Federal Register Vol. 81, No.111,

Since the inception of the Broadband Loan Program, the Agency has faced, and continues to face, significant challenges in delivering the program due to the following factors: (1) The significant number of applicants proposing to offer broadband service that are start-ups with limited resources; (2) the continual evolution of telecommunications technology; and (3) the associated higher costs of serving rural communities. With the enactment of the Agricultural Act of 2014 (the 2014 Farm Bill), the Broadband Loan Program has been significantly modified, and was suspended while the Agency revised this regulation. Given that the program was unable to operate during the revision, the Agency published an interim rule on July 30, 2015 in the Federal Register (80 FR 45397) so that the program could immediately reopen. The Agency invited comments to guide its efforts in drafting the new procedures implementing the 2014 Farm Bill and received comments from the National Cable & Telecommunications Association, WTA-Advocates for Rural Broadband and Mr. James Cook. These comments and the Agency's responses are summarized as follows:

Comment: Respondents commented that the definitions for Broadband Service, which sets the eligibility standard for an area, and Broadband Lending Speed, which sets the construction standard, are too low and should be raised to higher standards to be more in line with the current Federal Communications Commission (FCC) definition for broadband of 25 megabits downstream and 3 megabits upstream.

Response: As the respondents noted in their comments, the regulation establishes a process to change these definitions by publishing new requirements when a NOSA/NOFA is published opening up an application window. The Agency agrees that higher definitions would be beneficial to rural residents. However, when these definitions are set, it is not only the bandwidth requirement for rural areas that is considered but also the amount of funding that is available for any given application window. If a higher definition for bandwidth is used, more of the country then becomes eligible for funding. When limited funding is available, the Agency has to ensure that those funds are directed to the most unserved rural areas. The Agency will re-evaluate these requirements every time a NOSA/NOFA is published and set the standards accordingly.

Comment: Respondents commented that the RUS investment should go into unserved areas and that the Agency count all terrestrial providers in the proposed service territory when determining area eligibility.

Response: RUS agrees that unserved areas should be the target of the program. To ensure that all terrestrial broadband providers are counted in an area where an application is being considered, RUS has developed a multi-layer approach to locate them. First, when an application is submitted, the proposed service territory maps will be posted online utilizing the RUS Mapping Tool and existing service providers may respond to the public notice. If three or more existing providers are identified in the area and they meet the minimum eligibility speeds, then that area is considered ineligible for funding. If no providers respond to the public notice, then the Agency will have its field staff visit the proposed service area and locate all broadband providers in the area. The field staff will contact these providers and request that they respond to the public notice.

Comment: One respondent suggested that instead of three incumbents making a service area ineligible for funding, that the requirement be changed to two incumbents. The respondent also suggested that the definition of broadband service be raised to the current FCC definition for broadband of 25 megabits downstream and three megabits upstream.

Response: Although there is merit in using a higher bandwidth definition to determine area eligibility, the requirement that three incumbents in an area make that area ineligible is a statutory requirement and cannot be changed. The regulation does allow for the eligibility definition to be changed and the Agency will consider higher speeds whenever a NOSA/NOFA is published. As stated previously, the Agency must also recognize the amount of funding that is available each time an application window is opened and will set the eligibility definition accordingly.

Comment: One commenter reiterated that broadband service in rural areas needs to be affordable.

Response: Applicants must complete a market survey and a competitive analysis of all providers in the proposed service area as part of the application. This ensures that price points are set at the proper level for the area in question and that the operation is sustainable. There is a balance between providing high quality broadband service and charging the appropriate rate. It must be recognized that in less dense population areas, it may be necessary to charge a higher rate to ensure the viability of the operation.

Comment: One commenter proposed that affiliate or affiliated companies providing broadband service in the same proposed funded service area should be recognized as one incumbent service provider when considering if an area is eligible for funding.

Response: Each company that is providing broadband service in an area and meets the definition of an incumbent service provider will be counted as an incumbent service provider in determining the eligibility of an area. RUS cannot treat legally established companies properly acting as independent companies as the same entity.

Comment: One commenter recommended that if a company has capped the amount of bandwidth that is allowed for a given period, that additional standards should be established in determining if this provider would be counted as an incumbent service provider when determining service eligibility.

Response: The Agency appreciates this suggestion and will consider it during the next revision to the regulation. The main goal of the program is to provide funding to areas that do not have any broadband service. Most companies that cap bandwidth have options where a consumer can buy more bandwidth at an additional cost.

Comment: One commenter recommended that wireless solutions for broadband service should be validated during busy hour/busy time when determining if the wireless provider meets the definition for an incumbent service provide when determining area eligibility.

Response: There are many levels of providing broadband service and a number of ways for determining this. The Agency has elected to use advertised broadband rates that are being sold and to validate that this level of service is being provided in an area. We will consider implementing additional tests the next time the regulation is revised. If tests of this nature are implemented for wireless service providers then corresponding tests will have to be implemented for wireline service providers.

The Agency appreciates the interest of the commenters and thanks them for their comment submissions.

The Rural Utilities Service did not receive any significant adverse comments during the public comment period on the interim rule, and therefore confirms the rule without change.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to BLANIK LIMITED Models L-13 Blanik and L-13 AC Blanik gliders. That NPRM was published in the Federal Register on March 4, 2016 (81 FR 11473), and proposed to supersede AD 99-19-33, Amendment 39-11320 (64 FR 50440; September 17, 1999) (“AD 99-19-33”).

The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states that:

A review of records since issuance of AD 99-19-33 revealed that the FAA inadvertently did not address this MCAI for the EVEKTOR, spol. s.r.o. Models L 13 SEH VIVAT and L 13 SDM VIVAT gliders and the BLANIK LIMITED Model L-13 AC Blanik gliders. This AD would supersede AD 99-19-13 to add the BLANIK LIMITED Model L-13 AC Blanik gliders to the applicability of the AD.

The FAA is addressing the EVEKTOR, spol. s.r.o. Models L 13 SEH VIVAT and L 13 SDM VIVAT gliders in another AD action.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 11473, March 4, 2016) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (81 FR 11473, March 4, 2016) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (81 FR 11473, March 4, 2016).

We reviewed LET Aeronautical Works LET Mandatory Bulletin MB No.: L13/082a, dated December 10, 1998. The service information describes procedures for painting the left arm of the elevator drive. 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 of the AD.

We estimate that this AD will affect 124 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $10 per product.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $11,780, or $95 per product.

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.

We are 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.

We 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 this AD:

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

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

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

(4) 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.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4233; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to EVEKTOR, spol. s.r.o. Models L 13 SEH VIVAT and L 13 SDM VIVAT gliders. That NPRM was published in the Federal Register on March 4, 2016 (81 FR 11465), and proposed to supersede AD 2000-20-12, Amendment 39-11923 (65 FR 61262, October 17, 2000).

The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states that:

A review of records since issuance of AD 2000-20-12 revealed that the FAA inadvertently did not address this MCAI for the EVEKTOR, spol. s.r.o. Model L 13 SDM VIVAT gliders and the BLANIK LIMITED Model L-13 AC Blanik gliders. This AD supersedes AD 2000-20-12 to add the EVECTOR, spol. s.r.o. Model L 13 SDM VIVAT gliders to the applicability of the AD.

The FAA is addressing the BLANIK LIMITED Model L-13 AC Blanik gliders in another AD action.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 11465, March 4, 2016) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We identified that we inadvertently included a parts cost for the initial inspection in the NPRM (81 FR 11465, March 4, 2016), and we removed that parts cost from this final rule AD action. The basic estimated cost for U.S. operators remains the same. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (81 FR 11465, March 4, 2016) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (81 FR 11465, March 4, 2016).

AEROTECHNIK CZ s.r.o. issued Mandatory Service Bulletin SEH 13-005a, dated November 18, 1999. The service information describes procedures for testing the material strength of attachment fitting part number A 102 021N and instructions for contacting the manufacturer for replacement information if necessary. 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 of the AD.

We estimate that this AD will affect 9 products of U.S. registry. We also estimate that it would take about 4 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $3,060, or $340 per product.

In addition, we estimate that any necessary follow-on actions would take about 16 work-hours and require parts costing $500, for a cost of $1,860 per product. We have no way of determining the number of products that may need these actions.

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our 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.

We are 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.

We 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 this AD:

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

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

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

(4) 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.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4230; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it updates the geographic coordinates of Billings Logan International Airport, Billings, MT.

During a review of the airspace for Billings Logan International Airport, Billings, MT, the FAA identified that the airport's geographic coordinates were incorrect. This action updates the geographic coordinates to coincide with the FAA's aeronautical database for the respective Class C airspace area.

Class C airspace designations are published in paragraph 4000 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class C airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class C airspace at Billings Logan International Airport, Billings, MT, by adjusting the geographic coordinates to reflect recent survey data.

This is an administrative change and does not affect the boundaries, altitudes, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary.

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

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

The Danny Keysar Child Product Safety Notification Act. The Consumer Product Safety Improvement Act of 2008 (CPSIA, Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the CPSIA, also known as the Danny Keysar Child Product Safety Notification Act, requires the Commission to promulgate consumer product safety standards for durable infant or toddler products. The law requires that these standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standards if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product. On March 10, 2014, the Commission published a final rule issuing a standard for carriages and strollers that incorporated by reference the standard in effect at that time, ASTM F833-13b, with a modification to address potential hazardous openings created by adjustable grab bar/tray and foot rest configurations. 79 FR 13208. The standard was codified in the Commission's regulations at 16 CFR part 1227.

Public Law 112-28. On August 12, 2011, Congress enacted Public Law 112-28, amending and revising several provisions of the CPSIA, including the Danny Keysar Child Product Safety Notification Act. The revised provision sets forth a process for updating CPSC's durable infant or toddler standards when the voluntary standard upon which the CPSC standard was based is changed.

If an organization revises a standard that has been adopted, in whole or in part, as a consumer product safety standard under this subsection, the Commission must be notified. The statute further provides that the revised voluntary standard shall be considered to be a consumer product safety standard issued by the Commission under section 9 of the Consumer Product Safety Act (15 U.S.C. 2058), effective 180 days after the date on which the organization notifies the Commission (or such later date specified by the Commission in the Federal Register) unless, within 90 days after receiving that notice, the Commission notifies the organization that it has determined that the proposed revision does not improve the safety of the consumer product covered by the standard and that the Commission is retaining the existing consumer product safety standard. Public Law 112-28, section 3.

Notification of Revisions. On April 5, 2016, ASTM notified the CPSC of ASTM's approval and publication of revisions to ASTM F833-13b in a revised standard approved on November 1, 2015, ASTM F833-15, Standard Consumer Safety Performance Specification for Carriages and Strollers (ASTM F833-15). As discussed below, the Commission has reviewed the differences between 16 CFR part 1227 and ASTM F833-15.

There are several differences between 16 CFR part 1227 (which references ASTM F833-13b) and the revised version of the standard, ASTM F833-15. We summarize the differences and the CPSC's assessment of the revisions below.

Definition of Convertible Car Seat/Stroller. The 2015 version of the ASTM standard adds a definition for a “convertible car seat/stroller” to clarify the distinction between a convertible car seat/stroller (i.e., a car seat with wheels and a handle that can convert to a stroller) and a combined unit of a car seat on a stroller. The definition is referenced in a revised section regarding convertible car seat/strollers, which allows an exemption for restraints used in motor vehicles.

CPSC staff's review shows that the addition of a definition for “convertible car seat/stroller” adds clarity to the revised standard because this definition is used in a revised section regarding performance requirements for combination units of a car seat on a stroller and convertible car seat/stroller. The addition of this definition is neutral regarding safety.

Definitions of Tray/Grab BarLocking and Stop Positions. The 2015 version of the ASTM standard adds two new definitions that describe locking and stop positions of the tray/grab bar. These definitions are then referenced in revised sections clarifying the performance requirement and test methods associated with passive containment/foot opening.

CPSC staff's review shows that the addition of definitions for tray/grab bar locking and stop positions improve clarity to the revised standard because these definitions are used in revised sections for performance requirements and test methods applicable to passive containment/foot openings. The addition of these definitions is neutral regarding safety.

Requirements for Static Load Associated with Step/Footrest. The 2015 version of the ASTM standard repeats a requirement that any step or footrest on a stroller shall support a static load of 50 lbs under the performance requirements section, as well as under the test methods for static load.

CPSC staff's review shows that the addition of a separate section repeating the static load requirement adds clarity to the revised standard because the provision is equally applicable to both the performance requirement and test method sections. The addition of this section is neutral regarding safety.

Requirements for Combination Unit of a Car Seat on a Stroller and Convertible Car Seat/Stroller. The 2015 version of the standard allows products that are used as a car seat and that can convert to a stroller using the same restraint as the car seat, to be exempt from the stroller restraint system anchor points and crotch strap location requirements. The restraint systems for car seats sold in the United States are regulated under Federal Motor Vehicle Safety Standard No. 213 (FMVSS 213).

CPSC staff's review shows that adding the exemption for a restraint system that is certified to restrain a child in a motor vehicle is neutral regarding safety because the restraint systems must comply with the FMVSS requirements. In addition, aside from the restraint system, the combination unit of a car seat on a stroller must still comply with all of the other applicable requirements when the car seat is installed in all of the manufacturer's recommended use positions.

Requirements for Passive Containment/Foot Opening, Testing Tray/Grab Bar Locking Positions, and Testing Tray/Grab Bar Positions. The 2015 version of the standard requires testing of all applicable positions of the adjustable grab bar/tray that may create a hazardous opening. These positions consist of locking positions (including positions intended for non-occupant use), as well as stop positions (not a locking position but a position where tray/grab bar can remain stationary when a 5 lb force is applied for 10 seconds).

CPSC staff's review shows that the revisions improve the safety of the standard set forth in 16 CFR part 1227 to address hazardous openings created by adjustable grab bar/tray and foot rest configurations. In its regulation, the CPSC required that tests be conducted in the position “most likely to cause failure.” See 16 CFR 1227.2(b). The 2015 version of the standard provides additional clarity indicating that the test has to be repeated, depending on the number of adjustments that can be made in the grab bar/tray, as well as footrest or calf support positions. The revised test method is a clearer test and will improve the safety of the standard because all potentially hazardous openings will be evaluated.

Warning Statements for Jogging Strollers. The 2015 version of the standard clarifies the warning label requirements associated with strollers that have a removable-wheel fork assembly and strollers that are three-wheeled with a locking front wheel and are intended to be used for running, jogging, or walking fast, requiring the units to display the warning label. The warning content remains unchanged.

CPSC staff's review shows that the revisions on the warning label requirements improve the safety of strollers. The version referenced in 16 CFR part 1227, ASTM F833-13b, could be interpreted to require warning labels only on jogging strollers with a removable-wheel fork assembly. The 2015 version of the standard clarifies that the warning label requirements apply to: (1) Any stroller with a removable wheel fork assembly for the label that is placed on the front wheel fork; and (2) any three-wheeled stroller intended to be used while jogging, walking fast, or running with a locking front wheel. Accordingly, the revised standard makes clear that all of these types of three-wheeled strollers must display warning labels.

Assessment of the Revisions to the ASTM Standard. Under Public Law 112-28, unless the Commission determines that ASTM's revision “does not improve the safety of the consumer product covered by the standard,” ASTM F833-15 will become the new mandatory standard for carriages and strollers. As discussed above, based on the CPSC staff's review, the Commission believes that certain revisions are neutral regarding safety. However, other revisions will improve the safety of standard, including the clarifications to the testing for adjustable grab bar/tray and foot rest configurations and warning labels. Consequently, the Commission did not determine or notify ASTM that the revised standard does not improve the safety of carriages and strollers.

In accordance with Public Law 112-28, the revised ASTM standard for carriages and strollers, therefore, becomes the new CPSC standard 180 days after the date the CPSC received notification of the revision from ASTM. This rule revises the incorporation by reference at 16 CFR part 1227, to reference the ASTM standard, ASTM F833-15.

The Commission is issuing this rule as a direct final rule. Although the Administrative Procedure Act (“APA”) generally requires notice and comment rulemaking, section 553 of the APA provides an exception when the agency, for good cause, finds that notice and public procedure are “impracticable, unnecessary, or contrary to the public interest.” The Commission concludes that, in the context of these revisions to ASTM standards upon which CPSC's durable infant or toddler product standards are based, which automatically become consumer product standards and that simply would be incorporated by reference into applicable regulatory provisions, notice and comment is not necessary.

Without Commission action to update the incorporation by reference in the CPSC's mandated standards, the standard published in the Code of Federal Regulations will not reflect the revised ASTM standard that will be in effect by operation of law under Public Law 112-28. For accuracy, and to avoid misleading the public about the applicable consumer product standard, the Commission believes that issuing a rule revising the incorporation by reference in these circumstances is appropriate. In Recommendation 95-4, the Administrative Conference of the United States (“ACUS”) endorsed direct final rulemaking as an appropriate procedure to expedite promulgation of rules that are noncontroversial and that are not expected to generate significant adverse comment. See 60 FR 43108 (August 18, 1995). Consistent with the ACUS recommendation, the Commission is publishing this rule as a direct final rule because we do not expect any significant adverse comments.

Revising the regulatory reference to the ASTM standard will conform the regulation to the substantive change in the applicable consumer product standard that will occur by operation of law under Public Law 112-28. Public comment will not impact the substantive changes to the standard or the effect of the revised standard as a consumer product safety standard under Public Law 112-28. Therefore, there is little for the public to comment upon.

Unless we receive a significant adverse comment within 30 days, the rule will become effective on October 2, 2016. In accordance with ACUS's recommendation, the Commission considers a significant adverse comment to be one where the commenter explains why the rule would be inappropriate, including an assertion challenging the rule's underlying premise or approach, or a claim that the rule would be ineffective or unacceptable without change.

Should the Commission receive a significant adverse comment, the Commission would withdraw this direct final rule. Depending on the comments and other circumstances, the Commission may then incorporate the adverse comment into a subsequent direct final rule or publish a notice of proposed rulemaking, providing an opportunity for public comment.

Under the procedure set forth in Public Law 112-28, when a voluntary standard organization revises a standard upon which a consumer product safety standard issued under the Danny Keysar Child Product Safety Notification Act was based, the revision becomes the CPSC standard within 180 days of notification to the Commission, unless the Commission determines that the revision does not improve the safety of the product, or the Commission sets a later date in the Federal Register. In accordance with this provision, this rule establishes an effective date that is 180 days after we received notification from ASTM of revisions to these standards. As discussed in the preceding section, this is a direct final rule. Unless we receive a significant adverse comment within 30 days, the rule will become effective on October 2, 2016.

The Regulatory Flexibility Act (“RFA”) generally requires that agencies review proposed and final rules for their potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604. The change to the incorporation by reference in the carriages and stroller standard will not result in any substantive changes to the standard. Therefore, this rule will not have any economic impact on small entities.

The Commission's regulations provide a categorical exclusion for the Commission's rules from any requirement to prepare an environmental assessment or an environmental impact statement because they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required.

The carriages and stroller standard contain information collection requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). No changes have been made to that section of the standard. Thus, these revisions will not have any effect on the information collection requirements related to that standard.

Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a “consumer product safety standard under [the Consumer Product Safety Act (CPSA)]” is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances.

The Danny Keysar Child Product Safety Notification Act (at section 104(b)(1)(B) of the CPSIA) refers to the rules to be issued under that section as “consumer product safety standards,” thus, implying that the preemptive effect of section 26(a) of the CPSA would apply. Therefore, a rule issued under section 104 of the CPSIA will invoke the preemptive effect of section 26(a) of the CPSA when it becomes effective.

Section 14(a) of the CPSA imposes the requirement that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, be certified as complying with all applicable CPSC requirements. 15 U.S.C. 2063(a). Such certification must be based on a test of each product, or on a reasonable testing program or, for children's products, on tests on a sufficient number of samples by a third party conformity assessment body accredited by the Commission to test according to the applicable requirements. As noted in the preceding discussion, standards issued under section 104(b)(1)(B) of the CPSIA are “consumer product safety standards.” Thus, they are subject to the testing and certification requirements of section 14 of the CPSA.

Because carriages and strollers are children's products, samples of these products must be tested by a third party conformity assessment body whose accreditation has been accepted by the Commission. These products also must comply with all other applicable CPSC requirements, such as the lead content requirements of section 101 of the CPSIA, the tracking label requirement in section 14(a)(5) of the CPSA, and the consumer registration form requirements in the Danny Keysar Child Product Safety Notification Act.

In accordance with section 14(a)(3)(B)(iv) of the CPSIA, the Commission has previously published a notice of requirements (“NOR”) for accreditation of third party conformity assessment bodies for testing carriages and strollers (79 FR 13208 (March 10, 2014)). The NORs provided the criteria and process for our acceptance of accreditation of third party conformity assessment bodies for testing carriages and strollers to 16 CFR part 1227 (which incorporated ASTM F833-13b with modifications). The NORs are listed in the Commission's rule, “Requirements Pertaining to Third Party Conformity Assessment Bodies.” 16 CFR part 1112.

The revisions discussed above do not add any new provisions that would require a third party conformity assessment body (testing laboratory) to conduct additional tests. As discussed above, most of the revisions clarify the existing standard and will not change existing test methods. Although the test method associated with passive containment/foot opening has been clarified to require testing depending on the number of adjustments that can be made in the grab bar/tray as well as footrest or calf support positions, the revision is not expected to affect how a test laboratory tests strollers and convertible carriages/strollers in a stroller mode. Revising the reference to ASTM F833-15 for the carriages and stroller standard will not necessitate any change in the way that third party conformity assessment bodies test these products for compliance to CPSC standards. Therefore, the Commission considers the existing accreditations that the Commission has accepted for testing to this standard also to cover testing to the revised standard. The existing NOR for this standards will remain in place, and CPSC-accepted third party conformity assessment bodies are expected to update the scope of the testing laboratories' accreditation to reflect the revised standard in the normal course of renewing their accreditation.

The OFR has regulations concerning incorporation by reference. 1 CFR part 51. Under these regulations, agencies must discuss, in the preamble of the final rule, ways that the materials the agency incorporates by reference are reasonably available to interested persons and how interested parties can obtain the materials. In addition, the preamble to the final rule must summarize the material. 1 CFR 51.5(b).

In accordance with the OFR's requirements, section B of this preamble summarizes the ASTM F833-15 standard that the Commission incorporates by reference into 16 CFR part 1227. The standard is reasonably available to interested parties and interested parties may purchase a copy of the standard from ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959 USA, phone: 610-832-9585; http://www.astm.org/. A copy of the standard can also be inspected at CPSC's Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923.

For the reasons stated above, the Commission amends title 16 CFR chapter II as follows:

We are adopting an interim final amendment to Form 10-K 1 under the Securities Exchange Act of 1934.2

We are adopting an interim final amendment to Form 10-K that implements Section 72001 of the FAST Act,3 which became law on December 4, 2015. Section 72001 of the FAST Act directs the Commission, not later than 180 days after the date of enactment, to issue regulations to permit “issuers” 4 to submit a “summary page” 5 on Form 10-K, but only if each item on such summary page includes a cross-reference (by electronic link or otherwise) to the material contained in Form 10-K to which such item relates.

Although our current rules do not prohibit a registrant from including voluntary information, such as a summary, in its Form 10-K,6 we are amending Part IV of Form 10-K 7 to add new Item 16. This new item will expressly allow a registrant, at its option, to include a summary in the Form 10-K. To implement the statutory requirement that each item in the summary be accompanied by an electronic or other cross-reference, new Item 16 requires that each summary topic be hyperlinked to the related, more detailed disclosure item in the Form 10-K.

In light of the varied nature of registrants' size and operations, we believe that registrants should have the flexibility to determine how best to prepare the summary. Accordingly, the amendment does not prescribe the length of the summary (other than to state that the summary shall be brief), specify the Form 10-K disclosure items that should be covered by the summary,8 or dictate where the summary must appear in the Form10-K.

We recognize that it might not be practicable or necessary to summarize every Form 10-K disclosure item. The amendment is principles-based and affords a registrant choosing to include a summary the flexibility to decide which items to summarize,9 as long as the information is presented fairly and accurately.

We are also including an instruction in Item 16 of Form 10-K that addresses information incorporated by reference into the Form 10-K that a registrant may choose to summarize. Exchange Act Rule 12b-23 allows registrants to incorporate information by reference in answer, or partial answer, to any item of an Exchange Act registration statement or report subject to certain conditions.10 Generally, the incorporated information must be filed as an exhibit to the registration statement or report.11 Under General Instruction G to Form 10-K, a registrant may incorporate by reference the information required by Parts I or II of Form 10-K from the registrant's annual report to security holders.12 The information required by Part III of Form 10-K also may be incorporated by reference from a proxy or information statement involving the election of directors, if filed within 120 days of the end of the fiscal year.13

As stated above, the interim final amendment to Form 10-K requires the summary to include hyperlinks to the related, more detailed disclosure item in the Form 10-K, regardless of whether the more detailed disclosure appears in the sections of the Form 10-K that follow the summary or in a Form 10-K exhibit. Currently, registrants can hyperlink to different sections within the same document, as well as to specific sections of exhibits that are part of the same filing.

Therefore, the interim final amendment requires registrants electing to prepare a Form 10-K summary that discusses information that is incorporated by reference into the Form 10-K and for which an exhibit is filed with the form to include a hyperlink from the summary to the discussion in the accompanying exhibit. Under the interim final amendment, a registrant choosing to include a summary will only be able to summarize information that is included in the Form 10-K at the time the form is filed, and will not have to file a Form 10-K amendment to summarize Part III information that is incorporated by reference from a proxy or information statement that will be filed after the date that the registrant files its Form 10-K.14 In that case, however, the registrant must indicate that the summary omits the Part III information.

We request and encourage any interested person to submit comments on any aspect of the interim final amendment, other matters that might have an impact on the amendment, and any suggestions for further revisions. In addition, we seek comment on the following:

1. Are companies and investors likely to find a Form 10-K summary useful? If so, should we propose mandating a summary? 15

2. Would it be helpful to EDGAR users for the Form 10-K summary or a link to the summary to be displayed on a registrant's EDGAR search results landing page? 16

3. Should we impose a length limitation on the summary? If so, what limitation would be appropriate (e.g., a page limit, word limit, character limit)?

4. Should we provide further guidance on preparation of the summary? For example, should we include language similar to Item 503(a) of Regulation S-K, which covers a prospectus summary? 17

We are revising and making final the rules for evaluating respiratory disorders we proposed in a Notice of Proposed Rulemaking (NPRM) published in the Federal Register on February 4, 2013 (78 FR 7968). The preamble to the NPRM provided an explanation of the changes from the current rules and our reasons for proposing those changes. To the extent that we are adopting the proposed rules as published, we are not repeating that information here. You can view the NPRM by visiting www.regulations.gov and searching for document “SSA-2006-0149-0024.” We are making a number of changes because of public comments we received in response to the NPRM. We explain those changes in our summary of public comments and our responses later in this preamble. We are also making minor editorial changes for clarity throughout these final rules.

We are revising the listings for evaluating respiratory disorders to reflect our program experience and advances in medical knowledge since we last comprehensively revised the listings for this body system, and comments we received from medical experts and the public at an outreach policy conference, in response to an Advance Notice of Proposed Rulemaking (ANPRM), and in response to an NPRM. We last published final rules making comprehensive revisions to section 3.00—the respiratory system listings for adults (people who are at least 18 years old)—and section 103.00—the respiratory system listings for children (people under age 18)—on October 7, 1993.1 Since that time, we have revised the introductory text for children, revised some testing requirements, added adult and child listings for lung transplants, removed criterion C from listing 3.09, added listing 103.06 and corresponding introductory text, and extended the effective date of the rules.2

We will begin to use these final rules on their effective date. We will continue to use the current listings until the date these final rules become effective. We will apply the final rules to new applications filed on or after the effective date of these final rules and to claims that are pending on or after the effective date.3 These final rules will remain in effect for 3 years after the date they become effective, unless we extend them, or revise and issue them again.

In the NPRM, we provided the public with a 60-day comment period that ended on April 5, 2013. We received 212 comments. The commenters included advocacy groups, legal services organizations, State agencies that make disability determinations for us, medical organizations, and people who have respiratory disorders or have relatives with respiratory disorders.

We carefully considered all of the comments that were relevant to this rulemaking. We have tried to present the commenters' concerns and suggestions accurately and completely, and we have responded to all significant issues that were within the scope of these rules. We provide our reasons for adopting or not adopting the recommendations in the summaries of the comments and our responses. We also received several comments supporting our proposed changes. We appreciate those comments; however, we did not include them in our discussion of the rules below.

As part of the rulemaking process, we held an informational teleconference with the public on May 10, 2013, during which we discussed general background information on the disability program, information for people with cystic fibrosis who either apply for Social Security disability benefits or are currently receiving disability benefits, information we received from medical experts and members of the public, and proposed criteria in listings 3.04 and 103.04.4 We did not accept public comments during the teleconference. We have included information related to the teleconference in the rulemaking docket for these rules under Docket ID number SSA-2006-0149-0237.5

Comment: One commenter suggested that we not refer to arterial blood gas (ABG) tests and pulse oximetry as pulmonary function tests (PFTs) because they are monitoring devices.

Response: We are not adopting this recommendation because we use the results of these tests to document the severity of respiratory disorders and we believe it is appropriate, for this purpose, to refer to ABG tests and pulse oximetry as PFTs.

Comment: Many commenters did not support removing the requirement for spirometry tracings of the forced expiratory maneuvers used to determine a person's highest forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC). Some commenters explained that the tracings allow us to confirm that the American Thoracic Society (ATS) testing standards were met. One commenter stated that requiring tracings will enhance the quality of the test and ensure confidence in the disability decision-making process for respiratory disorders. Another commenter agreed with us that accepting providers' interpretations of spirometry results without requiring tracings might reduce the number of tests that we purchase, but stated that not also requiring tracings might result in inappropriate allowances. One commenter suggested that, if we do not require tracings, we should require flow-volume loops to ensure the integrity of the test.

Response: We are adopting the recommendation that we continue to require spirometry tracings. In the proposed rule, we indicated that we believed it would be appropriate to trust the professional who supervises the test and for us to use the resulting spirometry values without corresponding tracings to assess the severity of a person's respiratory disorder. The public commenters (including medical experts who use the results of spirometry in their treatment of people with respiratory disorders, and disability examiners), however, disagreed with us.

In its public comment, the ATS recommended that we continue to require documentation of three acceptable tracings. We agree with that comment.

For most claims involving respiratory disorders and in which spirometry results are available, the evidence we receive usually does not include the spirometry tracings. By requiring tracings, we may need to recontact the medical source to seek the tracings or, if we know from experience that the source either cannot or will not provide the tracings, we may need to purchase consultative examinations to obtain spirometry results with tracings, unless we can make a fully favorable determination or decision on another basis. We will provide guidance to our adjudicators on when it is appropriate to purchase a PFT when we conduct training on the final rules.

Comment: Some commenters recommended that we continue to require documentation of equipment calibration for spirometry.

Response: We are not adopting these recommendations because, in our program experience, recorded calibrations that we receive almost invariably establish spirometer accuracy. We do not believe it is necessary to continue to require proof of equipment calibration. We expect the professional who supervises the test to comply with the professional standards for equipment calibrations. If, however, we have reason to believe that the equipment was not calibrated, we may then request calibration logs from the medical source.

Comment: Several commenters explained that the spirometry values (FEV1 and FVC) for several listings (proposed 3.02A, 3.02B, 3.02C4, 3.03A, 3.04A, 3.04B, 103.02A, 103.02B, 103.04A, and 103.04B) include too much variability in percent predicted between females and males, as well as between different height and age categories.

Response: We agree with these commenters. While we based the values in the spirometry tables on reference values from Hankinson, et al., 6 as noted in the NPRM, we agree that there was too much variability between categories (age, gender, and height). In these final rules, the percent predicted values (from which we derive the spirometry values that we use in final 3.02A, 3.02B, 3.03A, 3.04A, 103.02A, 103.02B, and 103.04A) by height are all within three percentage points of one another for a given age and gender cohort.

Comment: Some commenters recommended that we include percent predicted values in our rules rather than tables of absolute values for measurement of lung function.

Response: We did not adopt these recommendations. We believe that both percent predicted values and absolute values accurately represent the severity of a person's respiratory disorder. While the percent predicted values represent the percentage of lung function remaining, the absolute values of FEV1 and FVC represent the actual volumes of air that a person exhales during a forced expiratory maneuver.

Comment: Two commenters suggested that we use the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) calculator, which calculates percent predicted values, to determine the severity of a person's respiratory disorder.7

Response: We did not adopt these recommendations because the calculator is intended for use with a NIOSH spirometry training course and the Food and Drug Administration has not approved the calculator for clinical use.

Comment: One commenter agreed with using diffusing capacity of the lungs for carbon monoxide (DLCO) to measure respiratory function but recommended that we use percent predicted values rather than absolute values to more accurately capture condition severity.

Response: We did not adopt this recommendation. DLCO test results include both the actual (absolute) and percent predicted values for the measurement. Both values represent the ability of the lungs to transfer gases across the alveolar-capillary membrane. Neither value is more accurate than the other value because they both represent the same DLCO measurement.

Comment: One commenter had three concerns with the use of pulse oximetry in proposed 3.02C4a. First, requiring pulse oximetry and spirometry decreases the utility of the listing. Second, the key finding on a 6-minute walk test (6MWT) is whether desaturation occurs with exertion and not the baseline or post-6MWT results. Lastly, requiring printouts of pulse oximetry will dramatically reduce the availability of pulse oximetry evidence that we can use. This commenter suggested that the listing require desaturation with exercise independent of spirometry.

Response: We partially adopted these recommendations. We revised proposed 3.02C4, final 3.02C3, to require only pulse oximetry. We believe that the percent of oxygen saturation of blood hemoglobin measured by pulse oximetry required in 3.02C3 demonstrates a chronic gas exchange defect of listing-level severity. If resting pulse oximetry does not establish listing-level severity, we may use pulse oximetry during or after a 6MWT. We require a printout of the pulse wave during measurement because we use it to verify that perfusion to the area covered by the probe is adequate and that the probe is positioned properly, and because motion artifact may limit the accuracy of pulse oximetry during the 6MWT. Furthermore, to be consistent with this revision to final 3.02C3, we combined proposed 3.02C2, which required two resting ABG tests to document a chronic gas exchange defect of listing-level severity, and proposed 3.02C3, which required one exercise ABG test, into final 3.02C2 requiring one ABG test, either resting or during steady state exercise.

Comment: One commenter recommended that a clinical evaluation accompany the pulse oximetry measurement in proposed 3.02C4 because a pulse oximetry measurement should not be considered a primary diagnostic tool.

Response: We agree with the commenter, but did not make any changes as a result. Proposed and final 3.00D1 explain that we need a person's medical history, physical examination findings, the results of imaging, and pulmonary function tests to document and assess the severity of a person's respiratory disorder. Consequently, the rules already require the type of clinical evaluation of a person's respiratory disorder that the commenter suggested.

Comment: One commenter suggested that we require pulse oximetry be performed while the person is breathing room air or on oxygen supplementation. This commenter also suggested that we include a requirement that nail polish is removed prior to testing and that, if finger circulation is not good, we accept ear lobe pulse oximetry.

Response: We did not adopt these recommendations because the purpose of the pulse oximetry measurement is to determine oxygen (O2) saturation on room air and not with oxygen supplementation. We do not require that a finger probe be used. It is the responsibility of the professional supervising the test to choose the most appropriate probe (for example, finger or ear) and to also ensure that proper testing protocol (including removal of nail polish) is followed.

Comment: One commenter suggested that we remove the requirement for reduced lung function between asthma exacerbations (that is, baseline obstruction).

Response: We did not propose to change this requirement and, therefore, are not adopting this recommendation. We currently require baseline obstruction (current 3.00C) established by spirometry while the person is medically stable to document listing-level asthma. We continued to include this requirement in final 3.00I2a and 3.03A.

Comment: One commenter asked us to continue to consider adherence to therapy for asthma.

Response: We agree with the commenter, but did not make any changes as a result. We consider any hospitalization for an exacerbation of asthma lasting at least 48 hours to be despite prescribed therapy, unless we have evidence to the contrary.

Comment: One commenter suggested that we add a criterion to proposed 103.03 for the need for endotracheal intubation, which is a type of treatment for respiratory failure.

Response: We did not adopt this recommendation because we do not believe we need to specify the types of treatments we consider under 103.03 when a child is hospitalized for asthma. We did, however, add guidance in final 3.00I1 and 103.00G1 to explain that we evaluate respiratory failure resulting from chronic asthma under final 3.14 or 103.14.

Comment: Many commenters recommended that we continue to consider treatment for cystic fibrosis (CF) outside of the hospital. The commenters stated that physicians treat CF pulmonary exacerbations in a variety of ways including hospitalization and through use of intravenous antibiotics and inhaled nebulized therapies outside of the hospital setting. Some commenters explained that treatment at home for CF pulmonary exacerbations indicates the same severity of illness as a hospitalization for CF and is increasingly the method preferred by treating physicians.

Response: We adopted these recommendations. We included a criterion in final 3.04G and 103.04G that requires 10 consecutive days of intravenous antibiotic treatment, without specifying where (for example, in a hospital) the treatment occurs, for CF pulmonary exacerbations. We also added guidance in final 3.00J3 and 103.00H3 to explain that treatment for CF exacerbations usually includes intravenous antibiotics and intensified airway clearance therapy (for example, increased frequencies of chest percussion or increased use of inhaled nebulized therapies, such as bronchodilators or mucolytics). We want to assure the commenters that we are able to evaluate CF under the criteria in final listings 3.04 and 103.04, using medical equivalence, the functional equivalence rules for children, or at other steps in our sequential evaluation process.

Comment: Multiple commenters suggested that we revise proposed 3.04D and 103.04E, which required any two of six listed CF exacerbations and complications. Some commenters explained that four of the listed exacerbations and complications (spontaneous pneumothorax, respiratory failure, pulmonary hemorrhage, and hypoxemia) are serious health issues for people with CF. The commenters recommended that we revise the list to more accurately reflect the progression of CF and that we require only one of these four exacerbations or complications to establish that a person is disabled.

Response: We adopted these recommendations by adding standalone listing criteria for spontaneous pneumothorax in final 3.04C and 103.04D, respiratory failure in final 3.04D and 103.04E, pulmonary hemorrhage requiring vascular embolization in final 3.04E and 103.04F, and hypoxemia measured by pulse oximetry in final 3.04F.

Comment: One commenter stated that ABG tests in proposed 3.04B do not correlate well to disability for people with CF, and that ABG tests are not generally used in most specialized CF care centers.

Response: We adopted this recommendation and removed proposed 3.04B that required ABG test results to evaluate the severity of CF in the final rule.

Comment: One commenter said that proposed 103.04C for hypoxemia with the need for at least 1.0 liter per minute of oxygen supplementation for at least 4 hours per day for at least 90 consecutive days is “significantly too strict” for children with CF. The commenter stated that any child whose CF meets the proposed listing would already be on a lung transplant list.

Response: We adopted this recommendation and have not included proposed 103.04C in the final rule. While being on a lung transplant list is not a listing criterion, we believe children with CF whose impairment would have met proposed 103.04C will have an impairment that meets the requirements in one of the listings for CF included in the final rule.

Comment: Multiple commenters objected to the proposed lower spirometry values for evaluating CF in proposed 3.04A and 103.04A.

Response: We adopted these comments and modified the spirometry values in proposed 3.04A and 103.04A. Our revisions to all spirometry values to minimize variability, as we described above, in addition to the fact that people with CF are disabled at a comparatively higher level of lung function than people who do not have CF, resulted in none of the values in final 3.04A and 103.04A being lower than the corresponding values in current 3.04A and 103.04A.

Comment: Multiple commenters recommended that we not use echocardiograms to evaluate the severity of chronic pulmonary hypertension in proposed 3.09B. One commenter stated that results from echocardiograms do not accurately reflect the presence of moderate pulmonary hypertension that causes marked functional limitations. Another commenter stated that only cardiac catheterization should be used to evaluate disability for pulmonary hypertension in proposed 3.09A.

Response: We adopted these recommendations and removed the echocardiography requirement from final 3.09. We also removed echocardiography from the list of examples of medical imaging techniques in proposed 3.00D2 (final 3.00D3).

Comment: One commenter suggested that we add listing criteria to proposed 3.09A, which requires only cardiac catheterization for chronic pulmonary hypertension.

Response: We did not adopt this recommendation because adding the suggested listing criteria to 3.09 increases the severity level of the listing. We believe final 3.09 is medically appropriate and represents an inability to perform any gainful activity. When we have the results of cardiac catheterization and those results meet the requirements of the listing, we do not need additional criteria to support listing-level severity. Adding listing criteria creates an unnecessary evidence burden on claimants.

Comment: One commenter suggested that we exclude asthma and obesity as underlying conditions for respiratory failure in proposed 3.14 and 103.14.

Response: We did not adopt this recommendation. Final 3.14 and 103.14 require that we evaluate respiratory failure resulting from any chronic respiratory disorder except CF. Obesity is not a “chronic respiratory disorder” and, therefore, respiratory failure cannot be evaluated under these listings if obesity is the person's only impairment. (We address how to consider the effects of obesity combined with a respiratory disorder in final 3.00O.) We believe it is appropriate to evaluate respiratory failure resulting from chronic asthma under these listings.

Comment: One commenter recommended that we consider noninvasive ventilation as an alternative to invasive ventilation for treatment of respiratory failure resulting from CF.

Response: We adopted this recommendation because ventilatory support in respiratory failure associated with any underlying chronic respiratory disorder, including CF, while traditionally provided by invasive ventilation, is now often provided by noninvasive ventilation. In either case, cyclical positive pressure is applied to the airway to assist ventilation and reduce the work of breathing. We believe it is reasonable to count the total ventilatory support time, whether it be invasive or noninvasive ventilation, for our purposes, so we added this alternative to final 3.04D, 3.14, 103.04E, and 103.14.

Comment: One commenter suggested that we include a listing for people with respiratory disorders who are dependent on oxygen supplementation.

Response: We are not adopting this recommendation because the use of supplemental oxygen does not, by itself, indicate an impairment of listing-level severity. In proposed 3.00D1 and final 3.00D2 and 103.00D2, we explain that if a person uses supplementation oxygen, we still need medical evidence to establish the severity of his or her respiratory disorder.

Comment: One commenter suggested that we include a criterion in 3.02 that requires three hospitalizations within a 12-month period for any chronic respiratory disorder except CF.

Response: We adopted this recommendation in final 3.02D because we agree that three hospitalizations of 48 hours or longer, 30 days or more apart, within a 12-month period that we are considering in connection with an application or continuing disability review for exacerbations or complications of a chronic respiratory disorder will prevent a person from engaging in any gainful activity and, therefore, represents listing-level severity.

Additionally, we are able to evaluate chronic respiratory disorders resulting in fewer than three hospitalizations in a consecutive 12-month period using medical equivalence, under other listing criteria, or at other steps in our sequential evaluation process. For example, if a claimant's chronic respiratory disorder does not precisely meet the hospitalization requirements in final 3.02D, we may find that the disorder is medically equivalent to that listing, if the disorder is at least medically equal in severity and duration to the listing criteria. Our medical equivalence rules permit us to find that a disorder is medically equivalent to a listing at step 3 if there are other findings related to the disorder that are at least of equal medical significance to the listing criteria (see §§ 404.1526 and 416.926).

Although some of our listings include criteria for repeated hospitalizations (3.02D, 3.03B, 3.04B, 3.07, 103.02E, 103.03, and 103.04C), our medical equivalence policy accommodates recent trends in clinical care that emphasize quality of, rather than quantity of, medical treatment. The medical equivalence policy also accommodates claimants' varying level of access to medical care (as well as the preference of some medical providers to reduce the use of emergency department and hospital-level medical interventions). This accommodation accounts for differences in medical care people with similar disorders receive depending on the medical resources available to them. The medical equivalence policy provides some flexibility in determining whether a claimant is disabled at step 3 of the sequential evaluation process by allowing us to consider whether the claimant's impairment meets the listed criteria or is at least equal in severity and duration to the criteria of any listed impairment. The final listings do not provide substantive instructions to our adjudicators for determining such equivalence because we can better provide this information through operating instructions and training

If we are not able to find that a person's impairment due to a chronic respiratory disorder is disabling using our listings, we may still find the person disabled at the final steps of the sequential evaluation process.

Comment: One commenter suggested that we include a criterion in 3.02 for persistent chronic lung infections that are refractory to treatment or provide guidance in our internal operating instructions for how to evaluate these cases.

Response: We did not adopt this recommendation because we explain in final 3.00Q that we evaluate limitations in respiratory function resulting from chronic lung infections under 3.02. We will, however, provide guidance to our adjudicators on how to evaluate chronic lung infections that are resistant to treatment when we conduct training on these final rules.

Comment: One commenter suggested that we include a listing for prolonged, active infectious periods of mycobacterium tuberculosis (MTB) lasting longer than 12 months.

Response: We did not adopt this recommendation because prolonged, active infectious periods of MTB lasting longer than 12 months are extremely rare. MTB is generally treatable with a 6-month course of antibiotics. If, however, active infectious periods associated with resistance to, or intolerance of, multiple antibiotics last longer than 12 months, we will evaluate the impairment under an appropriate listing.

Comment: One commenter suggested that we place the tables in Part A directly following the listings for which they are used, similar to how the tables appear in Part B.

Response: We adopted this recommendation because we agree that it is easier for an adjudicator to use a table when it is located directly following its listing.

In proposed 3.00O and 103.00L, we included guidance explaining that, for listings that require a specific number of events within a 12-month period, the 12-month period must occur within the period we are considering in connection with the application or continuing disability review. We did not, however, provide a reference to proposed 3.00O and 103.00L in each proposed listing. In these final rules, we include this guidance in each listing (final 3.02D, 3.03B, 3.04B, 3.04F, 3.04G, 3.07, 3.14, 103.02E, 103.03, 103.04C, 103.04G, and 103.14) and, as a result, it is unnecessary to also include the same guidance in the introductory text.

In proposed 3.00D3 and 103.00D3, we included a requirement that pulmonary function testing be conducted in accordance with the most recently published standards of the ATS. We do not include this statement in these final rules because we now include in final 3.00E and 103.00E (for spirometry) and in final 3.00F (for DLCO) the specific ATS testing standards that we require to evaluate respiratory disorders. The ATS may revise its testing standards at any time, in which case we would review any new standards and, if appropriate, publish proposed changes to our requirements for public comment before revising the rules.

In these final rules, we are redesignating current 103.00F as 103.00K and revising the reference to 103.00F in listing 103.06 to 103.00K. We are not revising the introductory text or the listing requirements, both of which we added to the respiratory body system in 2015.8

The Act authorizes us to make rules and regulations and to establish necessary and appropriate procedures to implement them. Sections 205(a), 702(a)(5), and 1631(d)(1) of the Act.

We consulted with the Office of Management and Budget (OMB) and determined that these final rules meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB reviewed them.

We certify that these final rules will not have a significant economic impact on a substantial number of small entities because they affect individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

This final rule does not create any new or affect any existing collections and, therefore, does not require OMB approval under the Paperwork Reduction Act.

For the reasons set out in the preamble, we are amending 20 CFR part 404 subpart P and part 416 subpart I as set forth below:

The Transmissible Spongiform Encephalopathies Advisory Committee (the Committee) was established on June 9, 1995 (60 FR 31311, June 14, 1995; 21 CFR 14.100 erroneously lists the date of establishment as June 21, 1995). The Committee reviews and evaluates available scientific data concerning the safety of products that may be a risk for transmission of spongiform encephalopathies having an impact on the public health as determined by the Commissioner of Food and Drugs. The Committee makes recommendations to the Commissioner regarding the regulation of such products. In recent years, the number of issues requiring Committee advice has declined, and the Committee has met very infrequently. Therefore, the effort and expense of maintaining this advisory committee is no longer justified. Any relevant Transmissible Spongiform Encephalopathy issues in the future could be addressed by the Agency's other advisory committees, such as the Agency's Blood Products Advisory Committee, with additional augmentation of expertise by appropriate subject matter experts serving as temporary members on the committee.

The Committee is no longer needed and will be terminated on June 9, 2016.

Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40 (d) and (e), the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary and are not in the public interest as this final rule merely removes the name of the Transmissible Spongiform Encephalopathies Advisory Committee from the list of standing advisory committees in 21 CFR 14.100.

Therefore, the Agency is amending 21 CFR 14.100(b) as set forth in the regulatory text of this document.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows:

I. Background II. Method of Calculation III. Summary of Final Rule IV. Procedural Requirements I. Background

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74) (the Act). The Act requires Federal agencies to adjust each CMP amount with an initial catch-up adjustment through rulemaking and then make subsequent annual inflationary adjustments. The new CMP amounts must be published by July 1, 2016, and take effect no later than August 1, 2016. The purpose of these adjustments is to maintain the deterrent effect of civil penalties and to foster compliance with the law.

The Act provides that any increase in a CMP due to the calculated inflation adjustments shall apply only to a violation that occurs after the date when the increase takes effect and states that the initial inflation adjustment may not exceed 150 percent of the amount of the CMP on November 2, 2015.

OMB issued guidance on calculating the catch-up adjustments. See February 24, 2016, Memorandum for the Heads of Executive Departments and Agencies, from Shaun Donovan, Director, Office of Management and Budget, re: Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. Under this guidance, the Department of the Interior (Department) has identified applicable CMPs and calculated the catch-up adjustments. A CMP is any assessment with a dollar amount that is levied for a violation of a Federal civil statute or regulation and is assessed or enforceable through a civil action in Federal court or an administrative proceeding. A CMP does not include a penalty levied for violation of a criminal statute, fees for services, licenses, permits, or other regulatory review.

Under the Act, the inflation adjustment for each applicable CMP is determined by increasing the maximum CMP amount per violation by the cost-of-living adjustment. The cost-of-living adjustment is defined as the percent by which the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October of the calendar year preceding the adjustment exceeds the CPI-U for the month of October of the year in which the amount of such CMP was last set or adjusted pursuant to law.

The maximum CMP amounts for ONRR penalties under 30 U.S.C. 1719(a)-(d) were established in 1983 in the Federal Oil and Gas Management Act (FOGRMA). Since we have not updated the maximum CMP amounts for inflation since their establishment, we must calculate a new maximum CMP with an initial catch-up adjustment. The inflation adjustment amount for each maximum CMP amount is calculated by multiplying the 1983 maximum CMP amount by the 2016 CMP catch-up adjustment multiplier for 1983, which is 2.35483. In accordance with the Act, the new maximum CMP amount is rounded to the nearest dollar. For example:

The maximum CMP amount under 30 U.S.C. 1719(a) established in 1983 is $500.

The 2016 CMP catch-up adjustment multiplier for 1983 is 2.35483.

Therefore, $500 × 2.35483 = $1,177.415, which rounds to $1,177.

The new maximum CMP amount is $1,177.

Pursuant to the Act, in the event that a violation took place prior to the effective date of the new penalty amount—and we assess a penalty after the effective date—the new penalty amount is assessed in a manner consistent with the new maximum CMP calculation. As the Act applies to penalties assessed after the effective date of the applicable adjustment, the Act adjusts penalties prospectively. The Act does not retrospectively change previously assessed or enforced penalties that we are actively collecting or have collected. The Act does not alter our statutory authority to assess penalties below the maximum amount.

This final rule adjusts the maximum CMP amount within each of the four established civil penalty tiers specified in 30 U.S.C. 1719(a)-(d). The following list summarizes the existing ONRR regulations containing CMPs, as well as the penalties before and after adjustment. The increases in maximum CMP amounts contained in this final rule may not necessarily affect the amount of any CMP that we may seek for a particular violation; we will calculate each CMP on a case-by-case basis.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in OMB will review all significant rules. OIRA has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866, while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. Executive Order 13563 directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public, where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We developed this rule in a manner consistent with these requirements.

The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for all rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. See 5 U.S.C. 603(a) and 604(a). The Federal Civil Penalties Adjustment Act of 2015 requires agencies to adjust civil penalties with an initial catch-up adjustment through an interim final rule. An interim final rule does not include first publishing a proposed rule. Thus, the RFA does not apply to this rulemaking.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million or more.

b. Will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, local government agencies; or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.

This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. This rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. Therefore, we are not required to provide a statement containing the information that the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) requires because this rule is not an unfunded mandate.

Under the criteria in section 2 of E.O. 12630, this rule does not have any significant takings implications. This rule will not impose conditions or limitations on the use of any private property. Therefore, this rule does not require a takings implication assessment.

Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. Therefore, this rule does not require a Federalism summary impact statement.

This rule complies with the requirements of E.O. 12988. Specifically, this rule:

a. Meets the criteria of section 3(a), which requires that we review all regulations to eliminate errors and ambiguity and to write them to minimize litigation.

b. Meets the criteria of section 3(b)(2), which requires that we write all regulations in clear language using clear legal standards.

The Department strives to strengthen its government-to-government relationship with the Indian Tribes through a commitment to consultation with the Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. Under the Department's consultation policy and the criteria in E.O. 13175, we evaluated this rule and determined that it will have no substantial direct effects on Federally-recognized Indian Tribes and does not require consultation.

This rule:

(a) Does not contain any new information collection requirements.

(b) Does not require a submission to OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). See 5 CFR 1320.4(a)(2).

This rule does not constitute a major Federal action, significantly affecting the quality of the human environment. We are not required to provide a detailed statement under NEPA because this rule qualifies for categorical exclusion under 43 CFR 46.210(i) in that this rule is “. . . of an administrative, financial, legal, technical, or procedural nature. . . .” We also have determined that this rule is not involved in any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

This rule is not a significant energy action under the definition in E.O. 13211 and, therefore, does not require a Statement of Energy Effects.

We are required by E.O. 12866 (section 1(b)(12)), E.O. 12988 (section 3(b)(1)(B)), and E.O. 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) Be logically organized.

(b) Use the active voice to address readers directly.

(c) Use common, everyday words and clear language rather than jargon.

(d) Be divided into short sections and sentences.

(e) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that you find unclear, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

ONRR will post all comments, including the name and address of a respondent, at www.regulations.gov. Before including Personally Identifiable Information (PII), such as your address, phone number, email address, or other personal information in your comments, you should be aware that your entire comment (including PII) may be made available to the public at any time. While you may ask us, in your comment, to withhold PII from public view, we cannot guarantee that we will be able to do so.

In accordance with § 553(b), ONRR generally publishes a rule in a proposed form and solicits public comment on it before issuing the final rule. However, § 553(b)(3)(B) provides an exception to the public comment requirement if the agency finds good cause to omit advance notice and public participation. Good cause is shown when public comment is “impracticable, unnecessary, or contrary to the public interest.”

ONRR finds that there is good cause to promulgate this rule without first providing for public comment. We are promulgating this final rule to implement the statutory directive in the Act, which requires agencies to publish an interim final rule and to update the CMP amounts by applying a specified formula. ONRR has no discretion to vary the amount of the adjustment to reflect any views or suggestions provided by commenters. Accordingly, it would serve no purpose to provide an opportunity for pre-promulgation public comment on this rule. Also, it would not be possible to meet the deadlines imposed by the Act if we were to first publish a proposed rule, allow the public sufficient time to submit comments, analyze the comments, and publish a final rule. Thus, pre-promulgation notice and public comment is unnecessary and impracticable. These technical changes, required by law, do not substantively alter the existing regulatory framework nor in any way effect the terms under which ONRR assesses civil penalties.

For the reasons discussed in the preamble, ONRR amends 30 CFR part 1241 as set forth below:

The Coast Guard will enforce the regulated area in 33 CFR 100.501 from 9 a.m. until 11 a.m. on June 12, 2016, for the Oxford-Bellevue Sharkfest Swim. The date of this enforcement action has changed because the event was postponed by the sponsor due to inclement weather. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for Recurring Marine Events within the Fifth Coast Guard District, § 100.501, specifies the location of the regulated area for this event that includes all waters of the Tred Avon River from shoreline to shoreline, within an area bounded on the east by a line drawn from latitude 38°42′25″ N., longitude 076°10′45″ W., thence south to latitude 38°41′37″ N., longitude 076°10′26″ W., and bounded on the west by a line drawn from latitude 38°41′58″ N., longitude 076°11′04″ W., thence south to latitude 38°41′25″ N., longitude 076°10′49″ W., thence east to latitude 38°41′25″ N., longitude 076°10′30″ W., located at Oxford, MD. Only designated marine event participants and their vessels and official patrol vessels are authorized to enter the regulated area. As specified in § 100.501(c), during the enforcement period, the Coast Guard Patrol Commander or designated Marine Event Patrol may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel in these areas shall immediately comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both. The operator of any vessel in the regulated area shall: (i) Stop the vessel immediately when directed to do so by any Official Patrol and then proceed only as directed; (ii) All persons and vessels shall comply with the instructions of the Official Patrol; (iii) When authorized to transit the regulated area, all vessels shall proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the race course. The Coast Guard may be assisted by other Federal, state or local law enforcement agencies in enforcing this regulation. If the Captain of the Port or his designated on-scene Patrol Commander determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

This notice of enforcement is issued under authority of 33 CFR 100.501(f), Special Local Regulations and Safety Zones; Recurring Marine Events and Fireworks Displays Within the Fifth Coast Guard District and 5 U.S.C. 552(a). In addition to this notification in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via Broadcast Notice to Mariners and the Local Notice to Mariners. The Captain of the Port, Sector Maryland-National Capital Region, or a designated on-scene representative may be contacted via Channel 16, VHF-FM.

The bridge owner, Connecticut Department of Transportation, requested a temporary deviation from the normal operating schedule to perform timber ties and headblocks replacement at the bridge.

The Metro-North Saga Bridge, mile 1.1, across the Saugatuck River, has a vertical clearance in the closed position of 13 feet at mean high water and 20 feet at mean low water.

The existing bridge operating regulations are found at 33 CFR 117.221(b).

The waterway is transited by seasonal recreational vessels.

Under this temporary deviation, the Metro-North Saga Bridge will operate according to the schedule below:

Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Town of Hempstead Department of Public Safety requested and the bridge owner, Nassau County Department of Public Works, concurred with this temporary deviation from the normal operating schedule to facilitate a public event, the Annual Salute to Veterans and Fireworks Display.

The Long Beach Bridge, mile 4.7, across Reynolds Channel has a vertical clearance in the closed position of 22 feet at mean high water and 24 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.799(g).

Reynolds Channel is transited by commercial and recreational traffic.

Under this temporary deviation, the Long Beach Bridges may remain in the closed position between 9:30 p.m. and 11:59 p.m. on June 25, 2016 (rain date: June 26, 2016 between 9:30 p.m. and 11:59 p.m.).

Vessels able to pass under the bridge in the closed position may do so at anytime. The bridges will not be able to open for emergencies and there are no immediate alternate routes for vessels to pass.

The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Community Family Literacy Project, Inc. requested and Suffolk County Department of Public Works, the bridge owner concurred with this temporary deviation from the normal operating schedule to facilitate a public event, the annual 5K Run for Literacy.

The Smith Point Bridge, mile 6.1, across Narrow Bay has a vertical clearance in the closed position of 18 feet at mean high water and 19 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.799(d).

Narrow Bay is transited by seasonal recreational vessels of various sizes.

Under this temporary deviation, the Smith Point Bridges may remain in the closed position on Saturday September 10, 2016 between 9:00 a.m. and 10 a.m.

Vessels able to pass under the bridge in the closed position may do so at anytime. The bridges will not be able to open for emergencies and there are no immediate alternate routes for vessels to pass.

The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

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

Recreational boating traffic on the waters of Biscayne Bay increases significantly during New Year's Eve, Fourth of July, and Columbus Day Weekend events. In recent years, recreational vessel speed, especially in crossing navigational channels, contributed to incidents that resulted in severe injury and death. This regulation seeks to increase public safety on the waters of Biscayne Bay during New Year's Eve, Fourth of July, and Columbus Day Weekend, holidays known for increased vessel traffic, by requiring vessels to travel at a maximum speed of 15 knots. It also subjects recreational vessels to the control by Coast Guard and local law enforcement authorities. On November 20, 2015 the Coast Guard published a notice of proposed rulemaking (NPRM) titled Regulated Navigation Area; Columbus Day Weekend, New Year's Eve Events, and Fourth of July Events; Biscayne Bay, Miami, FL (80 FR 72663). 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 21, 2015, we received no comments.

The legal basis for this rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1. The District Seven Commander has determined that potential hazards associated with New Year's Eve, Fourth of July, and Columbus Day Weekend events pose a safety concern for anyone on the waters of Biscayne Bay. The purpose of this rule is to ensure safety of vessels and the navigable waters in Biscayne Bay before, during, and after the New Year's Eve, Fourth of July, and Columbus Day Weekend events.

As noted above, we received no comments on our NPRM published November 20, 2015. There are no significant changes in the regulatory text of this rule from the proposed rule in the NPRM. This rule establishes a regulated navigation area Columbus Day weekend, starting at noon on the Saturday before Columbus Day through 2 a.m. on Monday (the Columbus Day holiday); from 9 p.m. December 31st until 2 a.m. January 1st; and from 7 p.m. until 2 a.m. on the night Fourth of July fireworks are scheduled in Downtown Miami and Key Biscayne.

This regulated navigation area will encompass waters of Biscayne Bay between Julia Tuttle Causeway Bridge and Turkey Point in Homestead, Florida. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after New Year's Eve, Fourth of July, and Columbus Day Weekend Holidays.

All vessels within the proposed regulated navigation area are: (1) Required to transit the regulated navigation area at no more than 15 knots; (2) subject to control by the Coast Guard; and (3) required to follow the instructions of all law enforcement vessels in the area.

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

E.O.s 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Although the regulated navigation area covers most of Biscayne Bay, it is only enforced for a maximum of 38 hours during three holiday weekends. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 to provide notice of the zone and the regulations that allow vessels to enter the regulated navigation 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 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 regulated navigation area may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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

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

A rule has implications for federalism under E.O. 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 E.O. 13132.

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, 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 is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

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

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On February 25, 2016, at 81 FR 9391, EPA proposed to approve amendments to 326 IAC 8-4-6 and 326 IAC 8-4-1 of the Indiana Administrative Code, removing Stage II requirements from the Indiana's Federally-approved ozone SIP. The revision included copies of 326 IAC 8-4-1 and 326 IAC 8-4-6, as published in the Indiana Register on March 4, 2015 (Document ID Number: 20150304-IR-326120636FRA); a summary of state-specific calculations based on EPA guidance used to calculate program benefits and demonstrate widespread use of onboard refueling vapor recovery (ORVR) in Indiana; and a section 110(l) demonstration that includes offset emission documentation that addresses the 2013-2015 period, when Stage II requirements were waived in Indiana but widespread use of ORVR had not yet occurred.

EPA provided a 30-day review and comment period on the proposed action. The comment period closed on March 28, 2016. EPA received no comments.

EPA is approving revisions to the Indiana ozone SIP submitted dated April 27, and September 10, 2015, concerning the state's Stage II program in Indiana. EPA finds that the revisions will not interfere with any applicable requirement concerning attainment, reasonable further progress or any other applicable CAA requirement.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Indiana Regulations described in the proposed amendments to 40 CFR part 52 set forth below. Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.1 EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 8, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

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

In the SIP, the ELT River Road Industrial Center is subject to specific restrictions as part of Minnesota's SIP for SO2 in the Twin Cities Seven County SO2 area (Twin Cities area).1 The SIP for ELT's River Road Industrial Center was most recently approved by EPA on August 3, 2010, (75 FR 148).

Currently, four fossil fuel-fired boilers (#1, #2, #3, and #4) and four emergency generators (#5, #6, #7, and #8) are the primary emission units at the facility. Boilers #1, #2, and #3 use natural gas as their primary fuel with distillate oil as a backup fuel. Boiler #4 uses natural gas for fuel. All the emergency generators use low sulfur diesel fuel. In addition, the facility is subject to fuel usage limitations to restrict the total facility SO2 emissions.

On February 24, 2016, the MPCA submitted a revision to Minnesota's SO2 SIP for the ELT River Road Industrial Center. The revision, most specifically, reflects changes as a result of new ownership.

In 2015, as part of a purchase agreement, corporate ownership transferred from ELT to the Gramercy Property Trust Fridley Owner LLC (GPT Fridley). GPT Fridley changed the name of the facility from River Road Industrial Center to BAE.

Under new ownership, BAE will be used for office and warehouse space. The emergency generators are used for stand-by power, for both life-safety, and communications in the event of electrical power is lost.

The revised SIP identifies the boilers and emergency generators as both emission units (EU) and numbered equipment (EQUI). For example, boiler #4 (EU 004) is now identified as boiler #4 (EU 004/EQUI 1).

Because part of the BAE facility had been demolished, boilers #1, #2, and #3, and emergency generators #7 and #8 were decommissioned and removed from the facility. Boiler #4, and emergency generators #5 and #6 were relocated within the facility.

As part of the recent changes to the facility, boiler #4, which burns natural gas, has been modified to burn fuel oil as a backup fuel. Boiler #4 has a design capacity rated at 10.46 million British thermal units per hour (MMBtu/hr). BAE has imposed limits on boiler #4 to restrict its fuels to natural gas and distillate fuel oil, with a sulfur content limit on the fuel oil of less than or equal to 0.05 percent by weight.

Boilers #1, #2, and #3, which had design capacities rated at 69.8, 69.8, and 35.1 MMBtu/hr, respectively, have been replaced with a newer, more efficient boiler. The new boiler #5 has a design capacity rated at 19.674 MMBtu/hr. Boiler #5 is restricted to combusting natural gas and distillate fuel oil with a sulfur content limit on the fuel oil of less than or equal to 0.05 percent by weight as a backup fuel.

The SO2 emission units operating at the BAE facility are boilers #4 and #5 and two emergency generators (#5 and #6). Boilers #1, #2, and #3, and emergency generators #7 and #8 have been removed from the facility.

Boiler #4's potential SO2 emissions increase by 2.33 tons per year.2 Boiler #5's potential SO2 emissions using distillate fuel as a backup fuel are 4.37 tons per year.

Overall, the emissions change from replacing the three older boilers (#1, #2, and #3) with a new, more efficient boiler #5, coupled with modifications to boiler #4 to burn fuel oil as a backup fuel, result in a significant decrease in SO2 emissions at the BAE facility. This action reduces the facility's total SO2 emissions from 39.76 tons per year to 7.25 tons per year. The net emissions change is a reduction of 32.51 tons of SO2 per year for the BAE facility.

SO2 monitors near the BAE facility are currently measuring values less than 10 parts per billion (ppb), well below the 1-hour SO2 NAAQS of 75 ppb. EPA expects the air quality in the Twin Cities area to remain protected with the revisions being approved.

The revised SO2 SIP for the BAE facility provides for reductions in allowable emissions, and therefore, strengthens the SO2 SIP for the Twin Cities area. Thus, EPA believes the BAE facility revision request is approvable.

EPA is approving the request by Minnesota to revise the SO2 SIP as it applies to the BAE Technology Center. Specifically, EPA is approving into the SIP those portions of the BAE Technology Center facility Joint Title I/Title V document, permit No. 00300245-003, cited as “[Title I Condition: 40 CFR 50.4(SO2 SIP), Title I Condition: 40 CFR 51, Title I Condition: 40 CFR pt. 52, subp. Y].” This replaces the current SO2 SIP for ELT Minneapolis, LLC.

This revision will result in an overall reduction of SO2 emissions at the facility, which supports the continued attainment and maintenance of the SO2 NAAQS in the Twin Cities area.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective August 8, 2016 without further notice unless we receive relevant adverse written comments by July 11, 2016. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. If we do not receive any comments, this action will be effective August 8, 2016.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Minnesota regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available through www.regulations.gov and/or at the appropriate EPA office (see the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 8, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

The snapper-grouper fishery of the South Atlantic includes snowy grouper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The commercial ACL (commercial quota) for snowy grouper in the South Atlantic is 125,760 lb (57,044 kg), gutted weight, 148,397 lb (67,312 kg), round weight, for the current fishing year, January 1 through December 31, 2016, as specified in 50 CFR 622.190(a)(1)(ii).

Under 50 CFR 622.193(b)(1), NMFS is required to close the commercial sector for snowy grouper when the commercial quota is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS projects that commercial landings of South Atlantic snowy grouper, as estimated by the Science and Research Director, will reach the commercial ACL by June 14, 2016. Accordingly, the commercial sector for South Atlantic snowy grouper is closed effective 12:01 a.m., local time, June 14, 2016, until 12:01 a.m., local time, January 1, 2017.

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having snowy grouper on board must have landed and bartered, traded, or sold such snowy grouper prior to 12:01 a.m., local time, June 14, 2016. During the commercial closure, harvest and possession of snowy grouper in or from the South Atlantic EEZ is limited to the bag and possession limits, as specified in § 622.187(b)(2)(ii) and (c)(1). Also during the commercial closure, the sale or purchase of snowy grouper taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of snowy grouper that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, June 14, 2016, and were held in cold storage by a dealer or processor.

For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the bag and possession limits and the sale and purchase provisions of the commercial closure for snowy grouper would apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.190(c)(1)(ii).

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of snowy grouper and the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(b)(1) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act, because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA), finds that the need to immediately implement this action to close the commercial sector for snowy grouper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect snowy grouper since the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established commercial quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).