Federal Register Vol. 80, No.207,

Section 5304 of title 5, United States Code (U.S.C.), authorizes locality pay for General Schedule (GS) employees with duty stations in the United States and its territories and possessions. Section 5304(f) authorizes the President's Pay Agent (the Secretary of Labor, the Director of the Office of Management and Budget (OMB), and the Director of the Office of Personnel Management (OPM)) to determine locality pay areas. The boundaries of locality pay areas must be based on appropriate factors, which may include local labor market patterns, commuting patterns, and the practices of other employers. The Pay Agent must give thorough consideration to the views and recommendations of the Federal Salary Council, a body composed of experts in the fields of labor relations and pay policy and representatives of Federal employee organizations. The President appoints the members of the Federal Salary Council, which submits annual recommendations on the locality pay program to the Pay Agent. The establishment or modification of locality pay area boundaries must conform to the notice and comment provisions of the Administrative Procedure Act (5 U.S.C. 553).

On June 1, 2015, OPM published a proposed rule in the Federal Register on behalf of the Pay Agent. (See 80 FR 30955.) The proposed rule proposed linking locality pay area definitions to metropolitan areas defined by OMB in February 2013, and proposed establishing 13 new locality pay areas: Albany-Schenectady, NY; Albuquerque-Santa Fe-Las Vegas, NM; Austin-Round Rock, TX; Charlotte-Concord, NC-SC; Colorado Springs, CO; Davenport-Moline, IA-IL; Harrisburg-Lebanon, PA; Kansas City-Overland Park-Kansas City, MO-KS; Laredo, TX; Las Vegas-Henderson, NV-AZ; Palm Bay-Melbourne-Titusville, FL; St. Louis-St. Charles-Farmington, MO-IL; and Tucson-Nogales, AZ. The proposed rule did not propose modifying the standard commuting and GS employment criteria used in the locality pay program to evaluate, as possible areas of application, locations adjacent to the metropolitan area comprising the basic locality pay area. (A basic locality pay area is an OMB-defined metropolitan area on which the definition of a locality pay area is based, and an area of application is a location that is not part of a basic locality pay area but is included in the locality pay area.) However, the proposed rule proposed using updated commuting patterns data to calculate commuting interchange rates to evaluate, as potential areas of application, locations adjacent to the metropolitan area comprising the basic locality pay area. The updated commuting patterns data used to calculate commuting interchange rates were collected as part of the American Community Survey between 2006 and 2010. In January 2014, the Federal Salary Council recommended use of those commuting patterns data in order to calculate commuting interchange rates used in the locality pay program. (The commuting interchange rate is the sum of the percentage of employed residents of the area under consideration who work in the basic locality pay area and the percentage of the employment in the area under consideration that is accounted for by workers who reside in the basic locality pay area. The commuting interchange rate is calculated by including all workers in assessed locations, not just Federal employees.)

The proposed rule provided a 30-day comment period. The Pay Agent reviewed comments received through July 1, 2015. After considering those comments, the Pay Agent has decided to implement the locality pay area definitions in the proposed rule, with three additional changes. Those changes, which are further discussed below, are a name change for one locality pay area; the addition of Berkshire County, MA, to the Albany-Schenectady, NY, locality pay area; and the addition of Harrison County, OH, to the Cleveland-Akron-Canton, OH, locality pay area.

Based on questions OPM staff received on the definition of the “Harrisburg-York-Lebanon, PA” locality pay area defined in the proposed rule, the Pay Agent has decided to change the name of that locality pay area to “Harrisburg-Lebanon, PA.” The definition of the locality pay area remains the same as in the proposed rule, and the name change is intended to help clarify that York County, PA, is not included in the Harrisburg-Lebanon, PA, locality pay area. Before the name change, that locality pay area's name was based on the name of the February 2013 Harrisburg-York-Lebanon, PA, Combined Statistical Area, the OMB-defined metropolitan area to which the definition of the Harrisburg-Lebanon, PA, locality pay area is linked. However, York County, PA, which has been an area of application to the Washington-Baltimore locality pay area since January 2005, will remain in the Washington-Baltimore-Arlington, DC-MD-VA-WV-PA, locality pay area.

In the proposed rule, the Pay Agent invited comment on how to address “Rest of U.S.” locations that are almost but not completely surrounded by potentially higher-paying locality pay areas. After considering comments received, the Pay Agent has decided to include, as areas of application, Berkshire County, MA, in the Albany-Schenectady, NY, locality pay area and Harrison County, OH, in the Cleveland-Akron-Canton, OH, locality pay area. While not completely surrounded by potentially higher-paying locality pay areas, each of those two counties is bordered by three separate locality pay areas. This action includes Berkshire County, MA, and Harrison County, OH, in an adjacent locality pay area with which each county has the highest commuting interchange rate. This policy is consistent with the Pay Agent's treatment, in the proposed rule and under these final regulations, of completely surrounded locations.

Berkshire County, MA, and Harrison County, OH, if left in the “Rest of U.S.” locality pay area, would each have a land boundary more than 75 percent bordered by three separate locality pay areas. In addition, Berkshire and Harrison Counties each have commuting interchange rates, with the three locality pay areas they border, that sum to more than 7.5 percent. (The Pay Agent notes that the two completely surrounded locations included in separate locality pay areas under these final regulations—Kent County, MD, which will be included in the Washington-Baltimore-Arlington, DC-MD-VA-WV-PA, locality pay area, and Lancaster County, PA, which will be included in the Harrisburg-Lebanon, PA, locality pay area—also have significant commuting interchange rates. Kent and Lancaster Counties each have commuting interchange rates of more than 7.5 percent with the locality pay area to which they will become areas of application under these final regulations.)

In analyzing counties almost but not completely surrounded by separate locality pay areas under the locality pay area definitions proposed in the proposed rule, the Pay Agent also considered the driving distance by road between an evaluated county's most populous duty station, in terms of GS employment, and the most populous duty station, in terms of GS employment, in the closest county within the adjacent locality pay area with the highest commuting interchange rate. (Driving distances and commuting interchange rates served different purposes in the analysis of locations almost but not completely surrounded by potentially higher-paying locality pay areas. While commuting interchange rates were used to indicate the extent to which a location is part of each adjacent locality pay area's local labor market, driving distances were considered as an indicator of the potential for GS employees to commute to a higher-paying locality pay area.) For both Berkshire County, MA, and Harrison County, OH, the driving distance is less than 50 miles between the county's most populous duty station, in terms of GS employment, and the most populous duty station, in terms of GS employment, in the closest county within the adjacent locality pay area with the highest commuting interchange rate.

The Pay Agent does not believe that a “Rest of U.S.” county being mostly bordered by separate locality pay areas necessarily warrants action unless there is evidence of a substantial labor market linkage with one or more neighboring locality pay areas. However, the Pay Agent believes the aforementioned information on commuting and driving distances for Berkshire County, MA, and Harrison County, OH, when considered along with the extent to which each of these counties is bordered by three separate locality pay areas, does warrant action. The other single-county “Rest of U.S.” locations bordered by three separate locality pay areas have a smaller percentage of land boundary bordered by separate locality pay areas and/or have lesser commuting or greater driving distances to the adjacent locality pay areas. (No single-county “Rest of U.S.” locations are bordered by more than three separate locality pay areas.) Individuals concerned about agency recruitment or retention capabilities in locations bordered by multiple separate locality pay areas and remaining in the “Rest of U.S.” locality pay area under these final regulations may provide testimony to the Federal Salary Council on locations of concern.

Using February 2013 OMB-defined metropolitan area definitions as the basis for locality pay area boundaries and using updated commuting patterns data to evaluate potential areas of application will add a number of counties now included in the “Rest of U.S.” locality pay area to separate locality pay areas, which will impact about 6,300 GS employees.

Establishing 13 new locality pay areas will impact about 102,000 GS employees. Implementing the 13 new locality pay areas will not automatically change locality pay rates now applicable in those areas because locality pay percentages are established by Executive order under the President's authority in 5 U.S.C. 5304 or 5304a, and the President decides each year whether to adjust locality pay percentages. When locality pay percentages are increased, past practice has been to allocate a percent of the total GS payroll for locality raises and to have the overall dollar cost for such pay raises be the same, regardless of the number of locality pay areas. If a percent of the total GS payroll is allocated for locality pay increases, the addition of new areas could result in a smaller amount to allocate for locality pay increases in existing areas. Implementing higher locality pay rates in the 13 new locality pay areas could thus result in relatively lower pay increases for employees in existing locality pay areas than they would otherwise receive.

OPM received 707 comments on the proposed rule. Most commenters supported the proposed changes in the definitions of locality pay areas.

Many commenters expressed the belief that various indicators of living costs should be considered in defining locality pay areas or in setting locality pay. Living costs are not directly considered in the locality pay program. Locality pay is not designed to equalize living standards for GS employees across the country. Under 5 U.S.C. 5304, locality pay rates are based on comparisons of GS pay and non-Federal pay at the same work levels in a locality pay area. Relative living costs may indirectly affect non-Federal pay levels, but living costs are just one of many factors that affect the supply of and demand for labor, and therefore labor costs, in a locality pay area.

Some commenters disagreed it is appropriate to establish 13 new locality pay areas. A number of those commenters expressed concern that existing locality pay areas' future pay levels could be set lower than they otherwise would, due to establishment of new locality pay areas. The President's Pay Agent continues to believe it is appropriate to establish the 13 new locality pay areas. The goal of the locality pay program is to reduce disparities between GS pay and non-Federal pay for the same levels of work in locations where such disparities are significant. The Federal Salary Council recommended the 13 new locality pay areas after reviewing pay levels in all “Rest of U.S.” metropolitan statistical areas and combined statistical areas with 2,500 or more GS employees. The Federal Salary Council found that the percentage difference between GS and non-Federal pay levels for the same levels of work—i.e., the pay disparity—in these 13 locations was substantially greater than the “Rest of U.S.” pay disparity over an extended period. Because pay disparities calculated for the “Rest of U.S.” locality pay area are based on average pay across many metropolitan areas throughout the United States with varying pay levels, and because pay in those metropolitan areas can change over time, the Pay Agent believes it is appropriate to monitor pay levels in “Rest of U.S.” metropolitan areas to the extent it is feasible to do so. When such monitoring reveals that a metropolitan area has a pay disparity significantly exceeding the overall “Rest of U.S.” pay disparity over an extended period, the Pay Agent believes it is appropriate to establish the metropolitan area as a separate locality pay area.

Some commenters disagreed it is appropriate to use February 2013 OMB-defined metropolitan areas to define locality pay areas. Some of those commenters made living-cost comparisons between different portions of the February 2013 OMB metropolitan areas, e.g., comparisons between the central and outlying portions of those metropolitan areas. Some commenters expressed concern that future locality pay levels might be set lower than they otherwise would due to including certain portions of a metropolitan area, such as its outlying locations, in a locality pay area. Some commenters suggested splitting OMB-defined metropolitan areas into separate locality pay areas so that some locations in a metropolitan area could receive higher pay rates than other locations within the metropolitan area.

Prior to implementation of locality pay, the Federal Salary Council recommended, and the Pay Agent approved, the use of OMB-defined metropolitan areas as the basis for locality pay area boundaries, and OMB-defined metropolitan areas have been the basis for locality pay area boundaries since locality pay was implemented in 1994. (A detailed history of the use of OMB-defined metropolitan areas in the locality pay program can be found in the Federal Salary Council's January 2014 recommendations, which are posted on the OPM Web site at https://www.opm.gov/policy-data-oversight/pay-leave/pay-systems/general-schedule/federal-salary-council/recommendation13.pdf.)

The Pay Agent continues to believe it is appropriate to use OMB-defined metropolitan areas as the basis for locality pay area boundaries and has no evidence that it is appropriate to split an OMB-defined metropolitan area into separate locality pay areas. Since OMB-defined metropolitan areas will continue to serve as the basis for locality pay area boundaries, the Pay Agent believes it makes sense to update the metropolitan areas used in the locality pay program to the February 2013 OMB-defined metropolitan areas, since the definitions of those metropolitan areas reflect the most recent information on population distribution and commuting patterns. Departing from the practice of defining basic locality pay areas based on OMB-defined metropolitan areas or splitting those metropolitan areas into separate locality pay areas would be a significant change, and the implications would have to be carefully considered. Individuals interested in recommending alternatives to defining basic locality pay areas based on entire OMB-defined metropolitan areas may provide testimony to the Federal Salary Council.

Some commenters disagreed it is appropriate to establish new areas of application or maintain existing ones, with some commenters expressing concern that future locality pay levels could be set lower than they otherwise would due to including new areas of application in locality pay areas. Prior to implementation of locality pay, the Federal Salary Council recommended, and the Pay Agent agreed, that OMB-defined metropolitan areas not be the sole basis for defining locality pay areas. Ever since locality pay was implemented in 1994, criteria have been used in the locality pay program to evaluate, as potential areas of application, locations adjacent to the metropolitan area comprising the basic locality pay area. The Pay Agent continues to believe it is appropriate to establish areas of application when approved criteria for doing so are met.

Some commenters disagreed it is appropriate to retain, in their current locality pay area, locations that would otherwise move to a potentially lower-paying locality pay area as a result of using February 2013 OMB-defined metropolitan areas as the basis for locality pay area boundaries. The Pay Agent continues to believe it is appropriate to retain such locations in their current locality pay area. If such a location were moved to a lower-paying locality pay area, current GS employees in the location might be entitled to pay retention under 5 U.S.C. 5363 and 5 CFR part 536 and would not have a reduction in pay. GS employees hired after movement of the location to the lower-paying locality pay area would not be entitled to pay retention and would receive the lower locality pay rates that would be applicable in the location. The Pay Agent believes such an outcome would be disruptive for agencies and employees in affected locations.

A number of commenters objected that locations not included in a separate locality pay area were to remain in the “Rest of U.S.” locality pay area under the proposed rule. Some of those locations are metropolitan areas for which the Federal Salary Council has studied disparities between non-Federal pay and Federal pay (pay disparities) over several years of data and found that the pay disparities do not significantly exceed the pay disparity for the “Rest of U.S.” locality pay area over the same period. Other locations referred to in this category of comments do not meet the criteria for areas of application. In some cases, commenters cited possible recruitment and retention difficulties the commenters believe agencies may have in certain locations that would remain in the “Rest of U.S.” locality pay area when these final regulations are put into effect. The Pay Agent has no evidence that the changes these final regulations will make in locality pay area definitions will create recruitment and retention challenges for Federal employers. However, should recruitment and retention challenges exist in a location, Federal agencies have considerable administrative authority to address those challenges through the use of current pay flexibilities. Information on these flexibilities is posted on the OPM Web site at http://www.opm.gov/policy-data-oversight/pay-leave/pay-and-leave-flexibilities-for-recruitment-and-retention.

A number of commenters expressed their views on pay levels in locality pay areas. Some commenters suggested specific locality pay percentages to apply to new or existing locality pay areas, and some commenters offered opinions on the extent to which pay increases are needed in some locality pay areas compared to others. Such comments as these are outside of the scope of these final regulations. The purpose of these final regulations is to define the boundaries of locality pay areas. The role of the Pay Agent with regard to locality pay percentages is to report annually to the President what locality pay percentages would go into effect under the Federal Employees Pay Comparability Act of 1990. The President establishes a base General Schedule and sets locality pay percentages each year by Executive order.

Some commenters expressed concern that certain Federal pay systems outside of the General Schedule would not benefit from the changes planned for definitions of GS locality pay areas. Other commenters suggested that Federal retirees should receive increased retirement payments if, before they retired, they worked in a “Rest of U.S.” duty station that will now be included in a higher-paying locality pay area. Such comments as these are outside of the scope of these final regulations. The purpose of these final regulations is to define locality pay areas for current Federal employees who receive locality pay under 5 U.S.C. 5304, not to set pay levels for Federal employees who do not receive locality pay under 5 U.S.C. 5304 or to determine retirement payments.

A number of comments reflected misunderstanding of the proposed rule's definitions of locality pay areas, with some comments indicating a belief that certain counties actually included in a proposed locality pay area were excluded. The definitions of locality pay areas are based on combined statistical areas (CSAs) and metropolitan statistical areas (MSAs). Because over time counties can be added to CSAs and MSAs, and because the Pay Agent wanted any such changes in CSAs and MSAs to be reflected automatically in the definitions of locality pay areas, rather than list every county in each locality pay area, these final regulations will define locality pay areas by listing the CSA and MSA comprising the basic locality pay area, with areas of application listed as single counties. These final regulations define CSA as the geographic scope of a CSA, as defined in OMB Bulletin No. 13-01, plus any areas subsequently added to the CSA by OMB, and define MSA as the geographic scope of an MSA, as defined in OMB Bulletin No. 13-01, plus any areas subsequently added to the MSA by OMB. (OMB Bulletin 13-01 can be found at https://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf.)

A number of comments concerned locations which, under the locality pay area definitions in the proposed rule, would remain in the “Rest of U.S.” locality pay area and be bordered by multiple locality pay areas. For the reasons discussed above in the “Supplementary Information” section of this final rule, after evaluating single-county locations bordered by multiple locality pay areas, the Pay Agent has decided to include, as areas of application, Berkshire County, MA, in the Albany-Schenectady, NY, locality pay area and Harrison County, OH, in the Cleveland-Akron-Canton, OH, locality pay area. Individuals concerned about locations that are bordered by multiple separate locality pay areas and remain in the “Rest of U.S.” locality pay area, under the locality pay area definitions implemented by these final regulations, may provide testimony to the Federal Salary Council on locations of concern.

Several commenters expressed concern that U.S. counties that are isolated off the coast of the U.S. mainland, and which do not meet criteria for areas of application, remain in the “Rest of U.S.” locality pay area under the changes these regulations will make in the definitions of locality pay areas. Some of these comments anecdotally referred to recruitment and retention challenges the commenters attributed to the locations being limited to “Rest of U.S.” locality pay. Federal agencies have considerable discretionary authority to provide pay and leave flexibilities to address significant recruitment and retention challenges, and information on these flexibilities is posted on the OPM Web site at http://www.opm.gov/policy-data-oversight/pay-leave/pay-and-leave-flexibilities-for-recruitment-and-retention.

One commenter opposed any movement of “Rest of U.S.” locations to separate pay areas, and said the Government should find less costly alternatives, such as moving Federal employment sites to areas with lower living or labor costs and increasing the use of telework. The Pay Agent does not believe that the need to vary pay levels geographically based on labor costs can be substantially reduced in the near term by relocating Government agencies' duty stations or expanding telework programs. In addition, such a comment is outside the scope of these final regulations. The purpose of these regulations is to establish locality pay area boundaries the Pay Agent has determined to be appropriate.

One commenter suggested that adjacent locality pay areas be combined into single locality pay areas, with resultant cost savings to the Government. Such a change would be a significant departure from current practices in the locality pay program and could have significant implications. The implications for adjacent locality pay areas are unknown and would have to be carefully considered. Individuals interested in pursuing this idea may provide testimony to the Federal Salary Council.

Some comments reflected a mistaken belief that the calculation of commuting interchange rates in the locality pay program includes only commuting by Federal employees, rather than commuting by all types of workers in assessed locations. Some commenters expressed the opinion that commuting interchange rates including only commuting for Federal employees should be considered in defining locality pay areas. In evaluating locations adjacent to basic locality pay areas as potential areas of application, commuting by all types of workers, not just Federal employees, is used as a criterion. Commuting interchange rates used in the locality pay program are a measure of economic linkage between a basic locality pay area and an adjacent location. Commuting interchange rates used in the locality pay program are used to indicate the extent to which a location is part of the locality pay area's entire local labor market, not to indicate the extent to which Federal employees commute between locations.

OMB has reviewed this rule in accordance with E.O. 13563 and E.O. 12866.

I certify that these regulations would not have a significant economic impact on a substantial number of small entities because they would apply only to Federal agencies and employees.

Accordingly, OPM is amending 5 CFR part 531 as follows:

Title III of the Dodd-Frank Act 1 provided for a substantial reorganization of the regulation of State and Federal savings associations and their holding companies. Beginning July 21, 2011, the transfer date established by section 311 of the Dodd-Frank Act, codified at 12 U.S.C. 5411, the powers, duties, and functions formerly performed by the OTS were divided among the FDIC, as to State savings associations, the Office of the Comptroller of the Currency (“OCC”), as to Federal savings associations, and the Board of Governors of the Federal Reserve System (“FRB”), as to savings and loan holding companies. Section 316(b) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(b), provides the manner of treatment for all orders, resolutions, determinations, regulations, and advisory materials that had been issued, made, prescribed, or allowed to become effective by the OTS. The section provides that if such materials were in effect on the day before the transfer date, they continue to be in effect and are enforceable by or against the appropriate successor agency until they are modified, terminated, set aside, or superseded in accordance with applicable law by such successor agency, by any court of competent jurisdiction, or by operation of law.

Section 316(c) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(c), further directed the FDIC and the OCC to consult with one another and to publish a list of the continued OTS regulations which would be enforced by the FDIC and the OCC, respectively. On June 14, 2011, the FDIC's Board of Directors approved a “List of OTS Regulations to be Enforced by the OCC and the FDIC Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act.” This list was published by the FDIC and the OCC as a Joint Notice in the Federal Register on July 6, 2011.2

Although section 312(b)(2)(B)(i)(II) of the Dodd-Frank Act, codified at 12 U.S.C. 5412(b)(2)(B)(i)(II), granted the OCC rulemaking authority relating to both State and Federal savings associations, nothing in the Dodd-Frank Act affected the FDIC's existing authority to issue regulations under the Federal Deposit Insurance Act (“FDI Act”) and other laws as the “appropriate Federal banking agency” or under similar statutory terminology. Section 312(c) of the Dodd-Frank Act amended the definition of “appropriate Federal banking agency” contained in section 3(q) of the FDI Act, 12 U.S.C. 1813(q), to add State savings associations to the list of entities for which the FDIC is designated as the “appropriate Federal banking agency.” As a result, when the FDIC acts as the designated “appropriate Federal banking agency” (or under similar terminology) for State savings associations, as it does here, the FDIC is authorized to issue, modify and rescind regulations involving such associations, as well as for State nonmember banks and insured branches of foreign banks.

As noted, on June 14, 2011, pursuant to this authority, the FDIC's Board of Directors reissued and redesignated certain transferring OTS regulations. These transferred OTS regulations were published as new FDIC regulations in the Federal Register on August 5, 2011.3 When it republished the transferred OTS regulations as new FDIC regulations, the FDIC specifically noted that its staff would evaluate the transferred OTS rules and might later recommend incorporating the transferred OTS regulations into other FDIC rules, amending them, or rescinding them, as appropriate.

One of the OTS rules transferred to the FDIC requires State savings associations to notify the FDIC at least 30 days before establishing a transactional Web site. The OTS rule, formerly found at 12 CFR part 555, subpart B (“part 555, subpart B”), was transferred to the FDIC with only technical changes and is now found in the FDIC's rules at 12 CFR part 390, subpart L (“part 390, subpart L”), entitled “Electronic Operations.” The FDIC has no such corresponding rule. After careful review of part 390, subpart L, the FDIC has decided to rescind part 390, subpart L, in its entirety, because, as discussed below, it is obsolete, unnecessary, and burdensome.

On July 21, 2014, the FDIC published a Notice of Proposed Rulemaking (“Proposed Rule”) regarding the removal of part 390, subpart L, which governs electronic operations of State savings associations.4 The Proposed Rule would have removed part 390, subpart L, from the CFR in an effort to streamline FDIC regulations for all FDIC-supervised institutions. As discussed in the Proposed Rule, the FDIC carefully reviewed the transferred rule, part 390, subpart L, and determined that it should be rescinded because it is obsolete, unnecessary, and burdensome.

The FDIC issued the Proposed Rule with a 60-day comment period, which closed on September 19, 2014. No comments on the Proposed Rule were received by the FDIC. Consequently, the final rule (“Final Rule”) is adopted as proposed without any changes.

As discussed in the Proposed Rule, the OTS enacted the Electronic Operations rule, part 390, subpart L, unilaterally. This rule required savings associations to file a written notice with the OTS at least 30 days before establishing a transactional Web site. Neither the FDIC, the OCC, nor the FRB has a regulatory notice requirement similar to the Electronic Operations rule that requires insured depository institutions to notify the respective agency if they intend to establish transactional Web sites. Rescinding and removing the Electronic Operations rule will serve to streamline the FDIC's rules and eliminate obsolete, unnecessary, and burdensome regulations. It will also facilitate uniform supervision regarding notification requirements for electronic operation for all FDIC-supervised insured depository institutions. Accordingly, the Final Rule removes and rescinds part 390, subpart L, in its entirety.

In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995, 44 U.S.C. 3501-3521, the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (“OMB”) control number.

The Final Rule rescinds and removes from FDIC regulations part 390, subpart L, because it is obsolete, unnecessary, and burdensome. This rule was transferred with only nominal changes to the FDIC from the OTS when the OTS was abolished by title III of the Dodd-Frank Act. In republishing this rule, the FDIC made only technical changes to existing OTS regulations. The FDIC does not have a regulatory notice requirement similar to the Electronic Operations rule that requires insured depository institutions to notify the FDIC if they intend to set up transactional Web sites and, therefore, never established an information collection to account for the paperwork burden imposed on the public.

The Final Rule will neither create any new information collection nor modify any of the FDIC's existing information collections. Accordingly, the FDIC will not submit any information collection request to OMB.

The Regulatory Flexibility Act (“RFA”),5 generally requires an agency to consider whether a final rule will have a significant economic impact on a substantial number of small entities (defined in regulations promulgated by the Small Business Administration to include banking organizations with total assets of less than or equal to $500 million).6 Pursuant to section 605(b) of the RFA, a final regulatory flexibility analysis is not required if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities, and publishes its certification and a short explanatory statement in the Federal Register together with the rule. For the reasons provided below, the FDIC certifies that the Final Rule will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis is not required.

As discussed in the Proposed Rulemaking, part 390, subpart L, was transferred from part 555, subpart B, which governed notification provisions for savings associations that intended to establish transactional Web sites. Part 555, subpart B became effective on January 1, 1999, and all savings associations were required to comply with it. The FDIC's Final Rule rescinds and removes part 390, subpart L, because it is obsolete, unnecessary, and burdensome. Since the Electronic Operations rule is being rescinded, the Final Rule will reduce the paperwork and other regulatory burdens on State savings associations by eliminating the requirement to provide the FDIC with notice before establishing a transactional Web site. Therefore, the Final Rule will have no significant economic impact on any State savings association.

The Office of Management and Budget has determined that the Final Rule is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (“SBREFA”), 5 U.S.C. 801 et seq.

Section 722 of the Gramm-Leach-Bliley Act, 12 U.S.C. 4809, requires each Federal banking agency to use plain language in all of its proposed and final rules published after January 1, 2000. In the Proposed Rule, the FDIC invited comments on whether the Proposed Rule was clearly stated and effectively organized, and how the FDIC might make it easier to understand. Although the FDIC did not receive any comments, the FDIC sought to present the Final Rule in a simple and straightforward manner.

Under section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (“EGRPRA”), the FDIC is required to review all of its regulations, at least once every 10 years, in order to identify any outdated or otherwise unnecessary regulations imposed on insured institutions.7 The FDIC completed the last comprehensive review of its regulations under EGRPRA in 2006 and is commencing the next decennial review, which is expected to be completed by 2016. The Proposed Rule solicited comments on whether the proposed rescission of part 390, subpart L would impose any outdated or unnecessary regulatory requirements on insured depository institutions. No comments on this issue were received. Upon review, the FDIC does not believe that rescinding part 390, subpart L, imposes any outdated or unnecessary regulatory requirements on any insured depository institutions. Rather, because the Electronic Operations rule is being rescinded, the Final Rule eliminates an outdated and unnecessary regulatory burden on State savings associations by eliminating the requirement to provide the FDIC with notice before establishing a transactional Web site.

For the reasons stated in the preamble, the Board of Directors of the FDIC amends 12 CFR part 390 of the Code of Federal Regulations as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all PW PW4164, PW4168, PW4168A, PW4164C, PW4164C/B, PW4164-1D, PW4168-1D, PW4168A-1D, PW4170, PW4164C-1D, PW4164C/B-1D, PW4050, PW4052, PW4056, PW4060, PW4060A, PW4060C, PW4062, PW4062A, PW4152, PW4156, PW4156A, PW4158, PW4160, PW4460, PW4462, and PW4650 turbofan engines including models with a “-3” suffix with an LPT 4th stage IAS, P/N 51N038, installed. The NPRM published in the Federal Register on June 1, 2015 (80 FR 30963). The NPRM was prompted by nine occasions of discovering, during routine overhaul of the LPT, cracks in the barrel section of the LPT 4th stage IAS. The NPRM proposed to require removal of the LPT 4th stage IAS, P/N 51N038, according to a prescribed schedule. We are issuing this AD to prevent failure of the LPT 4th stage IAS, which could lead to an uncontained IAS release, damage to the engine, and damage to the airplane.

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

The Boeing Company expressed support for the NPRM.

United Airlines and Delta Airlines requested that the Definitions paragraph be changed. United Airlines requested we change the definition of LPT overhaul from “maintenance which involves disassembly of the LPT rotor module” to “when the LPT module is disassembled sufficiently to gain access to the LPT 4th stage rotor assembly (disk/blade/seal).” Delta Airlines requested we change the definition of an LPT overhaul to “when all disks in the rotor are removed from the engine and the blades are removed.”

We agree that the definition of an LPT overhaul should be clarified. We changed the definition of an LPT overhaul to “An LPT overhaul is defined as when all disks in the rotor are removed from the engine and the blades are removed.”

Delta Airlines requested changing the applicability to include models with any dash number suffix.

We agree with the intent of this request. We changed the Summary, Discussion, and Applicability sections by adding “. . . including models with a “-3” suffix . . .” following the listed engine models as required.

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

We estimate that this AD affects 72 engines installed on airplanes of U.S. registry. We also estimate that 9 of the engines will require replacement parts during shop visit, the pro-rated cost of these parts cost will be $23,805 per engine, and compliance with this AD will require about 49 hours of labor per engine. The average labor rate is $85 per hour. We also estimate that 63 of the engines will require replacement parts during LPT overhaul, the pro-rated replacement parts cost for these parts is $43,545 per engine, and that these 63 engines will require 0 additional hours of labor per engine since the parts are already exposed during LPT overhaul. Based on these figures, we estimate the cost of this AD on U.S. operators to be $2,995,065.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

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

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2007-16-08, Amendment 39-15147 (72 FR 44728, August 9, 2007). AD 2007-16-08 applied to all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-300, 747-400, 747-400D, and 747SR series airplanes. The NPRM published in the Federal Register on March 30, 2015 (80 FR 16606). The NPRM was prompted by reports of cracks found at the forward and aft inner chord strap and angles on the station 800 frame on the left-side and right-side main entry doors. The NPRM proposed to continue to require repetitive inspections for cracking of the station 800 frame assembly, and repair if necessary, and expand the inspection area. We are issuing this AD to detect and correct fatigue cracks that could extend and fully sever the frame, which could result in development of skin cracks that could lead to rapid depressurization of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 16606, March 30, 2015) and the FAA's response to each comment.

Boeing stated that it concurred with the contents of the NPRM (80 FR 16606, March 30, 2015).

United Airlines stated that it has reviewed the NPRM (80 FR 16606, March 30, 2015), and has no comment to submit.

UPS requested that we add an additional statement to paragraph (i) of the proposed AD (“Exception to the Service Information,”) to clarify that the removal of fasteners is not required for performing the surface high-frequency eddy current (HFEC) inspections specified by paragraph (g) of the proposed AD (80 FR 16606, March 30, 2015). UPS stated that by adding the clarification that the removal of fasteners is not required, significant time and materials would be saved by operators when accomplishing this inspection and prevent unnecessary alternative method of compliance (AMOC) requests. UPS explained that Boeing agreed in a response to a service request that fastener removal is not required for performing surface HFEC inspections.

We agree because the clarification will reduce costs while ensuring the same level of safety. We have added the following sentence to paragraph (g) of this AD: “It is not necessary to remove fasteners while performing the surface HFEC inspections.”

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

• Are consistent with the intent that was proposed in the NPRM (80 FR 16606, March 30, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 16606, March 30, 2015).

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

We reviewed Boeing Alert Service Bulletin 747-53A2451, Revision 2, dated June 13, 2014. The service information describes procedures for accomplishing repetitive inspections for cracking of the station 800 frame assembly, and repair. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this AD.

We estimate that this AD affects 124 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

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

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

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

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

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

Transport Canada, which is the aviation authority for Canada, issued Emergency AD No. CF-2015-16, dated July 2, 2015, to correct an unsafe condition for Bell Model 429 helicopters. Transport Canada advised that in-service reports showed that the tail rotor pitch link spherical bearings have experienced early and accelerated wear. On three occasions, bearings were found worn beyond limits during pre-flight inspections, showing a radial and axial play that was easily detectable. In one case, the spherical bearing separated from the tail rotor pitch link, resulting in damage to the tail rotor blade pitch horn assembly. In another case, the spherical bearing had been inspected and found acceptable during a maintenance inspection; about “1 hour air time” later, it was found worn beyond limits during a pre-flight inspection.

On August 6, 2015, we issued Emergency AD 2015-16-51, which was made immediately effective to all known U.S. owners and operators of Bell Model 429 helicopters. Emergency AD 2015-16-51 required, before further flight and thereafter at intervals not to exceed 50 hours TIS, inspecting each inboard and outboard tail rotor pitch link assembly for axial or radial bearing play. Emergency AD 2015-16-51 also required, if there was axial or radial bearing play, removing the tail rotor pitch link and performing a dimensional inspection for wear. Finally, Emergency AD 2015-16-51 required, if wear exceeded the allowable limits, replacing the tail rotor pitch link assembly.

On the same day that we issued Emergency AD 2015-16-51, Transport Canada issued a revised Emergency AD No. CF-2015-16R1, dated August 6, 2015, changing the applicability and compliance time to clarify that the inspections are required for all Model 429 helicopters. Transport Canada advises of the possibility that some operators would conclude that no action was required for low time helicopters. Transport Canada Emergency AD No. CF-2015-16R1 removes the following language from the applicability so that it applies to all Model 429 helicopters regardless of time: “that have accumulated 50 hours air time or more.” It also adds language to the compliance time so that the corrective actions must be accomplished within 10 hours air time “or before exceeding 60 hours air time since new, whichever occurs later.” Therefore, we are issuing this AD to make similar revisions.

These helicopters have been approved by Transport Canada and are approved for operation in the United States. Pursuant to our bilateral agreement with Canada, Transport Canada, its technical representative, has notified us of the unsafe condition described in its Emergency AD. We are issuing this AD because we evaluated all information provided by Transport Canada and determined the unsafe condition exists and is likely to exist or develop on other helicopters of this same type design.

Bell issued Alert Service Bulletin 429-15-16, dated February 18, 2015 (ASB) for Bell Model 429 helicopters, S/N 57001 and subsequent, which have accumulated more than 50 hours. The ASB specifies inspecting both inboard and outboard tail rotor pitch link assemblies for axial and radial play. If abnormal wear or bearing play is detected, the ASB specifies removing the affected tail rotor pitch link, performing a dimensional check of both axial and radial play, and replacing any tail rotor pitch link assembly 429-012-112-101 or -103 or pitch link bearing 429-312-107-103 that exceeds the allowable limits.

This AD retains the inspection requirements of Emergency AD 2015-16-51 but revises the applicability and compliance time. This AD applies to Model 429 helicopters regardless of accumulated TIS. The inspections in this AD are required before further flight for helicopters with 50 or more hours TIS and before accumulating 50 hours TIS for helicopters with less than 50 hours TIS.

The Transport Canada Emergency AD requires compliance within 10 hours TIS or before exceeding 60 hours air time, whichever occurs later. This AD requires compliance before further flight for helicopters with 50 or more hours TIS. For helicopters with less than 50 hours TIS, this AD requires compliance before the helicopter accumulates 50 hours TIS.

We consider this AD to be an interim action. If final action is later identified, we might consider further rulemaking then.

We estimate that this AD affects 54 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work hour. It will take about 2 work hours to do the inspections at an estimated cost of $170 per helicopter or $9,180 for the fleet per inspection cycle. Replacing a tail rotor pitch link assembly will take 4 work hours and required parts will cost $2,685 for a total cost of $3,025 per helicopter.

Providing an opportunity for public comments prior to adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we found and continue to find that the risk to the flying public justifies waiving notice and comment prior to adopting this rule because the previously described unsafe condition can adversely affect the controllability of the helicopter, and the initial required corrective actions must be accomplished before further flight or before accumulating 50 hours TIS, depending upon the hours TIS accumulated on the helicopter.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment before issuing this AD were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by Emergency AD 2015-16-51, issued on August 6, 2015, to all known U.S. owners and operators of these helicopters. These conditions still exist and the Emergency AD is hereby superseded.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

For the reasons discussed, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

I. Executive Summary

This action continues the prohibition on flight operations in the UKFV and UKDV FIRs by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers. This action also revises the FAA approval process for proposed operations authorized by other U.S. Government departments, agencies, and instrumentalities to clarify the FAA's expectations regarding requests for approval and revises the approval conditions and information about requests for exemptions to reflect the termination of statutory authorization for the FAA's premium war risk insurance program. This action also makes minor non-substantive corrections to the wording of the rule. The FAA finds this action necessary to address a continuing hazard to persons and aircraft engaged in such flight operations.

Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” In this instance, the FAA finds that notice and public comment to this immediately adopted final rule, as well as any delay in the effective date of this rule, are contrary to the public interest due to the immediate need to address the hazard to U.S. civil aviation that continues to exist in the UKFV and UKDV FIRs, as described in the Background section of this rule.

The FAA is responsible for the safety of flight in the U.S. and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. The FAA's authority to issue rules on aviation safety is found in title 49, U.S. Code. Subtitle I, section 106(f), describes the authority of the FAA Administrator. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise his authority consistently with the obligations of the U.S. Government under international agreements.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, subpart III, section 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security. This regulation is within the scope of that authority because it continues to prohibit the persons subject to paragraph (a) of SFAR No. 113, § 91.1607, from conducting flight operations in the UKFV and UKDV FIRs due to the hazard to the safety of such persons' flight operations, as described in the Background section of this rule.

On April 25, 2014, the FAA published SFAR No. 113, § 91.1607, which prohibited flight operations in a portion of the UKFV FIR by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons were operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators were foreign air carriers (79 FR 22862). At that time, the FAA viewed the possibility of civil aircraft receiving confusing and conflicting air traffic control instructions from both Ukrainian and Russian air traffic service providers when operating in the portion of the Simferopol (UKFV) FIR covered by SFAR No. 113, § 91.1607, as an unsafe condition that presented a potential hazard to U.S. civil flight operations in the disputed airspace. Because political and military tensions between Ukraine and the Russian Federation remained high, the FAA was also concerned that compliance with air traffic control instructions issued by the authorities of one country could result in a civil aircraft being misidentified as a threat and intercepted or otherwise engaged by air defense forces of the other country. The FAA continues to have these concerns.

On July 18, 2014 (UTC), the FAA expanded its flight prohibition through the issuance of Notice to Airmen (NOTAM) FDC 4/2182, due to ongoing safety concerns regarding U.S. civil flight operations in the entire UKFV and UKDV FIRs. The FAA determined that the ongoing conflict in the region posed a significant threat to U.S. civil aviation operations in these FIRs. In addition to a series of attacks on fixed-wing and rotary-wing Ukrainian military aircraft flying at lower altitudes, a Ukrainian An-26 flying at 21,000 feet southeast of Luhansk was shot down on July 14, 2014, and a Malaysia Airlines Boeing 777 was shot down on July 17, 2014, while flying over Ukraine at 33,000 feet just west of the Russian border. Two hundred ninety eight passengers and crew perished. The use of weapons capable of targeting and shooting down aircraft flying on civil air routes at cruising altitudes posed a significantly dangerous threat to civil aircraft flying in the UKFV and UKDV FIRs. The FAA published a final rule incorporating the expanded flight prohibition into SFAR No. 113, § 91.1607, on December 29, 2014 (79 FR 77857).

The FAA has continued to evaluate the situation in the UKFV and UKDV FIRs and has determined there is a continuing significant flight safety hazard to U.S. civil aviation from the ongoing risk of skirmishes in the area. There is also a potential for larger-scale fighting in eastern Ukraine involving pro-Russian separatists, which could result in civil aircraft being misidentified as a threat and then intercepted or otherwise engaged, as demonstrated by the shoot down of Malaysia Airlines Flight 17 on July 17, 2014. Pro-Russian separatists have access to a variety of anti-aircraft weapons, to include man-portable air defense systems (MANPADS) and possibly more advanced surface-to-air-missiles (SAMs) that have the capability to engage aircraft at higher altitudes. Separatists have demonstrated their ability to use these anti-aircraft weapons by successfully shooting down a number of aircraft during the course of the fighting in eastern Ukraine in 2014. There is also continuing concern over the hazard to U.S. civil aviation from possible conflicting air traffic control instructions from Ukrainian and Russian air traffic service providers due to a dispute over responsibility for providing air navigation services in portions of the Simferopol (UKFV) FIR. In addition, there have been reported incidents of purposeful interference, including GPS jamming, in the UKFV and UKDV FIRs.

Due to the previously described continuing hazards to U.S. civil aviation operations, the FAA is extending the expiration date of SFAR No. 113, § 91.1607, to continue the prohibition on flight operations in the UKFV and UKDV FIRs by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers. This rule extends the expiration date of SFAR No. 113, § 91.1607, from October 27, 2015, to October 27, 2016.

The FAA will continue to actively evaluate the area to determine to what extent U.S. civil aviation may be able to safely operate therein. Adjustments to this SFAR may be appropriate if the risk to aviation safety and security changes. The FAA may amend or rescind this SFAR as necessary prior to its expiration date.

Additionally, the FAA is revising its approval process for proposed operations authorized by other U.S. Government departments, agencies, and instrumentalities to clarify the FAA's expectations regarding requests for approval. The FAA is also revising the approval conditions that will apply to operations authorized by other U.S. Government departments, agencies, and instrumentalities and approved by the FAA, and the information about requests for exemption, to reflect the termination of statutory authorization for the FAA premium war risk insurance program. Section 102 of Division L of the Consolidated and Further Continuing Appropriations Act, 2015, Public Law 113-235, December 16, 2014, inter alia, amended 49 U.S.C. 44302(f) and 44310(a) to specify the termination dates in those sections as December 11, 2014. The effect was to terminate coverage under FAA's premium war risk insurance program as of December 11, 2014. This action also makes minor non-substantive corrections to the wording of the rule.

Because the circumstances described herein warrant immediate action by the FAA, I find that notice and public comment under 5 U.S.C. 553(b)(3)(B) are impracticable and contrary to the public interest. Further, I find that good cause exists under 5 U.S.C. 553(d) for making this rule effective immediately upon issuance. I also find that this action is fully consistent with the obligations under 49 U.S.C. 40105 to ensure that I exercise my duties consistently with the obligations of the United States under international agreements.

If a department, agency, or instrumentality of the U.S. Government determines that it has a critical need to engage any person covered under SFAR No. 113, § 91.1607, including a U.S. air carrier or a U.S. commercial operator, to conduct a charter to transport civilian or military passengers or cargo or other operations in either or both of the UKFV and UKDV FIRs, that department, agency, or instrumentality may request that the FAA approve persons covered under SFAR No. 113, § 91.1607, to conduct such operations. An approval request must be made directly by the requesting department, agency, or instrumentality of the U.S. Government to the FAA's Associate Administrator for Aviation Safety (AVS-1) in a letter signed by an appropriate senior official of the requesting department, agency, or instrumentality. Requests for approval submitted to the FAA by anyone other than the requesting department, agency, or instrumentality will not be accepted and will not be processed. In addition, the senior official signing the letter requesting FAA approval on behalf of the requesting department, agency, or instrumentality must be sufficiently highly placed within his or her organization to demonstrate that the senior leadership of the requesting department, agency, or instrumentality supports the request for approval and is committed to taking all necessary steps to minimize operational risks to the proposed flights. The senior official must also be in a position to: (1) Attest to the accuracy of all representations made to the FAA in the request for approval and (2) ensure that any support from the requesting U.S. government department, agency, or instrumentality described in the request for approval is in fact brought to bear and is maintained over time. Unless exigent circumstances exist, requests for approval must be submitted to the FAA not less than 30 calendar days before the date on which the requesting department, agency, or instrumentality wishes the proposed operations, if approved by the FAA, to commence.

The letter must be sent by the requesting department, agency, or instrumentality to the Associate Administrator for Aviation Safety (AVS-1), Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591. Electronic submissions are acceptable, and the requesting entity may request that the FAA notify it electronically as to whether the approval request is granted. If a requestor wishes to make an electronic submission to the FAA, the requestor should contact the Air Transportation Division, Flight Standards Service, at (202) 267-8166 to obtain the appropriate email address. A single letter may request approval from the FAA for multiple persons covered under SFAR No. 113, § 91.1607, and/or for multiple flight operations. To the extent known, the letter must identify the person(s) expected to be covered under the SFAR on whose behalf the U.S. Government department, agency, or instrumentality is seeking FAA approval, and it must describe—

• The proposed operation(s), including the nature of the mission being supported;

• The service to be provided by the person(s) covered by the SFAR;

• To the extent known, the specific locations in either or both of the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in either or both of the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs and the airports, airfields and/or landing zones at which the aircraft will take-off and land; and

• The method by which the department, agency, or instrumentality will provide, or how the operator will otherwise obtain, current threat information and an explanation of how the operator will integrate this information into all phases of its proposed operations (e.g., pre-mission planning and briefing, in-flight, and post-flight).

The request for approval must also include a list of operators with whom the U.S. Government department, agency, or instrumentality requesting FAA approval has a current contract(s), grant(s), or cooperative agreement(s) (or with whom its prime contractor has a subcontract(s)) for specific flight operations in either or both of the UKFV and UKDV FIRs. Additional operators may be identified to the FAA at any time after the FAA approval is issued. However, all additional operators must be identified to, and obtain an Operations Specification (OpSpec) or Letter of Authorization (LOA), as appropriate, from, the FAA, for operations in either or both of the UKFV and UKDV FIRs before such operators commence such operations. The revised approval conditions discussed below will apply to any such additional operators. Updated lists should be sent to the email address to be obtained from the Air Transportation Division by calling (202) 267-8166.

If an approval request includes classified information, requestors may contact Aviation Safety Inspector Michael Filippell for instructions on submitting it to the FAA. His contact information is listed in the “For Further Information Contact” section of this final rule.

FAA approval of an operation under SFAR No. 113, § 91.1607, does not relieve persons subject to this SFAR of their responsibility to comply with all applicable FAA rules and regulations. Operators of civil aircraft must also comply with the conditions of their certificate, OpSpecs, and LOAs, as applicable. Operators must further comply with all rules and regulations of other U.S. Government departments and agencies that may apply to the proposed operation, including, but not limited to, the Transportation Security Regulations issued by the Transportation Security Administration, Department of Homeland Security.

If the FAA approves the request, the FAA's Aviation Safety Organization (AVS) will send an approval letter to the requesting department, agency, or instrumentality informing it that the FAA's approval is subject to all of the following conditions:

(1) The approval will stipulate those procedures and conditions that limit, to the greatest degree possible, the risk to the operator, while still allowing the operator to achieve its operational objectives.

(2) Before any approval takes effect, the operator must submit to the FAA:

(a) A written release of the U.S. Government from all damages, claims, and liabilities, including without limitation legal fees and expenses; and

(b) The operator's agreement to indemnify the U.S. Government with respect to any and all third-party damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising from or related to the approved operations in either or both of the UKFV and UKDV FIRs.

(3) Other conditions that the FAA may specify, including those that may be imposed in OpSpecs or LOAs, as applicable.

The release and agreement to indemnify do not preclude an operator from raising a claim under an applicable non-premium war risk insurance policy issued by the FAA under chapter 443 of title 49, United States Code.

If the proposed operation or operations are approved, the FAA will issue an OpSpec or an LOA, as applicable, to the operator authorizing the operation or operations, and will notify the department, agency, or instrumentality that requested the FAA's approval of any additional conditions beyond those contained in the approval letter. The requesting department, agency, or instrumentality must have a contract, grant, or cooperative agreement (or its prime contractor must have a subcontract) with the person(s) described in paragraph (a) of this SFAR No. 113, § 91.1607, on whose behalf the department, agency, or instrumentality requests FAA approval.

Any operations not conducted under an approval issued by the FAA through the approval process set forth previously must be conducted under an exemption from SFAR No. 113, § 91.1607. A request by any person covered under SFAR No. 113, § 91.1607, for an exemption must comply with 14 CFR part 11, and will require exceptional circumstances beyond those contemplated by the approval process set forth previously. In addition to the information required by 14 CFR 11.81, at a minimum, the requestor must describe in its submission to the FAA—

• The proposed operation(s), including the nature of the operation;

• The service to be provided by the person(s) covered by the SFAR;

• The specific locations in either or both of the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in the UKFV and/or UKDV FIRs and the airports, airfields and/or landing zones at which the aircraft will take-off and land); and

• The method by which the operator will obtain current threat information and an explanation of how the operator will integrate this information into all phases of its proposed operations (e.g., the pre-mission planning and briefing, in-flight, and post-flight phases).

Additionally, the release and agreement to indemnify, as referred to previously, will be required as a condition of any exemption that may be issued under SFAR No. 113, § 91.1607.

The FAA recognizes that operations that may be affected by SFAR No. 113, § 91.1607, may be planned for the governments of other countries with the support of the U.S. Government. While these operations will not be permitted through the approval process, the FAA will process exemption requests for such operations on an expedited basis and prior to any private exemption requests.

Changes to Federal regulations must undergo several economic analyses. First, Executive Orders 12866 and 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39), as amended, 19 U.S.C. Chapter 13, prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Agreements Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), as codified in 2 U.S.C. Chapter 25, requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

In conducting these analyses, FAA has determined this final rule has benefits that justify its costs. This rule is a significant regulatory action as defined in section 3(f) of Executive Order 12866, as it raises novel policy issues contemplated under that Executive Order; further, this rule is “significant” as defined in DOT's Regulatory Policies and Procedures. This rule will not have a significant economic impact on a substantial number of small entities. This rule will not create unnecessary obstacles to the foreign commerce of the United States. This rule will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector by exceeding the threshold identified above.

Department of Transportation (DOT) Order 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits a statement to that effect and the basis for it to be included in the preamble if a full regulatory evaluation of the costs and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.

This rule extends the existing prohibition against U.S. civil flight operations in the UKFV and UKDV FIRs. As we noted in the most recent previous amendment to SFAR No. 113, § 91.1607 (79 FR 77860, December 29, 2014), almost all U.S. operators already had voluntarily ceased their operations in these FIRs prior to the issuance of the FAA NOTAM on July 18, 2014 (UTC), prohibiting U.S. civil flight operations in these two FIRS in their entirety. Prior to the issuance of the July 18, 2014 (UTC) NOTAM, the FAA had already prohibited U.S. civil flight operations in a portion of the UKFV FIR due to a dispute between Ukraine and the Russian Federation over which country is responsible for providing air navigation services in the area, first via NOTAM and subsequently when the FAA initially published SFAR No. 113, § 91.1607, on April 25, 2014. Consequently, no U.S. operators were operating in that portion of the UKFV FIR at the time of the December 29, 2014 amendment to the rule.

Because of the continuing significant hazards to U.S. civil aviation discussed in the Background section of this final rule, the FAA believes that few, if any, U.S. operators presently wish to conduct operations in either of these two FIRS. Moreover, both the amendment published on December 29, 2014, and this rule, permit a U.S. Government department, agency, or instrumentality to request FAA approval on behalf of a person described in paragraph (a) of SFAR No. 113, § 91.1607, to conduct operations under a contract (or subcontract), grant, or cooperative agreement with that department, agency, or instrumentality. As no U.S. Government department, agency, or instrumentality has requested such approval since December 29, 2014, there is apparently little demand for such approvals. Finally, the possibility of obtaining an approval, should one be requested, lowers the expected cost of the extended rule. Accordingly, the FAA believes the incremental costs of this final rule will be minimal. These minimal costs will be exceeded by the benefits of avoiding the deaths, injuries, and/or property damage that would result from a U.S. operator's aircraft being shot down (or otherwise damaged) while operating in either or both of the UKFV and UKDV FIRs.

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis, as described in the RFA.

However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

As described in the Regulatory Evaluation section of this preamble, the incremental costs of this rule are minimal. Therefore, as provided in § 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended, prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to this Act, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.

The FAA has assessed the effect of this final rule and determined that its purpose is to protect the safety of U.S. civil aviation from a hazard outside the U.S. Therefore, the rule is in compliance with the Trade Agreements Act.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million.

This final rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this immediately adopted final rule.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to this regulation.

FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act (NEPA) in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6f of this order and involves no extraordinary circumstances.

The FAA has reviewed the implementation of this SFAR and determined it is categorically excluded from further environmental review according to FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.6f. The FAA has examined possible extraordinary circumstances and determined that no such circumstances exist. After careful and thorough consideration of the action, the FAA finds that this Federal action does not require preparation of an Environmental Assessment or Environmental Impact Statement in accordance with the requirements of NEPA, Council on Environmental Quality (CEQ) regulations, and FAA Order 1050.1F.

The FAA has analyzed this immediately adopted final rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action would not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.

The FAA analyzed this immediately adopted final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it would not be a “significant energy action” under the executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.

Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.

An electronic copy of rulemaking documents may be obtained from the Internet by—

• Searching the Federal eRulemaking Portal (http://www.regulations.gov);

• Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or

• Accessing the Government Publishing Office's Web page at http://www.fdsys.gov

Copies may also be obtained by sending a request (identified by docket or amendment number of the rule) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677.

All documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced above.

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations, as follows:

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, after 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.

23andMe, Inc., submitted a direct de novo request for classification of the 23andMe PGS Carrier Screening Test for Bloom Syndrome under section 513(f)(2)(A)(ii) of the FD&C Act, based on a determination that there is no legally marketed device on which to base a determination of substantial equivalence.

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) of the FD&C Act. After review of the information submitted in the de novo request, FDA classified the device into class II because general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.

Therefore, on February 19, 2015, FDA issued an order to the requestor classifying the device into class II. The classification of the device will be codified at 21 CFR 866.5940.

The device is assigned the generic name autosomal recessive carrier screening gene mutation detection system, and it is identified as a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.

A gene mutation detection system indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis is separately classified under 21 CFR 866.5900—Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system (class II, special controls), and is thus not included in the de novo classification.

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

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

1. If the device is offered over-the-counter, the device manufacturer must provide information to a potential purchaser or actual test report recipient about how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre-and post-test counseling.

2. The device must use a collection device that is FDA cleared, approved, or classified as 510(k) exempt, with an indication for in vitro diagnostic use in DNA testing.

3. The device's labeling must include a prominent hyperlink to the manufacturer's public Web site where the manufacturer shall make the information identified in this subsection publicly available. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access. If the device can be purchased from the Web site or testing using the device can be ordered from the Web site, the same information must be found on the Web page for ordering the device or provided in a prominently placed and publicly accessible hyperlink on the Web page for ordering the device. Any changes to the device that could significantly affect safety or effectiveness would require new data or information in support of such changes, which would also have to be posted on the manufacturer's Web site. The information must include:

a. A detailed device description including:

i. Gene (or list of the genes if more than one) and variants the test detects (using standardized nomenclature, Human Genome Organization (HUGO) nomenclature, and coordinates);

ii. Scientifically established clinical validity of each variant detected and reported by the test, which must be well-established in peer-reviewed journal articles, authoritative summaries of the literature such as Genetics Home Reference (http://ghr.nlm.nih.gov/), GeneReviews (http://www.ncbi.nlm.nih.gov/books/NBK1116/), or similar summaries of valid scientific evidence, and/or professional society recommendations, including:

A. Genotype-phenotype information for the reported mutations.

B. Relevant American College of Medical Genetics (ACMG) or American Congress of Obstetricians and Gynecologists (ACOG) guideline recommending testing of the specific gene(s) and variants the test detects and recommended populations, if available. If not available, a statement stating that professional guidelines currently do not recommend testing for this specific gene(s) and variants.

C. Table of expected prevalence of carrier status in major ethnic and racial populations and the general population.

iii. The specimen type (e.g., saliva, whole blood), matrix, and volume;

iv. Assay steps and technology used;

v. Specification of required ancillary reagents, instrumentation, and equipment;

vi. Specification of the specimen collection, processing, storage, and preparation methods;

vii. Specification of risk mitigation elements and description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing;

viii. Information pertaining to the probability of test failure (e.g., failed quality control) based on data from clinical samples, description of scenarios in which a test can fail (i.e., low sample volume, low DNA concentration, etc.), how customers will be notified, and followup actions to be taken; and

ix. Specification of the criteria for test result interpretation and reporting.

b. Information that demonstrates the performance characteristics of the device, including:

i. Accuracy (method comparison) of study results for each claimed specimen type.

A. Accuracy of the device shall be evaluated with fresh clinical specimens collected and processed in a manner consistent with the device's instructions for use. If this is impractical, fresh clinical samples may be substituted or supplemented with archived clinical samples. Archived samples shall have been collected previously in accordance with the device's instructions for use, stored appropriately, and randomly selected. In some instances, use of contrived samples or human cell line samples may also be appropriate; the contrived or human cell line samples shall mimic clinical specimens as much as is feasible and provide an unbiased evaluation of the device's accuracy.

B. Accuracy must be evaluated as compared to bidirectional sequencing or other methods identified as appropriate by FDA. Performance criteria for both the comparator method and device must be predefined and appropriate to the test's intended use. Detailed appropriate study protocols must be provided.

C. Information provided shall include the number and type of specimens, broken down by clinically relevant variants, that were compared to bidirectional sequencing or other methods identified as appropriate by FDA. The accuracy, defined as positive percent agreement (PPA) and negative percent agreement (NPA), must be measured; accuracy point estimates must be greater than 99 percent (both per reported variant and overall) and uncertainty of the point estimate must be presented using the 95 percent confidence interval. Clinical specimens must include both homozygous wild type and heterozygous genotypes. The number of clinical specimens for each variant reported that must be included in the accuracy study must be based on the variant prevalence. Common variants (greater than 0.1 percent allele frequency in ethnically relevant population) must have at least 20 unique heterozygous clinical specimens tested. Rare variants (less than or equal to 0.1 percent allele frequency in ethnically relevant population) shall have at least three unique mutant heterozygous specimens tested. Any no calls (i.e., absence of a result) or invalid calls (e.g., failed quality control) in the study must be included in accuracy study results and reported separately. Variants that have a point estimate for PPA or NPA of less than 99 percent (incorrect test results as compared to bidirectional sequencing or other methods identified as appropriate by FDA) must not be incorporated into test claims and reports. Accuracy measures generated from clinical specimens versus contrived samples or cell lines must be presented separately. Results must be summarized and presented in tabular format, by sample, and by genotype. Point estimate of PPA should be calculated as the number of positive results divided by the number of specimens known to harbor variants (mutations) without “no calls” or invalid calls. The point estimate of NPA should be calculated as the number of negative results divided by the number of wild type specimens tested without “no calls” or invalid calls, for each variant that is being reported. Point estimates should be calculated along with 95 percent two-sided confidence intervals.

D. Information shall be reported on the clinical positive predictive value (PPV) and negative predictive value (NPV) for carrier status (and where possible, for each variant) in each population. Specifically, to calculate PPV and NPV, estimate test coverage (TC) and the percent of persons with variant(s) included in the device among all carriers: PPV = (PPA*TC * π)/(PPA*TC*π + (1 − NPA) * (1 − π)) and NPV = (NPA*(1 − π))/(NPA*(1 − π) + (1 − PPA*TC) * π) where PPA and NPA described either in paragraph (3)(b)(i)(D)(1) or in (3)(b)(i)(D)(2) that follow and π is prevalence of carriers in the population (pre-test risk to be a carrier for the disease).

1. For the point estimates of PPA and NPA less than 100 percent, use the calculated estimates in the PPV and NPV calculations.

2. Point estimates of 100 percent may have high uncertainty. If these variants are measured using highly multiplexed technology, calculate the random error rate for the overall device and incorporate that rate in the estimation of the PPA and NPA as calculated previously. Then use these calculated estimates in the PPV and NPV calculations. This type of accuracy study is helpful in determining that there is no systematic error in such devices.

ii. Precision (reproducibility): Precision data must be generated using multiple instruments and multiple operators, on multiple non-consecutive days, and using multiple reagent lots. The sample panel must include specimens with claimed sample type (e.g. saliva samples) representing different genotypes (i.e., wild type, heterozygous). Performance criteria must be predefined. A detailed study protocol must be created in advance of the study and then followed. The “failed quality control” rate must be indicated. It must be clearly documented whether results were generated from clinical specimens, contrived samples, or cell lines. The study results shall state, in a tabular format, the variants tested in the study and the number of replicates for each variant, and what testing conditions were studied (i.e., number of runs, days, instruments, reagent lots, operators, specimens/type, etc). The study must include all nucleic acid extraction steps from the claimed specimen type or matrix, unless a separate extraction study for the claimed sample type is performed. If the device is to be used at more than one laboratory, different laboratories must be included in the precision study (and reproducibility must be evaluated). The percentage of “no calls” or invalid calls, if any, in the study must be provided as a part of the precision (reproducibility) study results.

iii. Analytical specificity data: Data must be generated evaluating the effect on test performance of potential endogenous and exogenous interfering substances relevant to the specimen type, evaluation of cross-reactivity of known cross-reactive alleles and pseudogenes, and assessment of cross-contamination.

iv. Analytical sensitivity data: Data must be generated demonstrating the minimum amount of DNA that will enable the test to perform accurately in 95 percent of runs.

v. Device stability data: The manufacturer must establish upper and lower limits of input nucleic acid and sample stability that will achieve the claimed accuracy and reproducibility. Data supporting such claims must be described.

vi. Specimen type and matrix comparison data: Specimen type and matrix comparison data must be generated if more than one specimen type or anticoagulant can be tested with the device, including failure rates for the different specimen types.

c. If the device is offered over-the-counter, including cases in which the test results are provided direct-to-consumer, the manufacturer must conduct a study that assesses user comprehension of the device's labeling and test process and provide a concise summary of the results of the study. The following items must be included in the user study:

i. The test manufacturer must perform pre- and post-test user comprehension studies to assess user ability to understand the possible results of a carrier test and their clinical meaning. The comprehension test questions must directly evaluate the material being presented to the user in the test reports.

ii. The test manufacturer must provide a carrier testing education module to potential and actual test report recipients. The module must define terms that are used in the test reports and explain the significance of carrier status.

iii. The user study must meet the following criteria:

A. The study participants must be comprised of a statistically justified and demographically diverse population (determined using methods such as quota-based sampling) that is representative of the intended user population. Furthermore, the users must be comprised of a diverse range of age and educational levels that have no prior experience with the test or its manufacturer. These factors shall be well-defined in the inclusion and exclusion criteria.

B. All sources of bias (e.g., non-responders) must be predefined and accounted for in the study results with regard to both responders and non-responders.

C. The testing must follow a format where users have limited time to complete the studies (such as an onsite survey format and a one-time visit with a cap on the maximum amount of time that a participant has to complete the tests).

D. Users must be randomly assigned to study arms. Test reports given to users must: (1) Define the condition being tested and related symptoms, (2) explain the intended use and limitations of the test, (3) explain the relevant ethnicities regarding the variant tested, (4) explain carrier status and relevance to the user's ethnicity, (5) provide links to additional information pertaining to situations where the user is concerned about their test results or would like followup information as indicated in test labeling). The study shall assess participants' ability to understand the following comprehension concepts: The test's limitations, purpose, and results.

E. Study participants must be untrained, naive to the test subject of the study, and be provided only the materials that will be available to them when the test is marketed.

F. The user comprehension study must meet the predefined primary endpoint criteria, including a minimum of a 90 percent or greater overall comprehension rate (i.e. selection of the correct answer) for each comprehension concept to demonstrate that the education module and test reports are adequate for over-the-counter use.

iv. A summary of the user comprehension study must be provided and include the following:

A. Results regarding reports that are provided for each gene/variant/ethnicity tested.

B. Statistical methods used to analyze all data sets.

C. Completion rate, non-responder rate, and reasons for non-response/data exclusion, as well as a summary table of comprehension rates regarding comprehension concepts (purpose of test, test results, test limitations, ethnicity relevance for the test results, etc.) for each study report.

4. Your 21 CFR 809.10 compliant labeling and any test report generated must include the following warning and limitation statements, as applicable:

a. A warning that reads “The test is intended only for autosomal recessive carrier screening in adults of reproductive age.”

b. A statement accurately disclosing the genetic coverage of the test in lay terms, including, as applicable, information on variants not queried by the test, and the proportion of incident disease that is not related to the gene(s) tested. For example, where applicable, the statement would have to include a warning that the test does not or may not detect all genetic variants related to the genetic disease, and that the absence of a variant tested does not rule out the presence of other genetic variants that may be disease-related. Or, where applicable, the statement would have to include a warning that the basis for the disease for which the genetic carrier status is being tested is unknown or believed to be non-heritable in a substantial number of people who have the disease, and that a negative test result cannot rule out the possibility that any offspring may be affected with the disease. The statement would have to include any other warnings needed to accurately convey to consumers the degree to which the test is informative for carrier status.

c. For prescription use tests, the following warnings that read:

i. “The results of this test are intended to be interpreted by a board-certified clinical molecular geneticist or equivalent and should be used in conjunction with other available laboratory and clinical information.”

ii. “This device is not intended for disease diagnosis, prenatal testing of fetuses, risk assessment, prognosis or pre-symptomatic testing, susceptibility testing, or newborn screening.”

d. For over-the-counter tests, a statement that reads “This test is not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future. On its own, this test is also not intended to tell you anything about the health of your fetus, or your newborn child's risk of developing a particular disease later on in life.”

e. For over-the-counter tests, the following warnings that read:

i. “This test is not a substitute for visits to a healthcare provider. It is recommended that you consult with a healthcare provider if you have any questions or concerns about your results.”

ii. “The test does not diagnose any health conditions. Results should be used along with other clinical information for any medical purposes.”

iii. “The laboratory may not be able to process your sample. The probability that the laboratory cannot process your saliva sample can be up to [actual probability percentage].”

iv. “Your ethnicity may affect how your genetic health results are interpreted.”

f. For a positive result in an over-the-counter test when the positive predictive value for a specific population is less than 50 percent and more than 5 percent, a warning that reads “The positive result you obtained may falsely identify you as a carrier. Consider genetic counseling and followup testing.”

g. For a positive result in an over-the-counter test when the positive predictive value for a specific population is less than 5 percent, a warning that reads “The positive result you obtained is very likely to be incorrect due to the rarity of this variant. Consider genetic counseling and followup testing.”

5. The testing done to comply with paragraph 3 must show the device meets or exceeds each of the following performance specifications:

a. The accuracy must be shown to be equal to or greater than 99 percent for both PPA and NPA. Variants that have a point estimate for PPA or NPA of less than 99 percent (incorrect test results as compared to bidirectional sequencing or other methods identified as appropriate by FDA) must not be incorporated into test claims and reports.

b. Precision (reproducibility) performance must meet or exceed 99 percent for both positive and negative results.

c. The user comprehension study must obtain values of 90 percent or greater user comprehension for each comprehension concept.

6. The distribution of this device, excluding the collection device described in paragraph 2, shall be limited to the manufacturer, the manufacturer's subsidiaries, and laboratories regulated under the Clinical Laboratory Improvement Amendments.

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 believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements of the FD&C Act. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of intent to exempt an autosomal recessive carrier screening gene mutation detection system under section 510(m) of the FD&C Act. If there are questions about 510(k) submission prior to finalization of the 510(k) exemption, you should contact FDA at the number provided in this Final order. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the autosomal recessive carrier screening gene mutation detection system prior to marketing the device.

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

This final administrative 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 parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Posting of Public Comments

Please note that all comments received in response to this docket are considered part of the public record and will be made available for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document and supplemental information to this interim final rule is available at http://www.regulations.gov for easy reference.

The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and they are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II.

The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. 21 U.S.C. 801.

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

The CSA states that the Attorney General shall by regulation exclude any nonnarcotic drug which contains a controlled substance from the application of the CSA, if such drug may, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), [21 U.S.C. 301 et seq.] be lawfully sold over-the-counter without a prescription. 21 U.S.C. 811(g)(1). Such exclusions apply only to specific nonnarcotic drugs following suitable application to the DEA in accordance with 21 CFR 1308.21. The current table of Excluded Nonnarcotic Products is found in 21 CFR 1308.22. The authority to exclude such substances has been delegated to the Administrator of the DEA, 28 CFR 0.100, and redelegated to the Deputy Assistant Administrator of the Office of Diversion Control, section 7 of 28 CFR part 0, appendix to subpart R.

On December 10, 2013, pursuant to the application process of 21 CFR 1308.21, the DEA received correspondence from Aphena Pharma Solutions—New York, LLC (Aphena Pharma) stating that it had acquired Classic Pharmaceuticals LLC and requesting that the current exclusion for the drug product Nasal Decongestant Inhaler/Vapor Inhaler be transferred to Aphena Pharma. Aphena Pharma also stated that the manufacturing process (i.e., facility) and the formulation for the drug product Nasal Decongestant Inhaler/Vapor Inhaler had not changed.

Based on the application and other information received, the DEA has determined that this product may, under the FD&C Act, be lawfully sold over-the-counter without a prescription. 21 U.S.C. 811(g)(1). In addition, the Deputy Assistant Administrator of the Office of Diversion Control finds that the active ingredient in this drug product (levmetamfetamine) is a schedule II controlled substance 1 and is not a narcotic drug as defined by 21 U.S.C. 802(17). The Deputy Assistant Administrator of the Office of Diversion Control therefore finds and concludes that this drug product continues to meet the criteria for exclusion from the CSA pursuant to 21 U.S.C. 811(g)(1).

This exclusion only applies to the finished drug product in the form of an inhaler (in the exact formulation detailed in the application for exclusion), which is lawfully sold under the FD&C Act over-the-counter without a prescription. The extraction or removal of the active ingredient (levmetamfetamine) from the inhaler shall negate this exclusion and result in the possession of a schedule II controlled substance.

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), including notice of proposed rulemaking and the pre-promulgation opportunity for public comment, if it is determined to be impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). The DEA finds for good cause that it is unnecessary to seek public comment prior to amending the table of Excluded Nonnarcotic Products to update the listing for this product, as the amendment is technical in nature and would not result in any substantive change. The DEA is merely changing the name of the company associated with the Nasal Decongestant Inhaler/Vapor Inhaler as the result of the acquisition of Classic Pharmaceuticals LLC by Aphena Pharma. The manufacturing process (i.e., facility) and the formulation for the drug product Nasal Decongestant Inhaler/Vapor Inhaler have not changed as a result of this acquisition.

The APA requires the publication of a substantive rule to be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, this requirement need not apply for “a substantive rule which grants or recognizes an exemption or relieves a restriction” or “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(1). This rule continues the exclusion of a nonnarcotic drug product from the provisions of the CSA. Given that this amendment to the table of Excluded Nonnarcotic Products is technical in nature and thereby would not warrant any further delay, the DEA finds that there is good cause to make this rule effective immediately upon publication.

This regulation has been developed in accordance with the Executive Orders 12866, “Regulatory Planning and Review,” section 1(b) and Executive Order 13563, “Improving Regulation and Regulatory Review.” The DEA has determined that this rule is not a significant regulatory action, and accordingly this rule has not been reviewed by the Office of Management and Budget. This product was previously exempted under a different company name. This action will not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities; create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866.

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

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

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

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

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

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

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

Please note that all comments received in response to this docket are considered part of the public record and will be made available for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document and supplemental information to this interim final rule is available at http://www.regulations.gov for easy reference.

The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II.

The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. 21 U.S.C. 801.

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

The CSA states that the Attorney General shall by regulation exclude any non-narcotic drug which contains a controlled substance from the application of the CSA, if such drug may, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), [21 U.S.C. 301 et seq.] be lawfully sold over-the-counter without a prescription. 21 U.S.C. 811(g)(1). Such exclusions apply only to specific non-narcotic drugs following suitable application to the DEA in accordance with 21 CFR 1308.21. The current table of Excluded Nonnarcotic Products is found in 21 CFR 1308.22. The authority to exclude such substances has been delegated to the Administrator of the DEA, 28 CFR 0.100, and redelegated to the Deputy Assistant Administrator of the Office of Diversion Control, section 7 of 28 CFR part 0, appendix to subpart R.

On February 9, 2012, pursuant to the application process of 21 CFR 1308.21, the DEA received correspondence from The Proctor & Gamble Company (“P&G”) notifying the DEA that it had reduced the quantity of l-desoxyephedrine (levmetamfetamine) from 113 mg to 50 mg in their Vicks® InhalerTM product which is currently excluded under 21 CFR 1308.22. Levmetamfetamine is controlled in schedule II as an isomer of methamphetamine. 21 CFR 1308.12(d)(2). P&G requested that the DEA update the current exclusion for their Vicks® InhalerTM and indicated it had acquired Richardson-Vicks, Inc. (including its subsidiary, the Vick Chemical Company). The company also stated that the product name has been modified from Vicks® InhalerTM to Vicks® VapoInhaler® and that the change included a corresponding National Drug Code (NDC) number reassignment by the U.S. Food and Drug Administration. P&G also stated that the nomenclature for the active ingredient/controlled substance had been changed from l-desoxyephedrine to levmetamfetamine. P&G indicated that nothing in the formulation change affects other aspects of the drug delivery system.

Based on the application and other information received, including the quantitative composition of the substance and labeling and packaging information, the DEA has determined that this product may, under the FD&C Act, be lawfully sold over-the-counter without a prescription. 21 U.S.C. 811(g)(1). In addition, the Deputy Assistant Administrator of the Office of Diversion Control finds that the active ingredient in this drug product (levmetamfetamine) is a schedule II controlled substance and is not a narcotic drug as defined by 21 U.S.C. 802(17). The Deputy Assistant Administrator of the Office of Diversion Control therefore finds and concludes that this product continues to meet the criteria for exclusion from the CSA pursuant to 21 U.S.C. 811(g)(1).

This exclusion only applies to the finished drug product in the form of an inhaler (in the exact formulation detailed in the application for exclusion), which is lawfully sold under the FD&C Act over-the-counter without a prescription. The extraction or removal of the active ingredient (levmetamfetamine) from the inhaler shall negate this exclusion and result in the possession of a schedule II controlled substance.

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), including notice of proposed rulemaking and the pre-promulgation opportunity for public comment, if it is determined to be impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). The DEA finds for good cause that it is unnecessary to seek public comment prior to amending the table of Excluded Nonnarcotic Products to update the listing for this product, as the amendments are primarily technical in nature and would not result in any substantive change. The product was previously exempted under a different company name, which is no longer accurate due to acquisition of Vick Chemical Company by The Proctor & Gamble Company. Additionally, the product name has been modified and was reassigned a corresponding NDC number, and the nomenclature for the active ingredient has changed. Lastly, while the amount of the schedule II ingredient l-desoxyephedrine (levmetamfetamine) in this product has been reduced by half the original quantity, the changes in the formulation will not affect the effectiveness of the product or the public's ability to benefit from the use of the product. There is also no further formulation change which would affect other aspects of the drug delivery system.

The APA requires the publication of a substantive rule to be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, this requirement need not apply for “a substantive rule which grants or recognizes an exemption or relieves a restriction” or “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(1). This rule continues the exclusion of a nonnarcotic drug product from the provisions of the CSA. Given that these amendments to the table of Excluded Nonnarcotic Products are primarily technical in nature and thereby would not warrant any further delay, the DEA finds that there is good cause to make this rule effective immediately upon publication.

This regulation has been developed in accordance with the Executive Orders 12866, “Regulatory Planning and Review,” section 1(b) and Executive Order 13563, “Improving Regulation and Regulatory Review.” The DEA has determined that this rule is not a significant regulatory action, and accordingly this rule has not been reviewed by the Office of Management and Budget. This product is a modified version of a product that is currently exempted under the DEA's regulations. This action will not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities; create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866.

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

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

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

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

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

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

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

The Department's Final Rule amending FLSA regulations regarding domestic service employment, 78 FR 60454 (October 1, 2013), which extends minimum wage and overtime protections to most home care workers, had an effective date of January 1, 2015. The Department did not begin enforcement of the Final Rule on that date both because of its time-limited non-enforcement policy, 79 FR 60974 (October 9, 2014), and because it was a party to a federal lawsuit regarding the amended regulations in which the U.S. District Court for the District of Columbia issued opinions and orders vacating the rule's major provisions. Home Care Ass'n of Am. v. Weil, 76 F. Supp. 3d 138 (D.D.C. 2014); Home Care Ass'n of Am. v. Weil, 78 F. Supp. 3d 123 (D.D.C. 2015). On August 21, 2015, the U.S. Court of Appeals for the District of Columbia Circuit reversed the district court's judgment. Home Care Ass'n of America v. Weil, 799 F.3d 1084 (D.C. Cir. 2015). On September 14, 2015, the Department announced that it would not bring enforcement actions against any employer for violations of FLSA obligations resulting from the amended domestic service regulations for 30 days after the date the Court of Appeals issued a mandate making its opinion effective. 80 FR 55029 (September 14, 2015).

The Court of Appeals issued the mandate directing the district court to enter a new judgment in favor of the Department on October 13, 2015. The Department will therefore not bring enforcement actions against any employer for violations of FLSA obligations resulting from the amended domestic service regulations before November 12, 2015.

This 30-day non-enforcement policy does not replace or affect the timeline of the Department's existing time-limited non-enforcement policy announced in October 2014. 79 FR 60974. Therefore, from November 12, 2015 through December 31, 2015, the Department will exercise prosecutorial discretion in determining whether to bring enforcement actions, with particular consideration given to the extent to which States and other entities have made good faith efforts to bring their home care programs into compliance with the FLSA since the promulgation of the Final Rule. The Department will also continue to provide intensive technical assistance to the regulated community up to and after December 31, 2015, as it has since promulgation of the Final Rule.

This Policy Statement is guidance articulating considerations relevant to the Department's exercise of its enforcement authority under the FLSA. It is therefore exempt from the notice-and-comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b).

Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis. 5 U.S.C. 603(a), 604(a). The Department has determined that this guidance does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule publishing an NPRM would be impracticable as delayed promulgation may result in injury or damage to the maritime public and response vessels prior to conclusion of a notice and comment period.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable because immediate action is needed to minimize the potential impact to the waterway users and emergency response personnel involved in the training exercise.

The Coast Guard has authority to issue a rule under authority in 33 U.S.C. 1231. The Captain of the Port, Puget Sound has determined that potential hazards associated with the training exercise will be a safety concern for anyone transiting through the operational location of the exercise. A safety zone is needed to ensure the safety of the maritime public and emergency response vessels participating in the exercise by preventing collisions between exercising vessels and the maritime public, and by keeping the maritime public a safe distance away from elements associated with the exercise.

The Coast Guard is establishing a temporary safety zone that will encompass all navigable waters within an area established by the following points: 47°34′13″ N., 122°32′12″ W., thence southeast to 47°33′41″ N., 122°31′07″ W., thence southwest to 47°33′15″ N., 122°32′04″ W., thence south to 47°31′49 N., 122°31′47″ W., thence west to 47°31′55″ N., 122°32′28″ W., thence north to 47°33′20″ N., 122°32′29″ W., thence northeast to 47°34′08″ N., 122°32′17″ W., located near the Manchester fuel piers, Manchester, WA and is effective from 7 a.m. on November 2, 2015 until 6 p.m. on November 8, 2015 when vessel exercise participants are present in the safety zone. Vessels wishing to enter the safety zone must request permission to do so from the Captain of the Port, Puget Sound by contacting the Joint Harbor Operations Center at 206-217-6001 or the on-scene Law Enforcement patrol craft, if any, via VHF-FM Channel 16. If permission for entry is granted, vessels must proceed at a minimum speed for safe navigation.

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

E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the limited nature of the size and duration of the temporary safety zone. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM Channel 16 about the safety zone and the rule allows vessels to seek permission to enter the safety zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V above, this rule will not have a significant economic impact on any vessel owner or operator, because the zone established in this rule is limited in nature of size and duration.

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

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

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

A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting less than 29 days that will prohibit entry into various training exercise operations within the designated area. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

Executive Summary: Purpose: 37 CFR 1.14(h) regulates access by foreign IP offices to U.S. applications. Formerly, 37 CFR 1.14(h) contained only a specific provision by which an applicant could authorize the Office to give a foreign IP office participating with the Office in a bilateral or multilateral priority document exchange agreement access to a U.S. application-as-filed. 37 CFR 1.14(h) is now expanded to also include a specific provision by which, under certain circumstances, an applicant can authorize the Office to give a foreign IP office access to all or part of the file contents of a U.S. patent application in order to satisfy the foreign IP office's requirement for information.

Summary of Major Provisions: This final rule primarily provides a specific provision by which an applicant can authorize the Office to provide a foreign IP office access to all or part of the file contents of a U.S. patent application where the foreign IP office has imposed a requirement for information on a counterpart application filed with that office and is a party to a bilateral or multilateral agreement with the Office to provide the required information from the U.S. application.

This final rule also revises the rules of practice to indicate that there is no fee for providing a foreign IP office with an electronic copy of an application-as-filed or an electronic copy of file contents pursuant to a bilateral or multilateral agreement. Previously, the regulations only indicated that there was no fee for providing a foreign IP office with a copy of an application-as-filed pursuant to a priority document exchange agreement.

Additionally, the Office is revising the ADS form (PTO/AIA/14) as well as the PTO/SB/39 and PTO/SB/69 forms to facilitate applicant's authorization of access to unpublished U.S. applications by foreign IP offices.

Costs and Benefits: This rulemaking is not economically significant as that term is defined in Executive Order 12866 (Sept. 30, 1993).

Background: The electronic sharing of information and documents between IP offices is critical for increasing the efficiency and quality of patent examination worldwide. The electronic sharing of documents between IP offices also benefits applicants by reducing the cost of ordering documents from one IP office and then filing them in another IP office where a counterpart application has been filed.

Due to the confidential nature of unpublished U.S. patent applications, set forth in 35 U.S.C. 122, an applicant must provide the Office with written authority in accordance with 37 CFR 1.14 to grant a foreign IP office access to an unpublished U.S. patent application. With this grant of authority, the Office may provide the U.S. patent application-as-filed or the requested file contents, such as information and documents, from the U.S. patent application to the foreign IP office on behalf of the applicant. Previously, applicants used former 37 CFR 1.14(h) to authorize the Office to allow a foreign IP office participating in a bilateral or multilateral priority document exchange agreement access to an unpublished U.S. priority application-as-filed. Former 37 CFR 1.14(h), however, did not contain a specific provision by which an applicant could authorize the Office to provide a foreign IP office access to an unpublished U.S. patent application's file contents. As a result, U.S. applicants, unprompted by the rules, found it necessary to provide written authority for access by a foreign IP office to an unpublished application's contents in accordance with 37 CFR 1.14(c) in order to satisfy a requirement for information by the foreign IP office.

General Discussion of the Changes to 37 CFR 1.14(h): The Office is revising 37 CFR 1.14(h) to include a specific provision by which an applicant can authorize the Office to give a foreign IP office access to all or part of the file contents (as opposed to a copy of the application-as-filed) of an unpublished patent application, including search results, to satisfy a foreign IP office requirement for information in a counterpart application filed by a U.S. applicant. The changes to 37 CFR 1.14(h) consolidate the provisions by which applicants can authorize the Office to give access to an unpublished application-as-filed or its file contents to a foreign IP office, while also clarifying for applicants the provision of 37 CFR 1.14 under which such access authorization can be provided. The final rule changes will further serve as a reminder of the opportunity for applicants to grant the Office the authority to provide a foreign IP office with access to file contents of an unpublished U.S. patent application.

Any information concerning an unpublished application or documents from an unpublished application will only be shared in accordance with the authority provided by applicant and in accordance with the terms of an agreement between the Office and respective foreign IP offices. The Office is not requiring any fee for this service. In addition, sharing of information and documents would be limited to those foreign IP offices where applicant has filed a counterpart application and provided written authority to give a foreign IP office access to all or part of the file contents of an unpublished U.S. application.

The changes to 37 CFR 1.14(h) emphasize the Office's continued support of work sharing efforts between IP offices to increase the quality of issued patents, as well as its commitment to assist in reducing the expenditure of resources of its applicants when complying with the requirements of a foreign IP office in a counterpart application.

Revision to Application Data Sheet Form: In addition to the final rule changes, the Office is revising the application data sheet (ADS) form, PTO/AIA/14 (“the revised ADS form”). The revised ADS form includes separate access authorizations for the PDX program and for the program by which U.S. search results are delivered to the European Patent Office (EPO). The ADS form may be modified in the future to include access authorizations for new work sharing initiatives.

In contrast to the previous version of the ADS form, the revised ADS form includes an “opt-out” check box for each access authorization and not an “opt-in” check box. Therefore, when an “opt-out” check box for a specific authorization is selected, the Office would not provide access to the contents of the application identified in the authorization.

The revised ADS form will make it easier for applicants to give the necessary authorization for access to an application, as well as afford an applicant the opportunity to inform the Office that the required authority to allow a foreign IP office specific access to an application has not been given. The “Authorization to Permit Access” section containing an opt-in check box for the PDX program in the previous version of the ADS form will be replaced by the “Authorization or Opt-Out of Authorization to Permit Access” section in the first release of the revised ADS form, which is intended to contain two subsections. The first subsection will contain the authorization to permit access to the application-as-filed (the PDX program) and the authorization to permit access to the search results by the EPO. The second subsection will contain the corresponding “opt-out” check box for each authorization in the first subsection.

Appropriate authorization language for access in any ADS generated by applicant must be the same as the authorization language provided in the Office's revised ADS form. Use of the same language will permit the Office to readily recognize that applicant has given the necessary authorization. If an applicant-generated ADS does not include the required authorization language for access by a foreign IP office, the ADS will be interpreted as not providing the authorization necessary to give a foreign IP office access.

The submission of a properly signed revised ADS form with the appropriate authorization language on filing of the patent application under 35 U.S.C. 111(a) would be a specific act authorizing access. In addition to an application filed under 35 U.S.C. 111(a), if an ADS is present upon the initial submission of a patent application under 35 U.S.C. 371, the submitted ADS containing authorization would be a specific act authorizing access. Where a revised ADS form, including the authorization language for access by foreign IP office(s) and signed in accordance with 37 CFR 1.14(c) and 1.33(b), has been submitted with an application, the Office would give the foreign IP office(s) access to the contents in accordance with the specific authorization language, upon request of the foreign IP office.

If, however, applicant files a corrected ADS form (i.e., PTO/AIA/14) or a corrected applicant-generated ADS that was not submitted with an application, the authorization for access section will not be reviewed as any changes concerning authorization for access may not be readily apparent to the Office. Instead, applicants must use forms PTO/SB/39 and PTO/SB/69 (or an applicant-generated equivalent), as appropriate, to give or rescind authorization for access after the filing of the application. Forms PTO/SB/39 and PTO/SB/69 will be revised to include opt-in and opt-out check boxes for giving and rescinding the respective authorizations for access after the filing of an application. These two forms can be used in all applications, regardless of their filing dates. Therefore, a revised ADS form used to correct or update application data would only need to be signed in accordance with 37 CFR 1.33(b) because the authorization for access section is not effective if the revised ADS form is not submitted with the application.

To avoid duplicative processing, the Office is removing the opt-in check box and associated authorization language for the PDX program from the inventor's oath or declaration form PTO/AIA/08 (for applications filed on or after September 16, 2012). Form PTO/SB/39 for the PDX authorization and Form PTO/SB/69 for the search results to the EPO authorization will remain available for applicants that do not use an ADS or have selected the check boxes for opting out of specific authorizations for access by a foreign IP office on the revised ADS form submitted with the application, but later decide to give a foreign IP office access to the application.

The changes to the Office's ADS form PTO/AIA/14 should reduce those instances where an applicant inadvertently fails to provide the authorization necessary to participate in PDX (by not selecting the opt-in check box for priority document exchange authorization on the previous version of the PTO/AIA/14 form submitted with the application) and, as a result, must expend resources to obtain and file a copy of a U.S. priority document with a foreign IP office. Similarly, this approach will help eliminate those instances where an applicant inadvertently fails to give the Office authority (by filing the former version of form PTO/SB/69) to provide the EPO with the search results from an unpublished U.S. priority application and, as a consequence, must expend resources to file the results with the EPO.

If applicant has not provided proper written authority for access, the Office will not deliver an unpublished priority document or file contents of an unpublished application to a foreign IP office, even where a counterpart application has been filed. As discussed above, the revised ADS form would need to be executed in accordance with 37 CFR 1.33(b), and if there is written authority for any access by a foreign IP office, the revised ADS form also must be executed in accordance with 37 CFR 1.14(c). Applicants should be aware of the differences in signature requirements under 37 CFR 1.33(b) and under 37 CFR 1.14(c). For example, under 37 CFR 1.33(b) in applications filed on or after September 16, 2012, the following individuals can sign:

• A patent practitioner of record;

• A patent practitioner not of record who acts in a representative capacity under the provisions of 37 CFR 1.34; or

• The applicant under 37 CFR 1.42. Unless otherwise specified, all papers submitted on behalf of a juristic entity must be signed by a patent practitioner.

By contrast, under 37 CFR 1.14(c) in applications filed on or after September 16, 2012, the following individuals can sign:

• The applicant;

• A patent practitioner of record;

• The assignee or an assignee of an undivided part interest;

• The inventor or a joint inventor; or

• A registered attorney or agent named in the papers accompanying the application papers filed under 37 CFR 1.53 or the national stage under 37 CFR 1.495, if a power of attorney has not been appointed under 37 CFR 1.32.

If the revised ADS form submitted with an application is not signed in accordance with the relevant rules, then applicant has not provided written authority for access by a foreign IP office to an application. As can be seen by a comparison of the individuals listed in both 37 CFR 1.33(b) and 37 CFR 1.14(c), in most instances an individual listed in 37 CFR 1.33(b) that can sign the revised ADS form can also give access to the application. For example, a patent practitioner of record can sign under both of these regulations. However, if a power of attorney has been appointed under 37 CFR 1.32, which was effective on filing, and a patent practitioner not of record who acts in a representative capacity under the provisions of 37 CFR 1.34 signs the revised ADS form that is submitted with the application, the Office will not recognize that the applicant has provided written authority for access in the revised ADS form. Where forms PTO/SB/39 for PDX authorization and PTO/SB/69 for search results to the EPO authorization are used instead of the revised ADS form, these forms must still be executed in accordance with 37 CFR 1.14(c) even though written authority is provided for under 37 CFR 1.14(h) as amended by this final rule.

The transaction of sharing documents and information from a U.S. application with a foreign IP office has several built in safeguards to ensure that only authorized sharing occurs. For example, in order for a foreign IP office to receive information about a U.S. application, the Office requires that the foreign IP office expressly identify the U.S. application number, along with other elements of bibliographic data for each U.S. application in its request, to ensure that only information pertaining to the correct U.S. application will be provided to the foreign IP office. Once the application is properly identified, the Office will then determine whether the requisite authorization for access exists in the U.S. application. The Office will only share information or other file content from a U.S. application with a foreign IP office when both the correct application is identified and the existence of proper authorization is confirmed. If an unpublished application, which has not been foreign filed, includes an unintended access authorization pursuant to revised 37 CFR 1.14(h), a foreign IP office would not obtain access because it would not have the information necessary to request access to that specific U.S. application.

Further, the U.S. application's filing receipt will indicate whether applicant has provided written authority for access pursuant to 37 CFR 1.14(h). Applicants should inspect the application filing receipt and request a corrected filing receipt if authorization for access under 37 CFR 1.14(h) was incorrectly captured from the revised ADS form or from an applicant-generated ADS filed along with the application. If authorization for access was inadvertently given, a request for rescission of the authorization can be made by filing either the PTO/SB/39 form or the PTO/SB/69 form in each application where the authorization has been recognized by the Office. The Office should be informed of such rescission as early as possible so the Office has time to recognize the request for rescission and act upon it.

Discussion of Specific Rules: The following is a discussion of the amendments to Title 37 of the Code of Federal Regulations, part 1, in this final rule.

Section 1.14: Section 1.14(h)(1) is amended to retain the first sentence of former § 1.14(h)(1) and include the provisions from former § 1.14(h)(3). Section 1.14(h)(1) also is amended to include that the date of filing of the written authority for priority document exchange may be provided to the respective participating foreign IP office, which codifies the practice set forth in the Official Gazette of the United States Patent and Trademark Office (1328 OG 90 (March 11, 2008)). In § 1.14(h)(1), the text added from former § 1.14(h)(3) has been amended to delete the language “indicated in the written authority.” This deleted language is not necessary as written authority for access under former § 1.14(h) and § 1.14(h) as amended in this final rule will result in access being granted to all PDX and WIPO Digital Access Service (DAS) participating foreign IP offices in which a subsequently filed application claims benefit of the earlier filed U.S. application.

Sections 1.14(h)(1)(i) and (ii) also are amended to include the term “bibliographic data” to reflect that “bibliographic data” is used to ensure the correct application-as-filed is being provided to the participating foreign IP office requesting access in any access to the application-as-filed transaction. The term bibliographic data as used in § 1.14(h)(1) covers certain bibliographic data set forth in WIPO standard ST.9 for bibliographic data. The bibliographic data used to confirm that the correct application-as-filed is being provided may include the patent document identification, filing data, priority data, publication data, data concerning technical information such as patent classification (international or domestic), and the title of the invention.

Section 1.14(h)(2) is revised to include a provision by which an applicant can authorize the Office to grant a foreign IP office access to the file contents of an application where a counterpart application has been filed with a foreign IP office that has imposed a requirement for information on a counterpart application filed with the foreign IP office. The Office would only provide access to the relevant portion or portions of an unpublished U.S. application's file contents necessary to satisfy any requirement for information by the foreign IP office, triggered by the U.S. applicant filing a counterpart application with the foreign IP office. The Office and the foreign IP office would also need to have a bilateral or multilateral agreement for the Office to provide the required information. The agreement would provide for the secure transmission and receipt of any shared information. Section 1.14(h)(2)(i) is amended to include the term “bibliographic data” to reflect that “bibliographic data” is used to ensure the information is from the correct application for which access has been requested by the foreign IP office in any access to the application. The term bibliographic data as used in § 1.14(h)(2) includes the same types of bibliographic data set discussed above with respect to § 1.14(h)(1).

Former 1.14(h)(2) has been moved to § 1.14(h)(3).

Section 1.14(h)(3) is amended to indicate that written authority provided under §§ 1.14(h)(1) and (h)(2) should be submitted before the filing of any subsequent foreign application in which priority is claimed to the application. Section 1.14(h)(3) also is amended to indicate that the written authority under §§ 1.14(h)(1) and (2) must include the title of the invention (§ 1.72(a)), comply with the requirements of § 1.14(c), and must be submitted on an application data sheet (§ 1.76) or on a separate document (§ 1.4(c)).

Section 1.19: Section 1.19(b)(1)(iv) is amended to indicate there is no fee for providing a foreign IP office with a copy of either an application-as-filed or patent related file wrapper and contents pursuant to a bilateral or multilateral agreement (see § 1.14(h)).

Comments and Responses to Comments: The Office published a notice of proposed rulemaking on July 11, 2014, proposing to amend its rules of practice to include a specific provision by which an applicant can authorize the Office to give a foreign intellectual property (IP) office access to all or part of the file contents of an unpublished U.S. patent application in order to satisfy a requirement for information imposed on a counterpart application filed with the foreign IP office. See Changes to Facilitate Applicant's Authorization of Access to Unpublished U.S. Patent Applications by Foreign Intellectual Property Offices, 79 FR 40035 (July 11, 2014). The Office received comments from two intellectual property organizations, a patent practitioner, and a member of the public in response to this notice of proposed rulemaking. Three comments were very positive and supported the proposed changes. One comment opposed the proposed changes. Comments that supported the proposed changes are not discussed. The remaining comments and the Office's responses to those comments follow:

Comment 1: Three comments suggested removing the language “indicated in the written authority” from “all foreign intellectual property offices indicated in the written authority” in proposed § 1.14(h)(2). Two comments noted that this specific language was excluded from proposed § 1.14(h)(1) relating to access to an application-as-filed. One comment asserted that this language may be inconsistent with the statement in the notice of proposed rulemaking that the written authority to provide access to this information would be provided on an “opt-out” basis on the ADS and that any such provision on the ADS would not include a list of foreign intellectual property offices. One comment questioned whether an applicant will have to specify in advance all foreign IP offices that will receive pre-publication information.

Response: Section 1.14(h)(2) as adopted in this final rule does not include the language “indicated in the written authority.” Each written authorization on the revised ADS form will indicate either the specific foreign IP office(s) that is being granted access to the associated pre-publication information or that all the foreign IP offices participating with the Office in a particular work sharing initiative program are being granted access to pre-publication data.

Comment 2: One comment stated that access to pre-publication documents under the proposed rule change facilitates implementation of global projects like the IP5's Global Dossier project. Another comment raised concerns that the proposed rule change will require all of the IP5 Patent Offices to have mutual agreements with each other in order to implement the Global Dossier to cover pre-publication information and suggested that the Office review this requirement in light of the prospective Global Dossier System.

Response: The sharing of documents or information from unpublished U.S. applications between the Office and any foreign IP office has historically required a mutual agreement to cover these shared information or documents. An agreement is needed to ensure that the parties are aware of their obligations to one another (e.g., keeping pre-publication information in confidence). Additionally, as stated in the notice of proposed rulemaking, the Office and the foreign IP office would need to have a bilateral or multilateral agreement that provides for the secure transmission and receipt of any shared information. 79 FR at 40038. Furthermore, the agreement serves as notice to the public regarding what application information (with applicant's consent if the application is unpublished) the Office and other foreign IP office have agreed to share with one another to thereby reduce the resources applicants must expend to comply with any IP office's requirements for information imposed when a counterpart application is filed with a foreign IP office. Currently, the Office will not provide any information or documents from an unpublished U.S. application to a foreign IP office if the Office does not have an agreement to provide such information or documents. Should the Office determine that sharing documents from an unpublished U.S. application with other IP offices in the absence of an agreement would be beneficial, the Office would engage the public to seek its input.

Comment 3: One comment requested seeing the proposed new ADS form before actual implementation of the final rule to be sure that the language in the ADS meets the needs of our applicants.

Response: Due to IT constraints, the EFS-Web based version of the revised ADS form had to be finalized well in advance of the publication of the final rules. The public will have an opportunity to comment on the first release of the revised ADS form. The Office will consider these comments for the next release of the form.

Comment 4: One comment asserted that the proposed rule change is based upon the assumption that a specific authority is required from an applicant in order to send out pre-publication information to a foreign IP office where applicant has filed an application and that the Office should reconsider this assumption. The comment further asserted that once an applicant files an application in a foreign IP office, applicant inherently agrees to the rules and requirements of that foreign IP office. Accordingly, the comment suggests that the Office does not need a separate authorization to either send a priority document or pre-publication information to that foreign IP office. Therefore, the comment requested that the Office reconsider the need for any authorization for access in this circumstance. The comment stated that if the Office adopts this position, then the entire authorization section from the ADS can be removed and a filing of an application in a foreign IP office by an applicant can serve as authorization for access to send priority documents and/or pre-publication information to that foreign IP office(s).

Response: After due consideration of the comment, the Office has decided to not adopt the position expressed in the comment. The written authority requirement is in accord with 35 U.S.C. 122(a), and consistent with current Office policy, practice, and procedure regarding access. Therefore, the Office is retaining the requirement for written authority from an applicant for access to the file contents of an unpublished application.

Comment 5: One comment opposed the proposed rule and asserted that the proposed rule will do great harm to independent inventors, university technology licensing organizations, small entity inventors, and overall U.S. development. Specifically, the comment alleged that the majority of foreign patent offices are integral parts of their national industrial development efforts and serve as collectors of information about U.S. technologies and that permitting these foreign governments to have access to unpublished patent applications will significantly undermine U.S. inventors and U.S. innovation.

Response: Neither the proposed rule nor the final rule establish a new program for providing unpublished applications to foreign governments. Under the final rule, the Office would only provide information to a foreign IP office where the applicant has already filed a counterpart application with that foreign IP office coupled with applicant's written authorization for access in the U.S. application. Specifically, the Office would be satisfying a duty placed on a U.S. applicant by the foreign IP office due to the U.S. applicant filing a counterpart application with that foreign IP office. For example, the Office, after receiving applicant's written authorization for access, would provide the foreign IP office where the counterpart application was filed the required information, along with sufficient bibliographic data to confirm that the correct U.S. and foreign counterpart applications have been matched. Finally, the Office will not deliver an unpublished priority document, file contents of an unpublished application, including information about an unpublished application, to a foreign IP office, even where a counterpart application has been filed, if applicant has not provided proper written authorization for access.

This rulemaking amends the rules of practice to include a specific provision by which an applicant can authorize the Office to give a foreign IP office access to all or part of the file contents of an application, and thus pertains solely to the process for an applicant to provide a limited waiver of confidentiality under 35 U.S.C. 122(a) to allow a counterpart IP office access to all or part of the file contents of an application. Therefore, the changes in this final rulemaking involve rules of agency practice and procedure and/or interpretive rules. See Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are procedural under the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were procedural where they did not change the substantive standard for reviewing claims). The Office received no public comment on this section or any of the sections under the Rulemaking Considerations.

Accordingly, prior notice and opportunity for public comment are not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law). See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), does not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))). The Office, however, published proposed changes for comment as it sought the benefit of the public's views on the Office's proposed changes to include a specific regulatory provision by which an applicant can provide the Office with authority to give a foreign IP office access to all or part of the file contents of an application.

For the reasons set forth herein, the Deputy General Counsel for General Law of the United States Patent and Trademark Office has certified to the Chief Counsel for Advocacy of the Small Business Administration that changes in this final rule will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b).

This rulemaking amends the rules of practice to include a specific provision by which an applicant can authorize the Office to give a foreign IP office access to all or part of the file contents of an application. This rulemaking consolidates and clarifies in one place—37 CFR 1.14(h)—existing procedures in both 37 CFR 1.14(c) and (h) relevant to authorizing the Office to provide a foreign IP office access to all or part of the file contents of an application or to an application-as-filed. Moreover, the use of the revised forms discussed (PTO/AIA/14; PTO/SB/39; and PTO/SB/69) will provide applicants that wish to provide a foreign IP office access to their applications greater ease and efficiency in transmitting the requisite authorization. The changes in this rulemaking do not require any applicant to provide the Office with this authority. There is no fee for this service. Therefore, the changes in this final rule will not have a significant economic impact on a substantial number of small entities.

This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

The Office has complied with Executive Order 13563. Specifically, the Office has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).

This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the United States Patent and Trademark Office will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this final rule are not expected to result in an annual effect on the economy of 100 million dollars or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this final rule is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

The changes set forth in this final rule do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions which involve the use of technical standards.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) requires that the Office consider the impact of paperwork and other information collection burdens imposed on the public. This rulemaking involves information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549). The collection of information involved in this rulemaking has been reviewed and previously approved by OMB under OMB Control Numbers 0651-0031 and 0651-0032. The Office is not resubmitting an information collection package to OMB for its review and approval because the changes in this rulemaking do not change patent fees or change the information collection requirements (the estimated number of respondents, time per response, total annual respondent burden hours, or total annual respondent cost burden) associated with the information collections approved under OMB Control Numbers 0651-0031 and 0651-0032. The revised ADS form (PTO/AIA/14) as well as the PTO/SB/39 and PTO/SB/69 forms have already been reviewed and approved by OMB, or have been determined to not collect “information” within the meaning of the Paperwork Reduction Act of 1995.

Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB control number.

For the reasons stated in the preamble, 37 CFR part 1 is amended as follows:

Throughout this document wherever “we”, “us” or “our” is used, it is intended to refer to the EPA.

Section 110 of the CAA requires states to develop and submit to the EPA SIPs to ensure that state air quality meets National Ambient Air Quality Standards (NAAQS). Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. The EPA-approved SIP provisions and control strategies are federally enforceable. States revise the SIP as needed and submit revisions to the EPA for review and approval.

This action primarily addresses Oregon's SIP submittals dated February 5, 2009, November 1, 2010, and May 25, 2011. These submittals include amendments to rules that control volatile organic compound (VOC) emissions from gasoline dispensing facilities in the Air Quality Management Areas (AQMAs) of Portland-Vancouver (which includes portions of Clackamas, Multnomah, and Washington counties), Medford-Ashland, and Salem-Keizer Area Transportation Study (SKATS), as well as all of Clackamas, Multnomah, and Washington counties. The VOC rules were previously approved into the Oregon SIP to address Reasonably Available Control Technology (RACT) requirements for ozone nonattainment areas. (See for example 45 FR 42265, June 24, 1980). The VOC RACT rules support continued attainment and maintenance of the ozone NAAQS. They address emissions during the delivery of gasoline from gasoline cargo tank trucks to gasoline dispensing facility storage tanks as well as the emissions during the refueling of individual vehicles at gasoline dispensing facilities. During delivery, the emission controls generally include submerged fill pipes and stage I vapor balance systems. Stage I vapor balance systems capture vapors and return them to the gasoline cargo tank truck to keep the vapors from being emitted to the air. During the refueling of individual vehicles, special fuel dispensing nozzles at the pump (known as “stage II”) capture vapors and direct them into the gasoline dispensing facility storage tanks.

In general, the February 5, 2009 submittal amended the VOC rules to consolidate them with Oregon's then newly adopted rules that implemented the Federal National Emission Standards for Hazardous Air Pollutants (NESHAP) for gasoline dispensing facilities, (40 CFR part 63, subpart CCCCCC) (gasoline dispensing facility NESHAP). The effect of Oregon's rule amendments was to incorporate the substantive stage I VOC RACT rule requirements for gasoline dispensing facilities in Oregon Administrative Rules (OAR) 340 division 232 “Emission Standards for VOC Point Sources” and division 242 “Rules Applicable to the Portland Area” into division 244 “Oregon Federal Hazardous Air Pollutant Program,” and to incorporate the permitting requirements for these facilities into division 216 “Air Contaminant Discharge Permits.” The November 1, 2010 and May 25, 2011 submittals made additional amendments to the rules for gasoline dispensing facilities. These three submittals also include minor amendments to other rules in divisions 200 “State of Oregon Clean Air Act Implementation Plan,” 209 “Public Notice Categories and Timing,” and 210 “Registration in General”.

The April 20, 2015 submittal consists of comprehensive revisions to the ODEQ's air permitting and other air rules, including revisions to the rules for gasoline dispensing facilities in divisions 242 and 244. In a September 18, 2015 supplementary letter, the ODEQ requested that the EPA approve specific division 242 and 244 rules to ensure the most current version of the division 242 and 244 rules for gasoline dispensing facilities be approved into the SIP. Therefore, in this action, we are reviewing and acting only on the division 242 and 244 rule amendments in the April 20, 2015 submittal that were identified in the supplementary letter. We are not reviewing or acting on any other portion of the April 20, 2015 submittal at this time, but will address the remainder of that submittal in a future action. In addition, the ODEQ requested that the EPA approve the identified division 244 rules for gasoline dispensing facilities that replaced OAR 340-232-0070 and OAR 340-242-0520 in the February 5, 2009 submittal only to the extent they apply to sources in the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs, as well as all of Clackamas, Multnomah, and Washington counties.

In the February 5, 2009 submittal, the ODEQ repealed the SIP-approved rule OAR 340-232-0070 that applied to gasoline dispensing facilities in the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs. The ODEQ also removed references to stage I vapor balance systems from the SIP-approved rules OAR 340-242-0500 and -0520, which applied to gasoline dispensing facilities in Clackamas, Multnomah and Washington counties, but retained the stage II vapor collection system requirements in those rules. The stage I vapor balance requirements contained in OAR 340-232-0070, OAR 340-242-0500 and OAR 340-242-0520 were added to sections of new rules in division 244 (-0030, -0234, -0238, -0240, -0242, and -0244) and to amended sections of existing rules in division 216 (-0020, including tables 1 and 2, -0040, and -0060). The ODEQ made further amendments to the rules for gasoline dispensing facilities in the subsequent submittals, as explained in section II.

In addition to the VOC RACT gasoline dispensing facility rule amendments, the SIP submittals also include amendments to the following rules: OAR 340-200-0040, 340-209-0030, 340-210-0100, 340-210-0110, 340-210-0120, 340-216-0062, and 340-244-0020. A summary discussion of the rule amendments is provided below. A table that identifies which new rules address the SIP-approved gasoline dispensing facility provisions is included in the docket for this action.

As in the SIP-approved rules, the amended rules in OAR 340 divisions 244 and 216 continue to apply to the delivery of gasoline to a gasoline dispensing facility storage tank, require submerged filling and have specific piping requirements. The amended rules exempt all gasoline storage tanks with a capacity of less than 250 gallons from the submerged fill requirements. For tanks installed on or before October 14, 1999, this is more stringent than the SIP-approved rules which exempted tanks with a capacity of 1,500 gallons or less. However, the SIP-approved rules required submerged fill for all tanks installed after October 14, 1999. Thus, for those tanks with a capacity less than 250 gallons, the amended rules are less stringent. The ODEQ provided emissions estimates for these small tanks exempt from the submerged fill requirements under the amended rules and explained that, in general, such sources use the gasoline for their own equipment (e.g., golf courses to fuel golf carts or a facility that has a gasoline powered forklift) rather than for resale, and that not many tanks are under this size threshold. The ODEQ estimates increases in VOC emissions in the AQMAs from this minor exemption to be 55 pounds, or 0.027 tons, per year.

The vapor balance system requirements in the amended rules are similar to the SIP-approved rules, including requirements that equipment be vapor tight, maintained in good working order, and properly connected. Both the amended and the SIP-approved rules exempt tanks with floating roofs from the vapor balance system requirements. Similar to the SIP-approved rule, the amended rules require that vapor balance systems meet certain specifications and demonstrate compliance. The amended rules cite more recently adopted test methods for compliance than the SIP-approved test methods. In addition, the new rules require a compliance demonstration every three years after the initial compliance demonstration for gasoline dispensing facilities with a monthly throughput of 100,000 gallons of gasoline or more. This is more stringent than the SIP-approved rule. In the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs, the amended rules continue to exempt gasoline storage tanks that have a capacity of 1,500 gallons or less from the vapor balance system requirements. However, in Clackamas, Multnomah, and Washington counties, the requirements for vapor balance systems are slightly amended. In these counties, the SIP-approved rules required a vapor balance system for all tanks if the gasoline dispensing facility had an annual throughput of 120,000 gallons of gasoline or more regardless of the storage capacity of the tank. The amended rules exempt gasoline storage tanks that have a capacity less than 250 gallons from the vapor balance system requirements. The EPA does not consider this to be a relaxation of the SIP-approved rules because gasoline dispensing facilities that have an annual throughput of 120,000 gallons of gasoline or more would be expected to have storage tanks that are larger than 250 gallons.

The amended rules do not specify that training and written instructions be provided to the operators of gasoline dispensing facilities and gasoline transport vehicles as in the SIP-approved rules. The management practices for gasoline dispensing facilities and cargo tanks included in OAR 340-244-0242 tables 2 and 3 provide a similar level of assurance, however, that equipment is operated properly. In addition, the new rules for gasoline dispensing facilities in division 244 also include other requirements that are not currently in the SIP but are based on the requirements of the gasoline dispensing facility NESHAP. These include a specific timeframe for demonstrating initial compliance with the vapor balance system, demonstrating monthly throughput, general duties to minimize emissions, notifications, recordkeeping, and reporting. These requirements are consistent with the gasoline dispensing facility NESHAP and will either reduce VOC emissions or enhance the enforceability of VOC SIP requirements for gasoline dispensing facilities. Thus, while a few aspects of the amended requirements for gasoline dispensing facilities are less stringent than in the existing SIP, given the overall strengthening of the requirements for gasoline dispensing facilities in the identified areas under the amended rules, the EPA finds that the revisions to the requirements for gasoline dispensing facilities in the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs and in Clackamas, Multnomah, and Washington counties will not interfere with any applicable requirement concerning attainment or maintenance of the NAAQS or any other applicable CAA requirements. The EPA is therefore approving these requirements for the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs as well as all of Clackamas, Multnomah, and Washington counties.1

The General Air Contaminant Discharge Permits (ACDPs) rules in the amended OAR division 216 have replaced the vapor balance system (stage I) and stage II vapor collection permit requirements in the SIP-approved rules. The EPA has approved the submitted amendments to division 216 (See 76 FR 80747, December 27, 2011). Like the SIP-approved rules, the amended rules include equivalent 2 permitting requirements, permitting fees, and a 10 year limit on the permit. Other administrative requirements, however, such as the requirement to notify the ODEQ of a change of ownership, the date for submitting renewal applications, and the requirement to keep a copy of the permit on site at the facility, are included in the SIP-approved rule, but are not included in the ODEQ's amended permit provisions for gasoline dispensing facilities. The EPA notes that the ODEQ includes these types of provisions in its general permit for gasoline dispensing facilities. Given the administrative nature of such requirements, the EPA concludes that the revisions to the permitting requirements for gasoline dispensing facilities will not interfere with any applicable requirement concerning attainment or maintenance of the NAAQS or any other applicable CAA requirements.

The February 5, 2009, November 1, 2010, and May 25, 2011 submittals also include amendments to other rules that we are not approving in this action. The division 210 “Registration in General” rules have been superseded by a more recent submittal and have been approved by the EPA (See 78 FR 37124, June 20, 2013). The April 20, 2015 submittal superseded OAR 340-209-0030 and OAR 340-216-0062, and we will address them in a future action. We are also not approving OAR 340-244-0020, which was included in the February 5, 2009 submittal, because this rule addresses the authority of Lane Regional Air Protection Agency (LRAPA) to implement requirements within its jurisdiction, and LRAPA does not have jurisdiction in the geographic areas covered by this SIP approval. Finally, OAR 340-200-0040 describes the State's procedures for adopting its SIP and references all of the state air regulations that have been adopted by the ODEQ for approval into the SIP (as a matter of state law), whether or not they have yet been submitted to or approved by the EPA. The EPA is not approving the revisions to this provision in these SIP submittals because the federally-approved SIP consists only of regulations and other requirements that have been submitted by the ODEQ and approved by the EPA.

The EPA is taking the following action on the amendments to OAR Chapter 340 that were included in the February 5, 2009, November 1, 2010, and May 25, 2011 submittals and the division 242 and 244 rules in the April 20, 2015 submittal that were identified by the ODEQ for our review in the September 18, 2015 supplementary letter. We are acting on the most recent version of the rules in the submittal identified in parentheses below. Further action on the earlier adopted versions of these rules included in the submittals is not required because they are no longer in effect and have been superseded by the most recent submittal.

We are approving the following rule amendments: OAR 340-232-0070 (repeal) (February 5, 2009 submittal); OAR 340-242-0500, -0510, -0520 (April 20, 2015 submittal as identified in the September 18, 2015 supplementary letter); 3 OAR 340-244-0030,4 -0232, -0234, -0236, -0238 (except (1)(a) and (2)(c)),5 -0239, -0240, -0242 (including tables 2 and 3), -0244 (except (1)(b) and (c)),6 -0246, -0248 (except (4)(c) and (d)),7 -0250 (April 20, 2015 submittal as identified in the September 18, 2015 supplementary letter); and OAR 340-244-0252 (February 5, 2009 submittal). At the ODEQ's request, the EPA is approving the identified requirements in division 244 only for sources in the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs as well as all of Clackamas, Multnomah, and Washington counties. The EPA notes that, although Oregon's rules for gasoline dispensing facilities also regulate emissions of hazardous air pollutants, the EPA is approving these provisions for the purpose of regulating VOC emissions from these facilities. The EPA's authority to approve SIPs extends to provisions related to attainment and maintenance of the NAAQS and carrying out other specific requirements of section 110 of the CAA.

As discussed above, we are not approving OAR 340-200-0040 (May 25, 2011); OAR 340-209-0030, OAR 340-210-0100, -0110, -0120, and OAR 340-216-0062, -0064 (November 1, 2010 submittal); OAR 340-216-0020, -0060 (May 25, 2011); or OAR 340-244-0020 (February 5, 2009 submittal).

In this rule, the EPA is approving regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is incorporating by reference the Oregon regulations (OAR Chapter 340) described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

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

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

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

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

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

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

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

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

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standard; and

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 28, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, 40 CFR part 52 is amended as follows:

On September 2, 2015 (80 FR 53001), the EPA published a direct final rule approving a SIP revision submitted by the Arizona Department of Environmental Quality (ADEQ). The revision provides for the phased removal of Stage II vapor recovery equipment at gasoline dispensing facilities in the Phoenix-Mesa area. Specifically, the revision eliminates the requirement to install and operate such equipment at new gasoline dispending facilities, and provides for the phased removal of such equipment at existing gasoline dispensing facilities from October 2016 through September 2018. In the direct final rule, the EPA stated that if adverse comments were received by October 2, 2015, the EPA would publish a timely withdrawal of the direct final rule and address the comments in a subsequent final rule. The EPA received adverse comments and is therefore withdrawing the direct final rule. The EPA will address these comments in a separate final action based on the proposed action also published on September 2, 2015 (80 FR 53086). The EPA will not open a second comment period for this action.

Accordingly, the amendment to 40 CFR 52.120 which published in the Federal Register on September 2, 2015 (80 FR 53001) on page 53007 is withdrawn as of October 27, 2015.

I. Background

On September 4, 1992, EPA promulgated 40 CFR part 55 which established requirements to control air pollution from OCS sources in order to attain and maintain Federal and state ambient air quality standards and to comply with the provisions of part C of title I of the CAA. Forty CFR part 55 applies to all OCS sources offshore of the states except those locations in the Gulf of Mexico west of 87.5 degrees longitude. Section 328 of the CAA requires that for such source locations within 25 miles of a state's seaward boundary, the requirements shall be the same as would be applicable if the source were located in the COA. Because the OCS requirements are based on onshore requirements, and onshore requirements may change, section 328(a)(1) requires that EPA update the OCS requirements as necessary to maintain consistency with onshore requirements.

Pursuant to 40 CFR 55.12 of the OCS rule, consistency reviews will occur: (1) At least annually; (2) upon receipt of a Notice of Intent under 40 CFR 55.4; or (3) when a state or local agency submits a rule to EPA to be considered for incorporation by reference in 40 CFR part 55. This proposed action is being taken in response to requirements submitted by Maryland. Section 328(a) of the Act requires that EPA establish requirements to control air pollution from OCS sources located within 25 miles of states' seaward boundaries that are the same as onshore requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into 40 CFR part 55 as they exist onshore. This limits EPA's flexibility in deciding which requirements will be incorporated into 40 CFR part 55 and prevents EPA from making substantive changes to the requirements it incorporates. As a result, EPA may be incorporating rules into 40 CFR part 55 that do not conform to all of EPA's state implementation plan (SIP) guidance or certain requirements of the Act. Consistency updates may result in the inclusion of state or local rules or regulations into 40 CFR part 55, even though the same rules may ultimately be disapproved for inclusion as part of the SIP. Inclusion in the OCS rule does not imply that a rule meets the requirements of the Act for SIP approval, nor does it imply that the rule will be approved by EPA for inclusion in the SIP.

EPA reviewed Maryland's rules for inclusion in 40 CFR part 55 to ensure that they are rationally related to the attainment or maintenance of federal or state ambient air quality standards or part C of title I of the CAA; that they are not designed expressly to prevent exploration and development of the OCS; and that they are applicable to OCS sources. EPA has also evaluated the rules to ensure they are not arbitrary or capricious. In addition, EPA has excluded administrative or procedural rules 1 and requirements that regulate toxics which are not related to the attainment and maintenance of Federal and State ambient air quality standards.

EPA is taking direct final action to incorporate the applicable provisions of the Code of Maryland Regulations into 40 CFR part 55 as required under section 328(a)(1) of the CAA. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 28, 2015 without further notice unless EPA receives adverse comment by November 27, 2015. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Maryland Regulations described in the amendments to 40 CFR part 55 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

Under the Clean Air Act, the Administrator is required to establish requirements to control air pollution from OCS sources located within 25 miles of states' seaward boundaries that are the same as onshore air control requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into 40 CFR part 55 as they exist onshore. 42 U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, in promulgating OCS consistency updates, EPA's role is to maintain consistency between OCS regulations and the regulations of onshore areas, provided that they meet the criteria of the Clean Air Act. Accordingly, this action simply updates the existing OCS requirements to make them consistent with requirements onshore, without the exercise of any policy discretion by EPA. For that reason, this action:

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

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

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

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

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, nor does it impose substantial direct compliance costs on tribal governments, nor preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 28, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Accordingly, 40 CFR part 55 is amended as follows:

NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2015 flathead sole, rock sole, and yellowfin sole Amendment 80 allocations of the total allowable catch (TAC) specified in the BSAI are 11,035 metric tons (mt), 52,390 mt, and 118,962 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and as revised (80 FR 60073, October 5, 2015). The 2015 flathead sole, rock sole, and yellowfin sole Amendment 80 ABC reserves are 43,019 mt, 101,868 mt, and 82,051 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and as revised (80 FR 60073, October 5, 2015).

The Alaska Seafood cooperative has requested that NMFS exchange 600 mt of flathead sole and 1,350 mt of rock sole Amendment 80 allocations of the TAC for 1,950 mt of yellowfin sole Amendment 80 ABC reserves under § 679.91(i). Therefore, in accordance with § 679.91(i), NMFS exchanges 600 mt of flathead sole and 1,350 mt of rock sole Amendment 80 allocations of the TAC for 1,950 mt of yellowfin sole Amendment 80 ABC reserves in the BSAI. This action also decreases and increases the TACs and Amendment 80 ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and as revised (80 FR 60073, October 5, 2015) are further revised as follows:

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Alaska Seafood cooperative the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 19, 2015.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.