Federal Register Vol. 80, No.218,

DOE published a final rule, 79 FR 32050 (June 3, 2014), that set nineteen energy conservation standards pertaining to walk-in coolers and walk-in freezers (collectively, “walk-ins” or “WICFs”). A walk-in, at its basic level, is a refrigerated box, with a total chilled storage area of less than 3,000 square feet. The standards promulgated by DOE pertained to the primary components that comprise a walk-in—i.e. panels, doors, and the refrigeration systems. The panels and doors of a walk-in comprise the box, while the refrigeration system provides the cooling air to cool the interior of the box.

The Air-Conditioning, Heating and Refrigeration Institute (“AHRI”) and Lennox International, Inc. (a manufacturer of WICF refrigeration systems) filed petitions for review of DOE's final rule and DOE's subsequent denial of a petition for reconsideration of the rule with the United States Court of Appeals for the Fifth Circuit. Lennox Int'l, Inc. v. Dep't of Energy, Case No. 14-60535 (5th Cir.). A number of other WICF refrigeration system manufacturers—Rheem Manufacturing Co., Heat Transfer Products Group, and Hussmann Corp.—along with the Air Conditioning Contractors of America (a trade association representing contractors who install WICF refrigeration systems) intervened on the petitioners' behalf, while the Natural Resources Defense Council—representing itself, the American Council for an Energy-Efficient Economy, and the Texas Ratepayers' Organization to Save Energy—intervened on behalf of DOE. As a result of this litigation, a settlement agreement was reached to address, among other things, six of the refrigeration system standards.

The controlling court order from the Fifth Circuit, which was issued on August 10, 2015, vacates those six standards. These vacated standards relate to (1) the two energy conservation standards applicable to multiplex condensing refrigeration systems operating at medium and low temperatures and (2) the four energy conservation standards applicable to dedicated condensing refrigeration systems operating at low temperatures. See 10 CFR 431.306(e) (codifying these six standards, together with four distinct standards applicable to dedicated condensing refrigeration systems operating at medium temperatures).

The final rule on review also established thirteen other energy conservation standards applicable to other components of walk-in coolers and walk-in freezers: (1) Four standards applicable to dedicated condensing refrigeration systems operating at medium temperatures; (2) three standards applicable to panels; and (3) six standards applicable to doors. See 79 FR at 32051-32052 (Table I.1) and 32123-32124 (codified at 10 CFR 431.306(a), (c)-(e)). These standards have not been vacated and remain subject to the June 5, 2017 compliance date prescribed by the June 2014 final rule.

This final rule is not subject to the requirement to provide prior notice and an opportunity for public comment pursuant to 5 U.S.C. 553(b)(B). DOE finds good cause to waive the requirement to provide prior notice and an opportunity for public comment as such procedure is unnecessary. DOE must comply with the order of a Federal court, and has no discretion to do otherwise. In implementation of that order, DOE is vacating (1) the two energy conservation standards applicable to multiplex condensing refrigeration systems operating at medium and low temperatures and (2) the four energy conservation standards applicable to dedicated condensing refrigeration systems operating at low temperatures. Comments suggesting any other course would serve no useful purpose. DOE notes it is also actively engaged in a negotiated rulemaking to address the standards for these six classes of refrigeration systems.

The Secretary of Energy has approved publication of this final rule.

For the reasons stated in the preamble, DOE amends part 431 of chapter II, subchapter D, of title 10 of the Code of Federal Regulations, as set forth below:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all GE GEnx-1B turbofan engine models. The NPRM published in the Federal Register on June 17, 2015 (80 FR 34560). The NPRM was prompted by multiple reports of engine oil loss and resultant flight plan diversions. The NPRM proposed to require removal and replacement of the non-conforming ball valve in the oil filler cap. We are issuing this AD to correct the unsafe condition on these products.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 34560, June 17, 2015) and the FAA's response to each comment.

One individual commenter expressed support for the NPRM (80 FR 34560, June 17, 2015).

American Airlines (American) requested that paragraph (c) Applicability be changed. American stated that the part number and the post-SB markings are located on the oil filler cap scupper not on the oil filler cap itself. American indicated that this change would improve clarity and accomplishment of the AD.

We agree. We revised paragraph (c), Applicability, of this AD to read: “This AD applies to all General Electric Company (GE) GEnx-1B model turbofan engines with oil filler cap, part number (P/N) 2349M62G01, installed, that do not contain any of the following markings after the P/N on the oil filler cap scupper: “P/M BALL PP,” or “RW,” or “79-0022.”

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD with the change described previously. We determined that this change will not increase the economic burden on any operator or increase the scope of this AD.

We reviewed GE GEnx-1B Service Bulletin (SB) No. 79-0022, Revision 1, dated May 13, 2015. The SB describes procedures for removing and replacing the ball valve in the oil filler cap.

We estimate that this AD affects 86 engines installed on airplanes of U.S. registry. We also estimate that it will take about 1 hour per engine to comply with this AD. The average labor rate is $85 per hour. Required parts cost about $11 per engine. Based on these figures, we estimate the cost of the AD to U.S. operators to be $8,256.

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.

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

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

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

(2) Is not a “significant rule” under 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.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2002-07-08, Amendment 39-12702 (67 FR 17917, April 12, 2002). AD 2002-07-08 applied to certain The Boeing Company Model 737 airplanes. The NPRM published in the Federal Register on July 23, 2014 (79 FR 42710). The NPRM was prompted by the FAA's determination that certain modifications of the fuselage lap joints do not provide an adequate level of safety, and the subsequent discovery of cracks in additional fastener locations in the window belt skin panels, adjacent stringers and window frames in locations outside the previous inspection area. The NPRM proposed to continue to require repetitive inspections for cracking of the lower skin at the lower row of fasteners in the lap joints of the fuselage; repair of any cracking found; modification of the fuselage lap joints at certain locations, which would terminate the repetitive inspections of the modified areas; and replacement of a certain preventive modification with an improved modification. The NPRM also proposed to require repetitive inspections for cracking at certain window corner fastener holes, a preventive modification, and repair if necessary. We are issuing this AD to detect and correct fatigue cracking of the fuselage lap joints and window belt skin panels, which could result in reduced structural integrity and sudden decompression of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (79 FR 42710, July 23, 2014) and the FAA's response to each comment.

Boeing requested that we revise the preamble of the NPRM (79 FR 42710, July 23, 2014), by adding references to new inspection locations on the window belt skin panels. Boeing pointed out that the NPRM preamble defined structure that has been found to crack since release of AD 2002-07-08, Amendment 39-12702 (67 FR 17917, April 12, 2002). Boeing also indicated that Boeing Service Bulletin 737-53A1177, Revision 7, dated June 14, 2013, provides inspections for skin cracking at nine additional fastener holes in the corners of certain passenger windows from what is mandated by AD 2002-07-08.

We agree that clarification is necessary. We have added the description of the new inspection locations in the SUMMARY of this final rule accordingly. The unspecified inspection areas were accounted for in paragraph (p) of the proposed AD (79 FR 42710, July 23, 2014), which is retained in this AD.

Boeing requested that we revise the NPRM (79 FR 42710, July 23, 2014) to remove the “post-repair/alteration and butt joint repetitive inspections” requirement as specified in paragraph (r) of the proposed AD. Boeing pointed out that one of the proposed actions, “post-repair/alteration and butt joint repetitive inspections,” defined in paragraph (r) of the proposed AD, refers to damage-tolerance-based structural post-repair/post-alteration inspections. Boeing also stated that the inspections are provided in the service bulletin for operators' use to comply with the operational requirements of 14 CFR part 121.1109 and Part 129.109 and, therefore, the inspections do not need to be mandated separately in the NPRM.

We agree with the request. As Boeing stated, the inspections that were specified in paragraph (r) of the proposed AD (79 FR 42710, July 23, 2014) may be used in support of compliance with section 121.1109(c)(2) or 129.109(b)(2) of the Federal Aviation Regulations (14 CFR 121.1109(c)(2) or 129.109(b)(2)). However, this AD does not require those post-modification inspections. We have therefore removed paragraph (r) of the proposed AD and redesignated subsequent paragraphs accordingly. We have also revised the SUMMARY of this final rule to remove reference to the inspections.

Boeing requested that we clarify the “Difference Between the Proposed AD and the Service Information” section of the NPRM (79 FR 42710, July 23, 2014), by adding a reference to AD 2002-07-11, Amendment 39-12705 (67 FR 17931, April 12, 2002), for Model 737 airplanes, line numbers 1 through 291 inclusive. Boeing pointed out that the “Difference Between the Proposed AD and the Service Information” section of the NPRM (79 FR 42710, July 23, 2014) defined the applicability of the NPRM as Model 737 airplanes, line numbers 292 through 2565 inclusive, and explained that Model 737 airplanes, line numbers 1 through 291 inclusive, have been addressed by AD 2003-23-03, Amendment 39-13367 (68 FR 64980, November 18, 2003). Boeing also indicated that AD 2002-07-11, Amendment 39-12705 (67 FR 17931, April 12, 2002), addresses Model 737 airplanes line numbers 1 through 291 inclusive, and mandates the actions defined in Boeing Service Bulletin 737-53A1177, Revision 6, dated May 31, 2001.

Although the “Difference Between the Proposed AD and the Service Information” section of the NPRM (79 FR 42710, July 23, 2014) is not restated in this final rule, we agree with the commenter's clarification of the applicability. Paragraph (c) of this AD is retained as proposed in the NPRM, and no change has been made to this AD regarding this issue.

Boeing requested that we clarify paragraph (g) of the proposed AD (79 FR 42710, July 23, 2014), to include an additional exception. Boeing pointed out that paragraph (g) of the proposed AD provided an exception for paragraph (h) of the proposed AD to address lap joint modification (repair) instructions for certain lap joint areas on 737-200 and 737-200C airplanes. Boeing also indicated that paragraph (q)(2) of the proposed AD addresses an optional terminating action, window belt replacement for 737-300 and 737-500 airplanes, for the lap joint modification. Boeing also stated that paragraph (q)(2) of the proposed AD should be included as an exception for the lap joint modification (repair) defined in paragraph (g) of the proposed AD.

We agree with the request for an additional exception. We revised paragraph (g) of this AD to include a reference to paragraph (q)(2) of this AD as an exception.

Boeing requested that we clarify paragraph (m) of the proposed AD (79 FR 42710, July 23, 2014), to include an exception. Boeing indicated that Boeing Service Bulletin 737-53A1177, Revision 7, dated June 14, 2013, added an optional window belt skin panel replacement as terminating action for the S-10 and S-14 lap joint inspections and for the window corner inspections on Model 737-300 and 737-500 airplanes. Boeing also stated that paragraph (q) of the proposed AD addressed the optional terminating action, and that follow-on inspections are also necessary for the optional window belt skin panel replacement, and paragraph (q) of the proposed AD should be added as an exception to paragraph (m) of the proposed AD.

We disagree with the request to include an exception. Paragraph (q) of this AD is an optional action and terminates only paragraph (g) of this AD. If an operator chooses to use the modification option in paragraph (q) of this AD to do the repair required by paragraph (g) of this AD, the requirements of paragraph (m) of this AD have not been terminated, and those inspections must be accomplished. We have not changed this AD regarding this issue.

Boeing requested that we clarify paragraph (m) of the proposed AD (79 FR 42710, July 23, 2014), to include instruction for any crack found by the inspections. Boeing stated that paragraph (m) of the proposed AD contains follow-on inspections of the lap joint modification, which are contained in the Compliance and Accomplishment Instructions of Boeing Service Bulletin 737-53A1177, Revision 7, dated June 14, 2013. Boeing also stated that if any crack is found during the follow-on inspections, the Compliance section of Boeing Service Bulletin 737-53A1177, Revision 7, dated June 14, 2013, instructs operators to contact Boeing for repair instructions; therefore, reference to paragraph (s)(2) of the proposed AD should be added to paragraph (m) of the proposed AD.

We agree with the request to include instruction for any crack found by the inspections. The instructions for repair were inadvertently omitted in paragraph (m) of AD 2002-07-08, Amendment 39-12702 (67 FR 17917, April 12, 2002). The associated service information recommended that this repair be done by contacting Boeing for instructions. However paragraph (s)(2) of the proposed AD (79 FR 42710, July 23, 2014) specifically directed operators to contact the FAA for instructions when the service information specified to contact Boeing. We revised paragraph (m) of this AD to refer to paragraph (t) of this AD, which provides directions to request approval of an alternative method of compliance (AMOC).

Boeing requested that we clarify paragraph (o) of the proposed AD (79 FR 42710, July 23, 2014), by removing references to paragraphs (m) and (n) of the proposed AD. Boeing indicated that paragraph (o) of the proposed AD addresses repair of crack damage and references PART II of the Accomplishment Instructions of Boeing Service Bulletin SB 737-53A1177, Revision 7, dated June 14, 2013. Boeing also stated that PART II of Boeing Service Bulletin SB 737-53A1177, Revision 7, dated June 14, 2013, provides instructions for repair of cracks found in the lower skin of the lower row of the production lap joint, which could be found by the inspections defined in paragraphs (i), (j), and (k) of the proposed AD. Boeing pointed out that cracks found by the inspections in paragraphs (m) and (n) of the proposed AD are addressed individually by the same paragraphs respectively (with changes to paragraph (m) of the proposed AD, as discussed in the previous comment); therefore, repair of any crack found during the inspections in paragraphs (m) and (n) of the proposed AD should not be included in paragraph (o) of the proposed AD.

We agree with the request to revise paragraph (o) of this AD (79 FR 42710, July 23, 2014) to remove references to paragraphs (m) and (n) of the AD, for the reasons provided by the commenter. We revised paragraph (o) of this AD accordingly.

Boeing requested that we clarify paragraph (q)(1) of the proposed AD (79 FR 42710, July 23, 2014), by revising the wording for consistency with paragraph (q)(2) of the proposed AD, adding references to inspections in paragraph (n) of the proposed AD that are terminated by the actions in paragraph (q)(2) of the proposed AD, and adding wording to limit the number of window inspections that can be terminated by the replacement panel. Boeing pointed out that paragraphs (q)(1) and (q)(2) of the proposed AD address the same action, replacement of window belt skin panels. Boeing also pointed out that the inspections in paragraph (n) of the proposed AD, Retained Repetitive HFEC Inspections of the Window Corners, can also be terminated by replacement of the window belt panel and therefore, wording should be added to paragraph (q)(1) of the proposed AD to ensure inspections would only be terminated at window corners common to the replaced panel.

We partially agree. We agree to reword paragraph (q)(1) of this AD because consistent language makes the AD easier to read, and replacement of a panel will terminate the inspections only for the panel that is replaced. We disagree to add references to inspections in paragraph (n) of this AD, as Boeing proposed. Paragraph (q)(1) of this AD terminates the actions required by paragraph (p) of this AD, and doing the actions required by paragraph (p) of this AD terminates the inspections required by paragraph (n) of this AD.

Boeing requested that we clarify paragraph (q)(2) of the proposed AD (79 FR 42710, July 23, 2014), by revising the wording to show that the optional window belt skin panel replacement terminates the lap joint lower row inspections of AD 2013-09-01, Amendment 39-17442 (78 FR 27001, May 9, 2013), rather than terminating the lap joint modification. Boeing pointed out that paragraph (q)(2) of the proposed AD addresses an optional window belt skin panel replacement. Boeing also indicated that the skin panel replacement was included in Boeing Service Bulletin SB 737-53A1177, Revision 7, dated June 14, 2013, to provide an option for operators to terminate the lap joint lower row inspections, and was mandated by paragraphs (g) and (i) of AD 2013-09-01, in lieu of the lap joint modification which is addressed by paragraph (g) of the proposed AD.

We agree with the request for the reasons provided by the commenter. There is a direct AMOC connection between the window belt skin panel replacement and the inspections required by paragraphs (g) and (i) of this AD. However, we have added new paragraph (q)(3) of this AD to explain that the skin panel replacement terminates the specified inspections required by paragraphs (g) and (i) of AD 2013-09-01, Amendment 39-17442 (78 FR 27001, May 9, 2013), for the replaced skin panel only.

Boeing requested that we clarify paragraphs (t)(1) and (t)(2) of the proposed AD (79 FR 42710, July 23, 2014), by revising the wording to reference the Manager of the Los Angeles ACO instead of the Manager of the Seattle ACO. Boeing indicated that responsibility for the 737 Classic models (which include the airplanes affected by this AD) has been transferred from the Seattle ACO to the Los Angeles ACO and that authority for approval of AMOCs for the proposed AD should be changed from the Manager, Seattle ACO, to the Manager, Los Angeles ACO.

We infer that Boeing requested that we clarify paragraphs (t)(1) and (t)(3) of the proposed AD (79 FR 42710, July 23, 2014).

We agree with the request, and have revised paragraphs (t)(1) and (t)(3) of this AD as requested, and included the following in paragraph (t)(1) of this AD: [email protected]. We also revised paragraph (u) of this AD to include the appropriate contact information.

We have included a new paragraph (s) in this AD to provide credit for accomplishing lap joint repair before the effective date of this AD using Boeing Service Bulletin 737-53A1177, Revision 4, dated September 2, 1999; Boeing Service Bulletin 737-53A1177, Revision 5, dated February 15, 2001; or Boeing Service Bulletin 737-53A1177, Revision 6, dated May 31, 2001. The subsequent paragraphs have been redesignated accordingly.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 42710, July 23, 2014) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 42710, July 23, 2014).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

Boeing has issued Service Bulletin 737-53A1177, Revision 7, dated June 14, 2013. The service information procedures for repetitive inspections for cracking of the lower skin at the lower row of fasteners in the lap joints of the fuselage; repair of any cracking found; modification of the fuselage lap joints at certain locations to terminate the repetitive inspections of the modified areas; replacement of a certain preventive modification with an improved modification; repetitive inspections for cracking at certain window corner fastener holes; a preventive modification; and repair. 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 this AD.

We estimate that this AD affects 247 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary corrective actions that will be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these corrective actions:

The cost estimate figures discussed above are based on assumptions that no operator has yet accomplished any of the actions required by this AD, and that no operator will accomplish those actions in the future if this AD is not adopted. However, we have been advised that the lap joint modification has already been installed on some affected airplanes. Therefore, based on the current number of U.S.-registered airplanes below the threshold of 50,000 total flight cycles, the future economic cost impact of this AD on U.S. operators is expected to be less than the cost impact figure indicated above.

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

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

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

(2) Is not a “significant rule” under 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.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2009-18-15, Amendment 39-16011 (74 FR 48143, September 22, 2009). AD 2009-18-15 applied to all Airbus Model A300, A310, and A300 B4-600, B4-600R, and F4-600R series airplanes; and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). The NPRM published in the Federal Register on July 14, 2015 (80 FR 40942).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0248, dated October 14, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Model A300, A310, and A300-600 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-2461-0002.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 40942, July 14, 2015) or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting this 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 (80 FR 40942, July 14, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 40942, July 14, 2015).

Airbus has issued the following service information. “Sub-part 1-2: Life Limits” and “Sub-part 1-3: Demonstrated fatigue lives” of Part 1, “Safe Life Airworthiness Limitation Items,” in each of these documents describe procedures for revising the maintenance or inspection program to incorporate new maintenance requirements and airworthiness limitations.

• For Model A300 series airplanes: Part 1, “Safe Life Airworthiness Limitation Items,” Revision 01, dated September 5, 2013, of the Airbus Model A300 Airworthiness Limitations Section.

• For Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes): Part 1, “Safe Life Airworthiness Limitation Items,” Revision 01, dated September 5, 2013, of the Airbus Model A300-600 Airworthiness Limitations Section.

• For Model A310 series airplanes: Part 1, “Safe Life Airworthiness Limitation Items,” Revision 01, dated September 5, 2013, of the Airbus Model A310 Airworthiness Limitations Section.

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 this AD.

We estimate that this AD affects 177 airplanes of U.S. registry.

The retained ALS revision required by AD 2009-18-15, Amendment 39-16011 (74 FR 48143, September 22, 2009), takes about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that were required by AD 2009-18-15 is $85 per product.

We also estimate that it takes about 1 work-hour per product to comply with the new ALS revision of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $15,045, or $85 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 that 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/#!docketDetail;D=FAA-2015-2461; 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 this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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

The Entity List (Supplement No. 4 to Part 744) identifies entities and other persons reasonably believed to be involved, or to pose a significant risk of being or becoming involved, in activities contrary to the national security or foreign policy interests of the United States. The EAR imposes additional license requirements on, and limits the availability of most license exceptions for, exports, reexports, and transfers (in-country) to those listed. The “license review policy” for each listed entity or other person is identified in the License Review Policy column on the Entity List and the impact on the availability of license exceptions is described in the Federal Register notice adding entities or other persons to the Entity List. BIS places entities and other persons on the Entity List pursuant to sections of part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR.

The ERC, composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and all decisions to remove or modify an entry by unanimous vote.

This rule implements the decision of the ERC to add seven persons under ten entries to the Entity List. These seven persons are being added on the basis of § 744.11 (License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The ten entries added to the Entity List consist of three entries in China and seven entries in Hong Kong. There are ten entries for the seven persons because three persons are listed in both China and Hong Kong, resulting in three additional entries.

The ERC reviewed § 744.11(b) (Criteria for revising the Entity List) in making the determination to add these seven persons under ten entries to the Entity List. Under that paragraph, persons for whom there is reasonable cause to believe, based on specific and articulable facts, have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy interests of the United States and those acting on behalf of such persons may be added to the Entity List. Paragraphs (b)(1) through (b)(5) of § 744.11 include an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States. Pursuant to § 744.11 of the EAR, the ERC determined that the seven persons be added to the Entity List for actions contrary to the national security or foreign policy interests of the United States.

The ERC has determined that for the seven persons added, there is reasonable cause to believe, based on specific and articulable facts, that (Jack) Wang Wei, Sky Rise Technology Ltd., TiMi Technologies Co. Ltd., Caprice Group Ltd., Reekay Technology Limited, and 32 Group China Ltd. have made attempts to procure items, including U.S.-origin items, for activities contrary to the national security and foreign policy interests of the United States. Specifically, (Jack) Wang Wei has used these companies to supply U.S.-origin items to an Iranian party associated with the Iranian defense industry and to an Iranian party whose customers include companies designated by the Department of Treasury as Specially Designated Nationals.

Pursuant to § 744.11(b)(2) of the EAR, the ERC determined that the conduct of these seven persons raises sufficient concern that prior review of exports, reexports, or transfers (in-country) of items subject to the EAR involving these persons, and the possible imposition of license conditions or license denials on shipments to the persons, will enhance BIS's ability to prevent violations of the EAR.

For the seven persons this rule adds to the Entity List on the basis of § 744.11, the ERC specified a license requirement for all items subject to the EAR and a license review policy of presumption of denial. The license requirements apply to any transaction in which items are to be exported, reexported, or transferred (in-country) to any of the persons or in which such persons act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the persons being added to the Entity List in this rule.

This final rule adds the following seven persons under ten entries to the Entity List:

(1) Sky Rise Technology Ltd., a.k.a., the following one alias:

(2) TiMi Technologies Co., Ltd., a.k.a., the following two aliases:

(3) Wang Wei, a.k.a., the following one alias:

(1) 32 Group China Ltd., Room 1905, 19/F, Nam Wo Hong Bldg., 148 Wing Lok Street, Sheung Wang, Hong Kong; and Room 1119, 11/F, Block B, Yau Tong Industrial City, 17 Ko Fai Road, Yau Tong, Kowloon, Hong Kong;

(2) Caprice Group Ltd., Room 1119, 11/F, Block B1, Yau Tong Industrial City, 17 Ko Fai Road, Yau Tong, Kowloon, Hong Kong; and Unit B1, G/F, Pioneer Building, 213 Wai Yip St., Kwun Tong, Kowloon, Hong Kong; and Unit A, G/F, Pioneer Building, 213 Wai Yip St., Kwun Tong, Kowloon, Hong Kong;

(3) Kitronix Display, Unit B1, G/F, Pioneer Building, 213 Wai Yip St., Kwun Tong, Kowloon, Hong Kong;

(4) Reekay Technology Ltd., a.k.a., the following one alias:

(5) Sky Rise Technology Ltd., a.k.a., the following one alias:

(6) TiMi Technologies Co., Ltd., a.k.a., the following two aliases:

(7) Wang Wei, a.k.a., the following one alias:

This rule implements a decision of the ERC to remove two persons, Weihai New Era Chemical Industrial Company Limited, located in China; and Able City Development Limited, located in Hong Kong, from the Entity List. This rule removes Weihai New Era Chemical Industrial Company Limited on the basis of a removal request submitted by this listed person pursuant to § 744.16 (Procedure for requesting removal or modification of an Entity List entity) of the EAR. Able City Development Limited is being removed pursuant to a proposal submitted by an End-User Review Committee (ERC) member agency, in accordance with Supplement No. 5 to Part 744 of the EAR, as discussed below.

A. Removal pursuant to § 744.16.

Based upon a review of the information provided in a removal request made in accordance with § 744.16 of the EAR and further review conducted by the ERC, the ERC determined that the Weihai New Era Chemical Industrial Company Limited should be removed from the Entity List.

Weihai New Era Chemical Industrial Company Limited was added to the Entity List on May 1, 2014 (79 FR 24563) pursuant to § 744.11(b)(2) and (b)(5) of the EAR. The ERC's decision to remove Weihai New Era Chemical Industrial Company Limited from the Entity List was based on information provided by the company in its appeal request pursuant to § 744.16.

In accordance with § 744.16(c), the Deputy Assistant Secretary for Export Administration has sent written notification informing this person of the ERC's decision.

B. Other removal based on ERC decision.

This rule implements a decision of the ERC to remove one person located in Hong Kong, Able City Development Limited, from the Entity List. The ERC determined that this person no longer met the criteria for inclusion on the Entity List. Able City Development Limited was added to the Entity List on July 21, 2009 (74 FR 35797) pursuant to § 744.11(b) of the EAR. In accordance with the procedures outlined in Supplement No. 5 to part 744 of the EAR, any agency that participates in the ERC may make a proposal to add, modify or remove an entry from the Entity List by submitting that proposal to the chairman. For this removal, an ERC member agency proposed to the ERC to remove Able City Development Limited because a review of records indicated that the entity has dissolved. Because this entity does not exist, in accordance with § 744.16(c), the Deputy Assistant Secretary for Export Administration has not sent written notification informing this person of the ERC's decision.

This final rule implements the decision to remove the following two persons from the Entity List:

(1) Weihai New Era Chemical Industrial Company Limited, No. 985 Fenghua Shan Road, Yangting New Industrial District, Huancui District, Weihai, China.

(1) Able City Development Limited, Unit C, 9/F Neich Tower, 128 Gloucester Road, Wanchai, Hong Kong; and Unit 401, Harbour Ctr., Tower 2, 8 Hok Cheung Street, Hung Hom, Kowloon, Hong Kong.

The removal of the two entities referenced above, which was approved by the ERC, eliminates the existing license requirements in Supplement No. 4 to part 744 for exports, reexports and transfers (in-country) to these entities. However, the removal of these two entities from the Entity List does not relieve persons of other obligations under part 744 of the EAR or under other parts of the EAR. Neither the removal of an entity from the Entity List nor the removal of Entity List-based license requirements relieves persons of their obligations under General Prohibition 5 in § 736.2(b)(5) of the EAR which provides that, “you may not, without a license, knowingly export or reexport any item subject to the EAR to an end-user or end-use that is prohibited by part 744 of the EAR.” Additionally these removals do not relieve persons of their obligation to apply for export, reexport or in-country transfer licenses required by other provisions of the EAR. BIS strongly urges the use of Supplement No. 3 to part 732 of the EAR, “BIS's `Know Your Customer' Guidance and Red Flags,” when persons are involved in transactions that are subject to the EAR. Additionally, as noted above, Able City Development Limited no longer exists so there should be no transactions involving this person.

This final rule implements decisions of the ERC to modify ten existing entries on the Entity List. Under the destination of China, the ERC made a determination to add six additional addresses and eight additional aliases to the entry for China Electronics Technology Group Corporation 29 (CETC 29) Research Institute. Under the destination of Hong Kong, the ERC made a determination to make the following modifications to nine entries, as follows: add one additional address to the entry for Biznest, LTD; add one additional address to the entry for Giant Base Asia Limited; add one additional address to the entry for Jadeshine Engineering (HK) Co.; add one additional address to the entry for JLD Technology; add one additional address and two additional aliases to the entry for Kinglead Electronics Co., Ltd.; add one alias to the entry for PRC Lode Technology Company; add one additional address to the entry for Serko Limited; add one additional address and one alias to the entry for Tex-Co Logistics Ltd.; and add one additional address and one alias to the entry for Yeraz, LTD.

This final rule makes the following modifications to ten entries on the Entity List:

(1) China Electronics Technology Group Corporation 29 (CETC 29) Research Institute, a.k.a., the following ten aliases:

(1) Biznest, LTD, Room 927 9/F Far East Consortium Building, 121 Des Voeux Road C, Central District, Hong Kong; and 4/F, Hong Kong Trade Centre, 161-167 Des Voeux Road, Central, Hong Kong;

(2) Giant Base Asia Limited, Room 2205, 22/F, Kowloon Building, 555 Nathan Road, Hong Kong; and Flat E, Block 1, 12/F, Superluck Industrial Centre, Tsuen Wan, New Territories, Hong Kong;

(3) Jadeshine Engineering (HK) Co., Room 702, Boss Commercial Centre, Ferry Street 38, Kowloon, Hong Kong; and G/F BLK C 255 Sai Tau Wai DD 123 Lot 1307 Yuen Long, NT, Hong Kong;

(4) JLD Technology, Hong Kong Co., Ltd., Room 1237, Pacific Trade Centre, No. 2 Kai Hing Road, Kowloon Bay, Hong Kong; and Room 301-2, Hang Seng Wanchai Building, 3rd Floor, No. 200 Hennessy Road, Wanchai, Hong Kong;

(5) Kinglead Electronics Co., Ltd., a.k.a., the following four aliases:

(6) PRC Lode Technology Company, a.k.a., the following one alias:

(7) Serko Limited, Room 704 7/F, Landwide Commercial Building, 118-120 Austin Rd, Tsim Sha Tsui, Hong Kong; and Room 1509, Unit A, 15th Floor, Mai Shun Industrial Building, No. 18-24 Kwai Cheong Road, New Territories, Hong Kong;

(8) Tex-Co Logistics Ltd., a.k.a., the following one alias:

(9) Yeraz, LTD, a.k.a., the following one alias:

Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export or reexport, on November 12, 2015, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR).

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.

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

2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and carries a burden estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to [email protected], or by fax to (202) 395-7285.

3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

4. For the seven persons under ten entries added to the Entity List in this final rule, and the ten existing entities whose entries on the Entity List are being modified to provide additional or modified addresses and/or aliases, the provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. (See 5 U.S.C. 553(a)(1)). BIS implements this rule to protect U.S. national security or foreign policy interests by preventing items from being exported, reexported, or transferred (in-country) to the persons being added to the Entity List. If this rule were delayed to allow for notice and comment and a delay in effective date, then entities being added to the Entity List or modified by this action would continue to be able to receive items without a license and to conduct activities contrary to the national security or foreign policy interests of the United States. In addition, because these parties may receive notice of the U.S. Government's intention to place this entity on the Entity List if a proposed rule is published, doing so would create an incentive for these persons to either accelerate receiving items subject to the EAR to conduct activities that are contrary to the national security or foreign policy interests of the United States, or to take steps to set up additional aliases, change addresses, and other measures to try to limit the impact of the listing on the Entity List once a final rule was published. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule.

For the two removals from the Entity List in this final rule, pursuant to the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), BIS finds good cause to waive requirements that this rule be subject to notice and the opportunity for public comment because it would be contrary to the public interest.

In determining whether to grant removal requests from the Entity List, a committee of U.S. Government agencies (the End-User Review Committee (ERC)) evaluates information about and commitments made by listed persons requesting removal from the Entity List, the nature and terms of which are set forth in 15 CFR part 744, Supplement No. 5, as noted in 15 CFR 744.16(b). The information, commitments, and criteria for this extensive review were all established through the notice of proposed rulemaking and public comment process (72 FR 31005 (June 5, 2007) (proposed rule), and 73 FR 49311 (August 21, 2008) (final rule)). These two removals have been made within the established regulatory framework of the Entity List. One of the entities removed by this rule no longer exists. If the rule were to be delayed to allow for public comment, U.S. exporters may face unnecessary economic losses as they turn away potential sales to the other entity removed by this rule because the customer remained a listed person on the Entity List even after the ERC approved the removal pursuant to the rule published at 73 FR 49311 on August 21, 2008. By publishing without prior notice and comment, BIS allows the applicant to receive U.S. exports immediately since the applicant already has received approval by the ERC pursuant to 15 CFR part 744, Supplement No. 5, as noted in 15 CFR 744.16(b).

The removal from the Entity List as a result of a removal request granted by the ERC or for other reasons involve interagency deliberation and result from review of public and non-public sources, including sensitive law enforcement information and classified information, and the measurement of such information against the Entity List removal criteria. This information is extensively reviewed, including according to the criteria for evaluating removal requests from the Entity List, as set out in 15 CFR part 744, Supplement No. 5 and 15 CFR 744.16(b). For reasons of national security, BIS is not at liberty to provide to the public detailed information on which the ERC relied to make the decisions to remove these two entities. In addition, the information included in the removal request is information exchanged between the applicant and the ERC, which by law (section 12(c) of the Export Administration Act), BIS is restricted from sharing with the public. Moreover, removal requests from the Entity List contain confidential business information, which is necessary for the extensive review conducted by the U.S. Government in assessing such removal requests.

Section 553(d) of the APA generally provides that rules may not take effect earlier than thirty (30) days after they are published in the Federal Register. BIS finds good cause to waive the 30-day delay in effectiveness under 5 U.S.C. 553(d)(1) because this rule is a substantive rule which relieves a restriction. This rule's removal of two persons from the Entity List removes a requirement (the Entity-List-based license requirement and limitation on use of license exceptions) on these two persons being removed from the Entity List. The rule does not impose a requirement on any other person for these two removals from the Entity List.

No other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required under the APA or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. As a result, no final regulatory flexibility analysis is required and none has been prepared.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

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

Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by [21 U.S.C. 812(b)] for the schedule in which such drug is to be placed * * *.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on her own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS); 1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated at the request of the Assistant Secretary of the HHS and imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule IV controlled substances, on persons who handle or propose to handle eluxadoline.

Eluxadoline (5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid), is a new molecular entity with central nervous system opioid properties. Eluxadoline has mixed mu opioid receptor (MOR) and kappa opioid receptor (KOR) agonist and delta opioid receptor (DOR) antagonist properties. The Food and Drug Administration (FDA) approved eluxadoline (brand name “VIBERZI”) as a prescription drug for the treatment of irritable bowel syndrome with diarrhea (IBS-D) on May 27, 2015.

On May 5, 2015, the HHS provided the DEA with a scientific and medical evaluation document prepared by the FDA entitled “Basis for the Recommendation to Place Eluxadoline in Schedule IV of the Controlled Substances Act.” After considering the eight factors in 21 U.S.C. 811(c), including consideration of the substance's abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary of the HHS recommended that eluxadoline be controlled in schedule IV of the CSA. In response, the DEA completed its own eight-factor analysis of eluxadoline. Both the DEA and HHS analyses and other relevant documents are available in their entirety in the public docket of this rule (Docket Number DEA-419) at http://www.regulations.gov under “Supporting Documents.” 2

After a review of the available data, including the scientific and medical evaluation and the scheduling recommendation from the HHS, the Administrator of the DEA published in the Federal Register a notice of proposed rulemaking (NPRM) entitled “Schedules of Controlled Substances: Placement of Eluxadoline into Schedule IV” which proposed placement of eluxadoline in schedule IV of the CSA. 80 FR 48044, August 11, 2015. The proposed rule provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations by September 10, 2015. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before September 10, 2015.

The DEA received two comments on the proposed rule to schedule eluxadoline. One commenter supported controlling eluxadoline as a schedule IV controlled substance. One commenter opposed the control of eluxadoline as a schedule IV substance, and suggested it be controlled as a schedule V substance instead.

Support for the Proposed Rule. One commenter agreed with the DEA's proposal to control eluxadoline as a schedule IV controlled substance, and stated that the public health (specifically, an unmet medical need) necessitates an immediate effective date for the final order controlling eluxadoline.

DEA Response. The DEA appreciates the comment in support of this rulemaking. Generally, DEA scheduling actions are effective 30 days from the date of publication of the final rule in the Federal Register. 21 CFR 1308.45; see also 5 U.S.C. 553(d). The DEA believes that providing 30 days for this rule to become effective is both expeditious and sufficient to allow handlers to comply with regulatory requirements for handling Schedule IV controlled substances. Both the HHS' and the DEA's scientific and medical analyses, the data collectively suggest that eluxadoline does have sufficient abuse potential and the DEA does not agree that eluxadoline's effective date should be the date of publication of the final rule.

Opposition to the Proposed Rule. One commenter opposed the proposal to control eluxadoline as a schedule IV controlled substance, stating “I do not think that eluxadoline meets the factor [5] requirements for scheduling under schedule IV due to there being no general widespread use throughout other countries.” The commenter also stated that the best approach would be to place eluxadoline in schedule V, rather than schedule IV.

DEA Response. Although eluxadoline is a new chemical entity and information on actual abuse is not currently available, there is a sufficient factual basis to meet the requirements of Factor 5 (the scope, duration, and significance of abuse). The legislative history of the CSA provides guidance regarding the assessment of a new drug's potential for abuse. The legislative history of the CSA provides that a substance may have a potential for abuse if: “The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.” Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 91-1444 (1970); as reprinted in 1970 U.S.C.C.A.N. 4566, 4601. As discussed in the HHS and the DEA eight-factor analyses, both pre-clinical and clinical studies indicate eluxadoline shares pharmacological similarities with schedule IV drugs such as butorphanol and pentazocine and has similar abuse potential.

In addition, the HHS and DEA eight-factor analyses support the finding that the overall abuse potential of eluxadoline is comparable to schedule IV substances such as pentazocine and butorphanol. This indicates that placement in schedule IV is appropriate rather than schedule V.

Based on consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS, and the DEA's consideration of its own eight-factor analysis, the Administrator finds that these facts and all relevant data demonstrate substantial evidence of potential for abuse of eluxadoline. As such, the DEA is scheduling eluxadoline as a controlled substance under the CSA.

The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA outlines the findings required for placing a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of the HHS and review of all available data, the Administrator of the DEA, pursuant to 21 U.S.C. 812(b)(4), finds that:

(1) 5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid (eluxadoline) has a low potential for abuse relative to the drugs or other substances in schedule III. The overall abuse potential of eluxadoline is comparable to schedule IV substances such as pentazocine and butorphanol;

(2) 5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid (eluxadoline) has a currently accepted medical use in treatment in the United States. Recently, the FDA approved eluxadoline as a prescription drug for the treatment of IBS-D. Therefore, eluxadoline has a currently accepted medical use in treatment in the United States; and

(3) Abuse of 5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid (eluxadoline) may lead to limited psychological dependence similar to that of schedule IV drugs, but less than that of schedule III drugs.

Based on these findings, the Administrator of the DEA concludes that eluxadoline, including its salts, isomers, and salts of isomers, warrants control in schedule IV of the CSA. 21 U.S.C. 812(b)(4).

Upon the effective date of this final rule, any person who handles eluxadoline is subject to the CSA's schedule IV regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, engagement in research, and conduct of instructional activities, of schedule IV controlled substances including the following:

1. Registration. Any person who handles (manufactures, distributes, dispenses, imports, exports, engages in research, or conducts instructional activities with) eluxadoline, or who desires to handle eluxadoline, must be registered with the DEA to conduct such activities, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312 as of December 14, 2015. Any person who currently handles eluxadoline and is not registered with the DEA must submit an application for registration and may not continue to handle eluxadoline as of December 14, 2015 unless the DEA has approved that application, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.

2. Security. Eluxadoline is subject to schedule III-V security requirements and must be handled and stored pursuant to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71-1301.93, as of December 14, 2015.

3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of eluxadoline must comply with 21 U.S.C. 825 and 958(e) and be in accordance with 21 CFR part 1302, as of December 14, 2015.

4. Inventory. Every DEA registrant who possesses any quantity of eluxadoline on the effective date of this final rule must take an inventory of all stocks of eluxadoline on hand as of December 14, 2015, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a), (d), and (e).

Any person who becomes registered with the DEA after November 12, 2015 must take an initial inventory of all stocks of controlled substances (including eluxadoline) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a), (b), and (e).

After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including eluxadoline) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

5. Records. All DEA registrants must maintain records with respect to eluxadoline pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312 and § 1307.11, as of December 14, 2015.

6. Prescriptions. All prescriptions for eluxadoline or products containing eluxadoline must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR part 1306 and subpart C of 21 CFR part 1311 as of December 14, 2015.

7. Importation and Exportation. All importation and exportation of eluxadoline must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and be in accordance with 21 CFR part 1312 as of December 14, 2015.

8. Liability. Any activity involving eluxadoline not authorized by, or in violation of, the CSA, occurring as of December 14, 2015 is unlawful, and may subject the person to administrative, civil, and/or criminal proceedings.

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

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

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

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

The Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this final rule is to place eluxadoline, including its salts, isomers, and salts of isomers, into schedule IV of the CSA. No less restrictive measures (i.e., non-control, or control in schedule V) enable the DEA to meet its statutory obligations under the CSA. In preparing this certification, the DEA has assessed economic impact by size category and has considered costs with respect to the various DEA registrant business activity classes.

Eluxadoline is a new molecular entity which has not yet been marketed in the United States or any other country. The DEA has no basis to determine the level of contracted or outsourced manufacturing activities or the breadth of the distribution network. Furthermore, due to the wide variety of unidentifiable and unquantifiable variables that could potentially influence the dispensing and distribution rates of new pharmaceutical drugs, the DEA is unable to determine the number of potential small entities that might handle eluxadoline. However, the DEA estimates that all persons who would handle, or propose to handle, eluxadoline are currently registered with the DEA to handle schedule IV controlled substances, because it is a pharmaceutical controlled substance intended for medical treatment. Accordingly, the number of DEA registrations authorized to handle schedule IV controlled substances is a reasonable estimate for the maximum number of eluxadoline handlers. Therefore, the DEA estimates that 1.6 million (1,554,254 as of June 2015) controlled substance registrations, representing approximately 427,584 entities, would be the maximum number of entities affected by this final rule. The DEA estimates that 418,141 (97.8%) of 427,584 affected entities are “small entities” in accordance with the RFA and SBA size standards.

The DEA anticipates that prospective eluxadoline handlers already handle other schedule IV controlled substances and that the cost impact as a result of placing eluxadoline in schedule IV would be nominal. As the anticipated eluxadoline handlers already handle other schedule IV controlled substances, they already have DEA registrations and the required security and recordkeeping processes, equipment, and facilities in place, and would only require a nominal increase in security, inventory, recordkeeping and labeling costs.

As discussed above, while the DEA does not have a basis to estimate the number of affected entities, the DEA estimates that the maximum number of affected entities is 427,584 of which 418,141 are estimated to be small entities. Since the affected entities are expected to handle other schedule IV controlled substances and maintain security and recordkeeping facilities and processes consistent with schedule IV controlled substances, the DEA estimates any economic impact will be nominal.

Because of these facts, this final rule will not result in a significant economic impact on a substantial number of small entities.

The DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year * * *” Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of UMRA.

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

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

The APA requires the publication of a substantive rule to be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, one exception is “as otherwise provided by the agency for good cause found and published with the rule.” As fully discussed above in response to the comment suggesting an immediate effective date, an immediate effective date is necessary in this case because there are limited therapeutic options currently available to patients with IBS-D and the eluxadoline NDA received priority review with FDA. Therefore, it is unnecessary to delay the effective date of this final rule by 30 days, and this rule shall take effect immediately upon publication.

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

The CDBG program is a flexible program that provides communities with resources to address a wide range of unique community development needs. The CDBG program provides annual grants on a formula basis to units of general local government and States. The annual CDBG appropriation is allocated between metropolitan cities and urban counties, which are referred to as “entitlement areas,” and States, which must distribute the funds to their units of general local government, referred to as “nonentitlement areas.” HUD determines the amount of each grant by using a formula comprised of several measures of community need, including the extent of poverty, population, housing overcrowding, age of housing, and population growth lag.

A grantee must develop and follow a consolidated plan describing the planned use of CDBG funds, which includes a detailed plan that provides for and encourages citizen participation. This integral process emphasizes participation by persons of low or moderate income, particularly residents of predominantly low- and moderate-income neighborhoods, slum or blighted areas, and areas in which the grantee proposes to use CDBG funds. Not less than 70 percent of CDBG funds must be used for activities that benefit low- and moderate-income persons. In addition, each funded activity must meet one of the following national objectives for the program: Benefit low- and moderate-income persons, prevent or eliminate slums or blight, or address community development needs having a particular urgency because existing conditions pose a serious and immediate threat to the health or welfare of the community for which other funding is not available.

The regulations for the CDBG program are codified in 24 CFR part 570 (entitled “Community Development Block Grants”). The regulations governing the CDBG annual plan and citizen participation requirements are codified at 24 CFR part 91 (entitled “Consolidated Submissions for Community Planning and Development Programs”).

CDBG grants funds are currently disbursed through the Integrated Disbursement and Information System (IDIS) on a “first-in, first-out” (FIFO) basis. Under this methodology, CDBG grantees do not designate a specific fiscal year grant in IDIS when funding an activity or when creating an expenditure voucher. In general, all obligations and disbursements are recorded against the earliest annual grant with an available balance, thereby exhausting the oldest grant available before recording expenditures against the next grant.

Grantees' accounting systems, on the other hand, typically track expenditures according to each annual grant. During any given time period, grantees expend funds from multiple grants for a range of activities that have a variety of implementation schedules. Expenditures are incurred against more recent grants for activities that are on schedule; and, often simultaneously, expenditures are incurred against earlier annual grants for activities that experience acceptable delays.

These two distinct accounting methods often complicate reconciliation between grantees' accounting records and IDIS's FIFO records. The revised methodology will simplify reconciliation by aligning the accounting practices used by HUD and those used by grantees.

HUD is cognizant that Fiscal Year (FY) 2015 funding and formula allocations are underway, but the revised methodology is now available and, through this rule, HUD directs CDBG grantees to commence using the revised methodology. For the FY 2015 and subsequent fiscal year grants, IDIS will support grant-specific accounting. Therefore, as of the effective date of this interim rule, when obligating funds to be expended for a CDBG activity (i.e., when funding an activity in IDIS), grantees must identify the specific annual grant that is the source of the funds. When creating an expenditure voucher, HUD, through IDIS, will disburse the funds according to the specific annual grant that was obligated to that activity.

In order to complement and support this accounting change, conforming changes are needed to the regulations covering affected FY grants to reflect this accounting practice, such as clarifying which accounting practice is utilized, revising records retention requirements, and conforming the calculation of the cap on administrative and planning expenses. Conforming changes are not only needed to the CDBG regulations in 24 CFR part 570 but also to the CDBG planning and citizen participation regulations in part 91. In addition, certain grammatical and other technical corrections need to be made to the CDBG regulations.

The following section of this preamble provides a section-by-section overview of the regulatory changes.

HUD revises those provisions regarding the CDBG program components of the action plans for entitlements at § 91.220(l) and states at § 91.320(l). The interim rule adds clarifying language to reiterate that the available resources for that annual action plan may include a variety of sources of funding in addition to the annual grant.

For State CDBG recipients, HUD clarifies § 91.320(l) to address program income funds that are retained by units of general local government. By including locally retained program income funds, such as general program income and revolving loan funds, the State's action plan will include all the CDBG funds available throughout the State, regardless of whether those funds are retained by the State or units of general local government.

For state CDBG recipients, HUD amends § 91.325(b)(4)(ii), which provides that the State shall certify that 70 percent of the amount expended shall principally benefit low- and moderate-income families, on a program year basis. This regulatory provision is inconsistent with § 570.484, which requires the same certification to be provided on an annual grant basis. Therefore, § 91.325(b)(4)(ii) is amended to be consistent with § 570.484.

HUD amends § 91.505(a)(2) to clarify that an amendment would be necessary for the use of program income, repayments, or reallocations that were not previously included in an action plan.

The interim rule adds a definition to §§ 570.3 and 570.481(a)(3) for the term “origin year” to mean the Federal fiscal year in which the annual grant funds were appropriated. Current regulations use the term “grant year,” which has often been confused with a grantee's program year. The term “origin year” is intended to reinforce specificity concerning any one annual grant and support grant-specific accounting. In addition to the new definition, the interim rule makes corresponding language changes throughout parts 91 and 570.

The interim rule adds §§ 570.480(i) and 570.200(k) to incorporate the requirements of 31 U.S.C. 1552, which states that on September 30 of the 5th fiscal year after the period of availability for obligation of a fixed appropriation account ends, the United States Treasury account shall be canceled and any remaining balance (whether obligated or unobligated) shall be canceled and therefore not available for obligation or expenditure for any purpose. HUD's obligation period for CDBG is typically 3 fiscal years, including the origin year (as stated in each annual appropriations act). HUD obligates and makes the funds available to grantees as soon as possible, but has until the end of 3 fiscal years to do so. For example, a CDBG grant appropriated for Fiscal Year 2015 must be obligated by HUD by the end of Fiscal Year 2017, and any unexpended funds will be canceled and cease to be available on September 30, 2022. HUD reserves the right, however, to require an earlier expenditure and drawdown deadline under a grant agreement due to end-of-year accounting and timing issues. This provision is applicable to funds in the grantee's line of credit and any funds returned to the line of credit. However, this statute does not apply to funds repaid to a local account or program income deposited in a local account. CDBG funds have rarely been canceled because the FIFO accounting method disperses funds from the oldest source grant first, and timely expenditure of grant funds would prevent the grantee from having as many years' worth of grant funds in its line of credit.

In annual appropriations acts, Congress limits the amount grantees may use for planning, management development, and administration to not more than 20 percent of each grant. Under the FIFO method of accounting in IDIS, grantees would draw funds without distinguishing funds by origin year, making the application of a 20 percent limit to any one grant impractical for HUD to monitor. Current regulations at § 570.200(g) base the 20 percent limit upon obligations in a given program year, relative to the amount of the most recent grant plus program income. Therefore, § 570.200(g) is revised to better reflect the limitations imposed by annual appropriations acts.

Through this rule, HUD divides § 570.200(g) into two distinct compliance tests. The current test, retained and redesignated § 570.200(g)(2), which determines compliance based upon obligations of both grant funds and program income, will apply to all prior and future program years. For grants made in FY 2015 and subsequent years, an additional test is included at § 570.200(g)(1), which would limit planning and administration expenditures to no more than 20 percent of each separate origin year grant (excluding program income). This new test will be used to determine compliance with the annual appropriations acts requirement at the end of the grant. The key difference between the two tests is that the existing test addresses program income and the new test does not. The reason that two tests are necessary is because the existing test allows program income to be used in lieu of grant funds for planning, management development, and administration costs, thereby ensuring that grantees are compliant with the cash management principles that require program income to be spent ahead of draws of Treasury funds.

These two tests measure different things over different time periods. The existing test (the program year test) limits obligations of funds made by the grantee during a program year. The amount of funds obligated for planning and administrative costs is limited to 20 percent of the sum of the origin year grant amount for that program year plus the amount of program income received by the grantee (and all subrecipients) during that program year. Compliance is determined at the end of each program year based on the grantee's annual performance report submission. This test allows obligations of program income for planning and general administration cost to support grantee compliance with § 570.504(b)(2), which requires that program income be substantially disbursed before withdrawals of grant funds from the United States Treasury.

The origin year grant test limits expenditures for planning and administrative costs against a given origin year's grant. For any given origin year grant, compliance will be determined during the grant closeout. For purposes of the second test, it does not matter when the funds were obligated or expended. Beginning with origin year 2015 grants and with FY 2015 program years, grantees must ensure that they comply with both tests. Grantees are cautioned that compliance with one test does not automatically ensure compliance with the other test.

HUD recognizes that CDBG grantees are administering programs that typically have multiple grants open at any given time. The interim rule adds language at § 570.200(g) to reiterate that administration and planning costs support the general operation of a grantee's CDBG program, and thus are not tied to any specific origin year or CDBG grant. A grantee may use funds from any origin year grant for administration and planning costs for any CDBG grant. This provision is limited to only administration and planning costs and does not include staff and overhead costs directly related to carrying out activities eligible under § 570.201 through § 570.204, since those costs are eligible as part of such activities and allocable to specific origin year grants.

HUD revises regulations at § 570.201 in order to clarify that the public service cap determination is applicable to nonentitlement grantees in Hawaii and recipients of insular area funds under the CDBG program.

HUD revises the regulations for State administrative costs in § 570.489. Redundancies are removed and clarifying language is added to § 570.489(a)(1)(i)(ii) and (iii) and § 570.489(e)(3). Current regulations at § 570.489(a)(1)(v) allow State CDBG grantees the option of using cumulative accounting of administrative costs, consistent with the FIFO accounting method. Under the new grant-based accounting, for origin year 2015 grants and subsequent grants, State CDBG grantees will no longer have the option of cumulative accounting of the State's administrative costs and instead must use year-to-year tracking. The cumulative method will only continue to be available for State administrative expenses charged to FY 2014 and prior fiscal year grants.

HUD clarifies § 570.489(a)(3) to explain how HUD determines compliance with the planning and administration cost cap. While this provision is already grant-specific, the current calculation incorporates program income into the 20 percent administrative and planning cap. Therefore, the interim rule clarifies the compliance test at § 570.489(a)(3) by dividing it into multiple parts. Section 570.489(a)(3)(i) describes administration costs for both States and units of general local government. Section 570.489(a)(3)(ii) maintains current language of the administrative and planning cap, with added clarity. Section 570.489(a)(3)(iii) adds a second compliance test based solely upon use of funds from each annual grant (excluding program income) beginning with origin year 2015 and subsequent years' grants. The second compliance test will demonstrate compliance with annual appropriations acts limiting the amount grantees may use for planning, management development, and administration to not more than 20 percent of each grant.

As noted under the discussion of changes made to § 570.200, HUD recognizes that CDBG grantees are administering programs that typically have multiple grants open at any given time. Similar to the change made to § 570.200(g), the interim rule revises § 570.489(a)(3)(iv) to reiterate that administration and planning costs support the general operation of a grantee's CDBG program, and thus are not tied to any specific origin year or CDBG grant. A grantee may use funds from any origin year grant for administration and planning costs for any CDBG grant. This provision is limited to only administration and planning costs and does not include staff and overhead costs directly related to carrying out other eligible activities, since those costs are eligible as part of such activities and allocable to specific origin year grants.

Section 570.489(e)(3) is edited for clarity and to remove redundancies.

This rule adds language in § 570.506 specifying that grantees' records pertaining to obligations, expenditures, and drawdowns must be able to relate financial transactions to either a specific origin year's grant or to program income received during a specific program year.

The current regulations at § 570.509 have primarily applied when an entitlement CDBG grantee discontinued its participation in the program as a grantee. The interim rule will now permit and necessitate close out of each origin year grant from HUD. Starting with FY 2015 origin year grants, each year's grant will be closed out when all activity associated with the grant is completed.

This necessitates several changes to the closeout process, which also result in conforming changes to other portions of the regulations. The grant funds, as well as program income received during the program year corresponding to the grant's origin year, must be fully expended before the grant can be closed out. In addition, the grantee must enter final accomplishment data and all activities on which those funds were expended must be reported as completed in a final annual report. The interim rule clarifies that, in order to close out a grant, any unexpended program income received during the program year associated with the grant's origin year must be included in a subsequent year's action plan, thereby rolling forward those available resources onto a more recent action plan with ongoing activities. The funds will be included in the section describing the CDBG funds available pursuant to § 91.220(l), thereby allowing that prior origin year's grant to be closed out.

In addition, the interim rule adds closeout criteria based upon the changes to the administration and planning cap at § 570.200(g).

The interim rule change regarding expenditure of associated program income before grant closeout triggers corresponding changes to § 570.513, lump sum drawdown. A grant cannot be closed out if grant funds or associated program income remain unexpended in a deposit account subject to an existing lump sum drawdown agreement. The change to § 570.513 will require a grantee to execute a new lump sum drawdown agreement covering any unexpended funds, and that program income must be identified in the current program year action plan.

The interim rule makes minor changes to §§ 91.505, 570.206, 570.410, and 570.503 for regulatory and statutory cross-references and grammar. The interim rule also makes various technical changes to incorporate administrative requirements in 2 CFR part 200. These changes include a new paragraph § 570.485(d) to clarify that HUD is authorized to establish specific conditions on grants to States in accordance with 2 CFR 200.207; changes to § 570.489(g) to make clear that States can make subrecipient and contractor determinations in accordance with 2 CFR 200.330; and a new paragraph § 570.489(o), which states that HUD will close out grants to States in accordance with 2 CFR 200.343.

HUD solicits and welcomes comments on all aspects of this interim rule. HUD also specifically solicits comment on the following topics related to the accounting methodology changes for CDBG. HUD seeks the view of grantees, other program participants and interested members of the public. HUD may, at a future date, offer regulatory changes addressing one or more of these topics.

HUD solicits comments about the revisions made to § 570.489(e)(3)(ii)(B) beyond those made by this interim rule. The intent of the section is to reinforce the requirement that program income remains subject to CDBG requirements regardless of the status of any State award to a unit of general local government. The current language of this section uses terms such as “activity closeout” and “grant close out”, as well as concepts such as “part of the unit of general local government's grant” and “part of the state's program year,” and this language may not reflect HUD's intent as explicitly as contemplated by HUD. HUD therefore seeks comment on whether the regulatory language clearly reflects HUD's intent and, if not, what revisions are recommended to better convey the intent of this section.

HUD seeks information that better informs the nature of activities that continue with program income. For States that limit the local retention of program income, what types of limitations do States place upon the definition of the “same activity”? Do the limitations restrict the program income for the same activity in a very strict sense (i.e., limited to the same work, at the same address, with the same beneficiaries)? Do the limitations generally reflect an activity type, such as housing rehabilitation; and, if so, what are the considerations for not classifying this as a revolving loan fund? Do the limitations reflect multiple activities that are bundled into a single effort, such as a main street revitalization plan that might use program income from business loans for other activities in the vicinity, such as façade and side walk improvements along the same main street? Is tracking and reporting the use of these funds problematic, and what solutions have States found (especially for States that do not limit the local retention of program income)?

HUD has some flexibility in the manner program income applies to the administration and planning cap at § 570.200(g) and the public service cap at § 570.201(e). Currently, program income received during the current program year is considered in the determination of compliance with § 570.200(g) and program income received during the prior program year is considered in the determination of compliance with § 570.201(e). HUD solicits comments regarding the possibility of making these two determinations match in terms of which program year is considered for compliance. In this regard, HUD seeks comment on whether compliance with both caps should be based on prior year receipts of program income or current year receipts, or whether the current distinction between the two should be maintained.

HUD generally publishes rules for advance public comment in accordance with its rule on rulemaking at 24 CFR part 10. However, under 24 CFR 10.1, HUD may omit prior public notice and comment if it is “impracticable, unnecessary, or contrary to the public interest.” In this instance, HUD has determined that it is unnecessary to delay the effectiveness of this rule for advance public comment.

The interim rule provides that, for FY 2015 grants, Entitlement CDBG grantees are to track their obligations and expenditures of funds for each specific grant year. The scope of the interim regulatory amendments is limited to the change in the input of this information in IDIS and to those additional changes necessary to conform the regulations to the grant accounting system, such as the time periods of affected grants, records retention, and the calculation of the cap on administrative and planning expenses, along with minor clarifications and technical corrections.

This interim rule does not establish new and unfamiliar requirements for CDBG grantees. Rather the regulatory changes eliminate administrative burden on grantees by aligning CDBG accounting methodology, as reflected in IDIS, with the grant accounting system typically used by grantees, and the standard accounting practice of keeping track of grant commitments and expenditures on an annual grant basis.

Although, under the current regulations, Entitlement CDBG recipients have the option to track expenditures in a cumulative manner, HUD estimates that 80 to 90 percent of grantees adhere to the grant-specific accounting. In addition, the selection of the grant year is already required for State CDBG recipients when requesting funds, so grantees are already tracking this information.

Given that the overwhelming majority of CDBG grantees use grant-specific accounting (the use of which is also strongly recommended by HUD's Office of Inspector General) HUD has the justification necessary to issue this rule as an interim rule. While a small percentage of CDBG grantees are not using this system, it is not a system that is unfamiliar to them. In addition, IDIS itself provides the reports and tools necessary to document compliance with the regulatory changes for all grantees.

And with the grant year-specific accounting, it is now possible for HUD to determine compliance with the administrative expenditure cap on a grant-specific basis. The revised accounting methods also necessitate these additional regulatory changes specifying how grantees are to handle closeout procedures and maintain records. Since the accounting changes are required by existing appropriations law, HUD believes that it is appropriate for the remaining regulatory changes to be effective for the current grant year through an interim rule.

Although HUD has determined that good cause exists to publish this rule for effect without prior solicitation of public comment, HUD recognizes the value and importance of public input in the rulemaking process. Accordingly, HUD is issuing these regulatory amendments on an interim basis and providing a 60-day public comment period. All comments will be considered in the development of the final rule.

The Office of Management and Budget (OMB) reviewed this proposed rule under Executive Order 12866 (entitled “Regulatory Planning and Review”). OMB determined that this rule was significant under the order, but not an economically significant regulatory action. The docket file is available for public inspection in the Regulations Division, Office of General Counsel, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the docket file by calling the Regulations Division at 202-402-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Information Relay Service at 800-877-8339. The docket file is available for public inspection at the above address, or it may be viewed online at www.regulations.gov, under the above docket number. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).

In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number. The information collection requirements contained in this interim rule have been submitted to the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and assigned OMB control number 2506-0117.

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

This interim rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern, or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. As an initial matter, HUD notes that the scope of the rule is limited to accounting methodology, and does not add or modify other CDBG program requirements other than to provide grammatical and technical corrections. Further, accounting for grant funds by specific funding allocations is a practice used in other Federal programs, and so the requirements are not unfamiliar to, and may already be used by, CDBG grantees that also receive funding under such programs.

With respect to burden on small entities, as part of the development of HUD's Affirmatively Furthering Fair Housing (AFFH) final rule, HUD identified small entities participating in the CDBG program as those receiving a grant in FY 2015 of $500,000 or less (small CDBG grantees).1 The number of small CDBG grantees totaled 357 out of 1,258 CDBG grantees in FY 2015.

In this rule, HUD is now requiring small actions that were previously optional, but which many grantees were already performing. Further, any necessary accounting system changes would be one-time updates, rather than a recurring expense, and such costs would be reimbursed from the grantee's administrative expense account, funded by the CDBG grant. Therefore, the undersigned certifies that this rule will not have a significant impact on a substantial number of small entities.

Notwithstanding HUD's belief that this rule will not have a significant effect on a substantial number of small entities, HUD specifically invites comments regarding any less burdensome alternatives to this rule that will meet HUD's objectives as described in this preamble.

Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This rule does not have federalism implications and does not impose substantial direct compliance costs on State and local governments nor preempt State law within the meaning of the Executive order.

The Catalog of Federal Domestic Assistance numbers applicable to the program that would be affected by this rule are 14.218, 14.225, 14.228, and 14.248.

Accordingly, for the reasons stated in the preamble, HUD is amending 24 CFR parts 91 and 570 as follows:

The Coast Guard will enforce the special local regulation for the Savannah Parade of Lights and Fireworks in 33 CFR 100.701 Table 1 from 5 p.m. to 10 p.m. on November 28, 2015.

Under the provisions of 33 CFR 100.701 no person or vessel may enter the regulated area, unless they receive permission to do so from the Captain of the Port Savannah, or a designated representative. This temporary rule creates a regulated area that will encompass the entire Savannah River in Savannah, GA beginning at the Talmadge Bridge near River Street, coordinates 32°05′20″ N., 081°05′56.3″ W., and proceeding down river to a line drawn at 146 degrees true from day board 62, approximate coordinates are: 32°04′48.7″ N., 081°04′47.9″ W.

Spectator vessels may safely transit outside the regulated area, but may not anchor, block, loiter in, or impede the transit of festival participants or official patrol vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR 100.701 and 5 U.S.C. 552(a). The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

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

The background for today's action is discussed in detail in our August 27, 2015 proposal (80 FR 52003). In that notice, we proposed to approve updates to the New Mexico SIP for the City of Albuquerque-Bernalillo County Nonattainment New Source Review (NNSR) permitting program at 20.11.60 NMAC as submitted on August 16, 2010 and July 26, 2013. These revisions were submitted to address the following federal requirements for NNSR:

• Implementation of the NSR Program for PM2.5 (73 FR 28321);

• PSD for PM2.5-Increments, Significant Impact Levels (SILs) and Significant Monitoring Concentration (SMC) (75 FR 64864);

• Implementation of the 8-hour Ozone (O3) NAAQS-Phase; Final Rule to Implement Certain Aspects of the 1990 Amendments Relating to NSR and PSD as They Apply to Carbon Monoxide (CO), PM and O3 NAAQS (70 FR 71612);

• PSD and NNSR: Reasonable Possibility in Recordkeeping (72 FR 72607); and PSD and NNSR: Reconsideration of Inclusion of Fugitive Rule (76 FR 17548).

We did not receive any comments regarding our proposal.

We are approving severable portions of SIP submittals for the New Mexico SIP for the City of Albuquerque-Bernalillo County NNSR permitting program submitted on August 16, 2010, and July 26, 2013. The EPA has determined that the submitted rules were adopted and submitted in accordance with the CAA and are consistent with our regulations and policies regarding NNSR permitting. Therefore, we are taking final action under section 110 and part D of the CAA to approve the following as revisions to the New Mexico SIP for the City of Albuquerque-Bernalillo County:

• Revisions to 20.11.60.1 NMAC as adopted on July 14, 2010 and submitted on August 16, 2010;

• Revisions to 20.11.60.2 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.6 NMAC as adopted on July 14, 2010 and submitted August 16, 2010, and adopted on April 10, 2013 and submitted on July 26, 2013;

• Revisions to 20.11.60.7 NMAC as adopted on July 14, 2010 and submitted August 16, 2010, and adopted on April 10, 2013 and submitted on July 26, 2013;

• Revisions to 20.11.60.12 NMAC as adopted on July 14, 2010 and submitted August 16, 2010, and adopted on April 10, 2013 and submitted on July 26, 2013;

• Revisions to 20.11.60.13 NMAC as adopted on July 14, 2010 and submitted August 16, 2010, and adopted on April 10, 2013 and submitted on July 26, 2013;

• New 20.11.60.14 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• New 20.11.60.15 NMAC as adopted July 14, 2010 and submitted August 16, 2010, and revisions adopted on April 10, 2013 and submitted on July 26, 2013;

• New 20.11.60.16 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.17 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.18 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• New 20.11.60.19 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• New 20.11.60.20 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.21 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.22 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.23 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.24 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.25 NMAC as adopted on July 14, 2010 and submitted August 16, 2010;

• Revisions to 20.11.60.26 NMAC as adopted on July 14, 2010 and submitted August 16, 2010; and

• Revisions to 20.11.60.27 NMAC as adopted on July 14, 2010 and submitted August 16, 2010.

The EPA finds that the August 16, 2010 and July 26, 2013, submittals together address all required NNSR elements for the implementation of the 8-hour ozone NAAQS and the 1997 and 2006 PM2.5 NAAQS. We note that the City of Albuquerque-Bernalillo County NNSR program does not include regulation of VOCs and ammonia as PM2.5 precursors. However, section 189(e) of the Act requires regulation of PM2.5 precursors that significantly contribute to PM2.5 levels “which exceed the standard in the area” and PM2.5 levels in the City of Albuquerque-Bernalillo County do not currently exceed the standard. In the event that an area is designated nonattainment for the 2012 PM2.5 NAAQS or any other future PM2.5 NAAQS, New Mexico for the City of Albuquerque-Bernalillo County will have a deadline under section 189(a)(2) of the CAA to make a submission addressing the statutory requirements as to that area, including the requirements in section 189(e) that apply to the regulation of PM2.5 precursors.

In this rule, we are finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are finalizing the incorporation by reference of the revisions to the New Mexico for the City of Albuquerque-Bernalillo County regulations as described in the Final Action section above. We have made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the EPA Region 6 office.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 Clean Air Act; 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 11, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposed 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, “we,” “us” and “our” refer to the EPA.

On September 1, 2015 (80 FR 52710), the EPA proposed to approve the following document into the California SIP.

ICAPCD's submittal also included the following negative declarations which the District certified that it had no sources subject to the control techniques guidelines (CTG) documents.

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

Section 110(a) of the CAA requires states to adopt and submit regulations for the implementation, maintenance and enforcement of the primary and secondary NAAQS. Specifically, sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J) of the Act require such state plans to meet the applicable requirements of section 165 relating to a pre-construction permit program for the prevention of significant deterioration of air quality and visibility protection. The rules reviewed for this action are intended to implement a pre-construction PSD permit program as required by section 165 of the CAA for certain new and modified major stationary sources located in attainment and unclassifiable areas. Because the State does not currently have a SIP-approved PSD program within the Districts, the EPA is currently the PSD permitting authority within these Districts under a Federal Implementation Plan (FIP). Approval of the Districts' PSD rules into the SIP will transfer PSD permitting authority from the EPA to the Districts. The EPA will then assume the role of overseeing the Districts' PSD permitting programs, as intended by the CAA.

For a more detailed discussion of the District's rules, please refer to our proposed approval. See 80 FR 44001 (July 24, 2015).

On July 24, 2015 (80 FR 44001), the EPA proposed approval of the Districts' PSD rules into the California SIP. We proposed to approve these rules because we determined that they satisfied the applicable CAA requirements. Our proposed rule and related Technical Support document (TSD) contain more information about the basis for this rulemaking and our evaluation of the pertinent State SIP revision submittals.

EPA's proposed approval action for this SIP revision provided a 30-day public comment period. We did not receive any comments on our proposed action.

The EPA is finalizing a SIP revision for each District's portion of the California SIP, consistent with our proposed approval action. The SIP revision will be codified in 40 CFR 52.220 by incorporating by reference the rules listed in Table 1. On June 1, 2015, the California Air Resources Board (CARB) requested the withdrawal from its earlier SIP submittals of the portion of each District PSD rule that incorporates by reference a particular federal PSD rule provision—40 CFR 52.21(b)(49)(v). As such, our approval of these local District rules does not include the rules' incorporation by reference of 40 CFR 52.21(b)(49)(v).

In addition, letters from the Districts to the EPA providing certain clarifications regarding their PSD rules and the requirements of 40 CFR 51.166 will be included as additional material in 40 CFR 52.220. We are also revising 40 CFR 52.270 to reflect that upon the effective date of this final rule, each District will have a SIP-approved PSD program and will no longer be subject to the FIP for the PSD program. This SIP revision provides a federally approved and enforceable mechanism for each of the Districts to issue pre-construction PSD permits for certain new and modified major stationary sources subject to PSD review within the relevant District.

As discussed in the EPA's proposal, with the exception of San Luis Obispo, the Districts requested approval to exercise their authority to administer the PSD program with respect to those sources located in the relevant District that have existing PSD permits issued by the EPA, including authority to conduct general administration of these existing permits, authority to process and issue any and all subsequent PSD permit actions relating to such permits (e.g., modifications, amendments, or revisions of any nature), and authority to enforce such permits. Pursuant to the criteria in section 110(a)(2)(E)(i) of the CAA, we have determined that the four Districts have the authority, personnel, and funding to implement the PSD program within the relevant District for existing EPA-issued permits and therefore are transferring authority for such permits to the four Districts concurrent with the effective date of the EPA's approval of the Districts' PSD program into the SIP. The EPA intends to provide a copy of each such permit to the relevant District.

The EPA is approving five PSD rules submitted by CARB to establish a PSD permit program for pre-construction review of certain new and modified major stationary sources in attainment or unclassifiable areas. We are approving these rules as a revision to the California SIP pursuant to section 110(k)(3) of the Act. Specifically, we are approving the rules listed in Table 1, except for the portion of each rule that incorporates by reference 40 CFR 52.21(b)(49)(v), which was subsequently withdrawn from CARB's request for SIP approval, as explained in more detail in our proposal. See 80 FR at 44003-04. Our determination is based, in part, on the clarifications provided by the Districts related to the implementation of the PSD program, including the clarifications related to Significant Impact Levels (SILs) and the Significant Monitoring Concentrations (SMC) for PM2.5, in letters dated November 13, 2014, November 25, 2014, December 16, 2014, December 18, 2014, April 8, 2015, and April 15, 2015. See 80 FR at 44002-03. We are including these clarification letters as additional material in 40 CFR 52.220.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the rules listed in Table 1, with the exception of certain provisions incorporated into those rules as discussed in Section III. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES 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 Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:

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

• 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 (Public Law 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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 11, 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 CAA section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Under the CSAPR FIPs, a portion of each state budget for each of the four CSAPR trading programs is reserved as a NUSA from which allowances are allocated to eligible units through an annual one- or two-round process. EPA has described the CSAPR NUSA allocation process in three NODAs previously published in the Federal Register (80 FR 30988, June 1, 2015; 80 FR 44882, July 28, 2015; 80 FR 55061, September 14, 2015). In the most recent of these previous NODAs, EPA provided notice of preliminary lists of new units eligible for second-round 2015 NUSA allocations of CSAPR NOX Ozone Season allowances and provided an opportunity for the public to submit objections.

EPA received no substantive objections to the preliminary lists of new units eligible for second-round 2015 NUSA allocations of CSAPR NOX Ozone Season allowances whose availability was announced in the September 14 NODA. The only written objection that EPA received concerned the format of the data rather than the substance. EPA is therefore making second-round 2015 NUSA allocations of CSAPR NOX Ozone Season allowances to the new units identified on these lists in accordance with the procedures set forth in 40 CFR 97.512(a)(9) and (12).

As described in the September 14 NODA, any allowances remaining in the CSAPR NOX Ozone Season NUSA for a given state and control period after the second round of NUSA allocations to new units are to be allocated to the existing units in the state according to the procedures set forth in 40 CFR 97.512(a)(10) and (12). EPA has determined that CSAPR NOX Ozone Season allowances do remain in the NUSAs for a number of states following completion of second-round 2015 NUSA allocations; accordingly, EPA is allocating these allowances to existing units. The NUSA allowances are generally allocated to the existing units in proportion to the allocations previously made to the existing units under 40 CFR 97.511(a)(1), adjusted for rounding.

Under 40 CFR 97.512(b)(10), any allowances remaining in the CSAPR NOX Ozone Season Indian country NUSA for a given state and control period after the second round of Indian country NUSA allocations to new units are added to the NUSA for that state or are made available for allocation by the state pursuant to an approved SIP revision. No new units eligible for allocations of CSAPR NOX Ozone Season allowances from any 2015 Indian country NUSA have been identified, and no state has an approved SIP revision governing allocation of 2015 CSAPR allowances. The Indian country NUSA allowances are therefore being added to the NUSAs for the respective states and are included in the pools of allowances that are being allocated to existing units under 40 CFR 97.512(10) and (12).

The final unit-by-unit data and allowance allocation calculations are set forth in Excel spreadsheets titled “CSAPR_NUSA_2015_NOX_OS_2nd_Round_Final_Data_New_Units”, and “CSAPR_NUSA_2015_NOX_OS_2nd_Round_Final_Data_Existing_Units”, available on EPA's Web site at http://www.epa.gov/crossstaterule/actions.html.

Pursuant to CSAPR's allowance recordation timing requirements, the allocated NUSA allowances will be recorded in sources' AMS accounts by November 16, 2015. EPA notes that an allocation or lack of allocation of allowances to a given unit does not constitute a determination that CSAPR does or does not apply to the unit. EPA also notes that NUSA allocations of CSAPR NOX Ozone Season allowances are subject to potential correction if a unit to which NUSA allowances have been allocated for a given compliance year is not actually an affected unit as of May 1 of the compliance year.2

The Treaty between the Government of the United States of America and the Government of Canada concerning Pacific Salmon was signed at Ottawa on January 28, 1985, and subsequently was given effect in the United States by the Pacific Salmon Treaty Act (Act) at 16 U.S.C. 3631-3644.

Under authority of the Act, Federal regulations at 50 CFR part 300, subpart F, provide a framework for the implementation of certain regulations of the Commission and inseason orders of the Commission's Fraser River Panel for U.S. sockeye and pink salmon fisheries in the Fraser River Panel Area.

The regulations close the U.S. portion of the Fraser River Panel Area to U.S. sockeye and pink salmon tribal and non-tribal commercial fishing unless opened by Panel orders that are given effect by inseason regulations published by NMFS. During the fishing season, NMFS may issue regulations that establish fishing times and areas consistent with the Commission agreements and inseason orders of the Panel. Such orders must be consistent with domestic legal obligations and are issued by the Regional Administrator, West Coast Region, NMFS. Official notification of these inseason actions is provided by two telephone hotline numbers described at 50 CFR 300.97(b)(1) and in 80 FR 25611 (May 5, 2015). The inseason orders are published in the Federal Register as soon as practicable after they are issued. Due to the frequency with which inseason orders are issued, publication of individual orders is impractical.

The following inseason orders were adopted by the Panel and issued for U.S. fisheries by NMFS during the 2015 fishing season. Each of the following inseason actions was effective upon announcement on telephone hotline numbers as specified at 50 CFR 300.97(b)(1) and in 80 FR 25611 (May 5, 2015); those dates and times are listed herein. The times listed are local times, and the areas designated are Puget Sound Management and Catch Reporting Areas as defined in the Washington State Administrative Code at Chapter 220-22.

Areas 4B, 5, and 6C: Open to drift gillnets 12 p.m. (noon), Saturday, July 25, 2015, to 12 p.m. (noon), Wednesday, July 29, 2015.

Areas 4B, 5, and 6C: Extend for drift gillnets from 12 p.m. (noon), Wednesday, July 29, 2015, through 12 p.m. (noon), Saturday, August 1, 2015.

Areas 4B, 5, and 6C: Extend for drift gillnets from 12 p.m. (noon), Saturday, August 1, 2015, through 12 p.m. (noon), Wednesday, August 5, 2015.

Areas 6, 7, and 7A: Open for net fishing from 5 a.m. to 11:59 p.m. (midnight), Saturday, August 1, 2015, and from 5 a.m. to 11:59 p.m. (midnight), Monday, August 3, 2015.

Areas 7 and 7A: Open to reefnets from 9 a.m. to 9 p.m., Saturday, August 1, 2015.

Areas 7 and 7A: Open to purse seines from 9 a.m. to 9 p.m., Sunday, August 2, 2015.

Areas 7 and 7A: Open to drift gillnets from 11 a.m. to 11 p.m., Sunday, August 2, 2015.

Areas 4B, 5, and 6C: Extend for drift gillnets from 12 p.m. (noon), Wednesday, August 5, 2015, to 12 p.m. (noon), Saturday, August 8, 2015.

Areas 6, 7, and 7A: Open for net fishing from 5 a.m., Thursday, August 6, 2015, to 9 a.m., Friday, August 7, 2015.

Areas 7 and 7A: Open to reefnets from 5 a.m. to 9 p.m., Thursday, August 6, 2015, and 5 a.m. to 9 p.m., Friday, August 7, 2015.

Areas 7 and 7A: Open to purse seines from 5 a.m. to 9 p.m., Wednesday, August 5, 2015, and 5 a.m. to 9 p.m., Friday, August 7, 2015.

Areas 7 and 7A: Open to drift gillnets from 8 a.m. to 11:59 p.m. (midnight), Wednesday, August 5, 2015, and from 8 a.m. to 11:59 p.m. (midnight), Friday, August 7, 2015.

Areas 4B, 5, and 6C: Extend for drift gillnets from 12 p.m. (noon), Saturday, August 8, 2015, to 12 p.m. (noon), Wednesday, August 12, 2015.

Areas 6, 7, and 7A: Open for net fishing from 5 a.m., Sunday, August 9, 2015, to 9 a.m., Tuesday, August 11, 2015.

Areas 7 and 7a: Open to reefnets from 5 a.m. to 9 p.m., Saturday, August 8, 2015.

Areas 7 and 7A: Open to purse seines from 5 a.m. to 9 p.m., Saturday, August 8, 2015.

Areas 7 and 7A: Open to drift gillnets from 8 a.m. to 11:59 p.m. (midnight), Saturday, August 8, 2015.

Areas 4B, 5, and 6C: Open to drift gillnets from 12 p.m. (noon), Tuesday, August 25, 2015, through 12 p.m. (noon), Saturday, August 29, 2015. Sockeye may be retained for ceremonial and subsistence purposes only.

Areas 6, 7, and 7A: Open for net fishing from 5:00 a.m., Thursday, August 27, 2015, through 9:00 a.m., Saturday, August 29, 2015. Sockeye may be retained for ceremonial and subsistence purposes only.

Areas 7 and 7A: Open to reefnets, with non-retention of sockeye, from 5 a.m. to 9 p.m., Wednesday, August 26, 2015, and 5 a.m. to 9 p.m., Thursday, August 27, 2015.

Areas 7 and 7A: Open to purse seines, with non-retention of sockeye, from 5 a.m. to 9 p.m., Tuesday, August 25, 2015, and 5 a.m. to 9 p.m., Wednesday, August 26, 2015.

Areas 7 and 7A: Open to drift gillnets, with non-retention of sockeye, from 8 a.m. to 11:59 p.m. (midnight), Tuesday, August 25, 2015, and 8 a.m. to 11:59 p.m. (midnight), Wednesday, August 26, 2015.

Areas 4B, 5, and 6C: Extend for drift gillnets from 12 p.m. (noon), Saturday, August 29, 2015, through 12 p.m. (noon), Wednesday, September 2, 2015. Sockeye may be retained for ceremonial and subsistence purposes only.

Areas 6, 7, and 7A: Open for net fishing from 5 a.m., Monday, August 31, 2015, through 9 a.m., Tuesday, September 1, 2015. Sockeye may be retained for ceremonial and subsistence purposes only.

Areas 7 and 7A: Open to reefnets, with non-retention of sockeye, from 5 a.m. to 9 p.m., Sunday August 30, 2015, and from 5 a.m. to 9 p.m., Monday, August 31, 2015.

Areas 7 and 7A: Open to purse seines, with non-retention of sockeye, from 5 a.m. to 9 p.m., Sunday, August 30, 2015.

Areas 7 and 7A: Open to drift gillnets, with non-retention of sockeye, from 8 a.m. to 11:59 p.m. (midnight), Sunday, August 30, 2015.

Areas 7 and 7A: Open to reefnets, with non-retention of sockeye, from 5 a.m. to 9 p.m., Tuesday, September 1, 2015.

Areas 7 and 7A: Open to purse seines, with non-retention of sockeye, from 5 a.m. to 9 p.m., Tuesday, September 1, 2015.

Areas 7 and 7A: Open to drift gillnets, with non-retention of sockeye, from 8 a.m. to 11:59 p.m. (midnight), Tuesday, September 1, 2015.

Areas 4B, 5, 6, 6C, 7, and 7A, excluding the Apex: Relinquish regulatory control effective 11:59 p.m. (midnight), Tuesday, September 8, 2015. The Apex is those waters north and west of the Area 7A “East Point Line,” defined as a line projected from the low water range marker in Boundary Bay on the U.S./Canada border through the east tip of Point Roberts, WA, to the East Point Light on Saturna Island in the Canadian Province of British Columbia.

Area 7A, the Apex: Relinquish regulatory control in the remaining portion of catch area 7A, referred to as the Apex, effective 11:59 p.m. (midnight), Friday, October 9, 2015.

The Assistant Administrator for Fisheries NOAA (AA), finds that good cause exists for the inseason orders to be issued without affording the public prior notice and opportunity for comment under 5 U.S.C. 553(b)(B) as such prior notice and opportunity for comments is impracticable and contrary to the public interest. Prior notice and opportunity for public comment is impracticable because NMFS has insufficient time to allow for prior notice and opportunity for public comment between the time the stock abundance information is available to determine how much fishing can be allowed and the time the fishery must open and close in order to harvest the appropriate amount of fish while they are available.

The AA also finds good cause to waive the 30-day delay in the effective date, required under 5 U.S.C. 553(d)(3), of the inseason orders. A delay in the effective date of the inseason orders would not allow fishers appropriately controlled access to the available fish at that time they are available.

This action is authorized by 50 CFR 300.97, and is exempt from review under Executive Order 12866.

In the 2015 annual management measures for ocean salmon fisheries (80 FR 25611, May 5, 2015), NMFS announced the commercial and recreational fisheries in the area from the U.S./Canada border to the U.S./Mexico border, beginning May 1, 2015, and 2016 salmon fisheries opening earlier than May 1, 2016. NMFS is authorized to implement inseason management actions to modify fishing seasons and quotas as necessary to provide fishing opportunity while meeting management objectives for the affected species (50 CFR 660.409). Inseason actions in the salmon fishery may be taken directly by NMFS (50 CFR 660.409(a)—Fixed inseason management provisions) or upon consultation with the Pacific Fishery Management Council (Council) and the appropriate State Directors (50 CFR 660.409(b)—Flexible inseason management provisions). The state management agencies that participated in the consultations described in this document were: California Department of Fish and Wildlife (CDFW), Oregon Department of Fish and Wildlife (ODFW), and Washington Department of Fish and Wildlife (WDFW).

Management of the salmon fisheries is generally divided into two geographic areas: North of Cape Falcon (U.S./Canada border to Cape Falcon, OR) and south of Cape Falcon (Cape Falcon, OR, to the U.S./Mexico border). The inseason actions reported in this document affect fisheries north and south of Cape Falcon. Within the south of Cape Falcon area, the Klamath Management Zone (KMZ) extends from Humbug Mountain, OR, to Humboldt South Jetty, CA, and is divided at the Oregon/California border into the Oregon KMZ to the north and California KMZ to the south. All times mentioned refer to Pacific daylight time.

Description of action: Inseason action #37 adjusted the remaining coho quota in the commercial salmon fishery from Queets River, WA, to Cape Falcon, OR, on an impact-neutral basis, from mark-selective to non-mark-selective. The adjusted non-mark-selective coho quota was 6,100.

Effective dates: Inseason action #37 took effect on September 18, 2015, and remained in effect until the end of the commercial salmon fishing season.

Reason and authorization for the action: The purpose of this action was to allow for increased access to the coho quota, which had not been fully utilized, while not exceeding the impact limits for protected stocks. The annual management measures (80 FR 25611, May 5, 2015) provide for inseason action to modify the regulations that restrict retention of unmarked coho. To accommodate modifying the regulations from a mark-selective to non-mark-selective coho fishery while still achieving management objectives, including not exceeding allowable impacts on constraining stocks, the Council's Salmon Technical Team (STT) calculated the necessary adjustments to the coho quota on an impact-neutral basis for the constraining stocks in the Queets River to Cape Falcon area. In this instance, the constraining stock was Lower Columbia River natural coho. The RA approved the STT's impact-neutral conversion of the remaining recreational mark-selective coho quota to non-mark-selective coho quota. Modification of quotas and/or fishing seasons is authorized by 50 CFR 660.409(b)(1)(i).

Consultation date and participants: Consultation on inseason action #37 occurred on September 17, 2015. Participants in this consultation were staff from NMFS, WDFW, and ODFW. Council staff was unavailable to participate in the consultation, but was advised of the RA's decision after the consultation concluded.

Description of action: Inseason action #38 modified landing and possession limits in the commercial salmon fishery between Queets River and Cape Falcon to allow retention of 80 non-mark-selective coho per vessel per open period. The previous landing limit for coho was 50 marked coho per vessel per open period.

Effective dates: Inseason action #38 took effect on September 18, 2015, and remained in effect until the end of the commercial salmon fishing season.

Reason and authorization for the action: The purpose of this action was to allow for increased access to the coho quota, which had not been fully utilized, while not exceeding the impact limits for protected stocks. The annual management measures (80 FR 25611, May 5, 2015) provide for inseason action to modify the regulations that restrict retention of unmarked coho. The RA considered fishery effort, coho catch to date, and the non-mark-selective quota conversion implemented under inseason action #37, and determined that modifying the fishery to allow retention of unmarked coho could be implemented within the allowable impacts on the constraining stock and without exceeding the non-mark-selective coho quota. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(i).

Consultation date and participants: Consultation on inseason action #38 occurred on September 17, 2015. Participants in this consultation were staff from NMFS, WDFW, and ODFW. Council staff was unavailable to participate in the consultation, but was advised of the RA's decision after the consultation concluded.

Description of action: Inseason action #39 modified the open period in the commercial salmon fishery in the California KMZ from five days per week to seven days per week.

Effective dates: Inseason action #39 took effect on September 23, 2015, and remained in effect until the end of the 2015 commercial salmon fishery.

Reason and authorization for the action: During the preseason planning process, the open period for the commercial salmon fishery in the California KMZ, September 11 through September 30, was set at five days per week (Friday through Tuesday), to manage landings in this quota-based fishery. The RA considered fishery effort and Chinook landings to date, both of which were very low due to unfishable weather conditions and lack of productive fishing, and determined that allowing the fishery to remain open seven days per week would provide access to remaining Chinook quota without risk of exceeding the quota for the season. Modification of quotas and/or fishing seasons is authorized by 50 CFR 660.409(b)(1)(i).

Consultation date and participants: Consultation on inseason action #39 occurred on September 21, 2015. Participants in this consultation were staff from NMFS, Council, CDFW, and ODFW.

All other restrictions and regulations remain in effect as announced for the 2015 ocean salmon fisheries and 2016 salmon fisheries opening prior to May 1, 2016 (80 FR 25611, May 5, 2015) and as modified by prior inseason actions.

The RA determined that the best available information indicated that coho and Chinook salmon catch to date and fishery effort supported the above inseason actions recommended by the states of Washington, Oregon, and California. The states manage the fisheries in state waters adjacent to the areas of the U.S. exclusive economic zone in accordance with these Federal actions. As provided by the inseason notice procedures of 50 CFR 660.411, actual notice of the described regulatory actions was given, prior to the time the action was effective, by telephone hotline numbers 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.

The Assistant Administrator for Fisheries, NOAA (AA), finds that good cause exists for this notification to be issued without affording prior notice and opportunity for public comment under 5 U.S.C. 553(b)(B) because such notification would be impracticable. As previously noted, actual notice of the regulatory actions was provided to fishers through telephone hotline and radio notification. These actions comply with the requirements of the annual management measures for ocean salmon fisheries (80 FR 25611, May 5, 2015), the West Coast Salmon Fishery Management Plan (Salmon FMP), and regulations implementing the Salmon FMP, 50 CFR 660.409 and 660.411. Prior notice and opportunity for public comment was impracticable because NMFS and the state agencies had insufficient time to provide for prior notice and the opportunity for public comment between the time Chinook salmon catch and effort assessments and projections were developed and fisheries impacts were calculated, and the time the fishery modifications had to be implemented in order to ensure that fisheries are managed based on the best available scientific information, ensuring that conservation objectives and ESA consultation standards are not exceeded. The AA also finds good cause to waive the 30-day delay in effectiveness required under 5 U.S.C. 553(d)(3), as a delay in effectiveness of these actions would allow fishing at levels inconsistent with the goals of the Salmon FMP and the current management measures.

These actions are authorized by 50 CFR 660.409 and 660.411 and are exempt from review under Executive Order 12866.