Federal Register Vol. 80, No.120,

Table of Contents: I. Obtaining Information and Submitting Comments. II. Procedural Background. III. Background. IV. Discussion of Changes. V. Voluntary Consensus Standards. VI. Agreement State Compatibility. VII. Plain Writing. VIII. Environmental Assessment and Finding of No Significant Environmental Impact. IX. Paperwork Reduction Act Statement. X. Regulatory Flexibility Certification. XI. Regulatory Analysis. XII. Backfitting and Issue Finality. XIII. Congressional Review Act. XIV. Availability of Documents. I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2015-0067 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0067.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, (301) 415-4737, or by email to [email protected]. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2015-0067 in the subject line of your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

This rule is limited to the changes contained in Amendment No. 1 to CoC No. 1040 and does not include other aspects of the HI-STORM UMAX Canister Storage System. The NRC is using the “direct final rule” procedure to issue this amendment because it represents a limited and routine change to an existing CoC that is expected to be noncontroversial. The amendment to the rule will become effective on September 8, 2015. However, if the NRC receives significant adverse comments on this direct final rule by July 23, 2015, the NRC will publish a document that withdraws this action, and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rule section of this issue of the Federal Register. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or Technical Specifications (TSs).

For detailed instructions on submitting comments, please see the ADDRESSES section of this document.

Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the U.S. Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of Title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L within 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on March 6, 2015 (80 FR 12073), as corrected on March 25, 2015 (80 FR 15679), that approved the HI-STORM UMAX Canister Storage System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1040.

By letter dated July 11, 2014, and as supplemented on October 31, 2014, Holtec submitted an application to the NRC to amend the HI-STORM UMAX Canister Storage System, CoC No. 1040, under subpart K of 10 CFR part 72. Amendment No. 1 to CoC No. 1040 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version, that could be used in areas with higher seismic demands than those analyzed previously. Amendment No. 1 also includes minor physical design changes to help ensure structural integrity of the amended system. These are the addition of a hold-down system to the closure lid; replacing the fill material in the interstitial spaces between the CECs surrounding the casks with 3000 psi concrete; strengthening the MPC guides; and engineering the guides' nominal gap with the MPC to be tighter than the original HI-STORM UMAX Canister Storage System design.

As documented in the NRC staff's Safety Evaluation Report (SER) (ML15070A149), the NRC staff performed a detailed safety evaluation of the proposed CoC amendment request. This amendment does not reflect a significant change in design or fabrication of the HI-STROM UMAX Canister Storage System cask design previously approved by the NRC (see 80 FR 12073, as corrected 80 FR 15679). Considering the specific design requirements for accident conditions, the NRC staff determined that the design of the cask would continue to prevent loss of confinement, shielding, and criticality control.

This direct final rule revises the Holtec HI-STORM UMAX Canister Storage System listing in 10 CFR 72.214 by adding Amendment No. 1 to CoC No. 1040. The amendment consists of the changes previously described, as set forth in the revised CoC and TSs. The revised TSs are identified in the SER.

The amended Holtec HI-STORM UMAX Canister Storage System, when used under the conditions specified in the CoC, the TSs, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under 10 CFR 72.210 may load spent nuclear fuel into Holtec HI-STORM UMAX Canister Storage Systems that meet the criteria of Amendment No. 1 to CoC No. 1040 under 10 CFR 72.212.

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will amend the Holtec HI-STORM UMAX Canister Storage System design listed in 10 CFR 72.214, “List of approved spent fuel storage casks.” This action does not constitute the establishment of a standard that contains generally applicable requirements.

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this direct final rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR. Although an Agreement State may not adopt program elements reserved to the NRC, it may wish to inform its licensees of certain requirements via a mechanism that is consistent with the particular State's administrative procedure laws, but does not confer regulatory authority on the State.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

The action is to amend 10 CFR 72.214 to amend the Holtec HI-STORM UMAX Canister Storage System listing within the “List of approved spent fuel storage casks” to include Amendment No. 1 to CoC No. 1040. Under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the NRC has determined that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has made a finding of no significant impact on the basis of this environmental assessment.

This direct final rule amends the CoC for the Holtec HI-STORM UMAX Canister Storage System design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Specifically, Amendment No. 1 to CoC No. 1040 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version that could be used in areas with higher seismic demands than those analyzed previously. Amendment No. 1 also includes minor physical design changes to help ensure the structural integrity of the amended system. These are the addition of a hold-down system to the closure lid; replacing the fill material in the interstitial spaces between the CECs surrounding the casks with 3000 psi concrete; strengthening MPC guides; and engineering the guides' nominal gap with the MPC to be tighter than the original HI-STORM UMAX Canister Storage System.

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the environmental assessment for the 1990 final rule. The environmental assessment for this amendment tiers off of the environmental assessment for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under the National Environmental Policy Act.

Holtec HI-STORM UMAX Canister Storage Systems are designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an Independent Spent Fuel Storage Installation, the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

Considering the specific design requirements for accident conditions, the design of the storage system would prevent loss of containment, shielding, and criticality control. If there is no loss of containment, shielding, or criticality control, the environmental impacts would be insignificant. There are no significant changes to cask design requirements in the proposed CoC amendment. In addition, because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No.1 would remain well within the 10 CFR part 20 limits. Therefore, the proposed CoC amendment will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment supporting the July 18, 1990, final rule. There will be no significant change in the types or significant revisions in the amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents. The NRC staff documented its safety findings in the SER for this amendment.

The alternative to this action is to deny approval of Amendment No. 1 and terminate the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into Holtec HI-STORM UMAX Canister Storage Systems in accordance with the changes described in proposed Amendment No. 1 would have to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. Therefore, the environmental impacts of the alternative to the action would be the same or more than the impacts of the action.

Approval of Amendment No.1 to CoC No. 1040 would result in no irreversible commitments of resources.

No agencies or persons outside the NRC were contacted in connection with the preparation of this environmental assessment.

The environmental impacts of the action have been reviewed under the requirements in 10 CFR part 51. Based on the foregoing environmental assessment, the NRC concludes that this direct final rule entitled, “List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

This direct final rule does not contain any information collection requirements and, therefore, is not subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Public Protection Notification.

The NRC may not conduct or sponsor, and a person is not required to respond to a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and Holtec. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in 10 CFR 72.214.

On March 6, 2015 (80 FR 12073), as corrected on March 25, 2015 (80 FR 15679), the NRC issued an amendment to 10 CFR part 72 that approved the Holtec HI-STORM UMAX Canister Storage System design by adding it to the list of NRC-approved cask designs in 10 CFR 72.214. On July 11, 2014, and as supplemented on October 31, 2014, Holtec submitted an application to amend the HI-STORM UMAX Canister Storage System as described in Section IV, “Discussion of Changes,” of this document.

The alternative to this action is to withhold approval of Amendment No.1 and to require any 10 CFR part 72 general licensees seeking to load spent nuclear fuel into the Holtec HI-STORM UMAX Canister Storage System under the changes described in Amendment No. 1 to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the SER and the environmental assessment, the direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of the direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and therefore, this action is recommended.

The NRC has determined that the backfit rule (10 CFR 72.62) does not apply to this direct final rule. Therefore, a backfit analysis is not required. This direct final rule amends CoC No. 1040 for the Holtec HI-STORM UMAX Canister Storage System, as currently listed in 10 CFR 72.214, “List of approved spent fuel storage casks.” Amendment No. 1 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version that could be used in areas with higher seismic demands than those analyzed previously. It also includes minor physical design changes to help ensure structural integrity of the amended system.

Amendment No. 1 of CoC No. 1040 for the Holtec HI-STORM UMAX Canister Storage System was initiated by Holtec and was not submitted in response to new NRC requirements, or an NRC request for amendment. Holtec, as the CoC holder, is not protected by the backfitting provisions under 10 CFR 72.62.

In addition, the changes in Amendment No. 1 do not apply to casks which were manufactured to the initial CoC 1040. Amendment No. 1 applies only to new casks fabricated and used under Amendment No. 1. Therefore, these changes do not affect existing users of the Holtec UMAX Canister Storage System. For these reasons, Amendment No. 1 to CoC No. 1040 does not constitute backfitting under 10 CFR 72.62, 10 CFR 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, no backfit analysis or additional documentation addressing the issue finality criteria in 10 CFR part 52 has been prepared by the staff.

This action is not a rule as defined in the Congressional Review Act (5 U.S.C. 801-808).

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

The NRC may post materials related to this document, including public comments, on the Federal Rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2015-0067. The Federal Rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2015-0067); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72.

Authority for This Rulemaking

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

On September 2, 2014 the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E airspace extending upward from 700 feet above the surface at Cloverdale Municipal Airport, Cloverdale, CA. (79 FR 51919). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Y, airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface at Cloverdale, CA, with a segment that extends 6.3 miles south of the airport. Controlled airspace is needed for the RNAV (GPS) standard instrument approaches and departures at the airport.

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

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

I. What is the background and legal authority of this final rule? A. Background

Section 412(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(i)) establishes requirements for the nutrient content of infant formulas. Under section 412(i)(2) of the FD&C Act, the Secretary of Health and Human Services (the Secretary) is authorized to revise the list of required nutrients and the required level for any required nutrient. This authority has been delegated to the Commissioner of Food and Drugs (the Commissioner). The table in section 412(i) of the FD&C Act, and in FDA regulations at § 107.100(a) (21 CFR 107.100(a)), specifies that infant formulas must contain 29 nutrients; minimum levels for each nutrient and maximum levels for 9 of the nutrients are also specified. In 1989, the Food and Nutrition Board of the National Research Council established a Recommended Dietary Allowance for selenium for infants 0 to 6 months of age of 10.0 micrograms per day (μg/day), a level extrapolated from adult values on the basis of body weight and with a factor allowed for growth (Ref. 1).

In the Federal Register of April 16, 2013 (78 FR 22442), we proposed to amend the nutrient specifications for infant formula to include selenium as a required nutrient in § 107.100(a). We also proposed to establish minimum and maximum levels for selenium in infant formulas because evidence exists for both deficiency and toxicity of selenium. We proposed 2.0 μg selenium per 100 kilocalories (/100 kcal) as the minimum level of selenium in infant formulas and 7.0 μg/100 kcal as the maximum level of selenium in infant formulas.

Scientific evidence from multiple sources supported the proposed levels. Specifically, for the proposed requirements, we considered scientific evidence in: (1) The Institute of Medicine's (IOM) “Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids” (Ref. 2); (2) the Life Sciences Research Office's “Assessment of Nutrient Requirements for Infant Formulas” by Raiten et al. (Ref. 3); (3) “Global Standard for the Composition of Infant Formula. Recommendations of an ESPGHAN [European Society for Paediatric Gastroenterology, Hepatology and Nutrition] Coordinated International Expert Group” by Koletzko et al. (Ref. 4); and (4) “Selenium Status of Term Infants Fed Selenium-Supplemented Formula in a Randomized Dose-Response Trial” by Daniels et al. (Ref. 5). We also searched the scientific literature from 1998 through 2012 for published studies not included in these reports.

In addition, we proposed to amend the labeling requirements for infant formula in § 107.10(a)(2) to add selenium to the list of nutrients along with the requirement to list the amount of selenium per 100 kcal in the formula.

Section 412(i) of the FD&C Act contains a table of nutrients (including minimum and, in some cases, maximum levels for nutrients) that are required to be in an infant formula. Section 412(i)(2) of the FD&C Act authorizes the Secretary to revise the statutory table of nutrients and to revise the level of any required nutrient. The Secretary has delegated this authority to the Commissioner. Our regulations establishing the table of nutrients are codified at § 107.100.

The final rule amends § 107.100 to add selenium to the list of nutrients required for infant formula. The legal authority for the amendment to § 107.100 comes from section 412(i)(2) of the FD&C Act.

The final rule also requires adding selenium to the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2). “Infant formula” is defined as a food for “special dietary use” under section 201(z) of the FD&C Act (21 U.S.C. 321(z)). Under sections 403(j) and 701(e) of the FD&C Act (21 U.S.C. 343(j) and 21 U.S.C. 371(e)), the Secretary, and by delegation the Commissioner, may prescribe regulations concerning the vitamin and mineral content of foods for special dietary uses to fully inform purchasers as to the value of the food for such uses. As such, FDA has the authority to revise the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2) under sections 201(z), 403(j), 412(i), and 701(e) of the FD&C Act.

We invited public comment on the proposed rule. The comment period closed on July 1, 2013. We received fewer than 20 comments. Overall, the comments supported the addition of selenium to infant formula and agreed that selenium is an essential nutrient. We summarize and respond to the comments on the proposed rule and describe the final rule in this section. For ease of reading, we preface each comment discussion with a numbered “Comment,” and each response by a corresponding numbered “Response.” We have numbered each comment to help distinguish among different topics. The number assigned is for organizational purposes only and does not signify the comment's value, importance, or the order in which it was received.

The proposed rule would amend the infant formula nutrient labeling and nutrient specification regulations at §§ 107.10 and 107.100, respectively. Proposed § 107.10(a)(2) would add selenium to the statement of the amounts of nutrients required for infant formula labeling.

We did not receive any comments on proposed § 107.10(a)(2). However, we note that we have revised § 107.10(a)(2) in this final rule to correspond to changes resulting from an interim final rule that appeared in the Federal Register on February 10, 2014 (79 FR 7934), and later affirmed in a final rule that appeared in the Federal Register on June 10, 2014 (79 FR 33057). In brief, § 107.10(a)(2) was reworded by replacing “A statement of the amount of each of the following nutrients supplied by 100 kilocalories” with “A statement of the amount, supplied by 100 kilocalories, of each of the following nutrients and of any other nutrient added by the manufacturer.”

Proposed § 107.100(a) would add selenium to the list of required nutrients in infant formula. The proposal also would establish minimum and maximum levels for selenium in infant formula because evidence exists for both deficiency and toxicity of selenium, and there is no room for error in production of a food that serves as the sole source of nutrition for infants. We proposed to set 2.0 μg selenium/100 kcal as the minimum level of selenium in infant formulas and 7.0 μg/100 kcal as the maximum level of selenium in infant formulas. Since the publication of the proposed rule, we have conducted a search of the scientific literature to identify whether additional studies on selenium requirements of infants were published after we issued our proposal. We did not find any relevant studies in our search.

(Comment 1) One comment suggested we decrease the minimum level of selenium to 1.6 μg/100 kcal. The comment pointed to analytical variability that can occur between laboratories when testing the levels of selenium. According to the comment, due to this analytical variability, a minimum selenium level of 1.6 μg/100 kcal will likely result in manufacturers' formulating to deliver selenium levels close to 2.0 μg/100 kcal to ensure products do not fall below the minimum.

(Response 1) We decline to lower the minimum level of selenium in infant formula to 1.6 μg/100 kcal to accommodate analytical variability that can occur between laboratories as the comment suggested. The level of any substance (including nutrients, food additives, or contaminants) established for regulatory purposes must be a value that is based on and true to the available scientific evidence. We recognize that analytical variability is always present and manage this matter under our compliance program. We also note that lowering the minimum level of selenium would not change the analytical variability, and the tested level of selenium might fall below whatever minimum level is set, due to analytical variability. For example, if the minimum level was lowered to 1.6 μg/100 kcal, the tested level of selenium might fall below 1.6 μg/100 kcal due to analytical variability. However, on our own initiative we have revised proposed § 107.100(a) to insert the word “level” between the words “minimum” and “specified” in light of an inadvertent omission in the proposed rule.

(Comment 2) One comment said that the minimum level of selenium should be in the range reported in breast milk and specifically recommended the level of 1.6 μg selenium/100 kcal, consistent with the mean concentration of selenium in breast milk reported by Daniels et al. (2008). The comment continued, saying it was not aware of any reports of selenium deficiency in breast-fed infants or at this concentration of selenium in infant formula. The comment also stated that we did not consider the data from the breast-fed control group in the Daniels et al. study.

(Response 2) With regard to this comment suggesting that the selenium concentration in human milk (and more specifically, the level of 1.6 μg/100 kcal reported in the Daniels et al. study) be used as the basis for the required minimum selenium level in infant formula, the scientific evidence we discussed in the proposed rule (78 FR 22442 at 22444) was more broadly based. The discussion in the proposed rule considered the levels of selenium in human milk from the studies used to establish the adequate intake (AI) for selenium by the IOM and the levels of selenium in infant formulas fed in the randomized and double-blinded dose-response study in infants by Daniels et al. (2008).

Specifically, as discussed in the proposed rule (78 FR 22442 at 22444), the IOM established an AI for selenium of 15.0 μg/day (approximately 2.1 μg/kg body weight/day) for infants 0 to 6 months of age based on the average concentration of selenium in human milk from healthy women from 2 to 6 months of lactation as reported in four studies. The study by Daniels et al. was published after the IOM established the AI for selenium for infants 0 to 6 months of age, and the concentration of selenium in human milk reported in that study was not among the studies considered in the establishment of the AI. We note that the mean concentration of selenium in human milk in the studies included by the IOM in setting the AI for infants 0 to 6 months of age was 18 μg/L and that reported by Daniels et al. was 10.7 μg/L.

The study by Daniels et al. provides direct evidence of the effect of selenium concentration of infant formula on the circulating biochemical indicators of selenium status in infants. As described in the proposed rule (78 FR 22442 at 22444), this study included a control formula that contained 0.9 μg selenium/100 kcal (considered by the investigators to be a low-selenium formula) and two test formulas that contained 1.9 μg selenium/100 kcal or 3.1 μg selenium/100 kcal. The level of selenium in the formula containing 1.9 μg/100 kcal was somewhat higher than the level in human milk reported in the Daniels et al. study and close to the AI set by the IOM. In our consideration of the study by Daniels et al., we regarded the data from the human milk-fed infants as reference data, with the direct comparators being the indicators of selenium status of infants fed the formulas containing the three levels of selenium. The plasma and erythrocyte indicators of selenium status for both test formulas did not differ from each other but differed with statistical significance from the control formula. Compared to the infants fed the formula containing 1.9 μg selenium/100 kcal, infants fed the formula containing 3.1 μg selenium/100 kcal excreted more selenium in the urine. This increase in urinary selenium was found to be statistically significant. Combined with the finding of no dose-related changes in the circulating indicators of selenium status in infants fed formulas containing 1.9 μg selenium/100 kcal or 3.1 μg selenium/100 kcal, this dose-related increase in urinary selenium suggests that infants fed the formula containing a level of 1.9 μg selenium/100 kcal received sufficient selenium to meet their nutritional needs. Much of the selenium intake above the level of 1.9 μg selenium/100 kcal was apparently eliminated from the body through the body's homeostatic mechanisms.

As effects on indicators of selenium status have not been evaluated in infants fed formulas with concentrations of selenium between 0.9 μg selenium/100 kcal and 1.9 μg selenium/100 kcal, there are no data to support lowering the minimum level of selenium in infant formula from 2.0 μg/100 kcal to 1.6 μg/100 kcal. The scientific evidence discussed previously and in section III.A. of the proposed rule (78 FR 22442 at 22443) continues to justify 2.0 μg selenium/100 kcal as the minimum level for selenium in infant formulas.

(Comment 3) In support of a lower minimum level for selenium in infant formula, one comment pointed out that the Codex Alimentarius infant formula standard and the European Union Directive on Infant Formulae and Follow-On Formulae recommend a minimum level of selenium in infant formula of 1.0 μg selenium/100 kcal.

(Response 3) The level of 1.0 μg/100 kcal as the minimum level for selenium in infant formula was adopted by the Codex Alimentarius in 2007 for its Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981) (Ref. 6) based on recommendation of this level by an International Expert Group (IEG) of the ESPGHAN (Ref. 4). The IEG recommended 1.0 μg selenium/100 kcal for infant formula based on the median selenium content of human milk and an established history of apparent safe use. However, as described in the proposed rule (78 FR 22442 at 22444), no information was provided regarding the details of how such information was used in making the recommendation for 1.0 μg selenium/100 kcal in infant formula. In addition, the recommendation of the IEG was made in 2005 before the dose-response study of Daniels et al. was published in 2008, and data from that study suggest that a level of 1.9 μg selenium/100 kcal in infant formula meets infants' selenium needs. Further, although, as noted in the comment, the level of 1.0 μg/100 kcal was also adopted as the minimum level for selenium by the European Union in 2006 for its Directive on Infant Formulae and Follow-On Formulae (Commission Directive 2006/141/EC), identification of a scientific basis for the selection of 1.0 μg selenium/100 kcal was not included in the European Union Commission Directive.

(Comment 4) One comment suggested raising the maximum level of selenium added to infant formula to 9.0 μg/100 kcal. The comment said that the 9.0 μg selenium/100 kcal would align the maximum level of selenium with the upper levels recommended in the Codex Alimentarius Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants, and with the European Union Directive on Infant Formulae and Follow-on Formulae. The comment also stated that 9.0 μg selenium/100 kcal is more aligned with the use of 8.0 μg/100 kcal as the maximum value for selenium in the FDA Compliance Program Guidance Manual (CPGM).

(Response 4) We decline to increase the maximum level of selenium in infant formula to 9.0 μg selenium/100 kcal as the comment suggested. As noted in the response to comment 1 concerning the minimum level of selenium in infant formula, the maximum level of any substance (including nutrients, food additives, or contaminants) established for regulatory purposes must also be a value that is based on and true to the available scientific evidence.

The level of 9.0 μg selenium/100 kcal suggested in the comment is the maximum level recommended by the ESPGHAN IEG for infant formula. The report of the IEG stated that its recommendation was based on a history of safe use (not further described) and did not identify scientific data or other information relied upon for its recommendation for a maximum level of 9.0 μg selenium/100 kcal that was subsequently adopted by Codex Alimentarius in 2007 for its Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981). The level of 9.0 μg selenium/100 kcal was also listed in the European Union Directive on Infant Formulae and Follow-on Formulae. We considered the level of 9.0 μg selenium/100 kcal; however, we could not determine the scientific basis for this level.

Although we expressly invited comment regarding the proposed maximum level in infant formula of 7.0 μg selenium/100 kcal, including whether such a maximum level is needed and the scientific data or information that form the basis of any comments (78 FR 22442 at 22445), we did not receive any comments that disagreed with the need for a maximum level or that provided a scientific basis that would support a change from the proposed level. The report of the IOM, which we relied upon to propose the maximum level of 7.0 μg selenium/100 kcal, identified the data (concentration of selenium in human milk not associated with known adverse effects) and the method of calculation used to estimate a Tolerable Upper Intake Level (UL) of 7.0 μg/kg body weight/day for selenium intake of infants from 0 to 6 months of age. (As explained in the proposed rule (78 FR 22442 at 22444), a level of intake expressed as μg/kg body weight/day is consistent with an infant formula concentration expressed in μg/100 kcal.)

With regard to the use of 8.0 μg/100 kcal as a maximum in our CPGM, this level was incorporated into the CPGM when infant formula manufacturers in the United States began adding selenium to infant formulas starting as early as 1990 and preceded the establishment of the UL for infants 0 to 6 months of age by the IOM. We will update the minimum and maximum values for selenium in infant formula in our CPGM to align with the final rule.

(Comment 5) One comment said that setting 7.0 μg selenium/100 kcal as the maximum level of selenium, which is the amount we proposed, would mean some manufacturers would need to reformulate their products that currently meet the 8.0 μg selenium/100 kcal level that is listed in the FDA CPGM.

(Response 5) Although the comment said that some manufacturers whose products currently meet the 8.0 μg selenium/100 kcal level listed in the FDA CPGM would need to reformulate, it did not specify how many manufacturers or products would likely be affected or whether label changes would be required following any reformulations. It also did not provide estimates of possible costs resulting from establishing a maximum of 7.0 μg selenium/100 kcal. Other comments indicated that any formula changes could be made in a cost effective and timely manner with an effective date 12 months after publication of the final rule (see comment 7).

If some manufacturers who currently meet the 8.0 μg selenium/100 kcal level need to reformulate their products to avoid exceeding a selenium level of 7.0 μg/100 kcal, such a reformulation would involve only a small reduction in the amount of selenium added to the formula. Manufacturers routinely make such small changes in the rates of addition of ingredients (which may or may not result in the need for label changes) as a fundamental part of their current good manufacturing practices and quality control programs to ensure the consistent production of infant formulas of high quality. These types of changes are generally not considered to be major changes and are reported to FDA in a “before first processing” submission by the manufacturers if the change may adulterate the product, as required by section 412(d)(3) of the FD&C Act and our regulations in 21 CFR 106.140.

(Comment 6) One comment suggested that, in the absence of setting a higher maximum selenium level, FDA would need to establish a specific allowance for method bias to ensure that manufacturers can meet both the minimum and maximum selenium levels. The comment suggested an allowance of 30 percent to account for analytical variability.

(Response 6) As noted in the response to comment 4, the maximum level of any substance must be a value that is based on and true to the available scientific evidence. For this reason, we are not setting a higher maximum value that would include an allowance for analytical variability or method bias. We are not aware of method bias (consistent over- or under-measurement of the actual concentration) in the analysis of selenium in infant formula. We acknowledge that analytical variability occurs between laboratories when testing the levels of nutrients in infant formula, and we manage this matter under our compliance program as necessary. Further, we decline to set a 30 percent allowance for analytical variation for the chemical analysis of selenium in infant formula. The comment did not provide a reason for setting such a high allowance for analytical variation, and 30 percent variability is much higher than performance requirements for commonly used methods for chemical analysis of minerals in infant formula, which typically is about 10 to 15 percent.

In the Regulatory Impact Analysis of the proposed rule, we analyzed three options with respect to an effective date: (1) Take no new regulatory action (baseline); (2) require the provisions of this proposed rule and make the provisions of the rule effective 180 days after publication; and (3) require the provisions of this proposed rule, but make the provisions of the rule effective 12 months after publication (78 FR 22442 at 22446).

(Comment 7) Two comments supported FDA's option 3 in the proposed rule to make the final rule effective 12 months after publication to allow for cost effective and timely changes with no anticipated impact on infant health. One comment explained that because there have been no reports of full-term, breast-fed infants in the United States with evidence of selenium deficiency, there would be no anticipated impact to infant health due to a 6-month delay in the rule's effective date (from 6 months in option 2 to 12 months in option 3 of the Regulatory Impact Analysis of the proposed rule).

(Response 7) The final rule will be effective 12 months after publication of this document (see DATES). This will allow the industry to make any needed reformulations and label changes to their infant formula products in the 12-month period that the comment identified as cost effective and timely for needed changes.

Several comments addressed matters that were not specific to a particular provision in the proposed rule and/or that were not covered by the rule. We summarize and address those comments here.

(Comment 8) One comment suggested that FDA recommend or encourage the use of the organic form of selenium, selenomethionine, rather than the inorganic forms, sodium selenite or sodium selenate. The comment explained that selenomethionine is the selenium compound incorporated into body proteins and is available in dietary supplements or from brewer's yeast.

(Response 8) FDA's specifications for infant formula composition in § 107.100 identify nutrients that must be included in the formula. The regulations do not specify ingredients that can serve as sources of the nutrients, except for vitamin K in § 107.100(c). We decline to specify the form of selenium in infant formula because we do not have information that indicates that any specific source of selenium should be used in infant formula. Our recently published current good manufacturing practices for infant formulas require that ingredients used in infant formulas be safe and suitable for use in infant formula. Specifically, under § 106.40(a), the only substances that may be used in an infant formula are substances that are safe and suitable for use in infant formula under the applicable food safety provisions of the FD&C Act; that is, a substance is used in accordance with the Agency's food additive regulations, is generally recognized as safe for such use, or is authorized by a prior sanction.

(Comment 9) One comment agreed with the proposed selenium levels “unless a pediatrician otherwise recommends an alternative dosage because of a peculiar deficiency of selenium.” The comment did not explain the circumstances under which a pediatrician would recommend an “alternative dosage.”

(Response 9) The final rule adds selenium to the list of required nutrients in infant formula and establishes minimum and maximum levels of selenium in infant formula. Manufacturers will be required to add selenium to infant formula within the established bounds as of the effective date of this rule. The rule does not apply to what physicians may do within the practice of medicine. Thus, matters pertaining to the practice of pediatric medicine are outside the scope of this rulemaking.

(Comment 10) Another comment suggested that FDA consider establishing a higher maximum for vitamin D based on recent American Academy of Pediatrics and IOM recommendations.

(Response 10) The final rule adds selenium to the list of required nutrients in infant formula and establishes minimum and maximum levels of selenium in infant formula. With respect to vitamin D and infant formula, we may, as resources permit, reevaluate all the minimum and maximum required nutrient levels for infant formula in separate rulemakings.

(Comment 11) One comment supported the proposal to require the addition of selenium in infant formula. The comment stated that a child that does not receive enough selenium in the diet is at risk of developing Keshan disease.

(Response 11) FDA agrees that Keshan disease is linked to selenium deficiency. The preamble to the proposed rule discussed the known biological functions of selenium and Keshan disease (a cardiomyopathy that occurs almost exclusively in children) (see 78 FR 22442 at 22443).

FDA has determined under 21 CFR 25.32(n) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

On April 16, 2013, we proposed to amend our regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula (78 FR 22442). The Economic Impact Analysis in the proposed rule explained the economic impact of the changes to regulations at part 107. We did not receive any comments on the economic analysis of the proposed rule.

FDA has examined the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). FDA has developed a regulatory impact analysis that presents the benefits and costs of this proposed rule (Ref. 7). We believe that the final rule will not be a significant regulatory action as defined by Executive Order 12866.

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual third-party disclosure burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Third-Party Disclosure Requirements for Selenium in Infant Formula

Description of Respondents: The respondents to this information collection are manufacturers of infant formula marketed in the United States.

Description: The final rule revises § 107.10(a)(2) to require that selenium be listed in the nutrient list on the label for all infant formulas. In particular, in the nutrient list, selenium must be listed between iodine and sodium and the amount per 100 calories declared; and because selenium is a required ingredient in infant formula, selenium is required to be declared in the formula's ingredient statement by its common or usual name and positioned according to the descending order of its predominance in the formula, under § 101.4 (21 CFR 101.4). The present version of § 107.10(a)(2) is approved by OMB in accordance with the PRA and has been assigned OMB control number 0910-0256. This final rule modifies the information collection associated with the present version of § 107.10(a)(2) by adding 23 hours to the burden associated with the collection. A manufacturer not in compliance with the new minimum and maximum levels for selenium in infant formula would be required to make a one-time change to the nutrient list information disclosed to consumers on the label of its infant formula, to account for the required change in the amount of selenium in its products. The nutrient information disclosed by manufacturers on the infant formula label is necessary to inform purchasers of the value of the infant formula. As discussed previously in this document, FDA has the authority to revise the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2).

FDA estimates the burden of this collection of information as follows:

FDA concludes that there will be no additional burden associated with the requirement to disclose selenium in the ingredient statement as required under § 101.4 because all infant formula manufacturers currently add selenium as an ingredient to their infant formula products that are sold in the United States, and all manufacturers currently disclose selenium in the ingredient statement, as specified by § 101.4. Additionally, all manufacturers currently disclose selenium in the nutrient list, as required by § 107.10(b)(5). Under § 107.10(a)(2), only one manufacturer would need to make a one-time labeling change to modify the amount of selenium shown in the nutrient list on the labels of its infant formula.

The third-party disclosure burden consists of the setup time required to design a revised label and incorporate it into the manufacturing process. Based upon our knowledge of food and dietary supplement labeling, we estimate that the affected manufacturer would require less than 0.5 hour per product to modify the label's nutrient list to reflect the addition of more selenium to the product. We estimate that this manufacturer produces 46 separate infant formulas that would require relabeling. The one-time third-party disclosure burden is estimated in table 1 of this document.

The final column of table 1 gives the estimated capital cost associated with relabeling. This is the cost of designing a revised label and incorporating it into the manufacturing process. The cost stated in table 1, $792,439, is estimated based on an effective date of 1 year after publication. These costs are based on the cost model estimate that, over a longer period of time, any labeling change is more likely to be coordinated with a change in a label that may already be scheduled, and will diminish the need to, for example, purchase and apply stickers to packages affected by the change.

The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the PRA. The requirements were approved and assigned OMB control number 0910-0256. This approval expires on 04/30/2018.

An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. You must number each objection separately, and, within each numbered objection, you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, we will consider the absence of such a request as waiving the right to a hearing on that objection. If you request a hearing, your objection should include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held.

It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov.

For the reasons discussed in the preamble, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the Food and Drug Administration amends 21 CFR part 107 as follows:

In FR Doc. 2015-13393, appearing on page 31708 in the Federal Register of Wednesday, June 3, 2015, the following corrections are made:

I. Background

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

Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On November 21, 2013, Auris Medtech Europe, Ltd., submitted a request for classification of the ProlongTM under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). On June 17, 2014, the request for classification of ProlongTM was transferred from Auris Medtech Europe, Ltd., to Ergon Medical, Ltd., through an amendment to the request (Ref. 2).

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on March 20, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.5025.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a vibrator for climax control of premature ejaculation will need to comply with the special controls named in this final order. The device is assigned the generic name vibrator for climax control of premature ejaculation, and it is identified as a device used for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.

FDA has identified the following risks to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1.

FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness:

• The labeling must include specific instructions regarding the proper placement and use of the device.

• The portions of the device that contact the patient must be demonstrated to be biocompatible.

• Appropriate analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety, and thermal safety of the device.

• Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the vibrator for climax control of premature ejaculation they intend to market.

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

The Coast Guard will enforce the following special local regulations listed in 33 CFR part 100, Safety of Life on Navigable Waters, on the following dates and times, which are listed in chronological order:

(1) § 100.919 International Bay City River Roar, Bay City, MI. This special local regulation will be enforced from 9 a.m. to 6 p.m. on June 26, 27, and 28, 2015. A regulated area is established to include all waters of the Saginaw River bounded on the north by the Liberty Bridge, located at 43°36.3′ N, 083°53.4′ W, and bounded on the south by the Veterans Memorial Bridge, located at 43°35.8′ N, 083°53.6′ W. In case of rain on any of the race days, this special local regulation may be enforced an additional day on June 29, 2015 from 9 a.m. until 6 p.m.

(2) § 100.920 Tug Across the River, Detroit, MI. This special local regulation will be enforced from 6 p.m. to 6:45 p.m. on July 10, 2015. A regulated area is established to include all waters of the Detroit River, Detroit, Michigan, bounded on the south by the International boundary, on the west by 083°03′ W, on the east by 083°02′ W, and on the north by the U.S. shoreline. This position is located on the Detroit River in front of Hart Plaza, Detroit, MI.

(3) § 100.914 Trenton Rotary Roar on the River, Trenton, MI. This special local regulation will be enforced from 8 a.m. to 8 p.m. on July 17, 18, and 19, 2015. The regulated area is established to include all waters of the Detroit River, Trenton, Michigan, bounded by an east/west line beginning at a point of land at the northern end of Elizabeth Park in Trenton, MI, located at position 42°8.2′ N; 083°10.6′ W, extending east to a point near the center of the Trenton Channel located at position 42°8.2′ N; 083°10.4′ W, extending south along a north/south line to a point at the Grosse Ile Parkway Bridge located at position 42°7.7′ N; 083°10.5′ W, extending west along a line bordering the Grosse Ile Parkway Bridge to a point on land located at position 42°7.7′ N; 083°10.7′ W, and along the shoreline to the point of origin. This area is in the Trenton Channel between Trenton and Grosse Isle, MI.

(4) § 100.915 St. Clair River Classic Offshore Race, St. Clair, MI. This special local regulation will be enforced from 10 a.m. to 7 p.m. each day from July 20, 2015 through July 26, 2015. A regulated area is established to include all waters of the St. Clair River, St. Clair, Michigan, bounded by latitude 42°52′00″ N to the north; latitude 42°49′00″ N to the south; the shoreline of the St. Clair River on the west; and the international boundary line on the east.

Special Local Regulations:

(1) In accordance with § 100.901, entry into, transiting, or anchoring within these regulated areas is prohibited unless authorized by the Coast Guard patrol commander (PATCOM). The PATCOM may restrict vessel operation within the regulated area to vessels having particular operating characteristics.

(2) Vessels permitted to enter this regulated area must operate at a no wake speed and in a manner that will not endanger race participants or any other craft.

(3) The PATCOM may direct the anchoring, mooring, or movement of any vessel within this regulated area. A succession of sharp, short signals by whistle or horn from vessels patrolling the area under the direction of the PATCOM shall serve as a signal to stop. Vessels so signaled shall stop and shall comply with the orders of the PATCOM. Failure to do so may result in expulsion from the area, a Notice of Violation for failure to comply, or both.

(4) If it is deemed necessary for the protection of life and property, the PATCOM may terminate at any time the marine event or the operation of any vessel within the regulated area.

(5) In accordance with the general regulations in § 100.35 of this part, the Coast Guard will patrol the regatta area under the direction of a designated Coast Guard Patrol Commander (PATCOM). The PATCOM may be contacted on Channel 16 (156.8 MHz) by the call sign “Coast Guard Patrol Commander.”

(6) The rules in this section shall not apply to vessels participating in the event or to government vessels patrolling the regulated area in the performance of their assigned duties.

This document is issued under authority of 33 CFR 100.35 and 5 U.S.C. 552(a). If the Captain of the Port determines that any of these special local regulations need not be enforced for the full duration stated in this document, he may suspend such enforcement and notify the public of the suspension via a Broadcast Notice to Mariners.

The Coast Guard will enforce the safety zones listed in 33 CFR 165.160 on the specified dates and times as indicated in Table 1 below. This regulation was published in the Federal Register on November 9, 2011 (76 FR 69614).

Under the provisions of 33 CFR 165.160, vessels may not enter the safety zones unless given permission from the COTP or a designated representative. Spectator vessels may transit outside the safety zones but may not anchor, block, loiter in, or impede the transit of other vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR 165.160(a) and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide mariners with advanced notification of enforcement periods via the Local Notice to Mariners and marine information broadcasts. If the COTP determines that a safety zone need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the safety zone.

This document corrects § 51-6.4 by removing MR series 11000 and 12000 from paragraphs (b), (c)(4), and (d) so the series are no longer designated as “Exclusive”. All other parameters of the Final Rule remain the same as published on June 5, 2015.

For the reasons set out in the preamble, the Committee amends 41 CFR part 51-6 as follows:

Under Title XXI of the Public Health Service Act, as amended (PHS Act), individuals who demonstrate a vaccine-related injury or death may receive compensation through the VICP. To be eligible for compensation from the VICP, a petitioner must demonstrate that the injured or deceased individual received a vaccine set forth in the Table (a “covered vaccine”) and sustained a vaccine-related injury or death. A petitioner can prove a vaccine-related injury or death in three ways. First, the petitioner can show, by a preponderance of the evidence, that the vaccine recipient suffered an injury listed in the Table corresponding with the vaccine received, that the onset of such injury occurred within the timeframe specified in the Table, and that the injury meets the requirements set forth in the Table's QAI. A Table injury or death is given the legal presumption that it was caused by the vaccination. Sections 2111(c)(1)(C)(i), 2113(a)(1)(B), and 2114(a) of the PHS Act. Second, if the petitioner cannot demonstrate a Table injury, the petitioner can prevail by proving, by a preponderance of the evidence, that the vaccine caused the injury or death (off-Table injury). Third, a petitioner can prevail by proving, by a preponderance of the evidence, that the vaccine significantly aggravated a pre-existing condition. In all three cases, a petitioner must also show that the injury was sufficiently severe by demonstrating that such person suffered the residual effects of the injury for more than 6 months; died from the administration of the vaccine; or that the alleged injury resulted in inpatient hospitalization and surgical intervention. Section 2111(c)(1)(D) of the PHS Act. If the petitioner can prove a Table injury, off-Table injury, or significant aggravation of a pre-existing condition, the petitioner is entitled to compensation unless it is affirmatively shown that the injury was caused by some factor unrelated to the vaccination.

Under section 2114(e)(2) of the PHS Act, when the Centers for Disease Control and Prevention (CDC) recommends a vaccine for routine administration to children, the Secretary is required to amend the Table to include such vaccine. Coverage becomes effective when an excise tax is imposed on the vaccine. Additionally, the Secretary is authorized to include specific injuries on the Table with respect to each covered vaccine, including the timeframe when the first symptom or manifestation of the onset of such adverse event may occur. The Secretary may also define such injuries through the QAI. Under section 2114(c) of the PHS Act, the Secretary may make such modifications to the Table by promulgating regulations, with notice and opportunity for a public hearing, and at least 180 days of public comment.

As discussed in the NPRM (78 FR 44512, July 24, 2013), the Secretary has reviewed the currently available data regarding the Rotarix and RotaTeq vaccines and the risk of intussusception. The background of the RotaShield experience in the U.S. and the published literature from Mexico, Brazil, Australia, and the U.S. supports a small attributable risk of intussusception after the first and second doses of Rotarix and RotaTeq (with a greater amount of data supporting an association with the first dose of both vaccines). Evidence shows the increased risk within the 1-7 days following immunization with peaks in the fourth and fifth days. As a consequence, the Secretary is amending the Table to add the injury of intussusception to the general Table category of “rotavirus vaccines” to allow a presumption of causation for claims that meet the requirements set forth in the Table for that injury. To allow for a generous timeframe that will capture any cases related to the vaccine after day 7, the Secretary has assigned an onset interval of 1-21 days under sections 2114(c) and (e) of the PHS Act.

The Secretary will stay informed of new information in the scientific and medical field about intussusception and rotavirus vaccines and may propose changes in the future if such information warrants changes to the Table. In addition, the Secretary recognizes that one goal of the VICP is to provide compensation to petitioners harmed by vaccines through a less adversarial system. Therefore, the Secretary feels that adding the Table injury of intussusception after the first and second doses of rotavirus vaccines with a window of 1-21 days is appropriate.

The QAI section of the Table defines the injury of “intussusception” as the invagination of a segment of intestine into the next segment of intestine, resulting in bowel obstruction, diminished arterial blood supply, and blockage of the venous blood flow. This is characterized by a sudden onset of abdominal pain that may be manifested by anguished crying, irritability, vomiting, abdominal swelling, and/or passing of stools mixed with blood and mucus. The definition for presumption of vaccine causation only applies to the first and second dose of vaccine, and excludes intussusception occurring with or after the third dose. The third dose of rotavirus vaccines lacks sufficient evidence showing risk.

The definition also delineates the alternative causes of intussusception which, if present in a case, would prevent it from qualifying as a Table injury. The alternative causes were classified into four categories: infectious diseases; anatomic lead points; anatomic bowel abnormalities; and underlying gastrointestinal or systemic diseases. Cases of intussusception where the onset was within 14 days after an infectious disease secondary to non-enteric or enteric adenovirus, other enteric viruses (such as Enterovirus), enteric bacteria (such as Campylobacter jejuni), or enteric parasites (such as Ascaris lumbricoides) would not qualify as a Table injury. Proof of these alternate causes may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing.

Cases of intussusception in a person with a pre-existing condition identified as the lead point for intussusception, such as intestinal masses and cystic structures (e.g., polyps; tumors; Meckel's diverticulum; lymphoma; or duplication cysts), would not qualify as a Table injury. Additionally, cases of intussusception in a person with abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch Scholein purpura, hematoma, or hemangioma); or in a person with underlying conditions or systemic diseases associated with intussusception (such as cystic fibrosis, celiac disease, or Kawasaki disease) would not qualify as a Table injury.

Petitioners may be eligible for compensation for vaccine-related cases of intussusception in which the onset is before 1 day or beyond 21 days, or where the condition does not satisfy the criteria under the QAI for intussusception (an “off-Table” claim); however, the petitioners will be required to prove causation-in-fact. Regardless of whether the claim satisfies the criteria in the Table, all petitioners must demonstrate sufficient severity of the injury by proving that the injured person: 1) suffered the residual effects or complications of the alleged vaccine-related injury for more than 6 months after vaccine's administration; 2) died from administration of the vaccine; or 3) sustained inpatient hospitalization and surgery as a result of the alleged vaccine-related injury. Section 2111(c)(1)(D), PHS Act (42 U.S.C. 300aa-11(c)(1)(D)). In the case of rotavirus vaccine administration and subsequent intussusception, the Secretary does not consider a reduction of intussusception with therapeutic enemas to be “surgical intervention.”

Petitions must also be filed within the applicable statute of limitations. The general statute of limitations applicable to petitions filed with the VICP, set forth in section 2116(a) of the PHS Act (42 U.S.C. 300aa-16(a)), continues to apply. In addition, section 2116(b) of the PHS Act identifies a specific exception to this statute of limitations that applies when the effect of a revision to the Table makes a previously ineligible person eligible to receive compensation or when an eligible person's likelihood of obtaining compensation significantly increases. Under this section, individuals who may be eligible to file petitions based on the revised Table may file a petition for compensation not later than two years after the effective date of the revision if the injury or death occurred not more than eight years before the effective date of the revision of the Table (42 U.S.C. 300aa-16(b)).

The comment period for this regulation ran for 6 months (July 24, 2013-January 21, 2014) and included two public hearings that were held on January 13, 2014, and April 28, 2014. The Secretary received ten comments as a result of this process. None of the commenters objected to the Secretary's proposal to add intussusception as an injury for rotavirus vaccines to the Table, and the overwhelming majority of commenters expressed their support for the proposal. In addition, commenters raised four additional points. Below is a summary of those points and the Secretary's responses to them.

COMMENT: A commenter suggested that the Secretary make additional efforts to increase public awareness about expanding the Table and to increase the general public awareness about the VICP.

RESPONSE: The Secretary will continue efforts to increase the general public's awareness about the VICP, including revisions to the Table.

COMMENT: One commenter suggested that the definition of surgical intervention be broadened to include therapeutic enema treatment.

RESPONSE: Defining the term “surgical intervention” is beyond the scope of the Table amendments. While the preamble to both the NPRM and final rule includes the Secretary's view that a reduction of intussusception with an enema is not a “surgical intervention,” such language is not included in the regulatory text. Further, the definition of “surgical intervention” is decided by the court.

COMMENT: A commenter stated that none of the data for either vaccine supports an association with intussusception for days 8-21 after dose 2 and suggested that the Secretary consider revising the time frame for qualification as a Table injury after dose 2 to 1-7 days.

RESPONSE: The Secretary has considered the approach suggested by the commenter and also the recommendation of the Advisory Commission on Childhood Vaccines (ACCV). The ACCV unanimously recommended the proposed change of 1-21 days for all rotavirus vaccines.

The ACCV's “Guiding Principles for Recommending Changes to the Vaccine Injury Table,” consist of two overarching principles: (1) the Table should be scientifically and medically credible; and (2) where there is credible scientific and medical evidence both to support and to reject a proposed change (addition or deletion) to the Table, the change should, whenever possible, be made to the benefit of petitioners. The Guiding Principles were established in 2006 to assist the ACCV in evaluating proposed Table revisions and determining whether to recommend Table changes to the Secretary. The ACCV followed these Guiding Principles in making its recommendations to the Secretary for revising this Table. Therefore, the Secretary has decided that the 1-21 day timeframe for both vaccines is the best approach to capture any cases related to the vaccine after day 7.

COMMENT: A commenter identified studies that have been published since the initial NPRM was published.

RESPONSE: The Secretary has reviewed these studies and found that the most recent data have shown a small but statistically significant increased risk of intussusception within 7 days after the first and second doses of the licensed rotavirus vaccines. However, as discussed above, following the Guiding Principles, the ACCV unanimously recommended the proposed change of 1-21 days for all rotavirus vaccines. Therefore, the Secretary has decided that the 1-21 day timeframe for both vaccines is the best approach to capture any cases related to the vaccine after day 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 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive, and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

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.

The Secretary has determined that no resources are required to implement the requirements in this rule. Compensation will be made in the same manner used prior to the revisions of this final rule. The only purpose of this rule is to lessen the burden of proof for potential petitioners. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA) and the Small Business Regulatory Enforcement 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 it would not have a 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.

The Secretary finds that the provisions of this rule will not have an adverse effect on family well-being, because this rule does not affect the following family elements: 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.

This rule is not being treated as a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget. As stated above, this rule would modify the Table based on legal authority.

This rule will have the effect of making it easier for future VICP petitioners alleging the injury of intussusception as the result of a rotavirus vaccine that meets the criteria in the Table to receive the Table's presumption of causation (which relieves them of having to prove that the vaccine actually caused or significantly aggravated the injury).

This final rule has no information collection requirements.

Therefore, for the reasons stated in the preamble, the Department of Health and Human Services amends 42 CFR part 100 as follows:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

This is a summary of the Commission's Sixth Report and Order, CS Docket No. 98-120, FCC 15-65, which was adopted and released on June 10, 2015. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street SW., Room CY-A257, Washington, DC 20554. This document will also be available via ECFS at http://fjallfoss.fcc.gov/ecfs/. Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

This document contains new information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. It will be submitted to OMB for review under Section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new information collection requirements contained in this proceeding. In addition, we note that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees.

1. In this Sixth Report and Order, we adopt a proposal filed jointly by the American Cable Association (“ACA”) and the National Association of Broadcasters (“NAB”) 1 that modifies and extends the exemption from the requirement to carry high definition (“HD”) broadcast signals under “material degradation” provisions of the Communications Act of 1934, as amended (“the Act”) 2 that the Commission granted to certain small cable systems in 2012 (“HD carriage exemption”).3 As discussed below, we find that the joint proposal strikes a reasonable balance between the interests of broadcast stations in having their HD signals transmitted without material degradation and the technical and financial constraints that some small cable operators continue to experience. We set forth below a brief history of the HD carriage exemption and explain the basis for our decision.

2. Sections 614(b)(4)(A) and 615(g)(2) of the Act require that cable operators carry signals of commercial and noncommercial broadcast television stations, respectively, “without material degradation.” In the context of the carriage of digital signals, the Commission has interpreted this requirement: (i) To prohibit cable operators from discriminating in their carriage between broadcast and non-broadcast signals; and (ii) to require cable operators to carry HD broadcast signals to their viewers in HD. To address concerns expressed by small cable operators about cost and technical capacity, the Commission in 2008 granted a three-year exemption from the HD carriage requirement to certain small cable systems. In particular, the Commission applied the exemption to small cable systems with 2,500 or fewer subscribers that are not affiliated with a cable operator serving more than 10 percent of all MVPD subscribers, and those with an activated channel capacity of 552 MHz or less. In 2012, the Commission extended the HD carriage exemption for those cable systems until June 12, 2015.

3. In January 2015, ACA filed a Petition for Rulemaking asking the Commission: (i) To commence a rulemaking proceeding to extend for an additional three years the HD carriage exemption; and (ii) to clarify that analog-only cable systems are not subject to the HD carriage requirement because carriage of HD signals by such systems is not “technically feasible” under Section 614(b)(4)(A) of the Act. On March 12, 2015, the Commission issued a Fifth Further Notice of Proposed Rulemaking in this proceeding that, among other things, proposed to extend the HD carriage exemption for three more years.4 In their initial pleadings responsive to the Fifth Further Notice, multichannel video programming distributors (“MVPDs”) supported the Commission's proposal to extend the HD carriage exemption and broadcasters opposed it. After a series of discussions aimed at resolving their differences, ACA and NAB, on May 14, 2015, filed the joint proposal with the Commission.5

4. We conclude that it would serve the public interest to adopt the joint proposal put forth by ACA and NAB. Throughout the course of this proceeding, ACA and NAB have expressed differing views about the appropriate scope and duration of the HD carriage exemption, among other issues. We find that the compromise reached by ACA and NAB as reflected in the joint proposal reasonably balances the interest of broadcast stations in having their HD signals transmitted in HD and the interest of small cable operators in upgrading their systems to carry HD broadcast signals in a manner that is cost efficient. We note that no industry commenter has lodged any objection to the joint proposal. We, therefore, find that the public interest would be served by adopting ACA and NAB's joint proposal, as set forth below: 6

a. HD Carriage Exemption Eligibility after June 12, 2015: A small cable system not offering any programming in HD is exempt from the HD carriage requirement. Beginning December 12, 2016, a system utilizing the HD carriage exemption shall no longer be eligible to use it once the system offers any programming in HD.

b. Notice: Beginning December 12, 2016, at the time a small cable system utilizing the HD carriage exemption offers any programming in HD, the system must give notice that it is offering HD programming to all broadcast stations in its market that are carried on its system.

c. Transition for Some Systems: A cable system utilizing the HD carriage exemption on June 12, 2015 that does not qualify for the HD carriage exemption on or after June 13, 2015 must come into compliance by December 12, 2016. A cable system that becomes ineligible for the HD carriage exemption after December 12, 2016 would be expected to come into compliance promptly.

d. Revisions to Definition of “Small” Cable System: “Small” cable systems eligible for the HD carriage exemption would be redefined as those: (i) Serving 1,500 (rather than 2,500) or fewer subscribers, and not affiliated with a cable operator serving more than 2 percent (rather than 10 percent) of all MVPD subscribers, or (ii) having an activated channel capacity of 552 MHz or less.

5. Final Regulatory Flexibility Analysis. As required by the Regulatory Flexibility Act of 1980, as amended (“RFA”) 7 an Initial Regulatory Flexibility Act Analysis (“IRFA”) was incorporated in the Fifth Further Notice in this proceeding.8 The Commission sought written public comment on the proposals in the Fifth Further Notice, including comment on the IRFA. The Commission received no comments on the IRFA. This Final Regulatory Flexibility Act Analysis (“FRFA”) conforms to the RFA.9

6. This proceeding stems from a Petition for Rulemaking filed by the American Cable Association in January 2015 principally requesting that the Commission extend the exemption from the requirement to carry high definition (“HD”) broadcast signals under the “material degradation” provisions of the Communications Act of 1934, as amended, that it granted to certain small cable systems in the 2012 Fifth Report and Order (“HD carriage exemption”). The HD carriage exemption will expire on June 12, 2015 without action by the Commission.

7. In the accompanying Sixth Report and Order, the Commission adopts a proposal filed jointly by the American Cable Association (“ACA”) and the National Association of Broadcasters (“NAB”) that modifies and extends the HD carriage exemption. The joint proposal reflects a compromise between ACA and NAB on issues concerning, among other things, the appropriate scope and duration of the HD carriage exemption. The Sixth Report and Order concludes that the joint proposal strikes a reasonable balance between the interests of broadcast stations in having their HD signals transmitted without material degradation and the interests of small cable operators in upgrading their systems to provide HD broadcast signals in a manner that is cost efficient.

8. In particular, the Sixth Report and Order adopts the following provisions that are set forth in the joint proposal:

• HD Carriage Exemption Eligibility after June 12, 2015: A small cable system not offering any programming in HD is exempt from the HD carriage requirement. Beginning December 12, 2016, a system utilizing the HD carriage exemption shall no longer be eligible to use it once the system offers any programming in HD.

• Notice: Beginning December 12, 2016, at the time a small cable system utilizing the HD carriage exemption offers any programming in HD, the system must give notice that it is offering HD programming to all broadcast stations in its market that are carried on its system.

• Transition for Some Systems: A cable system utilizing the HD carriage exemption on June 12, 2015 that does not qualify for the HD carriage exemption on or after June 13, 2015 must come into compliance by December 12, 2016. A cable system that becomes ineligible for the HD carriage exemption after December 12, 2016 would be expected to come into compliance promptly.

• Revisions to Definition of “Small” Cable System: “Small” cable systems eligible for the HD carriage exemption would be redefined as those: (i) Serving 1,500 (rather than 2,500) or fewer subscribers, and not affiliated with a cable operator serving more than 2 percent (rather than 10 percent) of all MVPD subscribers, or (ii) having an activated channel capacity of 552 MHz or less.

9. The Commission did not receive any comments in response to the IRFA.

10. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed actions if adopted.10 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 11 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.12 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).13 The action taken in the accompanying Sixth Report and Order will affect small cable system operators and small television broadcast stations. A description of these small entities, as well as an estimate of the number of such small entities, is provided below.

11. Cable Companies and Systems. The Commission has developed its own small business size standards for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers nationwide.14 Industry data indicate that there are currently 660 cable operators.15 Of this total, all but ten cable operators nationwide are small under this size standard.16 In addition, under the Commission's rate regulation rules, a “small system” is a cable system serving 15,000 or fewer subscribers.17 Current Commission records show 4,629 cable systems nationwide.18 Of this total, 4,057 cable systems have less than 20,000 subscribers, and 572 systems have 20,000 or more subscribers, based on the same records. Thus, under this standard, we estimate that most cable systems are small entities.

12. Cable System Operators (Telecom Act Standard). The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” 19 There are approximately 54 million cable video subscribers in the United States today.20 Accordingly, an operator serving fewer than 540,000 subscribers shall be deemed a small operator if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate.21 Based on available data, we find that all but ten incumbent cable operators are small entities under this size standard.22 We note that the Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million.23 Although it seems certain that some of these cable system operators are affiliated with entities whose gross annual revenues exceed $250,000,000, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.

13. Open Video Systems. The open video system (OVS) framework was established in 1996, and is one of four statutorily recognized options for the provision of video programming services by local exchange carriers.24 The OVS framework provides opportunities for the distribution of video programming other than through cable systems. Because OVS operators provide subscription services,25 OVS falls within the SBA small business size standard covering cable services, which is “Wired Telecommunications Carriers.” 26 The SBA has developed a small business size standard for this category, which is: all such businesses having 1,500 or fewer employees.27 Census data for 2007 shows that there were 3,188 firms that operated for that entire year.28 Of this total, 2,940 firms had fewer than 100 employees, and 248 firms had 100 or more employees.29 Therefore, under this size standard, we estimate that the majority of these businesses can be considered small entities.

14. Television Broadcasting. This economic Census category “comprises establishments primarily engaged in broadcasting images together with sound.” 30 The SBA has created the following small business size standard for such businesses: those having $38.5 million or less in annual receipts.31 The 2007 U.S. Census indicates that 808 firms in this category operated in that year. Of that number, 709 had annual receipts of $25,000,000 or less, and 99 had annual receipts of more than $25,000,000.32 Because the Census has no additional classifications that could serve as a basis for determining the number of stations whose receipts exceeded $38.5 million in that year, we conclude that the majority of television broadcast stations were small under the applicable SBA size standard.

15. Apart from the U.S. Census, the Commission has estimated the number of licensed commercial television stations to be 1,387 stations.33 Of this total, 1,221 stations (or about 88 percent) had revenues of $38.5 million or less, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) on July 2, 2014. In addition, the Commission has estimated the number of licensed noncommercial educational (NCE) television stations to be 395.34 NCE stations are non-profit, and therefore considered to be small entities.35 Based on these data, we estimate that the majority of television broadcast stations are small entities.

16. We note, however, that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations 36 must be included. Because we do not include or aggregate revenues from affiliated companies in determining whether an entity meets the revenue threshold noted above, our estimate of the number of small entities affected is likely overstated. In addition, we note that one element of the definition of “small business” is that an entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television broadcast station is dominant in its field of operation. Accordingly, our estimate of small television stations potentially affected by the proposed rules includes those that could be dominant in their field of operation. For this reason, such estimate likely is over-inclusive.

17. In this section, we describe the reporting, recordkeeping, and other compliance requirements that the Commission adopts in the Sixth Report and Order.

18. Reporting Requirements. The Sixth Report and Order does not adopt reporting requirements.

19. Recordkeeping Requirements. The joint proposal adopted in the Sixth Report and Order requires that, “[b]eginning December 12, 2016, at the time a small cable system utilizing the HD carriage exemption offers any programming in HD, the system must give notice that it is offering HD programming to all broadcast stations in its market that are carried on its system.” This requirement obligates certain small cable operators to notify broadcast stations, and thus, to make and keep records of such notification.

20. Other Compliance Requirements. The joint proposal adopted in the Sixth Report and Order:

• Requires “[a] cable system utilizing the HD carriage exemption on June 12, 2015 that does not qualify for the HD carriage exemption on or after June 13, 2015 [to] come into compliance [with the HD carriage requirement] by December 12, 2016. A cable system that becomes ineligible for the HD carriage exemption after December 12, 2016 would be expected to come into compliance promptly.”

• Requires that “[b]eginning December 12, 2016, a system utilizing the HD carriage exemption shall no longer be eligible to use it once the system offers any programming in HD.”

21. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.37 We seek comment on the applicability of any of these alternatives to affected small entities.

22. The HD carriage exemption, as modified in the Sixth Report and Order, provides continued regulatory relief to operators of certain small cable systems, i.e., those that (i) serve 1,500 or fewer subscribers and are not affiliated with a cable operator serving more than two percent of all MVPD subscribers; or (ii) have an activated channel capacity of 552 MHz or less. Although some eligible cable systems will no longer qualify for the exemption as a result of the Sixth Report and Order, the joint proposal adopted in the order gives such systems until December 12, 2016 to come into compliance with the HD carriage requirement. We note that the modifications made to the exemption in the Sixth Report and Order were an outgrowth of discussions between ACA and NAB and thus reflect the interests of both small cable operators and broadcasters (including small broadcasters), respectively. The HD carriage exemption has a positive economic impact on any cable system operator that takes advantage of the exemption, and imposes no significant burdens on small television stations.

23. The Commission will send a copy of this Sixth Report and Order, including this FRFA, in a report to be sent to Congress pursuant to the SBREFA.38 In addition, the Commission will send a copy of this Sixth Report and Order, including the FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of this Sixth Report and Order and the FRFA (or summaries thereof) also will be published in the Federal Register.39

24. This Sixth Report and Order contains new information collection requirements subject to the Paperwork Reduction Act of 1995. It will be submitted to the Office of Management and Budget (OMB) for review under Section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new or modified information collection requirements contained in this proceeding. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees.

25. The Commission will send a copy of this Sixth Report and Order in a report to be sent to Congress and the Government Accountability Office, pursuant to the Congressional Review Act.40

26. For more information, contact Raelynn Remy, [email protected], Policy Division, Media Bureau, (202) 418-2936.

27. Accordingly, it is ordered that, pursuant to the authority found in sections 4, 303, 614, and 615 of the Communications Act of 1934, as amended, 47 U.S.C. 154, 303, 534, and 535, this Sixth Report and Order is adopted and will become effective July 23, 2015, except that the requirement described in paragraph III.4.b of the Supplementary Information, which contains new or modified information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13, will not become effective until the Federal Communications Commission publishes a notice in the Federal Register announcing OMB approval and the effective date of that rule.

28. It is further ordered that, pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A), the Commission will send a copy of this Sixth Report and Order in CS Docket No. 98-120 in a report to Congress and the Government Accountability Office.

29. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send a copy of this Sixth Report and Order in CS Docket No. 98-120, including the Final Regulatory Flexibility Act Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

This document corrects 49 CFR part 572, “Anthropomorphic Test Devices,” Subpart T, “Hybrid III 10-Year-Old Child Test Dummy (HIII-10C).” NHTSA published a final rule on February 27, 2012 (77 FR 11651), establishing Subpart T, which contains specifications and qualification requirements for the HIII-10C. The regulatory text adopted by that document contains errors, as do some of the drawings and other materials incorporated by reference pertaining to the test dummy. This document corrects those errors by revising regulatory text and incorporating by reference a corrected drawing package, parts list and users' manual.

The following corrections are made to the regulatory text.

a. Sections 572.170 and 572.171 of subpart T incorporate by reference a drawings and inspection package, a parts/drawing list, and a users' manual (“Procedures for Assembly, Disassembly and Inspection” (“PADI”)) for the HIII-10C by name and by date. NHTSA is correcting several drawings in the package, and is making conforming changes to the parts list and to several figures in the PADI. For ease of use, rather than switch out individual drawings from the previous drawings package and individual pages from the original PADI and risk confusion by users in the future about which drawings and pages were replaced, NHTSA is incorporating by reference a new set of materials. We are referencing a new drawings and inspection package that has the corrected drawings, a new parts/drawing list, and a new PADI. All these new materials are dated March 2015. We are amending § 572.170 and § 572.171 to reference the new versions of the materials.

b. The February 2012 final rule incorrectly specifies in 49 CFR 572.177(a)(1) that the thorax impact probe mass is 6.89 ± 0.012 kilograms (kg) (15.2 ± 0.05 pounds (lb)). Figure T4 of subpart T correctly lists the thorax impact probe mass as “6.89 ± 0.05 kg (15.2 ± 0.1 lb).” We are correcting the second sentence of 49 CFR 572.177(a)(1) so that it refers to “6.89 ± 0.05 kg (15.2 ± 0.1 lb).”

Likewise, the February 2012 final rule incorrectly specifies in § 572.177(a)(2) that the knee impact probe mass is 1.91 ± 0.01 kg (4.21 ± 0.02 lb). Figure T6 of subpart T correctly lists the knee impact probe mass as “1.91 ± 0.05 kg (4.2 ± 0.1 lb).” We are correcting the second sentence of 49 CFR 572.177(a)(2) to reference a mass of 1.91 ± 0.05 kg (4.21 ± 0.1 lb).

c. The February 2012 final rule inadvertently excluded a specification for the filter class used for the knee probe acceleration and for the thorax probe acceleration. The filter class used for the knee probe acceleration is SAE International (SAE) Channel Frequency Class (CFC) 600. CFC 600 has historically been applied to other dummy knee probe accelerations and NHTSA used CFC 600 in developmental testing of the HIII-10C. The filter class used for the thorax probe acceleration is CFC 180. NHTSA specifies the CFC 180 filter class with other test dummies and used it in developing the HIII-10C. Accordingly, NHTSA corrects 49 CFR 572.177(c) by adding the filter classes for the knee and thorax probe accelerations.

In the revisions table for this drawing, in Rev F, the overall Upper Leg Flesh height dimension is correctly specified as “4.50 +.06/−.18 (was 4.5 +.16/−.13).” Elsewhere on the drawing, the height dimension next to the part does not match this value in the table. We have corrected the height dimension next to the part to match that of the table.

In Drawing 420-5120, the dimension for the overall Upper Leg Flesh width is correctly listed, next to the part, as “4.92 +.05/−.20.” In the revisions table, Rev F, the width dimension is different and incorrect. We have corrected the revisions table to match the dimension listed next to the part.

In the revision history table, Rev F, the width of the abdomen pocket is correctly stated as (3.77) and the depth is correctly stated as (2.14). Elsewhere on the drawing, the dimensions listed for those parts do not match those correct dimensions in the revision history table. We have corrected the drawing to match the correct dimensions in the table.

In the revision history table, Rev E, Note #2 had read: “All Dimensional Tolerances Are ±0.12 inch.” The note was incorrectly removed, and in Rev F, a ±0.06 inch tolerance was incorrectly added to two dimensions (0.75 ±0.06 and 0.62 ±0.06). The ±0.06 inch tolerance is in error; it is an unrealistic dimensional requirement for a molded part. We have revised the drawing to reestablished the ±0.12 inch tolerance for this part.

The drawing package incorporated by the February 2012 final rule had drawing 880105-102, which had an error with respect to the dimensions called out for the center of gravity (CG) location of the skull. The correct CG dimensions for the head assembly are in drawing 420-0000, Sheet 4 of 5, as follows: CGx = 2.330 ± 0.100 inch and CGz = 1.200 ± 0.100 inch. We have removed drawing 880105-102 and have revised drawing 420-1001 (Rev D) to add information on the CG location.

Some of the drawings of the HIII-10C's shoulder area are incorrect because they depict the design of the dummy at the time of our publication of the notice of proposed rulemaking (NPRM) 1 preceding the February 2012 final rule, and not the design of the HIII-10C as it was adopted by the final rule. As adopted by the final rule, the HIII-10C has a shoulder assembly design that can be modified by switching a part of the shoulder assembly (the shoulder yoke), to enable the dummy shoulder to accommodate either a load cell or a structural replacement (SR) in place of a load cell. The drawings adopted by the final rule show the shoulder yoke that accommodates an SR, but we inadvertently did not include drawings showing the HIII-10C with the shoulder yoke assembly that accommodates a load cell. We have corrected this oversight by including in the new drawing package drawings of the alternate shoulder yoke assembly that accommodates a load cell, and drawings of the load cell and assorted hardware.

We have revised various figures in the PADI to conform the manual to the changes discussed above. Most of the revisions relate to using the shoulder yoke assembly when using the HIII-10C with a shoulder load cell. The revised figures are: 12, 21, 22, 24, 29, 82 and 83.

Accordingly, 49 CFR part 572 is corrected by making the following correcting amendments:

Purpose of Direct Final Rule and Final Action

The purpose of this direct final rule is to notify the public that we are revising the List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations (50 CFR 17.11(h)) and the List of Endangered and Threatened Plants (50 CFR 17.12(h)) to reflect the scientifically accepted taxonomy and nomenclature of 4 wildlife species and 50 plant species listed under section 4 of the Act (16 U.S.C. 1531 et seq.). These changes to the List of Endangered and Threatened Wildlife and the List of Endangered and Threatened Plants reflect the most recently accepted scientific names in accordance with 50 CFR 17.11(b) and 50 CFR 17.12(b).

We are publishing this rule without a prior proposal because this is a noncontroversial action that is in the best interest of the public and should be undertaken in as timely a manner as possible. This rule will be effective, as published in this document, on the effective date specified in DATES, unless we receive significant adverse comments on or before the comment due date specified in DATES. Significant adverse comments are comments that provide strong justifications as to why this rule should not be adopted or why it should be changed.

If we receive significant adverse comments regarding the taxonomic changes for any of these species, we will publish a document in the Federal Register withdrawing this rule before the effective date, and we will publish a proposed rule to initiate promulgation of those changes to 50 CFR 17.11 or 50 CFR 17.12.

You may submit your comments and materials regarding this direct final rule by one of the methods listed in ADDRESSES. Please include sufficient information with your comments that allows us to verify any scientific or commercial information you include. We will not consider comments sent by email or fax, or to an address not listed in ADDRESSES.

We will post all comments on http://www.regulations.gov. Before including your address, phone number, email address, or other personal information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we use in preparing this direct final rule, will be available for public inspection on the Internet at http://www.regulations.gov or by appointment, during normal business hours at the U.S. Fish and Wildlife Service office listed in the ADDRESSES section. Please note that comments posted to http://www.regulations.gov are not immediately viewable. When you submit a comment, the system receives it immediately. However, the comment will not be publicly viewable until we post it, which might not occur until several days after submission. Information regarding this rule is available in alternative formats upon request (see FOR FURTHER INFORMATION CONTACT). For information pertaining to specific species, please contact our Ecological Services field offices as follows:

Sections 17.11(b) and 17.12(b) of title 50 of the Code of Federal Regulations (CFR) requires us to use the most recently accepted scientific name of any wildlife or plant species that we have determined to be an endangered or threatened species. Using the best available scientific information, this direct final rule documents taxonomic changes of the scientific names to 4 entries on the List of Endangered and Threatened Wildlife (50 CFR 17.11(h)) and 31 entries on the List of Endangered and Threatened Plants (50 CFR 17.12(h)). The basis for these taxonomic changes is supported by published studies in peer-reviewed journals. Accordingly, we revise the scientific names of these species under section 4 of the Act (16 U.S.C. 1531 et seq.) as follows: northern Idaho ground squirrel (Urocitellus brunneus); Hawaiian common gallinule (Gallinula galeata sandvicensis); Guam kingfisher (Todiramphus cinnamominus); Hawaiian petrel (Pterodroma sandwichensis); Cyanea crispa (haha); Cyanea rivularis (haha); Cyperus fauriei (no common name); Erigeron decumbens (Willamette daisy); Euphorbia celastroides var. kaenana (`akoko); Euphorbia deppeana (`akoko); Euphorbia eleanoriae (`akoko); Euphorbia halemanui (`akoko); Euphorbia herbstii (`akoko); Euphorbia kuwaleana (`akoko); Euphorbia remyi var. kauaiensis (`akoko); Euphorbia remyi var. remyi (`akoko); Euphorbia rockii (`akoko); Euphorbia skottsbergii var. skottsbergii (`Ewa Plains `akoko); Kadua cookiana (`awiwi); Kadua st-johnii (no common name); Limnanthes pumila ssp. grandiflora (large-flowered woolly meadowfoam); Lobelia koolauensis (no common name); Polyscias bisattenuata (no common name); Polyscias flynnii (no common name); Polyscias gymnocarpa (`ohe`ohe); Polyscias lydgatei (no common name); Polyscias racemosa (no common name); Pritchardia maideniana (lo`ulu); Schiedea lychnoides (kuawawaenohu); Schiedea viscosa (no common name); Sicyos albus (`anunu); Asplenium dielfalcatum (no common name); Asplenium dielmannii (no common name); Asplenium dielpallidum (no common name); and Asplenium unisorum (no common name). We make these changes to the List of Endangered and Threatened Wildlife and the List of Endangered and Threatened Plants to reflect the most recently accepted scientific names in accordance with 50 CFR 17.11(b) and 50 CFR 17.12(b).

Additionally, common names of 3 additional species (Cyanea platyphylla (`aku`aku), Dubautia latifolia (koholapehu), and Geranium arboreum (nohoanu)) are revised to reflect currently accepted usage. And family assignments of 16 species (Flueggea neowawraea (mehamehame), Korthalsella degeneri (hulumoa), Lysimachia daphnoides (lehua makanoe), L. iniki (no common name), L. pendens (no common name), L. scopulensis (no common name), L. venosa (no common name), Myrsine juddii (kolea), M. knudsenii (kolea), M. linearifolia (kolea), M. mezii (kolea), M. vaccinioides (kolea), Pleomele hawaiiensis (hala pepe), Xylosma crenatum (no common name), Adenophorus periens (pendent kihi fern), and Diplazium molokaiense (no common name)) are also revised.

The northern Idaho ground squirrel was originally listed as threatened on April 5, 2000, under the scientific name Spermophilus brunneus brunneus (65 FR 17779). At that time this taxon and the southern Idaho ground squirrel (S. b. endemicus) were both considered to be subspecies of the Idaho ground squirrel, Spermophilus brunneus (Thorington and Hoffmann 2005, p. 805). Helgen et al. (2009, pp. 270-305) split the genus Spermophilus into eight genera: Urocitellus (including the Idaho ground squirrel), Notocitellus, Otospermophilus, Callospermophilus, Spermophilus, Ictidomys, Poliocitellus, and Xerospermophilus, based on skull morphology, pelage characteristics, and mitochondrial DNA analyses (Herron et al. 2004, pp. 1015-1030). The northern Idaho ground squirrel and the southern Idaho ground squirrel differ in pelage, life-history timing, and skull and bacular morphology (Yensen and Sherman 1997, pp. 1-3), and analysis of microsatellite and mitochondrial DNA shows no evidence of recent genetic exchange between the two taxa (Hoisington-Lopez et al. 2012, pp. 589-604). Consequently, Hoisington-Lopez et al. (2012, pp. 595-599) elevated both taxa to species rank, as Urocitellus brunneus and U. endemicus. This taxonomic change does not affect the range or threatened status of the northern Idaho ground squirrel. The Service has used the updated scientific name U. endemicus for the southern Idaho ground squirrel (currently a candidate for listing under the Endangered Species Act) since publication of the candidate notice of review on November 22, 2013 (78 FR 70104).

This subspecies was originally listed as endangered on March 11, 1967, under the name of Hawaiian common gallinule (Gallinula chloropus sandvicensis) (32 FR 4001). At that time, the range of Gallinula chloropus was considered to include both the Old World and New World, with the common name of “common gallinule” in American usage (American Ornithologists' Union [AOU] 1957, pp. 160-161) and “moorhen” or “common moorhen” in British usage (e.g., Dudley et al. 2006, p. 537). Subsequently the AOU (1982, p. 5CC) changed the common name of the species to “common moorhen” for consistency with international usage. The current List of Endangered and Threatened Wildlife is consistent with this approach, listing the species as “Hawaiian common moorhen”. However, more recent research indicates that the New World and Old World populations are separate species, based on differences in vocalizations and morphology of the bill and frontal shield (Constantine and the Sound Approach 2006, pp. 138-139) and mitochondrial DNA (Groenenberg et al. 2008, pp. 1-8). Based on this research, AOU accepts the two populations as distinct species (Chesser et al. 2011, p. 603), splitting them into the common gallinule (Gallinula galeata) of North and South America and the common moorhen (Gallinula chloropus) of Eurasia. Chesser et al. (2011, p. 603) includes the Hawaiian Islands within the range of the common gallinule. Data from Hawaiian birds were not analyzed by Constantine and the Sound Approach (2006, pp. 138-139) or Groenenberg et al. (2008, pp. 1-8); however, specimens from the Hawaiian Islands are similar to New World birds in frontal shield morphology, and a mitochondrial DNA sequence from a Hawaiian specimen is identical to those of New World specimens (T. Chesser in litt. 2012). Consequently, the Hawaiian subspecies is now classified as Gallinula galeata sandvicensis, and returns to its original common name of “Hawaiian common gallinule”. The taxonomic change does not affect the range or endangered status of the Hawaiian common gallinule.

The taxonomic position of the Mariana common moorhen, listed as endangered on August 27, 1984 (49 FR 33881) under the scientific name of Gallinula chloropus guami, has not been studied in detail; however, its frontal shield morphology appears more similar to Old World specimens (T. Chesser in litt. 2012). Consequently, the best available information indicates that its common and scientific names are still appropriate.

This bird was originally listed as endangered within its range on Guam on August 27, 1984, under the name of Micronesian kingfisher (Halcyon cinnamomina cinnamomina) (49 FR 33881). The Service's critical habitat designation (69 FR 62944; October 28, 2004) revised the common name of this taxon in the List of Endangered and Threatened Wildlife to “Guam Micronesian kingfisher”, given that two other subspecies of Micronesian kingfisher occur outside Guam.

At the time this taxon was listed, the genus Halcyon encompassed several dozen kingfisher species ranging from Africa to Australasia and the Pacific islands (Forshaw 1983; Fry et al. 1992, as cited in Moyle 2006, p. 496; Howard and Moore 1991, pp. 168-169). The Australasian and Pacific species within this group are distinctive based on plumage pattern, myology, osteology, feather proteins, and DNA hybridization data (Sibley and Monroe 1990, pp. 89-90; Woodall 2001; Christidis and Boles 2008, p. 169). Analysis of nuclear and mitochondrial DNA (Moyle 2006, pp. 487-499) further indicates that the group of species originally classified under the genus Halcyon is not monophyletic (a monophyletic group consists of an ancestral species and all its descendants, typically being characterized by shared derived characteristics). Consequently most recent authorities (e.g., Woodall 2001, p. 134; Dickinson 2003) have restricted Halcyon to the African species; other species in the group have been classified under the genera Todiramphus (including the Micronesian kingfisher), Pelargopsis, and Syma. When the Micronesian kingfisher was classified within Todiramphus, its specific epithet was changed to cinnamominus for consistency with the gender of the new genus name. Del Hoyo et al. (2014, p. 606) reviewed the three subspecies of Micronesian kingfisher (T. cinnamominus on Guam, T. pelewensis on Palau, and T. reichenbachi on Pohnpei) under the species delimitation criteria of Tobias et al. (2010, pp. 1-23), and concluded that they were distinct at the species level based on differences in plumage pattern, wing and tail proportions, body size, and voice. Consequently, the listed population on Guam is now classified as a full species, Guam kingfisher (Todiramphus cinnamominus). The taxonomic change does not affect the range or endangered status of the taxon.

This bird was originally listed as endangered on March 11, 1967, under the name of Hawaiian dark-rumped petrel (Pterodroma phaeopygia sandwichensis) (32 FR 4001). At that time, the dark-rumped petrel (Pterodroma phaeopygia) was considered to include two subspecies: P. sandwichensis, which breeds on the Hawaiian Islands; and P. phaeopygia, which breeds on the Galapagos Islands and is not known to occur in the United States (AOU 1983, p. 16). More recently, study of the morphology and vocalizations of these two taxa (Tomkins and Milne 1991, pp. 1-35; Browne et al. 1997, pp. 812-815) indicates that they are distinct at a level comparable to other species in the genus. Consequently, the AOU has split them into two species, the Hawaiian petrel (Pterodroma sandwichensis) and the Galapagos petrel (Pterodroma phaeopygia) (Banks et al. 2002, p. 898). On January 5, 2010, the Galapagos petrel was also listed (as threatened), under the now accepted scientific name of Pterodroma phaeopygia (75 FR 235). The taxonomic change does not affect the range or endangered status of the Hawaiian petrel, nor does it affect the range or threatened status of the Galapagos petrel.

The Willamette daisy was listed as endangered on January 25, 2000, under the scientific name Erigeron decumbens var. decumbens (65 FR 3875). At that time E. decumbens was considered to include two varieties, decumbens and robustior. Nesom (2004, pp. 19-39) elevated var. robustior to full species status, finding that the taxon was distinctive in morphology (involucre size, shape of phyllaries, length of corollas and cypselae) and soil habitat preference at a level similar to that of other species of Erigeron. Since var. decumbens was thus the only remaining variety within the species, rendering designation of a nominate variety superfluous, the taxon was renamed as the full species E. decumbens. This treatment has been adopted by the Flora of North America (Nesom 2006, pp. 274-279) and the Oregon Flora Project (Cook et al. 2014a, p. 64). Consequently, the current scientific name of the Willamette daisy is Erigeron decumbens. This taxonomic change does not affect the range or endangered status of the Willamette daisy.

The large-flowered woolly meadowfoam was listed as endangered on November 7, 2002, under the scientific name Limnanthes floccosa ssp. grandiflora (67 FR 68004). At that time the species L. floccosa was considered to include five subspecies: L. f. ssp. bellingeriana, L. f. ssp. californica, L. f. ssp. floccosa, L. f. ssp. grandiflora, and L. f. ssp. pumila (Arroyo 1973, pp. 177-191; Ornduff 1993, pp. 736-738; Morin 2010, pp. 174-183). Meyers (2010) analyzed chloroplast, mitochondrial, and nuclear DNA of these subspecies and found they represented two clades: ssp. grandiflora and ssp. pumila in one, and ssp. bellingeriana, ssp. californica, and ssp. floccosa in the other; moreover, ssp. grandiflora and ssp. floccosa showed pre- and post-zygotic reproductive isolation from one another when crossed by hand. Consequently, Meyers (2010, pp. 1-121) and Chambers and Meyers (2011, pp. 621-622) reclassified ssp. grandiflora and ssp. pumila within a separate species L. pumila. This treatment has been adopted by the Oregon Flora Project (Cook et al. 2014b, pp. 1-2). Consequently, the current scientific name of the large-flowered woolly meadowfoam is Limnanthes pumila ssp. grandiflora. This taxonomic change does not affect the range or endangered status of the large-flowered woolly meadowfoam.

The Hawaiian plants Alsinidendron lychnoides (kuawawaenohu) and A. viscosum (no common name) were listed as endangered on October 10, 1996 (61 FR 53070). At that time Alsinidendron was considered to be a genus of four species distinct from Schiedea (Wagner et al. 1999, pp. 499-502). However, analysis of nuclear DNA sequence data and morphology by Wagner et al. (2005, pp. 1-169) showed that the Alsinidendron clade is nested within Schiedea, as a sister group to Schiedea verticillata; thus the species in Alsinidendron were reassigned to Schiedea. The specific epithet viscosum was changed to viscosa to conform to the gender of the new generic name. These changes have been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 26). Consequently, the current scientific names of these species are Schiedea lychnoides and Schiedea viscosa. This taxonomic change does not affect the range or endangered status of either of these species.

The scientific names of Alsinidendron trinerve and A. obovatum (listed as endangered on October 29, 1991 (56 FR 55770)), were revised on the List of Endangered and Threatened Plants to their updated names of Schiedea trinervis and S. obovata when critical habitat was designated on September 18, 2012 (77 FR 57648); thus no further changes in nomenclature are needed for these two species.

The `Ewa Plains `akoko, a plant endemic to southwestern Oahu, was originally listed under the scientific name Euphorbia skottsbergii var. kalaeloana on August 24, 1982 (47 FR 36846), based on the taxonomy of Sherff (1938, pp. 1-94). Degener and Degener (1959, page unnumbered) moved this species to the genus Chamaesyce, as C. skottsbergii var. kalaeloana. Koutnik (1987, pp. 356-360; 1999, pp. 614-615) synonymized var. kalaeloana with var. skottsbergii, treating var. skottsbergii with a range including southwestern Oahu and northwestern Molokai. Morden and Gregoritza (2005, pp. 969-979) found that the Oahu and Molokai populations of var. skottsbergii differed genetically, and recommended treating them as separate varieties: var. audens on Molokai, and var. skottsbergii on Oahu (including the same range as the originally listed entity). Consequently, the Service revised the List of Endangered and Threatened Plants to refer to the `Ewa Plains `akoko as Chamaesyce skottsbergii var. skottsbergii when critical habitat was designated on September 18, 2012 (77 FR 57648); however, current research supports classifying this plant in the genus Euphorbia as discussed below.

Several other endangered Hawaiian plants are classified in the genus Chamaesyce as recognized by Degener and Degener (1959). Chamaesyce celastroides var. kaenana and C. kuwaleana were listed as endangered on October 29, 1991 (56 FR 55770); C. halemanui was listed as endangered on May 13, 1992 (57 FR 20580); C. deppeana was listed as endangered on March 28, 1994 (59 FR 14482); C. herbstii and C. rockii were listed as endangered on October 10, 1996 (61 FR 53089); C. eleanoriae, C. remyi var. kauaiensis, and C. remyi var. remyi were listed as endangered on April 13, 2010 (75 FR 18960). No common name was given for Chamaesyce halemanui when it was listed; the other species above were listed with the common name of `akoko.

Phylogenetic analysis of nuclear and chloroplast DNA sequence data for species in the tribe Euphorbieae (Steinmann and Porter 2002, pp. 453-490; Yang and Berry 2011, pp. 1486-1503) indicate that the genus Euphorbia was paraphyletic (i.e., consisting of all the descendants of the last common ancestor of the group's members except for a small number of monophyletic groups of descendants), with Chamaesyce and several other genera nested within it. Steinman and Porter (2002, pp. 479-480) recommended expanding Euphorbia to include Chamaesyce and the other genera in the subtribe Euphorbiinae. This approach has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, pp. 31-34). Consequently, the current scientific names of the listed Chamaesyce species are now Euphorbia celastroides var. kaenana, E. deppeana, E. eleanoriae, E. halemanui, E. herbstii, E. kuwaleana, E. remyi var. kauaiensis, E. remyi var. remyi, E. rockii, and E. skottsbergii var. skottsbergii. Although no common name was designated for E. halemanui when it was listed, the common name of `akoko is also appropriate for this species (Wagner et al. 1999, p. 607). These taxonomic changes do not affect the range or endangered status of any of these species.

Euphorbia haeleeleana (`akoko), which was listed as endangered on October 10, 1996 (61 FR 53108), is not a member of the Chamaesyce group (Wagner et al. 1999, p. 619), and its taxonomy has not changed.

The Hawaiian plant Rollandia crispa (haha) was listed as endangered on March 28, 1994 (59 FR 14482). Phylogenetic analyses of chloroplast DNA indicated that the species classified in Rollandia were nested within the paraphyletic genus Cyanea (Lammers et al. 1993, pp. 437-441), and the species in Rollandia were, therefore, merged into Cyanea; however, Wagner et al. (1999, pp. 480-481) continued to recognize Rollandia as a genus, including Rollandia crispa. When the Service designated critical habitat for the species on June 17, 2003 (68 FR 35950), the scientific name in the List of Endangered and Threatened Plants was revised to read “Cyanea (=Rollandia) crispa”. The merger of Rollandia into Cyanea has since been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 24); because Rollandia is no longer a recognized genus, the parenthetical reference to it as an alternative name is unnecessary. Consequently the current scientific name of the species, as it should read in the List of Endangered and Threatened Plants, is Cyanea crispa. The current listing of “Cyanea (=Rollandia) crispa” indicates that no common name exists; this is erroneous as the common name is haha. Therefore, we are correcting this error in this rule. These changes do not affect the range or endangered status of the species.

Cyanea platyphylla was listed as endangered on October 10, 1996 (61 FR 53137), with the common name of haha. Although this common name is generally used for species in the genus Cyanea, Wagner et al. (1999, p. 459) specifically identified `aku`aku as the appropriate common name for Cyanea platyphylla. This change in common name does not affect the range or endangered status of the species.

Delissea rivularis (oha) was listed as endangered on October 10, 1996 (61 FR 53070). However, Lammers (2005, p. 13) found that the morphology of its leaves, flowers, and seeds is more similar to Cyanea and that molecular data indicate it is more closely related to Cyanea coriacea than to species in Delissea and, therefore, recommended transferring the species to Cyanea. This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 23). Consequently, the current scientific name of this species is Cyanea rivularis. The common name is also changed to haha to correspond with the generally used common name for other species in Cyanea (Wagner et al. 1999, p. 437). This taxonomic change does not affect the range or endangered status of the species.

On June 11, 2012, a proposed critical habitat rule for multiple Hawaiian species (77 FR 34464) also included proposed scientific name changes for two additional Cyanea species: Cyanea dunbarii (changed to C. dunbariae) and C. macrostegia ssp. gibsonii (changed to C. gibsonii). We expect these changes to be finalized when the final critical habitat rule is published.

The Hawaiian plant Dubautia latifolia was listed as endangered on May 13, 1992 (57 FR 20580), with the common name of na`ena`e. Although this common name is generally used for species in the genus Dubautia, Wagner et al. (1999, p. 299) specifically identified koholapehu as the appropriate common name for D. latifolia. This change in common name does not affect the range or endangered status of the species.

The Hawaiian plant Geranium arboreum was listed as endangered on May 13, 1992 (57 FR 20589), with the common name of Hawaiian red-flowered geranium. This common name was not historically used prior to listing of the species; however, Wagner et al. (1999, p. 729) identified nohoanu or hinahina as accepted common names for native Hawaiian species of Geranium, including G. arboreum. Use of the common name nohoanu is consistent with Service practice for other listed species of Hawaiian Geranium. This change in common name does not affect the range or endangered status of the species.

The Hawaiian plant Hedyotis cookiana (`awiwi) was listed as endangered on February 25, 1994 (59 FR 9304). Hedyotis st.-johnii (Na Pali Beach hedyotis) was listed as endangered on September 30, 1991 (56 FR 49639). Terrell et al. (2005, pp. 818-833) reviewed seed and fruit morphology and floral characteristics of Hawaiian and South Pacific Hedyotis species and found that they were distinct from the Asian and North American species, reassigning them to the genus Kadua. This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, pp. 63-65). Consequently, the current scientific names of these species are Kadua cookiana and Kadua st.-johnii. The common name given for K. st.-johnii in the List of Endangered and Threatened Plants, Na Pali Beach hedyotis, was not historically used prior to listing of the species. Because Wagner et al. (1999, p. 1150) did not identify an independently accepted common name for this species, we are revising the List of Endangered and Threatened Plants to indicate that no common name exists. These taxonomic changes do not affect the range or endangered status of either of these species.

On June 11, 2012, a proposed critical habitat rule for multiple Hawaiian species (77 FR 34464) also included proposed scientific name changes for two additional Hedyotis species: Hedyotis schechtendahliana var. remyi (changed to Kadua cordata ssp. remyi) and Hedyotis mannii (changed to Kadua laxiflora). We expect these changes to be finalized when the final critical habitat rule is published.

The Hawaiian plant Lobelia gaudichaudii ssp. koolauensis (no common name) was listed as endangered on October 10, 1996 (61 FR 53089). While Wagner et al. (1999, p. 476) recognized two subspecies of L. gaudichaudii (ssp. koolauensis and ssp. gaudichaudii), differing in corolla color and branching of inflorescences, Lammers (2007, p. 797) determined that they do not interbreed where sympatric and elevated both taxa to full species status. This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 24). Consequently, the current scientific name of this species is Lobelia koolauensis. This taxonomic change does not affect the range or endangered status of the species.

The Hawaiian sedge species Mariscus fauriei (no common name) was listed as endangered on March 4, 1994 (59 FR 10305). Historically, the genus Mariscus has also been recognized as a subgenus of Cyperus, but taxonomists have noted that no consistent characters (e.g., leaf anatomy, spikelet structure, photosynthetic metabolism type) separate the Mariscus group from other species in Cyperus, and recommend merging it within Cyperus subg. Cyperus (Lye 1981, p. 57; Tucker 1994, p. 10; Strong and Wagner 1997, p. 39). This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 81). Consequently, the current scientific name of this species is Cyperus fauriei. This taxonomic change does not affect the range or endangered status of the species.

The Hawaiian plant Munroidendron racemosum (no common name) was listed as endangered on February 25, 1994 (59 FR 9304). Tetraplasandra gymnocarpa (`ohe`ohe) was listed as endangered on March 28, 1994 (59 FR 14482). Tetraplasandra bisattenuata (no common name) and T. flynnii (no common name) were listed as endangered on April 13, 2010 (75 FR 18960). Tetraplasandra lydgatei (no common name) was listed as endangered on September 18, 2012 (77 FR 57648).

Lowry and Plunkett (2010, pp. 55-84) determined, based on molecular phylogenetic studies (phylogenetics is the study of evolutionary relationships among groups of organisms that are discovered through molecular sequencing data and morphological data matrices) (Plunkett et al. 2001, pp. 213-230; 2004, pp. 861-873), that the genus Polyscias, as previously circumscribed, is paraphyletic, with six traditionally recognized genera (Arthrophyllum, Cuphocarpus, Gastonia, Munroidendron, Reynoldsia, and Tetraplasandra) nested within it. They recommended combining all of these genera into Polyscias. Species in the genera Munroidendron and Tetraplasandra were thus assigned to the genus Polyscias, subgenus Tetraplasandra. The specific epithet racemosum was changed to racemosa to conform with the gender of the new genus name. These changes have been accepted in the most recent update to the Manual of the Flowering Plants of Hawai`i (Wagner et al. 2012, pp. 7-8). Consequently, the current scientific names of these species are P. racemosa, P. gymnocarpa, P. bisattenuata, P. flynnii, and P. lydgatei. These taxonomic changes do not affect the range or endangered status of any of these species.

The Hawaiian palm tree Pritchardia affinis (lo`ulu) was listed as endangered on March 4, 1994 (59 FR 10305). This listing followed the taxonomy of Beccari and Rock (1921, pp. 37-41), who described P. affinis, including three additional varieties (var. gracilis, var. halophila, and var. rhopalocarpa) from localities on the island of Hawai`i. Previously, Beccari (1913, pp. 213-216) had described P. maideniana from cultivated plants in the Royal Botanic Gardens, Sydney, Australia, although the geographic origin of those individuals was unclear and no wild specimens had been located (Beccari and Rock 1921, p. 23). Hodel (2007, pp. S26-S27) examined an extant cultivated plant at the Royal Botanic Gardens, plants in Hawaii grown from its seeds, living plants within the native range of P. affinis on the island of Hawai`i, and photographs of type specimens attributed to both species, and found no differences between P. affinis and P. maideniana. Because P. affinis was the more recently described, Hodel reassigned the species (including all varieties) to P. maideniana. This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawai`i (Wagner et al. 2012, p. 76). Consequently, the current scientific name of this species is P. maideniana. This taxonomic change does not affect the range in the wild or the endangered status of the species.

The Hawaiian plant Sicyos alba (`anunu) was listed as endangered on October 10, 1996 (61 FR 53137). The most recent update to the Manual of the Flowering Plants of Hawai`i (Wagner et al. 2012, p. 30) corrected the specific epithet to albus, making it consistent with the gender of the genus name. Consequently, the current scientific name of the species is Sicyos albus. This correction does not affect the range or endangered status of the species.

The Hawaiian fern Diellia falcata was listed as endangered on October 29, 1991 (56 FR 55770). Diellia pallida was listed as endangered on February 25, 1994 (59 FR 9304). Diellia unisora was listed as endangered on June 27, 1994 (59 FR 32932). Diellia mannii was listed as endangered on April 13, 2010 (75 FR 18960).

Kramer and Viane (1990, p. 55) and Viane and Reichstein (1991, p. 157) classified all species within the family Aspleniaceae, including the above species of Diellia, under the genus Asplenium. Analysis of molecular data by Schneider et al. (2005, pp. 455-460) indicated that Asplenium is paraphyletic and Diellia is a Hawaiian endemic clade nested within it. Therefore, Snow et al. (2011, p. 12) merged Diellia with Asplenium. Because different species had previously been described under the names A. falcatum, A. mannii, and A. pallidum, these names were not available to designate the respective Hawaiian species after the generic change (Viane and Reichstein 1991; Snow et al. 2011, p. 12). Consequently, D. falcata has been renamed A. dielfalcatum; D. mannii has been renamed A. dielmannii; and D. pallida has been renamed A. dielpallidum (Viane and Reichstein 1991, pp. 159-160; Snow et al. 2011, p. 12). Diellia unisora was also renamed A. unisorum, with the specific epithet changing to conform to the gender of the new genus name (Viane and Reichstein 1991, p. 163; Snow et al. 2011, p. 12). These changes have been accepted in the most recent update to Hawaii's Ferns and Fern Allies (Wagner et al. 2012, pp. 103-104). These taxonomic changes do not affect the range or endangered status of any of these species.

On June 11, 2012, a proposed critical habitat rule for multiple Hawaiian species (77 FR 34464) also included proposed scientific name changes for two additional fern species: Asplenium fragile var. insulare (changed to A. peruvianum var. insulare) and Diellia erecta (changed to A. dielerectum). We expect these changes to be finalized when the final critical habitat rule is published.

Several genera of Hawaiian plants have been recently reassigned to different families (Wagner et al. 2012, pp. 108-109), based on phylogenetic research summarized by Smith et al. (2006, pp. 705-731), Mabberley (2008, pp. 14, 278, 341, 457, 508, 568, 916), the Angiosperm Phylogeny Group (2009, pp. 105-121), and Stevens (2015). These changes have resulted in a need for revisions in the List of Endangered and Threatened Plants where the family reassignments were not reflected in the original listing rules. Flueggea neowawraea (mehamehame) is listed as a member of the family Euphorbiaceae; this should be revised to Phyllanthaceae. Korthalsella degeneri (hulumoa) is listed as a member of the family Viscaceae; this should be revised to Santalaceae. Lysimachia daphnoides (lehua makanoe), L. iniki (no common name), L. pendens (no common name), L. scopulensis (no common name), L. venosa (no common name), Myrsine juddii (kolea), M. knudsenii (kolea), M. linearifolia (kolea), M. mezii (kolea), and M. vaccinioides (kolea) are listed as members of the family Myrsinaceae; this should be revised to Primulaceae. Pleomele hawaiiensis (hala pepe) is listed as a member of the family Liliaceae; this should be revised to Asparagaceae. Xylosma crenatum (no common name) is listed as a member of the family Flacourtiaceae; this should be revised to Salicaceae. Adenophorus periens (pendent kihi fern) is listed as a member of the family Grammitidaceae; this should be revised to Polypodiaceae. Diplazium molokaiense (no common name) is listed as a member of the family Aspleniaceae; this should be revised to Woodsiaceae. These taxonomic changes do not affect the threatened or endangered status or range of any of these species.

This rule does not contain any new 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 determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), need not be prepared in connection with regulations issued pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (43 FR 49244).

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) Be logically organized;

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

(c) Use clear language rather than jargon;

(d) Be divided into short sections and sentences; and

(e) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES. To help us to revise this rule, your comments should be as specific as possible.

A complete list of the referenced materials is available upon request from the U.S. Fish and Wildlife Service (see FOR FURTHER INFORMATION CONTACT).

For the reasons given in the preamble, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below: