Federal Register Vol. 80, No.152,

The substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.

Bombardier Inc. located in Montreal, Canada, applied to Transport Canada Civil Aviation (TCCA) on January 7, 2012, and May 30, 2012, for two amended type certificates in the transport airplane category for two new airplane models designated as the BD-700-2A12 and BD-700-2A13. The BD-700-2A12 and BD-700-2A13 airplanes are 19-passenger, twin-engine, ultra long-range large airplanes targeting the executive interior business jet market. These airplanes share an identical supplier base and significant common design elements.

The BD-700-2A12 and BD-700-2A13 airplanes will use side stick controllers for pitch and roll control. Regulatory requirements pertaining to conventional wheel and column, such as pilot strength and controllability, are not directly applicable for the side stick. In addition, pilot control authority may be uncertain because the side sticks are not mechanically interconnected as with conventional wheel and column controls.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Bombardier Inc. must show that the BD-700-2A12 and BD-700-2A13 airplanes meet the applicable provisions of 14 CFR part 25 as amended by Amendments 25-1 through 25-138 except for Amendment 25-137.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the BD-700-2A12 and BD-700-2A13 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.17(a)(2).

The BD-700-2A12 and BD-700-2A13 airplanes will incorporate the following novel or unusual design feature: Side stick controllers for pitch and roll control, which are not mechanically interconnected as with conventional wheel and column controls. These airplanes also have a fly-by-wire electronic flight control system. This system provides an electronic interface between the pilot's flight controls and the flight control surfaces for both normal and failure states, and it generates the actual surface commands that provide for stability augmentation and control about all three airplane axes. In addition, pilot control authority may be uncertain, because the side sticks are not mechanically interconnected as with conventional wheel and column controls.

Current FAA regulations do not specifically address the use of side stick controllers for pitch and roll control. The unique features of the side stick must therefore be demonstrated through flight and simulator tests to have suitable handling and control characteristics when considering the following:

1. The handling qualities tasks/requirements of the BD-700-2A12 and BD-700-2A13 airplanes special conditions and other part 25 stability, control, and maneuverability requirements, including the effects of turbulence.

2. General ergonomics: Arm rest comfort and support, local freedom of movement, displacement angle suitability, and axis harmony.

3. Inadvertent input in turbulence.

4. Inadvertent pitch-roll cross talk.

These special conditions elaborate on these requirements and contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The FAA Handling Qualities Rating Method (HQRM) in appendix 5 of Advisory Circular 25-7C, “Flight Test Guide for Certification of Transport Category Airplanes,” may be used to show compliance.

As discussed above, these special conditions are applicable to the Bombardier Inc. Models BD-700-2A12 and BD-700-2A13 series airplanes. Should Bombardier Inc. apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on two model series of airplanes. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.

Bombardier Inc. located in Montreal, Canada, applied to Transport Canada Civil Aviation (TCCA) on January 7, 2012, and May 30, 2012, for two amended type certificates in the transport airplane category for two new airplane models designated as the BD-700-2A12 and BD-700-2A13. These airplanes are 19-passenger, twin-engine, ultra long-range large airplanes targeting the executive interior business jet market. They share an identical supplier base and significant common design elements including a fly-by-wire electronic flight control system (EFCS).

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Bombardier Inc. must show that the BD-700-2A12 and BD-700-2A13 airplanes meet the applicable provisions of 14 CFR part 25 as amended by Amendments 25-1 through 25-138 except for Amendment 25-137.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the BD-700-2A12 and BD-700-2A13 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design features, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.17(a)(2).

The BD-700-2A12 and BD-700-2A13 airplanes will incorporate the following novel or unusual design features: A fly-by-wire EFCS and no direct coupling from the flight deck controller to the control surface. As a result, the pilot is not aware of the actual control surface position as envisioned under current airworthiness standards.

These special conditions require that the flightcrew receive a suitable flight control position annunciation when a flight condition exists in which nearly full surface authority (not crew-commanded) is being used. Suitability of such a display must take into account that some pilot-demanded maneuvers (e.g., rapid roll) are necessarily associated with intended full performance, which may saturate the surface. Therefore, simple alerting systems function in both intended and unexpected control-limiting situations. As a result, they must be properly balanced between providing necessary crew awareness and being a potential nuisance to the flightcrew. A monitoring system that compares airplane motion and surface deflection with the demand of the pilot side-stick controller could help reduce nuisance alerting.

These special conditions also address flight control system mode annunciation. Suitable mode annunciation must be provided to the flightcrew for events that significantly change the operating mode of the system but do not merit the classic “failure warning.”

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

As discussed above, these special conditions are applicable to the Bombardier Models BD-700-2A12 and BD-700-2A13 series airplanes. Should Bombardier Inc. apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design features, these special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on two model series of airplanes. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

This final rule amends the Export Administration Regulations (EAR) to further implement U.S. sanctions on certain Russian energy projects. Specifically, in this rule, the Bureau of Industry and Security (BIS) amends the EAR by adding a Russian oil and gas field, the Yuzhno-Kirinskoye Field located in the Sea of Okhotsk, to the Entity List.

This Russian field is reported to contain substantial reserves of oil in addition to reserves of gas. The U.S. Government has determined, therefore, that exports, reexports, and transfers (in-country) of all items subject to the EAR to this Russian field by any person without first obtaining a BIS license present an unacceptable risk of use in, or diversion to, the activities specified in the Russian industry sector sanctions. Thus, as part of the BIS “is informed” process, this final rule adds this Russian field to the Entity List to further implement the Russian industry sector sanctions. This Russian field will be listed on the Entity List under the destination of Russia.

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 licensing 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, rules on additions to, removals from, and other modifications to the Entity List. The ERC makes decisions to add an entry to the Entity List by majority vote and decisions to remove or modify an entry by unanimous vote.

Under § 746.5(a)(2), BIS in this final rule is adding a Russian oil and gas field to the Entity List and informing the public of a license requirement for exports, reexports, or transfers (in-country) of any item subject to the EAR to that location. This Russian field is added based on being the site of activities that are described in Executive Order 13662 (79 FR 16169), Blocking Property of Additional Persons Contributing to the Situation in Ukraine, issued by the President on March 20, 2014. This Order expanded the scope of the national emergency declared in Executive Order 13660 of March 6, 2014 and Executive Order 13661 of March 16, 2014. Specifically, Executive Order 13662 expanded the scope to include sectors of the Russian Federation's economy as may be determined by the Secretary of the Treasury, in consultation with the Secretary of State, such as financial services, energy, metals and mining, engineering, and defense and related materiel. The Department of the Treasury's Office of Foreign Assets Control (OFAC), pursuant to Executive Order 13662 and on behalf of the Secretary of the Treasury, has designated certain entities operating in these sectors.

The Yuzhno-Kirinskoye Field is being added to the Entity List because it is reported to contain substantial reserves of oil. Consequently, exports, reexports, and transfers (in-country) of all items subject to the EAR to this Russian oil and gas field by any person without first obtaining a BIS license has been determined by the U.S. Government to present an unacceptable risk of use in, or diversion to, the activities specified in paragraph (a)(1) of § 746.5, namely exploration for, or production of, oil or gas in Russian deepwater (greater than 500 feet) locations. Therefore, a license requirement for all items subject to the EAR is warranted.

License applications for such transactions will be reviewed with a presumption of denial because such exports, reexports, and transfers (in-country) are for use directly or indirectly in exploration or production from a deepwater (greater than 500 feet) project in Russia that has the potential to produce oil. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the field being added to the Entity List in this rule.

This final rule adds the following one Russian gas and oil field to the Entity List to expand the EAR license requirements in § 746.5:

(1) Yuzhno-Kirinskoye Field, in the Sea of Okhotsk.

As noted above, BIS places entities on the Entity List based on certain sections of part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR. This final rule, as a clarification for this existing BIS policy for adding persons to the Entity List, revises the first sentence of the introductory text of the Entity List to add a reference to part 746. This clarification to the introductory text will make it clear that this Supplement lists certain entities subject to license requirements for specified items under this part 744 and part 746 of the EAR.

In § 746.5 (Russian industry sector sanctions), this final rule revises the second sentence of paragraph (a)(2) for the additional prohibition on those informed by BIS to add the term “end-use” after the term “end-user.” This change clarifies that the additional prohibition described in this paragraph (a)(2), as part of the BIS “is informed” process, may be based on an end-user or end-use when BIS determines there is an unacceptable risk of use in, or diversion to, the activities specified in paragraph (a)(1) of this section in Russia. This clarification does not change the scope of § 746.5, but rather clarifies the cases in which BIS will use the “is informed” process to assist exporters, reexporters, and transferors to “know” when an export, reexport, or transfer (in-country) is subject to the license requirements specified in § 746.5.

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, 2014, 79 FR 46959 (August 11, 2014), 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 Entity List changes in this final rule, 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. foreign policy interests by preventing items from being exported, reexported, or transferred (in country) for use in, or diversion to, the activities specified in the Russian industry sector sanctions at the Russian field being added to the Entity List. If this rule were delayed to allow for notice and comment and a delay in effective date, then persons working on or in the Russian field being added to the Entity List by this action would continue to be able to receive items subject to the EAR without a license and to conduct activities contrary to the Russian industry sector sanctions. In addition, publishing a proposed rule would give parties trying to export, reexport, or transfer (in-country) to this location notice of the U.S. Government's intention to place this Russian field on the Entity List and would create an incentive for persons located at this Russian field to accelerate receiving items subject to the EAR to conduct activities that are contrary to the to the Russian industry sector sanctions, and/or to take steps to set up additional aliases and other measures to try to limit the impact of the listing on the Entity List. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

5. For the clarification to Russian industry sector sanctions and clarification to the introductory text of the Entity List, the Department finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because allowing for notice and comment would be contrary to the public interest. The revisions to § 746.5(a)(2) and the introductory text to Supplement No. 4 to Part 744, facilitate public understanding of existing interpretations of current EAR provisions, and therefore prior notice and the opportunity for public comment would prevent BIS promulgating these revisions as soon as possible so that the public will be aware of the correct text and meaning of these current EAR provisions.

BIS finds good cause to waive the 30-day delay in effectiveness under 5 U.S.C. 553(d)(3). As mentioned previously, the revisions described here made by this rule consist of minor clarifications that need to be in place as soon as possible to avoid confusion by the public regarding the intent and meaning of these changes to the EAR.

Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for these amendments by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable.

Accordingly, parts 744 and 746 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:

This document amends the U.S. Customs and Border Protection (CBP) regulations by: (1) Removing some of the requirements for drawback claimants to establish proof of exportation; (2) conforming Appendix B to part 191 of the CBP regulations to previous regulatory changes reflecting the closing of four drawback offices; (3) updating the regulations to reflect that CBP is now part of the Department of Homeland Security; and (4) making other non-substantive editorial and nomenclature changes.

This document amends title 19 of the Code of Federal Regulations (19 CFR) by making amendments to 19 CFR parts 181 and 191, specifically, sections 19 CFR 181.47, 191.72 and 191.74 to align CBP documentation requirements with current business practices related to the documents used to establish the date and fact of exportation for purposes of drawback. In order to qualify for drawback, claimants must establish that articles are exported or destroyed. When drawback is claimed for exported goods, the claimant must submit documentation that establishes fully the date and fact of exportation and the identity of the exporter. See 19 CFR 191.72. For certain types of drawback claims subject to the North American Free Trade Agreement (NAFTA), documentation must also establish the identity and location of the ultimate consignee of the exported goods. See 19 CFR 181.47 (b)(2)(ii)(G).

The documents for establishing exportation include, but are not limited to: a bill of lading, air waybill, freight waybill, Canadian Customs manifest, and/or cargo manifest. See 19 CFR 191.72(a). If the export is a mail shipment, vessel supply, or transfer to a foreign trade zone, other procedures to establish exportation may apply. See 19 CFR 191.72 (c)-(e). Current CBP regulations specify that the documents listed in paragraph (a) must be either originally signed or certified copies thereof. See 19 CFR 191.72(a). Additionally, certain claims subject to NAFTA require that the claimant produce an originally signed document or a certified copy of such document. See 19 CFR 181.47(b)(2)(ii)(G).

Acquiring pen and ink signatures for the original documentation or certified copies of such documentation is time consuming and often unrealistic for the trade. CBP realizes the difficulty of having to provide a pen and ink signature for documents when these documents are issued electronically and do not contain an actual pen and ink signature. As a consequence, drawback claims are often denied when claimants can produce only documentary evidence that does not contain a signature or copies of such documents that are not certified.

As such, CBP is amending its regulations by removing the requirement that the documentary evidence that establishes the date and fact of exportation for drawback eligibility be originally signed or that any copy of such documentary evidence must be certified. CBP will now allow claimants to provide unsigned originals or copies of documentary evidence as proof of export for drawback eligibility. Therefore, copies of original documentary evidence will no longer need to be certified.

Additionally, pursuant to 19 CFR 191.72(c), CBP currently requires a certified export invoice for mail shipments and references section 191.74. Even though section 191.72(c) cites to section 191.74 as a reference for the “certified export invoice” requirement for mail shipments, the regulatory text of 19 CFR 191.74 does not require a claimant to submit a certified copy of the export invoice, but only requires that the claimant provide the official postal records. There is no reference to “export invoice” in section 191.74. Further, the only reference to “certification” is in the title heading to section 191.74. Accordingly, CBP is removing the phrase “Certification of” from the heading text to section 191.74 as it is misleading as to what that regulation requires. Thus, CBP is clarifying that claimants submitting postal records in support of exportation in accordance with section 191.74 may submit either originals or uncertified copies of official postal records by clearly stating that within the text of section 191.74. Further, CBP is revising section 191.72(c) to accurately reflect the plain language of section 191.74 by requiring evidence of official postal records (originals or copies) that demonstrate exportation by mail.

Other non-substantive editorial changes to reflect the plain English mandate are made to these regulatory sections, 19 CFR 181.47, 191.72 and 191.74.

CBP inadvertently failed to remove from Appendix B to part 191 references to certain drawback offices when the agency previously amended the regulations to close four drawback offices. Three drawback offices were closed in 2003 (Boston, MA; New Orleans, LA; and Miami, FL) and one in 2010 (Long Beach, CA). See Consolidation of Customs Drawback Centers: Final rule, 68 FR 3381, dated January 24, 2003; and Further Consolidation of CBP Drawback Centers: Final rule, 75 FR 24392, dated May 5, 2010. Accordingly, this document amends Appendix B, Sections II through V within part 191 of 19 CFR to reflect the closure of those four drawback offices by removing the reference to eight drawback offices and by removing the references to the locations of the four closed offices (that is, Boston, MA; Long Beach, CA; Miami, FL; and New Orleans, LA).

On November 25, 2002, the President signed into law the Homeland Security Act of 2002 (Pub. L. 107-296, 116 Stat. 2135). Accordingly, as of March 1, 2003, the former U.S. Customs Service of the Department of the Treasury was transferred to DHS and reorganized to become CBP. Accordingly, this document further amends § 181.47 to reflect the change from the legacy agency name, U.S. Customs Service, to the current name, U.S. Customs and Border Protection or CBP.

Section 181.47 of the CBP regulations (19 CFR 181.47) pertains to the documents required for a NAFTA drawback claim. Paragraph (b)(2)(ii)(G) of § 181.47 is amended by removing the requirement that copies of the exemplar documents in that paragraph be certified.

In addition, section 181.47 contains the legacy agency name of Customs. Accordingly, § 181.47 is amended to remove the outdated information and replace it with the current agency name CBP in §§ 181.47(b)(2), 181.47(b)(2)(i)(A), 181.47(b)(2)(i)(B), 181.47(b)(2)(i)(F), 181.47(b)(2)(ii)(A), 181.47(b)(2)(ii)(B), 181.47(b)(2)(ii)(C), 181.47(b)(2)(ii)(D), 181.47(b)(2)(ii)(E), 181.47(b)(2)(iii)(A), 181.47(b)(2)(iii)(B), and 181.47(b)(2)(iii)(D). Additionally, the word “shall” is replaced with either “must”, “will” or “is”, as appropriate, in paragraphs (a), (b)(1), (b)(2)(i), (b)(2)(i)(E), (b)(2)(ii), (b)(2)(ii)(B), (b)(2)(ii)(G), (b)(2)(ii)(H), (b)(2)(iii), (b)(2)(iv), (b)(2)(v), and (c) of § 181.47 to conform with the plain English mandate.

Section 191.72 of the CBP regulations (19 CFR 191.72) pertains to exportation procedures for drawback. Section 191.72(a) is amended by removing the terms “originally signed” and “certified” from the list of acceptable documentary evidence for establishing the date and fact of exportation for drawback eligibility. Section 191.72(c) is revised to reflect the requirements of section 191.74 and to reflect that the postal records for export shipments no longer have to be certified. Section 191.74 is amended by removing the words “Certification of” from the heading text because the text of 191.74 does not require a claimant to submit a certified copy of the postal record and the title heading cannot impose a legal requirement that is not also reflected in the regulatory text. CBP is also making it clear that claimants may submit either originals or copies of official postal records by adding the parenthetical phrase “(originals or copies)” after the phrase “official postal records” in section 191.74.

This document also makes non-substantive amendments to Appendix B, Sections II through V within part 191 of 19 CFR as discussed above.

Because the amendments in parts 181 and 191 of 19 CFR set forth in this document merely relieve a burden on the public and the amendments to the Appendix of part 191 conform the regulations to previous regulatory changes to reflect the consolidation of drawback offices, CBP finds that good cause exists for dispensing with notice and public procedure as unnecessary under 5 U.S.C. 553(b)(B). For this same reason, pursuant to 5 U.S.C. 553(d)(3), CBP finds good cause for dispensing with the requirement for a delayed effective date.

Because this document is not subject to the notice and public procedure requirements of 5 U.S.C. 553, it is not subject to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

These amendments do not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866, as supplemented by Executive Order 13563.

This regulation is being issued in accordance with 19 CFR 0.1(a)(1), pertaining to the authority of the Secretary of the Treasury (or that of his delegate) to approve regulations concerning drawback.

For the reasons set forth above, parts 181 and 191 of the CBP Regulations (19 CFR parts 181 and 191) and Appendix B to part 191 of 19 CFR are amended as set forth below:

Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01, dated December 10, 2013, to the TTB Administrator to perform the functions and duties in the administration and enforcement of this law.

Part 4 of the TTB regulations (27 CFR part 4) authorizes TTB to establish definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.

Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.

Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grape-growing region as an AVA. Section 9.12(c) of the TTB regulations (27 CFR 9.12(c)) prescribes standards for petitions for the establishment or modification of AVAs. Petitions to establish an AVA must include the following:

• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;

• An explanation of the basis for defining the boundary of the proposed AVA;

• A narrative description of the features of the proposed AVA affecting viticulture, including climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA boundary;

• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and

• A detailed narrative description of the proposed AVA boundary based on USGS map markings.

TTB received a petition from Christine Flannigan, owner of the Sierra Peaks Winery and Purgatory Vineyards, on behalf of the Squaw Valley Grape Growers Group, proposing the establishment of the “Squaw Valley-Miramonte” AVA in Fresno County, California, approximately 40 miles east of the city of Fresno. The proposed AVA is a largely rural region in the foothills of the Sierra Nevada Mountains and does not overlap any established AVAs. To the northwest, west, and south of the proposed AVA is the San Joaquin Valley. The Sequoia National Forest is adjacent to the northern and eastern boundaries of the proposed AVA.

The proposed Squaw Valley-Miramonte AVA contains approximately 44,690 acres and has 3 bonded wineries and 5 commercially producing vineyards, covering a total of 7.5 acres, distributed across the proposed AVA. The petition states that vineyards within the proposed AVA are small due to the region's steep and rugged terrain, which requires most vineyard work to be done by hand rather than by machine.

According to the petition, the distinguishing features of the proposed AVA include its climate, topography, and soils. Daytime temperatures within the proposed AVA are generally cooler than in the neighboring San Joaquin Valley to the south, west, and northwest. However, nighttime temperatures are usually warmer within the proposed AVA than within the San Joaquin Valley because cool air drains off the slopes of the proposed AVA at night and settles in the valley. The cool daytime temperatures and warm nighttime temperatures during the growing season produce higher levels of sugar and anthocyanins (pigments responsible for the color of grape skins) at harvest than occur in grapes grown in the warmer San Joaquin Valley. The temperatures in the proposed AVA also contribute to later harvest dates than in the San Joaquin Valley. The proposed AVA also receives significantly more rainfall than the San Joaquin Valley, but less than the regions to the north and east of the proposed AVA, within the Sequoia National Forest. The high rainfall amounts within the proposed AVA increase the risk of erosion, so vineyard owners plant ground cover between the vineyard rows to help hold the soil in place.

The topography of the proposed AVA consists of steep and rugged hillsides covered with boulders and oak woodlands. Elevations range from 1,600 to 3,500 feet, and slope angles in the vineyards range from 15 to 40 percent. As a result of the steep terrain, mechanized vineyard equipment is not practical, so almost all vineyard work is done by hand. Therefore, the vineyards in the proposed AVA are much smaller than those in the neighboring San Joaquin Valley, where the terrain is much lower and flatter. To the north and east of the proposed AVA, the terrain becomes too steep for commercial viticulture.

The majority of the soils within the proposed Squaw Valley-Miramonte AVA are derived from granitic material, mainly quartz diorite. The three most common soil series are the Vista, Sierra, and Auberry series. All three soil series are described as having good drainage, which reduces the risk of root disease. The soils within the proposed AVA have pH levels ranging from a slightly acidic 5.6 to a neutral 7.3, levels which are adequate for viticulture and do not promote overly vigorous vine or canopy growth. The soils within the proposed AVA are severely deficient in nitrogen, a nutrient necessary for vine growth, and therefore require supplementation. Additionally, soils in some of the vineyards within the proposed AVA have an excess of potassium, which interferes with the vines' ability to uptake magnesium. As a result, magnesium must be added to the soil in these vineyards. To the north of the proposed AVA, the soils are primarily of the Coarsegold and Trabuco series, which are derived from weathered schist and igneous rock, respectively. The most common soil series east of the proposed AVA are the Holland series, derived from weathered granitic rock, and the Aiken series, derived from volcanic rocks. These soils are more acidic than the soils within the proposed AVA due to deep mats of decomposing needle litter from conifer trees. South and west of the proposed AVA, within the San Joaquin Valley, alluvial soils such as San Joaquin loam and San Joaquin sandy loam become common, as are soils of the Hanford and Greenfield series. These soils are all less acidic and have finer textures than the soils of the proposed AVA.

TTB published Notice No. 146 in the Federal Register on January 22, 2015 (80 FR 3184), proposing to establish the Squaw Valley-Miramonte AVA. In the notice, TTB summarized the evidence from the petition regarding the name, boundary, and distinguishing features for the proposed AVA. The notice also compared the distinguishing features of the proposed AVA to the surrounding areas. In Notice No. 146, TTB solicited comments on the accuracy of the name, boundary, and other required information submitted in support of the petition. The comment period closed on March 23, 2015. TTB received no comments in response to Notice No. 146.

After careful review of the petition, TTB finds that the evidence provided by the petitioner supports the establishment of the Squaw Valley-Miramonte AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and part 4 and part 9 of the TTB regulations, TTB establishes the “Squaw Valley-Miramonte” AVA in Fresno County, California, effective 30 days from the publication date of this document.

See the narrative description of the boundary of the AVA in the regulatory text published at the end of this final rule.

The petitioner provided the required maps, and they are listed below in the regulatory text.

Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.

With the establishment of this AVA, its name, “Squaw Valley-Miramonte,” will be recognized as a name of viticultural significance under 27 CFR 4.39(i)(3). The text of the regulation clarifies this point. Consequently, wine bottlers using the name “Squaw Valley-Miramonte” in a brand name, including a trademark, or in another label reference as to the origin of the wine, will have to ensure that the product is eligible to use the AVA name as an appellation of origin. TTB is not designating either “Squaw Valley” or “Miramonte,” standing alone, as terms of viticultural significance because both of these names are also associated with multiple locations within the United States outside the AVA.

TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.

It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866 of September 30, 1993. Therefore, no regulatory assessment is required.

Karen A. Thornton of the Regulations and Rulings Division drafted this final rule.

For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:

The BNSF Railway Company requested a temporary deviation from the operating schedule of the Galveston Causeway Railroad Vertical Lift Bridge across the Gulf Intracoastal Waterway, mile 357.2 west of Harvey Locks, at Galveston, Galveston County, Texas.

The bridge has a vertical clearance of 8.0 feet above mean high water, elevation 3.0 feet (NAVD88), in the closed-to-navigation position and 73 feet above mean high water in the open-to-navigation position. In accordance with 33 CFR 117.5, the draw shall open on signal for the passage of vessels.

This temporary deviation allows the vertical lift bridge to remain closed to navigation from 7:30 a.m. to 11:30 and then again from 1:30 p.m. to 5:30 p.m., daily, beginning August 31 through September 5, 2015. During this time, the bridge owner will complete cable lubing, welding joints and replacing span guide bearings. If the vessel can safely pass without an opening, the vessel may pass at the slowest safe speed. The bridge can open in case of emergency.

Navigation at the site of the bridge consists mainly of tows with barges and some recreational pleasure craft. Based on known waterway users, as well as coordination with those waterway users, it has been determined that this closure will not have a significant effect on these vessels. No alternate routes are available.

In accordance with 33 CFR 117.35, the draw bridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation.

This deviation from the operating regulations is authorized under 33 CFR 117.35.

Multnomah County has requested a temporary deviation from the operating schedule for the Broadway Bridge, mile 11.7, Burnside Bridge, mile 12.4, Morrison Bridge, mile 12.8, and Hawthorne Bridge, mile 13.1, all crossing the Willamette River at Portland, OR. The requested deviation is to accommodate the annual Providence Bridge Pedal event. To facilitate this event, the draws of the bridges will be maintained in the closed-to-navigation positions as follows: The Broadway Bridge, mile 11.7, provides a vertical clearance of 90 feet in the closed position; Burnside Bridge, mile 12.4, provides a vertical clearance of 64 feet in the closed position; Morrison Bridge, mile 12.8, provides a vertical clearance of 69 feet in the closed position; and Hawthorne Bridge, mile 13.1, provides a vertical clearance of 49 feet in the closed position; all clearances are referenced to the vertical clearance above Columbia River Datum 0.0. The normal operating schedule for all four bridges is set in 33 CFR 117.897, and states that the bridges need not open from 7 a.m. to 9 a.m., and from 4 p.m. to 6 p.m. Monday through Friday. These four bridges need not open for vessel traffic from 6 a.m. on August 9, 2015, to 12:30 p.m. on August 9, 2015. This deviation period is from 6 a.m. on August 9, 2015, to 12:30 p.m. August 9, 2015. The deviation allows the Broadway Bridge, Burnside Bridge, Morrison Bridge, and the Hawthorne Bridge all crossing the Willamette River, to remain in the closed-to-navigation position and need not open for maritime traffic from 6 a.m. to 12:30 p.m. on August 9, 2015. The four bridges shall operate in accordance to 33 CFR 117.897 at all other times. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft.

Vessels able to pass through the bridge in the closed-to-navigation positions may do so at any time. The bridges will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

On March 30, 2014, HHS published the Notice of Proposed Rulemaking (NPRM) in the Federal Register to amend the Countermeasures Injury Compensation Program's (CICP or Program) implementing regulation and establish a table of injuries resulting from the administration or use of covered pandemic influenza countermeasures. The NPRM provided a 60-day comment period resulting in HHS receipt of five sets of comments—one set from a physicians' organization and four sets from individuals. HHS carefully considered these comments when developing this final rule. In “Section III, Comments and Responses” of this final rule, the comments are summarized and HHS provides responses to them.

The Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) directs the Secretary to establish, through regulation, a Covered Countermeasures Injury Table (Table) identifying serious physical injuries that are presumed to be directly caused by the administration or use of covered countermeasures identified in PREP Act declarations issued by the Secretary.

The Secretary may only add to a Table injuries that are directly caused by the administration or use of the covered countermeasure based on “compelling, reliable, valid, medical and scientific evidence.” 1 This Table informs the public about serious physical injuries known to be directly caused by covered countermeasures through support by compelling, reliable, valid, medical and scientific evidence. In addition, this Table creates a rebuttable presumption of causation for eligible individuals whose injuries are listed on a Table and meet the requirements of a Table.

The PREP Act authorizes both liability protections and compensation based on the terms of the PREP Act declarations, but this final rule concerns only the compensation program, not the liability protections set forth therein.

The Secretary published the interim final rule implementing the Program on October 15, 2010.2 The final rule, which was published on October 7, 2011, explains the Program's policies, procedures, and requirements. Title 42 of the Code of Federal Regulations (CFR) § 110.20(a) states that individuals must establish that a covered injury occurred in order to be eligible for benefits under the Program. A covered injury is death or a serious injury determined by the Secretary to be: (1) An injury meeting the requirements of a Table, which is presumed to be the direct result of the administration or use of a covered countermeasure unless the Secretary determines there is another more likely cause; or (2) an injury (or its health complications) that is the direct result of the administration or use of a covered countermeasure. This includes a covered countermeasure causing a serious aggravation of a pre-existing condition.3 In general, only injuries that warranted hospitalization (whether or not the person was actually hospitalized), or injuries that led to a significant loss of function or disability are considered serious injuries.4

Individuals with injuries not meeting the requirements listed on the Table may still pursue their claims as non-Table injuries under the Program. In this instance, the requester does not receive the presumption of causation for a Table injury and must demonstrate that the use or administration of the covered countermeasure directly caused the injury. Proof of a causal association for the non-Table injury must be based on compelling, reliable, valid, medical and scientific evidence.

Through this final rule, the Secretary will be adding subpart K to 42 CFR part 110, which had been reserved for the purpose of creating a Covered Countermeasures Injury Table. The Table established in this final rule is limited to pandemic influenza covered countermeasures. These countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 virus, and other potential pandemic strains, such as H5N1 avian influenza. The Secretary may create and publish Tables in the Federal Register through separate amendments to 42 CFR part 110 in the future. Tables may be created for other countermeasures in accordance with the PREP Act. To date, declarations have been issued with respect to countermeasures against pandemic influenza A viruses, anthrax, botulism, smallpox, acute radiation syndrome, and the Ebola virus.

Through the Pandemic Influenza Countermeasures Injury Table Final Rule, the Secretary provides, as authorized by statute, a Table for several covered countermeasures listing serious physical injuries. The serious physical injuries included on the Table are injuries that are supported by compelling, reliable, valid, medical and scientific evidence showing that the administration or use of the covered countermeasures directly causes such injuries. The Table lists the serious injuries directly caused by a specific countermeasure, the time interval within which the first symptom or manifestation of onset of injury must appear, and the definition of the injury. Table definitions are included to further explain each covered injury and the level of severity necessary to qualify as a Table injury.

The injuries, time intervals, definitions, and requirements reflect the Secretary's efforts to identify those serious physical injuries causally related to the covered countermeasures. The causal linkages between the covered countermeasures and these associated injuries are based on compelling, reliable, valid, medical and scientific evidence. The Secretary will stay informed of updates in the scientific and medical field concerning new information about causal associations between injuries and covered countermeasures.

In this final rule, the Secretary has made the following changes to the Qualifications and Aids to Interpretation (QAI) of the Table for purposes of clarity.

a. Changed section (b)(4)(i) by adding an accent over the “e” in Guillain-Barre Syndrome (GBS). The revised section term reads, “Guillain-Barré Syndrome.” In the first sentence, added “currently is known to encompass” after “that” and delete “encompasses.” The revised sentence states, “GBS is an acute monophasic peripheral neuropathy that currently is known to encompass a spectrum of four clinicopathological subtypes described below.” In the fourth sentence, changed “nine” to “9.” The revised sentence states, “Treatment related fluctuations in all subtypes of GBS can occur within 9 weeks of GBS symptom onset and recurrence of symptoms after this time frame would not be consistent with GBS.”

b. Changed section (b)(4)(iv) by adding “The results of both . . .” to the beginning of the second sentence. The revised sentence states, “The results of both CSF and electrophysiologic studies are frequently normal in the first week of illness in otherwise typical cases of GBS.”

c. Deleted section (b)(4)(v) which states, “For all types of GBS, the onset of symptoms less than three days (72 hours) after exposure to the influenza vaccine excludes vaccine exposure as a cause” because timeframes for serious physical injuries to be Table injuries are listed in the Table, not in the QAI.

d. Changed section (b)(4)(vi) to (b)(4)(v) since (b)(4)(v) has been deleted as stated above and added to the beginning of the first sentence of section (b)(4)(v), “For GBS to qualify as a Table injury.” The revised sentence states, “For GBS to qualify as a Table injury, there must not be a more likely alternative diagnosis for the weakness.”

e. Changed section (b)(5)(i)(A) by adding “or” after “tube;”. The revised statement states, “(A) trauma or necrosis from an endotracheal tube; or.”

f. Changed section (b)(6)(i) by deleting “Definition -” before “VAP” at the beginning of the first sentence. In the fourth sentence, changed the phrase “radiographic infiltrate in the lungs that is consistent with pneumonia” to “radiographic infiltrate that is in the lungs and consistent with pneumonia.”

g. Changed section (b)(7) by adding “To qualify as Table injuries,” before “these” to the beginning of the last sentence. The revised sentence states, “To qualify as Table injuries, these manifestations must occur in patients who are being mechanically ventilated at the time of initial manifestation of the VILI.” VILI is Ventilator-Induced Lung Injury.

h. Changed section (b)(8) by adding “who are” after “patients” and before “under” to the first sentence. The revised sentence states, “Bleeding events are defined as excessive or abnormal bleeding in patients who are under the pharmacologic effects of anticoagulant therapy provided for extracorporeal membrane oxygenation (ECMO) treatment.”

The NPRM set forth a 60-day public comment period, which ended on May 30, 2014. During this comment period, HHS received five sets of comments—one set from a physicians' organization and four sets from individuals. Below is a summary of the comments and HHS's responses.

Comment: A commenter suggested expanding to 12 hours the time frame within which the first symptom or manifestation of anaphylaxis must appear, stating that some cases of anaphylaxis may exhibit a late phase response up to 8-12 hours after exposure, and thus the 0-4 hour time frame is not long enough.

Response: HHS respectfully disagrees with this comment. There is no consensus within the medical and scientific community about the time frame in which the late phase response starts. As stated in the NPRM, anaphylaxis after immunization is serious, but it occurs rarely. After initial treatment and clinical improvement, some patients with allergic reactions may develop a late phase or “biphasic” reaction, which may be more severe than the initial presentation. Little is known of the pathophysiology of biphasic reactions. The variations and the subjective nature of definitions used for determining the incidence of biphasic reactions in various studies are likely a major contributor to differing results, ranging from a 0.5 percent to 20 percent incidence rate. This makes comparisons of data across studies problematic. Previous guidelines have advocated the monitoring of patients post-anaphylaxis, with recommended durations varying between 4 and 24 hours. This is likely a testament to the uncertainty in the literature. Hence there is no compelling, reliable, valid, medical and scientific evidence upon which to base a Table time frame for biphasic anaphylactic reactions. HHS recognizes the occurrence of biphasic anaphylactic reactions in a minority of cases. Therefore, the Program will consider a claim for anaphylaxis occurring after the 4-hour time frame leading to a serious injury or death on a case-by-case basis as a non-Table claim.

Comment: A commenter asked if a child would be eligible to receive compensation if he/she is injured from the intranasal vaccine, which was administered because the child was advised by his/her doctor to have the intranasal vaccine, even if perhaps, the child would have been more suited for the vaccine injection.

Response: Under the CICP, any person who meets the appropriate declaration's definition of covered population, is administered or used a covered countermeasure in accordance with the terms of that declaration (or in good faith belief of such), and is seriously injured as a direct result of the countermeasure, may be eligible for CICP benefits.

Comment: A commenter was concerned that the guidelines for administration of Tamiflu (oseltamivir), Relenza (zanamivir), and peramivir for infants are not uniform. The commenter stated that the Food and Drug Administration has approved Tamiflu for children as young as 2 weeks of age but that the Centers for Disease Control and Prevention (CDC) recommends Tamiflu, through its safety profile, for treatment of both term and preterm infants from birth, as benefits for therapy are likely to outweigh possible risks of treatment. The commenter suggested that this rule establish the minimum age for administration of these countermeasures to children so that children are not denied compensation because of conflicting policy recommendations about the appropriate administration of these antiviral medications.

Response: The CICP is not authorized to establish age ranges for the administration of any drug, and therefore, cannot do so through this rule, as suggested by the commenter. The Program can only provide benefits to the population of individuals set forth in the applicable Secretarial declaration.

Comment: A commenter made the statement that his organization “firmly believes that the Table should better incorporate the needs of children.” The commenter wants HHS and HRSA to ensure that children are being considered in all aspects of the proposed countermeasures, as well as in this Table.

Response: As indicated above, Secretarial declarations describe the covered countermeasures and the covered population. Under the CICP, any person who meets the definition of the covered population in the relevant declaration, who receives or uses a covered countermeasure in accordance with the terms of that declaration (or in good faith belief of such), and is seriously injured as a direct result of the countermeasure may be eligible for CICP benefits.

Comment: One commenter was concerned that the description of Guillain-Barré Syndrome (GBS) is incomplete because it does not address the fact that GBS affects the peripheral nervous system.

Response: HHS respectfully disagrees with this comment. The description of GBS as stated in the NPRM and final rule is complete and explicitly addresses that GBS affects the peripheral nervous system. It is an acute monophasic peripheral neuropathy that currently is known to encompass a spectrum of four clinicopathological subtypes described in the Qualifications and Aids to Interpretation section of the Table. GBS may manifest with weakness, abnormal sensations, and/or abnormality in the autonomic (involuntary) nervous system.

Comment: A commenter was concerned that this allegedly incomplete description of GBS may make it difficult for requesters to prove injuries such as Miller-Fisher Syndrome or other variants of GBS that include attacks that lead to organ damage. Another commenter noted that the variants of GBS should be considered.

Response: HHS respectfully disagrees with the comments that the variants of GBS were not considered. The Table, including its Qualifications and Aids to Interpretation, explicitly addresses how variants of GBS, including Miller-Fisher Syndrome, can meet the Table requirements. GBS may present as one of a spectrum of four clinicopathological subtypes or variants. The most common type in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP), which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and roots.

Another subtype called acute motor axonal neuropathy (AMAN) is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. The axon is a portion of the nerve cell that transmits nerve impulses away from the nerve cell body. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the axons of sensory nerves and roots.

According to the Brighton Collaboration, Fisher Syndrome (FS), also known as Miller-Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and GBS may be seen with limb weakness.

GBS is proposed for inclusion on the Table because it is a serious physical injury, and the fact that it may be directly caused by the use of the monovalent 2009 H1N1 influenza vaccine (hereafter 2009 H1N1 vaccine) is supported by compelling, reliable, valid, medical and scientific evidence. Further, GBS is characterized by various degrees of weakness, sensory abnormality and autonomic dysfunction due to damage to peripheral nerves and nerve roots. These variants or subtypes of GBS were addressed fully in the NPRM and are adopted in the final rule.

Furthermore, as explained above, the description of GBS as stated in the NPRM, and adopted in this final rule, is complete. To the extent that one comment suggested that organ damage should be included as a Table injury, HHS respectfully disagrees. Although demyelination of peripheral nerves or axonal damage can lead to disruption of organ function, they do not lead directly to organ damage. At this time, there is no compelling, reliable, valid, medical and scientific evidence to support including organ damage on the Table.

Comment: A commenter was concerned that the 3- to 42-day window of GBS onset is unreasonable because some cases of GBS have been reported to have an onset outside of this interval. The commenter cited the article, “Chart-Confirmed Guillain-Barré Syndrome After 2009 H1N1 Influenza Vaccination Among the Medicare Population, 2009-2010, American Journal of Epidemiology, (2014), 179(5): 660.”

Response: HHS respectfully disagrees with this comment. The study that was cited by the commenter and published in the American Journal of Epidemiology looked at the risk of GBS development within 119 days of vaccination. The researchers found a slightly increased statistically significant risk of GBS only within the 6-week period after 2009 H1N1 vaccination when compared with the post-vaccination control period.

As stated in the NPRM, multiple studies performed to monitor the safety of 2009 H1N1 vaccine provide evidence that demonstrates a small statistically significant increased risk of GBS in the 6 weeks following administration of the 2009 H1N1 vaccine.5 Additionally, a meta-analysis was performed of the Emerging Infections Program, the Vaccine Safety Datalink, and the Post-Licensure Rapid Immunization Safety Monitoring System data, together with additional data from safety surveillance studies performed by the Centers for Medicare & Medicaid Services, the Department of Defense, and the Department of Veterans Affairs, which analyzed data from 23 million vaccinated people. The meta-analysis found that the 2009 H1N1 inactivated vaccine was associated with a small increased risk of GBS within 6 weeks of vaccination.

The symptoms of GBS do not develop immediately after exposure to the causative agent. The immune system requires a specified time to complete the steps leading to nerve injury and dysfunction and the early symptoms of GBS. A minimum of 3 days would be necessary from the time of exposure and immune system stimulation to the first symptoms of GBS. Therefore, onset of GBS within less than 72 hours or 3 days of immunization would be strong evidence that the vaccine is not the causative agent.6

HHS believes that the American Journal of Epidemiology study cited by the commenter is consistent with the other studies referenced above in indicating that the window of onset for GBS on the Table is appropriate based on current compelling, reliable, valid medical and scientific evidence.

Comment: A commenter compared the CICP Table injuries with the National Vaccine Injury Compensation Program (VICP) Table injuries because the 2009 H1N1 strain has been included in the seasonal influenza vaccine since 2010 and questioned why the Tables are different.

Response: The VICP and CICP are different programs authorized by two distinct federal statutes. The VICP covers certain vaccines that are recommended by the CDC for routine administration to children and are subject to an excise tax, whereas the CICP covers certain countermeasures, including pandemic influenza vaccines, as identified in Secretarial declarations. Accordingly, the VICP covers seasonal influenza vaccines, such as the quadravalent influenza vaccine, and the CICP covers pandemic vaccines, such as the 2009 monovalent H1N1 vaccine. Presently, the VICP's Table does not include any associated injuries for seasonal influenza vaccines.

Comment: A commenter stated “I strongly believe it is beneficial to have an injury compensation program implemented for those who have been extremely touched by West Nile and other harmful influenzas . . .” HHS' understanding is that the commenter wants a compensation program established that would cover the adverse effects of the underlying pandemic or epidemic condition itself.

Response: Injuries from the WNV or any influenza infection are not covered by the CICP. As stated in the NPRM, only serious injuries directly caused by the administration or use of the covered countermeasure—not injuries that result from the disease (or health condition or threat to health) itself—are covered injuries. For more information, see 42 CFR 110.20(d).

Comment: A commenter suggested that HHS inform all individuals who have previously applied but were deemed ineligible for compensation that they can reapply for compensation.

Response: HHS agrees with the commenter. Previous requesters, who were deemed ineligible for compensation, will be notified of the new Table by its publication in the Federal Register. The published final rule also will be posted on the CICP Web site at www.hrsa.gov/cicp. Such requesters may have an additional 1-year filing deadline from the effective date of the Table amendment or publication. This additional filing deadline will apply only if the new or amended Table enables a requester, who could not establish a Table injury before the new or amended Table, to establish a covered injury.7

HHS has examined the impact of this rulemaking as required by Executive Order 12866 on Regulatory Planning and Review, Executive Order 13563 on Improving Regulation and Regulatory Review, the Congressional Review Act (5 U.S.C. 804(2)), the Regulatory Flexibility Act (RFA), section 202 of the Unfunded Mandates Reform Act of 1995, section 654(c) of the Treasury and General Government Appropriations Act of 1999, and Executive Order 13132 on Federalism.

Executive Order 12866 requires that all regulations reflect consideration of alternatives, costs, benefits, incentives, equity, and available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis. In 2011, President Obama supplemented and reaffirmed Executive Order 12866. This rulemaking is not being treated as a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the final rule has not been reviewed by the Office of Management and Budget.

Executive Order 13563 provides that, to the extent feasible and permitted by law, the public must be given a meaningful opportunity to comment on any proposed regulations, with at least a 60-day comment period. In addition, to the extent feasible and permitted by law, agencies must provide timely on-line access to both proposed and final rules of the rulemaking docket on Regulations.gov, including relevant scientific and technical findings, in an open format that can be searched and downloaded. Federal agencies must consider approaches to maintain the freedom of choice and flexibility, including disclosure of relevant information to the public. Regulations must be guided by objective scientific evidence, easy to understand, consistent, and written in plain language. Furthermore, Federal agencies must attempt to coordinate, simplify, and harmonize regulations to reduce costs and promote certainty for the public.

In this final rule, the Secretary specifies a Table identifying serious physical injuries that shall be presumed to result from the administration or use of the covered countermeasures, and the time interval in which the onset of the first symptom or manifestation of each such serious physical injury must manifest in order for such presumption to apply. The Secretary is also specifying Table definitions and requirements. This final rule would have the effect of affording certain persons a presumption that particular serious physical injuries were sustained as the result of the administration or use of covered pandemic influenza countermeasures. The Table will establish a presumption of causation and relieve requesters of the burden of demonstrating causation for covered injuries listed on the Table. However, this presumption is rebuttable based on the Secretary's review of the evidence. In addition, this Table may afford some requesters a new filing deadline.

Other than showing that a serious physical injury or death directly resulted from an injury included on the Table, individuals may, in the alternative, be eligible for compensation if they otherwise meet the CICP's requirements and can show a causation-in-fact relationship between an injury or death and a covered countermeasure. This rule is based upon legal authority.

Because any resources required to implement the regulatory requirements imposed by the Program are not required by virtue of the establishment of a Table, and because the Secretary conducted an independent analysis concerning any burdens associated with the implementation of the Program when the Secretary published the companion regulation setting forth the Program's administrative implementation,8 the Secretary has determined that no resources are required to implement the provisions included in this final rule. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA) and the Small Business Regulatory Enforcement Fairness Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.

The Secretary has also determined that this rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. The Secretary has determined that this rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, local, and tribal governments or on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995. This final rule comports with the 2011 supplemental requirements.

The Secretary has determined that this final rule will not have effects on State, local, and tribal governments or on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

The Secretary has also reviewed this final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” This final rule will not “have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

This final rule will not adversely affect the following elements of family well-being: family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income, or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999. In fact, this rule may have a positive impact on the disposable income and poverty elements of family well-being to the extent that injured persons or their families may receive medical, lost employment income, and/or death benefits paid under this part without imposing a corresponding burden on them.

This final rule has no information collection requirements.

Therefore, for the reasons stated, the Department of Health and Human Services amends 42 CFR part 110 as follows:

On August 22, 2012, we published a proposed rule in the Federal Register (77 FR 50768) to list the Georgetown salamander (Eurycea naufragia), Salado salamander (Eurycea chisholmensis), Jollyville Plateau salamander (Eurycea tonkawae), and Austin blind salamander (Eurycea waterlooensis) as endangered species and to designate critical habitat for these species under the Endangered Species Act of 1973, as amended (Act) (16 U.S.C. 1533 et seq.). The Federal lists of endangered and threatened species and other protective regulations for listed species under the Act are in part 17 of title 50 of the Code of Federal Regulations (CFR). On February 24, 2014, we published a final determination to list the Georgetown salamander and the Salado salamander as threatened species under the Act (79 FR 10236) and a proposed rule under section 4(d) of the Act (a proposed 4(d) rule) for the Georgetown salamander (79 FR 10077) at 50 CFR 17.43. On April 9, 2015, we revised the proposed 4(d) rule for the Georgetown salamander and reopened the public comment period for 30 days, ending May 11, 2015 (80 FR 19050). Please see the final listing determination (79 FR 10236) for additional information concerning previous Federal actions for the Georgetown salamander.

The Georgetown salamander is entirely aquatic and depends on water from the Edwards Aquifer in sufficient quantity and quality to meet the species' life-history requirements for survival, growth, and reproduction. Degradation of habitat, in the form of reduced water quality and quantity and disturbance of spring sites, is the main threat to this species. For more information on the Georgetown salamander and its habitat, please refer to the February 24, 2014, final listing determination (79 FR 10236).

The Act does not specify particular prohibitions, or exceptions to those prohibitions, for threatened species. Instead, under section 4(d) of the Act, the Secretary of the Interior has the discretion to issue such regulations as she deems necessary and advisable to provide for the conservation of such species. The Secretary also has the discretion to prohibit by regulation, with respect to any threatened wildlife species, any act prohibited under section 9(a)(1) of the Act. Exercising this discretion, the Service developed general prohibitions (50 CFR 17.31) and exceptions to those prohibitions (50 CFR 17.32) under the Act that apply to most threatened wildlife species. Alternately, for other threatened species, under the authority of section 4(d) of the Act, the Service may develop specific prohibitions and exceptions that are tailored to the specific conservation needs of the species. In such cases, some of the prohibitions and authorizations under 50 CFR 17.31 and 17.32 may be appropriate for the species and incorporated into a rule under section 4(d) of the Act. However, these rules, known as 4(d) rules, will also include provisions that are tailored to the specific conservation needs of the threatened species and may be more or less restrictive than the general provisions at 50 CFR 17.31.

Based on information we received in both public comment periods on the proposed 4(d) rule (see Summary of Comments and Recommendations), we revised the provisions of the 4(d) rule to provide greater clarity around the activities that are covered and not covered by this rule.

Under section 4(d) of the Act, the Secretary may publish a rule that modifies the standard protections for threatened species and that contains prohibitions tailored to the conservation of the species and that are determined to be necessary and advisable. Under this 4(d) rule, the Service provides that all of the prohibitions under 50 CFR 17.31 and 17.32 are necessary and advisable and, therefore, apply to the Georgetown salamander, except as noted below. This 4(d) rule will not remove or alter in any way the consultation requirements under section 7 of the Act.

For activities outside of habitat occupied by the Georgetown salamander, the final 4(d) rule provides that take of Georgetown salamanders that is incidental to regulated activities (as defined in title 30, Texas Administrative Code, section 213.3(28)) that are conducted consistent with the water quality regulations contained in chapter 11.07 of the City of Georgetown Unified Development Code (UDC 11.07) (https://udc.georgetown.org/) will not be prohibited under the Act. The water quality regulations in UDC 11.07 were finalized on February 24, 2015. Chapter 11.07 of the UDC describes stream and spring buffers, water quality best management practices, and geologic assessments that are required for property development within the Northern Edwards Aquifer Recharge Zone and the City of Georgetown.

“Regulated activities” are defined in title 30, Texas Administrative Code, section 213.3(28) as any construction-related or post-construction activities on the Recharge Zone of the Edwards Aquifer having the potential for polluting the Edwards Aquifer and hydrologically connected surface streams. “Regulated activities” do not include the clearing of vegetation without soil disturbance, agricultural activities, oil and gas activities, routine maintenance of existing structures that does not involve additional site disturbance, and construction of single-family residences on lots larger than 2 hectares (ha) (5 acres (ac)). More specific details on spring and stream buffers can be found in sections 11.07.003A. and B. of the UDC.

When a property owner submits a development application for a regulated activity on a tract of land located over the Edwards Aquifer Recharge Zone, that individual is required to submit a geologic assessment to the City of Georgetown. The geologic assessment identifies and describes all springs and streams on any subject property, and the UDC establishes buffer zones around identified springs and streams. For springs, the buffer encompasses 50 meters (m) (164 feet (ft)) extending from the approximate center of the spring outlet that is identified in a geologic assessment. For streams, the boundaries of the buffer must coincide with either the boundaries of the Federal Emergency Management Agency (FEMA) one percent floodplain or a calculated one percent floodplain, whichever is smaller. In the absence of a FEMA floodplain or calculated one percent floodplain, these stream buffers may be no smaller than 61 m (200 ft) wide with at least 23 m (75 ft) from the centerline of the stream. Section 11.07.003 of the UDC states that no “regulated activities” may be conducted within the spring and stream buffers.

In addition to the establishment of these spring and stream buffers, the UDC outlines water quality best management practices designed to minimize sediment runoff, increase the removal of total suspended solids, prevent an increase in flow rates, and ensure spill containment for new or expanded roadways. These regulations in chapter 11.07 of the UDC are designed to reduce water quality degradation that may occur as a result of development. By reducing further water quality degradation that may result from development, these protective measures are also expected to reduce degradation to Georgetown salamander habitat that may occur.

The UDC 11.07 also outlines exemptions from the requirement to prepare a geologic assessment, the process by which a landowner may request a variance to the spring and stream buffer requirements, and exemptions to the spring and stream buffer requirements of section 11.07.003. Small (less than 2-ha (5-ac)) single-family and two-family residential developments are exempt from submitting a geologic assessment; however, these developments are required to implement UDC water quality measures. Landowners may request to the City of Georgetown a variance from the spring and stream buffer requirements in UDC 11.07 if: The variance is not contrary to the public interest; due to special conditions, a literal enforcement of the ordinance would result in unnecessary hardship; and the spirit of the ordinance is observed and substantial justice is done, in accordance with UDC section 2.05.010.A.6. These variances and exemptions apply only to sites not occupied by Georgetown salamanders.

Properties with a site occupied by the Georgetown salamander are exempt from the spring and stream buffer requirements in chapter 11.07. Rather, UDC Appendix A outlines conservation measures (which are voluntary under the UDC) to be implemented when undertaking regulated activities that occur on a tract of land with an occupied site or within 984 ft (300 m) of an occupied site. An “occupied site” is defined in the UDC as any spring identified as a critical habitat unit by the Service for the Georgetown salamander and includes the following sites: Cobb Well, Cobb Springs, Cowen Creek Spring, Bat Well Cave, Walnut Spring, Twin Spring, Hogg Hollow Spring, Cedar Hollow Spring, Knight (Crockett Garden) Spring, Cedar Breaks Hiking Trail Spring, Water Tank Cave, Avant's (Capitol Aggregates), Buford Hollow Springs, Swinbank Spring, Shadow Canyon, San Gabriel Spring, and Garey Ranch Springs. For the purposes of this 4(d) rule, however, we define an occupied site to be any site where Georgetown salamanders have been found in the past or new sites found in the future.

For activities involving habitat occupied by the Georgetown salamander, the final 4(d) rule provides that take of the Georgetown salamander that is incidental to regulated activities that are conducted consistent with the guidelines described in Appendix A of the UDC will not be prohibited under the Act. Similar to chapter 11.07 of the UDC, the guidelines in Appendix A establish stream and spring buffers and allowable activities within those buffers; however, the measures described in Appendix A create larger, more protective buffers than those that appear in chapter 11 for unoccupied sites. First, Appendix A establishes a “No-Disturbance Zone” in the stream or waterway into which a spring drains directly; this zone extends 80 m (264 ft) upstream and downstream from the approximate center of the spring outlet of an occupied site and is bounded by the top of the bank. No regulated activities may occur within the “No-Disturbance Zone.” In addition, Appendix A establishes a “Minimal-Disturbance Zone” for the subsurface area that drains to the spring(s) at an occupied site; this zone consists of the area within 300 m (984 ft) of the approximate center of the spring outlet of an occupied site, except those areas within the “No-Disturbance Zone.” Most regulated activities are also prohibited in the “Minimal-Disturbance Zone,” but single-family developments, limited parks and open space development, and wastewater infrastructure will be allowed. For additional details on the buffers around occupied sites and prohibited actions, please refer to the UDC Appendix A.

In general, this 4(d) rule does not apply to deviations from the water quality measures in UDC 11.07 and Appendix A. Any variance from the measures and guidelines described in UDC 11.07 (non-occupied sites) is not covered by this final 4(d) rule, unless that variance has been granted by the City of Georgetown. In addition, variances from the spring and stream buffer requirements of UDC 11.07 may be granted by the City of Georgetown only if the variance is not contrary to the public interest, if due to special conditions a literal enforcement of the ordinance would result in unnecessary hardship, and if the spirit of the ordinance is observed and substantial justice is done, in accordance with UDC section 2.05.010.A.6. Projects involving habitat occupied by the Georgetown salamander (which are not eligible for variances) where the project proponent chooses not to follow the voluntary guidelines in Appendix A of the UDC, may work with the Service to pursue take coverage by developing a habitat conservation plan (HCP) in accordance with section 10 of the Act.

Section 11.07.008 of the UDC also establishes an Adaptive Management Working Group (Working Group) that is responsible for reviewing data on a regular basis and making recommendations for specific changes in the management directions related to the voluntary conservation measures for occupied sites in Appendix A. Adaptive management for preservation of the Georgetown salamander is one of the duties tasked to the Working Group. The adaptive management described in the UDC specifically applies to the guidelines (i.e., conservation measures) found in Appendix A; therefore, the guidelines described in Appendix A may change over time if they would result in equal or better conservation benefits to the Georgetown salamander, as determined by the Service. For example, if experience gained during implementation of the guidelines or new scientific information suggests that a buffer distance was either too small, or larger than needed, to achieve the intended benefits, that buffer distance could be modified. However, the activities covered under Appendix A (i.e., regulated activities) are not subject to change under the adaptive management provisions described in the UDC. In other words, exercising of adaptive management under this 4(d) rule cannot expand the scope of the covered activities beyond regulated activities (as defined in title 30, Texas Administrative Code, section 213.3(28)). The Working Group will develop an annual report regarding the preservation of the Georgetown salamander, continuous monitoring of the Georgetown salamander, assessment of research priorities, and the effectiveness of the water quality regulations and guidelines. Copies of the February 24, 2015, dated UDC 11.07 and Appendix A are available at http://www.regulations.gov at Docket No. FWS-R2-ES-2014-0008. Any revisions to Appendix A will be made available at https://udc.georgetown.org/udc-amendments/.

Section 4(d) of the Act states that “the Secretary shall issue such regulations as [s]he deems necessary and advisable to provide for the conservation” of species listed as threatened species. Conservation is defined in the Act to mean “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to [the Act] are no longer necessary.”

The courts have recognized the extent of the Secretary's discretion under this standard to develop rules that are appropriate for the conservation of a species. For example, the Secretary may find that it is necessary and advisable not to include a taking prohibition, or to include a limited taking prohibition. See Alsea Valley Alliance v. Lautenbacher, 2007 U.S. Dist. Lexis 60203 (D. Or. 2007); Washington Environmental Council v. National Marine Fisheries Service, and 2002 U.S. Dist. Lexis 5432 (W.D. Wash. 2002). In addition, as affirmed in State of Louisiana v. Verity, 853 F.2d 322 (5th Cir. 1988), the rule need not address all the threats to the species. As noted by Congress when the Act was initially enacted, “once an animal is on the threatened list, the Secretary has an almost infinite number of options available to him [her] with regard to the permitted activities for those species. [S]he may, for example, permit taking, but not importation of such species,” or she may choose to forbid both taking and importation but allow the transportation of such species, as long as the prohibitions, and exceptions to those prohibitions, will “serve to conserve, protect, or restore the species concerned in accordance with the purposes of the Act” (H.R. Rep. No. 412, 93rd Cong., 1st Sess. 1973).

Section 9 prohibitions make it illegal for any person subject to the jurisdiction of the United States to take (including harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or attempt any of these), import or export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any wildlife species listed as an endangered species, without written authorization. It also is illegal under section 9(a)(1) of the Act to possess, sell, deliver, carry, transport, or ship any such wildlife that is taken illegally. Prohibited actions consistent with section 9 of the Act are outlined for threatened wildlife in 50 CFR 17.31(a) and (b). For the Georgetown salamander, the Service has determined that a 4(d) rule tailored to its specific conservation needs is necessary and advisable, as discussed below. This final 4(d) rule provides that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except as described below.

Under this final 4(d) rule, incidental take of the Georgetown salamander will not be considered a violation of section 9 of the Act if the take occurs on any non-Federal land and from regulated activities that are conducted consistent with the water quality protection measures contained in chapter 11.07 and Appendix A of the City of Georgetown Unified Development Code. This final 4(d) rule refers to the definition of “regulated activities” in title 30, Texas Administrative Code, section 213.3(28), which is any construction-related or post-construction activities on the recharge zone of the Edwards Aquifer having the potential for polluting the Edwards Aquifer and hydrologically connected surface streams. We have determined that this provision is necessary and advisable for the conservation of the Georgetown salamander, as explained in the paragraphs that follow.

The local community in the City of Georgetown and Williamson County has expressed a desire to design and implement a local solution to conserving the natural resources in their county, including water quality and the Georgetown salamander (City of Georgetown Resolution No. 082812-N). All currently known locations for the Georgetown salamander are within the jurisdiction of the City of Georgetown, making the city an appropriate entity to manage conservation measures that protect Georgetown salamander habitat. Because impervious cover levels within most of the watersheds known to be occupied by the Georgetown salamander are still relatively low, a window of opportunity exists to design and implement measures to protect water quality and, therefore, conserve the salamander. The City and County's approach for accomplishing this conservation goal includes regulatory and non-regulatory actions, as described below. Regulatory actions include passage of the Edwards Aquifer Recharge Zone Water Quality Ordinance (Ordinance No. 2013-59) by the Georgetown City Council on December 20, 2013, and the revisions to their UDC (chapter 11.07) finalized on February 24, 2015. Their approach also includes non-regulatory actions, such as the technical guidance provided in Appendix A of the UDC, which outlines additional conservation measures to protect water quality and to avoid direct destruction of occupied sites.

Habitat modification, in the form of degraded water quality and quantity and disturbance of spring sites, is the primary threat to the Georgetown salamander. The conservation measures in both chapter 11.07 and Appendix A of the UDC provide a variety of water quality protection measures, such as the creation of buffers around springs and streams where regulated activities are prohibited, designed to lessen impacts to the water quality of springs and streams in the Edwards Aquifer Recharge Zone. The UDC is applied throughout the watersheds that contain the Georgetown salamander. Absent this 4(d) rule, the status quo would be to address development impacts through traditional tools (that is, sections 7 and 10 of the Act) that are generally applied at the project-by-project scale. The watershed-level approach in UDC 11.07 and Appendix A works to avoid incremental environmental degradation that may go unnoticed on a small, individual project scale. Through this final 4(d) rule, we can achieve a greater level of conservation for the Georgetown salamander than we could without it because it encourages rangewide implementation of water quality protective measures that are aimed at addressing the primary threat of habitat modification and degradation for Georgetown salamanders. The majority of Georgetown salamanders occur within 164 ft (50 m) of a spring outlet (Pierce et al. 2010, p. 294; TPWD 2011, p. 3); this coincides with the spring and stream buffers for unoccupied sites. We also believe the salamander populations exist through underground conduits that may extend 300 m (984 ft) around cave or spring points; this area coincides with the size of the “Minimal-Disturbance Zones” for occupied sites. By limiting development activities within these respective areas, the measures in the UDC 11.07 and Appendix A are expected to limit water quality degradation in areas that may provide suitable surface or subsurface habitat for the Georgetown salamander now and in the future.

Although the areas that provide recharge and the source water for specific areas occupied by the salamander have not been precisely delineated, the watershed-level approach makes it likely that unknown recharge areas are receiving water quality protection under the UDC. This is because the UDC prohibits regulated activities within buffers around all streams located within the recharge zone and the City of Georgetown jurisdiction. In karst aquifer systems, streams often contain important recharge features called swallow holes or swallets, which allow the stream to continue flowing underground in a conduit and feed the larger aquifer or even small springs directly (White 1998, p. 172). For example, in the Barton Springs Segment of the Edwards Aquifer, hydrologists generally agree that most of the aquifer's recharge comes via these streambed recharge features (Mahler et al. 2011, p. 4). Although similar research is lacking in the Northern Segment of the Edwards Aquifer, it is likely that the aquifer feeding Georgetown salamander habitat works in a similar way because both areas are karst aquifer systems, thereby making the stream buffers of the UDC crucial in protecting groundwater quality.

This watershed-level approach also includes an adaptive management component that will allow the Adaptive Management Working Group (Working Group) to evaluate the response of salamander populations to management actions and quickly respond and recommend adjustments, if necessary, to management strategies to protect water quality consistent with conserving the Georgetown salamander. The UDC formalizes the Working Group with representatives from the City of Georgetown, Williamson County, Texas Commission on Environmental Quality, Texas Parks and Wildlife Department, university scientists, private real estate developers, and the Service. The role of the Working Group is to:

• Review scientific information to understand the latest science on watershed management practices and the conservation of the Georgetown salamander;

• Recommend support for additional Georgetown salamander scientific studies and oversee a long-term monitoring program to ensure that salamander abundance at monitored locations is stable or improving;

• Conduct and evaluate water quality trend analysis as part of its long-term monitoring program to ensure water quality conditions do not decline and, in turn, result in impacts to salamander abundance; and

• Develop recommendations for changes to the UDC Appendix A for occupied sites if scientific and monitoring information indicates that water quality and salamander protection measures need changes to minimize impacts to salamander populations and to help attain the goal of species conservation.

While a window of opportunity exists to design and implement conservation measures to conserve the Georgetown salamander, human population levels and development are expected to increase rapidly in Williamson County (Texas State Data Center 2012, pp. 166-167). The success of the local community's efforts depends on their robust adaptive management program. The program is designed to monitor and quickly assess the effectiveness of the identified conservation measures and strategies and to be able to respond quickly and adapt the conservation measures and strategies to provide equal or better conservation benefits to the Georgetown salamander. The adaptive management approach will ensure that the water quality protective measures are serving their intended purpose of conserving the Georgetown salamander, thereby providing for the conservation of the species. Changes to UDC Appendix A that are agreed upon by the Working Group through the adaptive management process, provide equal or greater conservation benefits to the Georgetown salamander, and approved by the Service would be covered under this 4(d) rule.

By not prohibiting incidental take resulting from regulated activities conducted in accordance with the UDC 11.07 and Appendix A, the Service is supporting and encouraging a local solution to conservation of the Georgetown salamander. This final 4(d) rule will provide the Service the opportunity to work cooperatively, in partnership with the local community and State agencies, on conservation of the Georgetown salamander and the ecosystems on which it depends. Leveraging our conservation capacity with that of the State, local governments, and the conservation community at large may make it possible to attain biological outcomes larger than those we could attain ourselves due to the watershed-scale protection the UDC requires. Further, our local partners are best able to design solutions that minimize socioeconomic impacts, thereby encouraging participation in measures that will protect water quality and conserve the Georgetown salamander. In addition, by not prohibiting incidental take resulting from regulated activities conducted in accordance with UDC 11.07 and Appendix A, the Service is providing a streamlining mechanism for compliance with the Act for those project proponents who comply with the protective measures in UDC 11.07 and Appendix A and, thus, are considered covered by this final 4(d) rule. Project proponents who comply with these protective measures, as outlined in this final rule, can implement their projects without any potential delay from seeking incidental take coverage from the Service, while also minimizing water quality degradation. This approach provides greater regulatory certainty and streamlines compliance for project proponents and thus is likely to result in increased implementation of water quality protective measures that benefit salamanders.

In summary, this 4(d) rule is necessary and advisable to provide for the conservation of the Georgetown salamander because it strengthens water quality protection measures throughout the species' range, allows for consideration of new information to optimize conservation measures, and furthers conservation partnerships that can be leveraged to improve the status of the Georgetown salamander. Implementation of water quality protection measures throughout the range of the species will provide greater protection for the species than would project-by-project efforts, and provide protections to recharge areas that we may not be able to protect under our traditional tools (e.g., sections 7 and 10 of the Act). Further, water quality protection is a crucial element of conservation for the Georgetown salamander. Because the best available information does not allow us to determine the exact amount of water quality protection needed to satisfy the life requirements of the Georgetown salamander, the adaptive management approach incorporated into UDC Appendix A provides a pathway to achieving our conservation goals for the species in the face of scientific uncertainty. Finally, this approach also encourages further cooperation between the Service and local government entities, enhancing our ability to work collaboratively with partners to further Georgetown salamander conservation.

If an activity that may affect the species is not regulated by UDC 11.07 or is not in accordance with UDC 11.07 and Appendix A, or a person or entity is not in compliance with all terms and conditions of UDC 11.07 and Appendix A and the activity would result in an act that would be otherwise prohibited under 50 CFR 17.31, then the general provisions of 50 CFR 17.31 and 17.32 for threatened species apply. In such circumstances, the prohibitions of 50 CFR 17.31 would be in effect, and authorization under 50 CFR 17.32 would be required. In addition, nothing in this 4(d) rule affects in any way other provisions of the Act, such as the designation of critical habitat under section 4, recovery planning provisions of section 4(f), and consultation requirements under section 7.

We requested written comments from the public on the proposed 4(d) rule for the Georgetown salamander during two comment periods: February 24 to April 25, 2014, and April 9 to May 11, 2015. We also contacted appropriate Federal, State, and local agencies; scientific organizations; and other interested parties and invited them to comment on the proposed 4(d) rule, draft environmental assessment, and chapter 11.07 and Appendix A of the UDC during the respective comment periods.

Over the course of the two comment periods, we received 39 comment submissions. All substantive information provided during these comment periods has either been incorporated directly into this final rule or is addressed below. Comments from peer reviewers and State agencies are grouped separately.

In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion from five knowledgeable individuals with scientific expertise that are familiar with the species, the geographic region in which the species occurs, and conservation biology principles. We received responses from two of the five peer reviewers. We reviewed all comments received from the peer reviewers for substantive issues and new information. These comments are addressed in the following summary and incorporated into the final rule as appropriate.

(1) Comment: An additional buffer specifically associated with where Georgetown salamanders are found, to minimize direct impacts by people (and domestic pets), is critical. Fencing is often an effective way to mark the boundaries (and potentially reduce their footprint) of such a protective buffer.

Our response: We agree that additional measures to protect Georgetown salamanders from the threat of trampling by people, pets, feral hogs, and livestock may contribute to the conservation of the species. However, as noted above, this 4(d) rule does not provide incidental take authority for all types of activities that may constitute take or harm of Georgetown salamanders. Rather, the 4(d) rule will promote the conservation of the species by helping to alleviate negative impacts that can occur from the threat of water quality degradation as a result of urbanization.

(2) Comment: I am uncertain as to whether the fixed-width buffers are appropriate in all localities to achieve the desired level of protection. Protection of surface and groundwater resources in karstified area can be quite challenging, and, therefore, simplified metrics such as horizontal setbacks may not achieve the desired results. Adequate buffers would require an understanding of both the detailed hydrogeology and the dispersal patterns of the listed species. For the former, I would expect that areas upgradient of springs (a more immediate source of recharge) would be more important than downgradient areas, all else being equal, to the maintenance of adequate springflow. For the latter, I would expect that downgradient areas (where the emergent surface water flows) would be more important than upgradient areas for the direct support of habitat. How these two attributes interact to define a truly “critical” area of influence is undoubtedly complex, and a fixed-width buffer may be the best alternative at the present time. However, I would hope that improved understanding of these interactions would be a focus of the adaptive management effort.

Our response: We agree and expect that improving the understanding of the detailed hydrogeology and dispersal patterns of the species will be a focus of the Working Group. Please see our response to Comment #8.

(3) Comment: The stormwater-management requirements for protection of the Edwards Aquifer (UDC) are laudable, but they lag behind the current understanding, and readily available applications, of what constitutes stormwater “best management practices” of the 21st century. Particularly given the importance of maintaining aquifer recharge, I would expect to see on-site retention of the 95th percentile storm (as is already mandated for federal facilities) rather than just 85 percent reduction in total suspended solids.

Our response: Because the on-site retention of the 95th percentile storm is a different type of stormwater measurement than 85 percent reduction in total suspended solids, it is difficult to compare the two in terms of water quality protection. However, we recognize that there may be more stringent water quality regulations that aim to remove more contaminants from stormwater runoff than the UDC. The adaptive management process will monitor the status of the species in response to implementation of the UDC and modify the regulations if more protective measures are needed to further reduce impacts to the species. At this time, we have determined that the UDC and Appendix A, which include the 85 percent reduction, are necessary and advisable for the conservation of the species (see Determination section above).

(4) Comment: I recommend that there should be no exemptions to the water quality regulations. Every proposed change in land use should have some form of review to ensure compatibility with management goals.

Our response: In general, deviations from the water quality regulations described in UDC 11.07 and the voluntary guidelines described in Appendix A of the UDC will not be covered under this 4(d) rule. Non-regulated activities, for example, are exempt from UDC 11.07 and are, therefore, not covered under this 4(d) rule. However, variances from UDC 11.07 may be granted by the City of Georgetown in special circumstances. These variances from the spring and stream buffer requirements apply only to non-occupied sites and undergo review by the City of Georgetown staff and may be granted only if the variance is not contrary to the public interest, due to special conditions a literal enforcement of this regulation would result in unnecessary hardship, and the spirit of the regulation is observed and substantial justice is done, in accordance with UDC Section 2.05.010.A.6. No variances to Appendix A, which covers all occupied sites, of the UDC will be covered under this 4(d) rule. Individual variances to UDC 11.07 that have been approved by the City of Georgetown can be tracked by the Working Group and incorporated into their discussions and recommendations on the adaptive management needed to attain conservation goals.

(5) Comment: Geologic and soil studies should be performed by the community to delineate locations where shallow soil cover prevents conventional onsite wastewater disposal. Green infrastructure and low-impact development should be required everywhere in Georgetown, Texas. This includes new development, redevelopment, and restoration projects.

Our response: We agree that groundwater vulnerability studies and low-impact development will be beneficial for the Georgetown salamander and its habitat. These are helpful suggestions for the Working Group to consider as they evaluate the effectiveness of the UDC conservation measures.

(6) Comment: The community should track water quality and flow at selected springs and streams in order to develop long-term databases able to detect changes.

Our response: We agree that water quality and quantity monitoring conducted in a manner that is able to detect changes needs to be a priority for the Working Group. Williamson County is currently monitoring salamander abundance and basic water chemistry (for example, temperature, dissolved oxygen, and specific conductance) at three sites with plans to add more monitoring sites in the future.

(7) Comment: We urge the Service to finalize and implement this proposed rule as efficiently as possible while following a transparent process in order to provide regulatory certainty.

Our response: By requesting input from the public on this 4(d) rule during two public comment periods, one 60-day and a second 30-day, we believe the rulemaking process has been transparent.

(8) Comment: Spring buffers and other water quality protection policies should be aligned with the hydrogeology that most directly influences conditions for the species' survival. It also appears that the current buffer strategy may unduly restrict landowners in some areas that do not influence survival conditions for the species while potentially not affording protection to other areas that do influence survival conditions. We believe the proposed rule affords the [Adaptive Management] Working Group the latitude to study these spring buffers and offer alternative recommendations if new science dictates that changes should be made.

Our response: The specific hydrogeology (for example, recharge area) for each site occupied by the Georgetown salamander has not been determined. The Act requires that we use the best available information and does not require that we conduct research to develop new science. In the absence of this information, we believe a fixed-width buffer is the best alternative for protecting these sites. As new information is discovered, the conservation measures can be modified through the adaptive management process.

(9) Comment: Conservation measures detailed in the UDC are limited to “Occupied Sites” with currently known populations. Conservation measures would not apply to newly discovered occupied sites. Since newly discovered sites could be important to the recovery of the species, we request that the Service clarify the applicability of the 4(d) rule to these sites and the role the Working Group should play in this regard.

Our response: In this final rule, we have clarified that any site determined to be occupied by Georgetown salamanders in the future will be considered “occupied” and the protective measures outlined in Appendix A of the UDC must be followed in order to be covered under this 4(d) rule. We recommend that the Working Group make efforts to survey suitable habitat within the range of the Georgetown salamander to identify all sites occupied by the species.

(10) Comment: It is unclear whether a landowner owning a newly discovered site occupied by Georgetown salamanders outside the City of Georgetown's extra-territorial jurisdiction would be covered for incidental take if [s]he were to conduct activities consistent with the conservation measures contained in the UDC. Regulatory predictability and incidental take coverage for all affected landowners are important for the ultimate recovery of the species.

Our response: Regulated activities located outside of the City of Georgetown's jurisdiction are not covered by the UDC. Therefore, only incidental take from those activities that are in the City of Georgetown's jurisdiction are potentially exempt from take prohibitions through this 4(d) rule. All currently known Georgetown salamander sites are covered by the UDC.

(11) Comment: The proposed revised 4(d) rule states that the boundaries of the stream buffer coincides with the boundaries of the FEMA or calculated floodplain, but may be no smaller than [61 m (200 ft)] in width. It should be noted that, while the stream buffer varies depending on the size of the stream (size of the stream is based on the size of the drainage area, which influences the size of the floodplain), there may be situations under the UDC where the stream buffer is smaller than [61 m (200 ft)] in width.

Our response: Per the UDC 11.07, only stream buffers without FEMA or calculated floodplains may be no smaller than 61 m (200 ft) in width. We have made the appropriate clarification in this final rule.

(12) Comment: The proposed exemption from prohibitions, as it will be outlined in § 17.43(e)(2) of [title 50 of] the CFR, states that “incidental take of the Georgetown salamander will not be considered a violation of section 9 of the Act if the take occurs on privately owned, State, or county land. . . .” This exemption must include, at a minimum, city-owned property.

Our response: We have edited the exemption to include all non-Federal land.

(13) Comment: The proposed rule, if finalized, could not be amended substantially unless and until the Service allowed for public comment and input. Public input would not be allowed to a greater degree in connection with an incidental take permit than it has been in connection with the proposed rule.

Our response: This is correct. Future changes to the content of this 4(d) rule require a public notice and comment period. However, future changes related to the conservation of the Georgetown salamander may be made to the conservation measures in UDC Appendix A, without public notice and comment, if they are agreed upon by the Working Group through the adaptive management process outlined in the UDC, provide equal or greater conservation benefits to the Georgetown salamander, and are approved by the Service.

(14) Comment: The proposed rule does not exempt any set of activities in the “red zone.” The proposed rule does not pick apart who is regulated or not. Rather, it focuses on actual implementation of water quality measures consistent with those set forth in the UDC and listed in the proposed rule. A non-regulated entity can presumably meet the standard set forth in the proposed rule, not because such an activity is exempt from regulations, but because it would have affirmatively implemented the water quality measure set forth in the proposed rule and UDC. While it is true that the UDC applies only to regulated activities, the exemption from take in the proposed rule applies to all activities (and only those activities), regulated or not, that are consistent with the conservation measures in the UDC; that is, activities for which the project proponent has performed a geologic assessment, abided by the limitations described in the UDC for no-disturbance and minimal-disturbance zones, established buffers around springs and streams, etc.

Our response: The UDC 11.07 and Appendix A were specifically designed for regulated activities. Other kinds of non-regulated activities could have different impacts not addressed with this set of measures. Non-regulated activities that voluntarily follow the UDC 11.07 or Appendix A are not covered by this final 4(d) rule, and project proponents may choose to work with the Service to obtain take coverage.

(15) Comment: The Service should permit take under section 10 rather than adopt a special 4(d) rule because the resulting HCP cannot be weakened through amendment (unlike the City of Georgetown UDC), the section 10 process provides greater protections for the salamanders compared to the City of Georgetown UDC, and the process provides an open process in which the public can be involved.

Our response: Section 10 permits are voluntary, are tailored towards individual applicants, would only cover known occupied sites, and have different criteria for permit issuance than the Act requires for issuance of a 4(d) rule. It is not certain that the Service would receive applications for section 10 permits that would provide greater protections for the Georgetown salamander over the entire range of the species. The 4(d) rule provides a landscape-level approach that is consistently implemented throughout the range of the Georgetown salamander, including unoccupied sites.

While it is true that the conservation measures in UDC Appendix A may be revised, those changes would not be covered under this 4(d) rule unless they are agreed upon by the Working Group through the adaptive management process outlined in the UDC, provide equal or greater conservation benefits to the Georgetown salamander, and are approved by the Service. In addition, we have a “No Surprises” policy for section 10 incidental take permits, which states, if unforeseen circumstances occur during the life of an HCP, the Service will not require additional lands, additional funds, or additional restrictions on lands or other natural resources released for development or use, from any permittee, who in good faith is adequately implementing or has implemented an approved HCP. This policy makes HCPs less flexible in terms of requiring more stringent conservation measures over time in response to new information. Given the amount of uncertainty in how best to protect Georgetown salamander habitat quality at individual sites, the flexibility provided in the adaptive management approach of the UDC is desirable.

We believe the development of this 4(d) rule has been an open process comparable to that of a section 10 permit process. In addition, the process of amending the UDC is very transparent, involving monthly meetings of the Unified Development Code Advisory Committee that are open to the public with minutes and agendas posted online (https://government.georgetown.org/unified-development-code-advisory-board-2/).

(16) Comment: The 4(d) rule allows degradation of water quality and, therefore, is not necessary and advisable for the conservation of the Georgetown salamander.

Our response: The protective measures provided for in the 4(d) rule are intended to address the threat of water quality degradation from urbanization throughout the range of the species. We have found that the 4(d) rule positively contributes to the recovery of the Georgetown salamander by addressing the primary threat to the species and that these measures are “necessary and advisable for the conservation” of the Georgetown salamander (see Determination section above).

(17) Comment: Numerous activities that may degrade water quality are entirely exempted and, therefore, allowed within the zones and buffers described in the City of Georgetown UDC. The Service should exempt only “regulated activities” because those are the only activities that are actually regulated by the UDC. In this way, threats such as oil and gas activities, agricultural operations, and residential developments on lots greater than 2 ha (5 ac), which are currently unregulated and, therefore, do not contribute to the conservation of the salamander, would not receive the benefit of protection from incidental take.

Our response: We agree and have clarified this issue in the final 4(d) rule. Also, please see our response to Comment #14.

(18) Comment: Because the proposed special rule references the Ordinance instead of prescribing all the necessary conservation measures, the City could receive the benefits of protection from section 9 even if the City weakens the Ordinance through amendment. To solve this problem, the Service must use the section 10 process, describe all the necessary conservation measures in the Ordinance, or modify the 4(d) rule to state on its face what is and what is not authorized. At a bare minimum, the agency must specifically reference the version of the Ordinance adopted on December 20, 2013.

Our response: The final rule clarifies that modifications to UDC Appendix A are covered under the 4(d) rule only if they are agreed upon by the Working Group through the adaptive management process, provide equal or greater conservation benefits to the Georgetown salamander, and are approved by the Service. In order to allow this important adaptive management process to be implemented, we have revised the final 4(d) rule to note that the provisions apply only to Service-endorsed versions of UDC 11.07 and Appendix A.

(19) Comment: It concerns us that the proposed 4(d) special rule is proceeding without scientific peer review.

Our response: Although our February 24, 2014, proposed 4(d) rule announced that we were not conducting a peer review, we did conduct a peer review of the proposed 4(d) rule during the second comment period (April 9, 2015, to May 11, 2015). We requested peer review from five water quality protection experts and received reviews from two of the five. The peer reviews, along with the other comments and materials we received, are available on the Internet at http://www.regulations.gov under Docket No. FWS-R2-ES-2014-0008.

(20) Comment: The UDC will not protect the quantity of spring flows or threats to water quality from points more distant than 50-300 m (164-984 ft) from spring sites. The UDC on which the proposed 4(d) rule is based does not adequately protect groundwater quality, including recharge features, caves, conduits, or local aquifers. The only substantive contribution made by the UDC is to decrease the probability of wholesale destruction by physical disturbance of occupied springs, but that is just one of many threats to the species.

Our response: We believe the regulations in the UDC provide some protections to recharge features and water quality in the aquifer as a whole, primarily through the required stream buffers. Although the UDC addresses water quality, regulating every threat to the species is outside the scope of the UDC. In addition, as affirmed in State of Louisiana v. Verity, 853 F.2d 322 (5th Cir. 1988), the rule need not address all the threats to the species. Activities that are not covered by this 4(d) rule and that may result in take to the species would need to be covered through sections 7 or 10 of the Act.

(21) Comment: The UDC does not specify whether any new population discoveries in the future will be treated as “Edwards Springs” with a 50-m (164-ft) buffer or as occupied sites with a 300-m (984-ft) buffer. Furthermore, the UDC does not require population surveys for salamander presence in currently occupied sites or at sites that are currently thought to be unoccupied. Therefore, it provides zero protection for spring sites that are determined in the future to be occupied by salamanders.

Our response: We have clarified in the final 4(d) rule that any site determined to be occupied by Georgetown salamanders in the future will be considered “occupied” and require the protective measures outlined in Appendix A of the UDC to be covered under this 4(d) rule.

(22) Comment: Under the 4(d) rule, the Service should allow the City of Georgetown to conduct all technical reviews related to compliance with the UDC, including review and approval of subdivision plats, site plans, or other plans to be in compliance with the UDC. The UDC already requires that all development within the salamanders' known distribution may not begin until a geologic assessment has been conducted and accepted by the City and all project plats, site plans, and infrastructure construction plans reflect occupied springs and required buffers. The City of Georgetown is the logical entity to conduct this review under the UDC, as City staff are the most knowledgeable about local codes, ordinances, and environmental conditions and will ensure technical reviews comply with the UDC.

Our response: The City of Georgetown will implement and enforce the regulations in chapter 11.07 of the UDC. The City, with assistance of the Working Group (comprising representatives from the City of Georgetown, Williamson County, Texas Commission on Environmental Quality, Texas Parks and Wildlife Department, university scientists, private real estate developers, and the Service), will also review and approve projects that wish to follow the guidelines described in Appendix A of the UDC. The Service has no intention of reviewing individual projects unless the developers wish to obtain an incidental take permit through section 10, or if a Federal nexus exists through section 7, instead of following the UDC.

(23) Comment: The required buffers will not infringe too seriously on Georgetown residents. The “Minimal-Disturbance Zone” will allow those who wish to live near rivers and springs that are the salamander's habitats to do so, as long as the residential areas are low density. Recreational activities like fishing or boating would not be severely limited either, as the “No-Disturbance Zone” on the river stretches only [80 m (262 ft)] in either direction. This is a significant buffer for the salamander, but it is not a far distance for humans to traverse.

Our response: The “No-Disturbance Zone” of Appendix A of the UDC does not apply to recreation activities. Only regulated activities (as defined in title 30, Texas Administrative Code, section 213.3(28)) are prohibited within this zone.

(24) Comment: Stream buffers of at least 23 m (75 ft) may not be large enough to considerably reduce water pollution. Salamanders are affected by slight changes in pH and increase of chemicals in the water. The small population sizes of Georgetown salamanders greatly increase their risk of extinction. Therefore, more studies on the biology and population demographics of this species should be performed before additional urban development is allowed near these crucial habitat sites.

Our response: The adaptive management process is a component of chapter 11.07 and Appendix A of the UDC that allows changes to the regulations in response to new information. If there is adequate evidence that the current regulations are not protective enough for the Georgetown salamander, the Working Group will recommend changes to the UDC that meet the overall management goals.

(25) Comment: This plan essentially provides a loophole for developers to continue construction if they survey the area themselves. There is no outside authority to check if salamander habitat will be disturbed. This could potentially allow for corrupt results of the investigation to be passed off as legitimate.

Our response: This 4(d) rule does not provide a loophole, because all individual project proponents continue to be responsible for determining impacts on listed species and seeking the appropriate take coverage based on their determination.

(26) Comment: If the development is single-family residential, two-family residential, or on a lot smaller than 2 ha (5 ac), the assessment from the Federal Government would be waived. Any construction, no matter how small it may be, will have an impact on the environment.

Our response: There is no Federal Government assessment that would be waived from residential developments. Geologic assessments (which have to be completed under the UDC 11.07 regulations) are not required to be submitted to the City of Georgetown if the proposed development is a small (less than 2-ha (5-ac)) single-family and two-family residential development located in a small (25.9-ha (64-ac)) watershed. However, these developments are required to implement all other UDC water quality measures.

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

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this final 4(d) rule in a manner consistent with these requirements.

Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency must publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effects of the rule on small entities (small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the RFA to require Federal agencies to provide a statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities. Thus, for a regulatory flexibility analysis to be required, impacts must exceed a threshold for “significant impact” and a threshold for a “substantial number of small entities.” See 5 U.S.C. 605(b). Based on the information that is available to us at this time, we certify that this regulation will not have a significant economic impact on a substantial number of small entities. The following discussion explains our rationale.

On February 24, 2014 (79 FR 10236), we published the final determination to list the Georgetown salamander as a threatened species. That rule became effective on March 26, 2014. As a result, the Georgetown salamander is currently covered by the full protections of the Act, including the full section 9 prohibitions that make it illegal for any person subject to the jurisdiction of the United States to take (harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct), import or export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any wildlife species listed as an endangered species, without written authorization. It also is illegal under section 9(a)(1) of the Act to possess, sell, deliver, carry, transport, or ship any such wildlife that is taken illegally. Prohibited actions consistent with section 9 of the Act are outlined for threatened species in 50 CFR 17.31(a) and (b). This final 4(d) rule states that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except regulated activities that are conducted consistent with the water quality protective measures contained in Chapter 11.07 and Appendix A of the Unified Development Code, which would result in a less restrictive regulation under the Act, as it pertains to the Georgetown salamander, than would otherwise exist. For the above reasons, we certify that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, a final regulatory flexibility analysis is not required.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.), we make the following findings:

(a) This final rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or Tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or [T]ribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and [T]ribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or Tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; AFDC work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”

(b) This 4(d) rule promulgates that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except activities that are conducted consistent with the water quality protection measures contained in Chapter 11.07 and Appendix A of the Unified Development Code, which would result in a less restrictive regulation under the Act, as it pertains to the Georgetown salamander, than would otherwise exist. As a result, we do not believe that this rule would significantly or uniquely affect small governments. Therefore, a Small Government Agency Plan is not required.

In accordance with Executive Order 12630, this final rule will not have significant takings implications. We have determined that the rule has no potential takings of private property implications as defined by this Executive Order because this 4(d) rule will result in a less-restrictive regulation under the Endangered Species Act than would otherwise exist. A takings implication assessment is not required.

In accordance with Executive Order 13132, this final 4(d) rule does not have significant Federalism effects. A federalism summary impact statement is not required. This rule will not have substantial direct effects on the State, on the relationship between the Federal Government and the State, or on the distribution of power and responsibilities among the various levels of government.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that this final rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking actions that significantly affect energy supply, distribution, and use. For reasons discussed within this final rule, we believe that the rule will not have any effect on energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

This rule does not contain collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. This rule will 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.

We have prepared a final environmental assessment, as defined under the authority of the National Environmental Policy Act of 1969. For information on how to obtain a copy of the final environmental assessment, see ADDRESSES, above.

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes. We determined that there are no known tribal lands within the range of the Georgetown salamander.

The primary authors of this final rule are the staff members of the Austin Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below: