific cod harvested by CVs directed fishing in the BSAI non-CDQ Pacific cod trawl CV fishery will be limited to two vessels, and all remaining AFA and Amendment 80 C/Ps will not be permitted to operate as a mothership in this fishery even if retired from and/or replaced in either the AFA or Amendment 80 Programs. All of the directly regulated entities have been determined to be large entities via ownership, cooperative, or contractual affiliations. Thus there are no adverse impacts on directly regulated small entities.

This final rule contains a collection-of-information requirement subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). This requirement has been submitted to OMB for approval under a new control number.

The public reporting burden for the collection-of-information requirement in this final rule is estimated to average 4 hours per response to submit an appeal, which includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments on these or any other aspects of the collection of information to NMFS Alaska Region (see ADDRESSES) by email to OIRA_Submission@omb.eop.gov, or by fax to (202) 395-5806.

Notwithstanding any other provision of law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at https://www.reginfo.gov/public/do/PRASearch#.

For the reasons set out in the preamble, NMFS amends 50 CFR part 679 as follows: