Background

USDA published a proposed rule in the Federal Register on June 25, 2012 (77 FR 37823), which would have added reporting for pork (fresh, chilled, or frozen muscle cuts/whether or not boxed) and DDG to the ESR. Under that proposed rule, all exporters of U.S. pork and DDG would have been required to report on a weekly basis, information on the export sales of pork and DDG to FAS. The 60-day public comment period ended on August 24, 2012.

A total of eight comments were received during the comment period. Adding pork to the ESR was supported by five comments and opposed by none. USDA is amending the regulation to add pork to the ESR, as is statutorily required.

Five comments mentioned DDG, of which three were favorable and two were unfavorable. One trade association stated: “We believe [adding DDG] would facilitate market transparency and allow our industry and our corn marketing partners with the ability to conduct accurate and timely analysis of U.S. market conditions.” Another commenter stated: “[Adding DDG] would help avoid future price inflation such as we had in 1973/74 when the `Great Russian Grain Robbery' occurred.” Another commenter stated “Having these [DDG] sales brings market transparency which will allow all market participants to digest the data.”

Another trade association expressed concerns about the impacts of adding DDG, stating: “DDGs are traded with highly variable and specific quality terms that differ greatly based on end use. For example, exported DDGs often require a specific color or nutritional profile that's not necessarily the same as the product that's traded domestically. Providing export sales reporting may skew the markets viewpoint on domestic sales.” Another commenter stated, “I would question why DDGs are listed to be reported, and other corn milling co-products like Corn Gluten Feed, etc., are not. I would also like to know the compelling reason for the need to have DDGs reported at all?”

In response to the comments on DDG, USDA has determined that adding the reporting requirement for export sales of DDG requires further review and will be publishing a proposed rule, with extension of comment period, on the proposed reporting requirement for this commodity.

The Administrative Procedure Act (5 U.S.C. 553) provides generally that before rules are issued by Government agencies, the rule must be published in the Federal Register , and the required publication of a substantive rule is to be not less than 30 days before its effective date. One of the exceptions is when the agency finds good cause for not delaying the effective date. USDA finds that there is good cause for making this rule effective less than 30 days after publication in the Federal Register because the Mandatory Price Reporting Act of 2010 (Pub. L. 111-239) mandates that pork be added to the ESR, and the comments with respect to pork favored adding pork to the ESR. Therefore, USDA has determined that it is in the public interest to amend the regulation to include pork as soon as possible and is immediately amending the regulation to add pork to the ESR.

The rule has been determined to be not-significant under Executive Order 12866.

The Regulatory Flexibility Act ensures that regulatory and information requirements are tailored to the size and nature of small businesses, small organizations, and small governmental jurisdictions. This rule will not have a significant economic impact on small businesses.

Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with state and local officials. The objectives of the Executive Order are to foster an intergovernmental partnership and a strengthened federalism, by relying on state and local processes for state and local government coordination and review of proposed federal financial assistance and direct federal development. This rule neither provides federal financial assistance nor direct federal development; it does not provide either grants or cooperative agreements. Therefore this program is not subject to Executive Order 12372.

This rule has been reviewed under Executive Order 12988. The provisions of this rule would not have a preemptive effect with respect to any state or local laws, regulations, or policies which conflict with such provision or which otherwise impede their full implementation. The rule would not have a retroactive effect. Before any judicial action may be brought forward regarding this rule, all administrative remedies must be exhausted.

The policies contained in this rule would not have any substantial direct effect on states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Nor would this rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with the states is not required.

This rule has been reviewed for compliance with Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” This Executive Order imposes requirements on the development of regulatory policies that have Tribal implications or preempt tribal laws. The policies contained in this rule do not preempt Tribal law.

The Administrator has determined that this action will not have a significant effect on the quality of the human environment. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is necessary for this rule.

Pub. L. 104-4 requires consultation with state and local officials and Indian tribal governments. This rule does not impose an unfunded mandate or any other requirement on state, local, or tribal governments. Accordingly, these requirements are not subject to the provisions of the Unfunded Mandates Reform Act.

This Order requires careful evaluation of governmental actions that interfere with constitutionally protected property rights. This rule would not interfere with any property rights and, therefore, does not need to be evaluated on the basis of the criteria outlined in Executive Order 12630.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Secretary of Agriculture is requesting comments from all interested individuals and organizations on a proposed revision to the currently approved information collection for this program. This revision includes the proposed change in information collection activities related to the regulatory changes in this rule.

Accordingly, 7 CFR part 20 is amended as follows:

On June 7, 2000, the FAA published a final rule entitled, “Type Certification Procedures for Changed Products” (65 FR 36244). In that final rule, the FAA revised the procedural requirements for the certification of changes to type-certificated products. The revision required the applicant to apply the latest airworthiness standards in effect, to the extent practical, for the certification of significant design changes of aircraft, aircraft engines, and propellers. Before this final rule, many changes to aeronautical products were not required to show compliance with the latest airworthiness standards. This final rule was needed because incremental design approval changes accumulated into significant differences from the original product. Also, the final rule was intended to expand under what conditions the latest airworthiness amendments needed to be applied to changes to aeronautical products.

To clarify what the 2000 final rule intended, the FAA published a final rule; request for comments also entitled, “Type Certification Procedures for Changed Products” (December 4, 2012, 77 FR 71691). The 2000 final rule requires an applicant to show that the “changed product” complies with applicable standards. The purpose of § 21.101 is to require an applicant to evaluate the proposed design change and its effect on the product rather than the re-evaluation (certification) of the entire changed product. Therefore, § 21.101 was amended in the 2012 final rule to replace “changed product” with “change and areas affected by the change” to accurately limit the scope of compliance responsibility for the applicant. That change was also made in § 21.97 for the same reason. The intended effect of the 2012 final rule is to make the applicable requirements consistent with the FAA's intent and with the certification practice both before and after the adoption of the 2000 final rule.

Two comments were received in the docket during the comment period for this final rule. The Boeing Company expressed concern with a possible increase in administrative burden of establishing the certification basis for changes it believes are significant at the product level. Transport Canada (TCCA) commented that it believes the final rule changes the significance of the assessment of the design change level relative to the entire product.

Boeing provided recommendations for changes to the preamble to the final rule regarding § 21.101 and to the final rule in general that it believes will reestablish and clarify the original intent of the regulation and concerns regarding the associated administrative burden to applicants. The FAA has considered Boeing's concerns and has determined that Boeing's recommendations need to be further evaluated before adoption. The FAA believes the original intent of the 2012 final rule as published is acceptable for clarifying an applicant's responsibility for showing compliance for the change and the areas affected by the change.

TCCA suggested that the final rule now has the unintended consequence of allowing a design change to be evaluated at an area, system, component, equipment, or appliance level only, rather than at the product level. TCCA further suggested that the final rule may lead to an interpretation that multiple design changes could now be evaluated individually for their significance, instead of their total effect on the product. TCCA believes the final rule will put into question the interpretation of what a significant change is and recommends that the FAA reconsider the rendering of the final rule. TCCA noted that implementation of the final rule may disrupt the harmonized implementation of pertinent regulations and guidance material.

The FAA agrees that the evaluation of a proposed design change needs to be at the product level and considered the effect of the final rule as it applied to product level and the evaluation of changes. However, it appears TCCA may have misunderstood the purpose and effect of the amendment and, as a result, conflated two separate issues. The first issue is the scope of the requirement of § 21.101 to show compliance. Prior to the amendment, § 21.101(a) required that the “changed product” must be shown to meet applicable requirements in effect on the date of application. “Product” is defined in § 21.1 to mean “aircraft, aircraft engine, or propeller.” Taken literally, the scope of the requirement to show compliance was the entire product, including the applicant's proposed change. In practice, applicants do not show that the entire product complies with applicable requirements; their compliance showings, and the FAA's findings, relate only to the proposed change and the areas affected by the change. The purpose of this amendment is simply to conform the wording of the rule to this long-standing practice.

The second issue is what requirements are applicable. Prior to this amendment, § 21.101(b) and (c) allowed the compliance showing to be made to earlier versions of the latest requirements if certain conditions are met. However, taken literally, these exceptions still required that the applicant show that the entire product complies at least with earlier versions of those requirements. Limiting the scope of this requirement eliminates the literal requirement to show compliance for areas not affected by the change. 1

However, nothing in this amendment changes the exceptions in § 21.101(b) and (c) or the policies that have been developed for applying them. For example, the harmonized policy for determining whether a change is “significant” is that this evaluation is done at the “product level.” Under this amendment, this policy is unchanged. Similarly, precisely identifying the scope of an applicant's obligation to show compliance does not affect the existing requirement of § 21.101(b)(1) that significance be evaluated in context with all previous relevant design changes. We continue to agree with TCCA's view that “the contribution to safety and practicality principles of 14 CFR 21.101 are intended to target a measurable benefit at a product level.”

The FAA finds that the original intent of the existing changed product final rule to apply to the evaluation of the change's particular effect on the total product level is maintained with this final rule. This rule is consistent with the preamble's goals and published guidance and is implemented as published on December 4, 2012.

After analyzing the comments submitted in response to this final rule, the FAA has determined that further revisions to it are unnecessary at this time. This determination is based on our finding that this final rule is necessary because it addresses the concern that the wording of the requirement in the 2000 rule for a compliance showing was too broad for an applicant for a major design change. Again, this rulemaking only clarifies the original intent of the 2000 final rule and makes the applicable requirements reflect the reality of existing practice. This rulemaking is not a departure from or addition to what is already being done by an applicant for a compliance showing to the FAA in this regard.

The Coast Guard published a notice of proposed rulemaking (NPRM) on February 4, 2013, in the Federal Register (78 FR 7663). The Coast Guard received no public comments in the docket and no requests for public meetings.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . The Coast Guard did not receive information from the event sponsor early enough to both publish a NPRM and allow 30 days after publication before making this rule effective. The Coast Guard chose to notify the public and seek comment on this rule by publishing a NPRM. This final rule is necessary to protect the public and race participants during the regatta, and therefore, must be effective by the start of the event on March 22, 2013.

The legal basis for the rule is the Coast Guard's authority to establish special local regulations under 33 U.S.C. 1233. The purpose of the rule is to ensure safety of life on navigable waters of the United States during the 2013 International Rolex Regatta.

The Coast Guard received no comments in the docket for this rulemaking. We made no changes to the regulation as originally proposed.

On March 22, 2013, through March 24, 2013, the St. Thomas Yacht Club is sponsoring the 2013 Rolex Regatta, a series of sail boat races. The races will be held on the waters of St. Thomas Harbor, St. Thomas, U. S. Virgin Islands. Approximately 65 sail boats will be participating in the races. It is anticipated that approximately 20 spectator vessels will be present during the races.

These special local regulations encompass certain waters surrounding on St. Thomas Harbor, St. Thomas, U. S. Virgin Islands. The special local regulations will be enforced from 11 a.m. until 2 p.m. every day from March 22, 2013 through March 24, 2013. The special local regulations consist of a race area. Within this area, all persons and vessels, except those persons and vessels participating in the sail boat races, are prohibited from entering, transiting through, anchoring in, or remaining within unless authorized by the Captain of the Port San Juan or a designated representative.

Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the race area by contacting the Captain of the Port San Juan by telephone at (787) 289-2041, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the race area is granted by the Captain of the Port San Juan or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port San Juan or a designated representative.

The Coast Guard will provide notice of the special local regulations by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The economic impact of this rule is not significant for the following reasons: (1) The special local regulation will be enforced for only three hours a day for three days, for a total of nine hours; (2) although persons and vessels will not be able to enter, transit through, anchor in, or remain within the race area without authorization from the Captain of the Port San Juan or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the race area during the enforcement period if authorized by the Captain of the Port San Juan or a designated representative; and (4) the Coast Guard will provide advance notification of the special local regulations to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

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

This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of St. Thomas Harbor encompassed within the special local regulations from 11:00 a.m. until 2:00 p.m. on March 22, 2013, through March 24, 2013. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

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

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

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves special local regulations issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

This action corrects an inadvertent omission in EPA's September 28, 2012, final action approving Georgia's RACT submittals. On October 21, 2009, Georgia submitted a SIP revision containing, among other things, the Atlanta Area RACT SIP. In this RACT submittal Georgia lists CTG source categories for which Georgia has rules or has made negative declarations. 1 On July 31, 2012 (77 FR 45307), EPA proposed approval of Georgia's October 21, 2009, SIP revision, including the negative declarations included therein. In EPA's September 28, 2012, final action (77 FR 59554), EPA approved Georgia's October 21, 2009, submission, including the list of Georgia rules and negative declarations. Towards the end of the September 28, 2012, final action, EPA inadvertently omitted the list of negative declarations in the CFR non-regulatory language. Today's correcting amendment will correct the CFR non-regulatory language to include the following information. Georgia made negative declarations in its October 21, 2009, SIP submittal related to the following CTG source categories:

1. Control of Volatile Organic Compound (VOC) Emissions from Reactor Processes and Distillation Operations in Synthetic Organic Chemical Manufacturing Industry (SOCMI) EPA-450/4-91-031, August 1993.

2. Control of VOC Emissions from Equipment Leaks from Natural Gas/Gasoline Processing Plants EPA-450/3-83-007, December 1983.

3. Control of VOC Leaks from Synthetic Organic Chemical Polymer and Resin Manufacturing Equipment EPA-450/3-83-006, March 1984.

4. Control of VOC Emissions from Air Oxidation Processes in SOCMI, EPA-450/3-84-015, December 1984.

EPA has determined that today's correcting action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation where public notice and comment procedures are impracticable, unnecessary, or contrary to the public interest. Public notice and comment for this action is unnecessary because today's action simply makes a correction to a previous inadvertent omission in the non-regulatory text of the CFR. EPA previously provided for public notice and comment on the substantive SIP revision approval. In addition, EPA does not believe the public would be interested in commenting on the correction prior to this action being finalized, since this correction action does not change the conclusion of EPA's analysis or action addressing approval of the Georgia RACT rules.

EPA also finds that there is good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action. Section 553(d)(3) of the APA allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in APA section 553(d)(3) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's action simply corrects an inadvertent omission in the CFR of a small portion of a SIP revision that EPA previously substantively approved. For these reasons, EPA finds good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely explicitly lists the CTG source categories for which Georgia made a negative declaration, is consistent with the substantive revisions to the Georgia SIP described in the final approval of the Georgia RACT SIP revisions and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule merely corrects an inadvertent omission for the non-regulatory text of EPA's September 28, 2012, final rule addressing the approval of the Georgia's RACT SIP, and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal Government and Indian tribes, or on the distribution of power and responsibilities between the federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This rule also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This rule merely corrects an inadvertent omission for the non-regulatory text of EPA's September 28, 2012, final rule addressing the approval of the Georgia RACT SIP, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In addition, this rule does not involve technical standards, thus the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule also does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This SUPPLEMENTARY INFORMATION section is arranged as follows:

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

On July 13, 2013, the Director of the Idaho Department of Environmental Quality submitted revisions to the Idaho SIP that relate to Idaho's open burning and crop residue disposal requirements and establish a streamlined permitting process for spot burns, baled agricultural residue burns, and propane flaming. The submitted revisions also make minor changes to the existing crop residue disposal rules to update cross references and clarify certain administrative information. In a proposed rule published on January 11, 2013, EPA proposed to approve these revisions to the Idaho SIP. 78 FR 2359. An explanation of the Clean Air Act requirements and implementing regulations that are met by this SIP, a detailed explanation of the revision, and EPA's reasons for approving it were provided in the notice of proposed rulemaking on January 11, 2013, and will not be restated here. The public comment period for this proposed rule ended on February 11, 2013. EPA did not receive any comments on the proposal.

EPA is approving the July 13, 2011, SIP submittal from the State of Idaho as meeting the requirements of the Clean Air Act.

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 20, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

40 CFR part 52 is amended as follows:

Throughout this document, wherever “we”, “us” or “our” are used, we mean EPA.

EPA sets the National Ambient Air Quality Standards (NAAQS) for certain ambient air pollutants at levels required to protect public health and welfare. Particulate matter with an aerodynamic diameter less than or equal to a nominal ten micrometers, or PM 10 , is one of these ambient air pollutants for which EPA has established health-based standards.

EPA revised the NAAQS for particulate matter on July 1, 1987 (52 FR 24633), replacing standards for total suspended particulates (TSP less than 30 microns in diameter) that were set in 1971 with new standards applying only to particulate matter up to 10 microns in diameter (PM 10 ). Simultaneously, EPA published revised requirements for state implementation plans (SIPs) to attain and maintain the standards (52 FR 24672, July 1, 1987). To focus Federal and State resources on implementing the PM 10 NAAQS first in those areas of the country believed to be violating the standards, EPA classified all areas of the Nation into one of three groups. Group I areas were those having a very high probability of violating the PM 10 standards based on ambient air quality data available for 1984 through 1987 for PM 10 and TSP. Group II areas had a moderate probability of violating the standards, and Group III areas were those believed to be currently attaining the standards.

A list of Group I and II areas in each State was published on August 7, 1987 (52 FR 29383). Within Imperial County, 1 EPA listed two areas, “Imperial Valley planning area” and “Yuma planning area,”  2 among the Group I areas. The remaining portions of any State not listed as Group I or II were classified in Group III.

On October 31, 1990 (55 FR 45799), EPA clarified the descriptions of several Group I and II areas of concern. In so doing, EPA did not clarify the description of the “Imperial Valley planning area” but did eliminate “Yuma planning area” as a Group I or II area of concern within Imperial County, California.

Under section 107(d)(4)(B) of the Clean Air Act (CAA or “Act”), as amended in 1990, certain areas were designated as nonattainment for PM 10 by operation of law upon enactment of the 1990 Amendments (i.e., November 15, 1990). These areas included all areas included in Group I in EPA's 1987 list (unless changed by EPA prior to the 1990 Amended Act) as well as certain Group II and III areas. The Imperial Valley planning area, as a former “Group I” area, was one of the areas designated as a PM 10 nonattainment area by operation of law effective November 15, 1990.

On March 15, 1991 (56 FR 11101), EPA announced all of those areas that were designated nonattainment for PM 10 by operation of law and announced that all of the nonattainment areas were classified as “moderate,” also effective November 15, 1990. The “Imperial Valley planning area” was one of the areas listed by EPA in March 1991 as an “initial” PM 10 nonattainment area. On November 6, 1991 (56 FR 56694), EPA codified the PM 10 nonattainment area designations, including the nonattainment area designation for “Imperial Valley planning area,” in 40 CFR part 81. 3

States with “moderate” PM 10 nonattainment areas were required under the CAA as amended in 1990 to revise their SIPs to provide for attainment of the PM 10 NAAQS no later than December 31, 1994. “Moderate” areas that failed to attain the PM 10 NAAQS by December 31, 1994 were subject to reclassification to “serious.” Such reclassification would extend the applicable attainment date to December 31, 2001 but would require the SIP for the area to be further revised to meet more stringent requirements than had applied to “moderate” areas. On August 11, 2004 (69 FR 48792), EPA determined that the Imperial Valley planning area failed to attain the PM 10 NAAQS by December 31, 1994 and reclassified the area to “serious.”

The listing of the “Imperial Valley planning area” in the PM 10 area designations table in 40 CFR 81.305 without further description has led to some confusion as to the precise boundaries of the designated nonattainment area, and the purpose of today's direct final rule is to clarify the description of the “Imperial Valley planning area” to eliminate such confusion. Specifically, we are clarifying in this action that the “Imperial Valley planning area” PM 10 nonattainment area is that portion of Imperial County that is defined as follows: Commencing at the southwest corner of Imperial County and extending north along the Imperial-San Diego County line to the northwest corner of Imperial County; then east along the Imperial-Riverside County line to the point of intersection of the eastern boundary line of Hydrologic Unit #18100200;  4 then southeasterly along the eastern boundary line of Hydrologic Unit #18100200 to the Imperial County-Mexico Border; then west along the Imperial County-Mexico Border to the point of the beginning.

For the purposes of this action, EPA reviewed the Federal Register documents listed above as well as EPA memoranda and State planning documents. Based on that review, EPA confirmed the accuracy of the above description. Specifically, EPA found that:

• EPA's 1987 listing of two Group I areas within Imperial County, i.e., the “Imperial Valley planning area” and the “Yuma planning area,” establishes that “Imperial Valley planning area” is a partial county area;

• The long-standing use of Hydrologic Units to describe other PM 10 area designations in desert areas of California ( see, e.g., the PM 10 area designations in 40 CFR 81.305 for Coso Junction planning area, Owens Valley planning area, Trona planning area, and Indian Wells planning area) establishes precedent for the use of such units to describe the PM 10 area designation for “Imperial Valley planning area,” which is also a California desert area;

• EPA staff memorandum dated July 17, 1991 describes the “Imperial Valley Study Area” boundary in terms of latitude and longitude that approximate the hydrologic unit boundary;

• EPA staff map, undated but believed to have been prepared in the early 1990s, illustrates the Imperial Valley planning area in terms of the northeastern boundary line for Hydrologic Unit #18100200;

• EPA map (dated May 1992) of PM 10 area designations within Region IX shows the Imperial Valley nonattainment area as covering that portion of the county east of a line that appears to approximate the northeastern boundary line for Hydrologic Unit #18100200; and

• A SIP submittal dated January 11, 1994 for the Imperial Valley planning area from the California Air Resources Board (CARB) to EPA includes a PM 10 plan that describes the nonattainment area as containing “most of Imperial County (approximately 80%) except for the portion east of the Chocolate Mountain Range” and includes a figure that illustrates the nonattainment area showing a northeastern boundary line that approximates the boundary for Hydrologic Unit #18100200. 5

Through today's action, EPA is not changing the boundaries of the Imperial Valley planning area PM 10 nonattainment area, but is simply clarifying the boundaries of the existing PM 10 nonattainment area by providing a more detailed description herein and in 40 CFR 81.305. EPA is also not changing the status or classification of the Imperial Valley planning area PM 10 nonattainment area. As such, the area remains designated as “nonattainment” for PM 10 and classified as “serious.”

EPA is clarifying that the Imperial Valley planning area PM 10 nonattainment area is that portion of Imperial County that is defined as follows: Commencing at the southwest corner of Imperial County and extending north along the Imperial-San Diego County line to the northwest corner of Imperial County; then east along the Imperial-Riverside County line to the point of intersection of the eastern boundary line of Hydrologic Unit #18100200; then southeasterly along the eastern boundary line of Hydrologic Unit #18100200 to the Imperial County-Mexico Border; then west along the Imperial County-Mexico Border to the point of the beginning. EPA is not changing the boundaries of the PM 10 area or the status of the area as a “serious” PM 10 nonattainment area but is simply clarifying the description of this partial county area and amending the applicable table in 40 CFR 81.305 accordingly.

EPA is publishing this rule without prior proposal because we view this as a non-controversial action and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if relevant adverse comments are received. This rule will be effective on May 20, 2013 without further notice unless we receive adverse comments by April 18, 2013. If we receive adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now.

This action simply clarifies the description of an existing air quality planning area and would not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

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

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

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

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

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

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

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

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

In addition, this action does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the action simply clarifies the description of existing air quality planning area and thus will not impose substantial direct costs on Tribal governments or preempt Tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 20, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

According to the Centers for Medicare & Medicaid Services (CMS) data, as of October 2011, there were 15,720 long-term care (LTC) facilities (commonly referred to as nursing homes) in the United States. These facilities are generally referred to as skilled nursing facilities (SNFs) in the Medicare program and as nursing facilities (NFs) in the Medicaid program. For the past decade, CMS Survey and Certification Tabulation of Certification and Survey Provider Enhanced Reporting (CASPER) data have shown a decline in the number of nursing homes, from 17,508 in 1999 to 15,720 in 2011. In 2010, there were 141 nursing home closures. In 2011, there were 90 closures.

LTC facility closures have implications related to access to care, the quality of care, availability of services, and the overall health of residents. Therefore, having an organized process that facilities must follow in the event of a nursing home closure will protect residents' health and safety, and make the transition as smooth as possible for residents, as well as family members and facility staff.

On February 18, 2011, we published in the Federal Register an interim final rule with comment period, entitled “Requirements for Long-Term Care (LTC) Facilities; Notice of Facility Closure” (76 FR 9503). In that rule, we revised the current requirements for LTC facilities under the provisions of section 1128I(h) of the Social Security Act (the Act), as added by section 6113(a) of the Patient Protection and Affordable Care Act (Pub. L. 111-148, March 23, 2010)(Affordable Care Act). The new statutory provision requires us, among other things, to impose sanctions on the administrator of an LTC facility for failure to provide proper notice to specified parties, including CMS, that the facility is about to close.

Sections 1819(b)(1)(A) of the Act for SNFs and 1919(b)(1)(A) of the Act for NFs both state that a SNF/NF must care for its residents in a manner and in an environment that will promote maintenance or enhancement of the quality of life of each resident.

Sections 1819(c)(2)(A)(vi) and 1919(c)(2)(A)(vi) of the Act state that in general, with certain specified exceptions, a SNF/NF must permit each resident to remain in the facility and must not transfer or discharge the resident from the facility, except under specified circumstances, including, at clause (vi), when the facility ceases to operate.

As described in detail in the preamble of the February 18, 2011 interim final rule, section 6113 of the Affordable Care Act added subsection 1128I(h) to the Act, setting forth certain requirements for LTC facility closures, effective March 23, 2011. We issued this rule in the form of an interim final rule because we believed delaying implementation would continue to cause unjustified harm to LTC facility residents, families and visitors, and to meet the March 23, 2011 statutory deadline for implementation (76 FR 9508).

In the February 18, 2011 interim final rule, we discussed our goal of addressing health care disparities (76 FR 9505). We noted that research has extensively documented the pervasiveness of vulnerable populations which can be defined by race/ethnicity, socioeconomic status, geography, gender, age, disability status, sexual orientation, and other factors. Although there has been much attention at the national level to ideas for reducing health disparities in vulnerable populations, we remain vigilant in our efforts to improve health care quality for all persons by improving health care access and by eliminating real and perceived barriers to care that may contribute to less than optimal health outcomes for vulnerable populations.

We specifically requested comments in regard to how our revised LTC facility closure requirements could be used to address disparities among facility residents.

The comments we received on this provision and our responses are set forth below.

Comment: Several commenters encouraged CMS to review a number of policies and make changes that would have a positive impact on health disparities. One commenter encouraged CMS to review disparate treatment of all the populations that were identified in the preamble of the regulation and provide the appropriate information and support that would improve access to culturally competent care, language access, legal and counseling services. The commenter suggested that CMS also work with the patient advocacy community.

Another commenter suggested that CMS examine all of the facilities owned by the provider to determine whether there are differences in the quality of care provided, including significant differences between predominantly Caucasian and predominantly minority facilities.

Other commenters suggested that CMS should require more monitoring of facility finances, following up on all indicators of financial problems through special surveys of compliance and financial audits. It was also suggested that the concentration of Medicaid beneficiaries in a small number of facilities would be reduced if CMS clarified that financial screening is illegal under existing law. Another commenter recommended CMS issue new guidance to State Survey Agencies of existing conditions of participation that prohibit discriminatory admissions practices and provide training for State Survey Agencies on how to identify discriminatory practices by facilities.

Response: We appreciate the comments received on this very important issue. CMS is committed to addressing health care inequalities for racial and ethnic minorities that rely on Medicare and Medicaid for quality health care. We will consider these comments in the development of future regulations.

In response to the February 18, 2011 interim final rule, we received 15 public comments. Interested parties that submitted comments included individuals, advocacy organizations, and industry associations. In this final rule, we provide a summary of each provision, a summary of the public comments received and our responses, and any changes to the interim final rule we are implementing as a result of comments received.

We revised § 483.12(a)(5)(i), Timing of the Notice, to accommodate the closure notice provisions of § 483.12(a)(8) and § 483.75(r)(1)(i). The February 18, 2011 interim final rule requires the administrator of a facility to provide written notification of a facility's closure to specified individuals, including facility residents, at least 60 days prior to the date of a voluntary closure. This 60-day notice requirement is an exception to the general 30-day advance notice requirement governing transfer and discharge of individual patients from an LTC facility. The comments we received on this provision and our responses are set forth below.

Comment: One commenter requested clarification regarding the interaction between existing State policies (where applicable) and Federal regulations when the State requires no less than 60 days notice. The commenter stated that many States already have notification of closure requirements in place, and expressed concern that in those States, a nursing facility administrator will be required to complete two notifications: one consistent with State law and regulations and one consistent with Federal law and regulations.

Response: Only one notification would be required by this regulation, either 60 days prior to closure for voluntary closures or as the Secretary determines appropriate for involuntary closures. CMS does not have authority over State licensure, health, reporting, or facility requirements. However, according to § 488.3(b)(3), any time a State law applicable to providers or suppliers of Medicaid services in that State is more stringent that the Federal requirements, as is hypothesized here, CMS must enforce the more stringent State requirement as a condition of Medicare payment. For example, if the State law requires the administrator of a NF participating in its State Medicaid program to provide a 90-day notice of closure, the administrator would provide 90 days notice, since it is more stringent for compliance with Federal law. Failure to do so would put both its Medicaid and Medicare payments at risk. We also note that regardless of whether State or Federal regulations provide for a longer notification period, no-preemption issue arises because a facility complies with both laws by complying with the longer notification period.

We added a new § 483.12(a)(8) to require that, in the case of a facility closure, any individual who is the administrator of the facility must provide written notification prior to the impending closure to the Secretary, the State LTC ombudsman, the residents of the facility, and the legal representatives of the resident or other responsible parties, as well as provide a plan for the transfer and adequate relocation of the residents, in accordance with the new section § 483.75(r). As discussed in detail below, in section III. B of this preamble, we have revised § 483.12(a)(8) to conform with changes to § 483.75(r). The comments we received on this provision and our responses are set forth below.

Comment: One commenter suggested that in the final rule, the LTC facility be required to notify the medical director, attending physicians and other clinicians who regularly provide healthcare services within the LTC facility of that facility's closure.

Response: We appreciate the commenter's suggestion; however, we do not consider it necessary to provide additional language in the final rule regarding notices to physicians and/or other clinicians providing services to the resident. We believe this issue is sufficiently addressed in § 483.12(a)(3)(i), “Documentation,” which requires that when a facility transfers or discharges a resident, the resident's clinical records must be documented and the documentation must be made by the resident's physician. Therefore, a resident's physician and/or other practitioners would have received notice of the impending closure because they are required to be involved in the discharge plan for the resident. We will incorporate language into the State Operations Manual (SOM) to specify that a resident's practitioner(s) must be involved as soon as the notice of closure has been sent to the residents to assure, as stated in § 483.75(r)(3), that the residents would be transferred to the most appropriate facility or other setting in terms of quality, services and location, taking into consideration the needs, choice, and best interests of each resident.

We added a new paragraph (r) to § 483.75, which requires any individual who is the administrator of the facility to submit to the Secretary, the State LTC ombudsman, residents of the facility, and the legal representative of such residents (or other responsible parties) written notification of an impending closure at least 60 days prior to the date of closure; or, in the case of a facility where the Secretary terminates the facility's participation in the Medicare and/or Medicaid programs, no later than the date that the Secretary determines appropriate for such notification. The language of this paragraph parallels that of section 1128I(h) of the Act, as added by section 6113(a) of the Affordable Care Act. The comments we received on this provision and our responses are set forth below.

Comment: The majority of commenters supported the February 18, 2011 interim final rule, stating that they believe the rule would improve resident notification and facility planning, and would ensure a smooth relocation of LTC facility residents in the event of a facility closure or relocation.

Response: We appreciate the support from the commenters on this rule. We believe that having a requirement that establishes an organized process that facilities must follow in the event of an LTC facility closure protects residents' health and safety, and makes the transition as smooth as possible for residents, family members and facility staff.

Comment: A few commenters recommended that the final rule define the term “closure.” Another commenter suggested specific changes to the language in § 483.75(r)(1). The commenter suggested that we revise the regulation to require that the administrator submit, “written notification of an impending closure whenever 10 or more residents are likely to be transferred due to any voluntary or involuntary change in the status of the license or operation of a facility, including but not limited to, a facility closure or voluntary or involuntary termination of a facility's Medicaid or Medicare certification.” One commenter recommended that an exception be made to the requirement of written notification for unplanned events, such as a fire, major storms, or flooding.

Response: For the purpose of this regulation, “closure” means an LTC facility that ceases to operate under § 483.12(a)(2)(vi), and therefore, is no longer providing care and services to residents. We believe that the notification requirements should be met regardless of the number of residents likely to be transferred. We do not believe that establishing criteria for a minimum number of residents that must be affected before the notice requirements apply promotes the highest quality of care during what can be a difficult situation. We believe that all residents should be made aware of a facility closure in a reasonable amount of time, regardless of the size of the facility, as this regulation currently requires.

Regarding unplanned events, current regulations at § 488.426(a), “Transfer of residents,” or closure of the facility and transfer of residents, gives a State the authority to transfer Medicare and Medicaid patients out of a facility (temporarily or permanently) in emergency situations. If the State orders the temporary relocation of residents during an emergency, with the expectation that the residents will return to the facility, this would not be regarded as a facility closure under this requirement and the notification requirements under § 483.75(r) would not be applicable. For example, if a facility's air conditioning failed during a heat wave, the State could order the facility to relocate all of its residents while the problem was being investigated, without closing the facility.

Comment: One commenter suggested that the final rule allow for a longer notification period for residents and their families, as well as others, in the case of an involuntary closure. A longer notice period would give family members time to consider whether a home and community-based setting would better meet the LTC facility resident's needs than placement in another LTC facility. The commenter further recommended that, to the extent possible, the closure notification requirement for involuntary terminations should be at least 60 days in advance of closure, consistent with the rule for voluntary closures, or at a minimum, 30 days, consistent with the transfer/discharge provisions at § 483.12(a)(5)(i), unless there is an immediate threat to the health and safety of residents that necessitates a shorter notification timeframe.

Response: This regulation does not preclude a facility from providing a longer notification period if it chooses. Only the State has the authority to close a facility. CMS has authority to terminate provider agreements and thereby Medicare payments, as well as the Federal Medicaid matching payment to the State. In this case, the notification requirements are determined by the Secretary in collaboration with the State. In the preamble of the February 18, 2011 interim final rule, we provided background information regarding how the Secretary may determine a date for notification (76 FR 9506).

Additionally, § 483.75(r)(3) requires that the administrator include in the written notification of closure assurances that the residents would be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident. We believe that this requirement sufficiently addresses the commenter's concern about ensuring that the resident's needs are successfully met upon relocation to another facility or location.

Comment: One commenter suggested that in addition to State's approving the closure plan prior to notification and overseeing closures, LTC facility administrators should also be required to send the notice directly to the State Survey Agencies.

Response: We agree with the commenter that the written notification should also be given to the State Survey Agency. The State Survey Agency acts on the behalf of the Secretary and the intent of the February 18, 2011 interim final rule was to ensure that the notification went to the State Survey Agency. Therefore, we are revising the regulation at § 483.75(r)(1) to clarify that any individual who is the administrator of the facility must submit to the State Survey Agency, the State LTC ombudsman, residents of the facility, and the legal representatives of such residents or other responsible parties, written notification of an impending closure. As noted above, we have also revised § 483.12(a)(8) to clarify that the written closure notification must be submitted to the State Survey Agency.

At § 483.75(r)(2), we require any individual who is the administrator of the LTC facility to ensure that the facility does not admit any new residents on or after the date, which such written notification of facility closure is submitted to the Secretary, the State LTC ombudsman, and the residents, and/or their representatives or other responsible parties.

We did not receive any public comments regarding this requirement; therefore, we are finalizing § 483.75(r)(2) as published in the interim final rule.

At § 483.75(r)(3), we require that any individual who is the administrator of an LTC facility include in the written notice of closure, a plan that has been approved by the State for the transfer and adequate relocation of the residents by a date that must be specified by the State prior to closure. The plan must include assurances that the residents will be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident.

In the preamble of the February 18, 2011 interim final rule, we expressed our expectation that the closure plan would include sufficient detail to identify clearly the steps the facility would take, and would specify the individual responsible for ensuring the steps were successfully carried out (76 FR 9507). We note that we inadvertently omitted language regarding the statutory requirement at section 1128I(h)(1)(C) of the Act for State approval of the plan. We are correcting the language accordingly in section § 483.75(r)(3) of the regulations text in this final rule. The comments we received on this provision and our responses are set forth below.

Comment: Several commenters suggested that the final rule include regulations text specifying the minimum requirements for the facility closure plan, including information on transfer and discharge rights.

Response: We appreciate the commenter's suggestion; however, we do not believe it is necessary to include specific requirements for the plan in the regulation text. We want to allow each LTC facility the flexibility to develop a plan that would most effectively protect the residents' health, safety, and well-being. We note that we included detailed examples of elements of a closure plan in the preamble of the February 18, 2011 interim final rule (76 FR 9507). In addition, we intend to issue further guidance regarding the elements of a closure plan subsequent to the publication of this final rule.

Comment: One commenter recommended that CMS require the facility administrator to share the required relocation plan with residents and family members, as well as making it available upon request and/or publish the plan on State government nursing home information Web sites.

Response: We appreciate the commenter's suggestion. However, we do not believe that sharing the facility's relocation plan with residents would be appropriate, since the plan includes information that does not directly pertain to the health, safety, and well-being of the residents (for example, continuation of appropriate staffing levels and paychecks at the facility; method for communicating with staff and/or unions; and ongoing provision of necessary supplies, for example, food, linens, and utilities). The facility must meet its obligation set out at existing § 483.12(a)(4), “Notice before transfer,” to provide notice to the resident before the transfer or discharge of the resident. Our requirements at existing § 483.12(a)(6), “Contents of the notice,” specifically set out what must be included in the notice of transfer given to residents and, if known, a family member or legal representative. Since the transfer and discharge requirements are tailored specifically to each resident's unique needs, we believe that the required information will sufficiently address the commenter's concerns.

Additionally, the Nursing Home Compare Web site is a tool available to individuals looking for updated comparative information regarding functioning LTC facilities; this information can be utilized during the relocation process, and is available online at: http://www.medicare.gov/nhcompare/include/datasection/questions/proximitysearch.asp?bhcp=1 .

Comment: Some commenters expressed concern that CMS was requiring the facility closure plan to include a commitment to retain and pay employees at the facility until it was closed (76 FR 9507). In particular, the commenters were concerned that the administrator might be held accountable for civil monetary penalties for any failure to adequately staff and pay employees. The commenters observed that unless the facility administrator was also the owner, the administrator generally would not have authority over, or access to, the funds that would be used to pay staff.

Response: While we expect the LTC facility administrator will be able to identify the necessary steps for a successful transfer of the residents, we note that the contents of the closure plan described in the preamble of the February 18, 2011 interim final rule were examples, not requirements (as incorrectly characterized by the commenter). Additionally, as mentioned in the preamble of the February 18, 2011 interim final rule, we expect that the closure plan include sufficient detail to clearly identify the steps the facility would take, and the individual responsible for ensuring the steps are successfully carried out, such as continuation of appropriate staffing levels, and paychecks at the facility. We intend to provide more detail on the contents of the closure plan in the interpretive guidance.

Comment: Several commenters requested clarification as to how a resident would be assessed for transfer to either an LTC facility or other community and home-based settings. Additionally, one commenter requested clarification regarding what would happen if admission to any of the settings deemed most appropriate for the resident were denied.

Response: We believe existing requirements at § 483.20(l), “Discharge summary,” should sufficiently address the commenter's concerns regarding how a resident would be assessed for transfer. According to those requirements, when the facility anticipates discharge, a resident must have a discharge summary that includes a final summary of the resident's status to include the elements in the comprehensive assessment of a resident's needs located in § 483.20(b). Section 483.20(l) also requires a post-discharge plan of care to be developed with the participation of the resident and his or her family. The plan of care will assist the resident with adjusting to his or her new living environment.

Additionally, § 483.75(r)(3) requires the LTC facility to include in the notice, the plan for the transfer and adequate relocation of the residents of the facility by a date that would be specified by the State prior to closure, that has been approved by the State, including assurances that the residents would be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident. If admission to any of the settings deemed most appropriate for the resident were denied, the facility would still be responsible for locating another setting comparable in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of the resident, in order to comply with the requirements of this regulation.

Comment: One commenter recommended that CMS require that SNFs and NFs give residents, to the extent possible, an opportunity to visit facilities in advance so that they can choose the facility they would like to move.

Response: This regulation does not prohibit residents of a SNF or NF from visiting other facilities in advance. Additionally, existing regulations at § 483.12(a)(7), state that a facility must provide sufficient preparation and orientation to residents to ensure safe and orderly transfer or discharge from the facility. The facility should actively involve, to the extent possible, the resident and the resident's family in selecting the new residence. Some examples of orientation may include trial visits, if possible, by the resident to a new location; orienting staff in the receiving facility to the resident's daily patterns; and reviewing with staff routines for handling transfer and discharges in a manner that minimizes unnecessary and avoidable anxiety or depression for the resident.

Comment: One commenter suggested that the facility's closure plan include a requirement to ensure that other nursing homes, including those owned by the same company as the facility that is closing, do not have access to a resident's record in order to “cherry pick” private pay residents or those with lighter care needs. Additionally, one commenter suggested that the facility's closure plan include information on how residents may contact the State's long-term care ombudsman and access CMS's Nursing Home Compare Web site since the updated data planned for the site will increase its value as a tool for residents to select an alternate nursing home in the event of a facility closure.

Response: The selection of an alternate facility is a decision collectively made by the resident (or their responsible party) and the care planning team. We believe that the provision at § 483.75(r)(3), which requires the written notice to assure residents that they will be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident, adequately addresses the commenter's concerns. In addition, to ensure that the residents' rights are protected, § 483.75(r)(1) requires the ombudsman to be contacted as part of the closure notice. Under the Federal Older Americans Act, every State is required to have an Ombudsman Program that addresses complaints and advocates for improvements in the LTC system ( http://www.ltcombudsman.org/ ).

Comment: Several commenters offered suggestions to CMS on what should be included in the SOM regarding the implementation guidelines for this regulation. One commenter suggested that CMS include in the SOM that nursing home residents displaced due to a facility closure be provided with information about and access to home and community-based setting options as appropriate.

Another commenter suggested that CMS provide additional guidance to State Survey Agencies regarding how to use monitors and temporary managers more effectively in facility closure situations. Additionally, one commenter recommended that the SOM should include guidance related to timeframes for completion of all paperwork assuring successful resident relocation. Another commenter recommended that CMS include guidance regarding post-transfer assessments of the residents' emotional health. The commenter stated that an assessment would ensure that evaluating the success of the residents relocation would not be limited to the mere physical move itself, but would also consider the residents' psychosocial adjustment.

Response: We appreciate the commenters' suggestions regarding guidance for surveyors. We will consider these comments when making changes to the interpretive guidance.

At § 483.75(s), we require that the facility have in place policies and procedures that will ensure the administrator's duties and responsibilities involve providing the appropriate notices in the event of a facility closure. In the preamble to the February 18, 2011 interim final rule, we noted that the facility will not be sanctioned for noncompliance with this rule; however, it may be cited for a deficiency during the survey process (76 FR 9507). We are finalizing these provisions as set forth in the interim final rule.

The comments we received on this provision and our responses are set forth below.

Comment: One commenter suggested that CMS withdraw § 483.75(s) from the final rule due to its inconsistency with the Congressional intent, which is to hold the administrator, not the facility, accountable for failure to provide proper notification in advance of a facility closure. Alternatively, a few commenters suggested that the final rule should establish a process for sanctioning facility owners in addition to administrators who do not comply with the closure provisions. Some commenters suggested that the provision was unnecessary because when a facility decides to close, the rule requires the administrator to prepare the closure plan and seek appropriate approvals, regardless of whether the facility has policies and procedures.

Response: As we stated in the preamble of the February 18, 2011 interim final rule, while this provision is not explicitly required by section 1128I(h) of the Act, we believe that it is implicitly authorized by this section of the Act, which set forth requirements for LTC facility closures. Moreover, issuance of this regulatory provision is permitted by the general rulemaking authority of sections 1819(d)(4)(B) and 1919(d)(4)(B) of the Act, which explicitly permits the Secretary to issue rules relating to the health, safety, and well-being of residents, as well as rules concerning physical facilities. Additionally, § 483.75(d), Governing body, requires the facility to have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing polices regarding the management and operation of the facility. Therefore, the facility is responsible for the overall functioning of the LTC facility, though it will not be sanctioned for noncompliance with this rule, a facility that does not meet the requirements at § 483.75(s) could be cited for a deficiency during the survey process. We continue to believe this level of added protection will ensure that the intent of the Congress is implemented and that residents receive adequate notice before a facility closure.

We revised § 488.426, Transfer of residents, or closure of the facility and transfer of residents, at § 488.426(b) to include a cross-reference to the new requirements at § 483.75(r). We also added a new requirement at § 488.426(c) to address the required notifications when a facility closes. We are finalizing these provisions set forth in the interim final rule.

The comments we received on this provision and our responses are set forth below.

Comment: A few commenters mentioned that the Affordable Care Act requires the notices issued by administrators to include a closure plan that has been approved by the State; however, the regulation does not establish any process for State review and action on facility closure plans. It was suggested that the final rule establish these procedures under which States would review and act on proposed closure plans. The commenter suggested that CMS prescribe in regulations (rather than through sub-regulatory guidance in the SOM) that States will be required to ensure safe relocation of residents following their facility's closure and that CMS has authority to enforce the requirements directly.

Response: Section 1128(h)(1)(C) of the Act states any individual who is the administrator of a facility must include in the notice a plan for the transfer and adequate relocation of the residents of the facility by a specified date prior to closure that has been approved by the State, including assurances that the residents will be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident. In accordance with the statute, States are required to approve the plan. We expect the State Survey Agency to manage the approval process. Thus, we do not believe it is necessary to add these requirements to the regulation, but will address it in the SOM. In this final rule, we have revised the language at § 483.75(r)(3) of the regulations text to incorporate the explicit requirement. The regulation text will now read, “Include in the notice the plan, that has been approved by the State, for the transfer and adequate relocation of the residents of the facility by a date that would be specified by the State prior to closure, including assurances that the resident would be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident.”

As required by section 6113 of the Affordable Care Act, we added a new § 488.446, which will potentially subject to sanctions any administrator of a facility that fails to comply with the requirements at § 483.75(r). We are finalizing these provisions as set forth in the interim final rule. The comments we received on this provision and our responses are set forth below.

Comment: Several commenters had concerns that an owner of a nursing facility could arrange for the closure of the facility after the prescribed timeframe for notification, without knowledge or involvement of the administrator, thus exposing the facility administrator to the sanction when they were not aware of the owner's plans to close the facility. Additionally, commenters requested that CMS consider waiving sanctions for administrators that are hired after the decision is made to close a facility.

Response: We agree with the commenters that the administrator may encounter a situation where adequate time to submit a notification of closure to the specified entities, as required by § 483.75(r)(1), was not given. In some cases, an administrator may not have had control over implementing the notice procedures. For example, an administrator may have been hired to oversee the facility's impending closure, although he or she was not present when the decision was made to close the facility. The administrator may have been employed less than 60 days prior to closure. Another possibility is that the facility owner may not have even informed the new administrator of plans to close the facility. However, the lack of previous involvement does not relieve the administrator (at the time of closing) of the responsibility for implementing the plan and the procedures as required to the extent possible. In these instances, the administrator would be expected to provide the closure notice as soon as possible and begin implementing the plan for closure, working with the State Survey Agency for transferring the residents. The administrator hired to assist with closure would be expected to implement the closure plan and work closely with the State and CMS to assure that appropriate procedures were implemented. From the time that the administrator was made aware of the closure, he or she would be responsible for compliance with this regulation.

Additionally, while it was not mandated by the Affordable Care Act, we have added § 498.5(m), which allows for appeal rights of an individual who is the administrator of a SNF or NF. Therefore, if an individual who is the administrator of a SNF or NF is dissatisfied with the decision of CMS to impose sanctions, he or she would be entitled to a hearing before an Administrative Law Judge (ALJ), to request the Departmental Appeals Board review of the hearing decision, and to seek judicial review of the Board's decision.

Comment: A few commenters expressed concerns about the Civil Monetary Penalty (CMP) levels being too low, considering that section 6113 of the Affordable Care Act permits fines of up to $100,000 and subsequent exclusion from participating in any Federal healthcare programs and suggested increasing the minimum penalty. Another commenter recommended enforcing CMPs from $100.00 up to $1,000.00, multiplying the amount of the CMP by the number of residents who were admitted after written notice of closure was provided to the State. Another commenter suggested that those facilities that committed multiple offenses should incur all penalties to the fullest extent possible, while another commenter requested clarification and/or criteria for what would constitute multiple offenses that would result in increased amounts of CMPs.

Response: We believe that the Congress intended for CMS to use sanctions as a method to ensure that the statutory requirements are enforced. The statutory language that was enacted stated “up to $100,000.” This language established a maximum limit, but afforded CMS the discretion to determine the actual amount of the sanctions. Due to the many possible combinations of violations that could be cited, the amount of the penalty will be determined based on the survey findings. For example, if it is determined that an administrator of record completely fails to take the necessary and timely actions to adhere to the closure requirements, thus potentially causing harm to residents, then the administrator could be subject to additional CMPs. Any sanctions that have been levied against an administrator could also be reviewed by the State's licensing agency for possible disciplinary action, including suspension or termination of the administrator's license, in those States that provide for the licensing of LTC facility administrators. Interpretive guidelines are being developed that will establish criteria for determination of its CMP amounts.

Comment: One commenter suggested that CMS and State licensing agencies consider sharing a percentage of any resultant CMP proceeds with any parties that may have directly been injured because of failures to notify and/or plan for relocation,

Response: Existing requirements at § 488.433, “Civil money penalties: Uses and approval of civil money penalties imposed by CMS,” state that 10 percent of the collected CMP funds that are required to be held in escrow and that remain after a final administrative decision will be deposited with the Department of Treasury. The remaining 90 percent of the collected CMP funds that are required to be held in escrow and that remain after a final administrative decision may not be used for survey and certification operations, but must be used entirely for activities that protect or improve the quality of care for residents. These activities must be approved by CMS and may include, but are not limited to: support and protection of residents of a facility that closes, time-limited expenses incurred in the process of relocating residents to home and community-based settings or another facility when a facility is closed or downsized pursuant to an agreement with a State Medicaid agency, facility improvement initiatives approved by CMS, such as, joint training or facility staff and surveyors or technical assistance for facility implementing quality assurance and performance improvement program, when facilities have been cited by CMS for deficiencies in the applicable requirements. While the collected CMPs are not dispersed to the affected parties directly, the money will be used to protect and improve the quality of care for residents. Therefore, we believe they ultimately will derive benefits from the collected CMP funds.

Comment: A few commenters requested clarification regarding what would constitute “unjustified harm” to the resident, family, and visitors, as mentioned in the preamble to the February 18, 2011 interim final rule with comment period cited as a justification for harsher administrator sanctions (75 FR 9507). One commenter stated that it was not clear how or why the administrator would have any legal obligation to third parties such as family members or visitors. A commenter suggested that we remove the language in the preamble suggesting that the administrator could be subject to additional CMPs if it was determined that family members and visitors of the resident experienced “unjustified harm” (75 FR 9507).

Response: We are clarifying that it was not our intention to make an LTC facility administrator personally liable to family members and visitors for harm resulting from a failure to notify. We used a technical term to describe deficiencies; however, this terminology does not create either a Federal or State standard of care. We do not believe that any level of harm, whether based on intent or negligence, is acceptable.

We revised § 488.450 by adding a new requirement to provide that, in the case of a facility closure, the Secretary may, as appropriate, continue to make payments under this title with respect to residents of an LTC facility that has submitted a notification of closure, during the period beginning on the date such notification is submitted and ending on the date, which the resident is successfully relocated. We note that in this final rule, we are correcting a typographical error in the regulations text. The provision in section § 488.450(c)(2) will now read, “ * * * ending on the date on which the residents are successfully relocated.”

The comments we received on this provision and our responses are set forth below.

Comment: One commenter suggested that CMS provide a procedure for residents, their representatives, citizen advocacy groups, and the State LTC ombudsman to comment on when payments can be terminated.

Response: We appreciate the commenter's concern regarding termination of payment in the event of a facility closure. However, we do not believe that any changes in this aspect of the rule are needed because the statute and our regulatory requirements address the concerns of the commenter. Section 1128I(h)(3) of the Act and requirements at § 488.450(c), authorize the Secretary to continue to make payments with respect to residents of an LTC facility that has submitted a notification of closure during the period beginning on the date such notification is submitted to CMS and ending on the date on which all residents are successfully relocated. Therefore, CMS will determine, as appropriate, whether to continue to make payments with respect to residents of an LTC facility that has submitted a notification of closure as required at § 483.75(r). We believe this matter is purely operational and not amenable to the discretion implied by an opportunity for public comment. If residents have concerns regarding a facility closure and relocation process, we would encourage them to make their concerns known to the State LTC Ombudsman.

We revised § 489.52(a)(1) to provide an exception for SNFs, and by adding a new requirement specific to SNF notifications to CMS. Specifically, at § 489.52(a)(2), we specify that a SNF provider that wishes to terminate its agreement must send CMS written notice of its intent at least 60 days prior to the date of closure, in accordance with § 483.75(r)(1)(i).

We did not receive any public comments regarding this provision. Therefore, we are finalizing the revisions of § 489.52(a)(2) as set forth in the interim final rule.

We added a new requirement at § 489.53(d)(3), to state that when CMS terminates a facility's participation under Medicare or Medicaid, CMS will determine the date of the required notifications. We also revised § 489.53(d)(1) to reflect this change.

We did not receive any public comments regarding this provision. Therefore, we are finalizing § 489.53(d)(1) and (d)(3) as set forth in the interim final rule.

We added a new requirement at § 489.55 that authorizes the Secretary to continue to make payments to the SNF or, for a NF, to the State, as the Secretary considers appropriate, during the period beginning at the time the notification is submitted and until the resident is successfully relocated. In this final rule, we are correcting a typographical error in the regulations text at § 489.55(a)(1). The provision will now read, “Inpatient hospital services (including inpatient psychiatric hospital services) and post hospital extended care services * * * ”

The comments we received on this provision and our responses are set forth below.

Comment: A few commenters recommended CMS consider the role economic factors play in a decision to close, the potential impact of discontinued funding to resident care and services during the closure process, and to support ongoing policy for continued payment through the 60-day notice period or until the last resident is successfully relocated, whichever is earlier.

Response: We agree with the need to provide continued funding until all of the residents are successfully relocated. As stated in a previous response, section 1128I(h)(3) of the Act authorizes the Secretary to continue to make payments with respect to residents of an LTC facility that has submitted the required notification of closure to CMS.

We added a new requirement at § 498.3(a)(2)(iv) to clarify that CMS may also impose sanctions on NF administrators for noncompliance with § 483.75(r). We also added a new requirement at § 498.3(a)(3)(ii) to indicate that the appeals process applies to NFs as well as SNFs. In addition, a new requirement was added at § 498.3(b)(18) to indicate that a sanction imposed on a SNF or NF administrator for noncompliance with the requirements set out at § 483.75(r) constitutes an initial determination of the agency.

We did not receive any public comments regarding this provision. Therefore, we are finalizing the revisions at § 498.3(a)(2)(iv) as set forth in the interim final rule. However, we are correcting a typographical error at § 498.3(a)(3), to include, “(iii)” when referring to Part 488, subpart E (§ 488.330(e)) and subpart F (§ 488.446)—for SNFs and NFs and their administrators.

We added a new requirement at § 498.5(m), to establish appeal rights for administrator sanctions for noncompliance with the requirements set out at § 483.75(r).

We did not receive any public comments regarding this provision. However, we are making a technical correction at § 498.5(m) to include, “or NF” when referring to the appeal rights of an individual who is the administrator. We had included the term “NF” in the February 18, 2011 interim final rule's preamble language on this provision, but inadvertently omitted it from the corresponding regulations text.

We are adopting as final the requirements set forth in the interim final rule published in the Federal Register on February 18, 2011 (76 FR 9503), with the following changes:

• We are revising § 483.12(a)(8) and § 483.75(r)(1) to clarify that the facility must submit written notification of an impending closure to “the State Survey Agency” instead of “the Secretary”.

• We note that we inadvertently omitted language regarding the statutory requirement at 1128I(h)(1)(C) for State approval of the plan. We are correcting the language accordingly in section § 483.75(r)(3) of the regulations text in this final rule.

• We are correcting a typographical error in the provision regarding the period of continued payments at § 488.450(c)(2), which will now read, “ * * * ending on the date on which the residents are successfully relocated.”

• We are correcting a typographical error in the provisions regarding Exceptions to the effective date of termination at § 489.55(a)(1), which will now read, “Inpatient hospital services (including inpatient psychiatric hospital services) and post hospital extended care services * * * ”

• We are correcting a typographical error at § 498.3(a)(3), to include, “(iii)” when referring to Part 488, subpart E (§ 488.330(e)) and subpart F (§ 488.446)—for SNFs and NFs and their administrators.

• We are making a technical correction at § 498.5(m) to include, “or NF” when referring to the appeal rights of an individual who is the administrator. We included NFs in the preamble language and inadvertently omitted it from the regulation text.

• We inadvertently omitted a citation from all authority citations in the regulation text. We are correcting that error by adding “1320a-7j” to all authority citations.

Under the Paperwork Reduction Act of 1995, we are required to provide 30-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 requested public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):

The revisions at § 483.12(a)(8) require any individual who is the administrator of the facility to submit to the Secretary, the State LTC ombudsman, residents and their legal representatives, or other responsible parties, written notification of an impending closure at least 60 days prior to such closure; or not later than the date that the Secretary deems appropriate in the case of a facility where the Secretary terminates the facility's participation under this title.

Current regulations at § 483.12(a)(5) require notification of transfer or discharge to a resident and, if known, a family member or legal representative, in writing. Except in certain specified circumstances, notification must be made at least 30 days prior to transfer or discharge. Facility closure is not a circumstance that permits a facility to make notification in fewer than 30 days. Although the requirement extends the time period for notification from 30 days to 60 days (or a date determined by the Secretary in case of CMS termination of the facility), we do not believe the change in the time period for reporting imposes any additional burden. In addition, notification of transfer or discharge to residents and their representatives is already a usual and customary business practice. Therefore, in accordance with 5 CFR 1320.3(b)(2), we will not include this activity in the ICR burden analysis.

Although there are no existing Federal regulatory requirements for LTC facilities to notify other individuals or entities of an impending closure, according to feedback to CMS from State surveyors for LTC facilities, nearly all States already require LTC facilities to notify the State within 30 to 90 days. Because we have found that notifications of impending closure are a standard business practice for most LTC facilities, we believe that this requirement would impose burden on only a small number of facilities.

Each facility that does not already notify the State and the State LTC ombudsman must develop a process for notifying these entities. We estimate that the burden associated with complying with this requirement would be due to the resources required to develop a process for notifying the State and the State LTC ombudsman and the time it takes to notify those entities. We expect that the notification process would involve the administrator of the facility and administrative support person and an attorney to review the plan.

The revisions at § 483.75(r)(2) require that the administrator of the facility ensure that the facility does not admit any new residents on or after the date written notification is submitted. We do not anticipate any ICR burden associated with this requirement.

Section 483.75(r)(3) requires the administrator of the facility to include in the notice the plan for the transfer and adequate relocation of the residents of the facility by a date that is specified by the State prior to closure, that has been approved by the State, including assurances that the residents would be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident.

Section 483.75(s) requires the facility to have in place policies and procedures to ensure that the administrator's duties and responsibilities include the provision of the appropriate notices in the event of a facility closure.

In our experience, based on feedback to CMS from State surveyors of LTC facilities, most facilities already have plans for transfer of residents, regardless of whether closure of the facility is expected. For example, most facilities have plans for transfer of residents to another facility in the event of an emergency. Also, based on our experience, nearly all facilities anticipating closure develop plans for the relocation of residents and other closure-related activities. Many States require these plans. For example, Vermont requires that the State licensing agency and the LTC ombudsman be notified by the administrator of the facility 90 days prior to the proposed date of closure. Additionally, the facility administrator is required to provide to the State licensing agency and LTC ombudsman a written transfer plan 60 days prior to closure. See http://www.sph.umn.edu/hpm/nhregsplus/NH%20Regs%20by%20Topic/NH%20Regs%20Topic%20Pdfs/Admission/admission_transfer_and_discharge_rights_ALL_STATES.pdf.

Because we have found that transfer plans are a standard business practice for most LTC facilities, we believe that this requirement would impose burden on only a small number of facilities.

Each facility that does not already have a plan in place must develop a plan for the transfer and adequate relocation of residents of the facility. We estimate that the burden associated with complying with this requirement would be due to the resources required to develop and review a new plan or, if necessary, modify an existing plan for the transfer of residents in the event of facility closure. We expect that development of a plan would involve the administrator of the facility, an administrative support person, and an attorney to review the plan.

LTC facilities are currently required to have a plan under § 483.12 for discharge and transfer of residents. A facility must provide sufficient preparation and orientation to residents to ensure safe and orderly transfer or discharge from the facility. Therefore, we anticipate that, on average, it will take 3 hours to develop the plan, 1 hour to ensure that the administrator's duties include policies and procedures relating to facility closures, 2 hours for an administrative support person to prepare the document(s), and 1 hour for an attorney to review the document(s), for a total estimated burden of 7 hours per facility. We also believe that the burden would remain approximately the same for the first year and beyond.

Currently, there are 15,720 LTC facilities in the U.S. Based on an hourly rate of $58.17 for a nursing home administrator, we estimate that development of the plan and incorporating facility closure policies and procedures into the administrator's duties would cost $3,657,729.60 (15,720 facilities × 4 hours per facility) × $58.17 per hour). Based on an hourly rate of $20.11 for an administrative assistant, we estimate that preparing the plan documents would cost $632,258.40 ((15,720 facilities × 2 hours per facility) × $20.11 per hour). Finally, based on an hourly rate of $82.50 for an attorney, we estimate that reviewing the plan document would cost $1,296,900.00 ((15,720 facilities × 1 hour per facility) × $82.50 per hour). The salary estimates include 33 percent of the mean hourly rate for overhead and fringe benefits (Source: BLS.gov). Therefore, we anticipate that the total burden associated with this provision is $5,586,888.00 (15,720 facilities × 7 hours per facility at $355.40).

If you comment on these information collection and recordkeeping requirements, please submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, CMS-3230-F Fax: (202) 395-6974; or

Email: OIRA_submission@omb.eop.gov

Executive Order 13563 directs agencies to consider and discuss qualitatively values that are difficult to quantify, including equity, human dignity, fairness and distributive impacts. This final rule will implement section 1128I(h) of the Act (as amended by section 6113 of the Affordable Care Act), which mandates specific procedures in the event of a closure of a nursing home. LTC facility closure procedures have implications related to access to care, the quality of care, and the overall health of residents. These procedures help protect the resident, the resident's family, and visitors because they require the facility to provide an organized plan that allows the resident, family, and visitors to make the necessary adjustments within a reasonable time frame.

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

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A 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. We estimate that these requirements will cost $355.40 (5,586,888.00/15,720) per facility the first year and each year thereafter. Due to the increase in the number of long-term care facilities, we recalculated the economic impact of the February 18, 2011 IFC and have determined that it has slightly increased by $2,488 in total. (The number of long-term care facilities has increased slightly since publication of the interim final rule.) As a result, the economic impact for the February 18, 2011 IFC is $5,586,888.

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, most physician practices, hospitals, and other providers are small entities, either by nonprofit status or by qualifying as small businesses under the Small Business Administration's size standards (revenues of less than $7.0 to $34.5 million in any 1 year). States and individuals are not included in the definition of a small entity. For details, see the Small Business Administration's Web site at http://www.sba.gov/about-sba-services/7591 . 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 will cost $355.40 ($5,586,888.00/15,720 facilities) per facility initially and $355.40 ($5,586,888.00/15,720 facilities) thereafter. This clearly is far below 1 percent of total facility costs or revenues; therefore, we do not anticipate it to have a significant impact. We do not have any data related to the number of LTC facilities that have facility closure plans in place; however, we are aware through our experience with LTC facilities and the survey process that most facilities have a plan for closure either because they are required to have a plan in place at the State level or because of their understanding that this is a standard business practice.

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 604 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 only affect those institutions that meet the definition of a “facility” in section 1128I(a) of the Act; that is, SNFs and NFs. Therefore, the Secretary has determined that this final 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 2012, that threshold is approximately $139 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 $5,586,888.00 the first year and $5,586,888.00, thereafter. These estimates are derived from our analysis of burden associated with these requirements in section IV, “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.

1. Effects on LTC Facilities

The purpose of this final rule is to ensure that, among other things, in the case of a facility closure, any individual who is the administrator of the facility will provide written notification of the closure and the plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate. This rule will protect residents' health and safety and make the transition to closure as smooth as possible for residents, as well as family members and facility staff.

2. Effects on Other Providers

This rule is expected to allow for a smoother transition when a facility closes. It requires facilities and facility administrators to prepare in advance for closure so that, in the event of a closure, the facility is equipped to protect resident rights and continue to provide quality care to residents who must be relocated. This final rule will also improve coordination of care between the transferring LTC facility and the chosen destination setting. For example, if a resident is transferred from an LTC facility to a non-LTC facility such as an assisted living facility, we do not believe that non-LTC facilities would experience any increase in administrative burden as a result of these provisions. In fact, we anticipate that the receiving facility would benefit from increased coordination with the transferring LTC facility.

3. Effects on the Medicare and Medicaid Programs

This rule will require that the State and CMS be notified in the case of a facility closure and provides them with the ability to make determinations regarding the timing of termination of provider agreements and continuation of payments to LTC facilities. This rule will also support efforts directed toward broad-based improvements in the quality of health care furnished by Medicare and Medicaid providers.

We considered the effects of not addressing specific requirements for the notification of facility closures in LTC facilities, although these requirements are statutory and only allow limited discretion on the part of the Secretary. However, we strongly believe that to improve quality and ensure consistency in the provision of care in LTC facilities, it is important to ensure that residents rights are protected in LTC facilities and that they are relocated appropriately, taking into consideration the needs, choice, and best interest of each resident should a facility closure take place. We expect that these requirements will result in improvement in the quality of services provided to LTC residents when they need to be involuntarily relocated as a result of the closures.

This final rule ensures that, among other things, in the case of a facility closure, any individual who is the administrator of the facility provide written notification of the closure and the plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate.

It is consistent with the requirements set forth in section 6113 of the Affordable Care Act and the Administration's efforts toward broad-based improvements in the quality of health care furnished by Medicare and Medicaid providers.

This final rule clarifies the responsibility of the administrator of a facility (which is to ensure that the designated parties are notified of an impending closure within a specified timeframe), and identifies penalties for non-compliance. It also clarifies the responsibility of the administrator of the facility to ensure that no new residents are admitted after written notice is submitted and that the notice of closure must include a plan for transfer and adequate relocation to another facility. These facilities must take into consideration the needs, choice, and best interests of each resident.

In accordance with the provisions of Executive Order 12866, this regulation was not reviewed by the Office of Management and Budget.

Accordingly, the interim rule amending 42 CFR Parts 483, 488, 489, and 498, which was published at 76 FR 9503 on February 18, 2011, is adopted as final with the following changes:

This is a summary of the Order in PS Docket No. 07-287, DA 13-280, adopted on February 25, 2013, and released on February 25, 2013. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room, CY-B402, Washington, DC 20554. The full text may also be downloaded at: www.fcc.gov.

1. The Warning Alert and Response Network Act (WARN Act) required the Commission to adopt the technical requirements necessary for commercial mobile service providers to transmit emergency alerts, if they elect to transmit those alerts. In the rulemaking proceeding that the Commission launched to implement this WARN Act requirement, the Commission used the name Commercial Mobile Alert System (CMAS) to describe the system that commercial mobile service providers could use to transmit emergency alerts to the public. The regulations governing this system are codified in part 10 of the Commission's rules and also refer to this system as CMAS. Recently, however, an increasing number of the commercial mobile service providers that participate in the system are referring to it as Wireless Emergency Alerts (WEA) in the information that they provide to their subscribers.

2. In this Order, the Commission revises part 10 of its rules by changing the name “Commercial Mobile Alert System” to “Wireless Emergency Alerts” throughout the part and by changing references to “CMAS” to “WEA.” These revisions will conform the name used for the wireless alert system regulated under our rules to the name used by the major commercial mobile service providers that participate in that system. Accordingly, the rules will more accurately reflect common parlance and thus reduce confusion.

3. The revisions adopted in this Order and set forth below merely change the name of the commercial mobile alert service regulated under Part 10 of the Commission's rules. These revisions are thus ministerial, non-substantive, and editorial. Accordingly, the Commission found good cause to conclude that notice and comment procedures are unnecessary and would not serve any useful purpose.

4. Because the rule revisions will not affect the substantive rights or interests of any licensee, the Commission also found good cause to make these non-substantive, editorial revisions of the rules effective upon publication in the Federal Register.

5. The Commission's Public Safety and Homeland Security Bureau adopted this Order pursuant to its delegated authority to “conduct[] rulemaking proceedings” in matters pertaining to public safety and homeland security. Pursuant to § 0.392 of the Commission's rules, the Bureau Chief is “delegated authority to perform all functions of the Bureau, described in . . . § 0.191” with certain specified exceptions. None of those exceptions are present here.

6. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

7. Because the Commission adopted this Order without the publication of a notice of proposed rulemaking, the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., does not require the Commission to prepare a regulatory flexibility analysis.

8. Accordingly, it is ordered that, effective upon publication in the Federal Register, part 10 of the Commission's rules is revised, as set forth below, pursuant to the authority contained in sections 4(i), 5(c), and 303(r) of the Communications Act, 47 U.S.C. 154(i), 155(c), and 303(r), and §§ 0.231(b) and 0.392(e) of the Commission's regulations, 47 CFR 0.191(e) and 0.392.

9. It is further ordered that the Secretary shall cause a copy of this Order to be published in the Federal Register.

10. It is further ordered that the Bureau shall send a copy of this Order in a report to Congress and the Government Accountability Office pursuant to the Congressional Review Act. See 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR Part 10 as follows:

This is a synopsis of the Commission's Report and Order, MB Docket No. 11-207, adopted February 14, 2013, and released February 15, 2013. See also Notice of Proposed Rule Making and Order to Show Cause, 77 FR 2241, published January 17, 2012. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC 20554. This document may also be purchased from the Commission's duplicating contractors, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or via email www.BCPIWEB.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Governmental Accountability Office, pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

To accommodate the new allotment at Munds Park, the Bureau also substitutes Channel 281C for vacant Channel 247C at First Mesa, Arizona, at reference coordinates 35-41-09 NL and 110-21-43 WL. The reference coordinates for Channel 246C2 at Munds Park are 34-58-06 NL and 111-30-29 WL.

In comparing the new allotment at Munds Park and the proposed increase in existing service at Wickenburg, Arizona, the Bureau recognized that the Wickenburg proposal would provide a second full-time reception service to 264 persons. However, the Bureau found that this was de minimis and did not trigger Priority 2 of the FM Allotment Priorities. The Munds Park proposal was preferred over the Wickenburg proposal under Priority 4, other public interest matters. Although the increase in existing service at Wickenburg would provide third and fourth reception services to some underserved populations, the Bureau determined on balance that they do not outweigh the need for a second local or first competitive service at Munds Park.

As stated in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

This is a synopsis of the Commission's Report and Order, MB Docket No. 11-139, adopted February 21, 2013, and released February 22, 2013. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW., Washington, DC, 20554. This document will also be available via ECFS ( http://fjallfoss.fcc.gov/ecfs/ ). This document may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-478-3160 or via the company's Web site, http://www.bcpiweb.com . To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional review Act, see 5 U.S.C. 801(a)(1)(A).

The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, and cobia) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

On April 27, 2000, NMFS implemented the final rule (65 FR 16336, March 28, 2000) that divided the Florida west coast subzone of the Gulf eastern zone into northern and southern subzones, and established their separate commercial annual catch limits (ACLs), equal to commercial quotas. The 2012 to 2013 fishing year ACL (quota) for the hook-and-line component of the commercial sector for king mackerel in the southern Florida west coast subzone is 607,614 lb (275,609 kg) (50 CFR 622.42(c)(1)(i)(A)( 2 )( i )).

The Florida west coast subzone is that part of the eastern zone located south and west of 25°20.4′ N. lat. (a line directly east from the Miami-Dade/Monroe County, FL boundary) along the west coast of Florida to 87°31′06″ W. long. (a line directly south from the Alabama/Florida boundary). The Florida west coast subzone is further divided into northern and southern subzones. From November 1 through March 31, the southern subzone is designated as the area extending south and west from 25°20.4′ N. lat. to 26°19.8′ N. lat. (a line directly west from the Lee/Collier County, Florida, boundary), i.e., the area off Collier and Monroe Counties. Beginning April 1, the southern subzone is reduced to the area off Collier County, Florida, between 25°48′ N. lat. and 26°19.8′ N. lat.

On March 12, 2013, NMFS implemented a 500-lb (227-kg) trip limit for vessels in the hook-and-line component of the commercial sector for king mackerel in or from the EEZ in the southern Florida west coast subzone (78 FR 15642, March 12, 2013).

Under 50 CFR 622.43(a), NMFS is required to close any component of the king mackerel commercial sector when its ACL (quota) has been reached, or is projected to be reached, by filing a notification at the Office of the Federal Register. NMFS has determined the ACL (quota) for hook-and-line component of the commercial sector for Gulf migratory group king mackerel in the southern Florida west coast subzone will be reached by March 17, 2013. Accordingly, the hook-and-line component of the commercial sector for Gulf migratory group king mackerel in the southern Florida west coast subzone is closed effective 12:01 a.m., local time, March 17, 2013, through June 30, 2013, the end of the fishing year.

During the closure period, no person aboard a vessel for which a commercial permit for king mackerel has been issued may use hook-and-line gear to harvest or possess Gulf migratory group king mackerel in or from Federal waters of the closed subzone. There is one exception, however, for a person aboard a charter vessel or headboat. A person aboard a vessel that has a valid charter/headboat permit and also has a commercial king mackerel permit for coastal migratory pelagic fish may continue to retain king mackerel in or from the closed subzone under the 2-fish daily bag limit, provided the vessel is operating as a charter vessel or headboat. Charter vessels or headboats that hold a commercial king mackerel permit are considered to be operating as a charter vessel or headboat when they carry a passenger who pays a fee or when more than three persons are aboard, including operator and crew.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of the Gulf king mackerel resource and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds that the need to immediately implement this action to close the hook-and-line component of the commercial sector constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself already has been subject to notice and comment, and all that remains is to notify the public of the closure.

Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect the fishery since the capacity of the fishing fleet allows for rapid harvest of the ACL (quota). Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in effectiveness of the action under 5 U.S.C. 553(d)(3).

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.