Federal Register Vol. 83, No.191,

On June 29, 2018, AMS published its request for comments from the public in the Federal Register (83 FR 30590) regarding the United States (U.S.) Standards for Canola under the United States Grain Standards Act (USGSA) (7 U.S.C. 71-87k). The comment period for the request for comments ended August 28, 2018. In response to requests from interested stakeholders, AMS is reopening the comment period an additional 60-days.

The realignment of offices within the U.S. Department of Agriculture authorized by the Secretary's Memorandum dated November 14, 2017, eliminates the Grain Inspection, Packers and Stockyards Administration (GIPSA) as a standalone agency. The grain inspection activities formerly part of GIPSA are now organized under AMS.

On June 29, 2018, AMS published its request for comments from the public in the Federal Register (83 FR 30592) regarding the United States (U.S.) Standards for Soybeans under the United States Grain Standards Act (USGSA) (7 U.S.C. 71-87k). The comment period for the request for comments ended August 28, 2018. In response to requests from interested stakeholders, AMS is reopening the comment period an additional 60-days.

The realignment of offices within the U.S. Department of Agriculture authorized by the Secretary's Memorandum dated November 14, 2017, eliminates the Grain Inspection, Packers and Stockyards Administration (GIPSA) as a standalone agency. The grain inspection activities formerly part of GIPSA are now organized under AMS.

On June 29, 2018, AMS published its request for comments from the public in the Federal Register (83 FR 30591) regarding the United States (U.S.) Standards for Corn under the United States Grain Standards Act (USGSA) (7 U.S.C. 71-87k). The comment period for the request for comments ended August 28, 2018. In response to requests from interested stakeholders, AMS is reopening the comment period an additional 60-days.

The realignment of offices within the U.S. Department of Agriculture authorized by the Secretary's Memorandum dated November 14, 2017, eliminates the Grain Inspection, Packers and Stockyards Administration (GIPSA) as a standalone agency. The grain inspection activities formerly part of GIPSA are now organized under AMS.

This action, pursuant to 5 U.S.C. 553, proposes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Agreement and Order No. 905, as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and pummelos grown in Florida. Part 905 (referred to as “the Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of growers and handlers operating within the area of production, and a public member.

The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This proposed rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, Florida citrus handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate would be applicable to all assessable citrus for the 2018-19 crop year, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

The Order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members are familiar with the Committee's needs and with the costs of goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

This proposed rule would decrease the assessment rate from $0.02, the rate that was established for the 2017-18 and subsequent fiscal periods, to $0.015 per 4/5-bushel cartons of citrus for the 2018-19 and subsequent fiscal periods. Shipments from last season exceeded initial projections after Hurricane Irma, allowing the Committee to maintain their financial reserve. As the industry continues to recover from Hurricane Irma, the Committee estimates that the 2018-19 Florida citrus crop will be around 8,250,000 regulated cartons, an increase of nearly one million cartons from last season. The anticipated increase in production prompted the Committee to recommend the reduction in the assessment rate.

The Committee met on July 17, 2018, and unanimously recommended 2018-19 expenditures of $130,260 and an assessment rate of $0.015 per 4/5-bushel cartons of citrus. The major expenditures recommended by the Committee for the 2018-19 year include $113,260 for management, $9,000 for auditing, and $4,000 for travel. Budgeted expenses for these items in 2017-18 were $75,000, $9,000, and $4,200, respectively.

The assessment rate recommended by the Committee was derived by considering anticipated expenses, expected shipments of 8.25 million 4/5-bushel cartons, and the amount of funds available in the authorized reserve. Income derived from handler assessments calculated at $123,750 (8.25 million × $0.015), along with interest income and funds from the Committee's authorized reserve, would be adequate to cover budgeted expenses of $130,260. Funds in the reserve are estimated to be at $147,500 and would be kept within the maximum permitted by the Order. As stated in §  905.42, the amount of the reserve is not to exceed two fiscal periods' expenses.

The assessment rate proposed in this rule would continue in effect indefinitely unless modified, suspended, or terminated by USDA based upon recommendation and information submitted by the Committee or other available information.

Although the proposed assessment rate would be effective for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2018-19 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 500 producers of Florida citrus in the production area and approximately 20 handlers subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to data from the National Agricultural Statistics Service (NASS), the industry, and the Committee, the weighted average f.o.b. price for Florida citrus for the 2016-17 season was approximately $15.20 per carton with total shipments of around 12.6 million cartons. Using the number of handlers, and assuming a normal distribution, the majority of handlers have average annual receipts of more than $7,500,000 ($15.20 times 12.6 million equals $191,520,000 divided by 20 handlers equals $9,576,000 per handler).

In addition, based on the NASS data, the weighted average grower price for the 2016-17 season was around $8.30 per carton of citrus. Based on grower price, shipment data, and the total number of Florida citrus growers, and assuming a normal distribution, the average annual grower revenue is below $750,000 ($8.30 times 12.6 million cartons equals $104,580,000 divided by 500 growers equals $209,160 per grower). Thus, the majority of Florida citrus handlers may be classified as large entities, while the majority of growers may be classified as small entities.

This proposal would decrease the assessment rate collected from handlers for the 2018-19 and subsequent fiscal periods from $0.02 to $0.015 per 4/5-bushel cartons of citrus. The Committee unanimously recommended 2018-19 expenditures of $130,260 and an assessment rate of $0.015 per 4/5-bushel cartons. The proposed assessment rate of $0.015 is $0.005 lower than the 2017-18 rate. The quantity of assessable citrus for the 2018-19 fiscal period is estimated at 8.25 million 4/5-bushel cartons. Thus, the $0.015 rate should provide $123,750 in assessment income (8.25 million × $0.015). Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve (currently $147,500), would be adequate to cover budgeted expenses.

The major expenditures recommended by the Committee for the 2018-19 fiscal year include $113,260 for management, $9,000 for auditing, and $4,000 for travel. Budgeted expenses for these items in 2017-18 were $75,000, $9,000, and $4,200, respectively.

Shipments from last season exceeded initial projections after Hurricane Irma, allowing the Committee to maintain its financial reserve. The Committee estimates the 2018-19 Florida citrus crop will be around 8,250,000 regulated cartons, an increase of nearly one million cartons from last season. The Committee recommended the reduction in the assessment rate based on the anticipated increase in production.

Prior to arriving at this budget and assessment rate, the Committee considered information from the Executive Committee. Alternative expenditure levels and assessment rates were discussed by the Executive Committee, based upon the relative value of various activities to the citrus industry. The Committee determined that all program activities were adequately funded and essential to the functionality of the Order, thus no alternate expenditure levels were deemed appropriate.

Based on these discussions and estimated shipments, the recommended assessment rate of $0.015 would provide $123,750 in assessment income. The Committee determined that assessment revenue, along with funds from reserves and interest income, would be adequate to cover budgeted expenses for the 2018-19 fiscal period.

A review of historical information and preliminary information pertaining to the upcoming fiscal period indicates that the average grower price for the 2018-19 season should be approximately $8.30 per 4/5-bushel cartons of citrus. Therefore, the estimated assessment revenue for the 2018-19 crop year as a percentage of total grower revenue would be about 0.2 percent.

This proposed rule would decrease the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers and may also reduce the burden on producers.

The Committee's meeting was widely publicized throughout the Florida citrus industry. All interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the July 17, 2018, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.

Based on its evaluation of the Committee recommendation and other available information, USDA has determined that a modification of the assessment rate for the 2018-19 Florida citrus fiscal period would be appropriate. Therefore, USDA issues this proposed rule.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by the OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements would be necessary as a result of this proposed rule. Should any changes become necessary, they would be submitted to OMB for approval.

This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large Florida citrus handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

For the reasons set forth in the preamble, 7 CFR part 905 is proposed to be amended as follows:

Three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h are included in the list of “covered equipment” for which DOE is authorized to establish and amend energy conservation standards and test procedures. (42 U.S.C. 6311(1)(B)) DOE's test procedure for three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h is prescribed at 10 CFR 431.96. The following sections discuss DOE's authority to establish and amend the test procedure for three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h, as well as relevant background information regarding DOE's consideration of test procedures for this equipment.

The Energy Policy and Conservation Act of 1975 (“EPCA” or “the Act”),1 Public Law 94-163 (42 U.S.C. 6291-6317, as codified), among other things, authorizes DOE to regulate the energy efficiency of a number of consumer products and industrial equipment. Title III, Part C 2 of EPCA, added by Public Law 95-619, Title IV, § 441(a), established the Energy Conservation Program for Certain Industrial Equipment, which sets forth a variety of provisions designed to improve energy efficiency. This equipment includes small commercial package air conditioning and heating equipment—which includes three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h, the subject of this RFI. (42 U.S.C. 6311(1)(B); 42 U.S.C. 6311(8)(B))

Under EPCA, the energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of the Act include definitions (42 U.S.C. 6311), energy efficiency standards (42 U.S.C. 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316).

Federal energy efficiency requirements for covered equipment established under EPCA generally supersede State laws and regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6316(a) and (b); 42 U.S.C. 6297) DOE may, however, grant a Federal preemption waiver to a State for a standard prescribed or established under 42 U.S.C. 6313(a)—which details DOE's authority for setting standards applying to commercial package air conditioning and heating equipment—in accordance with specific criteria. See 42 U.S.C. 6316(b)(2)(D).

The Federal testing requirements consist of test procedures that manufacturers of covered equipment must use as the basis for: (1) Certifying to DOE that their equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6316(b); 42 U.S.C. 6296), and (2) making representations about the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the equipment complies with relevant standards promulgated under EPCA.

Under 42 U.S.C. 6314, EPCA sets forth the criteria and procedures DOE follows when prescribing or amending test procedures for covered equipment. EPCA requires that any test procedures prescribed or amended under this section must (1) be reasonably designed to produce test results which reflect the energy efficiency, energy use or estimated annual operating cost of a covered equipment during a representative average use cycle or period of use and (2) not be unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)).

As a category of commercial package air conditioning and heating equipment, EPCA requires that the test procedures for this equipment—including three-phase systems with capacities of less than 65,000 Btu/h—be those generally accepted industry testing procedures or rating procedures developed or recognized by the Air-Conditioning, Heating, and Refrigeration Institute (“AHRI”) or by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (“ASHRAE”), as referenced in ASHRAE Standard 90.1, “Energy Standard for Buildings Except Low-Rise Residential Buildings” (“ASHRAE Standard 90.1”). (42 U.S.C. 6314(a)(4)(A)) Further, if such an industry test procedure is amended, DOE must amend its test procedure to be consistent with the amended industry test procedure, unless DOE determines, by rule published in the Federal Register and supported by clear and convincing evidence, that such amended test procedure would not meet the requirements in 42 U.S.C. 6314(a)(2) and (3) related to representative use and test burden. (42 U.S.C. 6314(a)(4)(B))

In addition, if DOE determines that a test procedure amendment is appropriate, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6314(b))

EPCA also requires that, at least once every 7 years, DOE evaluate test procedures for each type of covered equipment, including those at issue here, to determine whether an amended test procedure would more accurately or fully comply with the requirements that the procedure not be unduly burdensome to conduct and be reasonably designed to produce test results that reflect energy efficiency, energy use, and estimated operating costs during a representative average use cycle. (42 U.S.C. 6314(a)(1)) In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6314(b)) If DOE determines that test procedure revisions are not appropriate, DOE must publish its determination not to amend the test procedures. (42 U.S.C. 6314(a)(1)(A)(ii))

DOE is publishing this RFI to collect data and information to inform its decision consistent with its obligations under EPCA.

DOE's test procedure for three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h is codified at 10 CFR 431.96. The test procedure was last amended on May 16, 2012, to incorporate by reference ANSI/AHRI Standard 210/240-2008, “2008 Standard for Performance Rating of Unitary Air-Conditioning & Air-Source Heat Pump Equipment,” approved by ANSI on October 27, 2011, and updated by addendum 1 in June 2011 and addendum 2 in March 2012 (“AHRI 210/240-2008”). 77 FR 28928 (May 16, 2012). The May 2012 final rule also established additional testing requirements at 10 CFR 431.96(c) and (e), applicable to measuring seasonal energy efficiency ratio (“SEER”) and heating seasonal performance factor (“HSPF”) for this equipment. Id. ASHRAE Standard 90.1 was updated on October 26, 2016,3 but did not revise the test procedures for three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h. In late 2017, AHRI published an updated version of its standard, AHRI 210/240-2017. As outlined further in this document, that updated standard made a number of changes that are of relevance to DOE's current procedure.

In the following sections, DOE has identified a variety of issues on which it seeks input to aid in the development of the technical and economic analyses regarding whether to amend the test procedures for three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h. Specifically, DOE is requesting comment on opportunities to streamline and simplify the testing requirements for this equipment.

Additionally, DOE welcomes comments on other issues relevant to the conduct of this process that may not specifically be identified in this document. In particular, DOE notes that under Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” Executive Branch agencies such as DOE are directed to manage the costs associated with the imposition of expenditures required to comply with Federal regulations. See 82 FR 9339 (Feb. 3, 2017). Consistent with that Executive Order, DOE encourages the public to provide input on measures DOE could take to lower the cost of its regulations applicable to the equipment at issue in a manner consistent with the requirements of EPCA.

Three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h are a category of small commercial package air conditioning and heating equipment. Commercial package air-conditioning and heating equipment may be air-cooled, water-cooled, evaporatively-cooled, or water sourced (not including ground water source), and are electrically-operated, unitary central air conditioners or central air-conditioning heat pumps that are used for commercial applications. 10 CFR 431.92.

Three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h are further disaggregated into four equipment classes: Three-phase air-cooled single-package air conditioners, three-phase air-cooled single-package heat pumps, three-phase air-cooled split-system air conditioners, and three-phase air-cooled split-system heat pumps. This RFI seeks comment on the test procedure applicable to all four equipment classes.

As noted, the current DOE test procedure at 10 CFR 431.96 for three-phase commercial air-cooled air conditioners and heat pumps with a cooling capacity of less than 65,000 Btu/h incorporates by reference AHRI 210/240-2008 (except section 6.5), which is also referenced in the current version of ASHRAE Standard 90.1 (i.e., “ASHRAE 90.1-2016”). AHRI 210/240-2008 includes as normative appendix C the entirety of 10 CFR part 430, subpart B, appendix M (“Appendix M”) as amended by a final rule published on October 22, 2007. (72 FR 59906) Appendix M provides the test procedure for determining the efficiency of single-phase central air conditioners and heat pumps with rated cooling capacities of less than 65,000 Btu/h, a consumer product covered under 10 CFR part 430.

In late 2017, AHRI updated the incorporated industry standard, releasing AHRI 210/240-2017. Many of the revisions in the update attempted to harmonize AHRI 210/240-2017 with the updated federal test method for single-phase central air conditioners and heat pumps with rated cooling capacities of less than 65,000 Btu/h. AHRI 210/240-2017 no longer includes any version of Appendix M as a normative appendix, but has integrated requirements consistent with Appendix M throughout the standard.4 AHRI 210/240-2017 also includes additional updates beyond integrating the revised Appendix M. DOE understands that these changes, if adopted, would not conflict with Appendix M and would be highly unlikely to impact the measured efficiency of the subject equipment during a representative average use cycle as compared to conducting a test relying on the provisions already contained in Appendix M.5

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This proposed rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would establish Class E airspace extending upward from 700 feet above the surface at Leitchfield-Grayson County Airport, Leitchfield, KY, to support standard instrument approach procedures for IFR operations at this airport.

Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (Docket No. FAA-2018-0485 and Airspace Docket No. 18-ASO-10) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number.) You may also submit comments through the internet at http://www.regulations.gov.

Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0485; Airspace Docket No. 18-ASO-10.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is considering an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to establish Class E airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Leitchfield-Grayson County Airport, Leitchfield, KY, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at this airport.

Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

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

This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

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

Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2306) has been filed by Kemin Industries, Inc., 1900 Scott Ave., Des Moines, IA 50317. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the safe use of chromium propionate (21 CFR 573.304) as a source of supplemental chromium in horse feed.

The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the Agency is placing the environmental assessment (EA) submitted with the petition that is the subject of this notice on public display at the Dockets Management Staff for public review and comment (see DATES and ADDRESSES). FDA will also place on public display any amendments to, or comments on, the petitioner's EA without further announcement in the Federal Register.

If, based on its review, the Agency finds that an environmental impact statement is not required and this petition results in a regulation, the notice of availability of the Agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the Federal Register in accordance with 21 CFR 25.51(b).

Throughout this document “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:

EPA is proposing to approve a submission from the State of Iowa to revise the Iowa SIP and the Operating Permits Program. The revisions to the Iowa SIP revise the definition for EPA reference method and volatile organic compounds (VOCs), clarifies permit rule exemptions and the State's permit-by-rule regulation, and revises methods and procedures for performance test/stack test and continuous monitoring systems. In addition, the State has removed its rules that implement the CAIR. The State has also revised their Prevention of Significant Deterioration (PSD) regulations to incorporate the most recent Federal requirements. Iowa has also revised their Operating Permits Program by revising the definition for EPA Reference Method, clarifying insignificant activities as applied to internal combustion engines, revising forms used to submit emission inventories and due dates as well as revising the public participation rules. In addition, the State revised their acid rain rules to include the most recent EPA Reference Method.

EPA is not acting on Chapter 25.2—Continuous emission monitoring under the acid rain program, as these provisions are not approved in the operating permits program. EPA is also not acting on the New Source Performance Standards, emission standards for hazardous air pollutants, emission standards for hazardous air pollutants for source categories, and emission guidelines that were submitted in this SIP revision. These will be addressed separately.

EPA is proposing the following revisions to the Iowa SIP:

Chapter 20—Scope of Title-Definitions: The State revised the definition of “EPA reference method,” to adopt the most current EPA methods for measuring air pollutant emissions (stack testing and continuous monitoring). EPA revised the reference methods in 40 CFR parts 51, 60, 61 and 63 on August 30, 2016. These updates will ensure that state reference methods are equivalent to Federal reference methods and are no more stringent than Federal methods.

The State revised the definition of “volatile organic compounds” (VOC) to reflect changes made to the Federal definition of VOC on August 1, 2016. EPA finalized a regulation on August 1, 2016, to exclude the compound 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy) Ethane (HFE-347pcf2) from the Federal definition because this compound makes a negligible contribution to tropospheric ozone formation. This revision to the VOC definition ensures consistency with the Federal definition.

Chapter 22—Controlling Pollution: The State made three revisions under Chapter 22, “Permits required for new or existing stationary sources,” subrule 22.1(2), “Permitting exemptions.” The revisions to permitting exemptions do not relieve the owner or operator of any source from any obligation to comply with any other applicable requirements.

The introductory paragraph to 22.1(2) “i”, “Initiation of construction, installation, reconstruction, or alteration (modification) to equipment,” now cross-refers to subrule 31.3(1) in the Iowa SIP as the previous reference no longer exists. Subrule 31.3(1) refers to definitions for nonattainment new source review requirements for areas designated nonattainment on or after May 18, 1998.

Subparagraph 22.1(2) “r”, applies to the exemption for an internal combustion engine with a brake horsepower rating of less than 400 measured at the shaft. The added language (underlined below) clarifies that the owner or operator of an engine that was manufactured, ordered, modified or reconstructed after March 18, 2009, may use this exemption only if the owner or operator, prior to installing, modifying or reconstructing the engine, submits to the department a completed registration on forms provided by the department (unless the engine is exempted from registration, as specified in this paragraph or on the registration form). This revision clarifies that an engine that meets the definition of nonroad engine as specified in 40 CFR 1068.30,1 is exempt from registration requirements. The engine must be in compliance with New Source Performance Standards (NSPS) for stationary compression ignition internal combustion engines (40 CFR part 60, subpart IIII); NSPS for stationary spark ignition internal combustion engines (40 CFR part 60, subpart JJJJ), and National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines (40 CFR part 63, subpart ZZZZ). The State also corrected punctuation errors in this subparagraph.

Subparagraph 22.1(2)“w”(1) applies to “small unit” exemptions from construction permitting. The SIP-approved list of criteria has the word “or” between the last two items in the list, which could lead affected owners and operators to conclude that an emission unit does not need to meet all the criteria in the list. This proposed revision changes the word “or” to “and” between the provision for “PM2.5” and the one for “hazardous air pollutants” in the list of air pollutants. A spelling error will also be corrected with this proposed revision.

The revisions to subrule 22.8(1) “a”, “Permit by Rule,” allow powder coat material to be used in paint booths without being considered “sprayed material,” provided the powder coating is applied in an indoor-vented spray booth equipped with filters or an overspray powder recovery system. Included in this docket are justification materials from the state that evaluates that particulate emissions from powder coatings specified under the conditions in permit by rule, would not contribute to the exceedances of the ambient air quality standards for particulate matter. The justification was previously provided in support of the exemption for powder coatings for construction permits (22.1(2)“bb”). Owners and/or operators using the permit by rule must send a notification letter to the Department and complete applicability questions for the facility. Facilities not eligible for permit by rule are required to apply for a construction permit as specified under 567 IAC subrules 22.1(1) and 22.1(3).

Chapter 25—Measurement of Emissions: The State revised subrule 25.1(9), “Methods and Procedures,” to adopt the most current EPA reference methods for measuring air pollutant emissions (performance test/stack test, 25.1(9)a, and continuous monitoring systems, 25.1(9)b). EPA revised the reference methods in 40 CFR parts 51, 60, 61 and 63 on August 30, 2016. These proposed updates will ensure that state reference methods are equivalent to Federal reference methods and are no more stringent than Federal methods.

Chapter 33—Special Regulations and Construction Permit Requirements for Major Stationary Sources—Prevention of Significant Deterioration (PSD) of Air Quality:

33.1—Purpose. The State revised the applicable date to incorporate the recent changes EPA made to the Federal requirements of the PSD program from August 19, 2015, to October 18, 2016.

33.1(3)—Definitions. The State revised the definition of “volatile organic compounds” (VOC) to reflect changes made to the Federal definition of VOC on August 1, 2016. The compound 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy) Ethane (HFE-347pcf2) was excluded from the Federal definition at 40 CFR 51.100(s) because this compound makes a negligible contribution to tropospheric ozone formation. This proposed revision to the state's VOC definition ensures consistency with the Federal definition.

33.3(17)—Public participation. The State made revisions that addresses public participation requirements for the PSD program to reflect updates to the Federal regulations, at 40 CFR part 51, subpart I, published October 18, 2016. The revision removes the requirements for advertisement in a newspaper of general circulation in each region in which the proposed source will be constructed, and provides for posting of the public comment period on a website identified by the department.2 The electronic notice shall be available for the duration of the public comment period and include the notice of public comment, the draft permit(s), information on how to access the administrative record for the draft permit(s), and how to request or attend a public hearing on the draft permits(s). The revision also requires the department to be consistent in the method of providing public notice while using other means necessary to ensure adequate notice to the affected public.

33.3(22)—Permit rescission. This revision allows for rescission of PSD permits to be consistent with the Federal changes made to 40 CFR part 51, subpart I, published October 18, 2016, with regard to public participation. A notice of permit rescission may be posted on a publicly available website identified by the department.

Chapter 34—Provisions for Air Quality Emissions Trading Programs. Due to the regulations being phased out and replaced with the Cross-State Air Pollution Rule published in the Federal Register on August 8, 2011 at 76 FR 48208, Iowa is implementing the Cross-State Air Pollution Rule through a Federal Implementation Plan, and removing its regulations that implement CAIR. Because the State CAIR trading programs created by these rules are no longer being implemented, and because the rules serve no other purpose, removal of the rules from the SIP does not interfere with any applicable requirement concerning attainment or any other requirement of the CAA.

EPA is proposing to approve the rescission of the following chapters in the Iowa SIP:

34.201, CAIR NOX Annual Trading Program Provisions;

34.202, CAIR Designated Representative for CAIR NOX sources;

34.203, Permits;

34.204, Reserved;

34.205, CAIR NOX Allowance Allocations;

34.206, CAIR NOX Allowance Tracking System;

34.207, CAIR NOX Allowance Transfers;

34.208, Monitoring and Reporting;

34.209, CAIR NOX Opt-in Units;

34.210, CAIR SO2 Trading Program;

34.211-34.219, Reserved;

34.220, CAIR NOX Ozone Season Trading Program;

34.221, CAIR NOX Ozone Season Trading Program General Provisions;

34.222, CAIR Designated Representative for CAIR NOX Ozone Season Sources;

34.223, CAIR NOX Ozone Season Permits;

34.224, Reserved;

34.225, CAIR NOX Ozone Season Allowance Allocations;

34.226, CAIR NOX Ozone Season Allowance Tracking System;

34.227, CAIR NOX Ozone Season Allowance Transfers;

34.228, CAIR NOX Ozone Season Monitoring and Reporting, and 34.229, CAIR NOX Ozone Season Opt-in Units.

EPA is proposing to approve the following revisions to Iowa's Operating Permits Program (Title V) as follows:

Chapter 22.100—Definitions for Title V Operating Permits: The State revised the definition of “EPA reference method,” to adopt the most current EPA methods for measuring air pollutant emissions (stack testing and continuous monitoring). EPA revised the reference methods in 40 CFR parts 51, 60, 61 and 63 on August 30, 2016. These updates will ensure that state reference methods are equivalent to Federal reference methods and are no more stringent than Federal methods.

Chapter 22.103—Insignificant activities:

Subparagraph 22.103(2)“b”(6) applies to the exemption for internal combustion engines that are used for emergency response purpose with a brake horsepower rating of less than 400 measured at the shaft. The revision adds that emergency engines that are subject to the following rules are not to be considered insignificant: New Source Performance Standards (NSPS), 40 CFR part 60 subpart IIII (stationary compression ignition internal combustion engines); NSPS 40 CFR part 60, subpart JJJJ (stationary spark ignition internal combustion engines), and National Emission Standards for hazardous air pollutants, 40 CFR part 63, subpart ZZZZ (reciprocating internal combustion engines).

Chapter 22.106, Title V permit fees:

The revision to 22.106(2) applies to emission inventories and documentation due dates. The revision specifies that emissions inventories will be submitted with forms specified by the department. For emissions in Polk and Linn Counties, three copies of forms should be submitted that document actual emissions for the previous calendar year annually by March 31. Emissions in other counties are required to submit two copies of forms documenting actual emissions for the previous calendar year annually by March 31. With this revision, the following forms have been removed: Form 1.0, “Facility Identification”; Form 4.0, “Emission Unit—Actual Operations and Emissions” for each emission unit; Form 5.0, “Title V Annual Emissions Summary/Fee”, and Part 3, “Application Certification.”

Chapter 22.107, Title V permit processing procedures:

The revision to subrule 22.107(6), “Public notice and public participation,” updates the Title V program to reflect the changes made to Federal regulations at 40 CFR 70.7(h), published October 18, 2016. The revision removes the requirements for advertisement in a newspaper of general circulation and adds that posting of the notice, including the draft permit, for the duration of the public comment period on a public website identified by the permitting authority.3

Chapter 22.120: This chapter applies to the acid rain program. In Iowa, all provisions of the acid rain program are approved under the Title V Operating Permits Program. Therefore, the test methods as applied in Chapter 22.100 apply to Chapter 22.120 to include the most recent EPA reference method revision to 40 CFR part 75 (August 30, 2016).

Chapter 30—Fees: The revision to “Fees Associated with Title V Operating Permits” at 30.4(2) “b” removes the following forms: Form 1.0, “Facility Identification”; Form 5.0, “Title V Annual Emissions Summary/Fee”, and Part 3, “Application Certification.” The revision also adds the language “with forms specified by the department.”

The submission met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The State held a public comment period from December 20, 2017 to January 22, 2018, with a public hearing on January 22, 2018. No comments were received. The submissions also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, these revisions meet the substantive SIP requirements of the CAA, including section 110 and implementing regulations. These revisions are also consistent with applicable EPA requirements of Title V of the CAA and 40 CFR part 70.

EPA is proposing to approve revisions to the Iowa SIP and the Operating Permits Program. The proposed revisions clarify rules, makes revisions and corrections, and rescinds rules no longer relevant to the air program. EPA has determined that approval of these revisions will not impact air quality and will ensure consistency between the state and federally-approved rules, and ensure Federal enforceability of the state's revised air program rules.

In this document, EPA is proposing to include regulatory text in an EPA final rule that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the Iowa Regulations described in the proposed amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 7 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

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

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

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

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

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

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

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

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

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

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

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

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

For the reasons stated in the preamble, EPA proposes to amend 40 CFR parts 52 and 70 as set forth below:

The revisions read as follows:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

As specified under sections 1869 and 1860D-4 of the Social Security Act (the Act) and their implementing regulations, once Medicare makes a coverage or payment determination under Medicare Parts A, B, or D, affected parties have the right to appeal the decision through four levels of administrative review. If a minimum amount in controversy (AIC) is met, parties can then appeal the decision to federal district court.

Section 1869 of the Act sets forth the process for appealing Parts A and B claim determinations. For most Part A and B claims, the initial determination is made by a Medicare Administrative Contractor (MAC). If a party is dissatisfied with the initial determination, the party may request a redetermination by the MAC, which is a review by MAC staff not involved in the initial determination. If a party is dissatisfied with the MAC's redetermination, the party may request a Qualified Independent Contractor (QIC) reconsideration consisting of an independent review of the administrative record, including the redetermination. Provided a minimum AIC is met, parties then have the option to appeal to the Office of Medicare Hearings and Appeals (OMHA) where they may receive either a hearing or review of the administrative record by an Administrative Law Judge (ALJ), or a review of the administrative record by an attorney adjudicator. Parties then have the option to appeal to the Medicare Appeals Council (the Council) within the Departmental Appeals Board, where an Administrative Appeals Judge examines their claim. A party can then appeal the decision to federal district court if certain requirements are met, including a minimum AIC.

The appeals process described above for Parts A and B claim determinations was initially proposed in the November 15, 2002 Federal Register (67 FR 69312), which was promulgated to implement section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (Pub. L. 106-554). This process was implemented in an interim final rule with comment period published on March 8, 2005 (the 2005 interim final rule with comment period) (70 FR 11420), which also set forth new provisions to implement the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173). Correcting amendments to the 2005 interim final rule were published on June 30, 2005 (70 FR 37700) and August 26, 2005 (70 FR 50214), and the final rule was published on December 9, 2009 (74 FR 65296). Subsequent revisions to implement section 201 of the Strengthening Medicare and Repaying Taxpayers Act of 2012 (Pub. L. 112-242) were published on February 27, 2015 (80 FR 10611). These appeals procedures for Part A and B claims are set forth in regulations at part 405, subpart I.

Section 1860D-4 of the Act sets forth the appeals process for Part D coverage determinations. Under Medicare Part D, the Part D plan sponsor issues a coverage determination. If this coverage determination is appealed, the Part D plan sponsor reviews the determination, which is known as a redetermination. If a party is dissatisfied with the redetermination, the party may request a reconsideration by an independent review entity. Similar to the appeals process for Parts A and B claim determinations, provided a minimum AIC is met, parties then have the option to appeal to OMHA where they may receive either a hearing or review of the administrative record by an ALJ, or a review of the administrative record by an attorney adjudicator. If not satisfied with OMHA's decision, a party then may appeal to the Council. The Council decision then may be appealed to federal district court if certain requirements are met, including a minimum AIC. These procedures are set forth in regulations at part 423, subparts M and U.

On January 17, 2017, we issued a final rule entitled “Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures” (82 FR 4974) (the January 17, 2017 final rule), which revised the Parts A, B, C, and D appeals procedures. The goals of this rulemaking were to streamline the appeals process, increase consistency in decision-making, improve efficiency for both appellants and adjudicators, and provide particular benefit to beneficiaries by clarifying processes and adding provisions for increased assistance when they are unrepresented. On April 16, 2018, we issued a final rule (83 FR 16440) that made additional changes to subparts M and U in order to implement section 704 of the Comprehensive Addiction and Recovery Act of 2016 (Pub. L. 114-198), along with other changes.

Through our experience implementing the current appeals process, and through additional research, we have identified several opportunities to streamline the claims appeals process and reduce associated burden on providers, beneficiaries, and appeals adjudicators. We have also identified several technical corrections that should be made to correct cross-references, inconsistent definitions, and confusing terminology.

Existing regulations at part 405, subpart I; and part 423, subparts M and U, specify the required elements of requests for Medicare Parts A and B claims appeals and for Medicare Part D coverage determination appeals, respectively. Generally, when a contractor or plan issues a Part A or B initial determination or a Part D coverage determination, it notifies the provider, supplier, and/or beneficiary and offers the opportunity to appeal. If this determination is appealed, the contractor or plan reviews the determination, which, in Medicare Parts A, B and D appeals, is known as a redetermination (see §§ 405.940 and 423.580). This can be followed by a review by an independent contractor consisting of an independent review of the administrative record, including the redetermination, which is known as a reconsideration (§§ 405.960 and 423.600). If a minimum amount-in-controversy is met, parties then have the option to appeal to the OMHA where the administrative record may be reviewed by an attorney adjudicator or an ALJ or a hearing may be held by an ALJ (§§ 405.1000 et seq. and 423.2000 et seq.). Parties then have the option to appeal to the Council within the Departmental Appeals Board where an Administrative Appeals Judge reviews their claim (§§ 405.1100 et seq. and 423.2100 et seq.).

Appeal requests can be made using different standard forms. These standard forms include the following: Medicare Redetermination Request Form (CMS-20027); Medicare Reconsideration Request Form (CMS-20033); Request for Administrative Law Judge Hearing or Review of Dismissal (OMHA-100); and Request for Review of Administrative Law Judge (ALJ) Medicare Decision/Dismissal (DAB-101). A written request that is not made on a standard form is also accepted if it contains certain required elements. For example, see, §§ 405.944(b), 405.964(b), 405.1014(a), 405.1112, 423.2014(a), 423.2112.

As discussed previously, all Medicare Parts A, B, and D appeal requests must contain the information specified in our regulations. In addition, for Parts A and B claims appeal requests at the redetermination, reconsideration, and Council review levels (§§ 405.944(b)(4), 405.964(b)(4), and 405.1112(a)), and for Part D coverage determination appeal requests at the Council level (§ 423.2112(a)(4)), the appellants must sign their appeal requests. However, there is no signature requirement when the appellant requests OMHA review of Parts A and B claim determinations, or when the appellant requests a redetermination, reconsideration, or OMHA review of Part D coverage determinations. In addition, there is no requirement that appellants sign appeals requests for appeals of Part C organization determinations.

In order to promote consistency between appeal levels, ensure transparency in developing our appeal request requirements, help ensure that we do not impose nonessential requirements on appellants, reduce the burden on appellants, and improve the appeals process based on our experience, we are proposing that appellants in Medicare Parts A and B claim and Part D coverage determination appeals be allowed to submit appeal requests without a signature. Specifically, we are proposing to revise §§ 405.944(b)(4), 405.964(b)(4), 405.1112(a), and 423.2112(a)(4) to remove the requirement of the appellant's signature for appeal requests.

As discussed previously, there is no requirement that appellants sign appeal requests when appealing their cases to OMHA, for the Part C organization determination appeals process, or at the redetermination and reconsideration levels of Part D appeals. However, the other requirements for appeal requests are substantially similar between levels of appeal and appeals processes, or there is a clear reason for the differing requirements. For example, the requirements for Part A and B appeal requests at the redetermination and reconsideration levels are identical with the exception of the reconsideration requirement that the name of the contractor be listed on the reconsideration appeal request (§§ 405.944 and 405.964). The rationale for the requirement that the name of the contractor be included on reconsideration appeal requests is that without this information, the independent contractor does not have a method of determining which contractor made the initial determination and redetermination, and is unable to get the case file. Since the contractor doing the redetermination is the same contractor who performed the initial determination, it is not necessary that this information be included in the redetermination appeal request.

By contrast, we do not believe there is a compelling reason to require that a signature be included on redetermination, reconsideration, and Council-level appeal requests, but not on OMHA appeal requests. Removing the requirement that appellants sign their appeal requests, would help promote consistency between appeal request requirements, thus making the appeals process easier for parties to understand.

Eliminating the requirement that appellants sign their appeal requests would reduce the burden of developing the appeal request and appealing dismissals of appeal requests for lack of a signature to the next level of review (for example, §§ 405.952(b), 405.972(b)). Allowing adjudicators to review appeal requests without signatures would allow them to focus their attention on the merits of the appeal, rather than having to dismiss potentially meritorious appeals for a lack of a signature.

When we promulgated the requirement for appellants to sign the appeal requests in regulations, we included a signature on the appeal request to ensure that the person requesting the appeal was a proper party to the appeal. Through experience, we have found that, in practice, little verification of the signature is possible. To determine if the appeal requestor is a proper party to the appeal, the adjudicator uses the name of the beneficiary and name of the party listed on the appeal request, in addition to the information listed in the case file.

The other appeal request requirements consist of fields that are necessary for the adjudicators to properly process the appeal request. As discussed previously, the name of the contractor who made the redetermination is required for the independent contractor to review the case file. The Part A and B redetermination appeal request requirement to include the disputed service and/or item enables the contractor to determine the merit of the appellant's claim.

Thus, we believe there is no need for a signature on an appeal request at this time and propose to eliminate that requirement. However, if, we find in the future that there are other reasons that would warrant an appellant's signature on an appeal request (for example, for a good-faith attestation), we would re-examine the possibility of adding the requirement back in. However, given that our existing statutory authority limits our ability to enforce certain attestations, we find the signature requirement unnecessary.

We are inviting public comments on our proposal to revise §§ 405.944(b)(4), 405.964(b)(4), 405.1112(a), and 423.2112(a)(4) of the regulations to remove the requirement that the appellant sign the appeal request.

The regulations at §§ 405.952(d), 405.972(d), 405.1012(e), and 423.2052(e) allow adjudicators to vacate a dismissal of an appeal request for a Medicare Part A or B claim or Medicare Part D coverage determination within 6 months of the date of the notice of dismissal. This allows sufficient time for adjudicators to carefully evaluate their dismissals while taking into account the principle of administrative finality.

Through experience, we have concluded that the timeframe for vacating a dismissal would be better expressed in calendar days, rather than months, for two reasons. First, all timeframes in the regulations under part 405, subpart I and part 423 subpart U, associated with the filing of appeal requests, adjudication periods, reopening of prior determinations, and other time-limited procedural actions are expressed in calendar days, not months. For example, see §§ 405.942 and 423.2056. Second, applying a timeframe based on days, rather than months, leads to more consistency in interpretation and actual timeframes. A timeframe based on months could be subject to varying interpretations, as the number of days in a consecutive 6-month period varies from 181 to 184 days. For example, if an ALJ or attorney adjudicator's dismissal is dated August 31 of one calendar year, advancing the timeframe 6 months to February could be confusing for parties and adjudicators because February does not contain 30 or 31 days. Also, given that February has only 28 or 29 days (in a leap year), any 6-month period that includes February would be shorter than other 6 month periods, leading to some inconsistency in the actual timeframe for vacating a dismissal.

To provide more consistency and predictability for appellants and adjudicators, and better conformity with other timeframes in the part 405, subpart I and part 423 subpart U, we are proposing to revise the timeframe for vacating a dismissal from 6 months to 180 days in §§ 405.952(d), 405.972(d), 405.1052(e), and 423.2052(e).

Section 501 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), added section 205(c)(2)(C)(xiii) of the Act to prohibit Social Security Numbers (or derivatives) from being displayed on Medicare cards. As a result, CMS is undertaking efforts to issue new Medicare cards, which contain a randomly generated Medicare Beneficiary Identifier (MBI), rather than the Social Security Number-based Health Insurance Claim Number (HICN) that is on the current Medicare cards. In order to ensure that appellants can easily submit appointment of representative documentation and appeal requests, we would accept this documentation with HICNs or MBIs. Consistent with these efforts, we are proposing to remove references to the Social Security Number-based HICN on Medicare cards that are included in the Medicare appeals regulations, and to replace them with references to Medicare number to clarify that either a HICN or MBI can be included on appointment of representative documentation and appeal requests. Accordingly, we are proposing to revise the following provisions of Medicare regulations to remove the words “health insurance claim” from the phrase “Medicare health insurance claim number” so that there is only a reference to “Medicare number”: §§ 405.910(c)(5), 405.944(b)(2), 405.964(b)(2), 405.1014(a)(1)(i), 405.1112(a), 423.2014(a)(1)(i), and 423.2112(a)(4).

The January 17, 2017 final rule revised certain Medicare procedures for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries and enrollees. Since the publication of this final rule, we have identified four regulatory provisions in part 423, subpart U that are redundant. In order to reduce potential confusion, we are proposing to remove redundant provisions at §§ 423.1970, 423.1972, 423.1974, and 423.1976 and, where necessary, incorporate appropriate provisions in other sections of the regulations.

Section 423.1970 of the regulations relating to the rights of enrollees to an ALJ hearing provides—

• In paragraph (a), that, if the amount remaining in controversy after the independent review entity (IRE) reconsideration meets the threshold requirement established annually by the Secretary, an enrollee who is dissatisfied with the IRE reconsideration determination has a right to a hearing before an ALJ;

• In paragraph (b)(1), the methodology for computing the AIC when the basis for appeal is the refusal by the Part D plan sponsor to provide drug benefits;

• In paragraph (b)(2), the methodology for computing the AIC when the basis for appeal is an at-risk determination made under a drug management program in accordance with § 423.153(f); and

• In paragraph (c), the requirements for aggregating appeals to meet the AIC.

Section 423.2002 also contains provisions on the right to an ALJ hearing. This section contains cross-references to the provisions in § 423.1970, and also—

• Establishes a 60-calendar day timeframe for filing a written request for an ALJ hearing following receipt of the written notice of the IRE's reconsideration; and indicates the AIC requirement must be met to be entitled to an ALJ hearing;

• Provides the circumstances under which an enrollee may request that an ALJ hearing be expedited;

• Establishes a 5-calendar day presumption for receipt of the reconsideration following the date of the written reconsideration, unless there is evidence to the contrary; and

• Provides that, for purposes of the section, requests for hearing are considered as filed on the date they are received by the office specified in the IRE's reconsideration.

Because §§ 423.1970 and 423.2002 both address the right to an ALJ hearing, and because there is a possibility that confusion may arise from having two sections with the same title in the same CFR subpart, we are proposing to remove § 423.1970. Because § 423.1970(a) is redundant of §§ 423.2000(a) and 423.2002(a)(2) in describing that an enrollee has a right to an ALJ hearing when the enrollee is dissatisfied with an IRE reconsideration and meets the AIC requirement, we believe § 423.1970(a) should be eliminated. We are proposing to relocate § 423.1970(b) and (c) to new proposed § 423.2006 (“Amount in controversy required for an ALJ hearing and judicial review”) as paragraphs (c) and (d), respectively.

In addition, we are proposing to remove the reference to “CMS” in § 423.1970(b) (relocated to proposed § 423.2006(c)) to clarify that adjudicators, not CMS, ultimately compute the amount remaining in controversy in determining whether the AIC threshold is met for an ALJ hearing or review of an IRE dismissal, and judicial review.

We believe having one section titled “Right to an ALJ hearing” at § 423.2002 and another section titled “Amount in controversy required for an ALJ hearing and judicial review” at § 423.2006 is more consistent with the corresponding rules in 42 CFR part 405, subpart I for appeals of Medicare Part A and Part B initial determinations (§§ 405.1002 and 405.1006). For consistency with § 423.2000(a) and language that was removed from § 423.1970(a), we are also proposing to add language to § 423.2002(a) providing that the right to an ALJ hearing is available to enrollees who are dissatisfied with the IRE's reconsideration determination.

In order to further increase consistency with § 405.1006 and consolidate the Medicare Part D appeals rules regarding the AIC, we are proposing to incorporate provisions in proposed new § 423.2006(a) and (b) that are similar to those provisions contained at § 405.1006(b) and (c), describing the amounts in controversy required for an ALJ hearing and judicial review, respectively, including the annual adjustment of these amounts. In order to more clearly state the AIC requirements for appeals of Part D prescription drug plan coverage determinations, without the need for multiple statutory and regulatory cross-references, we are proposing that new § 423.2006 would include the following:

• At proposed paragraph (a)(1), a provision similar to § 405.1006(b)(1) that the required amount remaining in controversy must be $100 increased by the percentage increase in the medical care component of the Consumer Price Index for All Urban Consumers (U.S. city average) as measured from July 2003 to the July preceding the current year involved.

• At proposed paragraph (a)(2), a provision similar to § 405.1006(b)(2) that, if the figure in § 423.2006(a)(1) is not a multiple of $10, it is rounded to the nearest multiple of $10, and that the Secretary will publish changes to the AIC requirement in the Federal Register when necessary.

• At proposed paragraph (b), a provision similar to § 405.1006(c) that, to be entitled to judicial review, the enrollee must meet the AIC requirements of this subpart and have an amount remaining in controversy of $1000 or more, adjusted as specified in proposed § 423.2006(a)(1) and (2).

• At proposed paragraph (c), a provision similar to current § 423.1970(b) explaining how the amount remaining in controversy is calculated.

• At proposed paragraph (d), the text currently found in § 423.1970(c) concerning aggregation of appeals to meet the amount in controversy.

Finally, we are proposing to update or remove the cross-references to § 423.1970 in §§ 423.562(b)(4)(iv), 423.576, 423.602(b)(2), 423.1984(c); 423.2002(a) introductory text and (a)(2), and (b)(3), 423.2004(a)(2), and 423.2044(c) and to add a cross-reference to § 423.2006 in § 423.1990(b)(3) in place of the language “established annually by the Secretary.”

Section 423.1972, titled “Request for an ALJ hearing,” provides the procedures an enrollee must follow when filing a request for hearing as follows:

• Paragraph (a) provides that a written request must be filed with the OMHA office specified in the IRE's reconsideration notice.

• Paragraph (b) provides the timeframe for filing a request.

• Paragraph (c)(1) states that if a request for hearing clearly shows that the AIC is less than that required under § 423.1970, the ALJ or attorney adjudicator dismisses the request.

• Paragraph (c)(2) provides that if, after a hearing is initiated, the ALJ finds that the AIC is less than the amount required under § 423.1970, the ALJ discontinues the hearing and does not rule on the substantive issues raised in the appeal.

With the exception of paragraph (c)(2), all of the provisions in § 423.1972 are duplicative of or incorporate by reference other provisions found in § 423.2002(a) and (d) (Right to an ALJ hearing), § 423.2014(d)(2) and (e) (Request for an ALJ hearing or a review of an IRE dismissal), § 423.2020 (Time and place for a hearing before an ALJ), and § 423.2052(a)(2) (Dismissal of a request for a hearing before an ALJ or request for review of an IRE dismissal). In order to eliminate the redundancy and potential confusion, we are proposing to remove § 423.1972 in its entirety. As a part of this proposed change, we also are proposing to update or remove the cross-references to § 423.1972 in §§ 423.604, 423.1984(c), 423.2014(d) introductory text and (e)(1), and 423.2020(a). We do not believe it is necessary to retain § 423.1972(c)(2) in another location because ALJs have broad authority to regulate the course of the hearing. In the rare circumstances described in § 423.1972(c)(2) where an ALJ does not make a finding regarding the AIC until after a hearing is initiated, the ALJ may discontinue the hearing and issue a dismissal under §§ 423.2002(a)(2) and 423.2052(a)(2).

Section 423.1974, titled “Council review,” provides that an enrollee who is dissatisfied with an ALJ's or attorney adjudicator's decision or dismissal may request that the Council review the ALJ's or attorney adjudicator's decision or dismissal as provided in § 423.2102. This provision is similar to § 423.2100, titled “Medicare Appeals Council review: general.” To eliminate the redundancy, we are proposing to remove the language of § 423.1974 and incorporate it in § 423.2100(a). This language would replace the language in § 423.2100(a). We also are proposing to update or remove the cross-references to § 423.1974 in §§ 423.562(b)(4)(v) and 423.1984(d).

Section 423.1976, titled “Judicial review,” provides the following:

• In paragraph (a), that an enrollee may request judicial review of an ALJ's or attorney adjudicator's decision if the Council denied the enrollee's request for review and the AIC meets the threshold requirement established annually by the Secretary.

• In paragraph (b), that the enrollee may request judicial review of a Council decision if it is the final decision of CMS and the AIC meets the threshold established in paragraph (a)(2).

• In paragraph (c), that, in order to request judicial review, an enrollee must file a civil action in a district court of the United States in accordance with section 205(g) of the Act.

With the exception of paragraph (a), these provisions are largely duplicative of other provisions contained in § 423.2136, also titled “Judicial review.” To eliminate this redundancy, we are proposing to remove the provisions of § 423.1976 and revise § 423.2136 as follows:

• Section 423.2136(a) would be redesignated as § 423.2136(a)(1). The cross-reference to § 423.1976 would be removed, and language from § 423.1976(b) would be incorporated in § 423.2136(a)(1)(i) and (ii) and revised by replacing “CMS” with “the Secretary” for consistency with the language in section 1876(c)(5)(B) of the Act and § 423.2140, and replacing “paragraph (a)(2) of this section” with “§ 423.2006” which we are proposing to add to the regulations to address the AIC requirements.

• Language at § 423.1976(a) would be revised to incorporate a reference to § 423.2006 and the authorizing language from § 423.2136(a) (proposed § 423.2136(a)(1)) and moved to new § 423.2136(a)(2).

• We also are proposing to update or remove the cross-references to § 423.1976 in §§ 423.562(b)(4)(vi), 423.576, and 423.2136(b)(1). We seek comment on these proposed changes.

In summary, we are proposing to remove or relocate language as shown in the following table:

The regulations at §§ 405.1110(a) and (b)(2) and 423.2110(a) and (b)(2) give CMS or its contractors 60 calendar days after the date or issue date, respectively, of OMHA's decision or dismissal to refer the case to the Council. In the case of Part A and Part B appeals, CMS or its contractors are sent the decision notice when they are a party to the hearing or soon after the hearing occurred. For Part D appeals, as specified in § 423.2046(a)(1), the decision notice is sent to the enrollee, plan sponsor, and IRE.

Our regulations generally include regulatory timeframes that start when CMS or its contractors receive the decision notice, rather than the date the decision notice was issued. For example, § 405.1010(b)(3), which addresses the timing of when CMS or its contractor may elect to participate in an ALJ hearing, provides that CMS or its contractor must send notice of its intent to participate, if no hearing is scheduled, no later than 30 calendar days after notification that a request for hearing was filed or, if a hearing is scheduled, no later than 10 calendar days after receiving the notice of hearing. The rationale for starting the timeframe in § 405.1010(b)(3) after receipt of the notice was to ensure that CMS or its contractors have sufficient time to conduct a thorough evaluation of the facts and the case.

For the same reason, we are proposing to revise the timeframe in §§ 405.1110(a) and (b)(2) and 423.2110(a) and (b)(2) for CMS or it contractors to refer a case to the Council such that the timeframe would begin after the ALJ's or attorney adjudicator's decision or dismissal is received. Starting the timeframe after CMS or its contractor receives OMHA's written decision or dismissal would help ensure that CMS and its contractors have sufficient time to decide whether the case is the type of case that should be referred to the Council for review. This proposed change would help ensure that even if CMS and its contractors receive a delayed notice, they would have sufficient time to decide whether the case should be referred to the Council.

In order to ensure consistent implementation of this proposal, we also are proposing to add new §§ 405.1110(e) and 423.2110(e) to provide that the date of receipt of the ALJ's or attorney adjudicator's decision or dismissal is presumed to be 5 calendar days after the date of the notice of the decision or dismissal, unless there is evidence to the contrary. This would help facilitate the Council's determination on the timeliness of the referral by establishing a date by which the Council may presume that CMS or its contractor received the decision from OMHA. This 5 day mailing presumption is consistent with the presumption included in §§ 405.1102(a)(2) and 423.2102(a)(3) with respect to the timeframe for requesting Council review following an ALJ's or attorney adjudicator's decision or dismissal.

For these reasons, we are proposing to revise the Council referral timeframes in §§ 405.1110(a) and (b)(2) and 423.2110(a) and (b)(2), and proposing to add §§ 405.1110(e) and 423.2110(e) as discussed previously.

Section 405.910 sets forth provisions addressing the appointment of representatives in a Medicare Parts A and B claims appeals, including for secondary payer recovery claims. Specific requirements regarding the duration of time that an appointment of representative instrument is valid are provided under § 405.910(e).

On February 27, 2015, we published a final rule entitled “Medicare Program; Right of Appeal for Medicare Secondary Payer Determinations Relating to Liability Insurance (Including Self-Insurance), No-Fault Insurance, and Workers' Compensation Laws and Plans (80 FR 10611). In that final rule, we added paragraph (e)(4) to § 405.910 in order to provide applicable plans with the benefit of the existing rule for Medicare secondary payers regarding the duration of appointment for an appointed representative. Within this added provision, we included a citation to § 405.906(a)(1)(iv), as the regulation establishing party status for applicable plans. This citation is an incorrect cross-reference; and the correct cross-reference is § 405.906(a)(4). We are proposing to revise § 405.910(e)(4) to correct the cross-reference. This proposed correction would not alter any existing processes or procedures within the Medicare claims appeals process.

Section 405.926 sets forth actions that are not considered initial determinations subject to the administrative appeals process under part 405, subpart I. On October 4, 2016, we issued a final rule entitled “Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities” (81 FR 68688 through 68872) that moved the definition of “transfer and discharge” in § 483.12 to the definitions under § 483.5. Accordingly, we updated the cross-reference to “§ 483.5” within § 405.926(f) to the cross-reference to “§ 483.5(n)”. However, the citation of § 483.5(n) is an incorrect cross-reference.

To correct this error, we are proposing to revise § 405.926(f) to remove the incorrect reference to “§ 483.5(n)” and replace it with the cross-reference “§ 483.5 definition of `transfer and discharge' ”. This proposed technical correction would serve to correct an incorrect citation. It would not alter any existing processes or procedures within the Medicare claims appeals process.

Since we published the January 17, 2017 final rule, we have identified several provisions that, upon further review, pose unanticipated challenges with implementation, which are explained in this section. In addition, there are other regulatory provisions that we believe require additional clarification and the correction of technical errors and omissions. In the proposals listed in this section, we seek to help ensure the provisions are implemented as intended, provide clarification, and correct technical errors and omissions. Our proposed changes are as follows.

Section 405.1006 addresses the AIC required for an ALJ hearing and judicial review, and § 405.1006(d) provides the methodology for computing the AIC. In general, the AIC is computed as the amount that the provider or supplier bills for the items and services in the disputed claim, reduced by any Medicare payments already made or awarded for the items or services, and further reduced by any deductible and/or coinsurance amounts that may be collected for the items or services. In the January 17, 2017 final rule, we created several exceptions to this general computation methodology for situations where we believed an alternative methodology would more accurately describe the amount actually in dispute. Among these alternatives was the calculation methodology specified in § 405.1006(d)(4), which states that when an appeal involves an identified overpayment, the AIC is the amount of the overpayment specified in the demand letter for the items or services in the disputed claim. For appeals involving an estimated overpayment amount determined through the use of statistical sampling and extrapolation, § 405.1006(d)(4) further provides that the AIC is the total amount of the estimated overpayment determined through extrapolation, as specified in the demand letter.

When we created this exception, we did not account for the possibility that the amount of the overpayment or estimated overpayment specified in the demand letter might change throughout the administrative appeals process if, for example, an adjudicator finds that some of the items or services for which an overpayment was demanded are covered and payable, or alternatively, if an adjudicator raises a new issue that results in the denial of additional items or services. Even outside the administrative appeals process, the amount of an overpayment may be revised by a CMS contractor (for example, following a discussion period with the contractor that initially determined the overpayment). Although some of these situations may result in the issuance of a revised demand letter, such a letter may not always be issued during the pendency of the appeals process.

To account for situations where the amount of an overpayment specified in the demand letter does not reflect subsequent adjustments to the amount remaining in controversy, we are proposing to revise § 405.1006(d)(4) to state that when an appeal involves an identified overpayment, the AIC is the amount of the overpayment specified in the demand letter, or the amount of the revised overpayment if the amount originally demanded changes as a result of a subsequent determination or appeal, for the items or services in the disputed claim. For appeals involving an estimated overpayment amount determined through the use of statistical sampling and extrapolation, we are further proposing to revise § 405.1006(d)(4) to state that the AIC is the total amount of the estimated overpayment determined through extrapolation, as specified in the demand letter, or as subsequently revised.

In § 405.1010(b)(1), we stated that if CMS or a CMS contractor elects to participate in the proceedings on a request for hearing before receipt of a notice of hearing, or when notice of hearing is not required, it must send written notice of its intent to participate to the parties who were sent a copy of the notice of reconsideration, and to the assigned ALJ or attorney adjudicator, or if the appeal is not assigned, to a designee of the Chief ALJ. We discussed in the January 17, 2017 final rule that the requirement to notify the parties who were sent a copy of the notice of reconsideration helps ensure that the potential parties to a hearing, if a hearing is conducted, would receive notice of the intent to participate (82 FR 5016). However, the final regulation at § 405.1010(b)(1) does not account for requests for reconsideration that are escalated from the QIC level to the OMHA level of appeal without a notice of reconsideration having been issued.

In order to help ensure that the potential parties to a hearing would receive notice of CMS' or the contractor's intent to participate and address reconsideration escalations from the QIC to OMHA, we are proposing to revise § 405.1010(b)(1) to require that, for escalated requests for reconsideration, notice of the intent to participate would also be sent to any party that filed a request for reconsideration or was found liable for the services at issue subsequent to the initial determination, which we believe is consistent with circumstances under which a party would receive notice of a hearing under § 405.1020. (Section 405.1020(c)(1) also provides that a notice of hearing is sent to all parties that participated in the reconsideration. However, we do not believe this provision is necessary in circumstances where the QIC has not issued a reconsideration because, in practice, there is generally no opportunity for participation in these circumstances by parties other than the party that filed the request for reconsideration.) For the same reason, we also are proposing to revise § 405.1010(c)(3)(ii)(A), which currently requires that copies of CMS or contractor position papers or written testimony that are submitted before receipt of a notice of hearing must be sent to the parties who were sent a copy of the notice of reconsideration. We are proposing to revise § 405.1010(c)(3)(ii)(A) to instead provide that copies are sent to the parties that are required to be sent a copy of the notice of intent to participate in accordance with § 405.1010(b)(1). No corresponding revisions to § 423.2010 are needed because escalation is not available in Medicare Part D appeals.

In § 405.1010(b)(3)(ii), we stated that if CMS or a CMS contractor elects to participate after a hearing is scheduled, it must send written notice of its intent to participate no later than 10 calendar days “after receiving the notice of hearing.” Upon reviewing the revised rules, we noticed an inconsistency between this language and the language in § 405.1012(a)(1), which requires CMS or a CMS contractor electing to be a party to a hearing to send written notice of its intent to be a party no later than 10 calendar days “after the QIC receives the notice of hearing.” We explained in the January 17, 2017 final rule (82 FR 5020) that the timeframe in § 405.1012(a)(1) was based on receipt of the notice of hearing by the QIC because notices of hearing are currently sent to the QIC in accordance with § 405.1020(c). We believe these requirements should be consistent and the timeframes should begin on the same date, regardless of whether CMS or a CMS contractor is electing to be a party or participant. We also believe that the regulations should provide flexibility for CMS to designate another contractor, other than the QIC, to receive notices of hearing under § 405.1020(c) if that contractor is then tasked with disseminating the notice of hearing to other CMS contractors. Therefore, and as discussed in this section with regard to notices of hearing, we are proposing to revise § 405.1020(c)(1) to provide for this flexibility.

For conformity with proposed revised § 405.1020(c)(1) and to resolve the existing inconsistency in §§ 405.1010(b)(3)(ii) and 405.1012(a)(1), we are proposing to revise both sections to provide that written notice of the intent to participate or intent to be a party must be submitted no later than 10 calendar days after receipt of the notice of hearing by the QIC or another contractor designated by CMS to receive the notice of hearing. No corresponding revision is needed to the part 423, subpart U rules because notices of hearing are sent to both the Medicare Part D plan sponsor and the IRE.

In § 405.1010(c)(3)(i), we state that CMS or a CMS contractor that filed an election to participate must submit any position papers or written testimony within 14 calendar days of its election to participate if no hearing has been scheduled, or no later than 5 calendar days prior to the hearing if a hearing is scheduled, unless the ALJ grants additional time to submit the position paper or written testimony. In the January 17, 2017 final rule (82 FR 5017), we discussed that the requirement to submit any written testimony within 14 calendar days of the election to participate if no hearing has been scheduled helps to ensure that the position paper and/or written testimony are available when determinations are made to schedule a hearing or issue a decision based on the record in accordance with § 405.1038.

Although § 405.1010(c)(3)(i) allows an ALJ to extend the 5-calendar day submission timeframe for cases in which a hearing is scheduled, the regulation text may be unclear as to whether the same discretion is afforded to ALJs or attorney adjudicators with respect to the 14-calendar day submission timeframe for cases in which no hearing has been scheduled. Our intent was to apply this discretionary extension in both circumstances, as evidenced by the corresponding regulation at § 423.2010(d)(3)(i), which allows an ALJ or attorney adjudicator to grant additional time to submit a position paper or written testimony both in cases where a hearing has been scheduled and in cases where no hearing has been scheduled (82 FR 5019). Accordingly, to clarify our intent and help ensure consistency between the part 405 and part 423, we are proposing to revise § 405.1010(c)(3)(i) to clarify that an ALJ or attorney adjudicator may also extend the 14-calendar day timeframe for submission of position papers and written testimony in cases in which no hearing has been scheduled.

In § 405.1012(b), we stated that if CMS or a CMS contractor elects to be a party to the hearing, it must send written notice of its intent to the ALJ and to “the parties identified in the notice of hearing.” Upon reviewing the revised rules, we noticed an inconsistency between this language and the language in § 405.1010(b)(2), which states that if CMS or a CMS contractor elects to participate after receipt of a notice of hearing, it must to send written notice of its intent to participate to the ALJ and “the parties who were sent a copy of the notice of hearing.” Although the standard for who must receive notice is the same, the way in which it is articulated is different, which we believe may lead to confusion. To prevent potential confusion and help ensure consistency in the regulations, we are proposing to revise § 405.1012(b)(2) by replacing the language “identified in the notice of hearing” with “who were sent a copy of the notice of hearing”. No corresponding revision is needed to the part 423, subpart U rules because only the enrollee is a party to a Medicare Part D appeal and CMS, the IRE, and the Part D plan sponsor may only request to be nonparty participants.

Finally, § 405.1012(e)(1) states the circumstances under which an ALJ or attorney adjudicator may determine that a CMS or contractor election to be a party to a hearing made under § 405.1012 is invalid. Because § 405.1012(a) only permits CMS or a contractor to elect to be a party after the QIC receives a notice of hearing, and only an ALJ may schedule and conduct a hearing, we believe the determination as to whether an election made under § 405.1012 is valid should be left to the assigned ALJ. Therefore, we are proposing in § 405.1012(e)(1) to replace the phrase “ALJ or attorney adjudicator” with “ALJ.” No corresponding revision is needed to the part 423, subpart U rules because only the enrollee is a party to a Medicare Part D appeal and CMS, the IRE, and the Part D plan sponsor may only request to be nonparty participants.

Prior to the January 17, 2017 final rule, § 405.1014(c)(2) provided that any request for an extension of the time to request a hearing must be in writing, give the reasons why the request for a hearing was not filed within the stated time period, and must be filed with the entity specified in the notice of reconsideration. In the January 17, 2017 final rule, this provision was relocated to § 405.1014(e)(2) and revised, in part, to state that any request for an extension of the time to request a hearing or review of a QIC dismissal must be filed with the request for hearing or request for review. This change was motivated by questions from appellants concerning whether a request for an extension should be filed without a request for hearing so that a determination could be made on the extension request before the request for hearing was filed (82 FR 5038). However, in our attempt to provide clarity to appellants, we created a requirement that, in its strictest interpretation, would foreclose an appellant from requesting an extension of the time to request a hearing or review after a request for hearing is filed. The need for such a request to be made may arise when an appellant—particularly an unrepresented beneficiary—is not aware that a request for hearing is untimely at the time of filing. In these situations, OMHA frequently requests that the appellant provide an explanation for the untimely filing and, if the OMHA adjudicator finds good cause for the untimely filing, the time period for filing is extended in accordance with § 405.1014(e)(3).

In order to remedy this situation, we are proposing to revise § 405.1014(e)(2) to provide that requests for extension must be filed with the request for hearing or request for review, or upon notice that the request may be dismissed because it was not timely filed. We also are proposing a corresponding revision to § 423.2014(e)(3) for extension requests filed by Medicare Part D enrollees.

In § 405.1020(c)(1), we require that a notice of hearing be sent to all parties that filed an appeal or participated in the reconsideration, any party who was found liable for the services at issue subsequent to the initial determination or may be found liable based on a review of the record, the QIC that issued the reconsideration, and CMS or a contractor that elected to participate in the proceedings in accordance with § 405.1010(b) or that the ALJ believes would be beneficial to the hearing, advising them of the proposed time and place of the hearing. However, this rule does not account for requests for reconsideration that are escalated from the QIC level to the OMHA level of appeal without a reconsideration having been issued.

To help ensure that the QIC, and other CMS contractors who receive notice of scheduled hearings through the QIC, receive notice of all scheduled hearings, we are proposing to revise § 405.1020(c)(1) to require that notice be sent to the QIC that issued the reconsideration or from which the request for reconsideration was escalated. As discussed in section II.H.3. of this proposed rule with regard to CMS and CMS contractor submissions, we also are proposing to provide future flexibility for CMS to designate another contractor to receive notices of hearing by revising § 405.1020(c)(1) to state, in part, that the notice of hearing may instead be sent to another contractor designated by CMS to receive it. No corresponding revisions are needed in § 423.2020(c)(1) because escalation is not available in Medicare Part D appeals, and notices of hearing are sent to both the Medicare Part D plan sponsor and the IRE.

Section 405.1020(i)(1) and (i)(5) provides that if an unrepresented beneficiary who filed the request for hearing objects to a video-teleconference (VTC) hearing or to the ALJ's offer to conduct a hearing by telephone, or if a party other than an unrepresented beneficiary who filed the request for hearing objects to a telephone or VTC hearing, an ALJ may grant the unrepresented beneficiary's or other party's request for an in-person or VTC hearing if it satisfies the requirements in § 405.1020(i)(1) through (3), with the concurrence of the Chief ALJ or a designee and upon a finding of good cause. Prior to the January 17, 2017 final rule, § 405.1020(i) dealt exclusively with a party's request for an in-person hearing and § 405.1020(i)(5) required concurrence of the Managing Field Office ALJ and a finding of good cause for an ALJ to grant the request. (As we discussed in the January 17, 2017 final rule, the position of Managing Field Office ALJ was replaced by the position of Associate Chief ALJ, and we replaced the reference to “Managing Field Office ALJ” in § 405.1020(i)(5) with “Chief ALJ or a designee” to provide greater flexibility in the future as position titles change.) Managing Field Office ALJ concurrence and a finding of good cause were not required prior to the January 17, 2017 final rule for requests for a VTC hearing because VTC was the default method of hearing.

When we revised § 405.1020(i) in the January 17, 2017 final rule to reflect the change from VTC to telephone hearing as the default method for appearances by parties other than unrepresented beneficiaries, we neglected to restrict the requirement for the concurrence of the Chief ALJ or designee to requests for in-person hearing, in accordance with § 405.1020(b)(1)(ii) and (b)(2)(ii). In addition, we neglected to clarify that, because VTC is the default hearing method for unrepresented beneficiaries, a finding of good cause is not required when an unrepresented beneficiary who filed the request for hearing objects to an ALJ's offer to conduct a hearing by telephone and requests a VTC hearing. Accordingly, we are proposing to revise § 405.1020(i)(5) to clarify that concurrence of the Chief ALJ or designee is only required if the request is for an in-person hearing, and that a finding of good cause is not required for a request for VTC hearing made by an unrepresented beneficiary who filed the request for hearing and objects to an ALJ's offer to conduct a hearing by telephone. We also are proposing corresponding revisions to § 423.2020(i)(5) for objections filed by Medicare Part D enrollees.

In reviewing the January 17, 2017 final rule, we also noted potential confusion about whether § 405.1020(e) or (i) applies to objections to the place of a hearing when the objection is accompanied by a request for a VTC or an in-person hearing. While an objection to a hearing being conducted by telephone or VTC may broadly qualify as an objection to the place of the hearing under § 405.1020(e), our intent was for § 405.1020(i) to apply to such an objection when the objection is accompanied by a request for a different hearing format, because § 405.1020(i) is specific to an objection to the scheduled hearing format and request for an alternate hearing format. To mitigate the potential confusion as to which provisions applies, we are proposing to revise § 405.1020(e) by adding paragraph (e)(5) to make clear that it applies only when the party's or enrollee's objection does not include a request for an in-person or VTC hearing. We also are proposing a corresponding revision to § 423.2020(e) concerning a Medicare Part D enrollee's objection to the time and place of hearing.36. Dismissal of a Request for a Hearing (§§ 405.1052 and 423.2052)

Section 405.1052(a) describes the situations under which an ALJ may dismiss a request for hearing (other than withdrawals of requests for hearing, which are described in § 405.1052(c)). Although paragraph (a) pertains only to ALJ dismissals, paragraphs (a)(3), (4)(i), (5), and (6) contain inadvertent references to attorney adjudicators.

• Paragraph (a)(3) states that an ALJ may dismiss a request for hearing when the party did not request a hearing within the stated time period and the ALJ or attorney adjudicator has not found good cause for extending the deadline, as provided in § 405.1014(e).

• Paragraph (a)(4)(i) provides that when determining whether the beneficiary's surviving spouse or estate has a remaining financial interest, the ALJ or attorney adjudicator considers whether the surviving spouse or estate remains liable for the services that were denied or a Medicare contractor held the beneficiary liable for subsequent similar services under the limitation of liability provisions based on the denial of the services at issue. (As discussed in section II.H.10. of this proposed rule, we are proposing to change the reference to “limitation of liability” to “limitation on liability.”)

• Paragraph (a)(5) states that an ALJ or attorney adjudicator dismisses a hearing request entirely or refuses to consider any one or more of the issues because a QIC, an ALJ or attorney adjudicator, or the Council has made a previous determination or decision under part 405, Subpart I about the appellant's rights on the same facts and on the same issue(s) or claim(s), and this previous determination or decision has become binding by either administrative or judicial action.

• Paragraph (a)(6) states that an ALJ or attorney adjudicator may conclude that an appellant has abandoned a request for hearing when OMHA attempts to schedule a hearing and is unable to contact the appellant after making reasonable efforts to do so.

As discussed of in the January 17, 2017 final rule (82 FR 4982), our intent in finalizing the attorney adjudicator proposals was to provide authority for attorney adjudicators to dismiss a request for hearing only when an appellant withdraws his or her request for an ALJ hearing, and not under any other circumstances. We further explained that attorney adjudicators could not dismiss a request for hearing due to procedural issues or make a determination that would result in a dismissal of a request for an ALJ hearing (other than a determination that the appellant had withdrawn the request for hearing) (82 FR 5008 and 5009). Therefore, we are proposing to revise § 405.1052(a)(3), (a)(4)(i), and (a)(6) to remove the reference to attorney adjudicators and paragraph (a)(5) to remove the first reference to an attorney adjudicator. We also are proposing corresponding corrections to § 423.2052(a)(3), (5), and (6) for dismissals of Part D requests for hearing.

Prior to the January 17, 2017 final rule, § 405.1052(b) required that notice of a dismissal of a request for hearing be sent to all parties at their last known address. We explained in the final rule that the requirement to send notice of the dismissal to all parties was overly inclusive and caused confusion by requiring notice of a dismissal to be sent to parties who have not received a copy of the request for hearing or request for review that is being dismissed (82 FR 5086). Therefore, we revised this provision (and moved it to § 405.1052(d)) to state that OMHA mails or otherwise transmits a written notice of a dismissal of a request for hearing or review to all parties who were sent a copy of the request for hearing or review at their last known address.

However, in our effort to better tailor the list of recipients, we neglected to specify that notice is also sent to the appellant—who must receive notice of the dismissal, but would not have received a copy of its own request for hearing or review—and to account for CMS or a CMS contractor who elected to be a party to the appeal. We believe that CMS or a CMS contractor that is a party to an appeal has an interest in the outcome of the appeal and should be notified if the request for hearing or review is dismissed. Section 405.1046 helps ensure that CMS or CMS contractors who are a party to a hearing receive notice of the decision by requiring that the decision be sent to all parties at their last known address. In order to help ensure CMS and CMS contractors are afforded similar notice of dismissals, and that the appellant is notified of a dismissal of its request for hearing or review, we are proposing to revise § 405.1052(d) to require that notice be sent to the appellant, all parties who were sent a copy of the request for hearing or review at their last known address, and to CMS or a CMS contractor that is a party to the proceedings on a request for hearing. No corresponding revision to § 423.2052 is needed because only the enrollee is a party to a Medicare Part D appeal and receives notice of the dismissal.

Section 405.1056(a)(1) provides that if an ALJ or attorney adjudicator requests an official copy of a missing redetermination or reconsideration for an appealed claim in accordance with § 405.1034, and the QIC or another contractor does not furnish the copy within the timeframe specified in § 405.1034, the ALJ or attorney adjudicator may issue a remand directing the QIC or other contractor to reconstruct the record or, if it is not able to do so, initiate a new appeal adjudication. Section 405.1056(a)(2) provides that if the QIC does not furnish the case file for an appealed reconsideration, an ALJ or attorney adjudicator may issue a remand directing the QIC to reconstruct the record or, if it is not able to do so, initiate a new appeal adjudication. In § 405.1056(d), an ALJ or attorney adjudicator will remand a case to the appropriate QIC if the ALJ or attorney adjudicator determines that a QIC's dismissal of a request for reconsideration was in error.

Occasionally, an ALJ or attorney adjudicator may need to remand a request for review of a dismissal of a reconsideration request for reasons similar to those specified in § 405.1056(a)(1) and (2) because the ALJ or attorney adjudicator is unable to obtain an official copy of the dismissal determination, or because the QIC does not furnish the case file for an appealed dismissal. By restricting the bases for remand under § 405.1056(a)(1) and (2) to appeals of reconsiderations, we inadvertently made these reasons unavailable for remands of requests for review of a dismissal under § 405.1056(d). Therefore, we are proposing to revise § 405.1056(d) by redesignating existing paragraph (d) as paragraph (d)(1), and adding paragraph (d)(2) to state that an ALJ or attorney adjudicator may also remand a request for review of a dismissal in accordance with the procedures in paragraph (a) of the section if an official copy of the notice of dismissal or case file cannot be obtained from the QIC. We also are proposing corresponding revisions to § 423.2056(d) for Medicare Part D remands of a request for review of an IRE's dismissal of a request for reconsideration. This proposed change would necessitate two additional revisions.

First, §§ 405.1056(g) and 423.2056(g), which discuss reviews of remands by the Chief ALJ or designee, state that the review of remand procedures are not available for and do not apply to remands that are issued under §§ 405.1056(d) or 423.2056(d), respectively. In the January 17, 2017 final rule, we explained that this limitation was due to the fact that remands issued on review of a QIC's or IRE's dismissal of a request for reconsideration (that is, based on a determination that the QIC's or IRE's dismissal was in error) are more akin to a determination than a purely procedural mechanism (82 FR 5069 through 5070). Because remands issued under new proposed §§ 405.1056(d)(2) and 423.2056(d)(2) would be procedural remands, we are proposing to revise §§ 405.1056(g) and 423.2056(g) by replacing the references to paragraph (d) with a reference to paragraph (d)(1), so that remands issued under paragraph (d)(2) would be subject to the review of remand procedures in paragraph (g).

Second, we are proposing to revise §§ 405.1034(a)(1) and 423.2034(a)(1) to provide that the request for information procedures in these paragraphs apply not only to requests for official copies of redeterminations and reconsiderations, but also to requests for official copies of dismissals of requests for redetermination or reconsideration.

Section 405.1056(f) provides that OMHA mails or otherwise transmits written notice of a remand of a request for hearing or request for review to all of the parties who were sent a copy of the request for hearing or review, at their last known address, and to CMS or a contractor that elected to be a participant in the proceedings or party to the hearing. However, § 405.1056(f) does not require that notice be sent to the appellant, who would not have received a copy of its own request for hearing or review. For the same reasons described in section II.H.6 above with regard to notices of dismissal, we are proposing to revise § 405.1056(f) to require that notice be sent to the appellant, all parties who were sent a copy of the request for hearing or review at their last known address, and to CMS or a contractor that elected to be a participant in the proceedings or party to the hearing. No corresponding revision to part 423, subpart U is needed because § 423.2056(f) already provides that notice is sent to the enrollee, who is the only party to a Part D appeal.

In addition, § 405.1056(f) provides that the notice of remand states that there is a right to request that the Chief ALJ or a designee review the remand. However, § 405.1056(g) states that the review of remand procedures are not available for and do not apply to remands that are issued under § 405.1056(d) (which, as noted in section II.H.D.7. of this proposed rule, we are proposing to redesignate as § 405.1056(d)(1)). To resolve this discrepancy and help ensure that parties receive accurate information regarding the availability of the review of remand procedures, we are proposing to revise § 405.1056(f) to clarify that the notice of remand states that there is a right to request that the Chief ALJ or a designee review the remand, unless the remand was issued under § 405.1056(d)(1). We are also proposing corresponding changes to § 423.2056(d)(1).

Section 423.2056(b) provides that if an ALJ or attorney adjudicator finds that the IRE issued a reconsideration and no redetermination was made with respect to the issue under appeal or the request for redetermination was dismissed, the reconsideration will be remanded to the IRE, or its successor, to readjudicate the request for reconsideration. However, when we finalized this provision in the January 17, 2017 final rule, we did not account for situations in which no redetermination was issued because the Medicare Part D plan sponsor failed to meet the timeframe for a standard or expedited redetermination, as provided in § 423.590. In these situations, § 423.2056(b) does not provide a basis for remand because the failure of the Part D plan sponsor to provide a redetermination within the specified timeframe constitutes an adverse redetermination decision, and the Part D plan sponsor is required to forward the enrollee's request to the IRE within 24 hours of the expiration of the adjudication timeframe in accordance with § 423.590(c) (for requests for standard redeterminations) and (e) (for requests for expedited redeterminations). Accordingly, we are proposing to revise § 423.2056(b) to clarify that this reason for remand does not apply when the request for redetermination was forwarded to the IRE in accordance with § 423.590(c) or (e) without a redetermination having been conducted.

In the January 17, 2017 final rule, we amended regulations throughout 42 CFR part 405, subparts I and J; part 422, subpart M; Part 423, subparts M and U; and part 478, subpart B by replacing certain references to ALJs, ALJ hearing offices, and unspecified entities with a reference to OMHA or an OMHA office. We explained that these changes were being made to provide clarity to the public on the role of OMHA in administering the ALJ hearing program, and to clearly identify where requests and other filings should be directed (82 FR 4992). However, we neglected to revise two existing references to ALJs in § 405.970(c)(2) and one existing reference to an ALJ in § 405.970(d). To correct our oversight, we are proposing to revise § 405.970(c)(2) and (d) by replacing each instance of the phrase “to an ALJ” with “to OMHA” to clarify that appeals are escalated to OMHA, rather than an individual ALJ.

In the January 17, 2017 final rule, in order to reduce confusion with MACs, we revised references to the Medicare Appeals Council throughout part 405, subpart I; part 422, subpart M; and part 423, subparts M and U by replacing “MAC” with “Council” (82 FR 4993). However, we neglected to change one reference to “MAC” in § 423.1990(d)(2)(ii). Accordingly, we are proposing to revise § 423.1990(d)(2)(ii) by replacing “MAC” with “Council.”

In § 423.2010(d)(1), we stated that CMS, IRE, and/or Part D plan sponsor participation in an appeal may include filing position papers and/or providing testimony to clarify factual or policy issues in a case, but it does not include calling witnesses or cross-examining the witnesses of an enrollee to the hearing. This provision is similar to § 405.1010(c)(1), which describes the scope of CMS and CMS contractor participation in Medicare Part A and Part B appeals and provides, in part, that such participation does not include calling witnesses or cross-examining the witnesses of a party to the hearing. When finalizing § 423.2010(d)(1) in the January 17, 2017 final rule, which we based on § 405.1010(c)(1), we inadvertently retained the phrase “to the hearing” after “enrollee”. We believe this phrase is unnecessary in this context and reads awkwardly, and are proposing to revise § 423.2010(d)(1) to remove it.

Prior to the January 17, 2017 final rule, § 423.2016(b)(1) provided that an ALJ may consider the standard for granting an expedited hearing met if a lower-level adjudicator has granted a request for an expedited hearing. We revised this paragraph in the January 17, 2017 final rule to account for the possibility that a request for an expedited appeal could be granted by an attorney adjudicator. However, we neglected to correct the existing reference to a lower-level adjudicator having granted a request for an expedited hearing. Because lower-level adjudicators do not conduct hearings, we are proposing to revise § 423.2016(b)(1) by replacing “hearing” with “decision”.

Section 423.2032(c) describes the circumstances in which a coverage determination on a drug that was not specified in a request for hearing may be added “to pending appeal.” We inadvertently omitted the word “a” and are proposing to revise § 423.2032(c) by removing the phrase “to pending appeal” and adding “to a pending appeal” in its place.

Prior to the January 17, 2017 final rule, § 423.2036(g) stated, in part, that an ALJ may ask the witnesses at a hearing any questions relevant to the issues “and allow the enrollee or his or her appointed representative, as defined at § 423.560.” In the final rule, we redesignated this paragraph as paragraph (d), but neglected to correct the missing language at the end of the sentence. For consistency with § 405.1036(d), we are proposing to revise § 423.2036(d) by adding “, to do so” at the end of the paragraph, before the period.

Section 423.2036(e) discusses what evidence is admissible at the hearing, and states that an ALJ may not consider evidence on any change in condition of a Part D enrollee after a coverage determination, and further provides that if an enrollee wishes for such evidence to be considered, the ALJ must remand the case to the Part D IRE as set forth in § 423.2034(b)(2). Prior to the January 17, 2017 final rule, § 423.2034(b)(2) stated that an ALJ will remand a case to the appropriate Part D IRE if the ALJ determines that the enrollee wishes evidence on his or her change in condition after the coverage determination to be considered in the appeal. In the final rule, we moved this provision to § 423.2056(e), but neglected to update the cross-reference to it in § 423.2036(e). Accordingly, we are proposing to revise § 423.2036(e) to replace the reference to “§ 423.2034(b)(2)” with the reference “§ 423.2056(e)”.

In §§ 405.952(b)(4)(i), 405.972(b)(4)(i), 405.1052(a)(4)(i) and (b)(3)(i), and 405.1114(c)(1), when discussing determinations as to whether a beneficiary's surviving spouse or estate has a remaining financial interest in an appeal, we refer to limitation on liability under section 1879 of the Act as “limitation of liability.” To increase consistency with the language used in the statute and help reduce confusion as to which standard is being applied, we are proposing to replace the phrase “limitation of liability” with “limitation on liability” in each of these sections.

We have identified one provision in part 405, subpart I, and two provisions in part 423, subpart U, where we used incorrect terminal punctuation at the end of a paragraph that is part of a list. To correct our errors, we are proposing to revise §§ 405.1046(a)(2)(ii), 423.2002(b)(1), and 423.2010(b)(3)(ii) by replacing the period at the end of each paragraph with a semicolon.

Lastly, we are proposing to revise the authority citations for parts 405 and 423 to meet current Office of the Federal Register regulatory drafting guidance. The guidance requires that we use only the United States Code (U.S.C.) citations for statutory citation unless the citation does not exist.

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. In addition, appeals are considered to be an information collection requirement that is associated with an administrative action pertaining to specific individuals or entities (5 CFR 1320.4(a)(2) and (c)). As a result, the burden for preparing and filing an appeal is exempt from the requirements and collection burden estimates of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Consequently, there is no need for review by the Office of Management and Budget under the authority of the PRA.

We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. This rule would have no consequential effect on state, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017 and requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” OMB's interim guidance, issued on April 5, 2017, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/M-17-21-OMB.pdf, explains that “E.O. 13771 deregulatory actions are not limited to those defined as significant under E.O. 12866 or OMB's Final Bulletin on Good Guidance Practices.” This proposed rule, if finalized, is considered a E.O. 13771 deregulatory action. Consistent with Executive Order 13771 requirements, when discounted from 2016 to infinity at 7 percent, this proposed rule would annually save $9,497,685.00 a year.

Our proposal to remove the requirement that appellants sign appeal requests would result in a slight reduction of burden to appellants by allowing them to spend less time developing their appeal request and appealing dismissals of appeal requests for lack of a signature to the next level of review. Using the data from the number of appeal requests received, we estimate that approximately 4,465,000 appeal requests per year require a signature. We estimate that it takes 1 minute to sign the appeal request. Therefore, the reduction in administrative time spent would be 4,465,000 × .016 hour = 71,440.00 hours.

We used an adjusted hourly wage of $34.66 based on the Bureau of Labor Statistics May 2016 website for occupation code 43-9199, “All other office and administrative support workers,” which gives a mean hourly salary of $17.33, which when multiplied by a factor of two to include overhead, and fringe benefits, results in $34.66 an hour. The consequent cost savings would be 71,440.00 × $34.66 = $2,476,110.40 for time spent signing the appeal requests.

Based on a sampling of the number of appeal requests that are dismissed for not containing a signature, we estimated that 284,486 appeal requests are dismissed per year for not containing a signature on them, and 5 minutes to request that the adjudicator vacate the dismissal or appeal the dismissal. For appellants, the reduction in administrative time spent would be 284,486 × .0083 hours = 23,612 hours with a consequent savings of 23,612 hours × $34.66 per hour = $818,404.00. The total amount saved for appellants would be $3,294,514.40, which consists of $2,476,110.40 for time spent signing the appeal requests added to $818,404.00 for time saved appealing the dismissed appeal requests.

When the cost of contractors dismissing appeal requests for the lack of signature is factored in, the cost savings becomes $11,757,600. This cost is calculated by multiplying the number of appeal requests dismissed at the MAC and QIC levels multiplied by the cost that we pay the contractors to adjudicate a dismissal. The average cost for a MAC to dismiss an appeal request would be $25 × 200,000 appeals dismissed for a lack of signature per year, which equates to $5,000,000. The average cost for a QIC to dismiss an appeal request would be $80 × 84,470 appeal requests dismissed for a lack of signature per year, which equates to a savings of $6,757,600. When these two costs are added together the cost savings becomes $11,757,600.

In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

For reasons stated in the preamble, CMS proposes to amend 42 CFR parts 405 and 423 as follows:

The addition reads as follows:

The revisions read as follows.

The addition reads as follows: