Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site http://www.regulations.gov. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publicly disclosed.

You can access publicly available documents related to this action using the following methods:

NRC's Public Document Room (PDR): The public may examine and have copied for a fee publicly available documents at the NRC's PDR, Room O-1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland.

NRC's Agencywide Documents Access and Management System (ADAMS) : Publicly available documents created or received at the NRC, including the incoming petition for rulemaking (ADAMS Accession No. ML102590440), are available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR reference staff at 1-800-397-4209, or 301-415-4737, or by e-mail to PDR.Resource@nrc.gov.

Federal Rulemaking Web Site: Public comments and supporting materials related to this action can be found at http://www.regulations.gov by searching on Docket ID NRC-2010-0304.

On March 31, 2008, the NRC published a final rule (73 FR 16965) that amended its regulations governing its fitness for duty programs at 10 CFR Part 26 (Fitness for Duty rule). The rule was corrected in an amendment dated August 3, 2009 (74 FR 38326). The requirements of the rule became effective on April 30, 2008, with the implementation of Subpart A deferred until March 31, 2009. Licensees and other applicable entities were required to implement the requirements of Subpart I of 10 CFR Part 26 no later than October 1, 2009.

Anthony R. Pietrangelo, on behalf of NEI (petitioner), submitted a petition for rulemaking dated September 3, 2010, and requests that the NRC revise its regulations as they relate to the fitness for duty programs. Specifically, the petitioner requests that the NRC amend Subparts A and I of 10 CFR Part 26. The petitioner states that initial experience, including survey data across the industry, indicates that implementation of the Fitness for Duty rule has resulted in unintentional consequences that have diminished the safety benefits of the rule.

The NRC has determined that the petition meets the threshold sufficiency requirements for a petition for rulemaking under 10 CFR 2.802, and the petition has been docketed as PRM-26-5. The NRC is requesting public comment on the petition for rulemaking.

The petitioner believes that the greatest contributor to the unintended consequences of the Fitness for Duty rule lies within the prescriptive requirements for minimum days off (MDO) that appear in 10 CFR 26.205(d)(3), (d)(4), (d)(5), and (d)(6). The petitioner states that the current requirements have created an undue level of complexity and inflexibility in managing worker fatigue, and requests that the NRC replace its MDO requirements at 10 CFR 26.205(d) with a performance-based objective. The petitioner proposes eliminating the MDO requirements addressed in 10 CFR 26.205(d)(3) through (d)(6).

The petitioner also proposes performing the actual hours worked assessment required by 10 CFR 26.205(e) on a more frequent quarterly basis as opposed to annually, and to perform the averaging over the previous quarter as opposed to over a shift cycle. The petitioner proposes that 10 CFR 26.205(e)(1)(i) be amended to establish a performance objective of an average of 54 hours per week (when not in a site outage, security outage, or increased threat condition), and any hours exceeding this objective would continue to be entered into a corrective action program.

Other changes that the petitioner proposes include:

• The elimination of the definitions of shift cycle, and 8-, 10-, and 12-hour shift schedules;

• The elimination of the outage duration of 60 days;

• The elimination of the force-on-force tactical exercise exception at 10 CFR 26.207(b);

• The elimination of the word “unscheduled” in the discussion of incidental duties at 10 CFR 26.205(b)(5);

• The addition of a new exception at 10 CFR 26.207(e) to address the suspension of work hours due to acts of nature or disasters that restrict access to the site by relief personnel;

• The modification of the exception for plant emergencies in 10 CFR 26.207(d) so that it applies as long as emergency facilities are activated in accordance with the licensee's emergency plan or implementing procedures; and

• The proposed change to the definition of “unit outage,” as submitted by the Professional Reactor Operator Society in a petition for rulemaking dated October 16, 2009 (PRM-26-3) (74 FR 62257), and modified in a letter from NEI dated February 9, 2010.

The petitioner believes that the implementation of the Fitness for Duty rule has resulted in a number of unintended consequences (numerous examples are cited in the petition) that have diminished the safety benefits of the rule. The petitioner believes that the petition addresses these consequences by proposing amendments that will make the requirements more performance-based, resulting in improved flexibility in work scheduling while maintaining adequate provisions to protect against worker fatigue.

Comments Invited

Interested persons are invited to comment on this rule 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 (FAA Docket No. FAA-2010-0936; Airspace Docket No. 10-AEA-23) and be submitted in triplicate to the Docket Management System ( see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Comments 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 Docket No. FAA-2010-0936; Airspace Docket No. 10-AEA-23.” 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 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 from and comments submitted through http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/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 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined during normal business hours at the office of the Eastern Service Center, Federal Aviation Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia 30337.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory circular No. 11-2A, Notice of Proposed Rulemaking distribution System, which describes the application procedure.

The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to modify Class E surface airspace and Class E airspace extending upward from 700 feet above the surface to accommodate new SIAPs developed for Easton Airport/Newnam Field, Easton, MD, as the Easton NDB has been decommissioned. This eliminates the need for Class E airspace designated as an extension to Class D surface area, and, therefore, would be removed for the continued safety and management of IFR operations

Class E airspace designated as surface areas, Class E airspace designated as extensions to Class D airspace, and Class E airspace extending upward from 700 feet above the surface are published in Paragraph 6002, 6004, and 6005 respectively of FAA order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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 proposed regulation is within the scope of that authority as it would amend the Class E airspace area at Easton Airport/Newnam Field, Easton, MD.

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

Comments Invited

Interested persons are invited to comment on this rule 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 (FAA Docket No. FAA-2010-1010; Airspace Docket No. 10-AEA-24) and be submitted in triplicate to the Docket Management System ( see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Comments 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 Docket No. FAA-2010-1010; Airspace Docket No. 10-AEA-24.” 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 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 from and comments submitted through http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/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 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined during normal business hours at the office of the Eastern Service Center, Federal Aviation Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia 30337.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace at Charleston, WV, to provide the controlled airspace necessary in support of the SIAPs developed for Yeager Airport, Charleston, WV. The existing Class E airspace extending upward from 700 feet above the surface would be modified for the safety and management of IFR operations.

Class E airspace designations are published in Paragraph 6005 of FAA order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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 proposed regulation is within the scope of that authority as it would amend Class E airspace at Yeager Airport, Charleston, WV.

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

Comments Invited

Interested persons are invited to comment on this rule 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 (FAA Docket No. FAA-2010-0992; Airspace Docket No. 10-ASO-36) and be submitted in triplicate to the Docket Management System ( see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Comments 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 Docket No. FAA-2010-0992; Airspace Docket No. 10-ASO-36.” 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 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 from and comments submitted through http://www.regulations.gov . Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/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 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined during normal business hours at the office of the Eastern Service Center, Federal Aviation Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia 30337.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory circular No. 11-2A, Notice of Proposed Rulemaking distribution System, which describes the application procedure.

The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet above the surface for new SIAPs developed at Sturgis Municipal Airport, Sturgis, KY. Airspace reconfiguration is necessary due to the decommissioning of the Tradewater NDB and cancellation of the NDB approach. Controlled airspace is necessary for the safety and management of IFR operations.

Class E airspace designations are published in Paragraph 6005, of FAA order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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 proposed regulation is within the scope of that authority as it would amend Class E airspace at Sturgis Municipal Airport, Sturgis, KY.

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

Comments Invited

Interested parties are invited to participate in 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 and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2010-0838/Airspace Docket No. 10-AGL-13.” The postcard will be date/time stamped and returned to the commenter.

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/airports_airtraffic/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 ADDRESSES section for address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Central Service Center, 2601 Meacham Blvd., Fort Worth, TX 76137.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), part 71 by establishing Class E airspace extending upward from 700 feet above the surface for SIAPs operations at Benton Municipal Airport, Benton, IL. Controlled airspace is needed for the safety and management of IFR operations at the airport.

Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9U, dated August 18, 2010 and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would 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 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.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish controlled airspace at Benton Municipal Airport, Benton, IL.

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

Comments Invited

Interested parties are invited to participate in 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 (FAA Docket No. FAA-2010-0903 and Airspace Docket No. 10-AWP-16) and be submitted in triplicate to the Docket Management System ( see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Commenters 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-2010-0903 and Airspace Docket No. 10-AWP-16”. The postcard will be date/time stamped and returned to the commenter.

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 action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. 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/airports_airtraffic/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 the address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue, SW., Renton, WA 98057.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace at Show Low Regional Airport, Show Low, AZ. Controlled airspace is necessary to accommodate aircraft using the new RNAV (GPS) SIAPs at the airport. This action would enhance the safety and management of IFR operations at the Airport. This also would correct the name of the airport from Show Low Municipal Airport to Show Low Regional Airport.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.

The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation: (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 this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the 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 modifies controlled airspace at Show Low Regional Airport, Show Low, AZ.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows:

I. Background

The National Marine Sanctuaries Act (NMSA) (16 U.S.C. 1431 et seq. ) authorizes the Secretary of Commerce (Secretary) to designate and protect as a national marine sanctuary areas of the marine environment that are of special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational, or esthetic qualities. Day-to-day management of national marine sanctuaries has been delegated by the Secretary to NOAA's Office of National Marine Sanctuaries (ONMS). The primary objective of the NMSA is to protect sanctuary resources, such as coral reefs, and cultural resources, such as historical shipwrecks, historic structures, and archaeological sites.

NOAA issued a notice of designation for Flower Garden Banks National Marine Sanctuary to Congress and simultaneously published the notice (together with implementing regulations) in the Federal Register in 1991 (56 FR 63634, Dec. 5, 1991). The sanctuary was subsequently designated by Congress and signed into law by the President, effective January 17, 1992 (Pub. L. 102-251).

The Flower Garden Banks National Marine Sanctuary originally consisted of two areas known as East and West Flower Garden Banks (56 FR 63634; Pub. L. 102-251). Congress added Stetson Bank to the sanctuary in 1996 (Pub. L. 104-283). These three areas are located in the northwestern Gulf of Mexico and are described as underwater hills formed by rising domes of ancient salt. The banks range in depth from 55 feet to nearly 500 feet, providing conditions that support several distinct habitats, including the northern-most coral reefs in the continental United States. These and similar formations throughout the northern Gulf of Mexico provide the foundation for essential habitat for a variety of species. The combination of location and geology makes the Flower Garden Banks an extremely productive and diverse ecosystem, but it also presents a unique set of challenges for managing and protecting its natural wonders.

The FGBNMS regulations implementing the designation were first published on December 5, 1991 (56 FR 63634). Those regulations became effective on January 18, 1994 (58 FR 65664) and were later amended with an effective date of January 22, 2001 to include Stetson Bank in the boundaries of the Flower Garden Banks National Marine Sanctuary consistent with Public Law 104-283 (65 FR 81176). The regulations set forth the sanctuary boundaries; prohibited a relatively narrow range of activities; established requirements applicable to certain activities; and established permit and certification procedures, among other things. To prevent injuries to corals from anchoring, NOAA amended the FGBNMS regulations in 2001 (66 FR 58370) to conform to the regulations adopted by the International Maritime Organization and prohibit all anchoring and mooring in the sanctuary with the exception that vessels 100 feet (30.48 meters) and under in length are permitted to moor at sanctuary mooring buoys.

The ONMS is required by NMSA Section 304(e) to periodically review sanctuary management plans to ensure that sanctuary management continues to best conserve, protect, and enhance the nationally significant living and cultural resources at each site. Management plans generally outline regulatory goals, describe boundaries, identify staffing and budget needs, and set priorities and performance measures for resource protection, research and education programs. They also guide the development of future management activities. Due to such review, NOAA has decided to update and revise the 1991 FGBNMS management plan to address recent scientific discoveries, advancements in managing marine resources, and new resource management issues.

The FGBNMS management plan review process began in October 2006 with the release of the Flower Garden Banks National Marine Sanctuary State of the Sanctuary Report and public meetings to obtain information about the public's interests and priorities for FGBNMS management. Subsequently, NOAA worked with the FGBNMS Advisory Council to prioritize issues and develop appropriate management strategies and activities for the preparation of a draft revised management plan. Based on this input, NOAA prepared a draft revised management plan that consists of six action plans: Sanctuary expansion, education and outreach, research and monitoring, resource protection, visitor use, and operations and administration. Pursuant to the National Environmental Policy Act, 42 U.S.C. 4331-4345 (NEPA), NOAA also prepared a programmatic environmental assessment to analyze the environmental impacts associated with the proposed management plan revision and this proposed rule.

The resource protection and visitor use action plans in the draft management plan include several strategies that would require changes to the FGBNMS regulations. NOAA therefore is proposing to amend the FGBNMS regulations to make several substantive changes to reflect these new strategies. The changes would address conflicts between different types of visitors, protection of rays and whale sharks, and vessel discharge and deposits. The changes would also eliminate outdated references to paragraphs that no longer exist, update cross references to other paragraphs, and establish definitions for various new terms adopted in this proposed rulemaking.

This rulemaking proposes to take the following five actions:

1. Require any vessel moored in the sanctuary to exhibit the blue and white International Code flag “A” (“alpha” dive flag) whenever a SCUBA diver is in the water and remove the “alpha” dive flag once all divers exit the water and return on board the vessel;

2. Clarify that the prohibition on discharge or deposit of any material or other matter applies to discharges and deposits “from within or into” the sanctuary; and clarify that the exception to the discharge/deposit prohibition for fish, fish parts, or chumming materials (bait) applies only to discharges or deposits made during the conduct of fishing with conventional hook and line gear within the sanctuary;

3. Eliminate the exception that allows for the discharge or deposit of biodegradable effluents in the sanctuary; eliminate the phrase “routine vessel operation”; clarify that the exception applies only to discharge or deposit of clean vessel deck wash down, clean vessel engine cooling water, clean bilge water, or anchor wash, and clean effluent from an operable Type I or II marine sanitation device (MSD); require vessel operators to lock all MSDs in a manner that prevents discharge or deposit of untreated sewage; and add definitions for the terms “clean” and “harmful matter” to provide quality requirements for discharges and deposits;

4. Add a new prohibition on killing, injuring, attracting, touching, or disturbing a ray or whale shark; and add definitions for the terms “attract or attracting” and “disturb or disturbing a ray or whale shark”; and

5. Make technical corrections to eliminate outdated references of paragraphs that no longer exist in the regulations; and update cross references to other paragraphs.

NOAA proposes to require any vessel engaged in diving activity within the FGBNMS to clearly exhibit the blue and white International Code flag “A” (“alpha” dive flag) whenever a SCUBA diver from that vessel is in the water and remove the “alpha” dive flag once all SCUBA divers exit the water and return on board the vessel. The U.S. Coast Guard (USCG) requires any vessel in Federal waters engaged in diving operations to use a rigid replica of the “alpha” dive flag of a size not less than 1 meter in height, when that vessel is of a size that makes it impracticable to exhibit all lights and shapes prescribed in USCG regulations (33 CFR 83.27). The USCG also requires the vessel operator to take measures to ensure all-round visibility of the “alpha” dive flag. Because the entire sanctuary is within Federal waters, NOAA proposes to require the use of the “alpha” dive flag, whenever a vessel is engaged in diving activity in the sanctuary. This regulation would apply to all vessels engaged in diving operations, not just to vessels of a size that makes it impracticable to exhibit all lights and shapes prescribed in USCG regulations.

To ensure consistency among the regulations for other sanctuaries, this rule clarifies that the prohibition on discharging or depositing any material or other matter applies to discharges and deposits “from within or into” the sanctuary. Adding the word “into” is intended to clarify that the prohibition does not only apply to discharges and deposits originating in the sanctuary. The prohibition also applies, for example, to discharges and deposits above the sanctuary. The rule also clarifies that the exception to the prohibition on discharges or deposits for fish, fish parts, or chumming materials (bait) applies only to discharges made during the conduct of fishing with conventional hook and line gear within the sanctuary. This rule prevents the dumping of fish, fish parts, or chumming materials at all other times except for during fishing with conventional hook and line gear within the sanctuary.

NOAA proposes to amend the FGBNMS prohibition on discharges or deposits from vessels. This rule clarifies that the FGBNMS regulation (§ 922.122 (a)(3)(i)(B)) for discharge or deposit of vessel waste generated by marine sanitation devices approved in accordance with the Clean Water Act, as amended, 33 U.S.C. 1251 et seq., was not intended to allow the discharge of untreated sewage ( e.g., discharges from Type III MSDs) into the sanctuary. Type I and Type II MSDs treat sewage, whereas Type III MSDs store waste until it is removed at designated pump-out stations on shore or discharged at sea. Therefore, NOAA proposes to modify the FGBNMS regulations to clarify that only discharges or deposits of effluent from properly functioning Type I or II MSDs are allowed in the sanctuary.

In addition, NOAA proposes to require all MSDs be locked in a manner that prevents discharge or deposit of untreated sewage. The requirement that MSDs be locked ( e.g., locking closed an overboard discharge valve) helps prevent both intentional and unintentional overboard discharges of untreated sewage within the sanctuary. The revised regulations would allow vessels to discharge clean effluent from a Type I or Type II MSD. The use of the word “clean” would replace the use of the word “biodegradable” in the discharge regulations. Under the revised regulations, “clean” means not containing detectable levels of harmful matter; and “harmful matter” means any substance, or combination of substances, that because of its quantity, concentration, or physical, chemical, or infectious characteristics may pose a present or potential threat to sanctuary resources or qualities, including but not limited to: fishing nets, fishing line, hooks, fuel, oil, and those contaminants (regardless of quantity) listed at 40 CFR 302.4 (§ 922.131) pursuant to 42 U.S.C. 9601(14) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended.

NOAA decided to remove the term “biodegradable” from the regulations because NOAA determined that the term has no recognized legal definition, and products are labeled “biodegradable” without reference to a fixed set of standards. NOAA could define the term; however, it would not be reasonable to expect a vessel operator to know which of the wide spectrum of products labeled as “biodegradable” meet NOAA's definition. Defining the terms “clean” and “harmful matter” provide vessel operators with a definition of what is prohibited, and focuses on the types of contaminants that pose the greatest threat to water quality within the sanctuary.

Since the phrase “routine vessel operations” lacks a legal definition and potentially raises enforcement and compliance issues, NOAA proposes to replace the exception for “water generated from routine vessel operations” with the requirement that clean deck wash down, clean cooling water, and clean bilge water all be free of detectable levels of “harmful matter” as defined by the regulations. This facilitates compliance by clearly identifying what types of discharges and deposits from routine vessel operations are permitted under the regulations, and focuses on those contaminants that pose the greatest threat to water quality. The requirement also makes the discharge regulations consistent with recent requirements implemented for other national marine sanctuaries.

Approximately 20 species of sharks and rays have been documented at the Flower Garden and Stetson Banks; some are seasonal, others frequent the sanctuary year-round. During the winter months, spotted eagle rays ( Aetobatus narinari ) are visitors to all three banks. The reason for the seasonality of their visits is unclear, but their occurrence is quite predictable. Summer months usually bring whale sharks ( Rhincodon typus ) to the area. These filter-feeding creatures can reach over 30 feet (9 meters) in length. Manta rays ( Manta birostris ) and the very similar-looking mobula rays ( Mobula spp. ) are regular visitors to the sanctuary throughout the year. At least 58 different individual manta rays have been documented and identified by distinctive markings on their undersides. Recent acoustic tracking of the manta rays has revealed that the mantas are moving between the three banks of the sanctuary.

Whale sharks and rays are transient creatures and migrate between areas for feeding and mating. The sanctuary is a place where rays and whale sharks should be protected from human-induced death, injury or other harm. Divers can physically harm rays and whale sharks by attracting, touching, riding, or pursuing these animals. Their external sensory systems are affected by unnatural activation, which has unknown consequences on their ability to sense their environment. These animals may actively avoid diver interaction by changing direction or diving, and may exhibit violent shuddering. When these responses occur, rays and whale sharks expend energy in ways other than feeding and other natural activities, which can affect their overall health. In addition, people can cause injury to the skin of these animals through touching, and can expose the animals to other potential injuries. Finally, attracting rays and whale sharks changes their behavior and may negatively impact their health. As an example of how rays have been affected by divers, stingrays in the Cayman Islands have developed shoaling behavior and altered feeding habits, as well as exhibit skin abrasions from handling. Scientific citations regarding the concerns and examples here can be found in the references section of the draft environmental assessment ( see ADDRESSES for instructions on obtaining a copy).

These species are not listed under the Endangered Species Act (ESA) or designated as depleted under the Marine Mammal Protection Act (MMPA) because they are not mammals. Therefore, they are not protected in the same manner as threatened or endangered species protected under the ESA or depleted marine mammals protected under the MMPA. NOAA proposes to strengthen the protection of rays and whale sharks from harm (or likelihood thereof) in the sanctuary by prohibiting killing, injuring, attracting, touching, or disturbing these animals. The intent is to prevent human interaction with rays and whale sharks in such a manner that the animals change direction, dive away from human interaction, shudder, or have any other adverse behavioral or physical reaction. In order to make this new prohibition as clear as possible, NOAA is proposing to add definitions for the terms “attract or attracting” and “disturb or disturbing a ray or whale shark” in § 922.121.

NOAA proposes to make a technical correction to eliminate the references in the regulations to § 922.122(a)(iv), because that clause no longer exists. This subparagraph references a specific prohibition on vessel anchoring activities that was eliminated from the FGBNMS regulations in 2001 (66 FR 58370).

NOAA also proposes to update cross references in § 922.122(a) that may change as a result of the re-designation of paragraphs associated with this proposed rule.

NOAA has prepared a draft programmatic environmental assessment to analyze the potential environmental impacts of this proposed rulemaking. Copies are available at the address and Web site listed in the ADDRESSES section of this proposed rule. Responses to comments received on this proposed rule will be published in the final programmatic environmental assessment and preamble to the final rule.

Under Executive Order 12866, if the proposed regulations are “significant” as defined in section 3(f) of the Order, an assessment of the potential costs and benefits of the regulatory action must be prepared and submitted to the Office of Management and Budget. This proposed rule has been determined to be not significant within the meaning of Executive Order 12866.

All of the proposed actions would occur in the Exclusive Economic Zone beyond State jurisdiction. NOAA has concluded this regulatory action does not have federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 13132.

This rule does not contain any new information or revisions to the existing information collection requirement that was previously approved for this rule by OMB (OMB Control Number 0648-0141) under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.

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

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this certification is as follows: Regulations regarding dive flag requirements. NOAA proposes to require any vessel engaged in diving activities within FGBNMS clearly exhibit the blue and white International Code flag “A” (“alpha” dive flag) whenever a SCUBA diver is in the water and remove the “alpha” dive flag once all SCUBA divers exit the water and return on board the vessel. The SBA does not provide a category of business for recreational fishing or diving operators in their list of size standards for small businesses; however, it provides a category for “sporting goods store” and “marina”, which can be used to approximate the size standards for the businesses affected by this rule. According to the SBA, a small business in the sporting goods or marina industries is one that has annual receipts of less than $7 million. Sanctuary staff identified three local businesses that currently offer trips to FGBNMS for customers from the Galveston, TX area that would be affected by the flag requirement. Each of these businesses falls under the SBA's definition of a “small entity” for the purposes of this action. It is possible that other diving businesses based from other areas in Texas and Louisiana might offer trips to FGBNMS, but this situation is unlikely given the availability of other dive sites closer to these areas. The cost of complying with this requirement would be the cost of acquiring a blue and white International Code flag “A.” This expense, even for the small entities affected, is a negligible one, and NOAA also considers the cost of exhibiting a flag negligible, particularly since many dive operators are already required to use the flag in coastal waters and therefore probably already own a flag. This proposed regulation would address a safety issue by reducing conflicts among users and is not expected to have any economic impact to these small businesses.

Regulation of Vessel Discharges/Deposits. Small entities that may be affected by the vessel discharge regulation fall under three categories: Commercial fishing businesses, recreational fishing businesses, and non-consumptive (diving) charter businesses. According to the SBA, a small business in the commercial fishing industry is one that has annual receipts of less than $4 million. A small business in the recreational fishing or dive operator industry is estimated to have less than $7 million in annual receipts, as discussed above. The exact number of commercial and recreational fishing businesses that operate in FGBNMS is unknown and currently being investigated, but NOAA social scientists estimate that there are fewer than 15 small businesses in these three categories combined. Each of these businesses is considered a “small entity” based on the standards set out above. Significant adverse impacts are not expected to result for any of the sanctuary's small entities from the proposed prohibition on discharging or depositing any material or other matter from within or into the sanctuary because in the course of normal, lawful operations, no small entity activities are expected to produce such discharges/deposits. Additionally, this proposed regulation would except discharges/deposits likely to come from vessel-based small entities, including clean effluent incidental to vessel use and generated by an operable Type I or II marine sanitation device (U.S. Coast Guard classification) approved in accordance with section 312 of the Federal Water Pollution Control Act, as amended (33 U.S.C. 1321 et seq. ). This proposed regulation would also except clean vessel wash down, clean vessel engine cooling water, clean vessel engine exhaust, and fish, fish parts, or chumming materials (bait) used in or resulting from fishing with conventional hook and line gear within the sanctuary, provided that such later discharge or deposit is during the conduct of such fishing.

The proposed modification to the sanctuary's discharge/deposit regulation clarifying that discharges allowed from marine sanitation devices applies only to Type I and Type II marine sanitation devices would not introduce any new restrictions on the 15 or fewer small entities operating in the sanctuary, and would merely clarify the original intent of the sanctuary's discharge regulation. Most vessels large enough to support fishing or diving business to an offshore location such as FGBNMS have a marine sanitation device on board. All types of marine sanitation devices allow a vessel operator to either withhold discharges if they are not properly treated (Type III) or to treat wastewater prior to discharge (Type I and II); therefore this proposed regulation would not require a small entity to significantly alter its usual practices. To the extent that this clarification might affect customary, though illegal, sewage discharge practices of some small entities, the adverse affect on those operations is expected to be less than significant because such discharges may legally occur beyond the sanctuary's boundary, or vessel sewage may be pumped out and disposed of at mainland ports and harbors. Additionally, some small entities may receive indirect benefits from this clarification, especially as it might pertain to preventing large volume discharges from larger vessels, since this prohibition may contribute to sustaining favorable environmental quality in their area of operation.

The proposed modification to the sanctuary's discharge/deposit regulation that would specify that discharging or depositing fish, fish parts, or chumming materials (bait) may occur only during the conduct of fishing with conventional hook and line gear within the sanctuary is not expected to have a significant adverse impact on small entities, because it would not apply to the conduct of such fishing within the sanctuary. NOAA believes no small entities currently discharge fish or fish parts in the sanctuary as a result of fishing outside the sanctuary boundaries, so no small businesses would be affected by this proposed regulation. In some areas “chumming” is a practice that has been associated with non-consumptive recreational activities ( e.g., attracting sharks for photography), or in some cases research activities ( e.g., attracting birds for study). NOAA believes that there are currently no small entities carrying on such activities in the sanctuary. Small businesses not engaged in fishing with conventional hook and line gear could apply for and, if appropriate, be granted a sanctuary permit ( e.g., research or education) to conduct this otherwise prohibited discharge/deposit.

Regulation to protect rays and whale sharks. NOAA proposes to increase protection of rays and whale sharks from harm and harassment by adding a prohibition on killing, injuring, attracting, touching, or disturbing these animals. As mentioned above, three small businesses currently operate vessels that allow customers the opportunity to swim and/or SCUBA dive with rays and whale sharks. NOAA believes that divers' experience of the sanctuary marine environment would not be diminished by this prohibition since swimming or diving near these animals would still be allowed under the proposed regulation. Because the divers' experience will not be significantly altered by these rules, NOAA anticipates no decreased demand for the services the affected small entities provide. Therefore, significant adverse economic impacts to small businesses are not expected to result from this proposed regulatory action even if the proposed regulation requires the companies to slightly alter their current practices.

Because this action would not have a significant economic impact on a substantial number of small entities, no initial regulatory flexibility analysis was prepared.

NOAA requests comments on this proposed rule and the draft environmental assessment for 90 days after publication of this notice.

For the reasons discussed in the preamble, NOAA proposes to amend part 922, title 16 of the Code of Federal Regulations as follows:

The Virginia Graeme Baker Pool and Spa Safety Act, 15 U.S.C. 8001, (“VGB Act” or “Act”) requires that drains in public pools and spas be equipped with ASME/ANSI A112.19.8 compliant drain covers, and that each public pool and spa with a single main drain other than an unblockable drain be equipped with certain secondary anti-entrapment systems. Section 1404(c) of the Act. The Act defines “public pool and spa” in relevant part as a “swimming pool or spa that is open exclusively to patrons of a hotel or other public accommodations facility.” Section 1404(c)(2)(B)(iii) of the Act. The Act does not define the term “public accommodations facility.”

In response to numerous inquiries regarding what constitutes a public accommodations facility under the VGB Act, the Commission published a proposed interpretive rule on the definition of “public accommodations facility” on March 15, 2010 (75 FR 12167). The proposed interpretive rule would interpret “public accommodations facility” to mean: “An inn, hotel, motel, or other place of lodging, except for an establishment located within a building that contains not more than five rooms for rent or hire and that is actually occupied by the proprietor of such establishment as the residence of such proprietor.”

CPSC received six comments on the proposed interpretive rule, including two comments from State health departments, one from the Tennessee Hospitality Association, one from an individual, one from a manufacturer, and one from members of Congress. CPSC staff prepared a draft final interpretative rule for the Commission's approval, but, on August 4, 2010, the Commission voted to withdraw the proposed interpretive rule and to direct CPSC staff to draft a new proposed interpretive rule with a 60 day comment period and interpreting “public accommodations facility” as “an inn, hotel, motel, or other place of lodging, including, but not limited to, rental units rented on a bi-weekly or weekly basis.” This proposed interpretive rule is in response to the Commission's vote; elsewhere in this issue of the Federal Register , we have published a document announcing the withdrawal of the proposed interpretive rule that was published in the Federal Register March 15, 2010.

1. Public Pool or Spa. A public pool or spa open exclusively to patrons of a hotel or other public accommodations facility is only one category of public pools and spas under the VGB Act. The Act also defines a public pool and spa to include a swimming pool or spa that is:

• Open to the public generally, whether for a fee or free of charge (Section 1404(c)(2)(A) of the Act);

• Open exclusively to members of an organization and their guests (Section 1404(c)(2)(B)(i) of the Act);

• Open exclusively to residents of a multi-unit apartment building, apartment complex, residential real estate development, or other multi-family residential area (other than a municipality, township, or other local government jurisdiction) (Section 1404(c)(2)(B)(ii) of the Act); and

• Operated by the Federal Government (or by a concessionaire on behalf of the Federal Government) for the benefit of members of the Armed Forces and their dependents or employees of any department or agency and their dependents (Section 1404(c)(2)(C) of the Act).

2. Comparable Federal Statutes. The term “public accommodation” is defined in several other Federal statutes in relevant part as “an inn, hotel, motel, or other place of lodging.” ( See, e.g., the Americans with Disabilities Act (ADA), 42 U.S.C. 12181(7), defining “public accommodation” in relevant part as “an inn, hotel, motel, or other place of lodging, except for an establishment located within a building that contains not more than five rooms for rent or hire and that is actually occupied by the proprietor of such establishment as the residence of such proprietor.” See also, the Federal Fire Prevention and Control Act of 1974 (FFPCA), 15 U.S.C. 2201 et seq., at section 2203(7); the Civil Rights Act (CRA), 42 U.S.C. 1981 et seq., at section 2000(b).) The Commission intends to incorporate this language into its proposed definition for “public accommodations facility.”

The ADA, FFPCA, and CRA exclude from the definition of public accommodation an establishment located within a building that contains not more than five rooms for rent or hire that is actually occupied as a residence by the proprietor of such establishment. While there may be a rationale for this exclusion in the context of these other Federal statutes, the Commission sees no basis for this exclusion in the context of pool and spa safety. The number of units in an establishment bears no relationship to whether a pool or spa on the premises may contain a safety hazard to the patrons of such an establishment. Thus, the proposed definition would not contain an exclusion for an establishment with five or fewer units for rent or hire.

3. “Other Place of Lodging.” The Commission's proposed interpretation of “public accommodations facility” would include the phrase “other place of lodging.” The Commission intends to follow the legal precedent of the ADA in interpreting this term. The legislative history to the ADA provides that the phrase “other places of lodging” does not include residential facilities. H.R. Resp. No. 101-485(11), 101st Cong., 2d Sess. 383 (1990), reprinted in U.S. Code Cong. & Admin. News 1990, at p. 267. The Appendix to the ADA regulations explains that the rationale for excluding solely residential facilities from the category places of lodging is “because the nature of a place of lodging contemplates the use of the facility for short term stays.” 28 CFR App. B, § 36.104, p. 614-615 (1997). Thus, a residential facility is excluded from the definition of public accommodation. However, under relevant ADA precedent, if the facility were to offer a significant number of short term stays, it would lose its characterization as a residential facility and become a “place of lodging,” thereby a public accommodation. Letters from the Department of Justice and case law illustrate this point. See, e.g., Letter from Joan A. Magagna, Deputy Chief, Public Access Section, U.S. Department of Justice (June 15, 1993) (condominium complex does not constitute a place of public accommodation, assuming it does not offer such short term stays that it could be considered a place of lodging); see also Access 4 All, Inc. v. The Atlantic Hotel Condominium Ass'n, 2005 U.S. Dist. LEXIS 41601 (November 22, 2005) (condominium buildings may be covered as places of public accommodation if they operate as places of lodging; determining whether a particular condominium facility is a place of public accommodation would depend on the extent to which it shares characteristics normally associated with a hotel, motel, or inn); Thompson v. Sand Cliffs Owners Ass'n, Inc., 1998 U.S. Dist. LEXIS 23632 (1998) (according to the commentary related to the ADA regulations, the difference between a residential facility and a non-residential “place of lodging” is the length of the occupant's stay; the nature of a place of lodging contemplates the use of a facility for short-term stays). The Commission intends to use the same criteria as that found in the ADA regulations, legislative history, case law, and DOJ guidance regarding whether a particular facility is residential in nature or, alternatively, an “other place of lodging” subject to the provisions for public accommodations facilities under the VGB Act. To make this clear, the proposed interpretive rule would include the phrase, “including, but not limited to, rental units rented on a bi-weekly or weekly basis.” (Note that while a residential apartment complex would be excluded from the definition of “public accommodations facility” under the ADA, a pool or spa located in a residential apartment complex would not be excluded from the definition of a public pool or spa under the VGB Act because section 1404(c)(2)(B)(ii) of the Act includes pools or spas open exclusive to “residents of a multi-unit apartment building, apartment complex, residential real estate development, or other multi-family residential area” within the definition of “public pool or spa.”)

Thus, for example, for spas within individual condominium units or mountain lodge homes, the inquiry would involve determining whether the condominium unit or mountain lodge itself shares characteristics with inns, hotels, or motels, or whether the unit is rented for a sufficient number of short-term stays such that it becomes a “place of lodging” and thus a public accommodations facility. These determinations are fact-specific, and the Commission will rely on the same criteria as that used by courts and the Department of Justice in making such determinations.

The proposed interpretive rule would amend part 1450. Section 1450.1, Scope, would explain that part 1450 pertains to the Virginia Graeme Baker Pool and Spa Safety Act and that the statute is designed to prevent child drowning, drain entrapments, and eviscerations in pools and spas.

Section 1450.2, Definitions, would define “public accommodations facility” at paragraph (a) as “an inn, hotel, motel, or other place of lodging, including, but not limited to, rental units rented on a bi-weekly or weekly basis.”

For the reasons stated above, the Commission proposes to amend part 1450 of title 16 of the Code of Federal Regulations as follows:

The Commission published a proposed interpretive rule on the definition of “public accommodations facility in the Federal Register of March 15, 2010 (75 FR 12167). The proposed interpretive rule would interpret “public accommodations facility” to mean: “An inn, hotel, motel, or other place of lodging, except for an establishment located within a building that contains not more than five rooms for rent or hire and that is actually occupied by the proprietor of such establishment as the residence of such proprietor.”

CPSC staff prepared a draft final interpretative rule for the Commission's approval, but, on August 4, 2010, the Commission voted to withdraw the proposed interpretive rule and to direct CPSC staff to draft a new proposed interpretive rule with a 60-day comment period and interpreting “public accommodations facility” as “an inn, hotel, motel, or other place of lodging, including, but not limited to, rental units rented on a bi-weekly or weekly basis.” The Commission preliminarily determined that the exception for an owner-occupied establishment located within a building that contains not more than five rooms for rent or hire is inappropriate in the context of pool and spa safety because the number of units for rent or hire has no bearing on the safety of the pool. In addition, the Commission wanted to make clear that a residential facility may become a “place of lodging” if the facility were to offer a significant number of short term stays.

Thus, the Commission, through this notice, is withdrawing the March 15, 2010 proposed interpretive rule. Elsewhere in this issue of the Federal Register , the Commission is issuing a new proposed interpretive rule to interpret “public accommodations facility” in the VGB Act as “an inn, hotel, motel, or other place of lodging, including, but not limited to, rental units rented on a bi-weekly or weekly basis.”

The Employee Retirement Income Security Act of 1974 (ERISA) is a comprehensive statute designed to promote the interests of participants in employee benefit plans and their beneficiaries by establishing standards of conduct, responsibility, and obligation for fiduciaries of those plans. ERISA imposes a number of stringent duties on those who act as plan fiduciaries, including a duty of undivided loyalty, a duty to act for the exclusive purposes of providing plan benefits and defraying reasonable expenses of administering the plan, and a stringent duty of care grounded in the prudent man standard from trust law. 1 Congress supplemented these general duties by categorically barring, subject to exemption, certain “prohibited” transactions. 2 Fiduciaries are personally liable for losses sustained by a plan that result from a violation of these rules. 3

Section 3(21)(A) of ERISA provides in relevant part that a person is a fiduciary with respect to a plan to the extent (i) it exercises any discretionary authority or discretionary control with respect to management of such plan or exercises any authority or control with respect to management or disposition of its assets, (ii) it renders investment advice for a fee or other compensation, direct or indirect, with respect to any moneys or other property of such plan, or has any authority or responsibility to do so, or (iii) it has any discretionary authority or discretionary responsibility in the administration of such plan. 4 On its face, section 3(21)(A)(ii) sets out a simple two-part test for determining fiduciary status: A person renders investment advice with respect to any moneys or other property of a plan, or has any authority or responsibility to do so; and the person receives a fee or other compensation, direct or indirect, for doing so.

In 1975, shortly after ERISA was enacted, the Department issued a regulation, at 29 CFR 2510.3-21(c), that defines the circumstances under which a person renders “investment advice” to an employee benefit plan within the meaning of section 3(21)(A)(ii) of ERISA. 5 A person who renders “investment advice” under the regulation, and receives a fee or other compensation, direct or indirect, for doing so, is a fiduciary under section 3(21)(A)(ii). The current regulation provides in relevant part as follows:

The regulation significantly narrows the plain language of section 3(21)(A)(ii), creating a 5-part test that must be satisfied in order for a person to be treated as a fiduciary by reason of rendering investment advice. For advice to constitute “investment advice,” an adviser who does not have discretionary authority or control with respect to the purchase or sale of securities or other property for the plan must—

(1) Render advice as to the value of securities or other property, or make recommendations as to the advisability of investing in, purchasing or selling securities or other property

(2) On a regular basis

(3) Pursuant to a mutual agreement, arrangement or understanding, with the plan or a plan fiduciary, that

(4) The advice will serve as a primary basis for investment decisions with respect to plan assets, and that

(5) The advice will be individualized based on the particular needs of the plan.

The Department further limited the term “investment advice” in a 1976 advisory opinion. Under the facts described therein, the Department concluded that a valuation of closely-held employer securities that an employee stock ownership plan (ESOP) would rely on in purchasing the securities would not constitute investment advice under the regulation. 6

The current regulation has not been updated since its promulgation in 1975. Since that time, however, the retirement plan community has changed significantly, with a shift from defined benefit (DB) plans to defined contribution (DC) plans. The financial marketplace also has changed significantly, and the types and complexity of investment products and services available to plans have increased. With the resulting changes in plan investment practices, and relationships between advisers and their plan clients, the Department believes there is a need to re-examine the types of advisory relationships that should give rise to fiduciary duties on the part of those providing advisory services. In this regard, we note that recent Department enforcement initiatives indicate there are a variety of circumstances, outside those described in the current regulation, under which plan fiduciaries seek out impartial assistance and expertise of persons such as consultants, advisers and appraisers to advise them on investment-related matters. 7 These persons significantly influence the decisions of plan fiduciaries, and have a considerable impact on plan investments. However, if these advisers are not fiduciaries under ERISA, they may operate with conflicts of interest that they need not disclose to the plan fiduciaries who expect impartiality and often must rely on their expertise, and have limited liability under ERISA for the advice they provide. Recent testimony by the Government Accountability Office noted an association between pension consultants with undisclosed conflicts of interest and lower returns for their client plans. 8 The Department believes that amending the current regulation to establish additional circumstances where investment advice providers are subject to ERISA's fiduciary responsibilities would better protect the interests of plans and their participants and beneficiaries. As a consequence of the current regulation, the Department's investigations of investment advisers must focus on establishing each of the elements of the 5-part test rather than on the precise misconduct at issue in particular cases. Even if an adviser advises a plan about its investments for a fee, the plan relied upon the advice based upon reasonable belief that it was impartial, and the advice was wholly abusive, the Department must still prove each of the test's five elements in order to assert a fiduciary breach. The Department does not believe that this approach to fiduciary status is compelled by the statutory language. Nor does the Department believe the current framework represents the most effective means of distinguishing persons who should be held accountable as fiduciaries from those who should not. For these reasons, the Department believes it is appropriate to update the “investment advice” definition to better ensure that persons, in fact, providing investment advice to plan fiduciaries and/or plan participants and beneficiaries are subject to ERISA's standards of fiduciary conduct.

In general, the proposal amends paragraph (c) of Sec. 2510.3-21 by striking the current paragraph (c)(1), redesignating the current paragraph (c)(2) as paragraph (c)(5), and adding new paragraphs (c)(1) through (c)(4). New paragraph (c)(1) sets out the general rule that a person renders “investment advice” for a fee or other compensation, direct or indirect, to an employee benefit plan, within the meaning of section 3(21)(A)(ii) of ERISA and the regulation, if the person provides advice or makes recommendations described in paragraph (c)(1)(i), directly or indirectly meets any of the conditions described in paragraph (c)(1)(ii), and receives a fee or other compensation, direct or indirect, for providing such advice or recommendations. New paragraph (c)(2) sets forth certain limitations in the application of paragraph (c). New paragraph (c)(3) provides guidance with respect to the meaning of the term “fee or other compensation, direct or indirect,” as used in section 3(21)(A)(ii) of ERISA. New paragraph (c)(4) clarifies the proposed amendment would apply for purposes of Code section 4975.

Under paragraph (c)(1)(i)(A) of the proposal, the types of advice and recommendations that may result in fiduciary status under ERISA section 3(21)(A)(ii) are: Advice, appraisals or fairness opinions concerning the value of securities or other property; recommendations as to the advisability of investing in, purchasing, holding, or selling securities or other property; or advice or recommendations as to the management of securities or other property.

This provision encompasses the same types of investment-related advice and recommendations as covered by paragraph (c)(1)(i) of the current regulation, except for the following modifications. First, the proposal specifically includes the provision of appraisals and fairness opinions. As discussed above, the Department concluded in AO 76-65A that a valuation of closely held employer securities that would be relied on in the purchase of the securities by an ESOP would not constitute investment advice under the current regulation. However, a common problem identified in the Department's recent ESOP national enforcement project involves the incorrect valuation of employer securities. 9 Among these are cases where plan fiduciaries have reasonably relied on faulty valuations prepared by professional appraisers. The Department believes that application of the proposal to appraisals and fairness opinions rendered in connection with plan transactions may directly or indirectly address these issues, and align the duties of persons who provide these opinions with those of fiduciaries who rely on them. Accordingly, paragraph (c)(1)(i)(A)( 1 ) of the proposal specifically includes the provision of appraisals and fairness opinions concerning the value of securities or other property. This paragraph is intended to supersede the Department's conclusion in AO 76-65A, but is not limited to employer securities. Therefore, if a person is retained by a plan fiduciary to appraise real estate being offered to the plan for purchase, then the provision of the appraisal would fall within paragraph (c)(1)(i)(A)( 1 ) of the proposal, and may result in fiduciary status under ERISA section 3(21)(A)(ii). The Department would expect a fiduciary appraiser's determination of value to be unbiased, fair, and objective, and to be made in good faith and based on a prudent investigation under the prevailing circumstances then known to the appraiser.

Second, the proposal at paragraph (c)(1)(i)(A)( 3 ) makes specific reference to advice and recommendations as to the management of securities or other property. This would include, for instance, advice and recommendations as to the exercise of rights appurtenant to shares of stock ( e.g., voting proxies), 10 and as to the selection of persons to manage plan investments.

Finally, the proposal at paragraph (c)(1)(i)(B) makes clear that fiduciary status under section 3(21)(A)(ii) may result from the provision of advice or recommendations not only to a plan fiduciary, but also to a plan participant or beneficiary. This reflects the Department's long-standing interpretation of the current regulation. 11 The Department notes that it also has taken the position that, as a general matter, a recommendation to a plan participant to take an otherwise permissible plan distribution does not constitute investment advice within the meaning of the current regulation, even when that advice is combined with a recommendation as to how the distribution should be invested. 12 Concerns have been expressed that, as a result of this position, plan participants may not be adequately protected from advisers who provide distribution recommendations that subordinate participants' interests to the advisers' own interests. The Department, therefore, is requesting comment on whether and to what extent the final regulation should define the provision of investment advice to encompass recommendations related to taking a plan distribution. The Department is specifically interested in information on other laws that apply to the provision of these types of recommendations, whether and how those laws safeguard the interests of plan participants, and the costs and benefits associated with extending the regulation to these types of recommendations.

Paragraph (c)(1)(ii) of the proposal sets forth alternative conditions, at paragraphs (c)(1)(ii)(A) through (D), at least one of which must be met by a person rendering advice described in paragraph (c)(1)(i) in order for the person to be considered rendering investment advice under the proposal. The conditions may be met by the person acting directly or indirectly, such as through or together with an affiliate. These alternative conditions generally relate to the degree of authority, control, responsibility or influence that is possessed, directly or indirectly, by the person rendering the advice, and the reasonable expectations of the persons receiving the advice. The conditions at paragraphs (c)(1)(ii)(B) and (D) of the proposal are based on paragraphs (c)(1)(ii)(A) and (B) of the current regulation (which include elements of the 5-part test described above), but with modifications to simplify their application and broaden their scope. The conditions at paragraphs (c)(1)(ii)(A) and (C) are new, and are intended to broaden the scope of the regulation based on readily-ascertainable criteria.

Paragraph (c)(1)(ii)(A) of the proposal includes persons providing advice or recommendations described in paragraph (c)(1)(i) that represent or acknowledge that they are acting as a fiduciary within the meaning of ERISA with respect to such advice or recommendations. The Department believes that explicitly claiming ERISA fiduciary status, orally or in writing, enhances the adviser's influence, and gives the advice recipient a reasonable expectation that the advice will be impartial and prudent. Therefore such a representation or acknowledgment in connection with provision of the advice or recommendations described in paragraph (c)(1)(i) is sufficient under the proposal to result in fiduciary status under section 3(21)(A)(ii) if provided for a fee or other compensation, direct or indirect.

Paragraph (c)(1)(ii)(B) of the proposal includes persons providing the types of investment-related advice or recommendations described in paragraph (c)(1)(i) that are fiduciaries with respect to the plan within the meaning of section 3(21)(A)(i) or (iii) of ERISA. This provision is based on the condition in paragraph (c)(1)(ii)(A) of the current regulation, which is met if the person rendering advice directly or indirectly has discretionary authority or control with respect to purchasing or selling securities or other property for the plan. However, the proposal broadens the scope of this condition by referencing a person who is a fiduciary within the meaning of section 3(21)(A)(i) or (iii) of ERISA, which is not limited to persons with authority or control relating to purchases or sales of investments for a plan. Specifically, section 3(21)(A)(i) and (iii) describe any person who exercises any discretionary authority or discretionary control with respect to management of the plan, exercises any authority or control with respect to management or disposition of its assets, or has any discretionary authority or discretionary responsibility in the administration of the plan.

Paragraph (c)(1)(ii)(C) includes persons providing advice or recommendations described in paragraph (c)(1)(i) that are investment advisers within the meaning of section 202(a)(11) of the Investment Advisers Act of 1940 (Advisers Act), 15 U.S.C. 80b-2(a)(11). This section generally defines an “investment adviser” as any person who, for compensation, engages in the business of advising others as to the value of securities or the advisability of investing in, purchasing, or selling securities, or who promulgates analyses or reports concerning securities. However, section 202(a)(11) specifically excludes the following: (1) A bank, or any bank holding company as defined in the Bank Holding Company Act of 1956, which is not an investment company, except that the term “investment adviser” includes any bank or bank holding company to the extent that such bank or bank holding company serves or acts as an investment adviser to a registered investment company, but if such services or actions are performed through a separately identifiable department or division of a bank, the department or division, and not the bank itself, is deemed to be the investment adviser; (2) any lawyer, accountant, engineer, or teacher whose performance of such services is solely incidental to the practice of his or her profession; (3) any broker or dealer whose performance of such services is solely incidental to the conduct of his business as a broker or dealer and who receives no special compensation therefor; (4) the publisher of any bona fide newspaper, news magazine or business or financial publication of general and regular circulation; (5) any person whose advice, analyses, or reports relate to no securities other than securities which are direct obligations of or obligations guaranteed as to principal or interest by the United States, or securities issued or guaranteed by corporations in which the United States has a direct or indirect interest which shall have been designated by the Secretary of the Treasury, pursuant to section 3(a)(12) of the Securities Exchange Act of 1934, as exempted securities for the purposes of that Act; (6) any nationally recognized statistical rating organization, as that term is defined in section 3(a)(62) of the Securities Exchange Act of 1934, unless such organization engages in issuing recommendations as to purchasing, selling, or holding securities or in managing assets, consisting in whole or in part of securities, on behalf of others; or (7) such other persons designated by the Securities and Exchange Commission (SEC) by rules, regulations or orders. 13 Courts have determined that these investment advisers owe fiduciary duties to their clients under the Advisers Act. 14 In this regard, the SEC has stated: “the Investment Advisers Act imposes on investment advisers an affirmative duty to their clients of utmost good faith, full and fair disclosure of all material facts, and an obligation to employ reasonable care to avoid misleading their clients.”  15 Thus, the Department proposes to include these persons under the regulation.

Paragraph (c)(1)(ii)(D) includes persons that provide advice or make recommendations described in paragraph (c)(1)(i) pursuant to an agreement, arrangement or understanding, written or otherwise, between such person(s) and the plan, a plan fiduciary, or a plan participant or beneficiary, that such advice may be considered in connection with making investment or management decisions with respect to plan assets, and will be individualized to the needs of the plan, a plan fiduciary, or a participant or beneficiary.

Paragraph (c)(1)(ii)(D) of the proposal is based on the elements of the 5-part test contained in paragraph (c)(1)(ii)(B) of the current regulation which, as described above, requires that a person render advice on a regular basis to the plan pursuant to a mutual agreement, arrangement or understanding, written or otherwise, between such person and the plan or a fiduciary with respect to the plan, that such services will serve as a primary basis for investment decisions with respect to plan assets, and that such person will render individualized investment advice to the plan based on the particular needs of the plan regarding such matters as, among other things, investment policies or strategy, overall portfolio composition, or diversification of plan investments. The Department notes several differences between the proposal and current paragraph (c)(1)(ii)(B). The proposal does not require the advice to be provided on a regular basis. The Department has observed that in those instances where a plan fiduciary retains a service provider such as a consultant or appraiser to render advice, it often involves discrete advice with respect to distinct investment transactions, such as a purchase of employer securities. The Department does not believe that the significance of the advice on a plan fiduciary's decisions diminishes merely because it is rendered only once, rather than on a regular basis, or that fiduciary status under section 3(21)(A)(ii) should depend on such a distinction. For example, a fiduciary may retain a person to provide advice on a particular real estate investment in the plan's portfolio, and never have a reason to use this adviser again. Nevertheless, such advice may be critical to an important investment decision and the plan's agreement with the adviser may give the plan every expectation that the adviser is competent and has no conflicts of interest. The Department also believes that removal of the regular basis requirement will help address uncertainty under the current regulation by eliminating difficult factual questions relating to what constitutes a regular basis, and when it begins and ends, and by making clear that fiduciary status applies to each instance advice is rendered.

The proposal also does not require that the parties have a mutual understanding that the advice will serve as a primary basis for plan investment decisions. Nothing in ERISA compels conditioning fiduciary status on a requirement that an adviser and plan fiduciary have a mutual understanding as to the primacy of the advice given, in relation to other advice or information that the fiduciary may consider in making a decision. The Department believes that when a service provider is retained to render advice, the plan should generally be able to rely on the advice without regard to whether the parties intend it be a primary or lesser basis in the fiduciary's decision-making. For example, in a complex investment decision, a plan fiduciary may need to consult advisers with different areas of investment expertise in order to make a prudent decision. The relative importance of the different kinds of advice that the plan fiduciary obtains may be impossible to discern, and should not affect the question of whether the adviser is a fiduciary. Accordingly, under the proposal it is sufficient if the understanding of the parties is that the advice will be considered in connection with making a decision relating to plan assets. The Department also believes this modification will simplify this condition by eliminating difficult factual issues surrounding the primacy of the advice rendered. Other changes are editorial in nature and intended to improve the readability of the provision.

It is important to note generally that paragraphs (c)(1)(ii)(A), (B), (C) and (D) are independent, alternative conditions. Satisfaction of any one of these alternative conditions may result in fiduciary investment advice under the proposal if paragraph (c)(1)(i) also is satisfied. For example, a bank or a broker dealer that provides investment advice or recommendations described in paragraph (c)(1)(i) might fall within an exclusion from the definition of “investment adviser” in section 202(a)(11) of the Advisers Act, and therefore might not meet paragraph (c)(1)(ii)(C) of the proposal. Notwithstanding this exclusion, if the bank or broker dealer meets the requirements of paragraphs (c)(1)(ii)(A), (B) or (D), it would nevertheless be considered to render investment advice under the proposal.

Paragraphs (c)(2) of the proposal sets forth certain limitations with respect to the application of paragraph (c)(1).

Paragraph (c)(2)(i) provides that a person shall not be considered to be a person described in paragraph (c)(1) with respect to the provision of advice or recommendations if, with respect to a person other than a person described in paragraph (c)(1)(ii)(A), such person can demonstrate that the recipient of the advice knows or, under the circumstances, reasonably should know, that the person is providing the advice or making the recommendation in its capacity as a purchaser or seller of a security or other property, or as an agent of, or appraiser for, such a purchaser or seller, whose interests are adverse to the interests of the plan or its participants or beneficiaries, and that the person is not undertaking to provide impartial investment advice. This provision reflects the Department's understanding that, in the context of selling investments to a purchaser, a seller's communications with the purchaser may involve advice or recommendations, within paragraph (c)(1)(i) of the proposal, concerning the investments offered. The Department has determined that such communications ordinarily should not result in fiduciary status under the proposal if the purchaser knows of the person's status as a seller whose interests are adverse to those of the purchaser, and that the person is not undertaking to provide impartial investment advice. However, the Department believes there is an inherent expectation of impartial investment advice from a person described in paragraph (c)(1)(ii)(A) (involving representations or acknowledgment of ERISA fiduciary status with respect to providing advice or recommendations). Accordingly, paragraph (c)(2)(i) does not apply to such a person.

As an example, if a person selling securities to a plan is a fiduciary of the plan under section 3(21)(A)(i) or (iii) of ERISA (and therefore in paragraph (c)(1)(ii)(B) of the proposal), 16 or is an investment adviser as defined in the Advisers Act (and therefore in paragraph (c)(1)(ii)(C) of the proposal), 17 then the person may seek to utilize paragraph (c)(2)(i) to avoid fiduciary status under the proposal in connection with the sale. However, if the person also makes a representation of ERISA fiduciary status in connection with the sale, orally or in writing, then paragraph (c)(2)(i) would not be available. The Department intends that a person seeking to avoid fiduciary status under the proposal by reason of the application of paragraph (c)(2)(i) must demonstrate compliance with all applicable requirements of the limitation.

Paragraph (c)(2)(ii) describes certain activities taken in connection with individual account plans that will not, in and of themselves, be treated as rendering investment advice for purposes of ERISA section 3(21)(A)(ii). Paragraph (c)(2)(ii)(A) clarifies that the provision of investment education information and materials described in 29 CFR 2509.96-1(d) will not constitute the rendering of investment advice under section 3(21)(A)(ii) of ERISA. In 29 CFR 2509.96-1(d), the Department identified four specific categories of information and materials which, if furnished, alone or on combination, to plan participants or beneficiaries would not result in the rendering of investment advice under the current regulation. The Department reasoned that these categories of information and materials—plan information, general financial and investment information, asset allocation models, and interactive materials—would not involve advice or recommendations within the meaning of paragraph (c)(1)(i) of the current regulation. 18 The proposed modifications to the advice and recommendations described in paragraph (c)(1)(i) would not change this conclusion. This is reflected in paragraph (c)(2)(ii)(A). The Department notes that the information and materials described in 29 CFR 2509.96-1(d) merely represent examples of the type of information and materials that may be furnished to a participant or beneficiary without being considered the rendering of investment advice under the proposal.

Paragraphs (c)(2)(ii)(B) and (c)(2)(ii)(C) address certain common practices that have developed with the growth of participant-directed DC plans. Service providers such as recordkeepers and third party administrators sometimes make available a menu of investments from which a plan fiduciary selects a more limited menu that will be available under the plan for participant or beneficiary investment. The provider may simply offer a “platform” of investments from which the plan fiduciary selects those appropriate for the plan, or the provider may select, or assist the plan fiduciary in selecting the investments that will be available under the plan. The service provider also sometimes retains the ability to later make changes to the plan's investment menu, subject to advance approval by the plan fiduciary. In some instances, the provider and the plan fiduciary clearly understand that the provider is offering investments as to which the provider has financial or other relationships, and is not purporting to provide impartial investment advice regarding construction of the plan's investment menu. In other instances, the plan fiduciary is relying on the provider's impartial expertise in selecting an investment menu for the plan. Also, to assist in the plan fiduciary's selection or monitoring of investments from those made available, such a service provider also might provide to the fiduciary general financial information and data regarding matters such as historic performance of asset classes and of the investments available through the provider.

To help address any uncertainty as to how these arrangements are treated under the proposal, the Department is clarifying at paragraph (c)(2)(ii)(B) that, with respect to an individual account plan, the marketing or making available ( e.g., through a platform or similar mechanism), without regard to the individualized needs of the plan, its participants, or beneficiaries, securities or other property from which a plan fiduciary may designate investment alternatives into which plan participants or beneficiaries may direct the investment of assets held in, or contributed to, their individual accounts, will not, by itself, be treated as the rendering of investment advice within the meaning of section 3(21)(A)(ii) of ERISA if the person making available such investments discloses in writing to the plan fiduciary that the person is not undertaking to provide impartial investment advice. 19 Paragraph (c)(2)(ii)(C) of the proposal further clarifies that, in connection with the activities described in paragraph (c)(2)(ii)(B), the provision of certain information and data to assist a plan fiduciary's selection or monitoring of such plan investment alternatives will not be treated as rendering investment advice if the person providing such information or data discloses in writing to the plan fiduciary that the person is not undertaking to provide impartial investment advice.

The Department recognizes that compliance with a number of ERISA's reporting and disclosure provisions requires information on the value of plan assets. The Department does not intend, as a general matter, for such information provided solely for compliance purposes to fall within the type of advice described under that proposal. Paragraph (c)(2)(iii) provides that advice described in paragraph (c)(1)(i)(A)( 1 ) does not encompass the preparation of a general report or statement that merely reflects the value of an investment of a plan or a participant or beneficiary, provided for purposes of compliance with the reporting and disclosure requirements of the Act, the Internal Revenue Code, and the regulations, forms and schedules issued thereunder, unless such report involves assets for which there is not a generally recognized market and serves as a basis on which a plan may make distributions to plan participants and beneficiaries.

Pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat. 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat. 892; 33 U.S.C. 3), the Corps proposes to amend the regulations in 33 CFR part 334 by adding § 334.420 (b)(1)(v) to establish an Intermittent Danger Zone abutting the existing 1.8 mile Danger Zone [as described in § 334.420(b)(1)(i)] in the Pamlico Sound and adjacent waters in Carteret County, North Carolina. The public is currently restricted from accessing the existing 1.8 mile radius circular area and has limited access to three additional 0.5 mile radius circular danger zones described at §§ 334.420(b)(1)(ii), (iii), and (iv), but has unrestricted access to the surrounding waters. To better protect the public from potentially hazardous conditions during scheduled live fire training, Marine Corps Air Station Cherry Point has requested that the Corps establish the Intermittent Danger Zone that will enable the Marine Corps to ensure security and safety for the public.

The current military training mission requires enhanced public safety and protection of vessels that operate in the vicinity of the Bombing Target-11 range. This proposed amendment to the current danger zone regulation at 33 CFR 334.420 includes the addition of a danger zone in Pamlico Sound that abuts the existing 1.8 mile radius danger zone and extends out to 2.5 miles from the common center point. Establishment of this additional danger zone will allow the Marine Corps to minimize the public safety hazard resulting from the increased use of .50 caliber weapons firing from rotary-wing aircraft and small boats during training exercises at Bombing Target-11 Range. The new danger zone will optimize public safety and military training, and protect any vessels that operate in the vicinity of Bombing Target-11 Range.

a. Review Under Executive Order 12866. This proposed rule is issued with respect to a military function of the Defense Department and the provisions of Executive Order 12866 do not apply.

b. Review Under the Regulatory Flexibility Act. This proposed rule has been reviewed under the Regulatory Flexibility Act (Pub. L. 96-354) which requires the preparation of a regulatory flexibility analysis for any regulation that will have a significant economic impact on a substantial number of small entities ( i.e., small businesses and small governments). The Corps has determined that revising this proposed rule would have practically no economic impact on the public, or result in no anticipated navigational hazard or interference with existing waterway traffic. This proposed rule will have no significant economic impact on small entities.

c. Review Under the National Environmental Policy Act. The Corps expects that the proposed rule will not have a significant impact to the quality of the human environment and, therefore, preparation of an environmental impact statement will not be required. After the comment period, an environmental assessment will be prepared and it may be reviewed at the District office listed at the end of the FOR FURTHER INFORMATION CONTACT , above.

d. Unfunded Mandates Act. The proposed rule does not impose an enforceable duty among the private sector and, therefore, is not a Federal private sector mandate and is not subject to the requirements of Section 202 or 205 of the Unfunded Mandates Reform Act (Pub. L. 104-4, 109 Stat. 48, 2 U.S.C. 1501 et seq. ). We have also found under Section 203 of the Act, that small governments will not be significantly or uniquely affected by this proposed rule.

For the reasons set out in the preamble, the Corps proposes to amend 33 CFR part 334 as follows:

A final rule was published in the Federal Register at 74 FR 21258 amending 38 CFR 3.309(e) by adding AL amyloidosis to the list of diseases associated with exposure to certain herbicide agents. Currently, the rating schedule does not have a diagnostic code for AL amyloidosis. As an unlisted condition, it is rated by analogy to non-Hodgkin's lymphoma using the “built-up” diagnostic code 7799-7715. However, AL amyloidosis is not part of the group of diseases under the non-Hodgkin's lymphoma classification, but a disorder of the bone marrow characterized by the accumulation and deposition of abnormal, insoluble proteins called light chain amyloid proteins in any organ of the body, interfering with the structure and function of the organ. Therefore, AL amyloidosis requires a set of evaluation criteria with a unique diagnostic code, which will serve as a basis for disability rating. VA proposes a regulation that would amend the rating schedule by adding rating guidance and a diagnostic code specifically for AL amyloidosis.

AL amyloidosis is a seriously disabling, progressive, and incurable condition. It is usually fatal within 1 to 2 years of diagnosis. Because of its rarity and rapid progression, AL amyloidosis may not be diagnosed until it has resulted in considerable multi-organ damage (to heart, kidney, liver, spleen, intestine, etc. ). At the time of diagnosis, the most common findings are nephrotic syndrome with or without renal insufficiency, congestive cardiomyopathy, peripheral neuropathy, and hepatomegaly. The extent of the disease limits the specific types of treatments that can be used. Stem cell transplantation with high dose chemotherapy, an aggressive and risky treatment with serious side effects and a significant mortality rate, can be used in a limited number of patients who meet the criteria to undergo such severe treatment. This treatment has shown promise in prolonging life but does not cure the disease. Accumulations of amyloid in a specific area of the body can sometimes be removed surgically. Organ transplants (for example, of a kidney or the heart) have extended the lives of a small number of people with organ failure due to amyloidosis but eventually the transplanted organ accumulates amyloid. In general, treatment can slow the course of the disease and help alleviate the symptoms of organ damage, but it is not curative.

AL amyloidosis is a disease most closely aligned with other diseases of the hemic and lymphatic systems. Therefore, VA proposes diagnostic code 7717 for AL amyloidosis because it is the first available diagnostic code in the Hemic and Lymphatic Systems listed in § 4.117.

VA proposes to assign a 100 percent rating because the disease is incurable and progressive, generally causing death in a few years. While AL amyloidosis may or may not be totally disabling at the time of diagnosis or time of claim for VA compensation, its clinical course is usually associated with rapid disease progression and involvement of multiple organ systems. The usual cause of death is cardiac, hepatic, or renal failure, or infection. The median survival rate for AL amyloidosis is 12-18 months in the United States. Providing a 100-percent evaluation in all cases would obviate the need to reassess and reevaluate veterans with AL amyloidosis repeatedly over a short period of time. Because of the poor prognosis, no follow-up examination will be required for re-evaluation of this disability rating.

We also propose to refer to AL amyloidosis as “primary amyloidosis”, which is another common name for the same disease. Although the disease may also be identified as “immunocyte-derived amyloidosis” and “light chain-related amyloidosis”, these terms for the disease are much less common. Therefore, we propose not to include them under diagnostic code 7717 because their inclusion would not be useful to the public or VA personnel.

Finally, we propose to amend 38 CFR Part 4, Appendices A, B, and C to reflect the proposed addition of diagnostic code 7717 for AL amyloidosis to the rating schedule.

The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This proposed rule will not directly affect small entities. Only VA beneficiaries will be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB) unless OMB waives such review, as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The economic, interagency, budgetary, legal, and policy implications of this proposed rule have been examined and it has been determined not to be a significant regulatory action under Executive Order 12866.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. This proposed rule would have no such effect on State, local, and Tribal governments, or on the private sector.

The Catalog of Federal Domestic Assistance program numbers and titles for this proposal are 64.104, Pension for Non-Service-Connected Disability for Veterans, and 64.109, Veterans Compensation for Service-Connected Disability.

This action contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on October 4, 2010, for publication.

For the reasons stated in the preamble, the Department of Veterans Affairs proposes to amend 38 CFR part 4 as set forth below:

Status: The meeting will be open to the public, limited only by the space available. The meeting room accommodates approximately 125 people.

Instructions: Requests to make presentations at the public meeting should be mailed to the NIOSH Docket Officer, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Requests may also be submitted by telephone 513-533-8611, fax 513-533-8285, or e-mailed to niocindocket@cdc.gov. All requests to present should contain the name, address, and telephone number, relevant business affiliations of the presenter, topic of the presentation, and the approximate time requested for the presentation. Oral presentations should be limited to 15 minutes.

After reviewing the requests for presentations, NIOSH will notify the presenters that their presentations are scheduled. If a participant is not present when his/her presentation is scheduled to begin, the remaining participants will be heard in order. At the conclusion of the meeting, an attempt will be made to allow presentations by scheduled participants who missed their assigned times. Attendees who wish to speak but did not submit a request for the opportunity to make a presentation may be given this opportunity at the conclusion of the meeting, at the discretion of the presiding officer.

This meeting will also be using Audio/Live Meeting Conferencing, remote access capabilities where interested parties may listen in and review the presentations over the internet simultaneously. Parties remotely accessing the meeting will have the opportunity to ask questions during the open comment period. To register to use this capability, please contact the NPPTL, Policy and Standards Development Branch, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, telephone 412-386-5200, fax 412-386-4089. This option will be available to participants on a first come, first served basis and is limited to the first 50 participants.

Background: NIOSH, National Personal Protective Technology Laboratory (NPPTL), will present information to attendees concerning the development of the concepts being considered for performance criteria of various classes of respirators. Participants will be given an opportunity to ask questions and to present individual comments that they may wish to have considered.

Reference: Information regarding documents that will be discussed at the meeting may be obtained from the NIOSH Web site using this link: http://www.cdc.gov/niosh/review/public/ using the docket numbers listed in this notice.

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 Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

According to CMS data, at any point in time, approximately 1.4 million elderly and disabled nursing home residents are receiving care in nearly 16,000 Medicare- and Medicaid-certified Long-Term Care (LTC) facilities in the United States. More than 20 percent of older Americans die in nursing homes. (Johnson, Sandra H., Hastings Center Report, Making Room for Dying: End of Life Care in Nursing Homes; November/December 2005, Special Report 35 (6), S37-S41.) Therefore, providing care at the end of life, particularly palliative care, is an important part of nursing home care.

Palliative care means patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care in an LTC facility involves addressing physical, intellectual, emotional, social, and spiritual needs, as well as facilitating resident autonomy, access to information, and choice throughout the continuum of illness. Palliative care independent of the hospice benefit may also be provided by LTC facilities, which may eliminate the need for hospice services for their residents.

Hospice care is provided for terminally ill individuals with a prognosis of 6 months or less if their terminal illness runs its normal course. These patients have elected to forgo curative care and wish to remain in their place of residence. A Medicare-certified hospice provides services in family homes, LTC facilities, and any other dwelling that individuals call “home.” Hospice care may also be provided while individuals are hospitalized. According to a March 2000 Office of the Assistant Secretary for Planning and Evaluation's (ASPE) study, entitled “Use of Medicare's Hospice Benefit by Nursing Facility Residents,” nursing facilities served approximately 35 percent of all hospice beneficiaries in some markets. The study concluded, “hospice in nursing homes is a very prevalent phenomenon,” but added that “Guidelines are * * * needed to clarify the need for nursing facilities to provide palliative care and the roles and responsibilities of hospices and nursing facilities when treating a hospice patient. Minimal contract provisions affecting the two types of providers when treating residents enrolled in hospice are needed as well.” ( http://aspe.hhs.gov/daltcp/reports/2000/samhbes.htm. )

Under current regulations, an LTC facility may choose to have a written agreement with one or more hospice providers to provide hospice care to a Medicare eligible resident who wishes to elect the hospice benefit. However, if the facility chooses not to contract with a Medicare-certified hospice to provide hospice services for the resident who wishes to elect the benefit, the LTC facility is responsible for assisting the resident in transferring to a facility that will arrange for the provision of such services, as requested by the resident. ( See 42 CFR 483.12(a)(2)(i), Transfer and discharge requirements.)

Hospice care for residents who choose to live in various types of facilities has come under scrutiny as a result of a variety of findings, including Operation Restore Trust (ORT) activities, Office of Inspector General (OIG) reports from 1997, (U.S. D.H.H.S. OIG, “Hospice and Nursing Home Contractual Relationships,” Nov. 1997, OEI-05-95-00251, http://oig.hhs.gov/oei/reports/oei-05-95-00251.pdf ) and 1998 (OIG Special Fraud Alert, “Fraud and Abuse, Nursing Home Arrangements with Hospices,” Mar. 1998 http://oig.hhs.gov/fraud/docs/alertsandbulletins/hospice.pdf ), and a 2000 report from the Department's Assistant Secretary for Planning and Evaluation (ASPE) Office of Disability, Aging and Long-Term Care Policy and the Urban Institute; “Synthesis and Analysis of Medicare Hospice Benefit Executive Summary and Recommendations.” (Harvell, J.; Jackson, B.; Gage, B.; Miller, S.; and Mor, V., Mar. 2000, http://aspe.hhs.gov/daltcp/reports/2000/samhbes.htm ). In addition, based on feedback to CMS from state surveyors, there is a lack of coordination between LTC facilities and Medicare-certified hospice providers.

We believe there is a lack of clear regulatory direction regarding the responsibilities of providers in caring for LTC facility residents who receive hospice care from a Medicare-certified hospice provider, which could result in duplicative or missing services. We believe this problem would be remedied by a regulatory requirement for a written agreement between the two types of entities when they are both involved in the care of a Medicare beneficiary. A written agreement would help ensure that required services are provided to beneficiaries and protect beneficiary health and safety, which could be endangered by a lack of coordination between hospice and LTC providers. Such an agreement ensures that care is coordinated by specifying what services each provider will provide. For instance, an LTC facility is considered a resident's home. An agreement between the providers would specify that the LTC facility must furnish room and board and meet personal care and nursing needs, while the hospice must provide services that are necessary for the care of the resident's terminal illness, such as counseling and palliation of pain.

Sections 1819(b)(4)(A)(i) and 1919(b)(4)(A)(i) of the Social Security Act (the Act) state that, to the extent needed to fulfill all plans of care described in sections 1819(b)(2) and 1919(b)(2) of the Act, a skilled nursing facility or nursing facility must provide (or arrange for the provision of) nursing and related services and specialized rehabilitative services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident. The Omnibus Budget Reconciliation Act (OBRA) of 1986 permitted States to add a hospice benefit to their State Medicaid plans. The original legislation (OBRA '86), adding the optional hospice benefit, specified, “hospice care may be provided to an individual while such individual is a resident of a skilled nursing facility or intermediate care facility” (Pub. L. 99-272, Sec. 9505(a)(2)).

This proposed rule would set forth requirements consistent with requirements in the June 5, 2008 final rule (73 FR 32088) entitled “Medicare and Medicaid Program: Hospice Conditions of Participation.” The hospice care final rule set forth new requirements that a Medicare-certified hospice provider must meet when it provides services, including the provision of hospice care to residents of an LTC facility who elect the hospice benefit. Section 418.112(e) specifies what must be included in a written agreement between a Medicare-certified hospice provider and an LTC facility. We propose making the requirements for LTC facilities consistent with the June 2008 final rule. To this end, the language in this proposed rule was crafted to mirror the hospice final rule as much as possible to ensure that both entities are held equally responsible for the written agreement.

This proposed rule would also support current LTC requirements that protect a resident's right to a dignified existence, self-determination, and communication with, and access to, persons and services inside and outside the facility.

A 2002 Secretary of the Department of Health and Human Services' (DHHS) Advisory Committee Report and a 2003 Hastings Center Report have identified a lack of coordination between LTC facilities and Medicare-certified hospice providers. In 2002, the Secretary of DHHS' Advisory Committee on Regulatory Reform developed recommendations to address key regulatory issues. One of the recommendations of the DHHS Secretary's Advisory Committee report was to clarify the relationship between nursing facilities and hospice providers. The DHHS Secretary's Advisory Committee report stated that there was a need to “reconcile conflicts in regulations and/or guidance that prevent clear delineation as to which entity (LTC facility or the hospice) is required to have the lead in providing required end-of-life care to SNF residents once they elect their hospice benefit.” The report recommended revising guidance and procedures to recognize hospice care in the context of the SNF survey protocol. The report further recommended that, if necessary, CMS revise the CoPs for Medicare-certified hospices, SNFs, and NFs to ensure beneficiaries' access to the full range of benefits to which they are statutorily entitled, and to ensure the appropriate entity is accountable for care that should be provided, which is based on a resident's unique needs ( http://regreform.hhs.gov/finalreport.htm ).

An article in the March/April 2003 Hastings Center Report, “Is discontinuity in palliative care a culpable act of omission?” stated, “Hospice patients sign up to obtain palliative care, regardless of the care setting in which they reside. Part of honoring this obligation requires a hospice to attend to the needs of continuity when the site of care does change.” The article further stated that, while most non-hospice healthcare providers do not follow their terminally ill patients to other care sites, hospice staff are required by the Medicare CoPs at § 418.56, as well as by industry and accreditation standards, to both provide and oversee palliative care as the patient moves across care sites with which the hospice has a contractual relationship. The article concludes that continuity of care is optimized by care management across care sites. (True Ryndes, Linda Emanuel, The Hastings Center Report, Hastings-on-Hudson: March/April 2003, page S45). ( http://findarticles.com/p/articles/mi_go2103/is_2_33/ai_n7517557/?tag=content;col1 )

This proposed rule, therefore, seeks to clarify the role of the LTC facility and the Medicare-certified hospice by requiring clear delineation of each provider's responsibility for maintaining continuity of care.

The problems LTC facilities and hospices have with the coordination of care, as identified in both the Hastings Center Report and the HHS Secretary's Advisory Committee report, is a direct result of the lack of Medicare requirements specifically related to the provision of contracted hospice care in the current regulatory requirements for LTC facilities. The overall intent of this proposed rule is to promote consistency and continuity of care by requiring that a written agreement between the LTC facility and the Medicare-certified hospice provider clearly identify the responsibilities of each entity when arranging for the provision of hospice services to an LTC resident who elects the hospice benefit. This agreement would be required even if the Medicare-certified hospice and the LTC facility were under common control and/or ownership.

Therefore, in light of the HHS Secretary's Advisory Committee report and Hastings Center Report, and to ensure quality hospice care is provided in a coordinated manner to LTC facility residents who have elected to receive hospice services, we are proposing a new standard at 42 CFR 483.75(r), entitled “Hospice services.” At § 483.75(r)(1), we propose that LTC facilities that choose to arrange for the provision of hospice services through an agreement with one or more Medicare-certified hospices, must have a signed agreement with the hospice before any hospice care is provided to any resident. In addition, for those LTC facilities that decline to arrange for the provision of hospice services through an agreement with a Medicare-certified hospice provider, we propose that facilities would be required to assist a resident in transferring to a facility that would arrange for the provision of these services when the resident requested such a transfer.

Requirements for discharge and transfer from LTC facilities are specified at § 483.12. The current regulations do not specifically address a resident's request for transfer. Thus, an LTC facility may accept a written or verbal request for transfer. We propose that all transfers would have to be documented in the resident's medical record.

Under this proposed rule, when hospice care is provided by a Medicare-certified hospice in an LTC facility through an agreement, the LTC facility would be required to meet additional requirements specific to written agreements between the two entities. The LTC facility would be required to ensure that the hospice services met professional standards and principles that apply to individuals providing services in the facility, and to ensure the timeliness of the services. The term, “timeliness of services” means that the LTC facility would be required to ensure that, from the time the resident elected the hospice benefit until the services were terminated, the Medicare-certified hospice would provide hospice services meeting the resident's needs in a timely manner, without any delay in the provision of services for the resident. We anticipate that LTC facilities would address timeliness of services in their agreements with hospices, based on resident needs.

We propose requiring the signatures of both an authorized representative of the hospice and an authorized representative of the LTC facility for such agreements. These provisions would have to be met before any hospice care was furnished to an LTC facility resident who elected the hospice benefit.

The purpose of the written agreement would be to ensure that the duties and responsibilities of the hospice and the LTC facility were clearly described. The signature requirement would prevent misunderstandings that could affect resident care because a responsible person representing each provider would be aware of the respective roles of each entity under the agreement. In addition, the written agreement would ensure that mechanisms were in place to ensure needs of the resident were identified and met, including the need for high quality hospice care.

Under the agreement between the LTC facility and the hospice, the hospice would be responsible for making decisions related to a resident's care for the palliation and management of the terminal illness and related conditions, because § 418.58 requires a hospice to establish and maintain a written plan of care for every individual admitted to its hospice program. The LTC facility would be responsible for making decisions that were not related to a resident's terminal illness, because § 483.20(k) requires a LTC facility to develop a comprehensive care plan for each resident that meets the resident's medical, nursing, mental, and psychosocial needs. Under this proposed rule, the LTC facility would also be responsible for ensuring the hospice provider was informed about changes made to the resident's care plan.

In general, a care plan is a document that provides a “road map” for everyone who is involved with a patient's care. The care planning process includes the interdisciplinary team that will be involved in the care of the patient. The ultimate purpose of a care plan is to guide all involved in the care of the patient in providing the appropriate treatment to ensure an optimal outcome for the patient. A healthcare worker should be able to find all the information needed to care for an individual in that person's care plan.

To encourage the completeness of patient information available to all staff responsible for the care of the patient, we are proposing to require that any written agreements would need to delineate: (1) Which services the Hospice would provide and which services the LTC facility would continue to provide, as delineated in the care plans; (2) how the LTC facility and hospice would communicate to ensure that needs of residents were being addressed and met; and (3) the conditions under which the LTC facility would need to contact the hospice immediately (specifically, this would include significant changes in the resident's physical, mental, social, or emotional status; clinical complications that suggested a need to alter the care plan; a need to transfer the resident from the LTC facility for any condition not related to the terminal condition; or resident death).

As stated above, we are also specifically proposing at § 483.75(r) (2)(ii)(D) that the written agreement identify a specific method of communication between the LTC facility staff and the hospice staff to ensure the effectiveness and timeliness of care. In an emergency, staff could communicate orally, but we would expect facilities to use best practices and document the communication so there could be appropriate follow-up. Best practices are similar to the term “professional standards of quality,” which is defined in current guidelines for surveyors in the State Operations Manual (SOM) ( http://www.cms.hhs.gov/manuals/Downloads/som107ap_pp_guidelines_ltcf.pdf ).

The term “best practices” means that services are provided according to recognized standards of clinical practice. Standards may apply to care provided by a particular clinical discipline or in a specific clinical situation or setting. Standards regarding quality care practices may be established by professional organizations, licensing boards, accreditation bodies, and/or regulatory agencies.

In addition to these requirements for the written agreement, we are proposing that the agreement include a provision stating that the hospice assumes responsibility for determining the appropriate course of hospice care, including changing the level of services provided, if necessary. Among the LTC facility's responsibilities under the written agreement, we are proposing that the agreement include a provision requiring the LTC facility to furnish 24-hour room and board care, meet the resident's personal care and nursing needs in coordination with the hospice representative, and ensure that the level of care provided is appropriate based on the individual resident's needs.

We are proposing that, under the written agreement, there also be a delineation of the hospice's responsibilities, which include, but are not limited to the following: Providing medical direction and management of the patient's hospice care; nursing; counseling (including spiritual, dietary and bereavement); social work; providing medical supplies, durable medical equipment and drugs necessary for the palliation of pain and symptoms associated with the terminal illness and related conditions; and all other hospice services that are necessary for the care of the resident's terminal illness and related conditions.

For example, the written agreement might state that the hospice would be responsible for determining the correct medication for the terminal condition, but the LTC facility staff would be responsible for the medication's administration, because the LTC facility provides 24-hour care for its residents. Delineating responsibility for these key services would ensure not only continuity of care, but would also guarantee appropriate care in a timely manner. For example, if a resident were in pain and needed medication, it would be vital to the care of the resident to have a clear delineation of each provider's specific responsibilities regarding pain control, including all steps from contacting the prescribing practitioner to obtaining medication, following the procedures set up by the hospice, administering the medication and monitoring its effectiveness.

We propose at § 483.75(r)(2)(ii)(I) that when the LTC facility personnel are responsible for the administration of prescribed therapies, including those therapies determined by the hospice and delineated in the hospice plan of care, the LTC facility personnel may be permitted to administer the therapies where permitted by State law and as specified by the LTC facility.

We propose at § 483.75(r)(2)(ii)(J) that the LTC facility report all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by hospice personnel, to the hospice administrator immediately when the LTC facility becomes aware of the alleged violation. This requirement would assure that the hospice is made aware of the alleged violation in a timely manner so that it can begin its own investigation and implement its own intervention(s). We note that under current regulations at § 483.13(c)(3), an LTC facility must immediately provide protection for the resident continuing throughout the investigation. The hospice final rule includes a similar provision at § 418.112(c)(8), which requires reporting of alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by LTC facility personnel to the facility administrator. Such provisions enhance LTC facility-hospice communication and cooperation.

We propose at § 483.75(r)(2)(ii)(K) that the agreement include a delineation of the responsibilities of the hospice to offer bereavement services to LTC facility staff. We propose at § 483.75(r)(3) that each LTC facility that arranges for the provision of hospice care through a written agreement designate a member of the facility's interdisciplinary team to be responsible for working with hospice representatives to coordinate care provided by the LTC facility staff and the hospice staff. In addition, the designated interdisciplinary team member would be responsible for: (1) Collaborating with hospice representatives and coordinating LTC facility staff participation in the hospice care planning process for those residents receiving these services; (2) communicating with hospice representatives and other healthcare providers participating in the provision of care for the terminal illness and related conditions, as well as other conditions, to ensure quality of care for the patient and family; (3) ensuring that the LTC facility communicates with the hospice medical director, the patient's attending physician, and other physicians participating in the provision of care as needed to coordinate the hospice care of the hospice patient with the medical care provided by other physicians; (4) obtaining information from the hospice, including the most recent hospice plan of care specific to each patient, the hospice election form, any advance directives specific to each patient, and physician certification and recertification of the terminal illness specific to each patient, as well as names and contact information for hospice personnel involved in hospice care of each patient; instructions on how to access the hospice's 24-hour on-call system; hospice medication information specific to each patient; and hospice physician and attending physician (if any) orders specific to each patient. In addition, we propose requiring that the LTC facility staff provide orientation to relevant hospice staff about the facility's policies and procedures, including patient rights, appropriate forms, and recordkeeping requirements.

These proposed requirements would apply regardless of the financial and/or ownership relationship between the LTC facility and the hospice.

Although we believe such orientation is critical for the protection of residents receiving hospice care, we understand that it may be difficult for an LTC facility to properly orient other hospice staff who, in unexpected circumstances, may occasionally provide coverage for a member of the identified hospice interdisciplinary group (IDG). Therefore, we welcome public comment on how LTC facilities can provide orientation for hospice staff that is quick and efficient but sufficient to protect residents who receive hospice care.

Our intention is to ensure continuity of care by involving designated representatives from both the LTC facility and the hospice in the hospice care planning and hospice care implementation processes, as well as in LTC facility processes. The LTC facility would have the flexibility to assign one employee from the facility's interdisciplinary team as a coordinator for all hospice residents, or assign a separate coordinator for each hospice resident. The designated coordinator would ensure that the hospice plan of care and the LTC facility plan of care were implemented and updated as appropriate. “Interdisciplinary team” refers to the professionals who work together to provide services to the resident, as defined at § 483.20(k)(2)(ii). Interdisciplinary team members may include physicians, nurses, therapists, social workers, dietitians, and other professionals, such as developmental disabilities specialists. Involvement of other disciplines is dependent upon resident needs.

We propose at § 483.75(r)(4) that each LTC facility that arranges for hospice care under a written agreement with a Medicare-certified hospice ensure that each resident's written plan of care includes both the hospice plan of care and a description of the services furnished by the LTC facility to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being, as required at § 483.20(k). We expect that the LTC facility's designated coordinator would work with hospice representatives to meet this requirement.

We believe that including the hospice plan of care (which addresses care for the terminal condition and related conditions) with the LTC facility care plan would improve care coordination and result in better implementation of the overall plan of care. We believe these proposed requirements would facilitate effective communication and coordination between the Medicare-certified hospice provider and the LTC facility, ensuring that quality care would be provided to residents receiving hospice services. We note that these proposed requirements would not limit the scope of the relationship between the Medicare-certified hospice and the facility. Each party could add provisions, subject to mutual agreement, as long as they met or exceeded the proposed requirements.

We anticipate that these proposed requirements, aimed at improving the coordination of care between LTC facilities and Medicare-certified hospice care providers, would lead to improved consistency and quality of care for LTC facility residents who elect to receive hospice services.

In addition, we are taking this opportunity to make a technical correction due to an incorrect citation at § 483.10(n). The language states, “An individual resident may self-administer drugs if the interdisciplinary team, as defined by § 483.20(d)(2)(ii), has determined that this practice is safe.” However, § 483.20(d)(2)(ii) does not exist. The correct citation is § 483.20(k)(2)(ii). In § 483.10(n), we are proposing that the reference “§ 483.20(d)(2)(ii)” be revised to read “§ 483.20(k)(2)(ii).”

Our intent in proposing these requirements for LTC facilities is to ensure they are in accord with our existing requirements at § 418.112 for hospices that provide services to residents of LTC facilities. Our proposed requirements for LTC facilities to have agreements with hospices and to collaborate and communicate with hospices to provide care for LTC facility residents largely parallels the language and intent of the hospice requirements. There are, however, instances where employing the same language would not reflect the distinct roles of each entity or where we believe it is important to provide clarity and detail without disturbing the substance or the proper interpretation of the requirements. In some instances, we are proposing different requirements because we believe they are in the best interests of the residents of LTC facilities. For instance, at proposed § 483.75 (r)(2)(ii)(J), the LTC facility would be required to report all alleged violations by hospice personnel to the hospice administrator immediately when the LTC facility becomes aware of the alleged violation. However, the hospice is required at § 418.112(c)(8) to report these same violations within 24 hours of the hospice becoming aware of the alleged violation.

The rationale for both these rules is to require a written agreement between the hospice and the LTC facility. (See § 418.112(c)(1) through (9) and proposed § 483.75(r)(2)(ii)(A) through (K).) While the rules have slight differences in language, substantively, the requirements are the same. We believe it is appropriate for the remainder of the rule, including the coordination of care requirements at proposed § 483.75(r)(3)(i)(v) and § 418.112(e), to reflect the difference in the roles between the LTC facility and the hospice in providing resident care. Therefore, we are proposing requirements for communication and collaboration specific to the LTC facility that do not mirror the language in the hospice requirements. Rather, the proposed rule for LTC facilities would complement the hospice requirements, and our objective is that, together, these rules will allow for better coordination of care and quality of care for LTC facility residents.

Notwithstanding our analysis that these rules are complimentary and substantively similar, and in view of the slight differences between these rules, we are requesting public comment on whether the differences found in the proposed rule would create a barrier to forming agreements between LTC facilities or interfere in coordination of residents' care between LTC facilities and hospices.

As stated above, we are proposing a new standard at 42 CFR 483.75(r), entitled “Hospice services.” At § 483.75(r)(1), we propose that LTC facilities may either arrange for the provision of hospice services through an agreement with one or more Medicare-certified hospice providers or not arrange for such services and assist a resident in transferring to a facility that will arrange for the provision of these services when the resident requests such a transfer.

At § 483.75(r)(2)(i) and (ii), we propose specific requirements for LTC facilities choosing to have hospice care provided by a Medicare-certified hospice in their facility. The LTC facility would be required to ensure that the hospice services met professional standards and principles that would apply to individuals providing services in the facility, and the timeliness of the services. We also propose requiring that, before any hospice care was provided to a facility resident, a written agreement would have to be signed by both an individual authorized by the hospice administration and an individual authorized by the LTC facility administration.

In addition, under this section, we are proposing that the written agreement would have to include, at the very least, the following provisions:

• Under § 483.75(r)(2)(ii)(A), the services the hospice will provide;

• Under § 483.75(r)(2)(ii)(B), the hospice's responsibilities for determining the appropriate hospice plan of care as specified in § 418.112(d) of this chapter;

• Under § 483.75(r)(2)(ii)(C), the services the LTC facility will continue to provide, based on each resident's care plan; and

• Under § 483.75(r)(2)(ii)(D), a communication process, including how the communication will be documented between the LTC facility and the hospice provider, to ensure that the needs of the resident are addressed and met 24 hours per day.

Additionally, under § 483.75(r)(2)(ii), we are proposing the inclusion of other duties and responsibilities that must be delineated by the LTC facility and the hospice in their written agreement. Under § 483.75(r)(2)(ii)(E), we are proposing that the agreement contain a provision that the LTC facility must notify the hospice provider immediately regarding—

• A significant change in the resident's physical, mental, social, or emotional status;

• Any clinical complication(s) that would suggest a need to alter the plan of care;

• A condition unrelated to the terminal condition that might require transfer of the resident from the facility; or

• The resident's death.

We propose at § 483.75(r)(2)(ii)(F) that the hospice must assume responsibility for determining the appropriate course of hospice care, including the determination to change the level of services provided.

We propose at § 483.75(r)(2)(ii)(G) that the LTC facility must continue to provide 24-hour room and board care, meet the resident's personal care and nursing needs in coordination with the hospice representative, and ensure that the level of care provided is appropriate based on the individual resident's needs.

At § 483.75(r)(2)(ii)(H), we are proposing that the written agreement include a delineation of additional hospice responsibilities, which include, but are not limited to:

• Providing medical direction and management of the patient.

• Nursing.

• Counseling (including spiritual, dietary, and bereavement).

• Social work; providing medical supplies, durable medical equipment, and drugs necessary for the palliation of pain and symptoms associated with the terminal illness and related conditions.

• All other hospice services that are necessary for the care of the resident's terminal illness and related conditions.

We propose at § 483.75(r)(2)(ii)(I) that the agreement include a provision that the hospice may use LTC facility personnel, where permitted by State law and as specified by the LTC facility, to assist in the administration of prescribed therapies included in the hospice plan of care.

We are also specifically proposing, at § 483.75(r)(2)(ii)(J), that the written agreement contain a provision that the LTC facility must report all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by hospice personnel, to the hospice administrator immediately when the LTC facility becomes aware of the alleged violation. We propose at § 483.75(r)(2)(ii)(K) that the agreement must also include a delineation of the responsibilities of the hospice to offer bereavement services to LTC facility staff.

At § 483.75(r)(3)(i) through (v), we are proposing that the LTC facility that arranges for the provision of hospice care under a written agreement must designate a member of the facility's interdisciplinary team to be responsible for working with hospice representatives to coordinate care provided by the LTC facility and hospice staff to the resident. This individual must be responsible for:

(1) Collaborating with hospice representatives and coordinating LTC facility staff participation in the hospice care planning process for those residents receiving these services;

(2) Communicating with hospice representatives and other healthcare providers participating in the provision of care for the terminal illness, related conditions, and other conditions to ensure quality of care for the patient and family;

(3) Ensuring that the LTC facility communicates with the hospice medical director, the patient's attending physician, and other physicians participating in the provision of care to the patient as needed to coordinate the hospice care of the hospice patient with the medical care provided by other physicians;

(4) Obtaining pertinent information from the hospice (that is, the most recent hospice plan of care specific to each patient; hospice election form and any advance directives specific to each patient; physician certification and recertification of the terminal illness specific to each patient; names and contact information for hospice personnel involved in hospice care of each patient; instructions on how to access the hospice's 24-hour on-call system; hospice medication information specific to each patient; and hospice physician and attending physician (if any) orders specific to each patient); and

(5) Ensuring that the LTC facility staff provide orientation in the policies and procedures of the facility, including patient rights, appropriate forms, and record keeping requirements, to hospice staff furnishing care to LTC residents.

At § 483.75(r)(4), we are proposing that each LTC facility providing hospice care under a written agreement must ensure that each resident's written plan of care includes both the hospice plan of care and a description of the services furnished by the LTC facility to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being, as required at § 483.20(k).

As stated in the previous section above, we are also taking this opportunity to make a technical correction due to an incorrect citation at § 483.10(n). In § 483.10(n), we are proposing that the reference “§ 483.20(d)(2)(ii)” be revised to read “§ 483.20(k)(2)(ii).”

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):

Proposed § 483.75(r)(2)(ii) states that if hospice care is provided in an LTC facility through an agreement with a Medicare-certified hospice, the LTC facility must have a written agreement with the Medicare-certified hospice before care is furnished to any resident.

An LTC facility would be required to have only one written agreement with each hospice that provides services in the facility. This proposed rule would not require an LTC facility to have an individual agreement with a hospice for each resident receiving hospice services. Therefore, the burden associated with this requirement is the time and effort necessary for an LTC facility to develop and finalize one written agreement. Initially, the development of an agreement would require staff time; however, it would also require additional staff time to coordinate the care between the hospice and the LTC facility.

We estimate the number of hours to develop and finalize a written agreement to be approximately 5 hours the first year. The estimated burden associated with the first year is 80,695 hours or $5,512,275. The current requirements at § 483.75(h) “Use of Outside Resources,” requires a written agreement when contracting for outside services. Therefore, we would expect that a facility would modify an existing agreement to make it specific to hospice services. Review and revision of an already existing agreement would be expected to take less time thereafter. We estimate that it would take 2 hours to review and revise the agreement annually. The estimated annual burden associated with each successive year after the first is 32,278 hours or $2,204,910. We have based our projections of the hourly cost on the rate for a staff lawyer at $68.31 an hour, which includes fringe benefits (estimated to be 25 percent of the salary). (Source: Bureau of Labor Statistics, Occupational Employment Statistics Survey. )

Proposed sections 483.75(r)(2)(ii)(E)(1) through (4) state that the LTC must notify the hospice immediately about—

• A significant change in the resident's physical, mental, social, or emotional status;

• Clinical complications that suggest a need to alter the plan of care;

• A need to transfer the resident from the facility for any condition that is not related to the terminal condition; or

• The resident's death.

The burden associated with these requirements is the time and effort it would take the LTC facility to provide notification to the hospice. We estimate it would take approximately 5 minutes per notification. We anticipate that this would affect 16,139 LTC facilities. If each LTC facility makes 1 notification each month, the burden associated with this requirement is 16,139 annual burden hours and the cost would be $504,344 annually, based on an hourly rate of $31.25 for a blended salary of a registered nurse and licensed practical nurse that includes fringe benefits, since either practitioner could notify the hospice of stated changes. (Source: Bureau of Labor Statistics, Occupational Employment Statistics Survey).

Proposed § 483.75(r)(2)(ii)(J) states that under the agreement, the LTC facility must report all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by hospice personnel to the hospice administrator immediately when the LTC facility becomes aware of the alleged violation. The burden associated with this requirement is the time and effort it would take the LTC facility to report this information to the hospice administrator. We estimate it would take approximately 10 minutes per incident. We anticipate that this would affect 16,139 LTC facilities. If each LTC facility made one report per month, the burden associated with this requirement would be 32,278 annual burden hours and the cost would be $1,032,895 annually based on an hourly rate of $32 for a registered nurse that includes fringe benefits. (Source: Bureau of Labor Statistics, Occupational Employment Statistics Survey)

If you comment on these information collection and recordkeeping requirements, please do either of the following:

1. Submit your comments electronically as specified in the ADDRESSES section of this proposed rule; or

2. Mail copies to the address specified in the ADDRESSES section of this proposed rule and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, CMS-3140-P.

Fax: (202) 395-6974; or

E-mail: OIRA_submission@omb.eop.govIV.

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.

We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Order 12866 directs 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 regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not qualify as a major rule, as the estimated economic impact is $7,049,515 the first year and $3,742,150 thereafter.

The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small government jurisdictions. The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the SBA definition of a small business (having revenues of less than $7.0 million to $34.5 million in any 1 year). For purposes of the RFA, the majority of hospitals, LTC facilities and hospices are considered to be small entities. Individuals and States are not included in the definition of a small entity. A rule has a significant economic impact on the small entities it affects, if it significantly affects their total costs or revenues. Under statute, we are required to assess the compliance burden the regulation will impose on small entities. Generally, we analyze the burden in terms of the impact it will have on entities' costs if these are identifiable or revenues. As a matter of sound analytic methodology, to the extent that data are available, we attempt to stratify entities by major operating characteristics such as size and geographic location. If the average annual impact on small entities is 3 to 5 percent or more, it is to be considered significant. We estimate that these requirements would cost $437 ($7,049,515/16,139 facilities) per facility initially and $232 ($3,742,150/16,139 facilities) thereafter. This clearly is much below 1 percent; therefore, we do not anticipate it to have a significant impact. We do not have any data related to the number of LTC facilities contracting hospice care through an outside hospice provider; however, we are aware through annual surveys that not all LTC facilities arrange for the provision of hospice care.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis 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 the 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 and has fewer than 100 beds. This rule would impact only long-term care facilities. Therefore, the Secretary has determined that this proposed rule would not have any impact on the operations of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 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 2010, that threshold is approximately $135 million. This rule would not have a significant impact on the governments mentioned or on private sector costs. The estimated economic effect of this rule is $7,049,515 the first year and $3,742,150 thereafter. These estimates are derived from our analysis of burden associated with these requirements in section III, “Collection of Information Requirements.”

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. This rule will not have any effect on State or local governments.

The purpose of this rule is to ensure the coordination of care for LTC facility residents who elect hospice services. The coordination of care is anticipated to result in better outcomes related to quality of care and quality of life for residents. With appropriate coordination of care as proposed in this rule, we anticipate improved outcomes through more efficient coordination of care between the LTC facility staff and hospice staff, a decrease in duplication of services provided, and improved resident care.

We expect improved consistency in the provision of services to residents receiving hospice care in an LTC facility. We anticipate that primarily only LTC facilities and Medicare-certified hospice providers would be affected, as this proposed rule would be expected to improve coordination of care between LTC facilities and Medicare-certified hospice providers. In instances where a patient is transferred to the hospital for care unrelated to their terminal illness, the hospital should be notified that the patient has elected hospice care.

An Office of the Inspector General (OIG) report released in 1997 found that “contractual arrangements between hospice providers and nursing homes present vulnerabilities for inappropriate use of excessive Medicare and Medicaid payments being made to hospice providers or to nursing homes” (U.S. HHS OIG, Hospice and Nursing Home Contractual Relationships, 1997 Nov., OEI-05-95-00251). We anticipate that the proposed rule would decrease these vulnerabilities, as the services provided by both the LTC facility and the Medicare-certified hospice would be clearly defined.

We considered the effects of not addressing specific requirements for the provision of hospice care in LTC facilities. However, we believe that to improve quality and ensure consistency in the provision of hospice services in LTC facilities, it is important to delineate clear responsibilities for Medicare-certified hospice providers and LTC facilities. We expect that these requirements would result in improvement in the quality of care provided to LTC residents receiving hospice services.

This proposed rule for a written agreement when arranging for the provision of hospice services in LTC facilities is intended to improve the continuity and quality of care provided to terminally ill LTC facility residents. It is consistent with the Administration's efforts toward broad- based improvements in the quality of health care furnished by Medicare and Medicaid providers.

This proposed rule identifies an LTC facility's choices if a resident elects to receive hospice care. This proposed rule also clarifies the responsibility of the facility that chooses not to arrange for the provision of hospice services at the facility through an agreement with a Medicare-certified hospice. These facilities must assist the resident in transferring to a facility that will arrange for the provision of hospice services when a resident requests a transfer.

This proposed rule would ensure that the duties and responsibilities of a hospice are clearly articulated if the hospice provides care in an LTC facility. Therefore, in order to ensure that quality hospice care is provided to LTC residents we believe it is essential to add these proposed requirements to the LTC regulations.

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

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR Chapter IV as set forth below: